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					federal register
                   Friday
                   September 15, 1995




                   Part II

                   Department of
                   Health and Human
                   Services
                   Health Care Financing Administration

                   42 CFR Part 493
                   CLIA Program; Categorization and
                   Certification Requirements for a New
                   Subcategory of Moderate Complexity
                   Testing; Proposed Rule




                                                          47981
47982           Federal Register / Vol. 60, No. 179 / Friday, September 15, 1995 / Proposed Rules

DEPARTMENT OF HEALTH AND                     Allison Herron Eydt, HCFA Desk                 In response to publication of the
HUMAN SERVICES                               Officer.                                    February 28, 1992 regulations, we
                                                Copies: To order copies of the Federal   received approximately 16,000 letters
Health Care Financing Administration         Register containing this document, send     from professional organizations and
                                             your request to: New Orders,                individuals providing around 71,000
42 CFR Part 493                              Superintendent of Documents, P.O. Box       comments.
[HSQ–222–P]                                  371954, Pittsburgh, PA 15250–7954.             In response to those comments, we
                                             Specify the date of the issue requested     have published three rules (in addition
RIN 0938–AG98                                and enclose a check or money order          to this proposed rule). One of those
                                             payable to the Superintendent of            rules responds to the comments
CLIA Program; Categorization and                                                         received on the waived criteria, tests
                                             Documents, or enclose your Visa or
Certification Requirements for a New                                                     presently included in the waived
                                             Master Card number and expiration
Subcategory of Moderate Complexity                                                       category and those tests that
                                             date. Credit card orders can also be
Testing                                                                                  commenters believed should be added.
                                             placed by calling the order desk at (202)
AGENCY:  Health Care Financing               512–1800 or by faxing to (202) 512–         At our request, the CLIAC evaluated the
Administration (HCFA) and Public             2250. The cost for each copy is $8.00.      waived category and suggested that the
Health Service (PHS), HHS.                   As an alternative, you can view and         Centers for Disease Control and
ACTION: Proposed rule.                       photocopy the Federal Register              Prevention (CDC) clarify the criteria and
                                             document at most libraries designated       develop a process for review of requests
SUMMARY: In this proposed rule we are        as Federal Depository Libraries and at      for waiver. We clarified the criteria for
responding to some of the comments on        many other public and academic              waiver and the process for requesting
categories of tests received in response     libraries throughout the country that       waived categorization and published the
to the rule published on February 28,        receive the Federal Register.               clarified criteria and process for
1992. To reduce the regulations burden       FOR FURTHER INFORMATION CONTACT:            requesting waiver in a proposed rule
on laboratories, we are proposing to         Rosemary Bakes-Martin (404) 488–7655,       with comment on September 13, 1995
revise our regulations to create a new       for questions regarding the APT             (60 FR 47534). (The other two rules
subcategory of high quality moderate         requirements and criteria for APT           appeared in the Federal Register on
complexity procedures called accurate        categorization; and Judy Yost, (410)        January 19, 1993 (58 FR 5215) and on
and precise technology (APT) tests.          786–3531, for certificate, fee, and         April 24, 1995.
                                                                                            In this rule, in response to numerous
DATES: Comments will be considered if        inspection issues.
                                                                                         comments regarding the test complexity
we receive them at the appropriate
                                             SUPPLEMENTARY INFORMATION:                  model, we are proposing to establish a
address, as provided below, no later
                                             I. Background                               new subcategory of moderate
than 5 p.m. on November 14, 1995.
                                                                                         complexity that would include high
ADDRESSES: Mail written comments (1             Under section 353 of the Public          quality tests that would be subject to
original and 3 copies) to the following      Health Service Act (42 U.S.C. 263a), as     less stringent requirements.
address: Centers for Disease Control and     amended by the Clinical Laboratory          Establishment of this subcategory
Prevention, Public Health Service,           Improvement Amendments of 1988              should encourage manufacturers to
Department of Health and Human               (CLIA), all laboratories that examine       produce accurate, easy-to-use test
Services, Attention: HSQ–222–P, 4770         human specimens for the diagnosis,          systems for use by physicians and
Buford Highway, N.E., MSF11, Atlanta,        prevention or treatment of any disease      laboratories to improve test quality and
Georgia 30341–3724.                          or impairment of, or the assessment of      enhance patient care.
  If you prefer, you may deliver your        the health of, human beings, must meet
written comments (1 original and 3           certain requirements to perform the         II. Response to Comments Received to
copies) to one of the following              examination. In accordance with the         Previous CLIA Regulations
addresses: Room 714–B, Hubert H.             law, regulations implementing CLIA             In this rule we address additional
Humphrey Building, 200 Independence          that HHS published on February 28,          comments received in response to the
Avenue, SW., Washington, DC 20201.           1992 (57 FR 7002) established               establishment of the three testing
  Because of staffing and resource           laboratory requirements based on the        categories. Below we have provided a
limitations, we cannot accept comments       complexity of the tests performed. There    general overview of the comments and
by facsimile (FAX) transmission. In          are currently three test categories:        our responses, followed by some
commenting, please refer to file code        waived, moderate, and high complexity.      additional specific comments
HSQ–222–P. Comments received timely             Following publication of the February    concerning the categories of testing and
will be available for public inspection as   28, 1992 regulations, HHS established a     our response to these comments, which
they are received, generally beginning       Clinical Laboratory Improvement             includes the rationale used to develop
approximately 3 weeks after publication      Advisory Committee (CLIAC) to advise        the proposed accurate and precise
of a document, in Room 309–G of the          and make recommendations on                 technology (APT) subcategory.
Department’s offices at 200                  technical and scientific aspects of the        Upon review of the comments, we
Independence Avenue, SW.,                    regulations. The CLIAC is composed          believe that additional revision of the
Washington, DC, on Monday through            primarily of individuals involved in the    test categorization model is warranted.
Friday of each week from 8:30 a.m. to        provision of laboratory services, use of    The revisions to the regulations
5 p.m. (phone: (202) 690–7890).              laboratory services, development of         proposed in this rule would address the
  For comments that relate to                laboratory testing devices or               commenters’ concerns that many high
information collection requirements,         methodologies, and others as approved       quality tests are less complex than many
mail a copy of comments to: Office of        by HHS. The CLIAC has four                  of the tests currently categorized as
Information and Regulatory Affairs,          subcommittees: cytology; personnel;         moderate complexity, but they do not
Office of Management and Budget,             proficiency testing, quality control and    meet the criteria for waiver. The
Room 10235, New Executive Office             quality assurance; and test                 commenters feel and we agree that these
Building, Washington, DC 20503, Attn:        categorization.                             tests should be subject to less stringent
               Federal Register / Vol. 60, No. 179 / Friday, September 15, 1995 / Proposed Rules                              47983

requirements than those currently             determining types of laboratory services        To obtain broad public review, we are
associated with moderate complexity           to provide.                                  publishing this proposed rule and
tests.                                           We therefore designed a subcategory       encourage commenters to provide
  In addition, we received numerous           of moderate complexity testing that we       suggestions on how we might revise the
comments from professional                    proposed to call APT testing that would      CLIA requirements to ensure that they
organizations and individuals                 include high quality, less complex tests     promote access to quality services and
expressing concern about the burden           that would be unique in that the test        stimulate technological advances in
associated with regulating laboratories       system instructions would not only           testing. With respect to the provisions
based on test complexity and the criteria     contain complete procedures for test         contained in this rule, we are seeking
used to categorize tests as moderate or       performance, including instructions          specific suggestions and
high complexity. Many commenters              regarding the preanalytic, analytic and      recommendations concerning the
indicated that the special circumstances      postanalytic phases of testing, but          criteria and process for categorizing
involved in physician offices, rural and      would also include protocols that would      tests in the APT subcategory, as well as
public health clinics providing               assist laboratories in meeting the CLIA      comments on the appropriateness of the
laboratory services should justify            requirements. We proposed that, in           proposed requirements for APT testing.
minimizing the regulatory burden on           order to be considered for categorization
them. Some commenters believed that                                                        III. Provisions of the Proposed Rule
                                              in the APT subcategory, the producer or
regulating laboratories on the basis of       manufacturer of the test system would        Criteria for APT Categorization
test complexity and the requirements          have to submit data demonstrating that
applicable to moderate and high                                                               In this rule, we are proposing to
                                              the test system meets the criteria for       establish at 42 CFR 493.18 a new
complexity tests would increase the cost      APT categorization. In addition, the test
of laboratory testing. Several                                                             subcategory of moderate complexity
                                              system instructions would have to            testing designated as APT, and we are
commenters thought this regulatory            specify clearly what laboratories must
burden would cause many laboratories                                                       outlining the proposed criteria for
                                              do to be in compliance with the CLIA         determining which tests would be
to discontinue providing services,            requirements. For APT testing,
thereby limiting health care in                                                            categorized as APT. The proposed
                                              laboratories could rely on the               criteria for inclusion in the APT
underserved and rural areas. Some             manufacturer’s or producer’s test system
commenters recommended reducing                                                            subcategory are structurally similar to
                                              instructions to meet the CLIA                our proposed clarifications to the
some of the regulatory burden by              requirements. Since, for APT testing,
creating a category of tests at a level                                                    criteria for waived tests published on
                                              compliance with the CLIA requirements        September 13, 1995.
between waived and moderate
                                              would be based on laboratories                  For quantitative and qualitative tests,
complexity. Other commenters
                                              following the test system instructions,      the similarities between the proposed
suggested creating additional categories
                                              we believe that random, rather than          criteria for APT categorization and the
and provided examples for alternatives
                                              routine, inspections of laboratories         proposed clarifications to the criteria for
to the current test complexity model.
  In response to these comments, the          having an APT certificate would be           waiver are as follows:
CDC developed a proposal to create a          sufficient.                                     • Quantitative APT tests and
new subcategory of moderate                      We discussed with the CLIAC the           quantitative waived tests would have to
complexity that would include simple,         proposed criteria and requirements to be     meet similar test characteristics and
easy-to-use tests with proven accuracy        applicable to the new subcategory. The       performance specifications by
and precision and therefore would             CLIAC supported the concept of the           demonstrating, through scientifically
require somewhat less stringent               APT subcategory. However, the CLIAC          valid studies, a high level of accuracy
requirements than the requirements            expressed the view that the subcategory      and precision.
currently applicable to other moderate        (as currently structured) would not             • Qualitative APT tests would have to
complexity tests.                             provide the amount of regulatory relief      meet the same requirements for
  During the development of the               desired by many commenters who               allowable error as we have proposed for
subcategory, we were especially               requested revisions to the complexity        qualitative waived tests.
cognizant of the concerns of the              model. We understand the CLIAC’s                The proposed criteria for inclusion in
commenters who stated that there are          concerns; however, we believe that it is     the APT subcategory would differ from
many high quality, moderate complexity        essential that we reevaluate the             the proposed criteria for waiver in that:
tests that might not qualify for waiver,      complexity model to determine whether           • Waived tests must be fail-safe with
but, on the other hand, should not be         the regulations are effective in ensuring    no operator intervention, whereas APT
subject to the full range of requirements     public access to quality laboratory          test protocols could allow some operator
currently applicable to moderate              services. When we established the CLIA       intervention to investigate questionable
complexity testing. We agree with the         requirements in 1992, we sought to           results and to resolve test system
commenters that regulatory relief for         devise a regulatory model based on the       failures.
high quality tests is appropriate. In         complexity of testing performed that            • Waived qualitative tests are limited
order to justify less stringent application   would establish the minimum                  to reagent impregnated devices (such as
of the requirements, we are proposing         requirements necessary to ensure             dipsticks), whereas qualitative APT tests
that the tests meet rigid performance         accurate testing. At this point, we          would not be limited to any specific
specifications and have demonstrated,         believe there are many highly accurate,      type of technology. [It is important to
through scientifically valid studies, a       simple, easy-to-use test systems             clarify what is meant by qualitative tests
high level of accuracy and precision.         currently categorized as moderate            in this regulation. Qualitative tests are
Through this process, test systems            complexity that could be eligible for less   test methods that provide two
would be evaluated to ensure they             stringent requirements, and laboratories     categorical responses (e.g., positive/
provide quality results and physicians        performing such testing should be            negative or presence/absence). For these
and laboratories would have access to         provided financial and regulatory relief     types of tests, the concentration of the
this categorization information to            through a reduction in the CLIA              analyte is defined as being above or
employ in test selection and                  requirements.                                below a certain discrimination zone that
47984          Federal Register / Vol. 60, No. 179 / Friday, September 15, 1995 / Proposed Rules

defines negativity or positivity.] On the     meeting the CLIA requirements. The test    tests. Laboratories that qualify for a
other hand, test methods that give            system instructions should remind          certificate of APT tests would have to
results by defining specific absorbance       laboratories to enroll in an HHS-          pay a fee for the issuance of a certificate.
values at which tests will be considered      approved proficiency testing program, if   Each laboratory would be assessed a fee
positive are essentially quantitative tests   applicable.                                representing the certificate fee and a fee
in that they directly depend on defined          Since many manufacturers are            for the costs of the random inspections.
concentrations of the analyte producing       currently providing this type of           The certificate fee would be based on
the discrete absorbance value. In this        assistance to laboratories, often in the   the fee schedule (which is based on the
regulation, we are proposing to consider      form of complete protocols containing      test volume and scope of specialties
the latter as quantitative tests.             instructional materials that cover all     tested) in effect. This fee would
   • Waived tests may use only direct         aspects of the regulations and, in         represent the APT laboratory’s share of
unprocessed specimens, have direct            addition, examples of suggested forms      the general cost to HHS of administering
readout of results and require no             to use to document monitoring              the laboratory certification program.
invasive troubleshooting or electronic or     activities, we believe that the APT        This would include, but would not be
mechanical maintenance. However,              subcategory merely strengthens and         limited to, the cost of issuing the
APT tests could have simple                   confirms that interaction between the      certificate, the cost of collecting fees, the
noncalculated conversions and some            producer of the test system and the        administrative costs of determining
troubleshooting and maintenance               laboratory user. Formalizing this          which tests would qualify for inclusion
performed by the analyst.                     relationship and making it uniform for     in the APT test category, and the
   • Instructions for performance of          all manufacturers and producers of         administrative costs associated with
waived tests must be written at no            these test systems should reduce the       processing and evaluating laboratory
higher than a seventh grade reading           regulatory burden on laboratories, while   applications. The fee for random
level and include a description of the        providing an effective mechanism for       inspection would represent the cost to
analytic skills required to perform the       laboratories to achieve regulatory         HHS of conducting random inspections
test. APT test instructions would have        compliance with the CLIA                   of approximately five percent of the
no such requirements, since personnel         requirements.                              laboratories issued a certificate for APT
performing APT testing would, at a               We encourage individuals to submit      tests to assess compliance with the
minimum, have to have a high school           their comments and suggestions on how      applicable requirements of 42 CFR part
diploma, or equivalent, and relevant          we might improve the APT                   493. Random inspection costs would be
training.                                     categorization criteria or process and     shared by all laboratories issued a
   • Quantitative waived tests may have       revise the regulations to incorporate      certificate for APT tests.
a certain amount of random error but          these changes. Following review of
                                              comments received in response to this        If, in the case of a laboratory subject
they must be shown to be essentially
                                              notice, we will make the necessary         to a random inspection, it is determined
free of systematic error, whereas
                                              revisions to the APT requirements,         that a follow-up survey is necessary
quantitative APT tests would be allowed
                                              including the criteria for APT             because of identified deficiencies, HHS
a minimal amount of error that may be
                                              categorization and the process for         would assess that laboratory an
either random or systematic, or both.
                                              reviewing requests for APT                 additional fee to cover the cost of the
Review Process                                categorization of test systems.            follow-up survey activities. The fee
  Also at § 493.18, we are proposing the         After a final rule responding to the    would be based on the actual resources
process for approving tests for the APT       comments received to this proposed         and time necessary to perform the
subcategory. We are proposing that            rule is published establishing the APT     follow-up visits. Failure of a laboratory
requests for placement of tests in this       subcategory, requests for APT              to pay any assessed costs would result
subcategory be in conformance with the        categorization may be submitted for        in HHS revoking the laboratory’s
proposed submission process outlined          review. Once a test system review has      certificate.
in this regulation. The data submitted        been completed, the manufacturer or        Patient Test Management
for evaluation would have to meet             producer would be notified of the APT
specific criteria related to operational      categorization decision, whether denied      We are proposing to add a new
characteristics, ease of use, and test        or granted. APT categorization would be    § 493.1102 to subpart J (patient test
performance. The test system’s                effective on the date of notification to   management) to include the new patient
instructions will be reviewed by PHS to       the applicant. Any test categorized as     test management requirements that
ensure that laboratories can rely on          APT also would be published in the         would be applicable to APT testing.
these instructions to assist them in          Federal Register as a notice with an       These requirements would be less
meeting the regulations in subparts J, K      opportunity for public comment. (As        burdensome to the laboratory than the
and P when performing APT testing.            with all comments received on test         requirements currently applicable to
                                              categorization, our responses to the       other moderate complexity testing
Submission Requirements                                                                  because the manufacturer’s or
                                              comments received on APT
  Under the proposed rule, the                categorization will be included in a       producer’s PHS-approved test system
manufacturer or test system producer          subsequent Federal Register notice.)       instructions would specify what
would have to determine which                 Once we receive comments on the            laboratories must do to comply with the
procedures in the preanalytic, analytic       Federal Register notice, we reserve the    CLIA patient test management
and postanalytic phases of testing are        right to reevaluate and recategorize the   requirements. There would be two
essential to ensure accurate test results.    test based upon those comments.            requirements in this new standard. The
These procedures would be identified in                                                  two requirements would be that the
the submission to PHS as mandatory            Administration                             laboratory must: (a) have available and
procedures for the laboratory to follow.        We are proposing to make conforming      follow the patient test management
In addition, the manufacturer or test         changes to subpart F (General              procedures specified in the PHS-
system producer would have to include         Administration) to accommodate the         approved instructions; and (b) maintain
protocols to assist laboratories in           addition of the new certificate for APT    records documenting compliance with
               Federal Register / Vol. 60, No. 179 / Friday, September 15, 1995 / Proposed Rules                            47985

the patient test management                     For APT tests, we would require           certificate since the laboratory would be
requirements for two years.                  laboratories to have a qualified director,   required only to follow the PHS-
                                             clinical consultant and testing              approved instructions to meet the CLIA
Quality Control
                                             personnel. The qualifications required       requirements for APT testing. During a
   In subpart K (quality control), we        for director and clinical consultant         random inspection, as with any
propose to recodify the current              would be the same as for moderate            inspection of other test complexity
§ 493.1204 as § 493.1206 and add a new       complexity testing, while the testing        categories, not all test systems would be
§ 493.1204 to accommodate the quality        personnel training requirements would        reviewed. A few test systems would be
control provisions resulting from the        be modified slightly from the training       randomly selected and assessed for
proposed addition of the new                 required for other moderate complexity       compliance. We would also clarify in
subcategory of APT tests. Since the          testing because the test system              this section that if the same laboratory
PHS-approved test system instructions        manufacturer or producer would be            is performing provider-performed
for APT procedures would include             providing specific instructions on test      microscopy procedures, those tests may
instructions for meeting the CLIA            system performance, including reagent        also be assessed for compliance with all
requirements, the laboratory quality         stability and storage and quality control.   applicable requirements specific to that
control requirements for APT testing         The responsibility requirements for each     subcategory of testing during the
would be less stringent than for other       level of personnel within the APT            random inspection.
moderate complexity tests. We are            subcategory would be somewhat less              Additionally, we would revise the
proposing that, before reporting patient     stringent in accordance with the             introductory paragraph to § 493.1777,
test results, laboratories, at a minimum,    laboratory’s reliance on the                 which currently contains the condition
use the PHS-approved test system             manufacturer or producer of the test         concerning inspection of laboratories
instructions for verifying the test          system to provide detailed test              requesting or issued a certificate of
system’s performance specifications.         instructions, protocols for meeting the      compliance, to clarify the inspection
The laboratory may include, as               regulatory requirements, performance         requirements for a laboratory with a
appropriate, expanded or additional          specifications and information regarding     certificate of compliance when the
protocols for verifying the test system’s    test results and interpretation.             laboratory also performs APT
performance specifications. As with          Quality Assurance                            procedures. Specifically, for laboratories
other procedures of moderate                                                              that perform APT procedures and have
                                               We are proposing to add a new              a certificate of compliance, APT
complexity, quality control activities for   § 493.1702 to the quality assurance
APT tests would have to be documented                                                     procedures may be included in the
                                             requirements located in subpart P to         sample of moderate complexity tests
and the records retained for two years,      include the proposed requirements
except immunohematology records,                                                          inspected during the laboratory’s
                                             applicable to APT testing. These             routine, biennial inspections.
which must be maintained for a period        requirements would be less burdensome
of no less than five years. We would         than the requirements currently              Summary of Changes to the Regulations
stress that laboratories must not modify     applicable to other moderate complexity
the test system’s PHS-approved test                                                          We are proposing to add or change the
                                             testing, since the PHS-approved test         following sections to incorporate
performance instructions, since any          system instructions would assist the
modification would result in the test no                                                  requirements applicable to APT tests:
                                             laboratory in meeting the quality               • Section 493.18, Accurate and
longer being categorized as APT. Any         assurance requirements. Like § 493.1102      precise technology (APT) tests.
modified procedure would become an           in subpart J (patient test management),         • Section 493.21, Laboratories
uncategorized test and would be              there would be two requirements in           performing accurate and precise
considered high complexity until             § 493.1702. To meet the quality              technology (APT) tests.
categorized by PHS.                          assurance requirements in subpart P, we         • Section 493.48, Requirements for a
Personnel                                    are proposing that: (a) laboratories must    certificate for accurate and precise
                                             have available and follow procedures         technology (APT) tests.
   The personnel requirements for APT        specified in the test system’s PHS-             • Section 493.1102, Patient test
testing would be located at § 493.1371       approved instructions to meet the            management requirements for accurate
through § 493.1387. APT personnel            quality assurance requirements; and (b)      and precise technology (APT) tests.
requirements would be somewhat less          laboratories must document and                  • In subpart K, we are proposing to
stringent than for other moderate            maintain records of quality assurance        add the new quality control
complexity testing because APT tests         activities for two years.                    requirements applicable to APT testing
would have been reviewed to ensure                                                        at § 493.1204 and move the facilities
that they meet the criteria for simple,      Inspections                                  requirements (without change) currently
reliable, accurate and precise tests. The      We are proposing to establish a new        located at § 493.1204 to a new
personnel requirements for this              § 493.1778 specifying that laboratories      § 493.1206.
subcategory would not include a              with a certificate for APT tests are            • To subpart M, we are proposing to
technical consultant because                 subject to announced or unannounced          add nine new sections to include the
manufacturers or producers of APT tests      inspections on a random basis to assess      personnel requirements for laboratories
would develop maintenance protocols,         compliance with the applicable               performing APT testing. At § 493.1371,
calibration and control procedures,          requirements of part 493, to evaluate        we are proposing to add the condition
remedial action policies and criteria for    compliance when indicated by                 requirements for director, and at
reporting and interpreting test results,     unsuccessful participation in                §§ 493.1373 and 493.1375, respectively,
which would fulfill most of the              proficiency testing and complaints, and      we plan to include the qualification and
technical consultant’s responsibilities.     to collect information for determining       responsibility requirements for director.
The remaining technical consultant           the appropriateness of tests categorized     The condition level requirements for
responsibilities (e.g., employee             as APT. We are proposing to require          clinical consultant would be located at
evaluations) would be performed by the       random, rather than routine, inspections     § 493.1377, with clinical consultant
laboratory director.                         for a laboratory having an APT               qualifications to be specified under
47986         Federal Register / Vol. 60, No. 179 / Friday, September 15, 1995 / Proposed Rules

§ 493.1379 and responsibilities to be        to review by the Office of Management       quality control standards for monitoring
included under § 493.1381. The testing       and Budget (OMB) under the Paperwork        and evaluating the quality of the testing
personnel condition requirements             Reduction Act of 1980. The title,           process to assure accurate and reliable
would be at § 493.1383, with testing         description, and respondent description     patient test results and reports as
personnel qualifications at § 493.1385       of the information collection               required under CLIA. Section 493.1204
and responsibilities to be included at       requirements are shown below with an        is a new section required to reflect the
§ 493.1387.                                  estimate of the annual reporting and        addition of the new subcategory for
   • Section 493.1702, Quality assurance     recordkeeping burden. Included in the       accurate and precise technology testing
requirements for accurate and precise        estimate is the time for reviewing          (APT).
technology (APT) tests.                      instructions, searching existing data          § 493.1702: Sections 493.1701 through
   • Section 493.1778, Inspection of         sources, gathering and maintaining the      493.1721 are currently approved under
laboratories issued a certificate for        data needed, and completing and             OMB approval number 0938–0612 with
accurate and precise technology (APT)        reviewing the collection of information.    an expiration date of February 28, 1998.
tests.                                          § 493.18: This section outlines the      Section 493.1702 is a new section
   We are proposing to make conforming       criteria a manufacturer must follow in
technical changes to the following                                                       developed to address specific
                                             order to have its moderate complexity       requirements that relate to quality
sections and headings: §§ 493.2;             test categorized as an ‘‘Accuracy and
493.3(a)(1); 493.5 (a)(2), (b) and (c)(4);                                               assurance for a laboratory performing
                                             Precise Technology’’ (APT) test. These      APT testing. Specifically it requires a
493.20 (a) and (b); 493.25(c); the           include but are not limited to test
headings for subpart C and 493.43;                                                       laboratory to have available and follow
                                             system characteristics, instructions,       the PHS-approved instructions and
493.43(a); 493.45 introductory               field studies and evaluation of data.
paragraph and (a); 493.49; 493.51                                                        supplements (where appropriate) and
                                                §§ 493.43, 493.45, 493.48, 493.49,       maintain records documenting
heading, introductory paragraph and          493.51, 493.53: Sections 493.43 through
paragraphs (b) and (c) and new (d);                                                      compliance for a 2-year period.
                                             493.53 are currently approved under            §§ 493.1777 and 493.1778: Sections
493.53(a); 493.602; 493.638 (a) and (b);     OMB approval number 0938–0612 with
493.639(b); 493.643(a); 493.645 heading                                                  493.1725 through 493.1780 are currently
                                             an expiration date of February 28, 1998.    approved under OMB approval number
and new paragraph (c) and paragraph          The information is gathered on form
(d) (redesignated from paragraph (c));                                                   0938–0612 with an expiration date of
                                             number HCFA-R–26. These sections            February 28, 1998. Section 493.1777
subpart H; 493.803(a); 493.807 heading;      outline the requirements for a laboratory
subheading preceding 493.821; subpart I                                                  concerns the inspections of laboratories.
                                             to follow to submit application forms for   The burden associated with inspections
heading; subpart J heading; 493.1101
                                             CLIA certification. The requirements        consists of retrieving the records and
heading and introductory paragraph;
                                             include laboratory notification to HHS      documentation requested by the
subpart K heading; 493.1201 heading,
                                             of changes to the types of tests            inspector, participating in the entrance
revision to paragraph (a) and (b) and
                                             performed or changes in ownership,          and exit interviews, responding to the
addition of new paragraph (c);
                                             name location or director.                  statement of deficiencies that may result
493.1202(c); 493.1203; part M heading;
                                                Section 493.48 is a new section added
493.1351; subpart P heading; 493.1777                                                    from the inspection and documenting
                                             to reflect the addition of the new
introductory paragraph; 493.1814(b)(3);                                                  any corrective actions taken that are
                                             certificate category for laboratories
493.1834 (b) and (f)(2)(iii); and 493.1836                                               appropriate to the plan of correction for
                                             performing tests categorized as accurate
(c)(2) and (c)(3); and 493.2001.                                                         the deficiencies cited. Section 493.1778
   In addition, we are deleting the words    and precise technology testing (APT).
                                                                                         is a new section developed to address
‘‘of this part’’ wherever they follow a         §§ 493.1101 and 493.1102: Sections
                                                                                         the inspection requirements as they
specific section number in regulations       493.1101 through 493.1111 are currently
                                                                                         apply to laboratories with an APT
text appearing in this Federal Register      approved under OMB approval number
                                                                                         certificate. This section sets forth the
document to conform with rules of the        0938–0612 with an expiration date of
                                                                                         policy of random inspections for
Office of the Federal Register.              February 28, 1998. This section
                                                                                         laboratories with an APT certificate.
                                             concerns patient test management for
IV. Response to Comments                     laboratories performing tests of               When OMB approves those provisions
                                             moderate and high complexity that           not currently approved we will publish
   Because of the large number of items
                                             implement the CLIA statutory mandate        a notice in the Federal Register to that
of correspondence we normally receive
                                             for laboratories to meet requirements       affect.
on Federal Register documents
published for comment, we are not able       relating to the proper collection,          Description of Respondents
to acknowledge or respond to them            transportation, and storage of specimens
individually. We will consider all           and the reporting of results. Section         § 493.18: Small businesses or
comments we receive by the date and          493.1102 is a new section added to          organizations, businesses or other for
time specified in the DATES section of       reflect the addition of the new             profit, non-profit institutions, who
this preamble, and, if we proceed with       subcategory for tests categorized as        manufacture laboratory tests.
a subsequent document, we will               accurate and precise technology testing       §§ 493.43, 493.45, 493.48, 493.49,
respond to the comments in the               (APT).                                      493.51, 493.53; 493.1101 and 493.1102;
preamble to that document.                      §§ 493.1201, 493.1202 and 493.1204:      493.1201, 493.1202 and 493.1204;
                                             Sections 493.1201 and 493.1202 are          493.1702; 493.1777 and 493.1778: Small
V. Collection of Information                 currently approved under OMB                businesses or organizations, businesses
Requirements                                 approval number 0938–0612 with an           or other for profit, non-profit
  The proposed rule contains                 expiration date of February 28, 1998.       institutions, state and local
information collections that are subject     These sections set forth the general        governments, federal agencies.
                         Federal Register / Vol. 60, No. 179 / Friday, September 15, 1995 / Proposed Rules                                                                          47987

                                                     ESTIMATED ANNUAL REPORTING AND RECORDKEEPING BURDEN
                                                                                                                                                                     Average
                                                                                                                                     Annual num-     Annual fre-   burden per    Annual bur-
                                                      CFR sections                                                                    ber of re-      quency        response      den hours
                                                                                                                                       sponses                       (hours)

493.18 ...........................................................................................................................   50                        1          336         16,800
493.43, 493.45, 493.48, 493.49, 493.51, 493.53 .........................................................                             28,700                    1          .25          7,175
493.1101, 493.1102 ......................................................................................................            82,000                    1            .5        41,000
493.1201, 493.1202 and 493.1204 ...............................................................................                      82,000                    1           12        984,000
493.1702 .......................................................................................................................     24,600(a)                 1           42      1,033,200
493.1777 and 493.1778 ................................................................................................               1,230(a)                  1             4         4,920



  (a) Assuming 30% of 82,000 non-                                             This proposed rule would modify                                    for APT would experience a decrease in
waived laboratories become APT.                                            CLIA regulations published February                                   compliance costs and the number of
  The agency has submitted a copy of                                       28, 1992 by establishing a new                                        surveys, since APT laboratories would
the proposed rule to OMB for its review                                    subcategory of moderate complexity                                    not be subject to routine inspections and
of these information collections.                                          testing, accurate and precise technology                              the associated fees. The laboratories that
Interested persons are invited to send                                     (APT) tests. There are approximately                                  would realize the greatest benefit from
comments regarding this burden                                             157,000 entities enrolled under CLIA                                  these savings would most likely be
estimate or any other aspect of these                                      that could be affected by this rule;                                  physician office laboratories and public
collections of information, including                                      however, the significance of the effect                               health laboratories. Laboratories,
any of the following subjects: (1) The                                     would vary depending on the volume                                    specifically many physician offices and
necessity and utility of the proposed                                      and complexity of tests performed.                                    other limited service laboratories,
information collection for the proper                                      While we cannot estimate the number of                                expanding from a certificate of waiver or
performance of the agency’s functions;                                     entities that may make changes in their                               PPM to a certificate for APT would be
(2) the accuracy of the estimated                                          laboratory testing practices, we believe                              able to enhance the range of laboratory
burden; (3) ways to enhance the quality,                                   the modifications to the CLIA program                                 services available to patients, while
utility, and clarity of the information to                                 would be beneficial to the affected                                   their costs (including certification fees
be collected; and (4) the use of                                           entities and would be well received,                                  and costs inherent in meeting applicable
automated collection techniques or                                         since they are being proposed in                                      requirements such as personnel and
other forms of information technology to                                   response to comments requesting                                       quality control), would remain less than
minimize the information collection                                        revisions to the test complexity                                      the costs of obtaining a certificate of
burden. Comments should be sent to                                         categories.                                                           compliance. The availability of a CLIA
HCFA, OFHR, MPAS, C2–26–17, 7500                                              In proposing this new subcategory, we                              certificate that allows an expanded test
Security Boulevard, Baltimore,                                             acknowledge the unique aspects of the                                 menu at less cost also may encourage
Maryland 21244–1850 and to the OMB                                         many tests with proven accuracy and                                   new entities to begin providing services,
official whose name appears in the                                         precision that may not qualify for                                    thereby increasing physician and
ADDRESSES section of this preamble.                                        waiver, but should not be subject to all                              patient access to health care,
                                                                           of the requirements applicable to                                     particularly in underserved and rural
VI. Regulatory Impact Statement                                                                                                                  areas.
                                                                           moderate complexity testing, including
   We generally prepare a regulatory                                       routine inspection. To this end, this                                   This proposed rule may affect some
flexibility analysis that is consistent                                    proposed rule would establish less                                    manufacturers of laboratory tests who
with the Regulatory Flexibility Act                                        stringent requirements, including less                                would be required to submit specific
(RFA) (5 U.S.C. 601 through 612) unless                                    frequent (random) inspections and                                     information and data demonstrating that
the Secretary certifies that a rule would                                  fewer personnel requirements, for                                     their test meets the criteria for APT
not have a significant economic impact                                     laboratories providing tests categorized                              categorization. We estimate that
on a substantial number of small                                           as APT. We expect no clinically                                       approximately 500 test systems may
entities. For purposes of the RFA, all                                     meaningful decrease in test accuracy, or                              qualify for this subcategory. These test
laboratories and manufacturers of                                          patient health, from this proposal.                                   systems are predominantly small
laboratory test systems are considered to                                  Furthermore, to the extent that it                                    automated instruments or ‘‘desktop’’
be small entities. Individuals and States                                  encourages cost-effective testing more                                analyzers. Manufacturers of any test
are not included in the definition of a                                    than the present CLIA rules, and                                      system approved by PHS in the APT
small entity.                                                              increases the amount of such testing in                               subcategory also must provide
   Also, section 1102(b) of the Act                                        settings that might otherwise eschew                                  laboratories with complete instructions,
requires the Secretary to prepare a                                        testing, it is likely to improve patient                              which include protocols to assist
regulatory impact analysis if a rule may                                   health. In addition, this proposed rule                               laboratories in meeting the CLIA
have a significant impact on the                                           would reduce the financial burden for                                 requirements. However, many
operations of a substantial number of                                      some laboratories by enabling them to                                 manufacturers are currently providing
small rural hospitals. This analysis must                                  provide an expanded test menu without                                 this type of information and assistance
conform to the provisions of section 603                                   incurring the higher costs associated                                 to laboratories in the form of
of the RFA. For purposes of section                                        with a certificate of compliance.                                     instructional materials and protocols.
1102(b) of the Act, we define a small                                         The changes proposed in this                                       Because laboratories would not be
rural hospital as a hospital that is                                       regulation may affect a laboratory’s test                             required to develop their own
located outside of a Metropolitan                                          menu and choice of certificate.                                       operational policies and quality control
Statistical Area and has fewer than 50                                     Laboratories holding a certificate of                                 protocols, a wider variety of laboratories
beds.                                                                      compliance that change to a certificate                               might decide to offer APT testing.
47988         Federal Register / Vol. 60, No. 179 / Friday, September 15, 1995 / Proposed Rules

Therefore, we anticipate that                  Authority: Sec. 353 of the Public Health       procedures, only APT tests, only tests of
categorization as an APT test would          Service Act, secs. 1102, 1861(e), the sentence   high complexity, or any combination.
result in increased sales and                following 1861(s)(11), 1861(s)(12),                (c) Each laboratory must be either
distribution for the manufacturers.          1861(s)(13), 1861(s)(14), 1861(s)(15), and       CLIA-exempt or possess one of the
                                             1861(s)(16) of the Social Security Act (42
   As indicated above, we believe that                                                        following certificates, as defined in this
                                             U.S.C. 263a, 1302, 1395x(e), the sentence
the creation of the subcategory of APT       following 1395x(s)(11), 1395x(s)(12),            part:
and subsequent decrease in the               1395x(s)(13), 1395x(s)(14), 1395x(s)(15), and      (1) Registration certificate.
regulatory and financial burden for          1395x(s)(16)).                                     (2) Certificate of waiver.
laboratories performing APT tests would                                                         (3) Certificate for PPM procedures.
                                               2. In Section 493.2, in the definition           (4) Certificate for APT tests.
benefit patients, laboratories, and          of ‘‘CLIA certificate’’ the introductory           (5) Certificate of compliance.
manufacturers. However, we are unable        text is republished and paragraph (6) is           (6) Certificate of accreditation.
to quantify these likely long run effects    added to read as follows:                          5. A new § 493.18 is added to read as
because they depend on market                                                                 follows:
decisions, research results, and             § 493.2   Definitions.
technological change that cannot be          *     *      *    *     *                        § 493.18 Accurate and precise technology
predicted.                                     CLIA certificate means any of the              (APT) tests.
   Regardless, we believe that for the       following types of certificates issued by           (a) Requirement. To be included in
most part these effects would involve        HCFA or its agent:                               the APT subcategory, the test system
relatively small savings of a few            *     *      *    *     *                        must be categorized as moderate
hundred or a few thousand dollars a            (6) Certificate for accurate and precise       complexity using the criteria in § 493.17
year for each laboratory, mainly due to      technology (APT) tests means a                   and it must meet the descriptive criteria
reduced inspection fees or QC costs. In      certificate issued or reissued before the        specified in paragraph (b) of this
the aggregate these savings would be         expiration date, pending an appeal in            section.
substantial, because they are shared by      accordance with § 493.48, to a                      (b) Criteria. (1) For quantitative tests,
thousands of laboratories. However, few      laboratory that only performs tests              methods must be easy to use, accurate,
if any entities are likely to achieve very   approved by PHS as APT tests and, if             and precise as evidenced by the
substantial savings.                         desired, tests specified as PPM                  following items:
   This proposed rule would establish        procedures, tests approved by PHS as                (i) Test systems that have the
the process for categorizing moderate        waived tests, or both.                           following characteristics:
complexity tests into a new subcategory                                                          (A) Are fully automated (no operator
                                             *     *      *    *     *                        intervention during the analytic phase).
of moderate complexity testing and             3. In § 493.3, the introductory text of
would also establish a new type of                                                               (B) Provide direct readout of results or
                                             paragraph (a) is republished and                 simple noncalculated conversions.
certificate. Proper realignment of the fee   paragraph (a)(1) is revised to read as
schedule, if necessary, would follow                                                             (ii) Test system instructions that
                                             follows:                                         address the following items:
implementation of this rule.
                                             § 493.3   Applicability.
                                                                                                 (A) Requirements for specimen
   For these reasons, we are not                                                              collection, handling, storage and
preparing analyses for either the RFA or       (a) Basic rule. Except as specified in         preservation.
section 1102(b) of the Act because we        paragraph (b) of this section, a                    (B) Reportable range for patient
have determined, and the Secretary           laboratory will be cited as out of               results.
certifies, that this proposed rule would     compliance with section 353 of the                  (C) Reference range (normal values)
not have a significant economic impact       Public Health Service Act unless it—             and suggested panic values (values
on a substantial number of small entities      (1) Has a current, unrevoked or                requiring immediate medical
or a significant impact on the operations    unsuspended certificate of waiver, a             intervention).
of a substantial number of small rural       registration certificate, a certificate of          (D) Units of measurement used for
hospitals. We do request comments,           compliance, certificate for PPM                  reporting patient results.
however, on possible improvements in         procedures, certificate for APT tests, or           (E) Step-by-step protocols that
these proposed regulations to achieve        a certificate of accreditation issued by         include, as appropriate, the following
even greater savings to affected entities    HHS applicable to the category of                items:
and will consider them carefully in          examinations or procedures performed                (1) Instrument or test system
formulating the final rule.                  by the laboratory; or                            operation and test performance
   In accordance with the provisions of      *     *     *      *    *                        instructions.
Executive Order 12866, this regulation         4. Section 493.5 is revised to read as            (2) Test system maintenance
was reviewed by the Office of                follows:                                         procedures.
Management and Budget.                                                                           (3) Preparation and storage of
                                             § 493.5 Categories of tests by complexity.       reagents, calibrators, controls, or other
List of Subjects in 42 CFR Part 493            (a) Laboratory tests are categorized as        materials used in testing.
  Grant programs-health, Health              one of the following types of tests:                (4) Control procedures including the
facilities, Laboratories, Medicaid,            (1) Waived tests.                              type of materials, suggested
Medicare, Reporting and recordkeeping          (2) Tests of moderate complexity,              concentrations, and frequency of assay.
requirements.                                including the subcategories of moderate             (5) Calibration procedures including
  42 CFR part 493 would be amended           complexity, which are limited to the             the number and type of materials and
as set forth below:                          following tests and procedures:                  frequency of assay.
                                               (i) PPM procedures.                               (6) Acceptable ranges for any control
PART 493—LABORATORY                            (ii) APT tests.                                or calibration material included with
REQUIREMENTS                                   (3) Tests of high complexity.                  the test system.
                                               (b) A laboratory has the option of                (7) Action to be taken when
  1. The authority citation continues to     performing only waived tests, only tests         calibration or control results do not
read as follows:                             of moderate complexity, only PPM                 meet the acceptable range of values.
              Federal Register / Vol. 60, No. 179 / Friday, September 15, 1995 / Proposed Rules                              47989

   (8) Methods for converting test system    introduction of error due to the presence       (A) Are generated from protocols that
values to reportable results.                of these substances.                         address the points described in
   (9) Description of course of action to       (vi) Demonstration that the total         paragraph (b)(2)(iii) of this section.
be taken when the test system becomes        amount of error, which includes all             (B) Are adequate to produce measures
inoperable.                                  components contributing to imprecision       of performance that are both statistically
   (10) Any limitations to methodologies     and inaccuracy as defined by studies         valid and defensible.
such as interfering substances.              described in paragraphs (b)(1)(iv)(D)           (C) Confirm that study participants
   (11) A written protocol for reporting     through (b)(1)(iv)(F) and (b)(1)(v)(A)       are able to read and interpret test
patient test results.                        through (b)(1)(v)(C) of this section, is     endpoints with the same precision as
   (iii) Field studies that meet the         less than one fourth of the reference        laboratory professionals.
following requirements:                      range for the analyte divided by the            (D) Confirm that the performance of
   (A) Demonstrate that the                  mean of the reference interval.              study participants is essentially the
manufacturer’s or producer’s written            (2) For qualitative tests, methods must   same as laboratory professionals when
instructions are the only protocols          be easy to use, accurate, and precise as     testing samples at or near the cutoff and
required to perform the test accurately      evidenced by the following items:            at sufficient distance above and below
and reliably.                                   (i) Test systems that meet the            the cutoff to confirm precision at all
   (B) Demonstrate that individuals with     following requirements:                      analytical decision points.
no formal laboratory training can               (A) Contain steps that are limited in        (E) Demonstrate minimal among-
correctly perform the test.                  number and complexity, are self-             operator imprecision using results of all
   (iv) Data from field studies that meet    contained and are packaged as a              study participants.
the following requirements:                  complete system.                                (F) Demonstrate minimal within-site
   (A) Are generated from protocols that        (B) Have a qualitative endpoint that      imprecision using test results generated
address the points described in              requires no interpretation beyond            at each site by an adequate number of
paragraph (b)(1)(iii) of this section.       discerning agglutination patterns, color     participants to produce measures of
   (B) Are adequate to produce measures      comparisons, or other easily interpreted     performance that are statistically valid
of performance that are both statistically   reactions.                                   and defensible. Testing must be
valid and defensible (estimates must            (ii) Test system instructions that        performed at a minimum of three
support valid confidence limits for all      address the following items:                 independent study sites.
statistical parameters).                        (A) Requirements for specimen                (G) Using results generated by study
   (C) Evaluate performance at all           collection, handling, storage and            participants, demonstrate minimal
medical decision points and relevant         preservation.                                among-site imprecision at an adequate
upper and lower limits of the reportable        (B) Reportable range for patient          number of sites to produce measures of
range using at least three concentrations    results.                                     performance that are statistically valid
of the analyte being tested.                    (C) Reference range (normal values).      and defensible.
   (D) Evaluate among-operator                  (D) Step-by-step protocols that              (v) Method accuracy studies
imprecision using test results of all        include, as appropriate, the following       demonstrating that there is no
study participants.                          items:                                       statistically significant difference
   (E) Evaluate within-site imprecision         (1) Test performance instructions.
                                                (2) Preparation and storage of            between observed values and expected
using test results generated at each site                                                 values at the cutoff point when—
by an adequate number of participants        reagents, calibrators, controls, or other
                                                                                             (A) The test values are compared to a
to produce measures of performance           materials used in testing.
                                                (3) Control procedures including the      quantitative result such as the value of
that are statistically valid and                                                          a reference material or the presence or
defensible. Testing must be performed        type of materials and frequency of assay.
                                                (4) Calibration procedures including      absence of a particular biologic
at a minimum of three independent                                                         component;
                                             the number and type of materials and
study sites.                                                                                 (B) Confirming that there are no
                                             frequency of assay.
   (F) Evaluate among-site imprecision at       (5) Acceptable ranges for any control     significant equivocal test results on
an adequate number of sites to produce       or calibration material included with        either side of the cutoff;
measures of performance that are             the test system.                                (C) Comparing results between study
statistically valid and defensible using        (6) Action to be taken when               participants and laboratory
results generated by study participants      calibration or control results do not        professionals on samples with values at
on aliquots of a single testing material.    meet acceptable range of values.             the cutoff;
   (v) Method accuracy studies                  (7) The correct interpretation of test       (D) The test is performed on patient
demonstrating little or no systematic        reactions or endpoints.                      samples instead of reference materials,
error when—                                     (8) Description of course of action to    confirming there is no introduction of
   (A) Using reference materials assayed     be taken when test reactions or              error due to sample matrix; and
by study participants that produce data      endpoints cannot be determined.                 (E) Samples contain substances that
that show there is little or no                 (9) Any limitations to methodologies.     commonly cause interference
statistically significant difference            (iii) Field studies that meet the         confirming there is no introduction of
between the test results and the value of    following requirements:                      error because of these substances.
the reference materials.                        (A) Demonstrate that the                     (c) Provisions for inclusion of tests in
   (B) Using patient samples instead of      manufacturer’s or producer’s written         the APT subcategory—(1) Process for
reference materials, demonstrating there     instructions are the only protocols          requesting APT categorization.
is little or no introduction of error in     required to perform the test accurately         (i) Requests for APT categorization
patient test results due to the effects of   and reliably.                                must be submitted to PHS.
the sample matrix.                              (B) Demonstrate that individuals with        (ii) PHS reviews requests for APT
   (C) Adding or simulating common           no formal laboratory training can            categorization that meet the criteria
interfering substances known to affect       correctly perform the test.                  specified in paragraph (b) of this section
the analyte in patient samples,                 (iv) Data from field studies that meet    and the submission requirements under
demonstrating that there is little or no     the following requirements:                  paragraph (c)(2) of this section.
47990         Federal Register / Vol. 60, No. 179 / Friday, September 15, 1995 / Proposed Rules

  (iii) The CLIAC, as specified in              (iv) Patient test management protocols       (1) Determining specimen
subpart T of this part, conducts reviews     must be complete and include sufficient      acceptability.
upon the request of HHS and makes            information to assist laboratories in           (2) Reporting patient test results,
recommendations to HHS concerning            meeting each of the requirements in          including suggested panic values, if
APT test categorization.                     subpart J of this part. These protocols      applicable.
  (iv) Any change or modification to an      must meet the following requirements:           (3) The course of action to be taken in
APT test system by the manufacturer or          (A) Clearly specify the instructions      the event that a test system becomes
producer that could affect the accuracy      that must be followed by the laboratory      inoperable.
or reliability of that test must be          to ensure proper specimen handling and          (4) Referral of samples, as specified in
resubmitted to PHS for evaluation and        accurate test result reporting and assist    § 493.1111, including procedures for
review. Until this review is completed       laboratories in meeting the requirements     specimen submission and handling as
and categorization status is determined,     of subpart J of this part, including the     described in § 493.1103.
the modified test is considered              following requirements listed in                (E) Verification of method
uncategorized and, in accordance with        paragraphs (c)(2)(iv)(A)(1) through          performance specifications and
§ 493.17(c)(4), is considered high           (c)(2)(iv)(A)(4) and (c)(2)(iv)(B) of this   verification that the reference range is
complexity.                                  section, as applicable:                      appropriate for the laboratory’s patient
  (v) A request for reconsideration of a        (1) Section 493.1103(a), procedures       population.
test denied APT categorization is            for specimen submission and handling,           (vi) Quality assurance protocols must
accepted for review if the request is        including protocols for preparation of       be complete and include sufficient
based on information not previously          patients, specimen collection,               information to assist laboratories in
submitted.                                   preservation, and conditions for             meeting each of the requirements in
  (2) Submission requirements.               specimen transport.                          subpart P of this part. These protocols
  (i) Requests for APT categorization           (2) Section 493.1105(f), any test         must meet the following requirements:
must meet the criteria described in          requisition information that is relevant        (A) Clearly specify the instructions
paragraph (b) of this section. In the        and necessary to a specific test to assure   that must be followed by the laboratory
event that a request does not include        accurate testing and reporting of results.   in establishing a comprehensive quality
complete information, the request is not        (3) Sections 493.1107(c) and              assurance program for monitoring and
reviewed and the manufacturer or             493.1109(c), test records and test report    evaluating the overall quality of the total
producer of the test system is notified.     information related to the criteria for      testing process (preanalytic, analytic,
  (ii) Data collection protocols and data    specimen acceptability.                      and postanalytic) and identifying and
submitted must be complete and data             (4) Section 493.1109, test report         correcting problems based on the results
submitted must be statistically valid and    information including the following          of the evaluation to assure the accurate,
meet the criteria described under            information:                                 reliable and prompt reporting of patient
paragraph (b) of this section.                  (i) Section 493.1109(d), pertinent        results and assist laboratories in meeting
  (iii) Test system instructions must be     ‘‘reference’’ or ‘‘normal’’ ranges.          the requirements of subpart P of this
complete and must include, as                   (ii) Section 493.1109(f), any imminent    part listed in paragraphs (c)(2)(vi)(A)(1)
applicable, the items defined in             life-threatening laboratory results or       through (c)(2)(vi)(A)(4) and (c)(2)(vi)(B)
paragraph (b)(1)(ii) of this section for     panic values.                                of this section, and, as applicable, meet
quantitative tests and under paragraph          (iii) Section 493.1109(g), the test       the requirements of the following
(b)(2)(ii) of this section for qualitative   methodology employed and any                 sections:
tests. In addition, test system              information that may affect the                 (1) Section 493.1703, Patient test
instructions must include the following      interpretation of test results.              management assessment, including the
statements:                                     (B) Provide information (for example,     following requirements:
  (A) ‘‘Any modification by the              written instructions, instructional             (i) The criteria established for patient
laboratory to the PHS-approved test          materials or samples of forms for            preparation, specimen collection,
system instructions will result in the       documentation of activities performed)       preservation and transportation.
test no longer meeting the requirements      that laboratories may follow or                 (ii) The completeness and relevance of
for APT categorization. Modified tests       supplement, in accordance with the test      the information solicited on the
are considered high complexity and are       system’s PHS-approved instructions, in       laboratory’s test requisition.
subject to all applicable CLIA               meeting the requirements in subpart J of        (iii) The use and appropriateness of
requirements contained in 42 CFR part        this part.                                   the criteria established for specimen
493.’’                                          (v) Quality control instructions must     rejection.
  (B) ‘‘The laboratory must notify the       include the following items:                    (iv) The completeness, usefulness and
producer of this test system of any             (A) Protocols for documentation of all    accuracy of the test report information
performance, perceived or validated,         control and calibration results, any         necessary for the interpretation or
that does not meet the performance           remedial action to be taken, and the         utilization of test results.
specifications as outlined in these          appropriate record retention                    (2) Section 493.1705, Quality control
instructions.’’ The name, address and        requirements as described at § 493.1221.     assessment, including a mechanism to
phone number(s) of the producer’s               (B) Protocols for documentation of        assess the effectiveness of the corrective
contact person(s) must follow this           equipment maintenance performance            actions taken in the following
statement.                                   and the appropriate record retention         situations:
  (C) If applicable: ‘‘Laboratories          requirements as described at § 493.1221.        (i) Problems identified during the
performing accurate and precise                 (C) Safety precaution instructions that   evaluation of calibration and control
technology (APT) tests are subject to the    cover any physical hazard or                 data for the test method.
proficiency testing (PT) requirements        biohazardous material, including the            (ii) Problems identified during the
under 42 CFR part 493, subpart H of this     proper handling and disposal of testing      evaluation of patient test values for the
part. The laboratory must enroll and         materials.                                   purpose of ensuring the appropriateness
successfully participate in an HHS-             (D) Protocols for developing written      of the reference range of the test
approved PT program.’’                       procedures for the following activities:     method.
               Federal Register / Vol. 60, No. 179 / Friday, September 15, 1995 / Proposed Rules                                 47991

   (3) Section 493.1709, Comparison of        § 493.21 Laboratories performing accurate      a separate application for each
test results, including procedures for        and precise technology (APT) tests.            laboratory location.
evaluating and defining the relationship        (a) A laboratory may qualify for a           *      *     *    *      *
between test results using different          certificate to perform APT tests if it            11. In § 493.45, the introductory
methodologies, instruments, or testing        performs tests categorized by PHS as           paragraph is revised, the introductory
sites.                                        APT tests and no other procedures,             text of paragraph (a) is republished, and
   (4) Section 493.1711, Relationship of      except those specified as PPM                  paragraphs (a)(1) and (a)(2) are revised
patient information to patient results,       procedures or those approved by PHS as         to read as follows:
including procedures for identifying          waived tests.
                                                (b) Laboratories performing APT tests        § 493.45 Requirements for a registration
and evaluating patient test results that
                                                                                             certificate.
appear inconsistent with any relevant         must meet the following requirements:
criteria specified in § 493.1711.               (1) Follow each test system’s PHS-              Laboratories performing only waived
                                              approved instructions for performing           tests, PPM procedures, APT tests, or any
   (B) Provide information (for example,                                                     combination of these tests, are not
written instructions, instructional           the test; and
                                                (2) Meet the applicable requirements         required to obtain a registration
materials, or samples of forms for                                                           certificate.
documentation of activities performed)        in subpart C or subpart D of this part
                                              and subparts F, H, J, K, M, P, and Q of           (a) A registration certificate is
that laboratories may follow or                                                              required—(1) Initially for all
supplement, in accordance with the test       this part.
                                                                                             laboratories performing test procedures
system’s PHS-approved instructions, in          (c) If the laboratory also performs
                                                                                             of moderate complexity (other than the
meeting the requirements in subpart P         PPM procedures, the laboratory must
                                                                                             subcategories of APT tests and PPM
of this part.                                 meet the applicable requirements in
                                                                                             procedures) or high complexity, or both;
   (3) Notification of decision.              subparts H, J, K, M, P, and Q of this part.
                                                                                                (2) For all laboratories that have been
                                                (d) If the laboratory also performs          issued a certificate of waiver, certificate
   (i) PHS determines whether a
                                              waived tests, the requirements of              for PPM procedures, or certificate for
laboratory test meets the criteria listed
                                              subparts H, J, K, M, and P of this part        APT tests that intend to perform tests of
under paragraph (b) of this section for
                                              are not applicable for the waived tests.       moderate or high complexity, or both in
an APT test.
                                              However, the laboratory must comply            addition to those tests listed in
   (ii) PHS notifies the applicant of APT     with the requirements in §§ 493.15(e)
categorization, whether denied or                                                            § 493.15(c) or specified as PPM
                                              and 493.1775.                                  procedures, or categorized as APT tests;
granted.                                        8. In § 493.25, paragraph (c) is revised     and
   (iii) APT categorization is effective as   to read as follows:
of the date of notification to the                                                           *      *     *     *     *
applicant.                                    § 493.25 Laboratories performing tests of         12. A new § 493.48 is added to read
                                              high complexity.                               as follows:
   (iv) PHS publishes additions and
revisions periodically to tests               *      *      *    *     *                     § 493.48 Requirements for a certificate for
categorized as APT in the Federal                (c) If the laboratory also performs tests   accurate and precise technology (APT)
Register in a notice with opportunity for     of moderate complexity, the applicable         tests.
public comment. PHS reserves the right        requirements of subparts H, J, K, M, P           (a) A certificate for APT tests is
to reevaluate and recategorize a test         and Q of this part must be met. Under          required for all laboratories that intend
based upon the comments it receives in        a registration certificate or certificate of   to perform only the following tests:
response to the Federal Register notice.      compliance, PPM procedures and APT               (1) Tests that have been categorized
                                              tests must meet the inspection                 by PHS as APT tests.
   6. In § 493.20, paragraphs (a) and (b)
                                              requirements at § 493.1777.                      (2) APT tests in addition to waived
are revised to read as follows:
                                              *      *      *    *     *                     tests or PPM procedures.
§ 493.20 Laboratories performing tests of        9. The heading of subpart C is revised        (3) APT tests, waived tests and PPM
moderate complexity.                          to read as follows:                            procedures.
  (a) A laboratory may qualify for a                                                           (b) HHS issues a certificate for APT
certificate to perform tests of moderate      Subpart C—Registration Certificate,            tests if the laboratory meets the
complexity if it restricts its test           Certificate for Provider-Performed             following requirements:
performance to waived tests or                Microscopy Procedures, Certificate for           (1) Complies with the requirements of
examinations and one or more tests or         Accurate and Precise Technology                § 493.43 for applying for a certificate.
examinations meeting criteria for tests       Tests, and Certificate of Compliance             (2) Agrees to treat proficiency testing
of moderate complexity including the                                                         samples in the same manner as it treats
                                                10. In § 493.43, the section heading
subcategories of PPM and APT tests.                                                          patient specimens.
                                              and paragraph (a) are revised to read as
                                                                                               (3) Agrees to be inspected by HHS as
  (b) A laboratory that performs tests or     follows:
                                                                                             specified in § 493.1778.
examinations of moderate complexity
                                              § 493.43 Application for registration            (4) Remits the fee for the certificate as
must meet the applicable requirements
                                              certificate, certificate for provider-         specified in subpart F of this part.
in subpart C or subpart D, and subparts
                                              performed microscopy (PPM) procedures,           (c) A laboratory issued a certificate for
F, H, J, K, M, P, and Q of this part.         certificate for accurate and precise           APT tests is subject to the following
Under a registration certificate or           technology (APT) tests, and certificate of     requirements:
certificate of compliance, laboratories       compliance.                                      (1) The notification requirements of
also performing PPM procedures and              (a) Filing of application. Except as         § 493.51.
APT tests must meet the inspection            specified in paragraph (b) of this               (2) The applicable requirements of
requirements at § 493.1777.                   section, all laboratories performing tests     this subpart and subparts H, J, K, M, P
*     *      *     *    *                     of moderate complexity (including the          and Q of this part.
  7. A new § 493.21 is added to read as       subcategories) or high complexity, or            (d) A laboratory requesting a
follows:                                      any combination of these tests, must file      certificate for APT tests that also
47992          Federal Register / Vol. 60, No. 179 / Friday, September 15, 1995 / Proposed Rules

performs PPM procedures is subject to            (iv) Collection of information                registration certificate or certificate for
the following requirements:                   regarding the appropriateness of tests           APT technology tests as required in
   (1) Ensuring that PPM procedures are       listed in § 493.15 or tests categorized as       subpart C or subpart D, as applicable, of
performed only by individuals meeting         moderate complexity (including the               this part.
the personnel requirements of subpart         subcategories) or high complexity.               *      *     *    *     *
M of this part.                               *      *     *    *      *                          16. In § 493.638, introductory
   (2) Undergoing random inspections as          14. Section 493.51 is revised to read         paragraph (a) is revised, paragraph (a)(4)
specified in § 493.1778.                      as follows:                                      is redesignated as (a)(5), new paragraph
   (e) In accordance with subpart R of
                                                                                               (a)(4) is added, and paragraph (b) is
this part, HHS initiates suspension,          § 493.51 Notification requirements for           revised to read as follows:
limitation, or revocation of a                laboratories issued a certificate for accurate
laboratory’s certificate for APT tests for    and precise technology (APT) tests or a          § 493.638   Certificate fees.
failure to comply with the applicable         certificate of compliance.
                                                                                                  (a) Basic rule. Laboratories must pay
requirements set forth in this subpart.          Laboratories issued a certificate for         a fee for the issuance of a registration
HHS may also impose certain                   APT tests or a certificate of compliance         certificate, certificate for PPM
alternative sanctions. In addition,           must meet the following requirements:            procedures, certificate of waiver,
failure to meet the requirements of this         (a) Notify HHS or its designee within         certificate for APT tests, certificate of
subpart may result in suspension of all       30 days of any change in any of the              accreditation, or a certificate of
or part of payments under Medicare and        following items:                                 compliance, as applicable. Laboratories
Medicaid.                                        (1) Ownership.                                must also pay a fee to reapply for a
   (f) A certificate for APT tests is valid      (2) Name.                                     certificate for PPM procedures,
for a period of no more than 2 years. A          (3) Location.                                 certificate of waiver, certificate for APT
laboratory must follow the procedures            (4) Director.                                 tests, certificate of accreditation, or a
established by HHS for renewal of this           (5) Technical supervisor (laboratories        certificate of compliance. The total of
certificate.                                  performing high complexity testing
   13. Section 493.49 is amended by                                                            fees collected by HHS under the
                                              only).                                           laboratory program must be sufficient to
revising the introductory text and               (b) Notify HHS no later than 6 months
paragraphs (a) and (b) to read as follows:                                                     cover the general costs of administering
                                              after performing any test or examination         the laboratory certification program
§ 493.49 Requirements for a certificate of    within a specialty or subspecialty area          under section 353 of the PHS Act.
compliance.                                   that is not included on the laboratory’s
                                                                                               *      *     *     *      *
  A certificate of compliance may             certificate for APT tests or a certificate
                                                                                                  (4) For a certificate for APT tests, the
include any combination of tests              of compliance, so that compliance with
                                                                                               costs include issuing the certificate,
categorized as high complexity or             requirements can be determined.
                                                                                               collecting the fees, determining if a
moderate complexity or listed in                 (c) Notify HHS no later than 6 months
                                                                                               certificate for APT tests should be
§ 493.15(c) as waived tests. Moderate         after any deletions or changes in test
                                                                                               issued, evaluating which test systems
complexity tests may include those            methodologies for any test or
                                                                                               qualify for inclusion in the subcategory
specified as PPM procedures or                examination included in a specialty or
                                                                                               of APT tests, and other direct
categorized as APT tests.                     subspecialty, or both, for which the
                                                                                               administrative costs.
  (a) HHS issues a certificate of             laboratory has been issued a certificate
                                                                                                  (5) For a certificate of accreditation,
compliance to a laboratory only if the        for APT tests or a certificate of
                                                                                               the costs include issuing the certificate,
laboratory meets the following                compliance.
                                                                                               collecting the fees, evaluating the
requirements:                                    (d) Notify HHS before performing and
                                                                                               programs of accrediting bodies, and
  (1) Meets the requirements of               reporting results for tests not included
                                                                                               other direct administrative costs.
§§ 493.43 and 493.45.                         under the certificate for APT tests
                                                                                                  (b) Fee amount. The fee amount is set
  (2) Remits the certificate fee specified    (which are tests other than waived tests,
                                                                                               annually by HHS on a calendar year
in subpart F of this part.                    PPM procedures, and APT tests) unless
                                                                                               basis and is based on the category of test
  (3) Meets the applicable requirements       the laboratory has been issued a
                                                                                               complexity, or on the category of test
of this subpart and subparts H, J, K, M,      registration certificate as required in
                                                                                               complexity and schedules or ranges of
P, and Q of this part.                        subpart C or subpart D of this part, as
  (b) A laboratory issued a certificate of                                                     annual laboratory test volume
                                              applicable.
compliance must meet the following                                                             (excluding waived tests and tests
                                                 15. Section 493.53 is amended by
requirements:                                                                                  performed for quality control, quality
                                              revising the introductory text and
  (1) Meets the notification                                                                   assurance, and proficiency testing
                                              paragraph (a) to read as follows:
requirements of § 493.51.                                                                      purposes) and specialties tested, with
  (2) Permits announced or                    § 493.53 Notification requirements for           the amounts of the fees in each schedule
unannounced inspections by HHS in             laboratories issued a certificate for            being a function of the costs for all
accordance with subpart Q of this part        provider-performed microscopy (PPM)              aspects of general administration of
                                              procedures.                                      CLIA as set forth in § 493.649 (b) and
for the following reasons:
  (i) Routine determination of                  Laboratories issued a certificate for          (c). This fee is assessed and payable at
compliance with the applicable                PPM procedures must notify HHS or its            least biennially. The methodology used
requirements of this part.                    designee in the following situations:            to determine the amount of the fee is
  (ii) Evaluation of complaints.                (a) Before performing and reporting            found in § 493.649. The amount of the
  (iii) Nonroutine survey of the              results for any test of moderate                 fee applicable to the issuance of the
laboratory when HHS has substantive           complexity (including the subcategory            registration certificate or the issuance or
reason to believe that tests are being        of APT tests) or high complexity, or             renewal of the certificate for PPM
performed, or the laboratory is being         both, in addition to tests specified as          procedures, certificate of waiver,
operated in a manner that constitutes an      PPM procedures, or any test or                   certificate for APT tests, certificate of
imminent and serious risk to human            examination that is not specified under          accreditation, or certificate of
health.                                       § 493.15(c) for which it does not have a         compliance is the amount in effect at
                Federal Register / Vol. 60, No. 179 / Friday, September 15, 1995 / Proposed Rules                                  47993

the time the application is received.            § 493.645 Additional fee(s) applicable to      HCFA, if applicable, as described in
Upon receipt of an application for a             approved State laboratory programs and         subpart I of this part for each specialty,
certificate, HHS or its designee notifies        laboratories issued certain certificates.      subspecialty, and analyte or test in
the laboratory of the amount of the              *      *      *    *      *                    which the laboratory is certified under
required fee for the requested certificate.         (c) Laboratories with a certificate for     CLIA.
                                                 APT tests.                                     *     *     *     *     *
  17. In § 493.639, paragraphs (b)                  (1) In addition to the certificate fee, a
introductory text and (b)(1) are revised         laboratory requesting a certificate for          22. The heading of § 493.807 is
to read as follows:                              APT tests is also assessed a fee               revised to read as follows:
§ 493.639   Fee for revised certificate.         representing the cost to HHS of random         § 493.807 Condition: Reinstatement of
*       *      *    *     *                      inspections to determine compliance            laboratories performing tests of moderate
                                                 with CLIA requirements. All                    complexity (including the subcategories),
   (b) A laboratory must pay a fee to            laboratories issued a certificate for APT      high complexity, or any combination of
cover the cost of issuing a revised              tests will share in the cost of these          these tests, after failure to participate
certificate in any of the circumstances          inspections.                                   successfully.
specified in paragraphs (b)(1) and (b)(2)           (2) If a laboratory issued a certificate    *     *     *    *      *
of this section.                                 for APT tests has been inspected and             23. The undesignated center heading
   (1) The fee for issuing an appropriate        followup visits are necessary because of       immediately preceding § 493.821 is
revised certificate is based on the cost         identified deficiencies, HHS assesses          revised to read as follows:
of issuing the revised certificate to the        the laboratory a fee to cover the cost of
laboratory as follows:                           these visits. The fee is based on the          Proficiency Testing by Specialty and
                                                 actual resources and time necessary to         Subspecialty for Laboratories
   (i) If a laboratory with a certificate of                                                    Performing Tests of Moderate
waiver wishes to perform tests in                perform the follow up visits. HHS
                                                 revokes the laboratory’s certificate for       Complexity (Including the
addition to those listed in § 493.15(c) as                                                      Subcategories), High Complexity, or
waived tests, it must, as set forth in           APT tests for failure to pay the assessed
                                                 fee.                                           Any Combination of These Tests
§ 493.638, pay an additional fee for the
                                                    (d) Other fees. If, in the case of a          24. The heading to subpart I is revised
appropriate certificate to cover the
                                                 laboratory that has been issued a              to read as follows:
additional testing.
                                                 certificate of accreditation, certificate of
   (ii) If a laboratory with a certificate for   waiver, certificate for PPM procedures,        Subpart I—Proficiency Testing
PPM procedures wishes to perform tests           or certificate for APT tests, it is            Programs for Tests of Moderate
in addition to those specified as PPM            necessary to conduct a complaint               Complexity (Including the
procedures or listed in § 493.15(c) as           investigation, impose sanctions, or            Subcategories), High Complexity, or
waived tests, it must, as set forth in           conduct a hearing, HHS assesses that           any Combination of These Tests
§ 493.638, pay an additional fee for the         laboratory a fee to cover the cost of these
appropriate certificate (registration or         activities. Costs are based on the actual        25. The heading to subpart J is revised
certificate for APT tests) to cover the          resources and time necessary to perform        to read as follows:
additional testing.                              the activities and are not assessed until
   (iii) If a laboratory with a certificate      after the laboratory concedes the              Subpart J—Patient Test Management
for APT tests wishes to perform tests in         existence of deficiencies or an ALJ rules      for Moderate Complexity (Including the
addition to those categorized as APT             in favor of HHS. HHS revokes the               Subcategories), High Complexity, or
tests, specified as PPM procedures, or           laboratory’s certificate for failure to pay    any Combination of These Tests
listed in § 493.15(c) as waived tests, it        the assessed costs. If a complaint               26. Section 493.1101 is revised to read
must, as set forth in § 493.638, pay an          investigation results in the                   as follows:
additional fee for a registration                determination that a complaint is
certificate to cover the additional              unsubstantiated, or if an HHS adverse          § 493.1101 Condition: Patient test
testing.                                         action is overturned at the conclusion of      management; moderate complexity
                                                 the administrative appeals process, the        (including the subcategories), high
*       *      *    *     *                                                                     complexity testing, or any combination of
   18. In § 493.643, paragraph (a) is            costs of these activities are not imposed
                                                                                                these tests.
revised to read as follows:                      upon the laboratory.
                                                    20. The heading of subpart H is                Each laboratory performing moderate
§ 493.643 Fee for determination of               revised to read as follows:                    complexity (including the
program compliance.                                                                             subcategories) or high complexity
                                                 Subpart H—Participation in Proficiency         testing, or any combination of these
   (a) Fee requirement. In addition to the       Testing for Laboratories Performing            tests, must employ and maintain a
fee required under § 493.638, a                  Tests of Moderate Complexity                   system that provides for proper patient
laboratory subject to routine inspections        (Including the Subcategories), High            preparation; proper specimen
must pay a fee to cover the cost of              Complexity, or any Combination of              collection, identification, preservation,
determining program compliance.                  These Tests                                    transportation, and processing; and
Laboratories issued a certificate for PPM                                                       accurate result reporting. This system
procedures, certificate of waiver,                 21. Section 493.803(a) is revised to
                                                                                                must assure optimum patient specimen
certificate for APT tests, or a certificate      read as follows:
                                                                                                integrity and positive identification
of accreditation are not subject to this         § 493.803 Condition: Successful                throughout the preanalytic (pre-testing),
fee for routine inspections.                     participation.                                 analytic (testing), and postanalytic
*      *     *    *    *                           (a) Each laboratory performing tests of      (post-testing) processes and must meet
   19. In section 493.645, the heading is        moderate complexity (including the             the standards as they apply to the
revised, paragraph (c) is redesignated as        subcategories) and/or high complexity          testing performed.
(d) and revised, and a new paragraph (c)         must successfully participate in a                27. A new § 493.1102 is added to read
is added:                                        proficiency testing program approved by        as follows:
47994          Federal Register / Vol. 60, No. 179 / Friday, September 15, 1995 / Proposed Rules

§ 493.1102 Standard; Patient test             procedure specified in appendix C of          The laboratory must meet the following
management requirements for accurate and      the State Operations Manual (HCFA             requirements:
precise technology (APT) tests.               Pub. 7). HCFA Pub. 7 is available from           (a) Have available and follow each test
  For each APT test performed, the            the National Technical Information            system’s PHS-approved written
laboratory must meet all applicable           Service, U.S. Department of Commerce,         instructions, which include the
patient test management requirements          5825 Port Royal Road, Springfield, VA         following protocols:
specified in §§ 493.1103 through              22161, telephone number (703) 487–               (1) Safety precautions.
493.1111. The laboratory meets these          4630.                                            (2) Protocols for instrument or test
requirements by doing both of the               (c) Applicability of subpart K to APT       system operation and test performance,
following activities:                         testing. The laboratory must follow each
  (a) Having available and following the                                                    including maintenance and function
                                              test system’s PHS-approved written            checks.
test system’s PHS-approved instructions       instructions for monitoring and
and, as appropriate, any supplements to                                                        (3) Calibration procedures.
                                              evaluating the quality of the analytical
the procedures established by the                                                              (4) Quality control procedures defined
                                              testing process to assure the accuracy
laboratory in accordance with the test                                                      by the manufacturer or producer of the
                                              and reliability of patient test results and
system’s PHS-approved instructions.                                                         test system, which include running at
                                              reports. For each APT test, the
  (b) Maintaining all records                                                               least two levels of control each day of
                                              laboratory must meet the quality control
documenting compliance with                                                                 testing to monitor all steps in the testing
                                              requirements of § 493.1204.
paragraph (a) of this section for 2 years.      30. In § 493.1202, the introductory         process, including the extraction phase
  28. The heading to subpart K is             text of paragraph (c) is revised to read      if applicable, unless one of the
revised to read as follows:                   as follows:                                   following circumstances applies:
                                                                                               (i) The test system’s PHS-approved
Subpart K—Quality Control for Tests           § 493.1202 Standard; Moderate or high         instructions specify other than two
of Moderate Complexity (Including the         complexity testing, or both: Effective from   levels of control.
Subcategories), High Complexity, or           September 1, 1992 to September 1, 1996.          (ii) The procedure cannot be
any Combination of These Tests                *     *     *     *     *                     controlled by conventional procedures
  29. Section 493.1201 is amended by            (c) For all other tests of moderate         and an alternative means of controlling
revising paragraph (a) introductory text      complexity, excluding the subcategory         the system has been approved by PHS.
and paragraph (b) and by adding               of APT testing, performed using an               (5) Remedial action procedures.
paragraph (c) to read as follows:             instrument, kit, or test system cleared by       (b) Ensure that it meets the following
                                              the FDA through premarket notification        requirements:
§ 493.1201 Condition: General quality         (510(k)) or the premarket approval               (1) It has available and follows written
control; Moderate complexity (including the   (PMA) process for in-vitro diagnostic         procedures, based on each test system’s
subcategories) or high complexity testing,    use, the laboratory must—
or any combination of these tests.                                                          PHS-approved instructions, as
                                              *     *     *     *     *                     applicable, for the following procedures:
  (a) General. Subpart K of this part is        31. Section 493.1203 is amended by
divided into two sections, general                                                             (i) Determining specimen
                                              revising the introductory text to read as     acceptability.
quality control and quality control for       follows:
specialties and subspecialties. The                                                            (ii) Reporting patient test results,
quality control requirements are              § 493.1203 Standard; Moderate complexity      including panic values (values requiring
specified in §§ 493.1201 through              (excluding accurate and precise technology    immediate medical intervention).
493.1285 unless—                              (APT) tests) or high complexity testing or       (iii) Course of action to be taken in the
                                              both: Effective September 1, 1996.            event that a test system becomes
*      *     *     *     *
  (b) Applicability of subpart K to             For each moderate complexity                inoperable.
moderate complexity (excluding APT            (excluding APT tests) or high                    (iv) Referral of samples as specified in
tests) and high complexity tests. The         complexity test performed, the                § 493.1111, including procedures for
laboratory must establish and follow          laboratory is in compliance with this         specimen submission and handling, as
written quality control procedures for        section if it—                                described in § 493.1103.
monitoring and evaluating the quality of      *     *      *    *   *                          (2) The written procedures, whether
the analytical testing process of each                                                      provided by the manufacturer, the test
                                              § 493.1204   [Redesignated as § 493.1206]
method to assure the accuracy and                                                           system producer, or the laboratory, are
                                                32. Section 493.1204 is redesignated        approved, signed and dated by the
reliability of patient test results and
                                              as § 493.1206.                                current director of the laboratory.
reports. The laboratory must meet the
                                                33. New § 493.1204 is added to read
applicable general quality control                                                             (3) Any change to a procedure by the
                                              as follows:
standards in §§ 493.1202 through                                                            manufacturer or producer of a test
493.1221, unless an alternative               § 493.1204 Standard; Quality control          system is approved by PHS and signed
procedure specified in the                    requirements for accurate and precise         and dated by the laboratory director for
manufacturer’s protocol has been              technology (APT) tests.                       use by laboratory personnel.
cleared by the Food and Drug                    For each APT test performed, the               (4) Any change to a laboratory’s
Administration (FDA) as meeting               laboratory is in compliance with this         protocol designed to meet the
certain CLIA requirements for quality         subpart if it meets all applicable quality    requirements is approved, signed and
control or HHS approves an equivalent         control requirements in this section.         dated by the laboratory director.
               Federal Register / Vol. 60, No. 179 / Friday, September 15, 1995 / Proposed Rules                             47995

   (5) A copy of each procedure with the      Subpart M—Personnel for Moderate             § 493.1375 Standard; Laboratory director
dates of initial use and discontinuance       Complexity (Including the                    responsibilities.
is retained for 2 years after a procedure     Subcategories) and High Complexity              The laboratory director is responsible
has been discontinued.                        Testing                                      for the overall operation and
   (c) Before reporting patient results,                                                   administration of the laboratory,
using at least the test system’s PHS-           35. Section 493.1351 is revised to read
                                                                                           including the employment of personnel
approved written instructions, verify         as follows:
                                                                                           who are competent to perform APT tests
that it can obtain performance                § 493.1351   General.                        in accordance with each test system’s
specifications for accuracy, precision          This subpart consists of the personnel     PHS-approved instructions, and record
and reportable range of patient results       requirements that must be met by             and report test results promptly,
that meet those established by the            laboratories performing moderate             accurately, and proficiently, and for
manufacturer or producer of the test          complexity testing, PPM procedures,          assuring compliance with applicable
system. The laboratory must also ensure       APT tests, high complexity testing, or       regulations.
that the laboratory’s patient population      any combination of these tests.                 (a) The laboratory director, if
is included in the reference range              36. Following § 493.1365, a new            qualified, may perform the duties of the
specified in the PHS-approved                 undesignated center heading and new          clinical consultant and testing
instructions.                                 §§ 493.1371 through 493.1387 are added       personnel or may delegate these
   (d) Document all remedial actions          to read as follows:                          responsibilities to personnel meeting
taken—                                                                                     the qualification requirements of
                                              Laboratories Performing Accurate and
   (1) In accordance with the test            Precise Technology (APT) Tests               §§ 493.1379 and 493.1385, respectively.
system’s PHS-approved written
instructions; and                             Sec.                                            (b) The laboratory director must be
                                              493.1371 Condition: Laboratories             accessible to the laboratory to provide
   (2) When errors in the reported                 performing APT tests; Laboratory
patient test results are detected. In such                                                 onsite, telephone or electronic
                                                   director.                               consultation as needed.
a case, the laboratory must perform the       493.1373 Standard; Laboratory director
following procedures:                              qualifications.                            (c) No individual may direct more
   (i) Promptly notify the authorized         493.1375 Standard; Laboratory director       than five laboratories.
person ordering the test or individual             responsibilities.                          (d) The laboratory director must meet
using the test results of report errors.      493.1377 Condition: Laboratories             the following requirements:
   (ii) Issue corrected reports promptly           performing APT testing; clinical
                                                                                              (1) Ensure that testing systems
to the authorized person ordering the              consultant.
                                              493.1379 Standard; Clinical consultant       selected for each of the tests performed
test or the individual using the test              qualifications.                         in the laboratory are appropriate for the
results.                                      493.1381 Standard: Clinical consultant       clinical use of the test results.
   (iii) Maintain exact duplicates of the          responsibilities.                          (2) Ensure that the physical plant and
original erroneous report as well as the      493.1383 Condition: Laboratories             environmental conditions of the
corrected report for 2 years.                      performing APT testing; testing         laboratory are appropriate for the testing
   (e) Document and maintain records of            personnel.
                                              493.1385 Standard; Testing personnel
                                                                                           performed and provide a safe
all quality control activities specified in                                                environment in which employees are
this section and retain records for at             qualifications.
                                              493.1387 Standard; Testing personnel         protected from physical, chemical, and
least 2 years or longer as specified by                                                    biological hazards.
                                                   responsibilities.
the manufacturer or producer of the test
                                              Laboratories Performing Accurate and            (3) Ensure that the following
system in accordance with § 493.1221.
                                              Precise Technology (APT) Tests               requirements are met:
   (f) Promptly report any inaccurate or
imprecise method performance, whether                                                         (i) Before reporting patient results,
                                              § 493.1371 Condition: Laboratories           using at least the test system’s PHS-
perceived or validated, to the                performing APT tests; Laboratory director.
manufacturer or producer of the test                                                       approved verification procedure, the
                                                The laboratory must have a director        laboratory can obtain or verify
system and, if the problem is not             who meets the qualification
rectified, to PHS.                                                                         performance specifications for accuracy,
                                              requirements of § 493.1373 and provides      precision and reportable range of patient
   (g) Ensure that no modification is         overall management and direction in
made in the test system’s PHS-approved                                                     results that meet those established by
                                              accordance with § 493.1375.                  the manufacturer or producer of the test
written instructions. Any changes made
to the test system will result in the test    § 493.1373 Standard; Laboratory director     system and can ensure that the reference
system no longer meeting the                  qualifications.                              range specified by the manufacturer or
requirements for categorization in the           The laboratory director must be           producer of the test system is
APT category. Modified tests are              qualified to manage and direct the           appropriate for the laboratory’s patient
considered high complexity and are            laboratory personnel and the                 populations.
subject to the applicable CLIA quality        performance of APT tests and must be            (ii) Testing personnel are following
control requirements contained in             eligible to be an operator of a laboratory   test analyses and quality control
subpart K of this part, as well as all        within the requirements of subpart R of      procedures in accordance with each test
other applicable requirements for high        this part and meet the requirements of       system’s PHS-approved instructions.
complexity testing.                           § 493.1405, which contain laboratory            (4) Ensure that the laboratory is
   34. The heading to subpart M is            director qualifications for moderate         enrolled in an HHS-approved
revised to read as follows:                   complexity testing.                          proficiency testing program for the
47996          Federal Register / Vol. 60, No. 179 / Friday, September 15, 1995 / Proposed Rules

testing performed and that the                whenever necessary, identify needs for         clinical consultant must meet the
laboratory meets the following                remedial training or continuing                following requirements:
requirements:                                 education to improve testing skills. The          (a) Be available to provide clinical
   (i) The proficiency testing samples are    director must ensure that evaluations          consultation to the laboratory’s clients.
tested as required under subpart H of         are conducted at least semiannually               (b) Be available to assist the
this part.                                    during the first year the individual tests     laboratory’s clients in ensuring that
   (ii) The results are returned within the   patient specimens and that, thereafter,        appropriate tests are ordered to meet the
time frames established by the                the evaluations are performed at least         clinical expectations.
proficiency testing program.                  annually unless test methodology or               (c) Ensure that reports of test results
   (iii) All proficiency testing reports      instrumentation changes, in which case,        include pertinent information required
received are reviewed to evaluate the         before reporting patient test results, the     for specific patient interpretation.
laboratory’s performance and to identify      individual’s performance must be                  (d) Ensure that consultation is
any problems that require corrective          reevaluated to include the use of the          available and communicated to the
action.                                       new test methodology or                        laboratory’s clients on matters related to
   (iv) An approved corrective action         instrumentation. The evaluation of the         the results of APT tests reported and
plan is followed and documented when          competency of testing personnel must           their interpretation concerning specific
any proficiency testing results are found     include at least one or more of the            patient conditions, including any
to be unacceptable or unsatisfactory.         following, but is not limited to the           relevant information provided in the
   (5) Ensure that a quality assurance        following procedures:                          test system’s PHS-approved
program is established and maintained           (i) Direct observations of routine           instructions.
to assure the quality of laboratory           patient test performance, including
services provided.                            patient preparation, if applicable,            § 493.1383 Condition: Laboratories
   (6) Ensure that all necessary remedial     specimen handling, and testing.                performing APT testing; testing personnel.
actions are taken and documented and            (ii) Monitoring the recording and              The laboratory must have a sufficient
that patient results are reported only        reporting of test results.                     number of individuals who meet the
when the test system is functioning             (iii) Review of work sheets, quality         qualification requirements of § 493.1385
properly.                                     control records, proficiency testing           to perform the functions specified in
   (7) Ensure that the producer or            results, and preventive maintenance            § 493.1387 for the volume of tests
manufacturer of the test system is            records.                                       performed.
notified when the test system does not          (iv) Assessment of test performance
meet the performance specifications as        through testing previously analyzed            § 493.1385 Standard; Testing personnel
                                                                                             qualifications.
outlined in the test system’s PHS-            specimens, internal blind testing
approved instructions and, if the             samples, or external proficiency testing          Each individual performing APT
problem is not rectified, notify PHS.         samples.                                       testing must meet the following
   (8) Ensure that reports of test results      (13) Ensure that an approved                 requirements:
include pertinent information required        procedure manual is available to all              (a) Possess a current license issued by
for interpretation.                           testing personnel.                             the State in which the laboratory is
   (9) Ensure that consultation is              (14) Specify, in writing, the                located, if such licensing is required.
available to the laboratory’s clients on      responsibilities and duties of each               (b) Meet one of the following
matters relating to the results of APT        person engaged in the performance of           requirements:
tests reported and their interpretation       APT testing that identifies which                 (1) Be a doctor of medicine, doctor of
concerning specific patient conditions,       examinations and procedures each               osteopathy, or doctor of podiatric
including any relevant information            individual is authorized to perform.           medicine licensed to practice medicine,
provided in the test system’s PHS-                                                           osteopathy, or podiatry in the State in
approved instructions.                        § 493.1377 Condition: Laboratories             which the laboratory is located or have
                                              performing APT testing; clinical consultant.   earned a doctoral, master’s, or
   (10) Employ a sufficient number of
testing personnel with the appropriate           The laboratory must have a clinical         bachelor’s degree in a chemical,
education and either experience or            consultant who meets the qualification         physical, biological or clinical
training to perform tests and report test     requirements of § 493.1379 and provides        laboratory science or medical
results in accordance with the personnel      clinical consultation in accordance with       technology from an accredited
responsibilities described in this            § 493.1381.                                    institution.
subpart.                                      § 493.1379 Standard; Clinical consultant          (2) Have earned an associate degree in
   (11) Ensure that, before they test         qualifications.                                a chemical, physical, or biological
patient samples, testing personnel               The clinical consultant must be             science, or in medical laboratory
receive the appropriate training for the      qualified to consult with and furnish          technology from an accredited
services offered and have demonstrated        opinions to the laboratory’s clients           institution.
that they can perform all testing             concerning the diagnosis, treatment and           (3) Be a high school graduate or
operations, in accordance with each test      management of patient care. The                equivalent and have successfully
system’s PHS-approved instructions, to        clinical consultant must meet the              completed an official U.S. military
provide and report accurate results.          requirements of § 493.1417, Clinical           medical laboratory procedures course of
   (12) Ensure that policies and              consultant qualifications for moderate         at least 50 weeks duration and have
procedures are established for                complexity testing.                            held the military enlisted occupational
evaluating and documenting the                                                               specialty of Medical Laboratory
performance of testing personnel              § 493.1381 Standard; Clinical consultant       Specialist (Laboratory Technician).
responsible for APT testing to ensure         responsibilities.                                 (4) (i) Have earned a high school
that they are competent and maintain            The clinical consultant provides             diploma or equivalent; and
their competency to handle specimens,         consultation regarding the                        (ii) Have documentation of training
perform test procedures, report test          appropriateness of the testing ordered         appropriate for the APT testing
results promptly and proficiently, and,       and interpretation of test results. The        performed before analyzing patient
              Federal Register / Vol. 60, No. 179 / Friday, September 15, 1995 / Proposed Rules                                 47997

specimens. This training must ensure        Subpart P—Quality Assurance for                  analytes specified in subpart I of this
that the individual has the following       Moderate Complexity (Including the               part.
skills and knowledge:                       Subcategories), High Complexity                     (iii) To evaluate complaints from the
                                            Testing, or any Combination of These             public.
   (A) The skills required for proper
                                            Tests                                               (2) Determine whether testing is being
specimen collection, including patient
                                                                                             performed or the laboratory is being
preparation (if applicable), labeling,      § 493.1701   [Amended]                           operated in a manner that does not
handling, preservation, transportation         38. Section 493.1701 is amended by            constitute an imminent and serious risk
and storage of specimens.                   revising the word ‘‘subcategory’’ to read        to public health.
   (B) The skills required for performing   ‘‘subcategories’’ wherever it appears in            (3) Collect information to determine
each test method and control procedure      the heading and text.                            the appropriateness of tests categorized
and for proper instrument use.                 39. A new § 493.1702 is added to read         as APT tests according to the criteria
   (C) The skills required for performing   as follows:                                      listed at § 493.18.
                                                                                                (4) Determine whether the laboratory
preventive maintenance,                     § 493.1702 Standard; Quality Assurance           is performing tests in addition to tests
troubleshooting and calibration             for accurate and precise technology (APT)        categorized as APT tests according to
procedures related to each test             tests.
                                                                                             the criteria listed at § 493.18, specified
performed.                                     For each APT test performed, the              as PPM procedures, or tests approved by
   (D) An awareness of the factors that     laboratory must meet all applicable              PHS as waived tests that are not
influence test results.                     quality assurance requirements                   included on the laboratory’s certificate.
                                            specified in §§ 493.1703 through                    (b) The laboratory may be required as
§ 493.1387 Standard; Testing personnel      493.1721. The laboratory meets these             part of this inspection to perform or
responsibilities.                           requirements by doing both of the                authorize the following activities:
  The testing personnel performing APT      following activities:                               (1) Test samples (including
tests are responsible for specimen             (a) Having available and following the        proficiency testing samples) or perform
                                            test system’s PHS-approved instructions          procedures as HHS or its designee
processing, test performance, and for
                                            and, as appropriate, any supplements to          requires.
reporting test results.
                                            the procedures established by the                   (2) Allow HHS or its designee to
  (a) Each individual performs only         laboratory in accordance with the test           interview all employees of the
those APT tests that they are authorized    system’s PHS-approved instructions.              laboratory concerning the laboratory’s
by the laboratory director to perform.         (b) Maintaining all records                   compliance with the applicable
  (b) Each individual performing APT        documenting compliance with                      requirements as noted in paragraph (d)
testing must meet the following             paragraph (a) of this section for 2 years.       of this section.
requirements:                                  40. In § 493.1777 the introductory text          (3) Permit employees to be observed
                                            is revised to read as follows:                   performing tests (including proficiency
  (1) Follow each test system’s PHS-                                                         testing specimens), data analysis and
approved written instructions and, as       § 493.1777 Condition: Inspection of              reporting.
applicable, the laboratory’s written        laboratories requesting or issued a                 (4) Permit HHS or its designee access
policies and procedures for specimen        certificate of compliance.                       to all areas of the facility, including the
submission and handling and for               Laboratories requesting a certificate of       following areas:
reporting and maintaining records of        compliance must permit an inspection                (i) Specimen procurement and
patient test results.                       to assess compliance with part 493 of            processing areas.
  (2) Maintain records that demonstrate     this chapter. All testing conducted,                (ii) Storage facilities for specimens,
that proficiency testing samples are        including testing in the subcategories of        reagents, supplies, records, and reports.
                                            APT tests or PPM procedures, may be                 (iii) Testing and reporting areas.
tested in the same manner as patient
                                            included in the laboratory’s routine or             (5) Provide copies to HHS or its
samples.
                                            complaint inspection. APT tests and              designee of all records and data required
  (3) Adhere to each test system’s PHS-     PPM procedures are assessed for                  under this part.
approved written instructions for           compliance with only the applicable                 (c) The laboratory must have all
quality control procedures, including       requirements specific to those                   records and data accessible and
the documentation of all quality control    subcategories of testing.                        retrievable within a reasonable time
activities, remedial actions, instrument    *     *     *     *     *                        frame during the inspection.
and procedural calibrations, and              41. A new § 493.1778 is added to read             (d) Applicable requirements for the
maintenance performed.                      as follows:                                      purpose of this section are located in
  (4) Be capable of identifying problems                                                     subparts C, H, J, K, M, and P of this part
                                            § 493.1778 Condition: Inspection of              and § 493.21.
that may adversely affect test              laboratories issued a certificate for accurate      (e) The laboratory must provide upon
performance or reporting of test results    and precise technology (APT) tests.              reasonable request all information and
and either must correct the problems or       (a) HHS or its designee may conduct            data needed by HHS or its designee to
immediately notify the director.            announced or unannounced inspections             make a determination of compliance
  (5) Notify the director of any test       of any laboratory issued a certificate for       with the applicable requirements.
system performance that does not meet       APT tests at any time during its hours              (f) HHS or its designee may reinspect
the performance specifications as           of operation for the following purposes:         a laboratory at any time necessary to
outlined in the test system’s PHS-            (1) Assess compliance with the                 assess the laboratory’s compliance with
approved instructions.                      following circumstances, as applicable:          the applicable requirements.
                                              (i) On a random basis.                            (g) Failure to permit an inspection
  37. The heading to subpart P is             (ii) Following a laboratory’s                  under this section will result in the
revised to read as follows:                 demonstration of unsuccessful                    suspension of Medicare and Medicaid
                                            participation in proficiency testing for         payments to the laboratory or
47998          Federal Register / Vol. 60, No. 179 / Friday, September 15, 1995 / Proposed Rules

termination of the laboratory’s               § 493.1834   Civil money penalty.                  (3) If the laboratory still does not
participation in Medicare and Medicaid        *      *    *     *      *                      correct its deficiencies, the Medicare
for payment, and suspension of, or              (b) Scope. This section sets forth the        sanction continues until the suspension,
action to revoke, the laboratory’s CLIA       procedures that HCFA follows to                 limitation, or revocation of the
certificate in accordance with subpart R      impose a civil money penalty in lieu of,        laboratory’s certificate of compliance,
of this part.                                 or in addition to, suspending, limiting,        registration certificate, certificate of
  42. In § 493.1814, the text of the          or revoking the certificate of                  accreditation, certificate for APT tests,
introductory text of paragraph (b) is         compliance, registration certificate,           or certificate for PPM procedures is
republished and paragraph (b)(3) is           certificate of accreditation, certificate for   effective.
revised to read as follows:                   APT tests, or certificate for PPM                  45. In § 493.2001, the introductory
                                              procedures of a laboratory that is found        text of paragraph (e) is republished and
§ 493.1814 Action when deficiencies are at    to have condition level deficiencies.           paragraph (e)(1) is revised to read as
the condition level but do not pose           *      *    *     *      *                      follows:
immediate jeopardy.                             (f) Accrual and duration of penalty.
*      *      *     *     *                   * * *                                           § 493.2001 Establishment and function of
                                                (2) Duration of penalty. The civil            the Clinical Laboratory Improvement
   (b) Failure to correct condition level                                                     Advisory Committee.
                                              money penalty continues to accrue until
deficiencies. If HCFA imposes
                                              the earliest of the following occurs:           *      *     *     *     *
alternative sanctions for condition level
deficiencies that do not pose immediate       *      *    *     *      *                         (e) The Clinical Laboratory
jeopardy and the laboratory does not            (iii) HCFA suspends, limits, or               Improvement Advisory Committee or
correct the condition level deficiencies      revokes the laboratory’s certificate of         subcommittee at the request of HHS will
within 12 months after the last day of        compliance, registration certificate,           review and make recommendations
inspection, HCFA—                             certificate of accreditation, certificate for   concerning—
                                              APT tests, or certificate for PPM
*      *      *     *     *                   procedures.                                        (1) Criteria for categorizing tests and
   (3) May impose (or continue, if                                                            examinations of moderate complexity
                                              *      *    *     *      *
already imposed) any alternative                44. In § 493.1836, the heading of             (including the subcategories) and high
sanctions that do not pertain to              paragraph (c) is republished and                complexity;
Medicare payments. (Sanctions imposed         paragraphs (c)(2) and (c)(3) are revised        *      *     *     *     *
under the authority of section 353 of the     to read as follows:                               Authority: Sec. 353 of the Public Health
PHS Act may continue for more than 12                                                         Service Act (42 U.S.C. 263a)
months from the last date of inspection,      § 493.1836   State onsite monitoring.             Dated: May 25, 1995.
while a hearing on the proposed               *      *      *    *     *                      Bruce C. Vladeck,
suspension, limitation, or revocation of         (c) Duration and sanction. * * *
                                                 (2) If the laboratory does not correct       Administrator, Health Care Financing
the certificate of compliance,                                                                Administration.
registration certificate, certificate of      all deficiencies within 12 months, and
                                              a revisit indicates that deficiencies             Dated: May 26, 1995.
accreditation, certificate for APT tests,
or certificate for PPM procedures is          remain, HCFA cancels the laboratory’s           Philip R. Lee,
pending.)                                     approval for Medicare payment for its           Assistant Secretary for Health.
                                              services and notifies the laboratory of its
*      *      *     *     *                                                                     Dated: June 5, 1995.
                                              intent to suspend, limit, or revoke the
   43. In § 493.1834, the heading and         laboratory’s certificate of compliance,         Donna E. Shalala,
introductory text of paragraph (f)(2) are     registration certificate, certificate of        Secretary.
republished and paragraphs (b) and            accreditation, certificate for APT tests,       [FR Doc. 95–22861 Filed 9–14–95; 8:45 am]
(f)(2)(iii) are revised to read as follows:   or certificate for PPM procedures.              BILLING CODE 4120–01–P

				
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