Title 42—Public Health--Volume 1
PART 493—LABORATORY REQUIREMENTS
§ 493.931   Routine chemistry.
(a) Program content and frequency of challenge. To be approved for proficiency testing for routine chemistry, a program must provide a minimum of five samples per testing event. There must be at least three testing events at approximately equal intervals per year. The annual program must provide samples that cover the clinically relevant range of values that would be expected in patient specimens. The specimens may be provided through mailed shipments.
(b) Challenges per testing event. The minimum number of challenges per testing event a program must provide for each analyte or test procedure listed below is five serum, plasma or blood samples.
Table 1 to Paragraph ( b )—Analyte or Test Procedure
(c) Evaluation of a laboratory's analyte or test performance. HHS approves only those programs that assess the accuracy of a laboratory's responses in accordance with paragraphs (c)(1) through (5) of this section.
(1) To determine the accuracy of a laboratory's response for qualitative and quantitative chemistry tests or analytes, the program must compare the laboratory's response for each analyte with the response that reflects agreement of either 80 percent or more of 10 or more referee laboratories or 80 percent or more of all participating laboratories. Both methods must be attempted before the program can choose to not grade a PT sample.
(2) For quantitative chemistry tests or analytes, the program must determine the correct response for each analyte by the distance of the response from the target value. After the target value has been established for each response, the appropriateness of the response must be determined by using either fixed criteria based on the percentage difference from the target value or the number of standard deviations (SD) the response differs from the target value.
Table 2 to Paragraph ( c )(2)—Criteria for Acceptable Performance
(3) The criterion for acceptable performance for qualitative routine chemistry tests is positive or negative.
(4) To determine the analyte testing event score, the number of acceptable analyte responses must be averaged using the following formula:
(5) To determine the overall testing event score, the number of correct responses for all analytes must be averaged using the following formula:
§ 493.933   Endocrinology.
(a) Program content and frequency of challenge. To be approved for proficiency testing for endocrinology, a program must provide a minimum of five samples per testing event. There must be at least three testing events at approximately equal intervals per year. The annual program must provide samples that cover the clinically relevant range of values that would be expected in patient specimens. The samples may be provided through mailed shipments.
(b) Challenges per testing event. The minimum number of challenges per testing event a program must provide for each analyte or test procedure is five serum, plasma, blood, or urine samples.
Table 1 to Paragraph ( b )—Analyte or Test
(c) Evaluation of a laboratory's analyte or test performance. HHS approves only those programs that assess the accuracy of a laboratory's responses in accordance with paragraphs (c)(1) through (5) of this section.
(1) To determine the accuracy of a laboratory's response for qualitative and quantitative endocrinology tests or analytes, a program must compare the laboratory's response for each analyte with the response that reflects agreement of either 80 percent or more of 10 or more referee laboratories or 80 percent or more of all participating laboratories. Both methods must be attempted before the program can choose to not grade a PT sample.
(2) For quantitative endocrinology tests or analytes, the program must determine the correct response for each analyte by the distance of the response from the target value. After the target value has been established for each response, the appropriateness of the response must be determined by using either fixed criteria based on the percentage difference from the target value or the number of standard deviations (SDs) the response differs from the target value.
Table 2 to Paragraph ( c )(2)-Criteria for Acceptable Performance
(3) The criterion for acceptable performance for qualitative endocrinology tests is positive or negative.
(4) To determine the analyte testing event score, the number of acceptable analyte responses must be averaged using the following formula:
(5) To determine the overall testing event score, the number of correct responses for all analytes must be averaged using the following formula:
§ 493.937   Toxicology.
(a) Program content and frequency of challenge. To be approved for proficiency testing for toxicology, the annual program must provide a minimum of five samples per testing event. There must be at least three testing events at approximately equal intervals per year. The annual program must provide samples that cover the full range of values that could occur in patient specimens and that cover the level of clinical significance for the particular drug. The samples may be provided through mailed shipments.
(b) Challenges per testing event. The minimum number of challenges per testing event a program must provide for each analyte or test procedure is five serum, plasma, or blood samples.
Table 1 to Paragraph ( b )—Analyte or Test Procedure
(c) Evaluation of a laboratory's analyte or test performance. HHS approves only those programs that assess the accuracy of a laboratory's responses in accordance with paragraphs (c)(1) through (4) of this section.
(1) To determine the accuracy of a laboratory's responses for quantitative toxicology tests or analytes, the program must compare the laboratory's response for each analyte with the response that reflects agreement of either 80 percent or more of 10 or more referee laboratories or 80 percent or more of all participating laboratories. Both methods must be attempted before the program can choose to not grade a PT sample.
(2) For quantitative toxicology tests or analytes, the program must determine the correct response for each analyte by the distance of the response from the target value. After the target value has been established for each response, the appropriateness of the response must be determined by using fixed criteria based on the percentage difference from the target value.
Table 2 to Paragraph ( c )(2)—Criteria for Acceptable Performance
(3) To determine the analyte testing event score, the number of acceptable analyte responses must be averaged using the following formula:
(4) To determine the overall testing event score, the number of correct responses for all analytes must be averaged using the following formula:
§ 493.941   Hematology (including routine hematology and coagulation).
(a) Program content and frequency of challenge. To be approved for proficiency testing for hematology, a program must provide a minimum of five samples per testing event. There must be at least three testing events at approximately equal intervals per year. The annual program must provide samples that cover the full range of values that would be expected in patient specimens. The samples may be provided through mailed shipments.
(b) Challenges per testing event. The minimum number of challenges per testing event a program must provide for each analyte or test procedure is five.
Table 1 to Paragraph ( b )—Analyte or Test Procedure
(c) Evaluation of a laboratory's analyte or test performance. HHS approves only those programs that assess the accuracy of a laboratory's responses in accordance with paragraphs (c) (1) through (5) of this section.
(1) To determine the accuracy of a laboratory's responses for qualitative and quantitative hematology tests or analytes, the program must compare the laboratory's response for each analyte with the response that reflects agreement of either 80 percent or more of 10 or more referee laboratories or 80 percent or more of all participating laboratories. Both methods must be attempted before the program can choose to not grade a PT sample.
(2) For quantitative hematology tests or analytes, the program must determine the correct response for each analyte by the distance of the response from the target value. After the target value has been established for each response, the appropriateness of the response is determined using either fixed criteria based on the percentage difference from the target value or the number of standard deviations (SD) the response differs from the target value.
Table 2 to Paragraph ( c )(2)—Criteria for Acceptable Performance
(3) The criterion for acceptable performance for the qualitative hematology test is correct cell identification.
(4) To determine the analyte testing event score, the number of acceptable analyte responses must be averaged using the following formula:
(5) To determine the overall testing event score, the number of correct responses for all analytes must be averaged using the following formula:
§ 493.945   Cytology; gynecologic examinations.
(a) Program content and frequency of challenge. (1) To be approved for proficiency testing for gynecologic examinations (Pap smears) in cytology, a program must provide test sets composed of 10- and 20-glass slides. Proficiency testing programs may obtain slides for test sets from cytology laboratories, provided the slides have been retained by the laboratory for the required period specified in §§ 493.1105(a)(7)(i)(A) and 493.1274(f)(2). If slide preparations are still subject to retention by the laboratory, they may be loaned to a proficiency testing program if the program provides the laboratory with documentation of the loan of the slides and ensures that slides loaned to it are retrievable upon request. Each test set must include at least one slide representing each of the response categories described in paragraph (b)(3)(ii)(A) of this section, and test sets should be comparable so that equitable testing is achieved within and between proficiency testing providers.
(2) To be approved for proficiency testing in gynecologic cytology, a program must provide announced and unannounced on-site testing for each individual at least once per year and must provide an initial retesting event for each individual within 45 days after notification of test failure and subsequent retesting events within 45 days after completion of remedial action described in § 493.855.
(b) Evaluation of an individual's performance. HHS approves only those programs that assess the accuracy of each individual's responses on both 10- and 20-slide test sets in which the slides have been referenced as specified in paragraph (b)(1) of this section.
(1) To determine the accuracy of an individual's response on a particular challenge (slide), the program must compare the individual's response for each slide preparation with the response that reflects the predetermined consensus agreement or confirmation on the diagnostic category, as described in the table in paragraph (b)(3)(ii)(A) of this section. For all slide preparations, a 100% consensus agreement among a minimum of three physicians certified in anatomic pathology is required. In addition, for premalignant and malignant slide preparations, confirmation by tissue biopsy is required either by comparison of the reported biopsy results or reevaluation of biopsy slide material by a physician certified in anatomic pathology.
(2) An individual qualified as a technical supervisor under § 493.1449(b) or (e) who routinely interprets gynecologic slide preparations only after they have been examined by a cytotechnologist can either be tested using a test set that has been screened by a cytotechnologist in the same laboratory or using a test set that has not been screened. A technical supervisor who screens and interprets slide preparations that have not been previously examined must be tested using a test set that has not been previously screened.
(3) The criteria for acceptable performance are determined by using the scoring system in paragraphs (b)(3) (i) and (ii) of this section.
(i) Each slide set must contain 10 or 20 slides with point values established for each slide preparation based on the significance of the relationship of the interpretation of the slide to a clinical condition and whether the participant in the testing event is a cytotechnologist qualified under § 493.1469 or § 493.1483 or functioning as a technical supervisor in cytology qualified under § 493.1449(b) or (e) of this part.
(ii) The scoring system rewards or penalizes the participants in proportion to the distance of their answers from the correct response or target diagnosis and the penalty or reward is weighted in proportion to the severity of the lesion.
(A) The four response categories for reporting proficiency testing results and their descriptions are as follows:
(B) In accordance with the criteria for the scoring system, the charts in paragraphs (b)(3)(ii)(C) and (D) of this section, for technical supervisors and cytotechnologists, respectively, provide a maximum of 10 points for a correct response and a maximum of minus five (−5) points for an incorrect response on a 10-slide test set. For example, if the correct response on a slide is “high grade squamous intraepithelial lesion” (category “D” on the scoring system chart) and an examinee calls it “normal or negative” (category “B” on the scoring system chart), then the examinee's point value on that slide is calculated as minus five (−5). Each slide is scored individually in the same manner. The individual's score for the testing event is determined by adding the point value achieved for each slide preparation, dividing by the total points for the testing event and multiplying by 100.
(C) Criteria for scoring system for a 10-slide test set. (See table at paragraph (b)(3)(ii)(A) of this section for a description of the response categories.) For technical supervisors qualified under § 493.1449(b) or (e):
(D) Criteria for scoring system for a 10-slide test set. (See table at paragraph (b)(3)(ii)(A) of this section for a description of the response categories.) For cytotechnologists qualified under § 493.1469 or § 493.1483:
(E) In accordance with the criteria for the scoring system, the charts in paragraphs (b)(3)(ii)(F) and (G) of this section, for technical supervisors and cytotechnologists, respectively, provide maximums of 5 points for a correct response and minus ten (−10) points for an incorrect response on a 20-slide test set.
(F) Criteria for scoring system for a 20-slide test set. (See table at paragraph (b)(3)(ii)(A) of this section for a description of the response categories.) For technical supervisors qualified under § 493.1449(b) or (e):
(G) Criteria for scoring system for a 20-slide test set. (See table at (b)(3)(ii)(A) of this section for a description of the response categories.) For cytotechnologists qualified under § 493.1469 or § 493.1483:
§ 493.959   Immunohematology.
(a) Types of services offered by laboratories. In immunohematology, there are four types of laboratories for proficiency testing purposes—
(1) Those that perform ABO group and/or D (Rho) typing;
(2) Those that perform ABO group and/or D (Rho) typing, and unexpected antibody detection;
(3) Those that in addition to paragraph (a)(2) of this section perform compatibility testing; and
(4) Those that perform in addition to paragraph (a)(3) of this section antibody identification.
(b) Program content and frequency of challenge. To be approved for proficiency testing for immunohematology, a program must provide a minimum of five samples per testing event. There must be at least three testing events at approximately equal intervals per year. The annual program must provide samples that cover the full range of interpretation that would be expected in patient specimens. The samples may be provided through mailed shipments.
(c) Challenges per testing event. The minimum number of challenges per testing event a program must provide for each analyte or test procedure is five.
(d) Evaluation of a laboratory's analyte or test performance. HHS approves only those programs that assess the accuracy of a laboratory's response in accordance with paragraphs (d)(1) through (5) of this section.
(1) To determine the accuracy of a laboratory's response, a program must compare the laboratory's response for each analyte with the response that reflects agreement of either 100 percent of 10 or more referee laboratories or 95 percent or more of all participating laboratories except for antibody identification. To determine the accuracy of a laboratory's response for antibody identification, a program must compare the laboratory's response for each analyte with the response that reflects agreement of either 95 percent or more of 10 or more referee laboratories or 95 percent or more of all participating laboratories. Both methods must be attempted before the program can choose to not grade a PT sample.
(2) Criteria for acceptable performance. The criteria for acceptable performance are—
Table 2 to Paragraph ( d )(2)—Criteria for Acceptable Performance
(3) The criterion for acceptable performance for qualitative immunohematology tests is positive or negative.
(4) To determine the analyte testing event score, the number of acceptable analyte responses must be averaged using the following formula:
(5) To determine the overall testing event score, the number of correct responses for all analytes must be averaged using the following formula:
§ 493.1100   Condition: Facility administration.
Each laboratory that performs nonwaived testing must meet the applicable requirements under §§ 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7).
(a) Reporting of SARS-CoV-2 test results. During the Public Health Emergency, as defined in § 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a “SARS-CoV-2 test”) must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe.
(b) [Reserved]
§ 493.1101   Standard: Facilities.
(a) The laboratory must be constructed, arranged, and maintained to ensure the following:
(1) The space, ventilation, and utilities necessary for conducting all phases of the testing process.
(2) Contamination of patient specimens, equipment, instruments, reagents, materials, and supplies is minimized.
(3) Molecular amplification procedures that are not contained in closed systems have a uni-directional workflow. This must include separate areas for specimen preparation, amplification and product detection, and, as applicable, reagent preparation.
(b) The laboratory must have appropriate and sufficient equipment, instruments, reagents, materials, and supplies for the type and volume of testing it performs.
(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements.
(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials.
(e) Records and, as applicable, slides, blocks, and tissues must be maintained and stored under conditions that ensure proper preservation.
§ 493.1103   Standard: Requirements for transfusion services.
A facility that provides transfusion services must meet all of the requirements of this section and document all transfusion-related activities.
(a) Arrangement for services. The facility must have a transfusion service agreement reviewed and approved by the responsible party(ies) that govern the procurement, transfer, and availability of blood and blood products.
(b) Provision of testing. The facility must provide prompt ABO grouping, D(Rho) typing, unexpected antibody detection, compatibility testing, and laboratory investigation of transfusion reactions on a continuous basis through a CLIA-certified laboratory or a laboratory meeting equivalent requirements as determined by CMS.
(c) Blood and blood products storage and distribution. (1) If a facility stores or maintains blood or blood products for transfusion outside of a monitored refrigerator, the facility must ensure the storage conditions, including temperature, are appropriate to prevent deterioration of the blood or blood product.
(2) The facility must establish and follow policies to ensure positive identification of a blood or blood product beneficiary.
(d) Investigation of transfusion reactions. The facility must have procedures for preventing transfusion reactions and when necessary, promptly identify, investigate, and report blood and blood product transfusion reactions to the laboratory and, as appropriate, to Federal and State authorities.
§ 493.1105   Standard: Retention requirements.
(a) The laboratory must retain its records and, as applicable, slides, blocks, and tissues as follows:
(1) Test requisitions and authorizations. Retain records of test requisitions and test authorizations, including the patient's chart or medical record if used as the test requisition or authorization, for at least 2 years.
(2) Test procedures. Retain a copy of each test procedure for at least 2 years after a procedure has been discontinued. Each test procedure must include the dates of initial use and discontinuance.
(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in §§ 493.1252 through 493.1289 for at least 2 years. In addition, retain the following:
(i) Records of test system performance specifications that the laboratory establishes or verifies under § 493.1253 for the period of time the laboratory uses the test system but no less than 2 years.
(ii) Immunohematology records, blood and blood product records, and transfusion records as specified in 21 CFR 606.160(b)(3)(ii), (b)(3)(iv), (b)(3)(v) and (d).
(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years.
(5) Quality system assessment records. Retain all laboratory quality systems assessment records for at least 2 years.
(6) Test reports. Retain or be able to retrieve a copy of the original report (including final, preliminary, and corrected reports) at least 2 years after the date of reporting. In addition, retain the following:
(i) Immunohematology reports as specified in 21 CFR 606.160(d).
(ii) Pathology test reports for at least 10 years after the date of reporting.
(7) Slide, block, and tissue retention —(i) Slides. (A) Retain cytology slide preparations for at least 5 years from the date of examination (see § 493.1274(f) for proficiency testing exception).
(B) Retain histopathology slides for at least 10 years from the date of examination.
(ii) Blocks. Retain pathology specimen blocks for at least 2 years from the date of examination.
(iii) Tissue. Preserve remnants of tissue for pathology examination until a diagnosis is made on the specimen.
(b) If the laboratory ceases operation, the laboratory must make provisions to ensure that all records and, as applicable, slides, blocks, and tissue are retained and available for the time frames specified in this section.
§ 493.1200   Introduction.
(a) Each laboratory that performs nonwaived testing must establish and maintain written policies and procedures that implement and monitor a quality system for all phases of the total testing process (that is, preanalytic, analytic, and postanalytic) as well as general laboratory systems.
(b) The laboratory's quality systems must include a quality assessment component that ensures continuous improvement of the laboratory's performance and services through ongoing monitoring that identifies, evaluates and resolves problems.
(c) The various components of the laboratory's quality system are used to meet the requirements in this part and must be appropriate for the specialties and subspecialties of testing the laboratory performs, services it offers, and clients it serves.
§ 493.1201   Condition: Bacteriology.
If the laboratory provides services in the subspecialty of Bacteriology, the laboratory must meet the requirements specified in §§ 493.1230 through 493.1256, § 493.1261, and §§ 493.1281 through 493.1299.
§ 493.1202   Condition: Mycobacteriology.
If the laboratory provides services in the subspecialty of Mycobacteriology, the laboratory must meet the requirements specified in §§ 493.1230 through 493.1256, § 493.1262, and §§ 493.1281 through 493.1299.
§ 493.1203   Condition: Mycology.
If the laboratory provides services in the subspecialty of Mycology, the laboratory must meet the requirements specified in §§ 493.1230 through 493.1256, § 493.1263, and §§ 493.1281 through 493.1299.
§ 493.1204   Condition: Parasitology.
If the laboratory provides services in the subspecialty of Parasitology, the laboratory must meet the requirements specified in §§ 493.1230 through 493.1256, § 493.1264, and §§ 493.1281 through 493.1299.
§ 493.1205   Condition: Virology.
If the laboratory provides services in the subspecialty of Virology, the laboratory must meet the requirements specified in §§ 493.1230 through 493.1256, § 493.1265, and §§ 493.1281 through 493.1299.
§ 493.1207   Condition: Syphilis serology.
If the laboratory provides services in the subspecialty of Syphilis serology, the laboratory must meet the requirements specified in §§ 493.1230 through 493.1256, and §§ 493.1281 through 493.1299.
§ 493.1208   Condition: General immunology.
If the laboratory provides services in the subspecialty of General immunology, the laboratory must meet the requirements specified in §§ 493.1230 through 493.1256, and §§ 493.1281 through 493.1299.
§ 493.1210   Condition: Routine chemistry.
If the laboratory provides services in the subspecialty of Routine chemistry, the laboratory must meet the requirements specified in §§ 493.1230 through 493.1256, § 493.1267, and §§ 493.1281 through 493.1299.
§ 493.1211   Condition: Urinalysis.
If the laboratory provides services in the subspecialty of Urinalysis, the laboratory must meet the requirements specified in §§ 493.1230 through 493.1256, and §§ 493.1281 through 493.1299.
§ 493.1212   Condition: Endocrinology.
If the laboratory provides services in the subspecialty of Endocrinology, the laboratory must meet the requirements specified in §§ 493.1230 through 493.1256, and §§ 493.1281 through 493.1299.
§ 493.1213   Condition: Toxicology.
If the laboratory provides services in the subspecialty of Toxicology, the laboratory must meet the requirements specified in §§ 493.1230 through 493.1256, and §§ 493.1281 through 493.1299.
§ 493.1215   Condition: Hematology.
If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in §§ 493.1230 through 493.1256, § 493.1269, and §§ 493.1281 through 493.1299.
§ 493.1217   Condition: Immunohematology.
If the laboratory provides services in the specialty of Immunohematology, the laboratory must meet the requirements specified in §§ 493.1230 through 493.1256, § 493.1271, and §§ 493.1281 through 493.1299.
§ 493.1219   Condition: Histopathology.
If the laboratory provides services in the subspecialty of Histopathology, the laboratory must meet the requirements specified in §§ 493.1230 through 493.1256, § 493.1273, and §§ 493.1281 through 493.1299.
§ 493.1220   Condition: Oral pathology.
If the laboratory provides services in the subspecialty of Oral pathology, the laboratory must meet the requirements specified in §§ 493.1230 through 493.1256, and §§ 493.1281 through 493.1299.
§ 493.1221   Condition: Cytology.
If the laboratory provides services in the subspecialty of Cytology, the laboratory must meet the requirements specified in §§ 493.1230 through 493.1256, § 493.1274, and §§ 493.1281 through 493.1299.
§ 493.1225   Condition: Clinical cytogenetics.
If the laboratory provides services in the specialty of Clinical cytogenetics, the laboratory must meet the requirements specified in §§ 493.1230 through 493.1256, § 493.1276, and §§ 493.1281 through 493.1299.
§ 493.1226   Condition: Radiobioassay.
If the laboratory provides services in the specialty of Radiobioassay, the laboratory must meet the requirements specified in §§ 493.1230 through 493.1256, and §§ 493.1281 through 493.1299.
§ 493.1227   Condition: Histocompatibility.
If the laboratory provides services in the specialty of Histocompatibility, the laboratory must meet the requirements specified in §§ 493.1230 through 493.1256, § 493.1278, and §§ 493.1281 through 493.1299.
§ 493.1230   Condition: General laboratory systems.
Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in §§ 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems as specified in § 493.1239 for each specialty and subspecialty of testing performed.
§ 493.1231   Standard: Confidentiality of patient information.
The laboratory must ensure confidentiality of patient information throughout all phases of the total testing process that are under the laboratory's control.
§ 493.1232   Standard: Specimen identification and integrity.
The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results.
§ 493.1233   Standard: Complaint investigations.
The laboratory must have a system in place to ensure that it documents all complaints and problems reported to the laboratory. The laboratory must conduct investigations of complaints, when appropriate.
§ 493.1234   Standard: Communications.
The laboratory must have a system in place to identify and document problems that occur as a result of a breakdown in communication between the laboratory and an authorized person who orders or receives test results.
§ 493.1235   Standard: Personnel competency assessment policies.
As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency.
§ 493.1236   Standard: Evaluation of proficiency testing performance.
(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part.
(b) The laboratory must verify the accuracy of the following:
(1) Any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS-approved proficiency testing program.
(2) Any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return of results).
(c) At least twice annually, the laboratory must verify the accuracy of the following:
(1) Any test or procedure it performs that is not included in subpart I of this part.
(2) Any test or procedure listed in subpart I of this part for which compatible proficiency testing samples are not offered by a CMS-approved proficiency testing program.
(d) All proficiency testing evaluation and verification activities must be documented.
§ 493.1239   Standard: General laboratory systems quality assessment.
(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at §§ 493.1231 through 493.1236.
(b) The general laboratory systems quality assessment must include a review of the effectiveness of corrective actions taken to resolve problems, revision of policies and procedures necessary to prevent recurrence of problems, and discussion of general laboratory systems quality assessment reviews with appropriate staff.
(c) The laboratory must document all general laboratory systems quality assessment activities.
§ 493.1240   Condition: Preanalytic systems.
Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in §§ 493.1241 and 493.1242, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the preanalytic systems and correct identified problems as specified in § 493.1249 for each specialty and subspecialty of testing performed.
§ 493.1241   Standard: Test request.
(a) The laboratory must have a written or electronic request for patient testing from an authorized person.
(b) The laboratory may accept oral requests for laboratory tests if it solicits a written or electronic authorization within 30 days of the oral request and maintains the authorization or documentation of its efforts to obtain the authorization.
(c) The laboratory must ensure the test requisition solicits the following information:
(1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values.
(2) The patient's name or unique patient identifier.
(3) The sex and age or date of birth of the patient.
(4) The test(s) to be performed.
(5) The source of the specimen, when appropriate.
(6) The date and, if appropriate, time of specimen collection.
(7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy.
(8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable.
(d) The patient's chart or medical record may be used as the test requisition or authorization but must be available to the laboratory at the time of testing and available to CMS or a CMS agent upon request.
(e) If the laboratory transcribes or enters test requisition or authorization information into a record system or a laboratory information system, the laboratory must ensure the information is transcribed or entered accurately.
§ 493.1242   Standard: Specimen submission, handling, and referral.
(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable:
(1) Patient preparation.
(2) Specimen collection.
(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source.
(4) Specimen storage and preservation.
(5) Conditions for specimen transportation.
(6) Specimen processing.
(7) Specimen acceptability and rejection.
(8) Specimen referral.
(b) The laboratory must document the date and time it receives a specimen.
(c) The laboratory must refer a specimen for testing only to a CLIA-certified laboratory or a laboratory meeting equivalent requirements as determined by CMS.
(d) If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section.
§ 493.1249   Standard: Preanalytic systems quality assessment.
(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at §§ 493.1241 through 493.1242.
(b) The preanalytic systems quality assessment must include a review of the effectiveness of corrective actions taken to resolve problems, revision of policies and procedures necessary to prevent recurrence of problems, and discussion of preanalytic systems quality assessment reviews with appropriate staff.
(c) The laboratory must document all preanalytic systems quality assessment activities.
§ 493.1250   Condition: Analytic systems.
Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in §§ 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in § 493.1289 for each specialty and subspecialty of testing performed.
§ 493.1251   Standard: Procedure manual.
(a) A written procedure manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens.
(b) The procedure manual must include the following when applicable to the test procedure:
(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in § 493.1242.
(2) Microscopic examination, including the detection of inadequately prepared slides.
(3) Step-by-step performance of the procedure, including test calculations and interpretation of results.
(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing.
(5) Calibration and calibration verification procedures.
(6) The reportable range for test results for the test system as established or verified in § 493.1253.
(7) Control procedures.
(8) Corrective action to take when calibration or control results fail to meet the laboratory's criteria for acceptability.
(9) Limitations in the test methodology, including interfering substances.
(10) Reference intervals (normal values).
(11) Imminently life-threatening test results, or panic or alert values.
(12) Pertinent literature references.
(13) The laboratory's system for entering results in the patient record and reporting patient results including, when appropriate, the protocol for reporting imminently life-threatening results, or panic, or alert values.
(14) Description of the course of action to take if a test system becomes inoperable.
(c) Manufacturer's test system instructions or operator manuals may be used, when applicable, to meet the requirements of paragraphs (b)(1) through (b)(12) of this section. Any of the items under paragraphs (b)(1) through (b)(12) of this section not provided by the manufacturer must be provided by the laboratory.
(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use.
(e) The laboratory must maintain a copy of each procedure with the dates of initial use and discontinuance as described in § 493.1105(a)(2).
§ 493.1252   Standard: Test systems, equipment, instruments, reagents, materials, and supplies.
(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under § 493.1253.
(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following:
(1) Water quality.
(2) Temperature.
(3) Humidity.
(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports.
(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following:
(1) Identity and when significant, titer, strength or concentration.
(2) Storage requirements.
(3) Preparation and expiration dates.
(4) Other pertinent information required for proper use.
(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality.
(e) Components of reagent kits of different lot numbers must not be interchanged unless otherwise specified by the manufacturer.
§ 493.1253   Standard: Establishment and verification of performance specifications.
(a) Applicability. Laboratories are not required to verify or establish performance specifications for any test system used by the laboratory before April 24, 2003.
(b)(1) Verification of performance specifications. Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results:
(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics:
(A) Accuracy.
(B) Precision.
(C) Reportable range of test results for the test system.
(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population.
(2) Establishment of performance specifications. Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable:
(i) Accuracy.
(ii) Precision.
(iii) Analytical sensitivity.
(iv) Analytical specificity to include interfering substances.
(v) Reportable range of test results for the test system.
(vi) Reference intervals (normal values).
(vii) Any other performance characteristic required for test performance.
(3) Determination of calibration and control procedures. The laboratory must determine the test system's calibration procedures and control procedures based upon the performance specifications verified or established under paragraph (b)(1) or (b)(2) of this section.
(c) Documentation. The laboratory must document all activities specified in this section.
§ 493.1254   Standard: Maintenance and function checks.
(a) Unmodified manufacturer's equipment, instruments, or test systems. The laboratory must perform and document the following:
(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer.
(2) Function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted.
(b) Equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer. The laboratory must do the following:
(1)(i) Establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting.
(ii) Perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section.
(2)(i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting.
(ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted.
§ 493.1255   Standard: Calibration and calibration verification procedures.
Calibration and calibration verification procedures are required to substantiate the continued accuracy of the test system throughout the laboratory's reportable range of test results for the test system. Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following:
(a) Perform and document calibration procedures—
(1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer;
(2) Using the criteria verified or established by the laboratory as specified in § 493.1253(b)(3)—
(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and
(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and
(3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification.
(b) Perform and document calibration verification procedures—
(1) Following the manufacturer's calibration verification instructions;
(2) Using the criteria verified or established by the laboratory under § 493.1253(b)(3)—
(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and
(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and
(3) At least once every 6 months and whenever any of the following occur:
(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes.
(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance.
(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem.
(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification.
§ 493.1256   Standard: Control procedures.
(a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process.
(b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in § 493.1253(b)(3).
(c) The control procedures must—
(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance.
(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance.
(d) Unless CMS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must—
(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at §§ 493.1261 through 493.1278.
(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section.
(3) At least once each day patient specimens are assayed or examined perform the following for—
(i) Each quantitative procedure, include two control materials of different concentrations;
(ii) Each qualitative procedure, include a negative and positive control material;
(iii) Test procedures producing graded or titered results, include a negative control material and a control material with graded or titered reactivity, respectively;
(iv) Each test system that has an extraction phase, include two control materials, including one that is capable of detecting errors in the extraction process; and
(v) Each molecular amplification procedure, include two control materials and, if reaction inhibition is a significant source of false negative results, a control material capable of detecting the inhibition.
(4) For thin layer chromatography—
(i) Spot each plate or card, as applicable, with a calibrator containing all known substances or drug groups, as appropriate, which are identified by thin layer chromatography and reported by the laboratory; and
(ii) Include at least one control material on each plate or card, as applicable, which must be processed through each step of patient testing, including extraction processes.
(5) For each electrophoretic procedure include, concurrent with patient specimens, at least one control material containing the substances being identified or measured.
(6) Perform control material testing as specified in this paragraph before resuming patient testing when a complete change of reagents is introduced; major preventive maintenance is performed; or any critical part that may influence test performance is replaced.
(7) Over time, rotate control material testing among all operators who perform the test.
(8) Test control materials in the same manner as patient specimens.
(9) When using calibration material as a control material, use calibration material from a different lot number than that used to establish a cut-off value or to calibrate the test system.
(10) Establish or verify the criteria for acceptability of all control materials.
(i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available.
(ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory.
(iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters.
(e) For reagent, media, and supply checks, the laboratory must do the following:
(1) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in § 493.1261(a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable.
(2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate.
(3) Check fluorescent and immunohistochemical stains for positive and negative reactivity each time of use.
(4) Before, or concurrent with the initial use—
(i) Check each batch of media for sterility if sterility is required for testing;
(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and
(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer.
(5) Follow the manufacturer's specifications for using reagents, media, and supplies and be responsible for results.
(f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results.
(g) The laboratory must document all control procedures performed.
(h) If control materials are not available, the laboratory must have an alternative mechanism to detect immediate errors and monitor test system performance over time. The performance of alternative control procedures must be documented.
§ 493.1261   Standard: Bacteriology.
(a) The laboratory must check the following for positive and negative reactivity using control organisms:
(1) Each day of use for beta-lactamase methods other than Cefinase TM .
(2) Each week of use for Gram stains.
(3) When each batch (prepared in-house), lot number (commercially prepared), and shipment of antisera is prepared or opened, and once every 6 months thereafter.
(b) For antimicrobial susceptibility tests, the laboratory must check each batch of media and each lot number and shipment of antimicrobial agent(s) before, or concurrent with, initial use, using approved control organisms.
(1) Each day tests are performed, the laboratory must use the appropriate control organism(s) to check the procedure.
(2) The laboratory's zone sizes or minimum inhibitory concentration for control organisms must be within established limits before reporting patient results.
(c) The laboratory must document all control procedures performed, as specified in this section.
§ 493.1262   Standard: Mycobacteriology.
(a) Each day of use, the laboratory must check all reagents or test procedures used for mycobacteria identification with at least one acid-fast organism that produces a positive reaction and an acid-fast organism that produces a negative reaction.
(b) For antimycobacterial susceptibility tests, the laboratory must check each batch of media and each lot number and shipment of antimycobacterial agent(s) before, or concurrent with, initial use, using an appropriate control organism(s).
(1) The laboratory must establish limits for acceptable control results.
(2) Each week tests are performed, the laboratory must use the appropriate control organism(s) to check the procedure.
(3) The results for the control organism(s) must be within established limits before reporting patient results.
(c) The laboratory must document all control procedures performed, as specified in this section.
§ 493.1263   Standard: Mycology.
(a) The laboratory must check each batch (prepared in-house), lot number (commercially prepared), and shipment of lactophenol cotton blue when prepared or opened for intended reactivity with a control organism(s).
(b) For antifungal susceptibility tests, the laboratory must check each batch of media and each lot number and shipment of antifungal agent(s) before, or concurrent with, initial use, using an appropriate control organism(s).
(1) The laboratory must establish limits for acceptable control results.
(2) Each day tests are performed, the laboratory must use the appropriate control organism(s) to check the procedure.
(3) The results for the control organism(s) must be within established limits before reporting patient results.
(c) The laboratory must document all control procedures performed, as specified in this section.
§ 493.1264   Standard: Parasitology.
(a) The laboratory must have available a reference collection of slides or photographs and, if available, gross specimens for identification of parasites and use these references in the laboratory for appropriate comparison with diagnostic specimens.
(b) The laboratory must calibrate and use the calibrated ocular micrometer for determining the size of ova and parasites, if size is a critical parameter.
(c) Each month of use, the laboratory must check permanent stains using a fecal sample control material that will demonstrate staining characteristics.
(d) The laboratory must document all control procedures performed, as specified in this section.
§ 493.1265   Standard: Virology.
(a) When using cell culture to isolate or identify viruses, the laboratory must simultaneously incubate a cell substrate control or uninoculated cells as a negative control material.
(b) The laboratory must document all control procedures performed, as specified in this section.
§ 493.1267   Standard: Routine chemistry.
For blood gas analyses, the laboratory must perform the following:
(a) Calibrate or verify calibration according to the manufacturer's specifications and with at least the frequency recommended by the manufacturer.
(b) Test one sample of control material each 8 hours of testing using a combination of control materials that include both low and high values on each day of testing.
(c) Test one sample of control material each time specimens are tested unless automated instrumentation internally verifies calibration at least every 30 minutes.
(d) Document all control procedures performed, as specified in this section.
§ 493.1269   Standard: Hematology.
(a) For manual cell counts performed using a hemocytometer—
(1) One control material must be tested each 8 hours of operation; and
(2) Patient specimens and control materials must be tested in duplicate.
(b) For all nonmanual coagulation test systems, the laboratory must include two levels of control material each 8 hours of operation and each time a reagent is changed.
(c) For manual coagulation tests—
(1) Each individual performing tests must test two levels of control materials before testing patient samples and each time a reagent is changed; and
(2) Patient specimens and control materials must be tested in duplicate.
(d) The laboratory must document all control procedures performed, as specified in this section.
§ 493.1271   Standard: Immunohematology.
(a) Patient testing. (1) The laboratory must perform ABO grouping, D(Rho) typing, unexpected antibody detection, antibody identification, and compatibility testing by following the manufacturer's instructions, if provided, and as applicable, 21 CFR 606.151(a) through (e).
(2) The laboratory must determine ABO group by concurrently testing unknown red cells with, at a minimum, anti-A and anti-B grouping reagents. For confirmation of ABO group, the unknown serum must be tested with known A1 and B red cells.
(3) The laboratory must determine the D(Rho) type by testing unknown red cells with anti-D (anti-Rho) blood typing reagent.
(b) Immunohematological testing and distribution of blood and blood products. Blood and blood product testing and distribution must comply with 21 CFR 606.100(b)(12); 606.160(b)(3)(ii) and (b)(3)(v); 610.40; 640.5(a), (b), (c), and (e); and 640.11(b).
(c) Blood and blood products storage. Blood and blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected.
(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period.
(2) Inspections of the alarm system must be documented.
(d) Retention of samples of transfused blood. According to the laboratory's established procedures, samples of each unit of transfused blood must be retained for further testing in the event of transfusion reactions. The laboratory must promptly dispose of blood not retained for further testing that has passed its expiration date.
(e) Investigation of transfusion reactions. (1) According to its established procedures, the laboratory that performs compatibility testing, or issues blood or blood products, must promptly investigate all transfusion reactions occurring in facilities for which it has investigational responsibility and make recommendations to the medical staff regarding improvements in transfusion procedures.
(2) The laboratory must document, as applicable, that all necessary remedial actions are taken to prevent recurrences of transfusion reactions and that all policies and procedures are reviewed to assure they are adequate to ensure the safety of individuals being transfused.
(f) Documentation. The laboratory must document all control procedures performed, as specified in this section.
§ 493.1273   Standard: Histopathology.
(a) As specified in § 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reaction(s) of the control slide with each special stain must be documented.
(b) The laboratory must retain stained slides, specimen blocks, and tissue remnants as specified in § 493.1105. The remnants of tissue specimens must be maintained in a manner that ensures proper preservation of the tissue specimens until the portions submitted for microscopic examination have been examined and a diagnosis made by an individual qualified under § 493.1449(b), (f), or (g).
(c) An individual who has successfully completed a training program in neuromuscular pathology approved by HHS may examine and provide reports for neuromuscular pathology.
(d) Tissue pathology reports must be signed by an individual qualified as specified in paragraph (b) or, as appropriate, paragraph (c) of this section. If a computer report is generated with an electronic signature, it must be authorized by the individual who performed the examination and made the diagnosis.
(e) The laboratory must use acceptable terminology of a recognized system of disease nomenclature in reporting results.
(f) The laboratory must document all control procedures performed, as specified in this section.
§ 493.1274   Standard: Cytology.
(a) Cytology slide examination site. All cytology slide preparations must be evaluated on the premises of a laboratory certified to conduct testing in the subspecialty of cytology.
(b) Staining. The laboratory must have available and follow written policies and procedures for each of the following, if applicable:
(1) All gynecologic slide preparations must be stained using a Papanicolaou or modified Papanicolaou staining method.
(2) Effective measures to prevent cross-contamination between gynecologic and nongynecologic specimens during the staining process must be used.
(3) Nongynecologic specimens that have a high potential for cross-contamination must be stained separately from other nongynecologic specimens, and the stains must be filtered or changed following staining.
(c) Control procedures. The laboratory must establish and follow written policies and procedures for a program designed to detect errors in the performance of cytologic examinations and the reporting of results. The program must include the following:
(1) A review of slides from at least 10 percent of the gynecologic cases interpreted by individuals qualified under § 493.1469 or § 493.1483, to be negative for epithelial cell abnormalities and other malignant neoplasms (as defined in paragraph (e)(1) of this section).
(i) The review must be performed by an individual who meets one of the following qualifications:
(A) A technical supervisor qualified under § 493.1449(b) or (e).
(B) A cytology general supervisor qualified under § 493.1469.
(C) A cytotechnologist qualified under § 493.1483 who has the experience specified in § 493.1469(b)(2).
(ii) Cases must be randomly selected from the total caseload and include negatives and those from patients or groups of patients that are identified as having a higher than average probability of developing cervical cancer based on available patient information.
(iii) The review of those cases selected must be completed before reporting patient results.
(2) Laboratory comparison of clinical information, when available, with cytology reports and comparison of all gynecologic cytology reports with a diagnosis of high-grade squamous intraepithelial lesion (HSIL), adenocarcinoma, or other malignant neoplasms with the histopathology report, if available in the laboratory (either on-site or in storage), and determination of the causes of any discrepancies.
(3) For each patient with a current HSIL, adenocarcinoma, or other malignant neoplasm, laboratory review of all normal or negative gynecologic specimens received within the previous 5 years, if available in the laboratory (either on-site or in storage). If significant discrepancies are found that will affect current patient care, the laboratory must notify the patient's physician and issue an amended report.
(4) Records of initial examinations and all rescreening results must be documented.
(5) An annual statistical laboratory evaluation of the number of—
(i) Cytology cases examined;
(ii) Specimens processed by specimen type;
(iii) Patient cases reported by diagnosis (including the number reported as unsatisfactory for diagnostic interpretation);
(iv) Gynecologic cases with a diagnosis of HSIL, adenocarcinoma, or other malignant neoplasm for which histology results were available for comparison;
(v) Gynecologic cases where cytology and histology are discrepant; and
(vi) Gynecologic cases where any rescreen of a normal or negative specimen results in reclassification as low-grade squamous intraepithelial lesion (LSIL), HSIL, adenocarcinoma, or other malignant neoplasms.
(6) An evaluation of the case reviews of each individual examining slides against the laboratory's overall statistical values, documentation of any discrepancies, including reasons for the deviation and, if appropriate, corrective actions taken.
(d) Workload limits. The laboratory must establish and follow written policies and procedures that ensure the following:
(1) The technical supervisor establishes a maximum workload limit for each individual who performs primary screening.
(i) The workload limit is based on the individual's performance using evaluations of the following:
(A) Review of 10 percent of the cases interpreted as negative for the conditions defined in paragraph (e)(1) of this section.
(B) Comparison of the individual's interpretation with the technical supervisor's confirmation of patient smears specified in paragraphs (e)(1) and (e)(3) of this section.
(ii) Each individual's workload limit is reassessed at least every 6 months and adjusted when necessary.
(2) The maximum number of slides examined by an individual in each 24-hour period does not exceed 100 slides (one patient specimen per slide; gynecologic, nongynecologic, or both) irrespective of the site or laboratory. This limit represents an absolute maximum number of slides and must not be employed as an individual's performance target. In addition—
(i) The maximum number of 100 slides is examined in no less than an 8-hour workday;
(ii) For the purposes of establishing workload limits for individuals examining slides in less than an 8-hour workday (includes full-time employees with duties other than slide examination and part-time employees), a period of 8 hours is used to prorate the number of slides that may be examined. The formula—
(iii) Nongynecologic slide preparations made using liquid-based slide preparatory techniques that result in cell dispersion over one-half or less of the total available slide may be counted as one-half slide; and
(iv) Technical supervisors who perform primary screening are not required to include tissue pathology slides and previously examined cytology slides (gynecologic and nongynecologic) in the 100 slide workload limit.
(3) The laboratory must maintain records of the total number of slides examined by each individual during each 24-hour period and the number of hours spent examining slides in the 24-hour period irrespective of the site or laboratory.
(4) Records are available to document the workload limit for each individual.
(e) Slide examination and reporting. The laboratory must establish and follow written policies and procedures that ensure the following:
(1) A technical supervisor confirms each gynecologic slide preparation interpreted to exhibit reactive or reparative changes or any of the following epithelial cell abnormalities:
(i) Squamous cell.
(A) Atypical squamous cells of undetermined significance (ASC-US) or cannot exclude HSIL (ASC-H).
(B) LSIL-Human papillomavirus (HPV)/mild dysplasia/cervical intraepithelial neoplasia 1 (CIN 1).
(C) HSIL-moderate and severe dysplasia, carcinoma in situ (CIS)/CIN 2 and CIN 3 or with features suspicious for invasion.
(D) Squamous cell carcinoma.
(ii) Glandular cell.
(A) Atypical cells not otherwise specified (NOS) or specified in comments (endocervical, endometrial, or glandular).
(B) Atypical cells favor neoplastic (endocervical or glandular).
(C) Endocervical adenocarcinoma in situ.
(D) Adenocarcinoma endocervical, adenocarcinoma endometrial, adenocarcinoma extrauterine, and adenocarcinoma NOS.
(iii) Other malignant neoplasms.
(2) The report of gynecologic slide preparations with conditions specified in paragraph (e)(1) of this section must be signed to reflect the technical supervisory review or, if a computer report is generated with signature, it must reflect an electronic signature authorized by the technical supervisor who performed the review.
(3) All nongynecologic preparations are reviewed by a technical supervisor. The report must be signed to reflect technical supervisory review or, if a computer report is generated with signature, it must reflect an electronic signature authorized by the technical supervisor who performed the review.
(4) Unsatisfactory specimens or slide preparations are identified and reported as unsatisfactory.
(5) The report contains narrative descriptive nomenclature for all results.
(6) Corrected reports issued by the laboratory indicate the basis for correction.
(f) Record and slide retention. (1) The laboratory must retain all records and slide preparations as specified in § 493.1105.
(2) Slides may be loaned to proficiency testing programs in lieu of maintaining them for the required time period, provided the laboratory receives written acknowledgment of the receipt of slides by the proficiency testing program and maintains the acknowledgment to document the loan of these slides.
(3) Documentation of slides loaned or referred for purposes other than proficiency testing must be maintained.
(4) All slides must be retrievable upon request.
(g) Automated and semi-automated screening devices. When performing evaluations using automated and semi-automated screening devices, the laboratory must follow manufacturer's instructions for preanalytic, analytic, and postanalytic phases of testing, as applicable, and meet the applicable requirements of this subpart K.
(h) Documentation. The laboratory must document all control procedures performed, as specified in this section.
§ 493.1276   Standard: Clinical cytogenetics.
(a) The laboratory must have policies and procedures for ensuring accurate and reliable patient specimen identification during the process of accessioning, cell preparation, photographing or other image reproduction technique, photographic printing, and reporting and storage of results, karyotypes, and photographs.
(b) The laboratory must have records that document the following:
(1) The media used, reactions observed, number of cells counted, number of cells karyotyped, number of chromosomes counted for each metaphase spread, and the quality of the banding.
(2) The resolution is appropriate for the type of tissue or specimen and the type of study required based on the clinical information provided to the laboratory.
(3) An adequate number of karyotypes are prepared for each patient.
(c) Determination of sex must be performed by full chromosome analysis.
(d) The laboratory report must include a summary and interpretation of the observations, number of cells counted and analyzed, and use the International System for Human Cytogenetic Nomenclature.
(e) The laboratory must document all control procedures performed, as specified in this section.
§ 493.1278   Standard: Histocompatibility.
(a) General. The laboratory must meet the following requirements:
(1) Use a continuous monitoring system and alert system to monitor the storage temperature of specimens (donor and recipient) and reagents and notify laboratory personnel when temperature limits are exceeded.
(2) Establish and follow written policies and procedures for the storage and retention of specimens based on the specific type of specimen. All specimens must be easily retrievable. The laboratory must have an emergency plan for alternate storage.
(3) If the laboratory uses immunologic reagents to facilitate or enhance the isolation or identification of lymphocytes or lymphocyte subsets, the efficacy of the methods must be monitored with appropriate quality control procedures.
(4) Participate in at least one national or regional cell exchange program, if available, or develop an exchange system with another laboratory in order to validate interlaboratory reproducibility.
(b) Human leukocyte antigen (HLA) typing. The laboratory must do the following:
(1) Use HLA antigen terminology that conforms to the World Health Organization (WHO) Nomenclature Committee for Factors of the HLA System.
(2) Have available and follow written criteria for determining when antigen and allele typing are required.
(c) Antibody screening and identification. The laboratory must make a reasonable effort to have available monthly serum specimens for all potential transplant recipients for periodic antibody screening, identification, and crossmatch.
(d) Crossmatching. For each type of crossmatch that a laboratory performs, the laboratory must do the following, as applicable:
(1) Establish and follow written policies and procedures for performing a crossmatch.
(2) Have available and follow written criteria for the following:
(i) Defining donor and recipient HLA antigens, alleles, and antibodies to be tested;
(ii) Defining the criteria necessary to assess a recipient's alloantibody status;
(iii) Assessing recipient antibody presence or absence on an ongoing basis;
(iv) Typing the donor, to include those HLA antigens to which antibodies have been identified in the potential recipient, as applicable;
(v) Describing the circumstances in which pre- and post-transplant confirmation testing of donor and recipient specimens is required;
(vi) Making available all applicable donor and recipient test results to the transplant team;
(vii) Ensuring immunologic assessments are based on test results obtained from a test report from a CLIA-certified laboratory; and
(viii) Defining time limits between recipient testing and the performance of a crossmatch.
(3) The test report must specify the type of crossmatch performed.
(e) Transplantation. Laboratories performing histocompatibility testing for infusion and transplantation purposes must establish and follow written policies and procedures specifying the histocompatibility testing (that is, HLA typing, antibody screening and identification, and crossmatching) to be performed for each type of cell, tissue, or organ to be infused or transplanted. The laboratory's policies and procedures must include, as applicable—
(1) Testing protocols that address:
(i) Transplant type (organ, tissue, cell);
(ii) Donor (living, deceased, or paired): and
(iii) Recipient (high risk vs. unsensitized);
(2) Type and frequency of testing required to support clinical transplant protocols; and
(3) Process to obtain a recipient specimen, if possible, for crossmatch that is collected on the day of the transplant and prior to transplantation. If the laboratory is unable to obtain a recipient specimen on the day of the transplant, the laboratory must have a process to document its efforts to obtain the specimen.
(f) Documentation. The laboratory must document all control procedures performed, as specified in this section.
§ 493.1281   Standard: Comparison of test results.
(a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites.
(b) The laboratory must have a system to identify and assess patient test results that appear inconsistent with the following relevant criteria, when available:
(1) Patient age.
(2) Sex.
(3) Diagnosis or pertinent clinical data.
(4) Distribution of patient test results.
(5) Relationship with other test parameters.
(c) The laboratory must document all test result comparison activities.
§ 493.1282   Standard: Corrective actions.
(a) Corrective action policies and procedures must be available and followed as necessary to maintain the laboratory's operation for testing patient specimens in a manner that ensures accurate and reliable patient test results and reports.
(b) The laboratory must document all corrective actions taken, including actions taken when any of the following occur:
(1) Test systems do not meet the laboratory's verified or established performance specifications, as determined in § 493.1253(b), which include but are not limited to—
(i) Equipment or methodologies that perform outside of established operating parameters or performance specifications;
(ii) Patient test values that are outside of the laboratory's reportable range of test results for the test system; and
(iii) When the laboratory determines that the reference intervals (normal values) for a test procedure are inappropriate for the laboratory's patient population.
(2) Results of control or calibration materials, or both, fail to meet the laboratory's established criteria for acceptability. All patient test results obtained in the unacceptable test run and since the last acceptable test run must be evaluated to determine if patient test results have been adversely affected. The laboratory must take the corrective action necessary to ensure the reporting of accurate and reliable patient test results.
(3) The criteria for proper storage of reagents and specimens, as specified under § 493.1252(b), are not met.
§ 493.1283   Standard: Test records.
(a) The laboratory must maintain an information or record system that includes the following:
(1) The positive identification of the specimen.
(2) The date and time of specimen receipt into the laboratory.
(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability.
(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s).
(b) Records of patient testing including, if applicable, instrument printouts, must be retained.
§ 493.1289   Standard: Analytic systems quality assessment.
(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in §§ 493.1251 through 493.1283.
(b) The analytic systems quality assessment must include a review of the effectiveness of corrective actions taken to resolve problems, revision of policies and procedures necessary to prevent recurrence of problems, and discussion of analytic systems quality assessment reviews with appropriate staff.
(c) The laboratory must document all analytic systems quality assessment activities.
§ 493.1290   Condition: Postanalytic systems.
Each laboratory that performs nonwaived testing must meet the applicable postanalytic systems requirements in § 493.1291 unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7) that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the postanalytic systems and correct identified problems as specified in § 493.1299 for each specialty and subspecialty of testing performed.
§ 493.1291   Standard: Test report.
(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following:
(1) Results reported from calculated data.
(2) Results and patient-specific data electronically reported to network or interfaced systems.
(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations.
(b) Test report information maintained as part of the patient's chart or medical record must be readily available to the laboratory and to CMS or a CMS agent upon request.
(c) The test report must indicate the following:
(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number.
(2) The name and address of the laboratory location where the test was performed.
(3) The test report date.
(4) The test performed.
(5) Specimen source, when appropriate.
(6) The test result and, if applicable, the units of measurement or interpretation, or both.
(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability.
(d) Pertinent “reference intervals” or “normal” values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results.
(e) The laboratory must, upon request, make available to clients a list of test methods employed by the laboratory and, as applicable, the performance specifications established or verified as specified in § 493.1253. In addition, information that may affect the interpretation of test results, for example test interferences, must be provided upon request. Pertinent updates on testing information must be provided to clients whenever changes occur that affect the test results or interpretation of test results.
(f) Except as provided in § 493.1291(l), test results must be released only to authorized persons and, if applicable, the persons responsible for using the test results and the laboratory that initially requested the test.
(g) The laboratory must immediately alert the individual or entity requesting the test and, if applicable, the individual responsible for using the test results when any test result indicates an imminently life-threatening condition, or panic or alert values.
(h) When the laboratory cannot report patient test results within its established time frames, the laboratory must determine, based on the urgency of the patient test(s) requested, the need to notify the appropriate individual(s) of the delayed testing.
(i) If a laboratory refers patient specimens for testing—
(1) The referring laboratory must not revise results or information directly related to the interpretation of results provided by the testing laboratory;
(2) The referring laboratory may permit each testing laboratory to send the test result directly to the authorized person who initially requested the test. The referring laboratory must retain or be able to produce an exact duplicate of each testing laboratory's report; and
(3) The authorized person who orders a test must be notified by the referring laboratory of the name and address of each laboratory location where the test was performed.
(j) All test reports or records of the information on the test reports must be maintained by the laboratory in a manner that permits ready identification and timely accessibility.
(k) When errors in the reported patient test results are detected, the laboratory must do the following:
(1) Promptly notify the authorized person ordering the test and, if applicable, the individual using the test results of reporting errors.
(2) Issue corrected reports promptly to the authorized person ordering the test and, if applicable, the individual using the test results.
(3) Maintain duplicates of the original report, as well as the corrected report.
(l) Upon request by a patient (or the patient's personal representative), the laboratory may provide patients, their personal representatives, and those persons specified under 45 CFR 164.524(c)(3)(ii), as applicable, with access to completed test reports that, using the laboratory's authentication process, can be identified as belonging to that patient.
§ 493.1299   Standard: Postanalytic systems quality assessment.
(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in § 493.1291.
(b) The postanalytic systems quality assessment must include a review of the effectiveness of corrective actions taken to resolve problems, revision of policies and procedures necessary to prevent recurrence of problems, and discussion of postanalytic systems quality assessment reviews with appropriate staff.
(c) The laboratory must document all postanalytic systems quality assessment activities.
§ 493.1351   General.
This subpart consists of the personnel requirements that must be met by laboratories performing moderate complexity testing, PPM procedures, high complexity testing, or any combination of these tests.
§ 493.1353   Scope.
In accordance with § 493.19(b), the moderate complexity procedures specified as PPM procedures are considered such only when personally performed by a health care provider during a patient visit in the context of a physical examination. PPM procedures are subject to the personnel requirements in §§ 493.1355 through 493.1365.
§ 493.1355   Condition: Laboratories performing PPM procedures; laboratory director.
The laboratory must have a director who meets the qualification requirements of § 493.1357 and provides overall management and direction in accordance with § 493.1359.
§ 493.1357   Standard; laboratory director qualifications.
The laboratory director must be qualified to manage and direct the laboratory personnel and the performance of PPM procedures as specified in § 493.19(c) and must be eligible to be an operator of a laboratory within the requirements of subpart R of this part.
(a) The laboratory director must possess a current license as a laboratory director issued by the State in which the laboratory is located, if the licensing is required.
(b) The laboratory director must meet one of the following requirements:
(1) Be a physician, as defined in § 493.2.
(2) Be a midlevel practitioner, as defined in § 493.2, authorized by a State to practice independently in the State in which the laboratory is located.
(3) Be a dentist, as defined in § 493.2.
§ 493.1359   Standard; PPM laboratory director responsibilities.
The laboratory director is responsible for the overall operation and administration of the laboratory, including the prompt, accurate, and proficient reporting of test results. The laboratory director must—
(a) Direct no more than five laboratories; and
(b) Ensure that any procedure listed under § 493.19(c)—
(1) Is personally performed by an individual who meets the qualification requirements in § 493.1363; and
(2) Is performed in accordance with applicable requirements in this subpart and subparts H, J, and K of this part;
(c) Evaluate the competency of all testing personnel and ensure that the staff maintains 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—
(1) Direct observations of routine patient test performance, including, if applicable, specimen handling, processing, and testing;
(2) Monitoring the recording and reporting of test results;
(3) Review of test results or worksheets;
(4) Assessment of test performance through testing internal blind testing samples or external proficiency testing samples; and
(5) Assessment of problem solving skills; and
(d) Evaluate and document the performance of individuals responsible for PPM testing at least semiannually during the first year the individual tests patient specimens. Thereafter, evaluations and documentation must be performed at least annually.
§ 493.1361   Condition: Laboratories performing PPM procedures; testing personnel.
The laboratory must have a sufficient number of individuals who meet the qualification requirements of § 493.1363 to perform the functions specified in § 493.1365 for the volume and complexity of testing performed.
§ 493.1363   Standard: PPM testing personnel qualifications.
Each individual performing PPM procedures must—
(a) Possess a current license issued by the State in which the laboratory is located if the licensing is required; and
(b) Meet one of the following requirements:
(1) Be a physician, as defined in § 493.2.
(2) Be a midlevel practitioner, as defined in § 493.2, under the supervision of a physician or in independent practice if authorized by the State in which the laboratory is located.
(3) Be a dentist as defined in § 493.2 of this part.
§ 493.1365   Standard; PPM testing personnel responsibilities.
The testing personnel are responsible for specimen processing, test performance, and for reporting test results. Any PPM procedure must be—
(a) Personally performed by one of the following practitioners:
(1) A physician during the patient's visit on a specimen obtained from his or her own patient or from a patient of a group medical practice of which the physician is a member or employee.
(2) A midlevel practitioner, under the supervision of a physician or in independent practice if authorized by the State in which the laboratory is located, during the patient's visit on a specimen obtained from his or her own patient or from the patient of a clinic, group medical practice, or other health care provider, in which the midlevel practitioner is a member or an employee.
(3) A dentist during the patient's visit on a specimen obtained from his or her own patient or from a patient of a group dental practice of which the dentist is a member or an employee; and
(b) Performed using a microscope limited to a brightfield or a phase/contrast microscope.
§ 493.1403   Condition: Laboratories performing moderate complexity testing; laboratory director.
The laboratory must have a director who meets the qualification requirements of § 493.1405 of this subpart and provides overall management and direction in accordance with § 493.1407 of this subpart.
§ 493.1405   Standard; Laboratory director qualifications.
The laboratory director must be qualified to manage and direct the laboratory personnel and the performance of moderate complexity tests and must be eligible to be an operator of a laboratory within the requirements of subpart R of this part.
(a) The laboratory director must possess a current license as a laboratory director issued by the State in which the laboratory is located, if such licensing is required; and
(b) The laboratory director must—
(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and
(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology; or
(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and
(ii) Have had laboratory training or experience consisting of:
(A) At least 1 year directing or supervising nonwaived laboratory testing; and
(B) Have at least 20 CE credit hours in laboratory practice that cover the laboratory director responsibilities defined in § 493.1407; or
(3)(i)(A) Hold an earned doctoral degree in a chemical, biological, clinical or medical laboratory science or medical technology from an accredited institution; or
(B) Hold an earned doctoral degree; and
( 1 ) Have at least 16 semester hours of doctoral level coursework in biology, chemistry, medical technology (MT), clinical laboratory science (CLS), or medical laboratory science (MLS); or
( 2 ) An approved thesis or research project in biology/chemistry/MT/CLS/MLS related to laboratory testing for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings; and
(ii) Have at least 20 CE credit hours in laboratory practice that cover the laboratory director responsibilities defined in § 493.1407; and
(A) Be certified and continue to be certified by a board approved by HHS; and
(B) Have had at least 1 year of experience directing or supervising nonwaived laboratory testing; or
(4)(i)(A) Have earned a master's degree in a chemical, biological, clinical or medical laboratory science or medical technology from an accredited institution; or
(B)( 1 ) Meet bachelor's degree equivalency; and
(2) Have at least 16 semester hours of additional graduate level coursework in biology, chemistry, medical technology, clinical or medical laboratory science; or
(C)( 1 ) Meet bachelor's degree equivalency; and
( 2 ) Have at least 16 semester hours in a combination of graduate level coursework in biology, chemistry, medical technology, clinical or medical laboratory science and an approved thesis or research project related to laboratory testing for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings; and
(ii) Have at least 1 year of laboratory training or experience, or both, in nonwaived testing; and
(iii) Have at least 1 year of supervisory laboratory experience in nonwaived testing; and
(iv) Have at least 20 CE credit hours in laboratory practice that cover the director responsibilities defined in § 493.1407; or
(5)(i)(A) Have earned a bachelor's degree in a chemical, biological, clinical or medical laboratory science or medical technology from an accredited institution; or
(B) At least 120 semester hours, or equivalent, from an accredited institution that, at a minimum, includes either—
( 1 ) Forty-eight (48) semester hours of medical laboratory science or medical laboratory technology courses; or
( 2 ) Forty-eight (48) semester hours of science courses that include—
( i ) Twelve (12) semester hours of chemistry, which must include general chemistry and biochemistry or organic chemistry;
( ii ) Twelve (12) semester hours of biology, which must include general biology and molecular biology, cell biology or genetics; and
( iii ) Twenty-four (24) semester hours of chemistry, biology, or medical laboratory science or medical laboratory technology in any combination; and
(ii) Have at least 2 years of laboratory training or experience, or both, in nonwaived testing; and
(iii) Have at least 2 years of supervisory laboratory experience in nonwaived testing; and
(iv) Have at least 20 CE credit hours in laboratory practice that cover the director responsibilities defined in § 493.1407.
(6) Notwithstanding any other provision of this section, an individual is considered qualified as a laboratory director of moderate complexity testing under this section if they were qualified and serving as a laboratory director of moderate complexity testing in a CLIA-certified laboratory as of December 28, 2024, and have done so continuously since December 28, 2024.
§ 493.1407   Standard; Laboratory director responsibilities.
The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations.
(a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of §§ 493.1409, 493.1415, and 493.1421, respectively.
(b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed.
(c) The laboratory director must:
(1) Be onsite at least once every 6 months, with at least 4 months between the minimum two on-site visits. Laboratory directors may elect to be on-site more frequently and must continue to be accessible to the laboratory to provide telephone or electronic consultation as needed; and
(2) Provide documentation of these visits, including evidence of performing activities that are part of the laboratory director responsibilities.
(d) Each individual may direct no more than five laboratories.
(e) The laboratory director must—
(1) Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing;
(2) Ensure that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed and provide a safe environment in which employees are protected from physical, chemical, and biological hazards;
(3) Ensure that—
(i) The test methodologies selected have the capability of providing the quality of results required for patient care;
(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; and
(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results;
(4) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed and that—
(i) The proficiency testing samples are tested as required under subpart H of this part;
(ii) The results are returned within the timeframes established by the proficiency testing program;
(iii) All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require corrective action; and
(iv) An approved corrective action plan is followed when any proficiency testing results are found to be unacceptable or unsatisfactory;
(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur;
(6) Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system;
(7) Ensure that all necessary remedial actions are taken and documented whenever significant deviations from the laboratory's established performance specifications are identified, and that patient test results are reported only when the system is functioning properly;
(8) Ensure that reports of test results include pertinent information required for interpretation;
(9) Ensure that consultation is available to the laboratory's clients on matters relating to the quality of the test results reported and their interpretation concerning specific patient conditions;
(10) Employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities described in this subpart;
(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results;
(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills;
(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; and
(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results.
§ 493.1409   Condition: Laboratories performing moderate complexity testing; technical consultant.
The laboratory must have a technical consultant who meets the qualification requirements of § 493.1411 of this subpart and provides technical oversight in accordance with § 493.1413 of this subpart.
§ 493.1411   Standard; Technical consultant qualifications.
The laboratory must employ one or more individuals who are qualified by education and either training or experience to provide technical consultation for each of the specialties and subspecialties of service in which the laboratory performs moderate complexity tests or procedures. The director of a laboratory performing moderate complexity testing may function as the technical consultant provided he or she meets the qualifications specified in this section.
(a) The technical consultant must possess a current license issued by the State in which the laboratory is located, if such licensing is required.
(b) The technical consultant must—
(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and
(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology; or
(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and
(ii) Have at least 1 year of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or
(3)(i)(A) Hold an earned doctoral or master's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or
(B) Meet either requirements in § 493.1405(b)(3)(i)(B) or (b)(4)(i)(B) or (C); and
(ii) Have at least 1 year of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or
(4)(i)(A) Have earned a bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or
(B) Meet § 493.1405(b)(5)(i)(B); and
(ii) Have at least 2 years of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or
(5)(i) Have earned an associate degree in medical laboratory technology, medical laboratory science, or clinical laboratory science; and
(ii) Have at least 4 years of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible.
(6) For blood gas analysis, the individual must—
(i) Be qualified under paragraph (b)(1), (2), (3), or (4) of this section; or
(ii)(A) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; and
(B) Have at least 2 years of laboratory training or experience, or both, in blood gas analysis; or
(7) Notwithstanding any other provision of this section, an individual is considered qualified as a technical consultant under this section if they were qualified and serving as a technical consultant for moderate complexity testing in a CLIA-certified laboratory as of December 28, 2024, and have done so continuously since December 28, 2024.
The technical consultant requirements for “laboratory training or experience, or both” in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service, excluding waived tests. For example, an individual who has a bachelor's degree in biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service.
§ 493.1413   Standard; Technical consultant responsibilities.
The technical consultant is responsible for the technical and scientific oversight of the laboratory. The technical consultant is not required to be onsite at all times testing is performed; however, he or she must be available to the laboratory on an as needed basis to provide consultation, as specified in paragraph (a) of this section.
(a) The technical consultant must be accessible to the laboratory to provide on-site, telephone, or electronic consultation; and
(b) The technical consultant is responsible for—
(1) Selection of test methodology appropriate for the clinical use of the test results;
(2) Verification of the test procedures performed and the establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system;
(3) Enrollment and participation in an HHS approved proficiency testing program commensurate with the services offered;
(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results;
(5) Resolving technical problems and ensuring that remedial actions are taken whenever test systems deviate from the laboratory's established performance specifications;
(6) Ensuring that patient test results are not reported until all corrective actions have been taken and the test system is functioning properly;
(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed;
(8) 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—
(i) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing;
(ii) Monitoring the recording and reporting of test results;
(iii) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records;
(iv) Direct observation of performance of instrument maintenance and function checks;
(v) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and
(vi) Assessment of problem solving skills; and
(9) Evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. Thereafter, evaluations must be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation.
§ 493.1415   Condition: Laboratories performing moderate complexity testing; clinical consultant.
The laboratory must have a clinical consultant who meets the qualification requirements of § 493.1417 of this part and provides clinical consultation in accordance with § 493.1419 of this part.
§ 493.1417   Standard; Clinical consultant qualifications.
The clinical consultant must be qualified to consult with and render opinions to the laboratory's clients concerning the diagnosis, treatment and management of patient care. The clinical consultant must—
(a) Be qualified as a laboratory director under § 493.1405(b)(1), (2), or (3); or
(b) Be a doctor of medicine, doctor of osteopathy or doctor of podiatric medicine and possess a license to practice medicine, osteopathy or podiatry in the State in which the laboratory is located.
§ 493.1419   Standard; Clinical consultant responsibilities.
The clinical consultant provides consultation regarding the appropriateness of the testing ordered and interpretation of test results. The clinical consultant must—
(a) Be available to provide clinical consultation to the laboratory's clients;
(b) Be available to assist the laboratory's clients in ensuring that appropriate tests are ordered to meet the clinical expectations;
(c) Ensure that reports of test results include pertinent information required for specific patient interpretation; and
(d) Ensure that consultation is available and communicated to the laboratory's clients on matters related to the quality of the test results reported and their interpretation concerning specific patient conditions.
§ 493.1421   Condition: Laboratories performing moderate complexity testing; testing personnel.
The laboratory must have a sufficient number of individuals who meet the qualification requirements of § 493.1423, to perform the functions specified in § 493.1425 for the volume and complexity of tests performed.
§ 493.1423   Standard; Testing personnel qualifications.
Each individual performing moderate complexity testing must—
(a) Possess a current license issued by the State in which the laboratory is located, if such licensing is required; and
(b) Meet one of the following requirements:
(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; or
(2) Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology, or nursing from an accredited institution; or
(3) Meet the requirements in § 493.1405(b)(3)(i)(B), (b)(4)(i)(B) or (C), or (b)(5)(i)(B); or
(4) Have earned an associate degree in a chemical, biological, clinical or medical laboratory science, or medical laboratory technology or nursing from an accredited institution; or
(5) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least a duration of 50 weeks and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or
(6)(i) Have earned a high school diploma or equivalent; and
(ii) Have documentation of laboratory training appropriate for the testing performed prior to analyzing patient specimens. Such training must ensure that the individual has—
(A) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation, and storage of specimens;
(B) The skills required for implementing all standard laboratory procedures;
(C) The skills required for performing each test method and for proper instrument use;
(D) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed;
(E) A working knowledge of reagent stability and storage;
(F) The skills required to implement the quality control policies and procedures of the laboratory;
(G) An awareness of the factors that influence test results; and
(H) The skills required to assess and verify the validity of patient test results through the evaluation of quality control sample values prior to reporting patient test results.
(7) For blood gas analysis, the individual must—

(i) Be qualified under paragraph (b)(1), (2), (3), (4), (5), or (6) of this section; or
(ii)(A) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; and
(B) Have at least 1 year of laboratory training or experience, or both, in blood gas analysis; or
(iii)(A) Have earned an associate degree related to pulmonary function from an accredited institution; and
(B) Have at least 2 years of laboratory training or experience, or both, in blood gas analysis.
(8) Notwithstanding any other provision of this section, an individual is considered qualified as a testing personnel under this section if they were qualified and serving as a testing personnel for moderate complexity testing in a CLIA-certified laboratory as of December 28, 2024, and have done so continuously since December 28, 2024.
§ 493.1425   Standard; Testing personnel responsibilities.
The testing personnel are responsible for specimen processing, test performance, and for reporting test results.
(a) Each individual performs only those moderate complexity tests that are authorized by the laboratory director and require a degree of skill commensurate with the individual's education, training or experience, and technical abilities.
(b) Each individual performing moderate complexity testing must—
(1) Follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results;
(2) Maintain records that demonstrate that proficiency testing samples are tested in the same manner as patient samples;
(3) Adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed;
(4) Follow the laboratory's established corrective action policies and procedures whenever test systems are not within the laboratory's established acceptable levels of performance;
(5) Be capable of identifying problems that may adversely affect test performance or reporting of test results and either must correct the problems or immediately notify the technical consultant, clinical consultant or director; and
(6) Document all corrective actions taken when test systems deviate from the laboratory's established performance specifications.
§ 493.1441   Condition: Laboratories performing high complexity testing; laboratory director.
The laboratory must have a director who meets the qualification requirements of § 493.1443 of this subpart and provides overall management and direction in accordance with § 493.1445 of this subpart.
§ 493.1443   Standard; Laboratory director qualifications.
The laboratory director must be qualified to manage and direct the laboratory personnel and performance of high complexity tests and must be eligible to be an operator of a laboratory within the requirements of subpart R.
(a) The laboratory director must possess a current license as a laboratory director issued by the State in which the laboratory is located, if such licensing is required; and
(b) The laboratory director must—
(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and
(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology; or
(2)(i) Be a doctor of medicine, a doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and
(ii) Have at least 2 years of experience directing or supervising high complexity testing; and
(iii) Have at least 20 CE credit hours in laboratory practice that cover the director responsibilities defined in § 493.1445; or
(3)(i)(A) Hold an earned doctoral degree in a chemical, biological, clinical or medical laboratory science or medical technology from an accredited institution; or
(B) Hold an earned doctoral degree; and
( 1 ) Have at least 16 semester hours of doctoral level coursework in biology, chemistry, medical technology (MT), clinical laboratory science (CLS), or medical laboratory science (MLS); or
( 2 ) An approved thesis or research project in biology/chemistry/MT/CLS/MLS related to laboratory testing for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings; and
(ii) Be certified and continue to be certified by a board approved by HHS; and
(iii) Have at least 2 years of:
(A) Laboratory training or experience, or both: and
(B) Laboratory experience directing or supervising high complexity testing; and
(iv) Have at least 20 CE credit hours in laboratory practice that cover the director responsibilities defined in § 493.1445; or
(4) Notwithstanding any other provision of this section, an individual is considered qualified as a laboratory director of high complexity testing under this section if they were qualified and serving as a laboratory director of high complexity testing in a CLIA-certified laboratory as of December 28, 2024, and have done so continuously since December 28, 2024.
(5) For the subspecialty of oral pathology, be certified by the American Board of Oral Pathology, American Board of Pathology, or the American Osteopathic Board of Pathology.
§ 493.1445   Standard; Laboratory director responsibilities.
The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations.
(a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under §§ 493.1447, 493.1453, 493.1459, and 493.1487, respectively.
(b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed.
(c) The laboratory director must:
(1) Be onsite at least once every 6 months, with at least 4 months between the minimum two on-site visits. Laboratory directors may elect to be on-site more frequently and must continue to be accessible to the laboratory to provide telephone or electronic consultation as needed; and
(2) Provide documentation of these visits, including evidence of performing activities that are part of the laboratory director responsibilities.
(d) Each individual may direct no more than five laboratories.
(e) The laboratory director must—
(1) Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing;
(2) Ensure that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed and provide a safe environment in which employees are protected from physical, chemical, and biological hazards;
(3) Ensure that—
(i) The test methodologies selected have the capability of providing the quality of results required for patient care;
(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; and
(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results;
(4) Ensure that the laboratory is enrolled in an HHS-approved proficiency testing program for the testing performed and that—
(i) The proficiency testing samples are tested as required under subpart H of this part;
(ii) The results are returned within the timeframes established by the proficiency testing program;
(iii) All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require corrective action; and
(iv) An approved corrective action plan is followed when any proficiency testing result is found to be unacceptable or unsatisfactory;
(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur;
(6) Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system;
(7) Ensure that all necessary remedial actions are taken and documented whenever significant deviations from the laboratory's established performance characteristics are identified, and that patient test results are reported only when the system is functioning properly;
(8) Ensure that reports of test results include pertinent information required for interpretation;
(9) Ensure that consultation is available to the laboratory's clients on matters relating to the quality of the test results reported and their interpretation concerning specific patient conditions;
(10) Ensure that a general supervisor provides on-site supervision of high complexity test performance by testing personnel qualified under § 493.1489(b)(5);
(11) Employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities described in this subpart;
(12) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results;
(13) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills;
(14) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; and
(15) Specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results.
§ 493.1447   Condition: Laboratories performing high complexity testing; technical supervisor.
The laboratory must have a technical supervisor who meets the qualification requirements of § 493.1449 of this subpart and provides technical supervision in accordance with § 493.1451 of this subpart.
§ 493.1449   Standard; Technical supervisor qualifications.
The laboratory must employ one or more individuals who are qualified by education and either training or experience to provide technical supervision for each of the specialties and subspecialties of service in which the laboratory performs high complexity tests or procedures. The director of a laboratory performing high complexity testing may function as the technical supervisor provided he or she meets the qualifications specified in this section.
(a) The technical supervisor must possess a current license issued by the State in which the laboratory is located, if such licensing is required; and
(b) The laboratory may perform anatomic and clinical laboratory procedures and tests in all specialties and subspecialties of services except histocompatibility and clinical cytogenetics services provided the individual functioning as the technical supervisor—
(1) Is a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and
(2) Is certified in both anatomic and clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology.
(c) Bacteriology, Mycobacteriology, Mycology, Parasitology or Virology. If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of bacteriology, mycobacteriology, mycology, parasitology, or virology, the individual functioning as the technical supervisor must—
(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and
(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology; or
(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and
(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months of experience in high complexity testing within the applicable microbiology subspecialty; or
(3)(i)(A) Have an earned doctoral degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or
(B) Meet the requirements in § 493.1443(b)(3)(i)(B); and
(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months of experience in high complexity testing within the applicable subspecialty; or
(4)(i)(A) Have earned a master's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or
(B)( 1 ) Meet bachelor's degree equivalency; and
( 2 ) Have at least 16 semester hours of additional graduate level coursework in chemical, biological, clinical or medical laboratory science, or medical technology; or
(C)( 1 ) Meet bachelor's degree equivalency; and
( 2 ) Have at least 16 semester hours in a combination of graduate level coursework in biology, chemistry, medical technology, or clinical or medical laboratory science and an approved thesis or research project related to laboratory testing for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings; and
(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months of experience in high complexity testing within the applicable subspecialty; or
(5)(i)(A) Have earned a bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or
(B) Have at least 120 semester hours, or equivalent, from an accredited institution that, at a minimum, includes either—
( 1 ) Forty-eight (48) semester hours of medical laboratory technology courses; or
( 2 ) Forty-eight (48) semester hours of science courses that include—
( i ) Twelve (12) semester hours of chemistry, which must include general chemistry and biochemistry or organic chemistry;
( ii ) Twelve (12) semester hours of biology, which must include general biology and molecular biology, cell biology or genetics; and
( iii ) Twenty-four (24) semester hours of chemistry, biology, or medical laboratory science or technology in any combination; and
(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months of experience in high complexity testing within the applicable subspecialty.
(d) Diagnostic Immunology, Chemistry, Hematology, Radiobioassay, or Immunohematology. If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of diagnostic immunology, chemistry, hematology, radiobioassay, or immunohematology, the individual functioning as the technical supervisor must—
(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and
(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology; or
(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and
(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the applicable specialty; or
(3)(i)(A) Have an earned doctoral degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or
(B) Meet the education requirement at § 493.1443(b)(3)(i)(B); and
(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the applicable specialty; or
(4)(i)(A) Have earned a master's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or
(B) Meet the education requirement at paragraph (c)(4)(i)(B) or (C) of this section; and
(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the applicable specialty; or
(5)(i)(A) Have earned a bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or
(B) Meet the education requirement at paragraph (c)(5)(i)(B) of this section; and
(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the applicable specialty.
(e) Cytology. If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of cytology, the individual functioning as the technical supervisor must—
(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and
(ii) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology; or
(2) An individual qualified under paragraph (b) or (e)(1) of this section may delegate some of the cytology technical supervisor responsibilities to an individual who is in the final year of full-time training leading to certification specified in paragraph (b) or (e)(1)(ii) of this section provided the technical supervisor qualified under paragraph (b) or (e)(1) of this section remains ultimately responsible for ensuring that all of the responsibilities of the cytology technical supervisor are met.
(f) Histopathology. If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of histopathology, the individual functioning as the technical supervisor must—
(1) Meet one of the following requirements:
(i)(A) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and
(B) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology; or
(ii) An individual qualified under paragraph (b) of this section or this paragraph (f)(1) may delegate to an individual who is a resident in a training program leading to certification specified in paragraph (b) or (f)(1)(i)(B) of this section, the responsibility for examination and interpretation of histopathology specimens.
(2) For tests in dermatopathology, meet one of the following requirements:
(i)(A) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and
(B) Meet one of the following requirements:
( 1 ) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology; or
( 2 ) Be certified in dermatopathology by the American Board of Dermatology and the American Board of Pathology; or
( 3 ) Be certified in dermatology by the American Board of Dermatology; or
(ii) An individual qualified under paragraph (b) or (f)(2)(i) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraph (b) or (f)(2)(i)(B) of this section, the responsibility for examination and interpretation of dermatopathology specimens.
(3) For tests in ophthalmic pathology, meet one of the following requirements:
(i)(A) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and
(B) Must meet one of the following requirements:
( 1 ) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology; or
( 2 ) Be certified by the American Board of Ophthalmology and have successfully completed at least 1 year of formal post-residency fellowship training in ophthalmic pathology; or
(ii) An individual qualified under paragraph (b) or (f)(3)(i) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraph (b) or (f)(3)(i)(B) of this section, the responsibility for examination and interpretation of ophthalmic specimens; or
(g) Oral Pathology. If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of oral pathology, the individual functioning as the technical supervisor must meet one of the following requirements:
(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and
(ii) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology; or
(2) Be certified in oral pathology by the American Board of Oral Pathology; or
(3) An individual qualified under paragraph (b) or (g)(1) or (2) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraph (b) or (g)(1) or (2) of this section, the responsibility for examination and interpretation of oral pathology specimens.
(h) Histocompatibility. If the laboratory performs tests in the specialty of histocompatibility, the individual functioning as the technical supervisor must either—
(1)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and
(ii) Have training or experience that meets one of the following requirements:
(A) Have 4 years of laboratory training or experience, or both, within the specialty of histocompatibility; or
(B)( 1 ) Have 2 years of laboratory training or experience, or both, in the specialty of general immunology; and
( 2 ) Have 2 years of laboratory training or experience, or both, in the specialty of histocompatibility; or
(2)(i) Have an earned doctoral degree in a biological, clinical or medical laboratory science, or medical technology from an accredited institution; or meet the education requirement at § 493.1443(b)(3)(i)(B); and
(ii) Have training or experience that meets one of the following requirements:
(A) Have 4 years of laboratory training or experience, or both, within the specialty of histocompatibility; or
(B)( 1 ) Have 2 years of laboratory training or experience, or both, in the specialty of general immunology; and
( 2 ) Have 2 years of laboratory training or experience, or both, in the specialty of histocompatibility.
(i) Clinical cytogenetics. If the laboratory performs tests in the specialty of clinical cytogenetics, the individual functioning as the technical supervisor must—
(1)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and
(ii) Have 4 years of laboratory training or experience, or both, in genetics, 2 of which have been in clinical cytogenetics; or
(2)(i) Hold an earned doctoral degree in a biological science, including biochemistry, clinical or medical laboratory science, or medical technology from an accredited institution; or meet the education requirement at § 493.1443(b)(3)(i)(B); and
(ii) Have 4 years of laboratory training or experience, or both, in genetics, 2 of which have been in clinical cytogenetics.
The technical supervisor requirements for “laboratory training or experience, or both” in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service. For example, an individual, who has a doctoral degree in chemistry and additionally has documentation of 1 year of laboratory experience working concurrently in high complexity testing in the specialties of microbiology and chemistry and 6 months of that work experience included high complexity testing in bacteriology, mycology, and mycobacteriology, would qualify as the technical supervisor for the specialty of chemistry and the subspecialties of bacteriology, mycology, and mycobacteriology.
(j) Notwithstanding any other provision of this section, an individual is considered qualified as a technical supervisor under this section if they were qualified and serving as a technical supervisor for high complexity testing in a CLIA-certified laboratory as of December 28, 2024, and have done so continuously since December 28, 2024.
§ 493.1451   Standard: Technical supervisor responsibilities.
The technical supervisor is responsible for the technical and scientific oversight of the laboratory. The technical supervisor is not required to be on site at all times testing is performed; however, he or she must be available to the laboratory on an as needed basis to provide supervision as specified in (a) of this section.
(a) The technical supervisor must be accessible to the laboratory to provide on-site, telephone, or electronic consultation; and
(b) The technical supervisor is responsible for—
(1) Selection of the test methodology that is appropriate for the clinical use of the test results;
(2) Verification of the test procedures performed and establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system;
(3) Enrollment and participation in an HHS approved proficiency testing program commensurate with the services offered;
(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results;
(5) Resolving technical problems and ensuring that remedial actions are taken whenever test systems deviate from the laboratory's established performance specifications;
(6) Ensuring that patient test results are not reported until all corrective actions have been taken and the test system is functioning properly;
(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed;
(8) 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—
(i) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing;
(ii) Monitoring the recording and reporting of test results;
(iii) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records;
(iv) Direct observation of performance of instrument maintenance and function checks;
(v) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and
(vi) Assessment of problem solving skills; and
(9) Evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. Thereafter, evaluations must be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation.
(c) In cytology, the technical supervisor or the individual qualified under § 493.1449(e)(2)—
(1) May perform the duties of the cytology general supervisor and the cytotechnologist, as specified in §§ 493.1471 and 493.1485, respectively;
(2) Must establish the workload limit for each individual examining slides;
(3) Must reassess the workload limit for each individual examining slides at least every 6 months and adjust as necessary;
(4) Must perform the functions specified in § 493.1274(d) and (e);
(5) Must ensure that each individual examining gynecologic preparations participates in an HHS approved cytology proficiency testing program, as specified in § 493.945 and achieves a passing score, as specified in § 493.855; and
(6) If responsible for screening cytology slide preparations, must document the number of cytology slides screened in 24 hours and the number of hours devoted during each 24-hour period to screening cytology slides.
§ 493.1453   Condition: Laboratories performing high complexity testing; clinical consultant.
The laboratory must have a clinical consultant who meets the requirements of § 493.1455 of this subpart and provides clinical consultation in accordance with § 493.1457 of this subpart.
§ 493.1455   Standard; Clinical consultant qualifications.
The clinical consultant must be qualified to consult with and render opinions to the laboratory's clients concerning the diagnosis, treatment and management of patient care. The clinical consultant must—
(a) Be qualified as a laboratory director under § 493.1443(b)(1), (2), or (3) or, for the subspecialty of oral pathology, § 493.1443(b)(5);
(b) Be a doctor of medicine, doctor of osteopathy, doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located.
§ 493.1457   Standard; Clinical consultant responsibilities.
The clinical consultant provides consultation regarding the appropriateness of the testing ordered and interpretation of test results. The clinical consultant must—
(a) Be available to provide consultation to the laboratory's clients;
(b) Be available to assist the laboratory's clients in ensuring that appropriate tests are ordered to meet the clinical expectations;
(c) Ensure that reports of test results include pertinent information required for specific patient interpretation; and
(d) Ensure that consultation is available and communicated to the laboratory's clients on matters related to the quality of the test results reported and their interpretation concerning specific patient conditions.
§ 493.1459   Condition: Laboratories performing high complexity testing; general supervisor.
The laboratory must have one or more general supervisors who are qualified under § 493.1461 of this subpart to provide general supervision in accordance with § 493.1463 of this subpart.
§ 493.1461   Standard: General supervisor qualifications.
The laboratory must have one or more general supervisors who, under the direction of the laboratory director and supervision of the technical supervisor, provides day-to-day supervision of testing personnel and reporting of test results. In the absence of the director and technical supervisor, the general supervisor must be responsible for the proper performance of all laboratory procedures and reporting of test results.
(a) The general supervisor must possess a current license issued by the State in which the laboratory is located, if such licensing is required; and
(b) The general supervisor must be qualified as a—
(1) Laboratory director under § 493.1443; or
(2) Technical supervisor under § 493.1449.
(c) If the requirements of paragraph (b)(1) or (2) of this section are not met, the individual functioning as the general supervisor must—
(1)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; and
(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing; or
(2)(i) Qualify as testing personnel under § 493.1489(b)(3); and
(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing; or
(3) Meet the requirements at § 493.1443(b)(3) or § 493.1449(c)(4) or (5); or
(4) Notwithstanding any other provision of this section, an individual is considered qualified as a general supervisor under this section if they were qualified and serving as a general supervisor in a CLIA-certified laboratory as of December 28, 2024, and have done so continuously since December 28, 2024.
(d) For blood gas analysis, the individual providing general supervision must—
(1) Be qualified under § 493.1461(b) (1) or (2), or § 493.1461(c); or
(2)(i) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; and
(ii) Have at least one year of laboratory training or experience, or both, in blood gas analysis; or
(3)(i) Have earned an associate degree related to pulmonary function from an accredited institution; and
(ii) Have at least two years of training or experience, or both in blood gas analysis.
(e) The general supervisor requirement is met in histopathology, oral pathology, dermatopathology, and ophthalmic pathology because all tests and examinations, must be performed:
(1) In histopathology, by an individual who is qualified as a technical supervisor under § 493.1449(b) or (f)(1);
(2) In dermatopathology, by an individual who is qualified as a technical supervisor under § 493.1449(b) or (f)(2);
(3) In ophthalmic pathology, by an individual who is qualified as a technical supervisor under § 493.1449(b) or (f)(3); and
(4) In oral pathology, by an individual who is qualified as a technical supervisor under § 493.1449(b) or (g).
§ 493.1463   Standard: General supervisor responsibilities.
The general supervisor is responsible for day-to-day supervision or oversight of the laboratory operation and personnel performing testing and reporting test results.
(a) The general supervisor—(1) Must be accessible to testing personnel at all times testing is performed to provide on-site, telephone or electronic consultation to resolve technical problems in accordance with policies and procedures established either by the laboratory director or technical supervisor;
(2) Is responsible for providing day-to-day supervision of high complexity test performance by a testing personnel qualified under § 493.1489;
(3) Except as specified in paragraph (c) of this section, must be onsite to provide direct supervision when high complexity testing is performed by any individuals qualified under § 493.1489(b)(5); and
(4) Is responsible for monitoring test analyses and specimen examinations to ensure that acceptable levels of analytic performance are maintained.
(b) The director or technical supervisor may delegate to the general supervisor the responsibility for—
(1) Assuring that all remedial actions are taken whenever test systems deviate from the laboratory's established performance specifications;
(2) Ensuring that patient test results are not reported until all corrective actions have been taken and the test system is properly functioning;
(3) Providing orientation to all testing personnel; and
(4) Evaluating and documenting the competency of all testing personnel.
(c) Exception. For individuals qualified under § 493.1489(b)(5), who were performing high complexity testing on or before January 19, 1993, the requirements of paragraph (a)(3) of this section are not effective, provided that all high complexity testing performed by the individual in the absence of a general supervisor is reviewed within 24 hours by a general supervisor qualified under § 493.1461.
§ 493.1467   Condition: Laboratories performing high complexity testing; cytology general supervisor.
For the subspecialty of cytology, the laboratory must have a general supervisor who meets the qualification requirements of § 493.1469 of this subpart, and provides supervision in accordance with § 493.1471 of this subpart.
§ 493.1469   Standard: Cytology general supervisor qualifications.
The cytology general supervisor must be qualified to supervise cytology services. The general supervisor in cytology must possess a current license issued by the State in which the laboratory is located, if such licensing is required, and must—
(a) Be qualified as a technical supervisor under § 493.1449(b) or (e); or
(b)(1) Be qualified as a cytotechnologist under § 493.1483; and
(2) Have at least 3 years of full-time (2,080 hours per year) experience as a cytotechnologist within the preceding 10 years.
§ 493.1471   Standard: Cytology general supervisor responsibilities.
The technical supervisor of cytology may perform the duties of the cytology general supervisor or delegate the responsibilities to an individual qualified under § 493.1469.
(a) The cytology general supervisor is responsible for the day-to-day supervision or oversight of the laboratory operation and personnel performing testing and reporting test results.
(b) The cytology general supervisor must—
(1) Be accessible to provide on-site, telephone, or electronic consultation to resolve technical problems in accordance with policies and procedures established by the technical supervisor of cytology;
(2) Document the slide interpretation results of each gynecologic and nongynecologic cytology case he or she examined or reviewed (as specified under § 493.1274(c));
(3) For each 24-hour period, document the total number of slides he or she examined or reviewed in the laboratory as well as the total number of slides examined or reviewed in any other laboratory or for any other employer; and
(4) Document the number of hours spent examining slides in each 24-hour period.
§ 493.1481   Condition: Laboratories performing high complexity testing; cytotechnologist.
For the subspecialty of cytology, the laboratory must have a sufficient number of cytotechnologists who meet the qualifications specified in § 493.1483 to perform the functions specified in § 493.1485.
§ 493.1483   Standard: Cytotechnologist qualifications.
Each person examining cytology slide preparations must meet the qualifications of § 493.1449 (b) or (e), or—
(a) Possess a current license as a cytotechnologist issued by the State in which the laboratory is located, if such licensing is required; and
(b) Meet one of the following requirements:
(1) Have graduated from a school of cytotechnology accredited by the Commission on Accreditation of Allied Health Education Programs (CAAHEP); or
(2) Be certified in cytotechnology by a certifying agency approved by HHS; or

(3) Notwithstanding any other provision of this section, an individual is considered qualified as a cytotechnologist under this section if they were qualified and serving as a cytotechnologist in a CLIA-certified laboratory as of December 28, 2024, and have done so continuously since December 28, 2024
§ 493.1485   Standard; Cytotechnologist responsibilities.
The cytotechnologist is responsible for documenting—
(a) The slide interpretation results of each gynecologic and nongynecologic cytology case he or she examined or reviewed (as specified in § 493.1274(c));
(b) For each 24-hour period, the total number of slides examined or reviewed in the laboratory as well as the total number of slides examined or reviewed in any other laboratory or for any other employer; and
(c) The number of hours spent examining slides in each 24-hour period.
§ 493.1487   Condition: Laboratories performing high complexity testing; testing personnel.
The laboratory has a sufficient number of individuals who meet the qualification requirements of § 493.1489 of this subpart to perform the functions specified in § 493.1495 of this subpart for the volume and complexity of testing performed.
§ 493.1489   Standard; Testing personnel qualifications.
Each individual performing high complexity testing must—
(a) Possess a current license issued by the State in which the laboratory is located, if such licensing is required; and
(b) Meet one of the following requirements:
(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; or
(2)(i) Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution;
(ii) Be qualified under the requirements of § 493.1443(b)(3) or § 493.1449(c)(4) or (5); or
(3)(i) Have earned an associate degree in a laboratory science or medical laboratory technology from an accredited institution or—
(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes—
(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, includes either—
( 1 ) Twenty-four (24) semester hours of medical laboratory technology courses; or
( 2 ) Twenty-four (24) semester hours of science courses that include—
( i ) Six (6) semester hours of chemistry;
( ii ) Six (6) semester hours of biology; and
( iii ) Twelve (12) semester hours of chemistry, biology, or medical laboratory technology in any combination; and
(B) Have laboratory training that includes:
( 1 ) Completion of a clinical laboratory training program approved or accredited by the ABHES or the CAAHEP (this training may be included in the 60 semester hours listed in paragraph (b)(3)(ii)(A) of this section); or
( 2 ) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing; or
(4) Successful completion of an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and having held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or
(5) Notwithstanding any other provision of this section, an individual is considered qualified as a high complexity testing personnel under this section if they were qualified and serving as a high complexity testing personnel in a CLIA-certified laboratory as of December 28, 2024, and have done so continuously since December 28, 2024.
(6) For blood gas analysis—
(i) Be qualified under paragraph (b)(1), (2), (3), (4), or (5) of this section; or
(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or
(iii) Have earned an associate degree related to pulmonary function from an accredited institution.
(7) For histopathology, meet the qualifications of § 493.1449(b) or (f) to perform tissue examinations.
§ 493.1495   Standard; Testing personnel responsibilities.
The testing personnel are responsible for specimen processing, test performance and for reporting test results.
(a) Each individual performs only those high complexity tests that are authorized by the laboratory director and require a degree of skill commensurate with the individual's education, training or experience, and technical abilities.
(b) Each individual performing high complexity testing must—
(1) Follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results;
(2) Maintain records that demonstrate that proficiency testing samples are tested in the same manner as patient specimens;
(3) Adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed;
(4) Follow the laboratory's established policies and procedures whenever test systems are not within the laboratory's established acceptable levels of performance;
(5) Be capable of identifying problems that may adversely affect test performance or reporting of test results and either must correct the problems or immediately notify the general supervisor, technical supervisor, clinical consultant, or director;
(6) Document all corrective actions taken when test systems deviate from the laboratory's established performance specifications; and
(7) Except as specified in paragraph (c) of this section, if qualified under § 493.1489(b)(5), perform high complexity testing only under the onsite, direct supervision of a general supervisor qualified under § 493.1461.
(c) Exception. For individuals qualified under § 493.1489(b)(5), who were performing high complexity testing on or before January 19, 1993, the requirements of paragraph (b)(7) of this section are not effective, provided that all high complexity testing performed by the individual in the absence of a general supervisor is reviewed within 24 hours by a general supervisor qualified under § 493.1461.
§ 493.1771   Condition: Inspection requirements applicable to all CLIA-certified and CLIA-exempt laboratories.
(a) Each laboratory issued a CLIA certificate must meet the requirements in § 493.1773 and the specific requirements for its certificate type, as specified in §§ 493.1775 through 493.1780.
(b) All CLIA-exempt laboratories must comply with the inspection requirements in §§ 493.1773 and 493.1780, when applicable.
§ 493.1773   Standard: Basic inspection requirements for all laboratories issued a CLIA certificate and CLIA-exempt laboratories.
(a) A laboratory issued a certificate must permit CMS or a CMS agent to conduct an inspection to assess the laboratory's compliance with the requirements of this part. A CLIA-exempt laboratory and a laboratory that requests, or is issued a certificate of accreditation, must permit CMS or a CMS agent to conduct validation and complaint inspections.
(b) General requirements. As part of the inspection process, CMS or a CMS agent may require the laboratory to do the following:
(1) Test samples, including proficiency testing samples, or perform procedures.
(2) Permit interviews of all personnel concerning the laboratory's compliance with the applicable requirements of this part.
(3) Permit laboratory personnel to be observed performing all phases of the total testing process (preanalytic, analytic, and postanalytic).
(4) Permit CMS or a CMS agent access to all areas encompassed under the certificate including, but not limited to, the following:
(i) Specimen procurement and processing areas.
(ii) Storage facilities for specimens, reagents, supplies, records, and reports.
(iii) Testing and reporting areas.
(5) Provide CMS or a CMS agent with copies or exact duplicates of all records and data it requires.
(c) Accessible records and data. A laboratory must have all records and data accessible and retrievable within a reasonable time frame during the course of the inspection.
(d) Requirement to provide information and data. A laboratory must provide, upon request, all information and data needed by CMS or a CMS agent to make a determination of the laboratory's compliance with the applicable requirements of this part.
(e) Reinspection. CMS or a CMS agent may reinspect a laboratory at any time to evaluate the ability of the laboratory to provide accurate and reliable test results.
(f) Complaint inspection. CMS or a CMS agent may conduct an inspection when there are complaints alleging noncompliance with any of the requirements of this part.
(g) Failure to permit an inspection or reinspection. Failure to permit CMS or a CMS agent to conduct an inspection or reinspection results in the suspension or cancellation of the laboratory's participation in Medicare and Medicaid for payment, and suspension or limitation of, or action to revoke the laboratory's CLIA certificate, in accordance with subpart R of this part.
§ 493.1775   Standard: Inspection of laboratories issued a certificate of waiver or a certificate for provider-performed microscopy procedures.
(a) A laboratory that has been issued a certificate of waiver or a certificate for provider-performed microscopy procedures is not subject to biennial inspections.
(b) If necessary, CMS or a CMS agent may conduct an inspection of a laboratory issued a certificate of waiver or a certificate for provider-performed microscopy procedures at any time during the laboratory's hours of operation to do the following:
(1) Determine if the laboratory is operated and testing is performed in a manner that does not constitute an imminent and serious risk to public health.
(2) Evaluate a complaint from the public.
(3) Determine whether the laboratory is performing tests beyond the scope of the certificate held by the laboratory.
(4) Collect information regarding the appropriateness of tests specified as waived tests or provider-performed microscopy procedures.
(c) The laboratory must comply with the basic inspection requirements of § 493.1773.
§ 493.1777   Standard: Inspection of laboratories that have requested or have been issued a certificate of compliance.
(a) Initial inspection. (1) A laboratory issued a registration certificate must permit an initial inspection to assess the laboratory's compliance with the requirements of this part before CMS issues a certificate of compliance.
(2) The inspection may occur at any time during the laboratory's hours of operation.
(b) Subsequent inspections. (1) CMS or a CMS agent may conduct subsequent inspections on a biennial basis or with such other frequency as CMS determines to be necessary to ensure compliance with the requirements of this part.
(2) CMS bases the nature of subsequent inspections on the laboratory's compliance history.
(c) Provider-performed microscopy procedures. The inspection sample for review may include testing in the subcategory of provider-performed microscopy procedures.
(d) Compliance with basic inspection requirements. The laboratory must comply with the basic inspection requirements of § 493.1773.
§ 493.1780   Standard: Inspection of CLIA-exempt laboratories or laboratories requesting or issued a certificate of accreditation.
(a) Validation inspection. CMS or a CMS agent may conduct a validation inspection of any accredited or CLIA-exempt laboratory at any time during its hours of operation.
(b) Complaint inspection. CMS or a CMS agent may conduct a complaint inspection of a CLIA-exempt laboratory or a laboratory requesting or issued a certificate of accreditation at any time during its hours of operation upon receiving a complaint applicable to the requirements of this part.
(c) Noncompliance determination. If a validation or complaint inspection results in a finding that the laboratory is not in compliance with one or more condition-level requirements, the following actions occur:
(1) A laboratory issued a certificate of accreditation is subject to a full review by CMS, in accordance with subpart E of this part and § 488.11 of this chapter.
(2) A CLIA-exempt laboratory is subject to appropriate enforcement actions under the approved State licensure program.
(d) Compliance with basic inspection requirements. CLIA-exempt laboratories and laboratories requesting or issued a certificate of accreditation must comply with the basic inspection requirements in § 493.1773.
§ 493.1800   Basis and scope.
(a) Statutory basis. (1) Section 1846 of the Act—
(i) Provides for intermediate sanctions that may be imposed on laboratories that perform clinical diagnostic tests on human specimens when those laboratories are found to be out of compliance with one or more of the conditions for Medicare coverage of their services; and
(ii) Requires the Secretary to develop and implement a range of such sanctions, including four that are specified in the statute.
(2) The Clinical Laboratory Improvement Act of 1967 (section 353 of the Public Health Service Act) as amended by CLIA 1988, as amended by section 2 of the Taking Essential Steps for Testing Act of 2012—
(i) Establishes requirements for all laboratories that perform clinical diagnostic tests on human specimens;
(ii) Requires a Federal certification scheme to be applied to all such laboratories; and
(iii) Grants the Secretary broad enforcement authority, including—
(A) Use of intermediate sanctions;
(B) Suspension, limitation, or revocation of the certificate of a laboratory that is out of compliance with one or more requirements for a certificate; and
(C) Civil suit to enjoin any laboratory activity that constitutes a significant hazard to the public health.
(3) Section 353 also—
(i) Provides for imprisonment or fine for any person convicted of intentional violation of CLIA requirements;
(ii) Specifies the administrative hearing and judicial review rights of a laboratory that is sanctioned under CLIA; and
(iii) Requires the Secretary to publish annually a list of all laboratories that have been sanctioned during the preceding year.
(b) Scope and applicability. This subpart sets forth—
(1) The policies and procedures that CMS follows to enforce the requirements applicable to laboratories under CLIA and under section 1846 of the Act; and
(2) The appeal rights of laboratories on which CMS imposes sanctions.
§ 493.1804   General considerations.
(a) Purpose. The enforcement mechanisms set forth in this subpart have the following purposes:
(1) To protect all individuals served by laboratories against substandard testing of specimens.
(2) To safeguard the general public against health and safety hazards that might result from laboratory activities.
(3) To motivate laboratories to comply with CLIA requirements so that they can provide accurate and reliable test results.
(b) Basis for decision to impose sanctions. (1) CMS's decision to impose sanctions is based on one or more of the following:
(i) Deficiencies found by CMS or its agents in the conduct of inspections to certify or validate compliance with Federal requirements, or through review of materials submitted by the laboratory (e.g., personnel qualifications).
(ii) Unsuccessful participation in proficiency testing.
(2) CMS imposes one or more of the alternative or principal sanctions specified in §§ 493.1806 and 493.1807 when CMS or CMS's agent finds that a laboratory has condition-level deficiencies.
(c) Imposition of alternative sanctions. (1) CMS may impose alternative sanctions in lieu of, or in addition to, principal sanctions.
(2) CMS may impose alternative sanctions other than a civil money penalty after the laboratory has had an opportunity to respond, but before the hearing specified in § 493.1844.
(d) Choice of sanction: Factors considered. CMS bases its choice of sanction or sanctions on consideration of one or more factors that include, but are not limited to, the following, as assessed by the State or by CMS, or its agents:
(1) Whether the deficiencies pose immediate jeopardy.
(2) The nature, incidence, severity, and duration of the deficiencies or noncompliance.
(3) Whether the same condition level deficiencies have been identified repeatedly.
(4) The accuracy and extent of laboratory records (e.g., of remedial action) in regard to the noncompliance, and their availability to the State, to other CMS agents, and to CMS.
(5) The relationship of one deficiency or group of deficiencies to other deficiencies.
(6) The overall compliance history of the laboratory including but not limited to any period of noncompliance that occurred between certifications of compliance.
(7) The corrective and long-term compliance outcomes that CMS hopes to achieve through application of the sanction.
(8) Whether the laboratory has made any progress toward improvement following a reasonable opportunity to correct deficiencies.
(9) Any recommendation by the State agency as to which sanction would be appropriate.
(e) Number of alternative sanctions. CMS may impose a separate sanction for each condition level deficiency or a single sanction for all condition level deficiencies that are interrelated and subject to correction by a single course of action.
(f) Appeal rights. The appeal rights of laboratories dissatisfied with the imposition of a sanction are set forth in § 493.1844.
§ 493.1806   Available sanctions: All laboratories.
(a) Applicability. CMS may impose one or more of the sanctions specified in this section on a laboratory that is out of compliance with one or more CLIA conditions.
(b) Principal sanction. CMS may impose any of the three principal CLIA sanctions, which are suspension, limitation, or revocation of any type of CLIA certificate.
(c) Alternative sanctions. CMS may impose one or more of the following alternative sanctions in lieu of or in addition to imposing a principal sanction, except on a laboratory that has a certificate of waiver.
(1) Directed plan of correction, as set forth at § 493.1832.
(2) State onsite monitoring as set forth at § 493.1836.
(3) Civil money penalty, as set forth at § 493.1834.
(d) Civil suit. CMS may bring suit in the appropriate U.S. District Court to enjoin continuation of any activity of any laboratory (including a CLIA-exempt laboratory that has been found with deficiencies during a validation survey), if CMS has reason to believe that continuation of the activity would constitute a significant hazard to the public health.
(e) Criminal sanctions. Under section 353(1) of the PHS Act, an individual who is convicted of intentionally violating any CLIA requirement may be imprisoned or fined.
§ 493.1807   Additional sanctions: Laboratories that participate in Medicare.
The following additional sanctions are available for laboratories that are out of compliance with one or more CLIA conditions and that have approval to receive Medicare payment for their services.
(a) Principal sanction. Cancellation of the laboratory's approval to receive Medicare payment for its services.
(b) Alternative sanctions. (1) Suspension of payment for tests in one or more specific specialties or subspecialties, performed on or after the effective date of sanction.
(2) Suspension of payment for all tests in all specialties and subspecialties performed on or after the effective date of sanction.
§ 493.1808   Adverse action on any type of CLIA certificate: Effect on Medicare approval.
(a) Suspension or revocation of any type of CLIA certificate. When CMS suspends or revokes any type of CLIA certificate, CMS concurrently cancels the laboratory's approval to receive Medicare payment for its services.
(b) Limitation of any type of CLIA certificate. When CMS limits any type of CLIA certificate, CMS concurrently limits Medicare approval to only those specialties or subspecialties that are authorized by the laboratory's limited certificate.
§ 493.1809   Limitation on Medicaid payment.
As provided in section 1902(a)(9)(C) of the Act, payment for laboratory services may be made under the State plan only if those services are furnished by a laboratory that has a CLIA certificate or is licensed by a State whose licensure program has been approved by the Secretary under this part.
§ 493.1810   Imposition and lifting of alternative sanctions.
(a) Notice of noncompliance and of proposed sanction: Content. If CMS or its agency identifies condition level noncompliance in a laboratory, CMS or its agent gives the laboratory written notice of the following:
(1) The condition level noncompliance that it has identified.
(2) The sanction or sanctions that CMS or its agent proposes to impose against the laboratory.
(3) The rationale for the proposed sanction or sanctions.
(4) The projected effective date and duration of the proposed sanction or sanctions.
(5) The authority for the proposed sanction or sanctions.
(6) The time allowed (at least 10 days) for the laboratory to respond to the notice.
(b) Opportunity to respond. During the period specified in paragraph (a)(6) of this section, the laboratory may submit to CMS or its agent written evidence or other information against the imposition of the proposed sanction or sanctions.
(c) Notice of imposition of sanction —(1) Content. CMS gives the laboratory written notice that acknowledges any evidence or information received from the laboratory and specifies the following:
(i) The sanction or sanctions to be imposed against the laboratory.
(ii) The authority and rationale for the imposing sanction or sanctions.
(iii) The effective date and duration of sanction.
(2) Timing. (i) If CMS or its agent determines that the deficiencies pose immediate jeopardy, CMS provides notice at least 5 days before the effective date of sanction.
(ii) If CMS or its agent determines that the deficiencies do not pose immediate jeopardy, CMS provides notice at least 15 days before the effective date of the sanction.
(d) Duration of alternative sanctions. An alternative sanction continues until the earlier of the following occurs:
(1) The laboratory corrects all condition level deficiencies.
(2) CMS's suspension, limitation, or revocation of the laboratory's CLIA certificate becomes effective.
(e) Lifting of alternative sanctions —(1) General rule. Alternative sanctions are not lifted until a laboratory's compliance with all condition level requirements is verified.
(2) Credible allegation of compliance. When a sanctioned laboratory submits a credible allegation of compliance, CMS's agent determines whether—
(i) It can certify compliance on the basis of the evidence presented by the laboratory in its allegation; or
(ii) It must revisit to verify whether the laboratory has, in fact, achieved compliance.
(3) Compliance achieved before the date of revisit. If during a revisit, the laboratory presents credible evidence (as determined by CMS or its agent) that it achieved compliance before the date of revisit, sanctions are lifted as of that earlier date.
§ 493.1812   Action when deficiencies pose immediate jeopardy.
If a laboratory's deficiencies pose immediate jeopardy, the following rules apply:
(a) CMS requires the laboratory to take immediate action to remove the jeopardy and may impose one or more alternative sanctions to help bring the laboratory into compliance.
(b) If the findings of a revisit indicate that a laboratory has not eliminated the jeopardy, CMS suspends or limits the laboratory's CLIA certificate no earlier than 5 days after the date of notice of suspension or limitation. CMS may later revoke the certificate.
(c) In addition, if CMS has reason to believe that the continuation of any activity by any laboratory (either the entire laboratory operation or any specialty or subspecialty of testing) would constitute a significant hazard to the public health, CMS may bring suit and seek a temporary injunction or restraining order against continuation of that activity by the laboratory, regardless of the type of CLIA certificate the laboratory has and of whether it is State-exempt.
§ 493.1814   Action when deficiencies are at the condition level but do not pose immediate jeopardy.
If a laboratory has condition level deficiencies that do not pose immediate jeopardy, the following rules apply:
(a) Initial action. (1) CMS may cancel the laboratory's approval to receive Medicare payment for its services.
(2) CMS may suspend, limit, or revoke the laboratory's CLIA certificate.
(3) If CMS does not impose a principal sanction under paragraph (a)(1) or (a)(2) of this section, it imposes one or more alternative sanctions. In the case of unsuccessful participation in proficiency testing, CMS may impose the training and technical assistance requirement set forth at § 493.1838 in lieu of, or in addition to, one or more alternative sanctions.
(b) Failure to correct condition level deficiencies. If CMS imposes alternative sanctions for condition level deficiencies that do not pose immediate jeopardy, and the laboratory does not correct the condition level deficiencies within 12 months after the last day of inspection, CMS—
(1) Cancels the laboratory's approval to receive Medicare payment for its services, and discontinues the Medicare payment sanctions as of the day cancellation is effective.
(2) Following a revisit which indicates that the laboratory has not corrected its condition level deficiencies, notifies the laboratory that it proposes to suspend, limit, or revoke the certificate, as specified in § 493.1816(b), and the laboratory's right to hearing; and
(3) May impose (or continue, if already imposed) any alternative sanctions that do not pertain to Medicare payments. (Sanctions imposed under the authority of section 353 of the PHS Act may continue for more than 12 months from the last date of inspection, while a hearing on the proposed suspension, limitation, or revocation of the certificate of compliance, registration certificate, certificate of accreditation, or certificate for PPM procedures is pending.)
(c) Action after hearing. If a hearing decision upholds a proposed suspension, limitation, or revocation of a laboratory's CLIA certificate, CMS discontinues any alternative sanctions as of the day it makes the suspension, limitation, or revocation effective.
§ 493.1816   Action when deficiencies are not at the condition level.
If a laboratory has deficiencies, that are not at the condition level, the following rules apply:
(a) Initial action. The laboratory must submit a plan of correction that is acceptable to CMS in content and time frames.
(b) Failure to correct deficiencies. If, on revisit, it is found that the laboratory has not corrected the deficiencies within 12 months after the last day of inspection, the following rules apply:
(1) CMS cancels the laboratory's approval to receive Medicare payment for its services.
(2) CMS notifies the laboratory of its intent to suspend, limit, or revoke the laboratory's CLIA certificate and of the laboratory's right to a hearing.
§ 493.1820   Ensuring timely correction of deficiencies.
(a) Timing of visits. CMS, the State survey agency or other CMS agent may visit the laboratory at any time to evaluate progress, and at the end of the period to determine whether all corrections have been made.
(b) Deficiencies corrected before a visit. If during a visit, a laboratory produces credible evidence that it achieved compliance before the visit, the sanctions are lifted as of that earlier date.
(c) Failure to correct deficiencies. If during a visit it is found that the laboratory has not corrected its deficiencies, CMS may propose to suspend, limit, or revoke the laboratory's CLIA certificate.
(d) Additional time for correcting lower level deficiencies not at the condition level. If at the end of the plan of correction period all condition level deficiencies have been corrected, and there are deficiencies, that are not at the condition level, CMS may request a revised plan of correction. The revised plan may not extend beyond 12 months from the last day of the inspection that originally identified the cited deficiencies.
(e) Persistence of deficiencies. If at the end of the period covered by the plan of correction, the laboratory still has deficiencies, the rules of §§ 493.1814 and 493.1816 apply.
§ 493.1826   Suspension of part of Medicare payments.
(a) Application. (1) CMS may impose this sanction if a laboratory—
(i) Is found to have condition level deficiencies with respect to one or more specialties or subspecialties of tests; and
(ii) Agrees (in return for not having its Medicare approval cancelled immediately) not to charge Medicare beneficiaries or their private insurance carriers for the services for which Medicare payment is suspended.
(2) CMS suspends Medicare payment for those specialities or subspecialties of tests for which the laboratory is out of compliance with Federal requirements.
(b) Procedures. Before imposing this sanction, CMS provides notice of sanction and opportunity to respond in accordance with § 493.1810.
(c) Duration and effect of sanction. This sanction continues until the laboratory corrects the condition level deficiencies or CMS cancels the laboratory's approval to receive Medicare payment for its services, but in no event longer than 12 months.
(1) If the laboratory corrects all condition level deficiencies, CMS resumes Medicare payment effective for all services furnished on or after the date the deficiencies are corrected.
(2) [Reserved]
§ 493.1828   Suspension of all Medicare payments.
(a) Application. (1) CMS may suspend payment for all Medicare-approved laboratory services when the laboratory has condition level deficiencies.
(2) CMS suspends payment for all Medicare covered laboratory services when the following conditions are met:
(i) Either—
(A) The laboratory has not corrected its condition level deficiencies included in the plan of correction within 3 months from the last date of inspection; or
(B) The laboratory has been found to have the same condition level deficiencies during three consecutive inspections; and
(ii) The laboratory has chosen (in return for not having its Medicare approval immediately cancelled), to not charge Medicare beneficiaries or their private insurance carriers for services for which Medicare payment is suspended.
(3) CMS suspends payment for services furnished on and after the effective date of sanction.
(b) Procedures. Before imposing this sanction, CMS provides notice of sanction and opportunity to respond in accordance with § 493.1810.
(c) Duration and effect of sanction. (1) Suspension of payment continues until all condition level deficiencies are corrected, but never beyond twelve months.
(2) If all the deficiencies are not corrected by the end of the 12 month period, CMS cancels the laboratory's approval to receive Medicare payment for its services.
§ 493.1832   Directed plan of correction and directed portion of a plan of correction.
(a) Application. CMS may impose a directed plan of correction as an alternative sanction for any laboratory that has condition level deficiencies. If CMS does not impose a directed plan of correction as an alternative sanction for a laboratory that has condition level deficiencies, it at least imposes a directed portion of a plan of correction when it imposes any of the following alternative sanctions:
(1) State onsite monitoring.
(2) Civil money penalty.
(3) Suspension of all or part of Medicare payments.
(b) Procedures —(1) Directed plan of correction. When imposing this sanction, CMS—
(i) Gives the laboratory prior notice of the sanction and opportunity to respond in accordance with § 493.1810;
(ii) Directs the laboratory to take specific corrective action within specific time frames in order to achieve compliance; and
(iii) May direct the laboratory to submit the names of laboratory clients for notification purposes, as specified in paragraph (b)(3) of this section.
(2) Directed portion of a plan of correction. CMS may decide to notify clients of a sanctioned laboratory, because of the seriousness of the noncompliance (e.g., the existence of immediate jeopardy) or for other reasons. When imposing this sanction, CMS takes the following steps—
(i) Directs the laboratory to submit to CMS, the State survey agency, or other CMS agent, within 10 calendar days after the notice of the alternative sanction, a list of names and addresses of all physicians, providers, suppliers, and other clients who have used some or all of the services of the laboratory since the last certification inspection or within any other timeframe specified by CMS.
(ii) Within 30 calendar days of receipt of the information, may send to each laboratory client, via the State survey agency, a notice containing the name and address of the laboratory, the nature of the laboratory's noncompliance, and the kind and effective date of the alternative sanction.
(iii) Sends to each laboratory client, via the State survey agency, notice of the recission of an adverse action within 30 days of the rescission.
(3) Notice of imposition of a principal sanction following the imposition of an alternative sanction. If CMS imposes a principal sanction following the imposition of an alternative sanction, and for which CMS has already obtained a list of laboratory clients, CMS may use that list to notify the clients of the imposition of the principal sanction.
(c) Duration of a directed plan of correction. If CMS imposes a directed plan of correction, and on revisit it is found that the laboratory has not corrected the deficiencies within 12 months from the last day of inspection, the following rules apply:
(1) CMS cancels the laboratory's approval for Medicare payment of its services, and notifies the laboratory of CMS's intent to suspend, limit, or revoke the laboratory's CLIA certificate.
(2) The directed plan of correction continues in effect until the day suspension, limitation, or revocation of the laboratory's CLIA certificate.
§ 493.1834   Civil money penalty.
(a) Statutory basis. Sections 1846 of the Act and 353(h)(2)(B) of the PHS Act authorize the Secretary to impose civil money penalties on laboratories. Section 1846(b)(3) of the Act specifically provides that incrementally more severe fines may be imposed for repeated or uncorrected deficiencies.
(b) Scope. This section sets forth the procedures that CMS follows to impose a civil money penalty in lieu of, or in addition to, suspending, limiting, or revoking the certificate of compliance, registration certificate, certificate of accreditation, or certificate for PPM procedures of a laboratory that is found to have condition level deficiencies.
(c) Basis for imposing a civil money penalty. CMS may impose a civil money penalty against any laboratory determined to have condition level deficiencies regardless of whether those deficiencies pose immediate jeopardy.
(d) Amount of penalty —(1) Factors considered. In determining the amount of the penalty, CMS takes into account the following factors:
(i) The nature, scope, severity, and duration of the noncompliance.
(ii) Whether the same condition level deficiencies have been identified during three consecutive inspections.
(iii) The laboratory's overall compliance history including but not limited to any period of noncompliance that occurred between certifications of compliance.
(iv) The laboratory's intent or reason for noncompliance.
(v) The accuracy and extent of laboratory records and their availability to CMS, the State survey agency, or other CMS agent.
(2) Range of penalty amount. (i) For a condition level deficiency that poses immediate jeopardy, the range is $3,050-$10,000 as adjusted annually under 45 CFR part 102 per day of noncompliance or per violation.
(ii) For a condition level deficiency that does not pose immediate jeopardy, the range is $50-$3,000 as adjusted annually under 45 CFR part 102 per day of noncompliance or per violation.
(iii) For a condition level deficiency under §§ 493.41 or 493.1100(a), the penalty amount is $1,000 for the first day of noncompliance and $500 for each additional day of noncompliance.
(3) Decreased penalty amounts. If the immediate jeopardy is removed, but the deficiency continues, CMS shifts the penalty amount to the lower range.
(4) Increased penalty amounts. CMS may, before the hearing, propose to increase the penalty amount for a laboratory that has deficiencies which, after imposition of a lower level penalty amount, become sufficiently serious to pose immediate jeopardy.
(e) Procedures for imposition of civil money penalty —(1) Notice of intent. (i) CMS sends the laboratory written notice, of CMS's intent to impose a civil money penalty.
(ii) The notice includes the following information:
(A) The statutory basis for the penalty.
(B) The proposed daily or per violation amount of the penalty.
(C) The factors (as described in paragraph (d)(1) of this section) that CMS considered.
(D) The opportunity for responding to the notice in accordance with § 493.1810(c).
(E) A specific statement regarding the laboratory's appeal rights.
(2) Appeal rights. (i) The laboratory has 60 days from the date of receipt of the notice of intent to impose a civil money penalty to request a hearing in accordance with § 493.1844(g).
(ii) If the laboratory requests a hearing, all other pertinent provisions of § 493.1844 apply.
(iii) If the laboratory does not request a hearing, CMS may reduce the proposed penalty amount by 35 percent.
(f) Accrual and duration of penalty —(1) Accrual of penalty. The civil money penalty begins accruing as follows:
(i) 5 days after notice of intent if there is immediate jeopardy.
(ii) 15 days after notice of intent if there is not immediate jeopardy.
(2) Duration of penalty. The civil money penalty continues to accrue until the earliest of the following occurs:
(i) The laboratory's compliance with condition level requirements is verified on the basis of the evidence presented by the laboratory in its credible allegation of compliance or at the time or revisit.
(ii) Based on credible evidence presented by the laboratory at the time of revisit, CMS determines that compliance was achieved before the revisit. (In this situation, the money penalty stops accruing as of the date of compliance.)
(iii) CMS suspends, limits, or revokes the laboratory's certificate of compliance, registration certificate, certificate of accreditation, or certificate for PPM procedures.
(g) Computation and notice of total penalty amount —(1) Computation. CMS computes the total penalty amount after the laboratory's compliance is verified or CMS suspends, limits, or revokes the laboratory's CLIA certificate but in no event before—
(i) The 60 day period for requesting a hearing has expired without a request or the laboratory has explicitly waived its right to a hearing; or
(ii) Following a hearing requested by the laboratory, the ALJ issues a decision that upholds imposition of the penalty.
(2) Notice of penalty amount and due date of penalty. The notice includes the following information:
(i) Daily or per violation penalty amount.
(ii) Number of days or violations for which the penalty is imposed.
(iii) Total penalty amount.
(iv) Due date for payment of the penalty.
(h) Due date for payment of penalty. (1) Payment of a civil money penalty is due 15 days from the date of the notice specified in paragraph (g)(2) of this section.
(2) CMS may approve a plan for a laboratory to pay a civil money penalty, plus interest, over a period of up to one year from the original due date.
(i) Collection and settlement —(1) Collection of penalty amounts. (i) The determined penalty amount may be deducted from any sums then or later owing by the United States to the laboratory subject to the penalty.
(ii) Interest accrues on the unpaid balance of the penalty, beginning on the due date. Interest is computed at the rate specified in § 405.378(d) of this chapter.
(2) Settlement. CMS has authority to settle any case at any time before the ALJ issues a hearing decision.
§ 493.1836   State onsite monitoring.
(a) Application. (1) CMS may require continuous or intermittent monitoring of a plan of correction by the State survey agency to ensure that the laboratory makes the improvements necessary to bring it into compliance with the condition level requirements. (The State monitor does not have management authority, that is, cannot hire or fire staff, obligate funds, or otherwise dictate how the laboratory operates. The monitor's responsibility is to oversee whether corrections are made.)
(2) The laboratory must pay the costs of onsite monitoring by the State survey agency.
(i) The costs are computed by multiplying the number of hours of onsite monitoring in the laboratory by the hourly rate negotiated by CMS and the State.
(ii) The hourly rate includes salary, fringe benefits, travel, and other direct and indirect costs approved by CMS.
(b) Procedures. Before imposing this sanction, CMS provides notice of sanction and opportunity to respond in accordance with § 493.1810.
(c) Duration of sanction. (1) If CMS imposes onsite monitoring, the sanction continues until CMS determines that the laboratory has the capability to ensure compliance with all condition level requirements.
(2) If the laboratory does not correct all deficiencies within 12 months, and a revisit indicates that deficiencies remain, CMS cancels the laboratory's approval for Medicare payment for its services and notifies the laboratory of its intent to suspend, limit, or revoke the laboratory's certificate of compliance, registration certificate, certificate of accreditation, or certificate for PPM procedures.
(3) If the laboratory still does not correct its deficiencies, the Medicare sanction continues until the suspension, limitation, or revocation of the laboratory's certificate of compliance, registration certificate, certificate of accreditation, or certificate for PPM procedures is effective.
§ 493.1838   Training and technical assistance for unsuccessful participation in proficiency testing.
If a laboratory's participation in proficiency testing is unsuccessful, CMS may require the laboratory to undertake training of its personnel, or to obtain necessary technical assistance, or both, in order to meet the requirements of the proficiency testing program. This requirement is separate from the principal and alternative sanctions set forth in §§ 493.1806 and 493.1807.