INSPECTION TOOL FOR LICENSURE OF A GENERAL CLINICAL LABORATORY by JeffreyVdeGuzman

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A copy of the inspection tool for licensure of a general clinical laboratory in the Philippines. This tool may serve as a guide for self-assessment of the facility in preparation for inspection/ monitoring visits.

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									Revised as of March 31, 2008                                                                          Page 1 of 9



                   INSPECTION TOOL FOR LICENSURE OF A GENERAL CLINICAL LABORATORY


Name of Laboratory: _____________________________________________________________________________

Address: ______________________________________________________________________________________
                           Number & Address                       Barangay/ Municipality

           ______________________________________________________________________________________
                             Province/City                          Region

Contact No./Fax No./E-mail Address: ________________________________________________________________

Application for:                Initial
                                Renewal         License No:             ____________
                                                Date Issued:            ____________
                                                Expiry Date:            ____________

GENERAL INFORMATION:

Name of Owner or Institution: ______________________________________________________________________

Name of Head of Laboratory: ______________________________________________________________________

Classification according to:

                   Ownership:                       Government                              Private

                   Institutional Character:         Institution-based                       Free-standing

                   Service Capability:              Primary
                                                    Secondary
                                                    Tertiary
                                                    Limited


                   LIST ACTUAL SERVICES OFFERED (include Mobile Lab if any)




Instructions:
(1)     Encircle (+) if item indicated is present, and (-) if item indicated is absent/ present but non-functional.
(2)     All items with (*) shall be posted in a conspicuously designated area.
(3)     This tool may serve as a guide for self-assessment of the facility in preparation for inspection/
        monitoring visits.
                                                                                                   Page 2 of 9




                    STANDARDS AND REQUIREMENTS                                 REFERENCE          FINDINGS



      Application Documents

                    Documentary requirements complete                         AO No. 2007-       (+)   (-)
                                                                               0027 Section
                    Certificates valid    and    required    forms    duly     VII. B. – C.      (+)   (-)
                     accomplished                                                p. 7 – 8




1. MANAGEMENT REQUIREMENTS

  1.1. Management Responsibility

      The clinical laboratory shall be managed effectively and efficiently
      and in accordance with its vision, mission, and objectives.

      1.1.1. There shall be a continuing program on staff development          AO No. 2007-
             and training.                                                     0027 Section
                                                                               VI. B. 1. (a) v.
            1.1.1.1. Proof of training through relevant certificates, memos,        p. 5          (+)   (-)
                     written reports, budgetary allocations, etc.

      1.1.2. There shall be a policy for hiring, orientation and promotion     AO No. 2007-
             for all levels of personnel.                                      0027 Section
                                                                                VI. B. 1. (a)
            1.1.2.1. Documented procedure/ process on hiring, orientation           p. 5          (+)   (-)
                     and promotion of personnel at all levels

      1.1.3. There shall be a policy for discipline, suspension, demotion      AO No. 2007-
             and termination of personnel at all levels.                       0027 Section
                                                                                VI. B. 1. (a)
            1.1.3.1. Documented procedure/ process on discipline,                   p. 5          (+)   (-)
                     suspension, demotion and termination of personnel at
                     all levels
                                                                                                       Page 3 of 9

                STANDARDS AND REQUIREMENTS                                       REFERENCE            FINDINGS

1.2. Manpower

   The clinical laboratory shall be organized to provide effective and
   efficient laboratory services.

    1.2.1. The organizational chart shall be clearly structured.                 AO No. 2007-
                                                                                 0027 Section
          1.2.1.1. Organizational chart clearly structured indicating the         VI. B. 1. (a)       (+)   (-)
                   names with pictures and designation, reflecting lines of           p. 5
                   authority,    accountability,    communication,      inter-
                   relationship, hierarchy of functions and flow of referrals

    1.2.2. Duties and responsibilities shall be clearly spelled out.

          1.2.2.1. Documented duties and responsibilities of all clinical                             (+)   (-)
                   laboratory personnel




    1.2.3. The general clinical laboratory shall be headed and managed           AO No. 2007-
           by a Clinical and/ or Anatomic Pathologist certified by the            0027 Section
           Philippine Board of Pathology (PBP). If the head is certified         VI. B. 1. (a) i. –
           in Anatomic Pathology only, there shall be a consultant                    iii. p. 5
           certified in Clinical Pathology.

          1.2.3.1. The clinical laboratory shall be headed and managed                                (+)   (-)
                   by a licensed physician certified by the Philippine Board
                   of Pathology. This shall apply to all general clinical
                   laboratories be they government or private, institution
                   based or freestanding.

          1.2.3.2. In laboratories offering Clinical Pathology services only,                         (+)   (-)
                   the head of such laboratory shall be certified in Clinical
                   Pathology or in both Clinical Pathology and Anatomic
                   Pathology.

          1.2.3.3. In laboratories offering both Anatomic and Clinical                                (+)   (-)
                   Pathology services, the head shall be certified in both
                   Anatomic and Clinical Pathology; if the head is certified
                   in Clinical Pathology only, he should have an associate
                   in Anatomic Pathology; and if the head is certified in
                   Anatomic Pathology only, he should have an associate
                   in Clinical Pathology.

          1.2.3.4. In tertiary clinical laboratories, the head shall undergo                          (+)   (-)
                   additional training in either laboratory management for
                   a period of at least 2 weeks or its equivalent or for
                   health service management for a period of no less than
                   2 months or its respective equivalent; however, those
                   with masters degree in hospital or health administration
                   or in public health or in business administration with
                   major in health services administration or their
                   equivalent shall be deemed to have complied with this
                   requirement.
                                                                                   Page 4 of 9

     STANDARDS AND REQUIREMENTS                                       REFERENCE   FINDINGS

1.2.3.5. An anatomic pathologist who has been head of a                           (+)   (-)
         primary or secondary clinical laboratory or a pathologist
         who has been head of a tertiary clinical laboratory but
         has not had laboratory management training as defined
         in item #1.2.3.4 for a period of at least 5 years at the
         time of effectivity of this A.O., shall continue to remain
         in such post up to and until his eventual retirement,
         resignation, end of term or termination for just cause.
         Any and all successors must comply with the provisions
         above; provided however, that this shall not prevent
         those falling under this provision from again assuming
         headship of a laboratory if and when the exigencies of
         the service so require.

1.2.3.6. An anatomic pathologist who currently heads primary or                   (+)   (-)
         secondary clinical laboratories for a period of less than
         5 years at the time of effectivity of this A.O., shall
         remain as head of such laboratories provided he/ she
         completes additional training in laboratory management
         within a period of one year. He/ she is allowed to retain
         headship of such laboratories in a prescribed
         geographic area of practice as may be determined by
         the Philippine Society of Pathologists (PSP).

1.2.3.7. In areas where clinical pathologists are not readily                     (+)   (-)
         available, as certified by the PSP, the BHFS shall allow
         the following to handle primary or secondary clinical
         laboratories in the following order of priority:

                   Board certified anatomic pathologists who
                    have had training in clinical pathology for at
                    least 2 years;
                   Board certified anatomic pathologists who
                    have no training in clinical pathology;
                   Licensed physicians who are not board
                    certified in either clinical or anatomic
                    pathology but who have residency training in
                    clinical pathology for at least 2 years.

1.2.3.8. In areas where pathologists are not readily available, as                (+)   (-)
         certified by the PSP, the BHFS shall allow duly licensed
         physicians who shall have undergone and successfully
         completed training in clinical laboratory medicine,
         quality assurance and laboratory management
         conducted by the BRL, CHD or PSP and jointly certified
         to with BHFS to head only one hospital clinical
         laboratory.

1.2.3.9. The head shall assume the technical and administrative                   (+)   (-)
         supervision and control of the clinical laboratory.
                                                                                                     Page 5 of 9

               STANDARDS AND REQUIREMENTS                                      REFERENCE            FINDINGS

    1.2.4. There is an adequate number of qualified staff with                 AO No. 2007-
           documented training and experience to conduct the                   0027 Section
           laboratory procedures performed.                                    VI. B. 1. (a) iii.
                                                                                  – iv. p. 5
          1.2.4.1. The staff shall be supervised by the head of the                                 (+)   (-)
                   laboratory.

          1.2.4.2. There shall be sufficient number of registered medical                           (+)   (-)
                   technologists proportional to the workload as
                   determined by the head of the lab and shall be
                   available at all times during hours of lab operation. For
                   hospital-based clinical labs, there shall be an adequate
                   number of med techs per shift to cover laboratory
                   operations.



1.3. PHYSICAL FACILITIES/ Work Environment

    Adequate facility shall be in place for the safe and efficient
    operation of the clinical laboratory.

    1.3.1. The clinical laboratory has adequate space for the conduct          AO No. 2007-
           of its activities.                                                  0027 Section
                                                                               VI. B. 1. (h) ii.
          1.3.1.1. Ocular inspection demonstrates adequate space for the            p. 6            (+)   (-)
                   equipment, furniture, storage of glassware, reagents
                   and supplies and the activities of the laboratory staff

          1.3.1.2. Work area accessible to laboratory personnel only and                            (+)   (-)
                   at least 10 square meters exclusive of areas not used
                   for technical work.



    1.3.2. The clinical laboratory shall be adequately ventilated, well-       AO No. 2007-
           lighted, clean, safe and functional based on the services it        0027 Section
           provides.                                                           VI. B. 1. (h) iii.
                                                                                    p. 6
          1.3.2.1. Ocular inspection demonstrates good ventilation,                                 (+)    (-)
                   lighting, cleanliness with no risk of physical and
                   chemical hazards



    1.3.3. There shall be a program of proper maintenance and                  AO No. 2007-
           monitoring of physical plant and facilities.                        0027 Section
                                                                               VI. B. 1. (h) iv.
          1.3.3.1. Documented program for the proper maintenance and                 p. 6           (+)    (-)
                   monitoring of physical plant and facilities



    1.3.4. There shall be a policy on laboratory biosafety and                 AO No. 2007-
           biosecurity and for the proper disposal of waste and                0027 Section
           hazardous/ infectious substances that shall conform to the          VI. B. 1. (h) v.-
           standards set by the DOH.                                               vi. p. 6

          1.3.4.1. Documented procedure/ process on laboratory                                      (+)   (-)
                   biosafety and biosecurity and for the proper disposal of
                   waste and hazardous/ infectious substances
                                                                                                   Page 6 of 9

              STANDARDS AND REQUIREMENTS                                      REFERENCE           FINDINGS

1.4. EQUIPMENT

   Adequate equipment shall be in good working order.

   1.4.1. There is an adequate number of operational equipment to             AO No. 2007-
          provide the laboratory procedures the laboratory is licensed        0027 Section
          for.                                                                 VI. B. 1. (b)
                                                                                  i. p. 5
         1.4.1.1. Equipment listed available in the laboratory                                    (+)   (-)

         1.4.1.2. Equipment are operational.                                                      (+)   (-)

         1.4.1.3. Provision for personal protective equipment                                     (+)   (-)


   1.4.2. There is a program for calibration, preventive maintenance          AO No. 2007-
          and repair for the equipment.                                       0027 Section
                                                                               VI. B. 1. (b)
         1.4.2.1. Record of schedule of calibration and maintenance of            ii. p. 5        (+)   (-)
                  equipment

         1.4.2.2. Record of reports of preventive maintenance and repair                          (+)   (-)




   1.4.3. There is a contingency plan in case of equipment                    AO No. 2007-
          breakdown.                                                          0027 Section
                                                                               VI. B. 1. (b)
         1.4.3.1. Documented contingency plan in case of equipment                iii. p. 5       (+)   (-)
                  breakdown



1.5. REAGENTS AND SUPPLIES

   Adequate reagents and supplies shall be in good working order.

   1.5.1. There is an adequate supply of properly stored and                  AO No. 2007-
          inventoried reagents and supplies for the laboratory                0027 Section
          examinations to be provided.                                         VI. B. 1. (c)
                                                                                i.- ii. p. 5
         1.5.1.1. Quality records of reagents/ supplies, their usage/                             (+)   (-)
                  consumption and disposal are available


   1.5.2. The reagents and supplies are stored under the required             AO No. 2007-
          conditions. There are adequate storage facilities such as           0027 Section
          refrigerators for perishable reagents and supplies.                  VI. B. 1. (c)
                                                                                 iii. p. 5
         1.5.2.1. Temperature monitoring records                                                  (+)    (-)



   1.5.3. There is appropriate storage area/ technique for flammable,         AO No. 2007-
          combustible and hazardous chemicals/ reagents.                      0027 Section
                                                                              VI. B. 1. (h) v.-
         1.5.3.1. Material Safety Datasheet (MSDS) available for all              vi. p. 6        (+)   (-)
                  reagents/ supplies and accessible to all personnel at all
                  times
                                                                                             Page 7 of 9

              STANDARDS AND REQUIREMENTS                                   REFERENCE        FINDINGS

1.6. ADMINSTRATIVE POLICIES AND PROCEDURES

   Policies and procedures for provision of laboratory services are        AO No. 2007-
   formulated for the laboratory and in each of the sections.              0027 Section
                                                                            VI. B. 1. (d)
   1.6.1. Documented and updated policies and procedures for                    p. 5        (+)   (-)
          provision of laboratory services in the laboratory and in
          each of the sections

   1.6.2. Documented policies, protocols, guidelines in the operation                       (+)   (-)
          and maintenance of the laboratory

   1.6.3. Documented policies and procedures on Point of Care              AO No. 2007-     (+)   (-)
          Testing, if hospital based                                       0027 Section
                                                                           VI. A. 6. p. 5

1.7. COMMUNICATION AND RECORDS

   There shall be a system of communication, reporting and recording
   of results of examinations.

   1.7.1. There are procedures for the receipt and performance of          AO No. 2007-
          routine and STAT requests for laboratory examinations.           0027 Section
                                                                            VI. B. 1. (g)
         1.7.1.1. Documented procedures for receipt and performance of         i. p. 6      (+)   (-)
                  routine and STAT requests for laboratory examinations

   1.7.2. There are procedures for reporting of results of routine and     AO No. 2007-
          STAT laboratory examinations.                                    0027 Section
                                                                            VI. B. 1. (g)
         1.7.2.1. Documented procedures for reporting of results of            ii. p. 6     (+)   (-)
                  routine and STAT laboratory examinations

   1.7.3. All laboratory reports on various examinations of specimens      AO No. 2007-
          shall bear the name of the pathologist or designated             0027 Section
          associate who shall be responsible for the reliability of the     VI. B. 1. (g)
          results. The reports shall bear the name of the registered           iii. p. 6
          medical technologist(s) who performed the examinations
          and duly signed by that person(s). Electronic signatures will
          be permitted in accordance to the E-Commerce Law.

         1.7.3.1. Laboratory report forms bearing the name of the head                      (+)    (-)
                  or associate

         1.7.3.2. Laboratory reports signed by the medical technologists                    (+)    (-)
                  who performed the examinations

   1.7.4. There are procedures for reporting of work load, quality         AO No. 2007-
          control, inventory control, etc.                                 0027 Section
                                                                            VI. B. 1. (g)
         1.7.4.1. Documented procedures for reporting of work load,           iv. p. 6      (+)   (-)
                  quality control, inventory control, etc

   1.7.5. There is a procedure for reporting and analysis of incidents,    AO No. 2007-
          adverse events, etc.                                             0027 Section
                                                                            VI. B. 1. (g)
         1.7.5.1. Documented procedure for reporting and analysis of           v. p. 6      (+)   (-)
                  incidents, adverse events, etc

   1.7.6. The retention of records of the laboratory shall follow          AO No. 2007-
          standards promulgated by the Department of Health and/ or        0027 Section
          competent professional organizations.                             VI. B. 1. (g)
                                                                              vi. p. 6
         1.7.6.1. Documented procedure for the retention of records                         (+)   (-)
                  which follows standards promulgated by the
                  Department of Health
                                                                                                   Page 8 of 9

                 STANDARDS AND REQUIREMENTS                                      REFERENCE        FINDINGS

2. TECHNICAL REQUIREMENTS

  2.1. TECHNICAL PROCEDURES

      The laboratory shall use appropriate technical procedures for              AO No. 2007-
      services provided in each section, which will assure the quality of        0027 Section
      laboratory results.                                                         VI. B. 1. (e)
                                                                                      p. 6
      2.1.1. Technical procedures of services provided in each section
             are available.

            2.1.1.1. Documented technical procedures for services provided                        (+)   (-)
                     in each section


  2.2. QUALITY ASSURANCE PROGRAM

      The laboratory shall practice quality assurance program.

      2.2.1. There shall be a policy on Quality Assurance Program and            AO No. 2007-
             Continuous Quality Improvement.                                     0027 Section
                                                                                  VI. B. 1. (f)
            2.2.1.1. Documented Internal Quality Assurance Program                   i. p. 6      (+)   (-)
                     including Internal Quality Control and Continuous
                     Quality Improvement

            2.2.1.2. Results/ findings     of   Quality   Assurance    audits/                    (+)   (-)
                     assessments

      2.2.2. The laboratory shall participate in an External Quality             AO No. 2007-
             Assessment Program (EQAP) administered by the                       0027 Section
             designated National Reference Laboratories (NRL) or other            VI. B. 1. (f)
             EQAP approved by the BHFS-DOH.                                         ii. p. 6

            2.2.2.1. Documented procedure in the actual performance of                            (+)   (-)
                     the EQAP activities administered by the NRLs.

            2.2.2.2. Certificate of participation of the laboratory in an EQAP                    (+)   (-)
                     administered by the NRLs or by a NEQAP approved by
                     the BHFS-DOH


  2.3. REFERRAL OF EXAMINATIONS OUTSIDE OF THE CLINICAL
       LABORATORY

      When laboratory examinations are referred to and provided by an            AO No. 2007-
      outside clinical laboratory, the referring clinical laboratory shall       0027 Section
      obtain assurance of the quality of services provided through an             VI. B. 1. (i)
      agreement or its equivalent with a licensed clinical laboratory                 p. 6
      performing the laboratory services needed.

      2.3.1. There shall be a policy on referral and outsourcing of
             examinations.

            2.3.1.1. MOA or its equivalent on referral of laboratory services                     (+)   (-)
                     to outside duly licensed clinical laboratory

            2.3.1.2. Documented Procedures on referral and outsourcing of                         (+)   (-)
                     examinations to other licensed clinical laboratories

            2.3.1.3. SOPs and records of outsourced examinations                                  (+)   (-)
                                                                                                                Page 9 of 9


Note for presence of other laboratories in the vicinity: If any, indicate the kind of laboratory and provide details.

            Research Lab                               Special Clinical Lab
            Teaching Lab                               Animal Lab
            Pulmo Lab, Neurology Lab, etc.             Others, specify: _________________________________

        Remarks:
        _________________________________________________________________________________
        _________________________________________________________________________________
        _________________________________________________________________________________
        _________________________________________________________________________________
        _________________________________________________________________________________



RESULT:

                     Compliance            -     Comply with ALL standards and requirements

                     Non-Compliance        -     Does not comply with ALL standards and requirements




Regulatory Officers:


_______________________________                    ____________________               __________________
    Signature over Printed Name                          Designation                        Date

_______________________________                    ____________________               __________________
    Signature over Printed Name                          Designation                        Date



Authorized Representative(s) of the Clinical Laboratory:


_______________________________                    ____________________               __________________
    Signature over Printed Name                          Designation                        Date

_______________________________                    ____________________               __________________
    Signature over Printed Name                          Designation                        Date

								
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