[Section II of this manual contains flow cytometry-specific information and copies of forms that can be used to help meet the requirements related to flow cytometry.]

 493.801 Condition: Enrollment and Testing of Samples

 Each laboratory performing tests of moderate and/or high complexity must enroll in a proficiency testing program that meets the CLIA federal regulation (Subpart I) and is approved by Health and Human Services (HHS). The laboratory must enroll in an approved program or programs for each of the specialties or subspecialties for which certification is desired. All of the usual criteria for running proficiency testing samples must be adhered to, including running each test sample as a patient.

 Under the regulation (a) Standard; Enrollment, the laboratory is required to:

Inform HHS of the approved programs in which it has chosen to participate. The laboratory must also list the tests performed and which PT programs will satisfy this requirement. For tests that are not covered under PT programs, the laboratory must establish and maintain the accuracy and reliability of its testing procedures in accordance with section 493.1709. The laboratory must also participate in the approved program or programs for one year for each specialty or test before choosing a different program and must notify HCFA before the change. The last requirement under this Standard asks the laboratory to authorize the PT program to release to HHS all data necessary to determine the laboratory's compliance.

Under the regulation (b) Standard; Testing of Proficiency Testing Samples, the laboratory is required to:

Test or examine the PT samples it receives with the regular patient workload by personnel who routinely perform the testing using the usual methods. The laboratory must test PT samples the same number of times it routinely tests patient samples. Additionally, the laboratory must not discuss PT sample results with any other laboratory until after the results are required to be sent to the service. This also applies to laboratories with multiple sites. If a laboratory performs a certain test, it must not send the PT sample to another laboratory for analysis and then report those results. Laboratories who engage in this practice will have their certification revoked for at least one year.

The laboratory must follow standard practices by documenting the handling, preparation, processing, examination, and each step in the testing and reporting of results for all PT samples. Copies of the PT report forms (with the signatures of the analyst and laboratory director) must be kept for a minimum of two years after the PT event. Only the primary method for patient testing requires PT data.

493.803 Condition: Successful Participation

 Each laboratory performing tests of moderate and/or high complexity must successfully participate in a PT program approved by HCFA, if applicable. If the laboratory fails the PT program for any specialty, subspecialty, analyte, or test, sanctions will be taken.

493.807 Condition: Reinstatement of Laboratories Performing Tests of Moderate or High Complexity, or Both After Failure to Participate Successfully.

The termination period for Medicare/Medicaid approval or period for suspension of certification under CLIA for the failed test, is a period of not less than six months. If the laboratory's certificate is suspended or Medicare/Medicaid approval is withdrawn for failing PT for one or more tests, or if the laboratory voluntarily withdraws its certification, the laboratory must demonstrate successful performance on two consecutive PT events (one of which may be on-site) before HCFA will consider it for reinstatement.

NOTE: Please refer to the CLIA regulation, Proficiency Testing by Specialty or Subspecialty for Laboratories Performing Tests of Moderate or High Complexity, or Both for the specific parameters required for successful PT performance.

 493.901 Approval of PT Programs

A PT program must be offered by a private, nonprofit organization, a Federal or State agency or its designee in order to receive HHS approval. The organization must submit its application for approval or re-approval for the next calendar year by July 1 of the current year. It must also provide technical assistance to laboratories which desire to qualify under the program. Additionally, the organization must assure the quality of test samples, evaluate and score the results, and identify performance deficits. Overall technical ability must be demonstrated to HHS. This includes: the preparation or purchase of samples made under good manufacturing practices; the adequate distribution of samples, with special consideration given to patient similarity, homogeneity, and stability; and mechanisms to provide adequate information to HHS and the PT participant on grading criteria, technical and administrative concerns.

493.1101 Condition: Patient Test Management; Moderate or High Complexity Testing, or Both

Optimum patient specimen integrity and positive identification must be maintained throughout the preanalytic, analytic, and postanalytic processes. Laboratories performing moderate or high complexity testing must have an adequate system which provides for proper patient preparation, specimen collection, identification, preservation, transportation, processing, and accurate result reporting.

493.1103 Standard; Procedures for Specimen Submission and Handling

Each laboratory must have written policies and procedures (readily available) for all methods. These include: preparation of patients, specimen collection, specimen labeling, specimen preservation, and specimen transportation. If the laboratory accepts referral specimens, the above information must be supplied to their clients.

493.1105 Standard; Test Requisition

Tests are performed by a laboratory only at the written or electronic request of an authorized person. Verbal requests must be followed by written authorization within 30 days. The test requisitions (or equivalent) must be retained for a minimum of two years. Each requisition must include: a unique patient identifier, any suitable identifiers of the requesting party, the tests to be performed, and the date of specimen collection.

493.1107 Standard; Test Record

A record system must be maintained by the laboratory to ensure reliable identification of patient specimens (and the testing personnel) as they are processed and tested. Records, including instrument printouts if applicable, must be retained for a minimum of two years. These records must include: a unique patient identifier, the date and time the specimen arrived at the laboratory, the disposition of specimens that do not meet the laboratory's acceptability criteria, and the dates of all specimen testing.

493.1109 Standard; Test Report

The laboratory report must be sent promptly to the requesting individual or party. A copy of each report must be maintained by the laboratory for a minimum of two years. The test report must indicate the name and address of the laboratory location, the test performed, the test result, and, if applicable, the units of measurement. Pertinent reference or normal ranges, determined by the laboratory performing the tests, must be available to the requester. Additionally, the laboratory must develop and follow written procedures for reporting imminent life-threatening test results or panic values. If requested by its clients, the laboratory must provide a list of test methods employed and the performance specifications.

493.1111 Standard; Referral of Specimens

A laboratory may refer specimens for testing only to another laboratory which holds a valid certificate authorizing the performance of that test. The referring laboratory must not revise the results provided by the testing laboratory. The referring laboratory may send results directly to the requesting individual or party as long as the referring laboratory maintains a copy of the report. The name and address at which a test was performed must be provided to the requester.

[Section III of this manual contains flow cytometry-specific information and copies of forms that can be used to help meet the requirements related to flow cytometry.]

NOTE: Effective May 12, 1997, the phase-in quality control requirements for moderate and high complexity tests are extended from September 1, 1996, to July 31, 1998.

493.1201 Condition: General QC; Moderate or High Complexity Testing, or Both

The laboratory must establish and follow written QC procedures for monitoring and evaluating the quality of the analytical testing process of each method to assure the accuracy and reliability of patient test results and reports. In addition, the laboratory must meet the applicable standards in 493.1202--493.1221 (which follows) unless an alternative procedure specified in the manufacturer's protocol has been cleared by the FDA as meeting the CLIA requirements for general QC, and the device/test QC instructions contain the following statement: "Unless this device is modified by a laboratory, compliance with these quality control instructions satisfies 42 CFR 493.1202--493.1221 implementing CLIA 88," or HCFA approves an equivalent procedure specified in Appendix C of the State Operations Manual (HCFA Pb. 7). HCFA Pb. 7 is available from the Technical Information Service, US Department of Commerce, 5825 Port Royal Road, Springfield, VA 22161 (703) 487-4630.

1202 Standard; Moderate or High Complexity Testing or Both Effective from September 1, 1992 to September 1, 1994

 NOTE: Effective May 12, 1997 the date for fulfilling the following guidelines was extended until July 31, 1998.

 For each test of high complexity performed, the laboratory must meet all applicable standards of this subpart. For each test of moderate complexity performed using a method developed in-house or using an instrument, kit or test system cleared by the FDA through the premarket notification (510(k)) or premarket approval (PMA) process but modified by the laboratory, the laboratory must meet all applicable standards of this subpart. However, for all other tests of moderate complexity performed using an instrument, kit or test system cleared by the FDA for in-vitro diagnostic use the laboratory must:

NOTE: Effective May 12, 1997 the date for fulfilling the following guidelines was extended until July 31, 1998.

A laboratory must meet all applicable QC requirements in this subpart or follow the manufacturer's instructions which meet the CLIA requirements.

493.1204 Standard; Facilities

The laboratory must be constructed to ensure an appropriate environment to enable the proper performance of all phases of testing (pre-analytic, analytic, and post-analytic). Safety precautions must be followed to ensure protection from biohazardous materials, and from electrical or physical hazards.

493.1205 Standard; Test Methods, Equipment, Instrumentation, Reagents, Materials, and Supplies

Accurate and reliable results must be obtained by ensuring that the equipment and methodologies are performed within the laboratory's stated performance specifications. A laboratory must define criteria for conditions essential for proper storage of reagents, specimens and accurate and reliable test system operation and test result reporting. Such conditions may include: water quality, temperature, humidity and electrical current fluctuation protection. Any remedial actions must be documented. Reagents, solutions, culture media, control materials, calibration materials, and other supplies must be labeled for: identity and titer or concentration, recommended storage requirements, preparation and expiration dates. The laboratory must comply with FDA product dating requirements and not use materials when they have exceeded their expiration date. Additionally, the laboratory must not interchange components of reagent kits of different lot numbers unless so specified by the manufacturer.

493.1211 Standard; Procedure Manual

A written procedure manual for the performance of all analytical methods used by the laboratory must be readily available and followed by laboratory personnel. Procedures may be organized in the form of manuals, computer memory, or card files. Manufacturer's operating instructions, package inserts, and other manuals (CDC or AFIP) are acceptable as long as the procedures are clearly indicated. The procedure manual must include: requirements for specimen collection, processing and specimen rejection criteria, step-by-step performance of the procedure, preparation of solutions, calibrators, controls and reagents, calibration and calibration verification procedures, the reportable range for test results, and control procedures. The procedure manual must also include the remedial action required when calibration or control results fall outside the laboratory's acceptability criteria. Defined reference ranges, "panic values", literature references, criteria for specimen storage, and the laboratory's system for reporting patient results must be clearly documented and available to all laboratory personnel. Procedures must be approved, signed, and dated by the director and must be reapproved if the director changes. The laboratory must maintain a copy of each procedure with the date of the initial use and discontinuance for a minimum of 2 years after a procedure has been discontinued.

Before a laboratory can report patient results, it must verify or establish performance specifications for accuracy, precision, sensitivity and specificity (if applicable), the reportable range of patient test results, the normal values, and any other applicable performance characteristics. Laboratories are not required to verify or establish performance criteria for a test method in use prior to September 1, 1992. However, after September 1, 1992, a laboratory which introduces a new procedure for patient testing (moderate or high complexity) which is cleared by the FDA as meeting the CLIA requirements for general QC must demonstrate that it can obtain the performance specifications comparable to those established by the manufacturer. The laboratory must also verify that the manufacturer's reference range is appropriate for their patient population. In addition, if a laboratory introduces a new procedure for patient testing which was developed in-house or is a modification of a manufacturer's procedure, or if that method has not been cleared by the FDA as meeting CLIA requirements for general QC, it must verify or establish performance characteristics (accuracy, precision, sensitivity, specificity, reportable range, reference range, and other applicable criteria). The laboratory must also establish and document calibration and control procedures as required under 493.1217 and 493.1218.

493.1215 Standard; Equipment Maintenance and Function Checks

Electronic, mechanical, and operational checks must be performed by the laboratory to ensure proper performance and accurate test results. For equipment cleared by the FDA as meeting the CLIA general QC requirements, the laboratory must perform and document the maintenance as defined by the manufacturer with at least the frequency specified. For equipment not cleared by the FDA as meeting the CLIA requirement or for equipment, instruments, or systems developed or modified in-house, the laboratory must establish and document a maintenance protocol which includes frequency of testing. In like manner, for equipment cleared by the FDA for CLIA compliance the laboratory must perform function checks as defined and with at least the frequency recommended. For equipment not cleared, or in-house modified or developed systems, the laboratory must define and document a function check protocol.

Calibration is the process of testing and adjusting an instrument or test system to provide a known relationship between the measurement response and the value of the substance that is being measured by the test procedure. Calibration verification is the assaying of calibration materials in the same manner as patient samples to confirm that the calibration of the instrument or test system has remained stable throughout the laboratory's reportable range for test results. Calibration and calibration verification must be performed and documented. For test procedures that are performed on test systems that have been cleared by the FDA as meeting CLIA requirements for general QC, the laboratory must follow the manufacturer's directions at a minimum. For procedures developed or modified in-house, or systems not cleared for CLIA compliance by the FDA the laboratory must perform calibration procedures provided by the manufacturer or in accordance with criteria established by the laboratory. These criteria should include: the number, type and concentration of calibration materials, acceptable limits for calibration, frequency of calibration, and the appropriate calibration materials that are traceable to a reference method or reference material, if possible. Additionally, calibration must be performed when calibration verification fails to meet the laboratory's acceptable limits.

Calibration verification procedures must be performed with the manufacturer's instructions, or in accordance with criteria established by the laboratory. The calibration materials must be appropriate for verifying the laboratory's established reportable range of patient results which must include at least a minimal (or zero) value, a mid-point value, and a maximum value at the upper limit of that range. Calibration verification must also be performed at least once every six months or when a complete change of reagents for a procedure is introduced (unless the laboratory can demonstrate that the change does not affect the reportable range), when major preventive maintenance requires the replacement of critical parts that may influence test performance, and when the controls demonstrate an unusual trend or shift. All calibration and calibration verification procedures that are performed must be documented.

493.1218 Standard; Control Procedures

The accuracy and precision of patient test results are indirectly assessed through use of control procedures and control and calibration materials. For each method cleared by the FDA for CLIA compliance, the laboratory must follow the manufacturer's instructions. For methods developed or modified in-house, or not cleared by the FDA for CLIA compliance, the laboratory must evaluate instrument and reagent stability and operator variance in determining the number, type and frequency of testing calibration and control materials and establish acceptability criteria used to monitor test performance during a patient specimens run. (A run is an interval within which accuracy and precision of a testing system is expected to be stable, but cannot be greater than 24 hours.)

For qualitative tests, the laboratory must include a positive and negative control with each run of patient specimens. For quantitative tests, the laboratory must include at least two samples of different concentrations of either calibration materials, control materials, or a combination, with a frequency of not less than once each run of patient specimens. The laboratory must have an alternative mechanism to assure the validity of patient results if calibration and control materials are not available. Control samples must be tested in the same manner as patient samples and results must meet the laboratory's acceptability criteria. When calibration or control materials are used, statistical values such as mean and standard deviation must be determined through repetitive testing. The manufacturer's stated values of an assayed control may be used, or if unassayed materials are used, the laboratory must establish these values through concurrent testing with previously determined values of calibration or control materials.

 493.1219 Standard; Remedial Actions

 Remedial action procedures must be established by the laboratory and applied as necessary to maintain the proper testing of patient samples. The laboratory must document all remedial actions taken when test systems do not meet the established performance specifications (due to equipment or patient values exceeding the reportable range) or when the laboratory's reference range is inappropriate for the laboratory's patient population. Remedial action must be taken if the results of control and calibration materials fail to meet the established acceptability criteria. All patient test results obtained in the unacceptable test run or since the last acceptable test run must be evaluated to determine if the patient results have been affected. If an error is found on the patient report, the requesting individual must be notified, the corrected reports forwarded to the requester, and the laboratory must maintain both the original and the corrected report for two years.

 493.1221 Standard; Quality Control Records

 The laboratory must document and maintain records of all QC activities specified and retain records for at least two years.

 493.1223 Condition; Quality Control--Specialties and Subspecialties for Tests of Moderate or High Complexity, or Both

 Written policies for an acceptable QC program must be established and should include verification and assessment of accuracy, measurement of precision, and detection of error for all procedures. Effective September 1, 1994, a laboratory that performs moderate or high complexity tests will be in compliance if it meets the QC requirements specified above, or follows manufacturer's instructions for products cleared by the FDA for CLIA QC requirements.

 NOTE: Please refer to the CLIA regulation for the applicable QC requirements specific to the subspecialties for which your lab is certified.

NOTE: Flow cytometry testing is classified as high complexity testing

493.1401 General

This subpart consists of the personnel requirements that must be met by laboratories performing moderate or high complexity testing, or both.

493.1441 Condition: Laboratories Performing High Complexity Testing; Laboratory Director

The laboratory must have a director who meets the qualification requirements and provides overall management and direction.

493.1443 Standard; Laboratory Director Qualifications

NOTE: Effective May 12, 1997, the board certification requirement has been extended from September 1, 1996, to July 31, 1998.

The laboratory director must possess a current license as a director issued in the state in which the laboratory is located, if such is required. The director may be a doctor of medicine or osteopathy licensed to practice in that state and be certified in anatomic or clinical pathology or both or possess qualifications that are equivalent to those required for such certification. The director may also be a doctor of medicine or osteopathy duly licensed and have at least one year of laboratory training during residency or at least 2 years experience directing high complexity testing. The director may also hold an earned doctoral degree in a chemical, physical, biological, or clinical laboratory science from an accredited institution and be appropriately certified or until September 1, 1994, have at least two years laboratory training, two years experience directing high complexity testing and on September 1, 1994, must be appropriately board certified.

493.1445 Standard; Laboratory Director Responsibilities

 The laboratory director is responsible for the overall operation of the laboratory including employing acceptable personnel. The director may perform the duties of the technical consultant, clinical consultant, and testing personnel or delegate these to the appropriate personnel. The director must ensure that testing systems developed and used provide quality services, that the physical plant conditions are appropriate for the testing performed, that the test methodologies will provide quality results, that verification procedures are adequate, and that personnel are performing the tests as required. The director must also ensure that the laboratory is enrolled in an HHS approved PT program and that the QC and QA programs are established and maintained to assure quality and identify failures as they occur. Additionally, the director must ensure remedial action is taken when necessary, that consultation is available to the laboratory's clients, that sufficient laboratory personnel with the appropriate education and experience are performing the tests, that policies are established for monitoring personnel to assess their competency, that an approved procedure manual is available, and that the responsibilities of each person are specified. The director must also ensure that a general supervisor provides on-site supervision of high complexity test performance.

 493.1447 Condition: Laboratories Performing High Complexity Testing; Technical Supervisor

 The laboratory must have a technical supervisor who meets qualification requirements and provides technical supervision.

 493.1449 Standard; Technical Supervisor Qualifications (TS)

 Individuals who are qualified by education and experience to provide technical supervision for the performed services must be employed by the laboratory. The TS must possess a current license issued in the state in which the laboratory is located, if such is required.

 The TS may be a doctor of medicine or osteopathy licensed to practice in that state and be certified in anatomic or clinical pathology or both or possess qualifications that are equivalent to those required for such certification.

 NOTE: Please refer to the CLIA regulation for the applicable qualification requirements for the specific high complexity subspecialties for the technical supervisor.

493.1451 Standard; Technical Supervisor Responsibilities

 The technical supervisor is responsible for the technical and scientific oversight of the laboratory. The TS is not required to be on-site at all times testing is performed, but must be available on an as-needed basis. The TS is responsible for the selection of the appropriate test methodology, ensuring that verification procedures are established. The TS must also ensure that the laboratory is enrolled in an HHS approved PT program and establish the QC and QA programs to assure quality and identify failures as they occur. Additionally, the TS must ensure remedial action is taken when necessary, resolve technical problems, ensure that each individual performing tests receives regular in-service training, and evaluate the competency of all testing personnel.

 NOTE: This section was amended in Federal Register Vol. 57, No. 40 on February 28, 1992, to include the following:

 Technical Supervisor Responsibilities: Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately, and proficiently. The procedures for evaluation of the competency of the staff must include, but are not limited to,

 Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing, and testing;

1. Monitoring the recording and reporting of test results;
2. Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records;
3. Direct observation of performance of instrument maintenance and function checks;
4. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and
5. Assessment of problem solving skills; and

493.1453 Condition: Laboratories Performing High Complexity Testing; Clinical Consultant

The laboratory must have a clinical consultant who meets the qualification requirements and provides clinical consultation.

 493.1455 Standard; Clinical Consultant Qualifications (CC)

 The CC must be qualified to consult with and render opinions to the laboratory's clients concerning the diagnosis, treatment and management of patient care. The CC must be qualified as a laboratory director, or be a doctor of medicine or osteopathy and possess a license to practice in the state in which the laboratory is located.

 493.1457 Standard; Clinical Consultant Responsibilities

 The CC provides consultation regarding the appropriateness of the tests ordered and the interpretation of results. This includes being available to the laboratory's clients to assist with choosing the appropriate tests and [ensuring] that the patient reports contain the pertinent information necessary for specific patient interpretation.

 493.1459 Condition: Laboratories Performing High Complexity Testing; General Supervisor (GS)

 The laboratory must have one or more general supervisors who are qualified to provide general supervision. The GS provides day-to-day supervision of testing personnel and reporting of test results under the direction of the laboratory director and the technical supervisor. The GS must possess a current license issued by the state where is laboratory is located, if required, be a laboratory director, or a technical supervisor.

 NOTE: Please refer to the CLIA regulation for the applicable qualification requirements for the specific high complexity subspecialties for the general supervisor.

493.1463 Standard: General Supervisor Responsibilities

The GS must be available to testing personnel at all times testing is performed (on-site, telephone, or electronic). The GS is responsible for providing day-to-day supervision of high complexity test performance by testing personnel, and monitoring test analyses and specimen examinations to ensure acceptable levels of analytic performance are maintained. If the director or TS chooses, the GS assures all remedial actions are taken, ensures results are not reported until the test system is properly functioning, provides orientation to testing personnel, and annually evaluates and documents personnel performance.

493.1487 Condition: Laboratories Performing High Complexity Testing; Testing Personnel

The laboratory must have a sufficient number of individuals who meet the qualification requirements.

493.1489 Standard; Testing Personnel Qualifications

Each individual must possess a current license issued in the state where the laboratory is located, if required, be a doctor of medicine or osteopathy duly licensed, have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological, or clinical laboratory science, or medical technology from an accredited institution, have earned an associate degree in a chemical, physical, biological, or medical laboratory technology from an accredited institution.

NOTE: Please refer to the CLIA regulation for the applicable qualification requirements for the specific high complexity subspecialties for testing personnel.

493.1495 Standard; Testing Personnel Responsibilities

Testing personnel are responsible for specimen processing, test performance, and reporting test results. Each individual performs only those high complexity tests that are authorized by the director and require a degree of skill commensurate with the individual's education, training, and technical abilities. Testing personnel must follow laboratory procedures, maintain records for testing of PT samples, adhere to the laboratory's QC policies, be capable of identifying problems and either correct them or notify the appropriate person, and document all corrective actions.

  [See Section IV of this manual for forms that can be used to help meet the requirements related to flow cytometry.]

 493.1701 Condition: Quality Assurance; Moderate or High Complexity Testing, or Both

 Written procedures for a comprehensive QA program designed to monitor and evaluate the overall quality of the total testing process must be developed by the laboratory. This QA program must evaluate the effectiveness of the QA program, identify and correct problems, assure accurate test results, and assure the competency of the staff.

 493.1703 Standard; Patient Test Management Assessment

 The laboratory must monitor, evaluate, and revise (if necessary) the criteria for specimen collection, preservation, and transportation; the overall relevancy of the requisition; the criteria for specimen rejection; the completeness of the test report; the timely reporting of results; and the appropriate storage of records.

493.1705 Standard; QC Assessment

The laboratory must have a mechanism to evaluate the effectiveness of corrective actions. These include: problems identified during the evaluation of calibration and control information, problems during the verification of reference ranges, and errors in reported results.

493.1707 Standard; Proficiency Testing Assessment

The corrective actions taken for any unacceptable, unsatisfactory, or unsuccessful proficiency test must be evaluated for effectiveness.

493.1709 Standard; Comparison of Test Results

The laboratory must have a system that evaluates and defines the relationship between test results using different methodologies (or instruments) twice a year if it performs a test using different methodologies. (This is also necessary if the test is performed at multiple testing sites.) If a laboratory performs tests that are not included in any PT programs, it must have a system of verifying the accuracy and precision of those tests twice a year.

493.1711 Standard; Relationship of Patient Information to Patient Test Results

The laboratory must have a mechanism to identify and assess patient results that appear inconsistent with clinically relevant data such as patient age, diagnosis, sex, and relationship with other test parameters.

493.1713 Standard; Personnel Assessment

The laboratory must have an ongoing mechanism to evaluate the effectiveness of its procedures for determining employee and consultant effectiveness.

493.1715 Standard; Communications

When difficulties in communication between the laboratory and the test requester arise, the laboratory must document them and take corrective actions.

493.1717 Standard; Complaint Investigation

The laboratory must have a program to assure that all complaints and problems reported to the laboratory are documented. Investigations of complaints and corrective actions (if necessary) should be taken.

493.1719 Standard; QA Review with Staff

If problems are identified during QA review, the laboratory must discuss these with the staff and take corrective actions to prevent recurrences.

493.1721 Standard; QA Records

The laboratory must maintain documentation of all QA activities including problems and corrective actions. All QA records must be available to HHS.

 493.1775 Condition: Inspection of Laboratories Issued a Certificate of Waiver

 An unannounced inspection of the laboratory by HHS or its designee can occur any time. The laboratory must allow HHS to interview all laboratory employees to assess compliance, to inspect all areas of the facility, to observe employees, and to request data and information in order to determine that testing is performed without public health risk. In addition, the laboratory must provide all records and data that are requested. If the laboratory refuses to permit an inspection, a suspension or termination of Medicare/Medicaid payments, and suspension of or action to revoke the laboratory's CLIA certificate of waiver will ensue.

 493.1777 Condition: Inspection of All Laboratories Not Issued a Certificate of Waiver or a Certificate of Accreditation

 HHS or its designee will conduct unannounced inspections at least biennially of any laboratory. HHS will inspect a laboratory possessing a registration certificate before issuance of a certificate. The laboratory may be required to test samples, allow HHS to interview and/or observe employees, inspect the facility, and provide all records and data that are requested (records are retained for at least two years). HHS may re-inspect a laboratory at any time necessary. If the laboratory refuses to permit an inspection, a suspension or termination of Medicare/Medicaid payments, and suspension of or action to revoke the laboratory's CLIA certificate of waiver will ensue.

 493.1780 Condition: Inspection of Accredited and State-Exempt Laboratories

 HHS or its designee will conduct unannounced validation inspections and complaint inspections of such laboratories. The laboratory may be required to test samples, allow HHS to interview and/or observe employees, inspect the facility, and provide all records and data that are requested (records are retained for at least two years). HHS may re-inspect a laboratory at any time necessary. If the laboratory refuses to permit an inspection, a suspension or termination of Medicare/Medicaid payments, and suspension of or action to revoke the laboratory's CLIA certificate of accreditation will ensue.

 493.2001 Establishment and Function of the Clinical Laboratory Improvement Advisory Committee (CLIAC)

 A CLIAC will be established by HHS to advise and make technical recommendations concerning criteria for categorizing tests of moderate and high complexity, categorizing of waived tests, personnel standards, QA/QC standards, patient test management, PT standards, and applicability of new technology to the standards. This committee will include individuals involved in the provision of laboratory services, utilization of laboratory services, development of test systems or methodologies, or others. Specialized subcommittees may be formed. All committees must meet at least once a year. HHS must provide information or data to the CLIAC.