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                                                       oft
                                                                                                                                                17
                                                                                                                                                2009
                                                                                                                                        PRINTED 03

DEPARTMENT OF HEALTH AND HUMAN SERVICE                                                                                                        FORM APPROVED
CENTERS FOR MEDICARE  MEDICAID SERVICES                                                                                                        0391
                                                                                                                                        OMB NO 0938

STATEMENT OF DEFICIENCIES               SUPPLIER
                                        CLIA
                                     X1 PROVIDER                                                                                        X3 DATE SURVEY
                                                                               X2 MULTIPLE CONSTRUCTION
AND PLAN OF CORRECTION                      IDENTIFICATION NUMBER                                                                             COMPLETED
                                                                               A BUILDING

                                                                               B WING
                                                   10D1062658                                                                                    03
                                                                                                                                                 16
                                                                                                                                                 2009

NAME OF PROVIDER OR SUPPLIER                                       STREET ADDRESS     CITY STATE ZIP CODE

SHORES PEDIATRICS                                                  9715 NE 2ND AVENUE
                                                                   MIAMI SHORES FL        33138

                      SUMMARY STATEMENT OF DEFICIENCIES                                              PROVIDER
                                                                                                     SPLAN OF CORRECTION
  X4 ID                                                                             ID                                                                        X5
 PREFIX            EACH DEFICIENCY MUST BE PRECEDED BY FULL                    PREFIX              EACH CORRECTIVE ACTION SHOULD BE                       COMPLETE
  TAG             REGULATORY OR LSC IDENTIFYING INFORMATION                     TAG             REFERENCED
                                                                                                CROSSTO THE APPROPRIATE                                      DATE
                                                                                                                  DEFICIENCY

    D 000    INITIAL COMMENTS                                                D 000




                                                                                                                                        r
             Surveyor      10530                                                                         I   jI                     q



             Recertification     Survey                                                                              IR
             State License 800022409


             Licensed and certified for

             Hematology

   D2000     493 ENROLLMENT AND TESTING OF
             801                                                             D2000
             SAMPLES


             Each laboratory must enroll in a proficiency

             testing PT program that meets the criteria in
             subpart I of this part and is approved by HHS
             The laboratory must enroll in an approved
             program or programs for each of the specialties
             and subspecialties for which it seeks
             certification The laboratory must test the
             samples in the same manner as patients
             specimens
                                                                                           I

             This Condition is not met        as   evidenced   by                              l
                                                                                               j
                                                                            V IM
             S urveyor 10530
                                                                                                                     e
                                                            test records
                                                                                               f
                                                                                               j
                                                                                               rG                           r

             Based    on   the absence of     proficiency
             from 2008 and 2009 and interview with the
             testing personnel     on     March 16 2009 at                                                                      L
                                                                                                                           Q
                            30
             approximately 11 am it was determined that
             the laboratory had performed patient Complete                                                                                         1r
                                                                                           Wkg         L
                                                                                                       l
                                                                                                       u
                                                                                                       GGLd
             Blood Count CBC testing since 2007 but there
             was no evidence that the laboratory had enrolled
                                                                                                                                d dyU
             in   an a pproved
                                 p roficienc y test pro g ram for CBC                                        i       h4 Sr S            y    2
             tes ti ng at any ti me i n 2008 an d 2009



             The    findings   showed



LABORATORY DIREC      OR OR PROVIDER REPRESENTATIVE SIGNATURE
                      S     SUPPLIER S                                                                       TITLE                                      X6   DATE



                         Jam       il     All      P   D 0                       holklD In
                                                                                  M                                   rn   riCY                   1       1a
 Any deficiency   statement ending with       ensk denot       a  deficiencywhichthe institution may be excused from correcting providing it is determined that
 other safeguards provide sufficient pr ection to the patients See instructions Except for nursing homes the findings stated above are disclosable 90 days
 following the date of survey whether or not a plan of corre   n is provided For nursing homes the above findings and plans of correction are disclosable 14




FORM CMS Previous Versions Obsolete
     02
     2567
     99                                                            021199
                                                                                                   B8QS11                                   If continuation sheet 1 of 13
                                                                                                                                      17
                                                                                                                                      2009
                                                                                                                              PRINTED 03
DEPARTMENT OF HEALTH AND HUMAN SERVICE                                                                                          FORM APPROVED
CENTERS FOR MEDICARE  MEDICAID SERVICES                                                                                               0391
                                                                                                                              OMB NO 0938

STATEMENT OF DEFICIENCIES           SUPPLIER
                                    CLIA
                                 X1 PROVIDER                          X2 MULTIPLE CONSTRUCTION                                X3 DATE SURVEY
AND PLAN OF CORRECTION                    IDENTIFICATION NUMBER                                                                     COMPLETED
                                                                      A BUILDING

                                                                      B WING
                                               1 OD1062658                                                                            16
                                                                                                                                      03
                                                                                                                                      2009

NAME OF PROVIDER OR SUPPLIER                               STREET ADDRESS   CITY STATE ZIP CODE

SHORES PEDIATRICS                                           9715 NE 2ND AVENUE
                                                           MIAMI SHORES FL      33138

                    SUMMARY STATEMENT OF DEFICIENCIES                                          PROVIDER
                                                                                               SPLAN OF CORRECTION
 X4 ID                                                                  ID                                                                          X5
 PREFIX           EACH DEFICIENCY MUST BE PRECEDED BY FULL            PREFIX                  EACH CORRECTIVE ACTION SHOULD BE                  COMPLETE
  TAG            REGULATORY OR LSC IDENTIFYING INFORMATION             TAG                REFERENCED
                                                                                          CROSSTO THE APPROPRIATE                                  DATE
                                                                                                           DEFICIENCY


  D2000   Continued From      Page    1                              D2000
                                                                                     4   id Itq 2mq
          The laboratory had no records including                                    le
                                                                                     fj
                                                                                     f               4             S    P
          completed enrollment forms or proof of
                                                                                             d PS   z
                                                                                                    e         Z 5i
                                                                                                              33
          enrollment for 2008 and 2009 Additionally the
          laboratory had no documentation such as graded
          test CBC results Coulter ACT Diff instrumen t
                                                               CM
          printouts or cop ies of com pleted result forms CLZt
          submitted toa p roficiency tet com pany showing

          CBC results for proficienc y test sam ples

          showing that it had participated in proficiency                                S
          testing at any time in 2007 2008 and 2009 The
          office manager and testing personnel verified                                  C5
                                                                                          c            C                    ZD6
          that the laboratory had performed patient CBC                                                                 4
                                                                                                                        G
                                                                                                                                        t
          testing since 2007 but had not enrolled in
          proficiency testing for CBCs in 2008 and 2009                                                S    c

  D2016   493 SUCCESSFUL
          803
          b
          c
          a                                                          D2016

          PARTICIPATION                                                                  J                              t4
                                                                                                                        1




                                                                                         V

          Each  laboratory performing nonwaived testing                                                        r   ti
                                                                                                                   CC

                                                                                                                       L
                                                                                         f
          must  successfully participate in a proficiency
          testing program approved by CMS if applicable
          as described in subpart I of this part for each

          specialty subspecialty and analyte or test in
          which the laboratory is certified under CLIA


          Except as specified    in   paragraph c      of this
          section if a laboratory fails to participate
          successfully in proficiency testing for a given
          specialty subspecialty analyte or test as
          defined in this section or fails to take remedial
          action when  an individual fails gynecologic

          cytology CMS imposes sanctions as specified
          in subpart R of this part


          If alaboratory fails to perform successfully in a
          CMS proficiency testing program for
          approved                                                               j
          the initial unsuccessful performance CMS may
          direct the laboratory to undertake training of its

          personnel or to obtain technical assistance or
          both rather than imposing alternative or principle


FORM CMS Previous Versions Obsolete
     2567
     02
     99                                                    021199
                                                                                             l38QS11                              If continuation sheet 2 of 13
                                                                                                                                         PRINTED        03
                                                                                                                                                        2009
                                                                                                                                                        17
DEPARTMENT OF HEALTH AND HUMAN SERVICE                                                                                                       FORM APPROVED
NTFRS FOR MFnICARF P MFnirAin SFRVIrFG
CF                                                                                                                                       nnnR Kin      n
                                                                                                                                                       gR
                                                                                                                                                       nQ
                                                                                                                                                       iQ1


STATEMENT OF DEFICIENCIES
                                             PROVIDER
                                             CLIA
                                             SUPPLIER                            X2 MULTIPLE CONSTRUCTION                                X3 DATE SURVEY
AND PLAN OF CORRECTION                      IDENTIFICATION NUMBER                                                                            COMPLETED
                                                                                 A BUILDING

                                                                                 B WING
                                                     10D1062658                                                                               03
                                                                                                                                              2009
                                                                                                                                              16
 NAME OF PROVIDER OR SUPPLIER                                      STREET ADDRESS    CITY STATE    ZIP CODE

SHORES PEDIATRICS                                                   9715 NE 2ND AVENUE
                                                                    MIAMI SHORES FL 33138

  X4 ID             SUMMARY STATEMENT OF DEFICIENCIES                              ID                 PROVIDER
                                                                                                      SPLAN OF CORRECTION                                   X5
 PREFIX          EACH DEFICIENCY MUST BE PRECEDED BY FULL                        PREFIX             EACH CORRECTIVE ACTION SHOULD BE                    COMPLETE
  TAG           REGULATORY OR LSC IDENTIFYING INFORMATION                         TAG              CROSSTO THE APPROPRIATE
                                                                                                   REFERENCED                                               DATE
                                                                                                                DEFICIENCY


   D2016   Continued From                   2
                                  Page                                          D2016                                                    r
                                                                                                                                             LV
                                                                                                         Q
           sanctions   except when          one or more      of the
           following   conditions exists
            1   Th ere i s i mme di atejeopardy to          pat i ent h ealth                 Gt
           and safety
           2 The laboratory fails to provide CMS or a CMS
                                                                                                                                               Z Gj
           agent with satisfactory evidence that it has taken
           steps to correct the problem identified by the
           unsuccessful proficiency testing performance
           3 The laboratory has a poor compliance history                                                           fed
                                                                                          MCI

           This Condition is not met            as   evidenced     by
           Surveyor      10530


           Based on the absence of proficiency surveys
                                                                                                              GcC
           records for 2007 and 2008 and interview with the
           office manager and testing personnel on March
                                     30
           16 2009 at approximately 11 AM it was                                                       E
                                                                                                       L
           determined that the         laboratory     was
                                                            performing
           pa ti en t C omp l e e Bl ood C oun t CBC tes ti ng
                               t
           during 2007 2008 and 2009 but had failed to
           participatein a proficiency testing program for
           these tests during any time in 2007 and 2008
                                                                                                       y
           The   findings   showed                                                                     P V            W           L
                                                                                                                                  if77

           The   laboratory      had   no   records such      as   graded                                                                     r

           test CBC    results Coulter ACT Diff machine
           printouts proficiency testing
           report forms     or
                                               program data input
                                 attestation statements submitted
                                                                                                      e
                                                                                                    lit
           to the                                                                                                         GC E
                  proficiency test program showing CBC
           results for proficiency test samples showing that
           it had participated in proficiency test at any time
           in 2007 and 2008
                                                                                                                          E
           The  testing personnel verified that the laboratory
                                                                                                                              C
           had performed patient CBC testing in 2007 and
           2008 but had not participated in a proficiency
                                                                                                                      tJp
                                                                                                                      c       G a41
                                                                                                                              n1
                               s
           testing program for CBC during 2007 and 2008




FORM CMS Previous Versions Obsolete
     02
     2567
     99                                                            021199
                                                                                                   B8QS11                                 If continuation sheet 3 of 13
                                                                                                                                             17
                                                                                                                                             2009
                                                                                                                                     PRINTED 03
DEPARTMENT OF HEALTH AND HUMAN SERVICE                                                                                                 FORM APPROVED
CENTERS FOR MEDICARE P MEDICAID SFRVICFS                                                                                                     391
                                                                                                                                     OMR NO 1938

STATEMENT OF DEFICIENCIES               SUPPLIER
                                        CLIA
                                     X1 PROVIDER                                    X2 MULTIPLE CONSTRUCTION                         X3 DATE SURVEY
AND PLAN OF CORRECTION                       IDENTIFICATION NUMBER                                                                         COMPLETED
                                                                                    A BUILDING

                                                                                    B WING
                                                  10D1062658                                                                                  03
                                                                                                                                              2009
                                                                                                                                              16
 NAME OF PROVIDER OR SUPPLIER                                   STREET     ADDRESS CITY STATE ZIP CODE

SHORES PEDIATRICS                                               9715 NE 2ND AVENUE
                                                                MIAMI SHORES FL              33138

       ID             SUMMARY STATEMENT OF DEFICIENCIES                               ID                 SPLAN OF CORRECTION
                                                                                                         PROVIDER
  X4                                                                                                                                                       X5
 PREFIX           EACH DEFICIENCY MUST BE PRECEDED BY FULL                          PREFIX           EACH CORRECTIVE ACTION SHOULD BE                  COMPLETE
   TAG            REGULATORY OR LSC IDENTIFYING INFORMATION                          TAG          REFERENCED
                                                                                                  CROSSTO THE APPROPRIATE                                  DATE
                                                                                                                  DEFICIENCY


   D3031    Continued From         Page   3                                        D3031

                                                                               I
   D3031                        RETENTION REQUIREMENTS
            1105
            493
            3
            a                                                                      D3031
                                                                                                                                                         1oc
                                                                                                                                                      17 1
            The  laboratory must retain quality control and                                                             Z                 Q
                                                                                                                                          L
            patient test records including instrument
            printouts if applicable and activities specified             in
                                                                                                                  pCClc Ceee         d

            493 through 493 for at least 2
            1252                  1289
                                                                                                                                    ta
            years                                                                                ta           Tv
            This Standard is not met as evidenced              by                                cam
            Surveyor       10530                                                                          1


            Based     on   review of the     laboratory quality
                                             s                                                                f

            control records of the Coulter ACT Diff
                   l
            h ematoogy  ana l yzer from 2007 2008 and 2009

            to date and interview with the testing personnel                                                                     Grl
            on                                  30
              March 16 2009 at approximately 12 PM it
            was determined that the laboratory had failed to

            document the current              lot numbers and

                                                                                                                                IPO e1V
                           dates of the Coulter 4C                                                                          s
            expiration                                 hematology                                                  W
            controls used to check the          accuracy   of CBC
                           the Coulter ACT Diff                                                                                     2
            testing   on                            analyzer                                                c
                                                                                                          c P


                                                                                                 t
                                                                                                 t4      ao7       Gt c
                                                                                                                   u            y         S
            The   findings   were as    follows


            The laboratory is performing the Complete Blood
            Count CBC in the Coulter ACT Diff The
            s
            laboratory quality control records consisted of
            dated daily instrument printouts which listed the
            name of the hematology controls These
                                                       quality                                                                      Q
                                                                                                                                    c
                                                                                                                                    et
            controls records show e th e CBC tes t
                                   d                         result s    for                                  7                  P
            the Coulter 4C Low Normal and Hi g h contr ol s
            but the records did not show the lot number and

            expiration
            2008 and 2009
                           dates of the controls in    use   during                              LQt
            On the day of the survey the quality control
            records showed Lot 068200 for the Low                                                j2c      asl 14b               bA
                                                                                                                                19uAeaf
            078200
            Lotfor the Normal and Lot 088200 for                                                     6
                                                                                                                                1
            the   High   control with    expiration date of
                                        an                                                       l                C di
                                                                                                                  QGc
                                                                                                                  1
            08The
            9
            04                current testing personnel stated

            that the Lot      had changed however the quality



FORM CMS Previous Versions Obsolete
     2567
     99
     02                                                         021199
                                                                                                     B8QS41                              If continuation sheet 4 of 13
                                                                                                                              PRINTED        03
                                                                                                                                             2009
                                                                                                                                             17
DEPARTMENT OF HEALTH AND HUMAN SERVICE                                                                                          FORM APPROVED
CENTERS FOR MEDICARE                  MEDICAID SERVICES                                                                               0391
                                                                                                                              OMB NO 0938

STATEMENT OF DEFICIENCIES               SUPPLIER
                                        CLIA
                                     X1 PROVIDER                              X2 MULTIPLE CONSTRUCTION                        X3 DATE SURVEY
AND PLAN OF CORRECTION                    IDENTIFICATION NUMBER                                                                   COMPLETED
                                                                              A BUILDING

                                                                              B WING
                                                   10D1062658                                                                       2009
                                                                                                                                    03
                                                                                                                                    16

 NAME OF PROVIDER OR SUPPLIER                                  STREET   ADDRESS CITY STATE ZIP CODE

SHORES PEDIATRICS                                               9715 NE 2ND AVENUE
                                                                MIAMI SHORES FL 33138

  X4 ID               SUMMARY STATEMENT OF DEFICIENCIES                         ID                SPLAN OF CORRECTION
                                                                                                  PROVIDER                                       X5
 PREFIX           EACH DEFICIENCY MUST BE PRECEDED BY FULL                    PREFIX             EACH CORRECTIVE ACTION SHOULD BE            COMPLETE
  TAG            REGULATORY OR LSC IDENTIFYING INFORMATION                     TAG          REFERENCED
                                                                                            CROSSTO THE APPROPRIATE                             DATE
                                                                                                             DEFICIENCY

                                                                                                     I
   D3031   Continued From                 4
                                   Page                                      D3031


           control records failed to reflect the actual Lot
           use
                                                                        in                 Gtr     CR    cL G
                                                                                                            GY
                                                                                                                    I
                                                                                                                          5
                                                                                                                          i1
                                                                                                                               JS
                                                                                             L     r
                                                                                                   P
                                                                                                             y
   D5291                     GENERAL LABORATORY
           493
           a
           1239                                                              D5291

    400M
           SYSTEMS QUALITY ASSESSMENT
                                                                                                                                              1r     a


           The  laboratory must establish and follow written
           policies and procedures for an ongoing
           mechanism to monitor assess and when                                                               e
                                                                                                              GGu
                                                                                             vt
                                                                                             y
           indicated correct problems identified in the                                                  I
           general laboratory systems requirements
           specified at 493 through 493
                        1231               1236
                                                                                                         rv                   J
           This Standard is not met           as   evidenced   by
                                                                                            j6vZ
                                                                                             Gtw01
           Surveyor        10530


           Based      observation the absence of a
                      on

           laboratory procedure manual and interview with                                                    A    I
                                                                                                                  jQS
           the testing personnel on March 16 2009 at

           approximately        30
                                12 pm it was determined that
                                                                                                              CTi
                                                                                                              c
           the   laboratory     did not have written Quality
           Assurance policies and no quality assurance                                                                          C
                                                                                             CL
           system in place to monitor and assess the                                                                      P         y
           overall          processes in the laboratory or to
                      testing
           identify   and correct problems identified in the
           Com p lete Blood Count         CBC       testing


           The               showed                                                                                       r
                  findings

           On the  day of the survey the laboratory had no
           written policies and procedures for a
           comprehensive Quality Assurance plan that
           encompasses pretesting testing and post testing
           with monitoring to evaluate the overall quality of
                                                                                           CLC
           the testing process The laboratory Quality
                                      s
           Assurance policies must identify problems take
           action to prevent their occurrence or
           re and continuously improve the
           occurrence
           quality of laboratory patient care The Quality
           Assurance activities must be performed to


FORM CMS Previous Versions Obsolete
     02
     2567
     99                                                        021199
                                                                                             B8QS11                            If continuation sheet 5 of 13
                                                                                                                                 17
                                                                                                                                 2009
                                                                                                                         PRINTED 03
DEPARTMENT OF HEALTH AND HUMAN SERVICE                                                                                       FORM APPROVED
CENTERS FOR MEDICARE  MEDICAID SFRVIrFS                                                                                  MR N f1QRR
                                                                                                                         f    n
                                                                                                                              iQ1


STATEMENT OF DEFICIENCIES                SUPPLIER
                                         CLIA
                                      X1 PROVIDER                         X2 MULTIPLE CONSTRUCTION                      X3 DATE SURVEY
AND PLAN OF CORRECTION                      IDENTIFICATION NUMBER                                                            COMPLETED
                                                                          A BUILDING

                                                                          B   WING
                                                     1OD1062658                                                                 16
                                                                                                                                03
                                                                                                                                2009
 NAME OF PROVIDER OR SUPPLIER                                  STREET ADDRESS   CITY STATE ZIP CODE

 SHORES PEDIATRICS                                             9715 NE 2ND AVENUE
                                                               MIAMI SHORES FL       33138

                     SUMMARY STATEMENT OF DEFICIENCIES                                         S
                                                                                               PROVIDER PLAN OF CORRECTION
  X4 ID                                                                       ID                                                            X5
 PREFIX          EACH DEFICIENCY MUST BE PRECEDED BY FULL                 PREFIX             EACH CORRECTIVE ACTION SHOULD BE           COMPLETE
  TAG            REGULATORY OR LSC IDENTIFYING INFORMATION                 TAG           CROSSTO THE APPROPRIATE
                                                                                         REFERENCED                                         DATE
                                                                                                        DEFICIENCY


   D5291   Continued From                  5
                                  Page                                   D5291
   400M

           ensure    that all   testing    instrument     maintenance
           calibration and       quality   control   policies are
           followed
           The testing personnel verified that the laboratory
           had no written Quality Assurance
                                             policies and
           procedures on the day of the survey

   D5403                   PROCEDURE MANUAL
           493
           b
           1251                                                          D5403


   400M    The  procedure manual must include the
           following when applicable to the test procedure
           1 Requirements for patient preparation
           specimen collection labeling storage
           preservation transportation processing and
           referral and criteria for specimen acceptability
           and rejection as described in 493
                                          1242
           2 Microscopic examination including the
           detection of inadequately prepared slides
                by
                step
           3 Step performance of the procedure
           including test calculations and interpretation of
           results

           4 Preparation of slides solutions calibrators
           controls reagents stains and other materials
           used in   testing
           5 Calibration and calibration verification
           procedures
           6 The reportable range for test results for the
           test
                system as established or verified in
           1253
           493
           7 Control procedures
           8 Corrective action to take when calibration or
           control results fail to meet the laboratory criteria
                                            s
           for acceptability

           9 Limitations in the test methodology including
           interfering substances
           10 Reference intervals normal values
           11 Imminently life test results or
                             threatening
           panic or alert values
           12 Pertinent literature references
           13 The laboratory system for entering results
                      s

FORM   CMS Previous Versions Obsolete
       02
       99
       2567                                                   021199                         138QS11                      If continuation sheet 6 of 13
                                                                                                                                                    17
                                                                                                                                                    2009
                                                                                                                                            PRINTED 03
 DEPARTMENT OF HEALTH AND HUMAN SERVICE                                                                                                       FORM APPROVED
CENTERS FOR MEDICARE                   MFDICAID SFRVICFS                                                                                            1391
                                                                                                                                            AMR No nQ3R

STATEMENT OF DEFICIENCIES
                                         SUPPLIER
                                         CLIA
                                      X1 PROVIDER                               X2 MULTIPLE CONSTRUCTION                                    X3 DATE SURVEY
AND PLAN OF CORRECTION
                                          IDENTIFICATION NUMBER                                                                                 COMPLETED
                                                                                A BUILDING

                                                                                B WING
                                                   10D1062658                                                                                        16
                                                                                                                                                     03
                                                                                                                                                     2009

 NAME OF PROVIDER OR SUPPLIER                                    STREET ADDRESS     CITY STATE ZIP CODE

 SHORES PEDIATRICS                                               9715 NE 2ND AVENUE
                                                                 MIAMI SHORES FL 33138

  X4 ID              SUMMARY STATEMENT OF DEFICIENCIES                            ID               PROVIDER PLAN OF CORRECTION
                                                                                                   S                                                            X5
 PREFIX           EACH DEFICIENCY MUST BE PRECEDED BY FULL                      PREFIX            EACH CORRECTIVE ACTION SHOULD BE                          COMPLETE
   TAG           REGULATORY OR LSC IDENTIFYING INFORMATION                       TAG             CROSSTO THE APPROPRIATE
                                                                                                 REFERENCED                                                    DATE
                                                                                                                    DEFICIENCY


   D5403   Continued From          Page   6                                    D5403
    400M                                                                                                                           1rG                              01
           in the   patient   record and      reporting patient   results
           includin g when appropr i ate the pro toco l for
                                                                                             u
           reporting imminent life threatening results or                                    v                            twtLi   L      100
           panic or alert values
           14 Description of the course of action              to take if
           a test
                  system becomes inoperable


           This Standard         is not met   as   evidenced    by
           S urveyor 10530                                                                                 t                             Gt
                                                                                                                                               op
           Based    on   observation review of the Coulter
           Operator Guide and interview with the testing
           s                                                                                       a           Gl U                         t
                                                                                                                                            1
                                                                                                                                            I    I

           personnel on March 16 2009 at approximately
           11 AM it was determined that the laboratory
           30
                                                                                                       S              I    CI J
                                                                                                                           c
           had no written policies approved by the director                                                     U

           describing the processes of Complete Blood
           Count CBC testing performed in the laboratory                                               I



           The   findings     showed
                                                                                                  L4
           The Coulter ACT         Operator Guide
                                   s                    was used         for
           the   hematology       tests and   none   of the   applicable
           procedures     were     underlined to alert the      testing
           personne l     There    was no ev id ence    that th e

           laboratory    had written
                                  policies describing the
           actual process from the sample collection to the
           final report The laboratory had no written step by
           step procedures showing
           a Specimen collection
                                    labeling processing
           criteria for specimen acceptability and rejection
           b Control procedures including the description
           of controls used identify the number of controls                                                         atA
           to be run and the frequency of their use when

           testing is performed
                                                                                                                                  Z 1 RIM
           c   Corrective action to take when control results
           fail to meet the      laboratory criteria
                                 s                      for

           acceptability      Define the criteria for   accepting
           control data     or   what to do if controls   were    not
           within the    acceptable     limits

FORM CMS Previous Versions Obsolete
     2567
     02
     99                                                         021199
                                                                                                 B8QS1 1                                      If continuation sheet 7 of 13
                                                                                                                             PRINTED        03
                                                                                                                                            2009
                                                                                                                                            17
DEPARTMENT OF HEALTH AND HUMAN SERVICE                                                                                        FORM APPROVED
CENTERS FOR MEDICARE                 MEDICAID SERVICFS                                                                              n391
                                                                                                                             MR NO n938

STATEMENT OF DEFICIENCIES            CLIA
                                     SUPPLIER
                                  X1 PROVIDER                                   X2 MULTIPLE CONSTRUCTION                    X3 DATE SURVEY
AND PLAN OF CORRECTION                 IDENTIFICATION NUMBER                                                                     COMPLETED
                                                                                A BUILDING

                                                                                B WING
                                               10D1062658                                                                           16
                                                                                                                                    03
                                                                                                                                    2009
 NAME OF PROVIDER OR SUPPLIER                                 STREET ADDRESS CITY STATE ZIP CODE


SHORES PEDIATRICS                                             9715 NE 2ND AVENUE
                                                              MIAMI SHORES FL            33138

  X4 ID              SUMMARY STATEMENT OF DEFICIENCIES                            ID               S
                                                                                                   PROVIDER PLAN OF CORRECTION
                                                                                                                                                X5
 PREFIX           EACH DEFICIENCY MUST BE PRECEDED BY FULL                      PREFIX           EACH CORRECTIVE ACTION SHOULD BE           COMPLETE
  TAG            REGULATORY OR LSC IDENTIFYING INFORMATION                       TAG         REFERENCED
                                                                                             CROSSTO THE APPROPRIATE                           DATE
                                                                                                            DEFICIENCY

   D5403   Continued From              7
                               Page                                            D5403
    400M

           d Indicate the   periodic maintenance calibration
           and routine   sample procedures that were done
           on the analyzer

           e The Life test results or
                   threatening                     panic
           values and how they would be handled i    e
           listing of the actual panic levels and whether the
           test would be repeated before reporting
           f Indicate the periodic maintenance calibration
           and routine sample procedure done on the

           analyzer
           g The laboratory system for entering CBC
                   s
           results in the patient record and reporting patient
           results                                                         j
           h  Description of the course of action         to take if   a

           test sytem becomes inoperable
           i There   was no   reference to the enrollment

           performance and participation in an approved
           proficiency testing program or what records to be
           kept
           All policies and procedures must be approved by
           the Director prior to implementation in the
           laboratory

   D5439
           493
           b
           1255
           VERIFICATION
                          CALIBRATION AND CALIBRATION                          D5439
                                                                                             Q                                             p
                                                                                                                                 xv
   400M
           Unless otherwise     specified    in this
                                           subpart for
           each               test
                             system the laborator y must
                applicable
           perform and document calibration verification
           proce d ures
           1 Following         s
                           the manufacturer calibration
           verification instructions
                                                               n
           2 Using     the criteria verified
                                     established by
                                               or

           the
             laboratory under 493
                              3
                              b
                              1253
           2 Including the number type and
           i
           concentration of the materials as well as
           acceptable limits for calibration verification and
           2 Including at
           ii                   least a minimal        or zero value
             point
           a mid value          and    a   maximum value      near

           the upper limit of the range to     verify   the
                                                                                                                  Me a
FORM CMS Previous Versions Obsolete
     2567
     99
     02                                                       021199                             B8QS11                       If continuation sheet 8 of 13
                                                                                                                                               17
                                                                                                                                               2009
                                                                                                                                       PRINTED 03
 DEPARTMENT OF HEALTH AND HUMAN SERVICE                                                                                                    FORM APPROVED
 CENTERS FOR MFnIrARF R nnFnlrrAln cFRVIrGe                                                                                            RAM 1
                                                                                                                                       e    nnnn              nnnw

                                                                                                                                       vlYlu11I                        1
                                                                                                                                                     V017
                                                                                                                                                     VJJV


 STATEMENT OF DEFICIENCIES
                                               CLIA
                                               SUPPLIER
                                            X1 PROVIDER                            X2 MULTIPLE CONSTRUCTION
 AND PLAN OF CORRECTION                                                                                                                X3 DATE SURVEY
                                               IDENTIFICATION NUMBER
                                                                                                                                          COMPLETED
                                                                                   A BUILDING

                                                                                   B WING
                                                        10D1062658                                                                           03
                                                                                                                                             2009
                                                                                                                                             16
 NAME OF PROVIDER OR SUPPLIER                                        STREET   ADDRESS CITY STATE ZIP CODE
 SHORES PEDIATRICS                                                   9715 NE 2ND AVENUE
                                                                     MIAMI SHORES FL 33138

  X4 ID                 SUMMARY STATEMENT OF DEFICIENCIES
                                                                                     ID                   SPLAN OF CORRECTION
                                                                                                          PROVIDER
                                                                                                                                                          X5
  PREFIX           EACH DEFICIENCY MUST BE PRECEDED BY FULL                        PREFIX          EACH CORRECTIVE ACTION SHOULD BE                   COMPLETE
   TAG            REGULATORY OR LSC IDENTIFYING INFORMATION
                                                                                    TAG           CROSS TO THE APPROPRIATE
                                                                                                  REFERENCED                                             DATE
                                                                                                             DEFICIENCY

   D5439    Continued From            Page    8                                  D5439
    400M                                                                                                          a
                                                                                                 tt               c
            laboratory reportable range of test results for
            s
            the test system and
            3 At least once every 6 month s and whenever
                                                                                                4ta G t

            any   of   th e fo ll ow i ng   occur                                               eazt                       r

                                                                                                                               G
            3 A complete change of reagents for a
            i
                                                                                                                       w           pct
            procedure is introduced unless the laboratory
            can demonstrate that
                                 changing reagent lot
                                                                                                           r   1
            numbers does not affect the range used to report                                t         e            Y               j
            patient test results and control values are not
            a dverse l y aff ected
                                                                                                          t   aVJ                  UA 1
                                   by reagent lot number
           changes
                                                                                                  Dy
           3 There is major preventive maintenance or
           ii
           replacement of critical parts that may influence                                               G
                                                                                                      l   G
           test performance
           3 Control materials reflect an unusual trend
           iii
           or shift or are outside of the
                                          laboratory
                                          s
           acceptable limits and other means of assessing
           and correcting unacceptable control values fail to                                                                  f

           identify and correct the problem
           3 The laboratory established schedule for
           iv          s
           verifying the reportable range for patient test
                                                                                                                           7 A
                                                                                                                           lv 4
           results requires more frequent calibration                                           IAO           A
           verification                                                                                                p




           This Standard           is not met      as   evidenced   by
           Surveyor         10530


           Based       on   review of patient test records from
           2007 2008 and 2009 calibration records for
           2007 and 2008 and interview with the
                                                                testing
           personnel on March 16 2009 at approximately
           12 30 PM it was determined that the
                                               laboratory
           did not
                 perform calibration of the Coulter                 ACT Diff
           hematology analyzer at least once every                  six
           months


           The                 showed
                  findings

           The    laboratory patient testing records showed
           that   Hematology testing had been performed
rvrcm                                                               021199
        1v1o evious versions
        ay r
        zuoituz r                                 UDSOIete
                                                                                                  B8QS11                               If continuation sheet 9 of 13
                                                                                                                                                           17
                                                                                                                                                           2009
                                                                                                                                                   PRINTED 03
DEPARTMENT OF HEALTH AND HUMAN SERVICE                                                                                                                 FORM APPROVED
                                FG
CFNTFRS FOR MFnirARF R MFnIrAin SFRVlr                                                                                                            r1MR Nr        nQiR
                                                                                                                                                                 iQ1
                                                                                                                                                                 n


STATEMENT OF DEFICIENCIES                SUPPLIER
                                         CLIA
                                      X1 PROVIDER                                        X2 MULTIPLE CONSTRUCTION                                 X3 DATE SURVEY
AND PLAN OF CORRECTION
                                          IDENTIFICATION NUMBER                                                                                       COMPLETED
                                                                                         A BUILDING

                                                                                         B WING
                                                   10D1062658                                                                                             2009
                                                                                                                                                          03116
 NAME OF PROVIDER OR SUPPLIER                                         STREET        ADDRESS CITY STATE ZIP CODE

 SHORES PEDIATRICS                                                    9715 NE 2ND AVENUE
                                                                      MIAMI SHORES FL 33138

                    SUMMARY STATEMENT OF DEFICIENCIES                                                         PROVIDER
                                                                                                              SPLAN OF CORRECTION
  X4 ID                                                                                    ID                                                                         X5
 PREFIX          EACH DEFICIENCY MUST BE PRECEDED BY FULL                                PREFIX            EACH CORRECTIVE ACTION SHOULD BE                       COMPLETE
   TAG          REGULATORY OR LSC IDENTIFYING INFORMATION                                 TAG             CROSS
                                                                                                          REFERENCED TO THE APPROPRIATE                               DATE
                                                                                                                           DEFICIENCY


   D5439   Continued From         Page   9                                              D5439
   400M

           during 2007 2008 and 2009
           On the day of the survey 3the
                                    16
                                    09                         available
           records indicated that the Coulter ACT Diff                   was

           only   calibrated    September 16 2008 There
                                 on

           were   no calibration records for 2007




   D5441
           493 CONTROL
           a
           1256
           b
           c
           g                                              PROCEDURES                   D5441


   400M    For each test  system the laboratory is
           responsible      having control procedures that
                           for
           monitor the accuracy and precision of the

           complete analytic process The laboratory must
           establish the number type and frequency of
           testing control materials using if applicable the
           performance specifications verified or
           established by the laboratory as specified in
           b
           3
           493
           1253

           The control procedures must                                                      I                                                 e
           Detect immediate errors that occur due to test

           system failure adverse environmental                                                       1     P
                                                                                                            1
                                                                                                            C
           conditions and operator performance
           M on i tor over ti me the accuracy and precision                    of                                      l

           test performance that may be influenced by                                                                                                 a
                                                                                                      210W                   G                    C
           changes in test system performance and
           environmental conditions and variance in
                                                                                                          1
                                                                                                          L1                     Cl     116
                                                                                                                                              ez   zte
           operator performance
                                                                                                                  il
           The laboratory must document
           procedures performed
                                                        all control                                   y
                                                                                                      C   L01ti        A                      Le      Auk
           This Standard         is not met   as   evidenced     by
                                                                                                      d
           Surveyor      10530                                                                                         i6        v
           Based    on   review of available    Hematology Quality
           Control records and        patient testing records from
           2007 2008      and    2009   an d i ntervi ew w ith    the




                                                                                                                              i
           laboratory testing personnel            on   March 16 2009                             r



           at approx i mate l y 12 30PM it was d e erm i ned
                                                  t                                                                                     tic
                                                                                                                                              y




           that the laboratory was performing Complete
                                                                                                                                                            l
FORM CMS Previous Versions Obsolete
     2567
     99
     02                                                               021199
                                                                                                           B8QS11                                  If continuation sheet 10 of 13
                                                                                                                                                PRINTED          03
                                                                                                                                                                 2009
                                                                                                                                                                 17

DEPARTMENT OF HEALTH AND HUMAN SERVICE                                                                                                            FORM APPROVED
CAITCDQ Cr1D K
r            nlrR KAPnIr CFR
             ADC  Alr    jC
                         Ir                                                                                                                     OMB NO 0938
                                                                                                                                                        0391


STATEMENT OF DEFICIENCIES                                                                                                                       X3 DATE SURVEY
                                        CLIA
                                        SUPPLIER
                                     X1 PROVIDER                                X2 MULTIPLE CONSTRUCTION
AND PLAN OF CORRECTION                    IDENTIFICATION NUMBER                                                                                         COMPLETED
                                                                                A BUILDING

                                                                                B WING
                                                 10D1062658                                                                                                 2009
                                                                                                                                                            03
                                                                                                                                                            16

NAME OF PROVIDER OR SUPPLIER                                   STREET     ADDRESS CITY STATE ZIP CODE

SHORES PEDIATRICS                                              9715 NE 2ND AVENUE
                                                               MIAMI SHORES FL           33138

                    SUMMARY STATEMENT OF DEFICIENCIES                             ID                    SPLAN OF CORRECTION
                                                                                                        PROVIDER                                                      X5
 X4 ID
 PREFIX           EACH DEFICIENCY MUST BE PRECEDED BY FULL                      PREFIX                EACH CORRECTIVE ACTION SHOULD BE                            COMPLETE
                 REGULATORY OR LSC IDENTIFYING INFORMATION                       TAG             REFERENCED
                                                                                                 CROSSTO THE APPROPRIATE                                             DATE
  TAG
                                                                                                                          DEFICIENCY


                                                                               D5441                                                                    L
  D5441
   400M
           Continued From          Page   10
                                                                                                 41
                                                                                                 8v
                                                                                                 n
           Blood Count
           2009 to date
                             CBC testing        in 2007 2008 and
                              but had not documented results of
                                                                                                       Itt
                                                                                                                                                                 t
                                                                                             G
           the Hematology
           testing
                                 controls each     day   of patient
                                                                                                 ti    did            1   0

           Th e fi ndi ngs   showe d



           The    laboratory Quality
                  s                        Control records                                                                                                         a
                                                                                                                                                                   j
           consi st d o da te Cou lt er AC T tapes showin g
                   e   f     d
           C BC    resu   l ts f l ow norma l and hi g h con tro l s
                                or                                       run

           each    day    patient CBC testing and dated                                                                                                     b
                                                                                                                                                            P
           Cumulative        History   sheets showing cumulative                                      f
                                                                                                      iF
           summary CBC results for each level and the
           dates these controls had been run
                                                                                              tL
                                                                                              L
                                                                                              i                                   9
                                                                                                                                       iQ


           On the  day of the survey the current testing
                                                                                                            IV a4jQ
                                                                                                               q
           person was unable to locate CBC Quality Control                                                                              fe
           results from September 2007 th roug h J u l y 2008
           The daily log showed that patient test results
                                                                                                            kl                                      er
           were    reported during     this    period

   D6000   493 LABORATORY DIRECTOR
           1403                                                                D6000


           The

           the
                laboratory must have a director who meets
               qualification requirements of 493 of
                                             1405                                            y        Imo                         ji
                                                                                                                                  6

           this subpart and provides overall management
           and direction in accordance with 493 of                                                          cut                                 1
                                             1407
           this subpart
                                                                                                                                       L
           This Condition is not met as evidenced              by                                                     1

           Surveyor        10530
                                                                                                      4     IN
                                                                                                                              A             AM
                                                                                                 I
                                                                                                                                        at      L
           Based
           the
                     on    review of records and interview with
               testing personnel on March 16 2009 at
                                                                                             LLA t
                                                                                                        5 i
                                                                                                          ecl
                                                                                                                                  ed
                                                                                                                                  fGfitc            r

                           30
           approximately 12 PM it was determined that                                                                                       G
           the laboratory director had failed to provide the
           overall management and direction to ensure the
           quality of the patient Complete Blood Count                                                                    7j
                                                                                                                          f                 1St             1
                                                                                                                          I                                 J
           CBC testing performed in this laboratory and to                                                        i

                                                                                             kQe Ct
                                                                                                                              t
           ensure that the CBC testing was performed in                                      UI
                                                                                                      B8QS11                                        If continuation sheet 11 of 13
FORM CMS Previous Versions Obsolete
     2567
     99
     02                                                         021199
                                                                                                                                                         17
                                                                                                                                                         2009
                                                                                                                                                 PRINTED 03
DEPARTMENT OF HEALTH AND HUMAN SERVICE                                                                                                             FORM APPROVED
CENTERS FOR MEDICARE                    MEDICAID SFRVICFS                                                                                                0391
                                                                                                                                                 OMR NO 0938

STATEMENT OF DEFICIENCIES               SUPPLIER
                                        CLIA
                                     X1 PROVIDER                                    X2 MULTIPLE CONSTRUCTION                                     X3 DATE SURVEY
AND PLAN   OF CORRECTION                 IDENTIFICATION NUMBER                                                                                      COMPLETED
                                                                                    A BUILDING

                                                                                    B WING
                                                   10D1062658                                                                                          03
                                                                                                                                                       16
                                                                                                                                                       2009

 NAME OF PROVIDER OR SUPPLIER                                   STREET ADDRESS            CITY STATE ZIP CODE

SHORES PEDIATRICS                                                9715 NE 2ND AVENUE
                                                                MIAMI    SHORES            FL   33138

  X4 ID             SUMMARY STATEMENT OF DEFICIENCIES                                 ID                    SPLAN OF CORRECTION
                                                                                                            PROVIDER                                                 X5
 PREFIX          EACH DEFICIENCY MUST BE PRECEDED BY FULL                           PREFIX              EACH CORRECTIVE ACTION SHOULD BE                         COMPLETE
  TAG           REGULATORY OR LSC IDENTIFYING INFORMATION                            TAG              REFERENCED
                                                                                                      CROSSTO THE APPROPRIATE                                        DATE
                                                                                                                        DEFICIENCY


   D6000    Continued From               11
                                  Page                                             D6000
                                                                                                            Ute 1                I   n   0
                                                                                                 U
            accordance to     applicable      Federal and State                                         p   v               1
                                                                                                                            14           6
                                                                                                                                         1c
            regulations

            The   findings   showed that the       laboratory   director

                                                                                                                                             QLG
                                                                                                                                             ti
            failed to   ensure   that
                                                                                                 th     P                                    J
            1 The   laboratory was enrolled          inan approve
                                                                                                     MCI
            proficiency testing program for          2008 and 2009
            See D2000
            2  Th e l a bora tory h a d par ti ci pate d i n an approve                         V

            pro fi ci ency tes ti ng program for CBC d uri ng 2007
            and 2008 See D2016                                                                                                                                    11
            3 The                                                                                    Y
                                                                                                     CI
                                                                                                              t
                                                                                                                                                                III
                e   procedure manual included all the Coulter                                                      I
            ACT   policies in place for the Hematology testing
            performed in the laborator y See D5403                                                                     Ul ttC
                                                                                                                       c                     vt
                                                                                                                                             l
            4 A Quality Control program was established
            and maintained See D5441
                                                                               I                 I                1       GLG
                                                                                                                          v
   D6020    493 1407 e 5 DIRECTOR RESPONSIBILITIES                                 D6020                          01 1A 41
            The  laboratory director must ensure that the
            quality control programs are established and
            mai nta i ned to assure the quality of laboratory                                        L
            services provided
                                                                               i                          C                  C           Cww
            This Standard        is not met   as   evidenced    by
            Surveyor     10530


            Based   on   review of the
                                  laboratory s Complete
            Blood Count CBC Quality Control records from
            2008 and 2009 and interview with the testing
            personnel on March 16 2009 at approximately
            30
            11 AM it was determined that there was no
            documentation showing that the director had
                                                                                   IItP
            provided oversi g ht of the laboratory s quality               j                                                                                     i

            control activities to ensure the quality of the CBC                                                                                  5
                                                                                                                                                 1
            testing performed      in this   laboratory
                                                                                                                                                  4A

            The   findings   showed
                                                                                                                                                       J
FORM CMS Previous Versions Obsolete
     2567
     02
     99                                                         021199
                                                                                                        B8QS1 1                                  If continuation sheet   12 of 13
                                                                                                                                                       17
                                                                                                                                                       2009
                                                                                                                                               PRINTED 03
DEPARTMENT OF HEALTH AND HUMAN SERVICE                                                                                                                FORM APPROVED
CENTERS FOR MEDICARE                    MEDICAID SERVICES                                                                                             0391
                                                                                                                                               OMB NO 0938

STATEMENT OF DEFICIENCIES                SUPPLIER
                                         CLIA
                                      X1 PROVIDER                               X2 MULTIPLE CONSTRUCTION                                       X3 DATE SURVEY
AND PLAN OF CORRECTION                     IDENTIFICATION NUMBER                                                                                      COMPLETED
                                                                                A BUILDING

                                                                                B WING
                                                  10D1062658                                                                                               2009
                                                                                                                                                           03
                                                                                                                                                           16

NAME OF PROVIDER OR SUPPLIER                                      STREET   ADDRESS CITY STATE ZIP CODE

SHORES PEDIATRICS                                                 9715 NE 2ND AVENUE
                                                                  MIAMI SHORES FL 33138

                        SUMMARY STATEMENT OF DEFICIENCIES                         ID                       SPLAN OF CORRECTION
                                                                                                           PROVIDER                                                 X5
 X4 ID
 PREFIX         EACH DEFICIENCY MUST BE PRECEDED BY FULL                        PREFIX                   EACH CORRECTIVE ACTION SHOULD BE                       COMPLETE
  TAG          REGULATORY OR LSC IDENTIFYING INFORMATION                         TAG             CROSSTO THE APPROPRIATE
                                                                                                 REFERENCED                                                        DATE
                                                                                                                       DEFICIENCY


  D6020   Continued From                  12                                   D6020
                                   Page
                                                                                                                                                     1 r
          The      s
                   laboratory Quality       Control records showed                                       n         G
                                                                                                                           J GY
          no   documentation such           as   comments     indicating                                                             j
                                                                                                                               15
          that the
                 laboratory          director had reviewed the                                                         1
          laboratory low normal
          s                                 and   high   CBC control
          resu l   ts   on an   ongoi ng bas i s Th ere    was no

          evidence that the director had evaluated control
                                                                                                                                          LD         Cf    j
                                                                                                                                                           a
          records initiated corrective action if needed On
          the day of the survey th ere were no quali ty
                                                                                                    o                                    G
          con tro l     recor ds
                            from S eptem ber 2007 th roug h                                  Gt UIE1                       C
          July     2008 The daily log showed that patient test
          results       were    reported during   this   period                                          ate vl
                                                                                                                               a    tj   1P   CL
                                                                                              Dr             oIu           4
                                                                                                                           e
                                                                                                                                                 i     I 1

                                                                                                 j
                                                                                                               9    rl
                                                                                                                   VIg

                                                                                                     i




                                                                                             p                     AA      I




                                                                                                                                                     a
                                                                                                                           G                 u   c

                                                                                                               c p
                                                                                                                ttv
                                                                                                                                    1    1
                                                                                                             Gy




                                                                                                         tia
                                                                                                                                          LV

FORM   CMS Previous
       2567
       02
       99                           Versions Obsolete             021199
                                                                                                         B8QS11                                  If continuation sheet 13 of 13
  2508
  MHR 14
  WEO
  2009                                           SHORES       PEDIATRICS                                                                             P
                                                                                                                                                     001
                                                                                                                                                     001
   2009
   25
   03                     93
                          15                305d992190                              AHCA                                                         PAGE 01

                                                                                                                                         PRINTED 031170
                                                                                                                                            FORM APPROVE
 A art      For   e   t           e    d           Ian                                                                                                                          1
                                                                                                                                                                                I
 STATEMENT OF DEFICIENCIES
                                             XI PROVIOCRISUPFLIERf4LU1                    MULTIPLE   CONSTRUCTION                        Imo                 RVEY
 AND PLAN OF CORRECTION                         IDENTIFICATION NUMBER
                                                                                   A BUILDING
                                                                                                                                                 CDATEE
                                                                                                                                                      TED
                                                                                                                                                  OMPLETED


                                                                                   B MNG
                                                         FL22021042                                                                               2009
                                                                                                                                                  03116
 NAME OF PROVIDER OR SUPPLIER                                           STRRGY ADDRESS    CITY STATE ZIP CODE

 SHORES PEDIATRICS                                                      9716 NE 2ND AVENUE
                                                                        MIAMI SHORES FL 33138

                     SUMMARY STATEMENT OF DEFICIENCIES                                                  PROVIDER PLAN OF CORRECTION
                                                                                                        S                                                                   I
   4 ID                                                                              ID
  PREFIX           ACH DEFICIENCY MUST BE PRECEDED BY FULL                                            EACH CORRECTIVE ACTION SHOULD BE                        COMPLET
                                                                                   PREFIX
   TAG            REGULATORY OR L tDENTIFYING INFORMATION
                                C                                                   TAG              GROSSTO THE APPROPRIATE
                                                                                                     REFERENCED                                                  DATE
                                                                                                                    DEFICIENCY
                                                                                                                                                                                I
     L 000    Initial Comments                                                    L 000

                                                                                                                                         t
                                                                                                                                         Ilk
                                                                                                                                         C
                                                                                                                                                                                1

                                                                                                                                     w


                                                                                                                        i        r
                                                                                                                                                             V              1

              Surveyor 10530
                                                                                                                1
              Recertification Survey

              State Ucense 800022409                                                                                        je                                                      I




              Licensed and certified for
              haematology

    L2501     025
              7
              59A PARTICIPATION IN PROFICIENCY                                    L2501                                 RAI
             TESTING
                                                                                   v
                                                                                                V               f                        P
              Each laboratory          must enroll in a       proficiency
             testing program that meets                the oriteft in Mule
             7
             026
             59A The laboratory                        must enroll in an

             approved
             program or programs for each of the                   specialties
             subspecialties           and   analytes or tests except for                                            VUW TD
             waived tests for which it seeks licensure except
             where there is no available
                                                       proficiency
                                                    test                                                                             j
             This Requirement is not met as evidenced by                                                   qj                                            f
             Surveyor       10530
                                                                                                              4kt
             1
             025
             7
             59A
             Ref
             FAC

             Based on the absence of proticlency test records                                                           f                q
             from 2008 and 2009 and intervlewwith the                                                                   I
                                                                                                                        Q            B   l
             testing personnel on March 16 2009 at
                                                                                                                                     f
             approximately 11 am it was determined that
                             30                                                                                             J
             the laboratory trod perfarmed patient Complete
             Blood Count CBC testing since 2007 but there
             was no evidence that the laboratory had enrolled
                                                                                                                    v
                                                                                                                                             f
             in an a roved profi ci ency t t es program f CI3C                                                          J

                                                                                                                                         W
                     pp                                  or
                                                                                                 tx
                                                                                                 U
             testin g at any ti me i n 2008 and 2009

                                                                                                     n
                                                                                                     I
                                                                                                                                 W 0WV
             The findings showed
                                                                                                       A



                                                                                                           fK
             The laboratory had no records Includin
             com pleted
                                                                     g
                             enrollment f r ms
                                         o              or proo f o f


AHCA Farm 3020
          0001
LABORATORY DIREC          RS OR             0 RlSUPP      R    1        SSIGNATURE
                                                                        ATIVE                                 TITLE                                          Oro DATE
                                                                                                                                                                                I
STATE FORM                                                                                            BSQ311                                 n rAngnuanon      eMSet    a
                                                                                                                                                   17
                                                                                                                                                   2009
                                                                                                                                           PRINTED 03
                                                                                                                                                FORM APPROVED
  A   enc     For Health Care Administration

  STATEMENT OF DEFICIENCIES
                                                       CLIA
                                                       SUPPLIER
                                                    X1 PROVIDER
  AND PLAN OF CORRECTION                                                                          X2 MULTIPLE CONSTRUCTION                X3 DATE SURVEY
                                                           IDENTIFICATION NUMBER
                                                                                                  A BUILDING                                COMPLETED

                                                                                                  B WING
                                                                FL22021042                                                                       03
                                                                                                                                                 2009
                                                                                                                                                 16
  NAME OF PROVIDER OR SUPPLIER
                                                                                STREET       ADDRESS CITY STATE ZIP CODE
  SHORES PEDIATRICS                                                             9715 NE 2ND AVENUE
                                                                                MIAMI SHORES FL 33138

   X4 ID                      SUMMARY STATEMENT OF DEFICIENCIES
                                                                                                    ID            S
                                                                                                                  PROVIDER PLAN OF CORRECTION
   PREFIX                EACH DEFICIENCY MUST BE PRECEDED BY FULL                                                                                              X5
                                                                                                  PREFIX        EACH CORRECTIVE ACTION SHOULD BE
      TAG               REGULATORY OR LSC IDENTIFYING                                                                                                      COMPLETE
                                                                      INFORMATION                  TAG         CROSS TO THE APPROPRIATE
                                                                                                               REFERENCED                                     DATE
                                                                                                                          DEFICIENCY

      L2501
              1    Continued From              Page    1                                        L2501
                                                                                                                             f
                  enrollment for 2008 and 2009
                                                                    Additionally       the
                  laboratory        had
                                   documentation such a s gra de d
                                             no

                  test CBC results Coulter ACT Diff instrument
                  printouts         or
                                         copies   of completed result forms
                  submitted to           a
                                             proficiency tet company showing
                  CBC results for             proficiency test samples
                  showing       that it had      participated in proficiency
                           at any time in 2007 2008 and 2009 The
                  testing
                  office manager and testing personnel verified
                  that the
                            laboratory had performed patient CBC
                  testing  since 2007 but had not enrolled in

                  proficiency testing             for CBCs in 2008 and 2009


      L2509
                  b
                  1
                  025
                  7
                  59A PARTICIPATION
                  2                                                      IN                     L2509
                  PROFICIENCY TESTING


                  1 Enrollment

                  b The laboratory must designate the
                  program to be used for each specialty
                  s
                  subspecialty and analyte or test to determine
                  compliance with this Rule if the laboratory
                  participates in more than one proficiency testing
                  program approved by the agency


                  2 For each       specialty subspecialty and analyte
                  or   test   thelaboratory must participate in one
                  approved      proficiency testing program or
              programs for one year before designating a
              different program and must
                                         notify the agency
              before any change in
                                   designation

              This       Requirement              is not met   as   evidenced      by
              Surveyor          10530


              Ref
                        025
                        7
                        59Ab FAC
                        1

              Based on the absence of
                                      proficiency surveys
              records for 2007 and 2008 and interview with the
              office         and
                         manager                  testing personnel
                                                   on March



AHCA Form 3020
          0001

STATE FORM                                                                    021199
                                                                                                               B8QS11                      If continuation sheet 2 of 12
                                                                                                                                            17
                                                                                                                                            2009
                                                                                                                                    PRINTED 03
                                                                                                                                         FORM APPROVED
  AaenCv Fnr HPAIth Cara Ariminicfrnfinn

  STATEMENT OF DEFICIENCIES
                                                SUPPLIER
                                                CLIA
                                             X1 PROVIDER                                       MULTIPLE CONSTRUCTION
  AND PLAN OF CORRECTION                                                                                                            X3 DATE SURVEY
                                                      IDENTIFICATION NUMBER
                                                                                                                                        COMPLETED
                                                                                         A BUILDING

                                                                                         B WING
                                                           FL22021042
                                                                                                                                          16
                                                                                                                                          03
                                                                                                                                          2009
  NAME OF PROVIDER OR SUPPLIER                                            STREET   ADDRESS CITY STATE ZIP CODE
  SHORES PEDIATRICS                                                       9715 NE 2ND AVENUE
                                                                          MIAMI SHORES FL 33138

   X4 ID               SUMMARY STATEMENT OF DEFICIENCIES
                                                                                          ID              PROVIDER PLAN OF CORRECTION
                                                                                                          S
   PREFIX           EACH DEFICIENCY MUST BE PRECEDED BY FULL                                                                                            X5
                                                                                        PREFIX          EACH CORRECTIVE ACTION SHOULD BE
    TAG             REGULATORY OR LSC IDENTIFYING                                                                                                   COMPLETE
                                                                INFORMATION              TAG           REFERENCED
                                                                                                       CROSS TO THE APPROPRIATE                        DATE
                                                                                                                       DEFICIENCY
    L2509     Continued From                      2
                                         Page                                          L2509


              16 2009          at   approximately       11 AM it
                                                        30              was
              determined that the
                                             laboratory        was
                                                                     performing
              patient Complete Blood Count CBC testing
              during 2007 2008 and 2009 but had failed to
              participate in a proficiency testing program for
              these tests during any time in 2007 and 2008


              The    findings       showed


             The     laboratory        had
                                      records such as graded
                                             no

             test CBC   results          Coulter ACT Diff machine
             printouts proficiency testing program data input
             report forms or attestation statements submitted
             to the proficiency test
                                     program showing CBC
             results for
                         proficiency test samples showing that
             it had participated in
                                    proficiency test at any time
             in 2007 and 2008
             The   testing personnel verified that the laboratory
             had   performed patient CBC testing in 2007 and
             2008 but had not participated in a
                                                  proficiency
             testing program for CBC during 2007 and 2008
                                  s


    L2833                            PATIENT TEST MANAGEMENT
             028
             7
             59A
             4                                                                         L2833


             4     Test records The
                                    laboratory must maintain
             a   recordsystem to ensure reliable identification
             of patient specimens as they are
                                               processed and
             tested to            that accurate test results are
                              assure

             reported       Records shall be retained in their
             original    form or stored on microfilm microfiche                   or
             other photographic record
                                         magnetic tapes or
             other media in an electronic data
                                               processing
             system These records must identify the
             personnel performing the testing procedure
             Records of patient
                                testing including if
             applicable instrument printouts must be
             retained for at least two years
             Immunohematology                records and transfusion
             records must be retained for                 no   less than five
            years        In   addition   records of blood and blood


AWr C
A           anon   nnn




STATE FORM                                                               ea
                                                                         oz

                                                                                                       B8QS11                       If continuation sheet 3 of 12
                                                                                                                                      PRINTED         03
                                                                                                                                                      2009
                                                                                                                                                      17
                                                                                                                                           FORM APPROVED
  Aaencv Fnr Haalth r   i
                        m
                    nr0 Ar4minic


  STATEMENT OF DEFICIENCIES
                                       X1 PROVIDER
                                           SUPPLIER
                                           CLIA
  AND PLAN OF   CORRECTION                                                        X2 MULTIPLE CONSTRUCTION                            X3 DATE SURVEY
                                          IDENTIFICATION NUMBER                                                                           COMPLETED
                                                                                  A BUILDING

                                                                                  B WING
                                                    FL22021042                                                                              16
                                                                                                                                            03
                                                                                                                                            2009
  NAME OF PROVIDER OR SUPPLIER                                    STREET     ADDRESS CITY STATE ZIP CODE
  SHORES PEDIATRICS                                               9715 NE 2ND AVENUE
                                                                  MIAMI SHORES FL 33138

   X4 ID              SUMMARY STATEMENT OF DEFICIENCIES
                                                                                                       S
                                                                                                       PROVIDER PLAN OF CORRECTION
                                                                                    ID
  PREFIX           EACH DEFICIENCY MUST BE PRECEDED BY FULL                                                                                               X5
                                                                                  PREFIX             EACH CORRECTIVE ACTION SHOULD BE
    TAG            REGULATORY OR LSC IDENTIFYING                                                                                                     COMPLETE
                                                         INFORMATION               TAG         CROSS
                                                                                               REFERENCED TO THE APPROPRIATE
                                                                                                                                                         DATE
                                                                                                                    DEFICIENCY

    L2833    Continued From                 3
                                     Page                                       L2833                       r
                                                                                                       tae                                  f
                                                                                                                                                    qoq
                                                                                           f lJ r

             product  testin g must be mai n ta i ne d for a period
             not less than five years after
                                            processing records
                                                                                                       rnLC21C
                                                                                                       C
             have been completed or six months after the
             latest    expiration date
                                  whichever is the later date
             Pathology records must be retained for at least
             ten years The record
                                   system must provide                                     CYPIVAW
                                                                                                1f
             documentation of information           in Rule
                                                    specified                                                                  tti
                                                                                                                            GG GI
                                                                                                                            I
             028
             7
             59A
             3
             This Requirement          is not met   as   evidenced      by
             S urveyor 105 30                                                                   1


             R ef59A
                 028
                 7
                 FAC
                 4

             Based on review of the
                                     laboratory quality
                                     s
             control records of the Coulter ACT Diff

             hematology analyzer from 2007 2008 and 2009                                                     2       x
                                                                                                                     1
             to date and interview with the
                                            testing personnel
             on March 16 2009 at                   30
                                                   12
                                  approximately         PM    it
             was determined that the laboratory had failed to
             document the current    lot numbers and
             expiration dates of th e C ou lter 4C h
                                                    ematology
             controls used to check the
                                          accuracy of CBC
             testing        the Coulter ACT Diff
                       on
                                                    analyzer                                                              vt     Lc
             The   findings   were as   follows


             The
                                                                                                                     avl
                   laboratory   is   performing   the
                                                Complete           Blood
             Count  CBC in the Coulter ACT Diff The
                                                                                                                                 Lc
             laboratory s quality control records consisted of
             dated daily instrument
                                     printouts which listed the                                LL                   I t
                                                                                                                     L
                                                                                                                    ll                   Z
             name of the
                           hematology controls These quality                                                    1
            controls records showed the CBC test results for
            the Coulter 4C Low Normal and
                                                         High controls
                                                                                                           DwM
                                                                                                           C
            but the records did not show the lot number and

            expiration dates of the controls in use during
                                                                                                    eaq
                                                                                                    firn
            2008 and 2009
            On the day of the survey the quality control
            records showed Lot 068200 for the
                                                                                               f1v
                                                 Low
            078200
            Lot for the Normal and Lot 088200 for
            the
             High control with         an expiration date of
            04 The current
            08
            9
                                       testing personnel stated
44Jr1A C   nnn




STATE FORM                                                      02199
                                                                                               B8QS11                                 If continuation sheet 4 of 12
                                                                                                                                              PRINTED         03
                                                                                                                                                              2009
                                                                                                                                                              17

  A                                                                                                                                               FORM APPROVED
      enc     For Health Care Administration

  STATEMENT OF DEFICIENCIES
                                             SUPPLIER
                                             CLIA
                                          X1 PROVIDER
  AND PLAN OF CORRECTION                                                                X2 MULTIPLE CONSTRUCTION                             X3 DATE SURVEY
                                                  IDENTIFICATION NUMBER
                                                                                                                                                  COMPLETED
                                                                                        A BUILDING

                                                                                         B WING
                                                          FL22021042                                                                                03
                                                                                                                                                    2009
                                                                                                                                                    16
  NAME OF PROVIDER OR SUPPLIER                                            STREET ADDRESS
                                                                                            CITY STATE ZIP CODE
  SHORES PEDIATRICS                                                       9715 NE 2ND AVENUE
                                                                          MIAMI                FL
                                                                                  SHORES            33138
   X4 ID                SUMMARY STATEMENT OF DEFICIENCIES
                                                                                          ID                   PROVIDER PLAN OF CORRECTION
                                                                                                               S
   PREFIX            EACH DEFICIENCY MUST BE PRECEDED BY FULL                                                                                                     X5
                                                                                        PREFIX             EACH CORRECTIVE ACTION SHOULD BE
      TAG            REGULATORY OR LSC IDENTIFYING                                                                                                           COMPLETE
                                                               INFORMATION               TAG              CROSS TO THE APPROPRIATE
                                                                                                          REFERENCED                                             DATE
                                                                                                                       DEFICIENCY
      L2833    Continued From          Page   4                                        L2833
                                                                                   i

               that the Lot  had changed however the
                                                            quality
               control records failed to reflect the actual Lot     in
               use




      L2901
               59A GENERAL
               029
               1
               7                                   QUALITY CONTROL                     L2901
               REQUIREMENTS                                                                                                              u
               The                                                                                  A6311
                     laboratory   shall establish and follow written
               quality control procedures for monitoring and
               evaluating the quality of the testing process of                                     vzf                                            rr
               each method to assure the
                                               accuracy and
               reliability of patient test results and reports in
               accordance with CILIA
                                              requirementsThe
                                                                                                                  1
                                                                                                                                         U
                                                                                                                                         L
               laboratory    shall follow the manufacturers
               instructions and recommendations for instrument
               or test system
                              operation and test performance if
               such instructions exceed
                                         requirements specified
              in this rule In the event of a conflict between
              these rules and CILIA
                                     requirements the more
              stringent requirement
                        s                         shall   prevail

                                                                                                                                    l2              1
                                                                                                                                                    t
              This   Requirement        is not met        as   evidenced    by
              Surveyor      10530                                                                   Det        ti ow           VA        1         O IL
                                                                                                                               lr
              FAC
              1
              029
              7
              59A
              Ref
                                                                                                          P
              Based      one
                         observation review of the Coulter
                                                                                                                      T4
              Operator Guide and
              s                                                                                                                     iC
              personnel     on
                                          interview with the
                                   March 16 2009 at
                                                             testing                                Gz                 1   t
                                                                                                                                         tat
                                                     approximately

                                                                                                                           p4to
              30
              11 AM it         was    determined that the
              had   no   written   policies approved by the
                                                                    laboratory
                                                                      director
                                                                                                     OA
                                                                                                      F




              describing
                      the processes of
                                       Complete Blood                                                     Tr                        L
              Count CBC testing performed in the
                                                                    laboratory
              The
                                                                                                    0
                                                                                                    ua
                    findings   showed

              The Coulter ACT
                                     Operator Guide
                                     s                          was   used for
              the   hematology      tests and     none     of the  applicable
              procedures     were     underlined to alert        the testing

AHCA Form 3020
          0001

STATE FORM                                                             021199
                                                                                                          B8QS 11                            If continuation sheet 5 of 12
                                                                                                                                                 17
                                                                                                                                                 2009
                                                                                                                                         PRINTED 03
                                                                                                                                              FORM APPROVED
         Aaencv For HP Cara Arlminicfratinn
                    Alth

         STATEMENT OF DEFICIENCIES
                                                  X1 PROVIDER
                                                     SUPPLIER
                                                     CLIA
     AND PLAN OF CORRECTION                                                                   X2 MULTIPLE CONSTRUCTION                   X3 DATE SURVEY
                                                     IDENTIFICATION NUMBER
                                                                                                                                              COMPLETED
                                                                                              A BUILDING

                                                                                              B WING
                                                            FL22021042                                                                         16
                                                                                                                                               03
                                                                                                                                               2009
         NAME OF PROVIDER OR SUPPLIER                                         STREET     ADDRESS CITY STATE ZIP CODE
         SHORES PEDIATRICS                                                    9715 NE 2ND AVENUE
                                                                              MIAMI      SHORES      FL 33138

          X4 ID                 SUMMARY STATEMENT OF DEFICIENCIES
                                                                                                ID              PROVIDER PLAN OF CORRECTION
                                                                                                                S
         PREFIX              EACH DEFICIENCY MUST BE PRECEDED BY FULL                                                                                        X5
                                                                                              PREFIX         EACH CORRECTIVE ACTION SHOULD BE
              TAG            REGULATORY OR LSC IDENTIFYING                                                                                              COMPLETE
                                                                INFORMATION                    TAG          CROSS TO THE APPROPRIATE
                                                                                                            REFERENCED                                      DATE
                                                                                                                       DEFICIENCY

              L2901    Continued From                5
                                              Page                                          L2901


                       personnel There         was no    evidence that the
                       laboratory      had written
                                             policies describing the
                      actual process from the sample collection to the
                      final report The laboratory had no written
                                                                     by
                                                                    step
                      step procedures showing
                      a
                         Specimen collection labeling processing
                      criteria for specimen
                                             acceptability and rejection
                      b Control procedures
                                                including the description
                      of controls used
                                         identify the number of controls
                      to be run and the
                                               frequency   of their   use    when
                      testing    is   performed
                      c Corrective action to take when control results

                      fail to meet the
                                       laboratory criteria for
                                       s
                      acceptability      Define the criteria for accepting
                      control data      orwhat to do if controls were not
                      within the acceptable limits
                      d Indicate the periodic maintenance calibration
                      and routine sample procedures that were done
                      on   the   analyzer
                      e    The
                            threatening
                            Life test results or panic
                      values and how they would be handled i
                                                           e
                      listingof the actual panic levels and whether the
                      test would be repeated before
                                                      reporting
                      f Indicate the
                                         periodic maintenancecalibration
                      and routine      sample procedure done on             the
                      analyzer
                      g The laboratory system for entering CBC
                              s
                      results in the patient record and
                                                               reporting patient
                      results
                      h   Description of the course of action         to take if     a
                      test sytem becomes inoperable
                      i There    was no      reference to the enrollment
                      performance and participation in an approved
                      proficiency testing program or what records to be
                      kept
                      All policies and procedures must be
                                                            approved by
                      the Director prior to
                                            implementation in the
                      laboratory



nuns                       nnn




QI   r    I     rv
              c rvr                                                         021199
                                                                                                            l38QS11                      If continuation sheet 6 of 12
                                                                                                                                               PRINTED        03
                                                                                                                                                              2009
                                                                                                                                                              17
                                                                                                                                                    FORM APPROVED
  AOencv For HPAIth Cara Ariminietrofinn

 STATEMENT OF DEFICIENCIES
                                                    CLIA
                                                    SUPPLIER
                                                 X1 PROVIDER                               X2 MULTIPLE CONSTRUCTION
 AND PLAN OF CORRECTION                                                                                                                    X3 DATE SURVEY
                                                    IDENTIFICATION NUMBER
                                                                                                                                                   COMPLETED
                                                                                           A BUILDING

                                                                                           B WING
                                                            FL22021042                                                                               16
                                                                                                                                                     03
                                                                                                                                                     2009
  NAME OF PROVIDER OR SUPPLIER                                             STREET     ADDRESS CITY STATE ZIP CODE
  SHORES PEDIATRICS                                                         9715 NE 2ND AVENUE
                                                                            MIAMI SHORES FL 33138

   X4 ID                         SUMMARY STATEMENT OF DEFICIENCIES
                                                                                             ID            S
                                                                                                           PROVIDER PLAN OF CORRECTION
  PREFIX                      EACH DEFICIENCY MUST BE PRECEDED BY FULL                                                                                             X5
                                                                                           PREFIX        EACH CORRECTIVE ACTION SHOULD BE                     COMPLETE
      TAG                    REGULATORY OR LSC IDENTIFYING
                                                                 INFORMATION                TAG         CROSS TO THE APPROPRIATE
                                                                                                        REFERENCED                                                DATE
                                                                                                                         DEFICIENCY
          L2909        Continued From Page 6                                              L2909

                                                                                                                    U           raj
                                                                                                                                tv
          L2909        029
                       7
                       59A GENERAL
                       c
                       2                                QUALITY                           L2909
                       CONTROL REQUIREMENT

                       All
                          equipment and supplies shall be in good
                       working order checked and calibrated for the
                                                                                                         co                   0 G
                                                                                                                              t L
                       proper performance of tests and services offered                                                                          L
                       in   accordance wi    th this rule and CLIA

                       requirements The laboratory must at            a

                       minimum follow the manufacturers                                                                       CQL
                                                                                                                              CfC l        C
                       recommendations and instructions for
                                                             equipment
                       operation and document all such activities
                       required for    maintenance and operation of such
                                                                                                        C G        Y W
                                                                                                                   Cc
                                                                                                                               17y 10
                       equipment
                                                                                                                    mo
                                                                                                                              MRIKA
                                                                                                                              L
                       This   Requirement      is not met   as   evidenced by                                                  2
                       Surveyor      10530
                                                                                                    tw
                       c
                       2
                       029
                       7
                       59A
                       Ref
                       FAC

                       Based    on   review of
                                         patient test records from
                       2007    2008 and
                                      2009 calibration records for
                       2007 and 2008 and interview with the
                                                            testing
                       personnel on March 16 2009 at approximately
                                                                                                                                          c
                       12 30 PM it     was   determined that the                                              rfi
                                                                     laboratory
                   did not
                         perform calibration of the Coulter ACT                    Diff                                   I

                   hematology analyzer at least once every six
                   months                                                                           I              LLB        trt
                                                                                                                                      0

                                                                                                                                    ems    4
                                                                                                                                          T1
                   The       findings showed

                   The  laboratory patient testing records showed
                   that Hematology tes ti ng ha d been
                                                        per formed
                   during 2007 2008 and 2009
                   On the day of the survey            the available
                                                    3
                                                    09
                                                    16
                   records indicated that the Coulter ACT Diff was

                   only calibrated on        September 16
                                                      2008 Ther
                   were no       calibration records for 2007
                                                                                   e

nuns      r




 ni   r       rvrcrv
                                                                          021199
                                                                                                        B8QS 1 1                               If continuation sheet 7 of 12
                                                                                                                                                  PRINTED        1712009
                                                                                                                                                                 03
                                                                                                                                                       FORM APPROVED
      Aaencv For Health Care          Ariminictratinn


      STATEMENT OF DEFICIENCIES
                                                CLIA
                                                SUPPLIER
                                             X1 PROVIDER
      AND PLAN OF     CORRECTION                                                          X2 MULTIPLE CONSTRUCTION                                X3 DATE SURVEY
                                                   IDENTIFICATION NUMBER
                                                                                                                                                       COMPLETED
                                                                                          A BUILDING

                                                                                          B WING
                                                            FL22021042                                                                                  16
                                                                                                                                                        03
                                                                                                                                                        2009
      NAME OF PROVIDER OR SUPPLIER                                       STREET      ADDRESS CITY STATE ZIP CODE
      SHORES PEDIATRICS                                                  9715 NE 2ND AVENUE
                                                                         MIAMI SHORES FL 33138

       X4 ID                  SUMMARY STATEMENT OF DEFICIENCIES
                                                                                            ID                  PROVIDER PLAN OF CORRECTION
                                                                                                                S
                                                                                                                                                                      X5
       PREFIX              EACH DEFICIENCY MUST BE PRECEDED BY FULL                       PREFIX           EACH CORRECTIVE ACTION SHOULD BE                      COMPLETE
        TAG               REGULATORY OR LSC IDENTIFYING
                                                                 INFORMATION               TAG         REFERENCED
                                                                                                       CROSSTO THE APPROPRIATE
                                                                                                                                                                     DATE
                                                                                                                            DEFICIENCY

         L2925       Continued From Page         7                                      L2925

                                                                                                            l    L             L
                                                                                                                               I                 IAA
         L2925
                    3
                    029
                    7
                    59A GENERAL
                    c                                      QUALITY                      L2925
                    CONTROL REQUIREMENTS
                                                                                                   i
                    All control   procedures required         above shall be
                    documented and        av a il abl e   to th e Agency
                                                                         upon                      t4 0A4                            At
                    request
                                                                                                                       T

                    This   Requirement      is not met      as   evidenced    by
                    Surveyor      10530


                    c
                    3
                    029
                    7
                    59A
                    Ref
                    FAC
                    Based  on review of available
                                                  Hematology Quality
                    Control records and patient
                                                testing records from
                    2007 2008 and 2009 and interview with the                                                                                L

                    laboratory testing personnel on March 16 2009                                                                            A
                    at                30PM
                      approximately 12 it was determined
                    that the laboratory was
                                                                                                                       Ur
                                            performing Complete
                    Blood Count CBC testing in 2007 2008 and
                    2009 to date but had not documented re su lt s              of

                    the Hematology controls each day of patient
                                                                                                                                 J
                    testing                                                                                       Lk        Uu           1   E
                                                                                                                                             Iti   rl          C
                                                                                                                       1


                    The   findings   showed


                    The s
                        laboratory Quality Control records
                    consisted of dated Coulter ACT tapes
                                                         showing
                    CBC results for low normal and       controls run
                                                   high                                                                              I   n
                    each   day patient    CBC
                                         testing and dated
                     Cumulative History sheets showing cumulative
                                                                                                                                         1
                    summary CBC results for each level and the
                    dates these controls had been run
                    On the day of the survey the current
                                                                    testing                            W
                                                                                                       L
                    person was unable to locate CBC Quality Control
                    results from September 2007 through July 2008
                    The   daily log showed      that patient test results
                    were
                           reported during    this   period

       n   FV1III   VuVI
                    ouN



J I   HI t   rVKM                                                      021199
                                                                                                       B8QS11                                     If continuation sheet 8 of 12
                                                                                                                                          PRINTED      03
                                                                                                                                                       2009
                                                                                                                                                       17
                                                                                                                                               FORM APPROVED
AnPnc Fnr Haalth rtnra Artminictratinn


STATEMENT OF DEFICIENCIES                                                                                                             X3 DATE SURVEY
                                     SUPPLIER
                                     CLIA
                                  X1 PROVIDER                                    X2 MULTIPLE CONSTRUCTION
AND PLAN OF CORRECTION                 IDENTIFICATION NUMBER                                                                                COMPLETED
                                                                                 A   BUILDING

                                                                                 B WING
                                               FL22021042                                                                                      03
                                                                                                                                               16
                                                                                                                                               2009

NAME OF PROVIDER OR SUPPLIER                                            T   ADDRESS CITY STATE ZIP CODE

SHORES PEDIATRICS



 X4 ID              SUMMARY STATEMENT OF DEFICIENCIES
                                                          E97           NE 2ND AVENUE
                                                                        I SHORES FL

                                                                                     ID
                                                                                           33138

                                                                                                          SPLAN OF CORRECTION
                                                                                                          PROVIDER                                          X5
 PREFIX        EACH DEFICIENCY MUST BE PRECEDED BY FULL                          PREFIX            EACH CORRECTIVE ACTION SHOULD BE                     COMPLETE
  TAG         REGULATORY OR LSC IDENTIFYING INFORMATION                           TAG            REFERENCED
                                                                                                 CROSSTO THE APPROPRIATE                                   DATE
                                                                                                                     DEFICIENCY


   L2925   Continued From              8                                        L2925                 I
                                Page



   L3101                     QUALITY ASSURANCE
                                                                                                                    LT            l
           031
           7
           59A
           1                                                                    L3101

                                                                                                                              WC
           1 Each laboratory must establish and follow
           written policies and procedures for a
                                                                                                C71
                                                                                                                    n
                                                                                                                    v
                                                                                                                     r
           comprehensive quality             program which
                                       assurance

           is designed to monitor and evaluate the ongoing
           and overall quality of the total testing process
           pre analytic post The
           analytic                 analytic
           s
           laboratory quality assurance program must
           evaluate the effectiveness of its policies and
           procedures identify and maintain correction of
                                                                                j11U
                                                                                i                               Pt                         t

                                                                                                                                  i
           problems assure the accurate reliable and                                                      lil

           prompt reporting of test results and assure the
           ade quac y and     com petenc y    of the staff    The                                               v

           laboratory   must revise    policies   and   procedures
           based upon the results of those evaluations              as

           applicable The laboratory must meet the
           standards of this Rule      as   they apply to    the
           services offered test results reported and the

           unique practices of each testing entity
           This                   is not met as evidenced
                  Requirement                                      by
           Surveyor     10530


           1
           031
           7
           59A
           Ref
           FAC

           Based   on observation the absence of a

           laboratory procedure manual and interview with
           the testing personnel on March 16 2009 at

           approximately 12 pm it was determined that
                           30                                                                      Au
           the laboratory did not have written Quality                                                                                j
           Assurance policies and no quality assurance                                                    ti    CL
           system in place to monitor and assess the
           overall testing processes in the laboratory or to
                                                                                                          Mq    I           C
           identify and correct problems identified in the
           Complete Blood Count CBC testing                                                                                           r         t


           The    findings   showed


           On the    day   of the survey the   laboratory    had    no



          0001
AHCA Form 3020

STATE FORM                                                     021199
                                                                                                   B8QS11                                  If continuation sheet 9 of 12
                                                                                                                                                  PRINTED        03
                                                                                                                                                                 2009
                                                                                                                                                                 17
                                                                                                                                                     FORM APPROVED
           r11
            IaI                           AJ             L
                                                 1   1   11         I
                                                              11J11 G
h GI Ili   I   VI   I   Iqua   11   VC11G 14 1




STATEMENT OF DEFICIENCIES                                                                                                                         X3 DATE SURVEY
                                                             SUPPLIER
                                                             CLIA
                                                          X1 PROVIDER                                 X2 MULTIPLE CONSTRUCTION
AND PLAN OF CORRECTION                                                                                                                               COMPLETED
                                                                 IDENTIFICATION NUMBER
                                                                                                      A BUILDING

                                                                                                      B WING
                                                                          FL22021042                                                                   1612009
                                                                                                                                                       03

NAME OF PROVIDER OR SUPPLIER                                                          STREET     ADDRESS CITY STATE ZIP CODE

                                                                                      9715 NE 2ND AVENUE
SHORES PEDIATRICS
                                                                                      MIAMI SHORES FL 33138

                               SUMMARY STATEMENT OF DEFICIENCIES                                        ID                SPLAN OF CORRECTION
                                                                                                                          PROVIDER                                    X5
  X4 ID
                                                                                                                        EACH CORRECTIVE ACTION SHOULD BE         COMPLETE
 PREFIX                  EACH DEFICIENCY MUST BE PRECEDED BY FULL                                     PREFIX
                        REGULATORY OR LSC IDENTIFYING INFORMATION                                      TAG             CROSS TO THE APPROPRIATE
                                                                                                                       REFERENCED                                     DATE
   TAG
                                                                                                                                  DEFICIENCY


                Continued From                                   9                                   L3101
   L3101                                     Page

               written  policies and procedures for a
                comprehensive Quality Assurance plan that
                encompasses pretesting testing and post testing
                with monitoring to evaluate the overall quality of
                the testing process The laboratory
                                           sQuality
                Assurance policies must identify problems take

                action to prevent their occurrence or
                re and continuously improve the
                occurrence

                quality of laboratory patient care The Quality
                Assurance activities must be performed to
                ensure that all testing instrument maintenance

                calibration and quality control policies are
                followed
                The testing personnel verified that the laboratory
                had    written Quality Assurance policies and
                          no

                procedures on the day of the survey

                                                                                                                                              pl J
    L3503                                      STAFFING REQUIREMENTS                                 L3503
                1
                035
                7
                59A
                a

                a Laboratory      director responsibilities The
                di rector i s responsibl e f r the technical and
                                            o

                scientific oversi g ht of the laboratory and must be
                available to the             laboratory              to   provide supervision                      1          Au              v


                as

                is also
                         specified       in this Rule The
                                responsible
                                                                         laboratory director
                                                                            operation and
                                                              for the overall
                                                                                                                          I
                administration of the                          laboratory and for assuring
                compliance              with Ch 483 Part I Fand this
                                                           S
                Rule                                                                                                                      l
                                                                                                                                   I
                This       Requirement                        is not met   as   evidenced   by
                Surveyor              10530



                FAC
                1
                035
                7
                59A
                Ref                                                                                                     1
                Based           on    review of records and interview with
                the testing personnel on March 16 2009 at
                approximately 12 PM it was determined that
                                30
                the laboratory director had failed to provide the                                                          i
                                                                                                                           ti1                     y
                overall management and direction to ensure the

                quality of the patient Complete Blood Count                                                                                                       i

                CBC testing performed in thi s l a bora tory and to

          0001
AHCA Form 3020
                                                                                                                                                    If continuation sheet   10 of 12
STATE FORM                                                                             021199                            B8QS1 1
                                                                                                                                                       17
                                                                                                                                                       2009
                                                                                                                                               PRINTED 03
                                                                                                                                                   FORM APPROVED
                          LL   r          nom
                                          a
          i   vi   i   caiui       aii     u
                                         rai n   nau uuv
h ci n




STATEMENT OF DEFICIENCIES                        SUPPLIER
                                              X1 PROVIDER
                                                 CLIA                                  X2 MULTIPLE CONSTRUCTION                                X3 DATE SURVEY
AND PLAN OF CORRECTION                             IDENTIFICATION NUMBER                                                                          COMPLETED
                                                                                       A BUILDING

                                                                                        B WING
                                                           FL22021042                                                                               03
                                                                                                                                                    16
                                                                                                                                                    2009

                                                                        STREET     ADDRESS CITY STATE       ZIP CODE
NAME OF PROVIDER OR SUPPLIER

                                                                        9715 NE 2ND AVENUE
SHORES PEDIATRICS
                                                                        MIAMI SHORES FL 33138

                           SUMMARY STATEMENT OF DEFICIENCIES                              ID                   PROVIDER PLAN OF CORRECTION
                                                                                                               S                                                   X5
 X4 ID
                        EACH DEFICIENCY MUST BE PRECEDED BY FULL                       PREFIX                EACH CORRECTIVE ACTION SHOULD BE                  COMPLETE
 PREFIX
                       REGULATORY OR LSC IDENTIFYING INFORMATION                         TAG                CROSSTO THE APPROPRIATE
                                                                                                            REFERENCED                                            DATE
  TAG
                                                                                                                        DEFICIENCY


   L3503       Continued From               Page   10                                 L3503
                                                                                                    Mid MuL
                                                                                                     I                         vib
                                                                                                                                     j
                                                                                                                                         tom   r
                      that the CBC testing was performed in
                                                                                                        d eq qlA
               ensure

               accordance to applicable Federal and State
               regulations
                                                                                                              La
               The      findings         showed that the   laboratory   director
               fa il ed t o ensure that                                                                     a              j

               1 The   laboratory was enrolled              inan approve


               proficiency testing program for              2008 and 2009
               See L2501
               2 The   laboratory had participated in             an approve
                                                                                                                       CI                lit
               proficiency testing program for CBC                d uri ng 2007                     l
               and 2008 See L2509
               3 The  procedure manual included all the Coulter
               ACT policies in place for the Hematology testing
                                                                                                                           ACA       A
                                                                                                                                     lu
               performed in the laboratory See L2901
               4 A Quality Control program was established

               and maintained See L2925
                                                                                                        l          V




   L3505       035
               7
               a
               59A
               1                              STAFFING REQUIREMENTS                    L3505            Rwb
               a        L abora tory di rector respo nsibilities


               1  Th e l a bora tory di rector if qua lifi e d i s                                                                   u   LL
                                                                                                                                         aA
               authorized to perform the duties of the general                                          q
               supervisor and clinical laboratory testing
               personnel or delegate these responsibilities to
               personnel meeting the qualifications set forth in
               Ch 483 Part IV F S                   and Rule 590


               2 If the laboratory director delegates
               performance of his or her responsibilities he or
               she remains responsible for ensuring that all
               duties are properly performed




                   This   Requirement            is not met as evidenced     by
                   Surveyor          10530




          0001
AHCA Form 3020
                                                                                                                                                 If continuation sheet   11 of 12
STATE FORM                                                               021199                              B8QS11
                                                                                                                                                     17
                                                                                                                                                     2009
                                                                                                                                             PRINTED 03
                                                                                                                                               FORM APPROVED
            r        u   lab               t
                                           A
                                           r
                                       r       111   11 uau auvII
h CI   1U   FUI      UCIILI I   valc




STATEMENT OF DEFICIENCIES                                                                                                                   X3 DATE SURVEY
                                                        CLIA
                                                        SUPPLIER
                                                     X1 PROVIDER                               X2 MULTIPLE CONSTRUCTION
                                                                                                                                               COMPLETED
AND PLAN OF CORRECTION                                    IDENTIFICATION NUMBER
                                                                                               A BUILDING

                                                                                               B WING
                                                                    FL22021042                                                                      03
                                                                                                                                                    16
                                                                                                                                                    2009

                                                                               STREET     ADDRESS CITY STATE ZIP CODE
NAME OF PROVIDER OR SUPPLIER

                                                                               9715 NE 2ND AVENUE
SHORES PEDIATRICS
                                                                               MIAMI SHORES FL 33138

                            SUMMARY STATEMENT OF DEFICIENCIES                                    ID                SPLAN OF CORRECTION
                                                                                                                   PROVIDER                                     X5
 X4 ID
 PREFIX                   EACH DEFICIENCY MUST BE PRECEDED BY FULL                             PREFIX            EACH CORRECTIVE ACTION SHOULD BE             COMPLETE
                                                                                                                CROSSTO THE APPROPRIATE
                                                                                                                REFERENCED                                      DATE
  TAG                    REGULATORY OR LSC IDENTIFYING INFORMATION                              TAG
                                                                                                                            DEFICIENCY
                i




   L35051           Continued From             Page      11                                   L3505
                                                                                                                                                                       61
                    59A
                    FAC
                    a
                    1
                    035
                    7
                    Ref                                                                                     f
                                                                                                               L
                                                                                                            IJtF         tab                   JJ
                    Based   on            s
                                          laboratory Complete
                                 review of the
                    Blood Count CBC Quality Control records from
                    2008 and 2009 and interview with the testing
                    personnel on March 16 2009 at approximately
                                                                                                                               aft
                    11 AM it
                    30               was determined                 that there was   no

                    documentation     showing              that the director had
                                                squality
                    provided oversight of the laboratory
                    control activities to ensure the quality of the CBC
                                                                                                            L                            yL
                    testing performed in this laboratory

                    The   findings   showed


                    The   laboratory       s   Quality      Control records showed
                    no   documentation such                   as   comments   indicating
                    that the laboratory              director had reviewed the

                    laboratory low normal and high CBC control
                    s
                    results on an ongoing basis On the day of the
                    survey there were no quality control records
                    from September 2007 through July 2008 The
                    daily log showed that patient test results were
                    reported during this period




                                                                                                                                                          I




          0001
AHCA Form 3020
                                                                                                                                              If continuation sheet 12 of 12
STATE FORM                                                                       021199                          B8QS11
                                                                   1



                                    FLORIDAAGENCY FOR HEALTH CARE ADMINISTRATION
 CHARLIE CRIST                                                                                  HOLLY BENSON

     GOVERNOR                                                                                    SECRETARY




March   17   2009




Laura Fernandez MD
      Ortiz
Laboratory Director
Shores Pediatrics
9715 NE   2nd   Avenue

Miami    Shores   Fl 33138




Re Condition deficiencies and Standard deficiencies
   level                      level
      CLIA      1 OD 1062658
      State License     800022409




Dear   Laboratory Director

In order for     laboratory to perform testing under the Clinical Laboratory Improvement
                  a


Amendments of 1988 CLIA Public Law 100 it must comply with all CLIA requirements
                                          578
                                                                                C
                                                                                S
These requirements are found in section 353 of the Public Health Service Act 42 U 263a
and 42 Code of Federal Regulations Part 493 42       R
                                                     F
                                                     C 493 Federal regulations require
onsite surveys to determine whether or not a laboratory is in compliance with the applicable

regulations Compliance with these regulations is a condition of certification for the CLIA
program


The Agency for Health Care Administration conducted arecertification and relicensure survey of
                                                         As a result of the survey it was
your laboratory that was completed on March 16 2009
determined that your facility is not in compliance with all of the Conditions required for
certification in the CLIA program Specifically the following Conditions were not met


D2000     42 CFR 493 Condition
                 801                   Proficiency Testing Enrollment
D2016      42 CFR 493 Condition
                  803                   Proficiency Testing Successful Participation
D6000             1403
           42 CFR 493          Condition Laboratory Director


In               other standards          also found to be not met Enclosed               are   Form   2567
                                                                                                       CMS
     addition                      were


Statement of Deficiencies and State Form of
                                    Statement                            Deficiencies listing   all the deficiencies

found   during   the survey




                                                                                   Tallahassee Field   Office
Headquarters
2727    Mahan   Drive                                                              2727           46
                                                                                         Mahan Dr MS
Tallahassee Florida 32308                                                          Tallahassee FL 32308
                                                       Nr
                                                       DD   WE                     Phone 850
                                                                                          922
                                                                                          8844
 ahca
 http
 com
 myflorida
                                                                                       922
                                                                                       9162
                                                                                   fax 850
                                            level
                                            Condition             of CLIA may not be certified to
Laboratories that do        not meet the                           requirements
                                    under the CLIA program You must take steps to bring any unmet
perform laboratory testing
Conditions into compliance immediately


You   are    directed    to submit    a   credible     allegation   compliance and acceptable evidence of
                                                                    of

correction for the deficiencies cited Please                document your allegation of compliance on both
                                                                            the columns
forms using the enclosed CMS Statement of Deficiencies and State Form in
                          2567
labeled Provider Plan of Correction and Completion Date located on the right side of the
                                                         left The laboratory director must sign
forms keying   your responses to the deficiencies on the
date and return the both the completed CMS and State Form documented with credible
                                         2567
                                                                                        address
allegations of compliance WITHIN 10 DAYS FROM RECEIPT of this notice to the
                                                                                              in
                                                                           up
in the lower right of the first page of this letter We may conduct a follow survey
                                                                            of compliance to be
approximately 30 days to verify the corrections if we find your allegation
                45
                                                                                       submit a
credible and the submitted evidence to be acceptable If your laboratory does not
                                                                          we will not conduct a
credible allegation of compliance and acceptable evidence of correction
                                    of compliance will be included in the public record of the
follow survey Your allegation
up
inspection

A credible    allegation    of compliance is       a   statement   or   documentation that is


                     representative of a laboratory with a history of having maintained
                                                                                                                a
            Made   by   a


              commitment to compliance and taking corrective action when required


            Realistic in    terms   ofthe   possibility ofthe      corrective action     being accomplished
              between the date ofthe survey and the date ofthe                allegation    and



            Indicates resolution ofthe        problems


For your information         acceptable     evidence of correction must include


                                                                                   been taken for         patients
             Documentation      showing     what corrective      action have
                                                                 s
        found     to have    been affected    by   the   deficient practice


                                                                                   the               to   be affected     by
             How the     laboratory   has identified other     patients having           potential
        the    same     deficient practice   and what corrective          s
                                                                          action   has been taken


                                                                                              you have made
                                                                                                                     to
             What measure has been put into place or what systemic                 changes
                                                    not recur and
            ensure that the deficient practice does




                                                                             to ensure the deficient practice does
             How the corrective       action are being monitored
                                      s
            not recur




 If you do not submit a credible allegation of compliance and acceptable evidence of correction
                                of compliance that is determined to be credible but are found to be
 or if
       you submit an allegation
 still out of compliance with any CLIA Condition requirements at the time of the follow
                                         level                                            up
visit   the   Agency   for Health Care Administration will recommend to the Atlanta          Regional Office
of the Centers for Medicare           Medicaid Services
                                                 CMS                    that sanctions be takenagainst your
laboratory CLIA certificate These may include alternative sanctions Civil Money Penalty of
s
up to 3 per day of noncompliance per 42 CFR 493 Directed Plan of Correction per
      000                                         1834
42 CFR 493 State Onsite Monitoring per 42 CFR 493 and principal sanctions
         1832                                            1836
            limitation and revocation of your laboratory CLIA certificate and cancellation
                       or                      s
suspension
of you laboratory approval for Medicare payments per 42 CFR 493
       s                                                    1814

Please note that the routine survey takes an overview of the laboratory through random sampling

By its nature the routine survey may not find every violation that the laboratory may have
committed It remains the responsibility of the laboratory and its director to ensure that the

laboratory     is at all times   following     all CLIA    requirements to identify any problems in the
laboratory     and take corrective action             to the
                                               specific       problems and to institute appropriate quality
assurance measures to      ensure   that   the deficient practices do not recur


                 routine CLIA certification surveys announced or unannounced investigations
In addition to the

surveys may  be conducted by the State agency at any time to address complaints or other non

compliance issues These investigations may well identify violations that may not have
                         surveys
surfaced      during routine survey using random
                       a
                                                             sampling   but for which the   laboratory   and its
director will still be held responsible


If you have                           this   letter please                                       499
                                                                                                 2165
                                                             feel free to contact this office at 305
                questions regarding


 incerely


R Steve
              Emling
Field Office     Manager
Area Office 11




Enclosure       CMS
                2567         Statement of Deficiencies State Form           Statement ofDeficiencies

				
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