Record Review

6116.4 - Record Review (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) Gather relevant information that will reflect the laboratory’s ability to provide quality testing from all areas of the laboratory including records encompassing the time period since the last certification survey. Determine all new tests, new test methods, and new equipment added since the prior survey and review documentation relevant to as many of these factors as possible when reviewing laboratory records. The number of records selected and reviewed is not intended to be statistically valid, but rather a representative cross-section of various records. Avoid predictable patterns of gathering information (e.g., same tests or time periods). Do not allow the laboratory to select the records for review. Consider the types of clients and/or facilities that the laboratory serves, e.g., nursing homes, pediatric, dialysis units, public health clinics, and cancer clinics. Choose a variety of patient records across the laboratory’s spectrum of clients. When test information must be gathered from medical records, be considerate when handling these records, as they contain confidential information. If possible, review medical records in the presence of office or laboratory personnel with consideration for confidentiality. Subpart K delineates the laboratory’s responsibility for performing its own internal reviews. This is an excellent starting point for an outcome-oriented survey. Review a cross-section of information selected from records of quality system assessment activities within each of the four systems. Review a cross-section of information while simultaneously assessing the laboratory’s ability to provide quality test results as well as its ability to identify and correct problems. Refer to the quality system assessment portions of the regulations as a guide for organizing your selection and review of information to assess the laboratory’s overall compliance. Investigate further any problems identified but not addressed by the laboratory’s quality system assessment. If the laboratory is failing to effectively monitor its own system and correct its problems, you can direct the laboratory to the requirements and the relevant sections for its particular setting. Make copies of any records needed to support deficient practice findings. Ensure that reviews of PT (Subpart H), Facility Administration (Subpart J), Quality System (Subpart K), and Personnel (Subpart M) include the following: 1. PT Laboratories must be appropriately enrolled and participating in a CMS approved PT program(s) for each Subpart I analyte, specialty and subspecialty that they perform. Laboratories also must perform biannual accuracy verification that meets 42 CFR 493.1236(c)(1) for any nonwaived tests that they conduct, that do not fall under Subpart I. Verify that both requirements have been met for the entire period of time the laboratory has been performing each test or procedure (not just shortly before the survey). If the laboratory has unacceptable PT scores or unsatisfactory performance in a specialty, subspecialty, analyte, or test since the last survey, review the specific record, corrective action, and any other data such as education and training of staff associated with PT remediation. Include both patient test results and QC records which were assayed in the same run as the failed PT in the review. In addition: • Verify that the laboratory has reported results under the appropriate methodology/instrumentation used for test performance, e.g., automated vs. manual hematology; • Verify that the laboratory did not engage in inter-laboratory communications regarding the PT sample(s) prior to the event cut-off date; • Verify that the laboratory did not refer its PT samples to another laboratory for testing prior to the event cut-off date; • Verify that PT samples were handled, prepared, processed, examined, tested, and reported, to the extent practical, in the same manner as patient samples. PT samples must not be sent to another laboratory for analysis prior to the event cut- off date; and • For tests where there is no PT available and/or those nonwaived tests performed by the laboratory that are not included in Subpart I, determine whether the laboratory verifies the accuracy of each test or procedure at least twice a year. 2. Facility Administration Review records for the appropriate retention times and ensure the laboratory adheres to appropriate safety, arrangement, space, ventilation, and contamination procedures. If the facility provides transfusion services, verify that the arrangement is current, the blood products are stored appropriately, and transfusion reactions are investigated and reported to the appropriate authorities in a timely manner. 3. Quality System General Laboratory, Preanalytic, Analytic, and Postanalytic System Quality Assessment- Using the patient test requisitions, test records, test results, and test reports or, as applicable, patient charts, review all phases of the laboratory testing processes, including instructions for specimen storage. If possible, when reviewing individual patient test results, correlate test requisition(s) or medical record information with final report(s). Refer to Postanalytic Systems Quality Assessment for guidance in reviewing and correlating patient test results. After determining the patient population serviced by the laboratory, e.g., geriatrics, public health clinics, dialysis units, health fairs, and hospitals, review the following: • A cross-section of patient test results encompassing all specialties and subspecialties of testing performed in the laboratory in sufficient numbers to determine if results vary significantly from expected population norms; • Worksheets or instrument printouts, looking for outliers, trends, etc., when tests are performed in batches; • Several worksheets, instrument printouts, or medical records over time for tests performed at random; • Test results that are disproportionately abnormal or normal; and • The correlation of initial test results and/or test results of various analytes of a patient over time. Review QC practices and evaluate whether the laboratory is following its own QC protocols or those procedures specified by the manufacturer. Review QC results, including outliers, shifts, trends, and corrective actions taken, when necessary. Refer to the establishment and verification of performance specifications at 42 CFR 493.1253 for guidance in reviewing the laboratory’s policies and criteria for adding a new method, test system or analyte to its test menu. Correlate reported patient test data with QC data and/or quality systems assessment records to ensure proper performance and documentation of controls. Review original test data (instrument printouts or computer files). Verify that patient results have not been reported when QC data was unacceptable according to the laboratory’s protocol. Consider the following in relation to the laboratory’s patient population: • New methodologies and equipment; • QC and calibration materials used; • Source and availability of QC limits; • Evaluation and monitoring of QC data; and • Corrective action for QC failures. Personnel: Review personnel records to determine compliance regarding whether individuals in the positions listed on the Form CMS-209 meet the CLIA personnel qualification and responsibility requirements stated in 42 CFR, Part 493, Subpart M. This includes the positions of laboratory director (LD), clinical consultant (CC), technical supervisor and consultant (TS, TC), general supervisor (GS), testing personnel (TP), cytology general supervisor (CGS), and cytotechnologist (CT). The process for verification of personnel qualifications requires surveyors to observe direct evidence of meeting academic requirements. Laboratories are required to complete the Form CMS-209 listing all testing personnel, individuals in the above positions, and including any contract personnel. Refer to subpart M for additional information concerning personnel training, experience, competency, qualifications, and responsibilities. General Qualification Guidance • When initially surveying the laboratory, surveyors evaluate the qualifications of the LD, TS or TC, CC, GS, CT, CGS, and a sample of TP (including point of care personnel and respiratory therapy technicians, if applicable). Surveyors are NOT required to evaluate qualifications for every TP. • For subsequent surveys, surveyors evaluate all changes to personnel (for the positions of LD, TS or TC, CC, GS, CT, CGS) that have occurred since the previous survey, in addition to another sample of TP (including point of care personnel). • Certain laboratory positions are NOT evaluated by the surveyor; examples include phlebotomists. • Request appropriate documents to be provided within a reasonable timeframe (such as the time it takes to complete a survey or within one week afterwards). Appropriate documents include but are not limited to: academic credentials such as degrees and transcripts. • Qualifications need only be provided at the highest level of academic achievement applicable to CLIA for the position held by the individual. It is not necessary to review a high school diploma, for example, of an individual whose position requires an advanced degree. • Laboratories are required to maintain documentation on its personnel in addition to paper records on point-of-care testing personnel that perform testing throughout a medical facility. • Surveyors may not require an individual to test for and obtain a General Education Degree (G.E.D.). If records for a high school diploma or G.E.D are not available and a high school diploma or G.E.D. is required, this individual is not qualified. • If a high school is closed, it is possible for the individual to solicit documentation from the local school board or State Board of Education to verify graduation. Primary Source Verification Primary source verification (PSV) is the process of confirming an applicant's credentials by verifying that a degree, certificate, or diploma was received; that licenses were granted; and, by confirming reported work history, such as company names and locations, dates, and positions held. Verifications are obtained either directly from an institution, former employers, or their authorized agents. Laboratories may choose to use PSV to confirm personnel credentials and provide surveyors PSV documentation as evidence of compliance with the personnel requirements stated in 42 CFR, Part 493, Subpart M. The use of a PSV report as evidence of meeting CLIA personnel qualifications is optional for the laboratory. Surveyors will continue to accept direct observation of documents, and the laboratory may also achieve compliance through a combination of the two. • NOTE: The PSV company is NOT responsible for determining whether a given individual meets the personnel requirements under CLIA; PSV companies merely confirm that the asserted training, degrees, and credentialing have been achieved or conferred. • It is always the responsibility of the laboratory to ensure that its personnel meet the CLIA requirements, and CMS, its agents and accreditation organizations retain full authority to determine compliance with those requirements. The PSV report is one tool that can be used by the surveyor and laboratory to determine if the applicant meets the personnel requirements. The laboratory is responsible for ensuring that individuals’ qualifications meet the personnel requirements. • CMS is not issuing standards to be applied to PSV companies - laboratories are responsible for assessing the services offered by PSV companies. • As needed, surveyors will continue to ask LDs to provide additional documentation on their employees’ qualifications when they find the PSV reports inadequate to confirm compliance. • If there are required elements in the personnel regulations that the PSV company does not verify, it is the LD’s responsibility to ensure that these personnel qualifications are met by other means. • Each LD should collect and maintain documentation and records as may be necessary to provide any information that is not included in the PSV report. Laboratories electing to use the PSV option must maintain either paper or electronic reports from the PSV company. • NOTE: Not all personnel qualifications will be verifiable by a PSV company. Based on our current understanding, PSV companies do not verify transcripts. Laboratories need to be aware that, even if they choose to use PSV, personnel may still need to produce documentation that cannot be verified by PSV companies for those positions in which a transcript is necessary to qualify the individual. Ultimately, the LD is responsible for making sure that personnel qualifications are met for each position and that there is available evidence of the qualifications. Additional Qualification Guidance • Professional Certification and State Licensure Requirements - An individual’s professional certification, such as medical technology certification or nursing licenses, as the only type of documentation to meet the CLIA personnel requirements, documentation IS NOT necessarily considered sufficient evidence of meeting all applicable personnel qualifications. More detailed information, such as degrees, transcripts, or PSV documents verifying degrees and transcripts, are required. One exception to this exists where professional certification is required by the CLIA regulations: for example, CT and cytology CGS positions may require American Society of Clinical Pathology (ASCP) certification, in addition to documentation of their highest level of academic achievement in education, training, and experiential requirements. When the CLIA regulations specify that the individual must possess a license for any personnel in Subpart M (e.g., laboratory director, testing personnel), if required by the State, such as a physician (M.D., D.O., DDS) Midlevel practitioner (as defined at 42 CFR 493.2), testing personnel or otherwise, the laboratory need only produce a copy of the individual’s State license or a report from a PSV company verifying the State license. No further academic documentation, such as diploma or transcripts, is required. • Nursing Degrees - A bachelor’s degree in nursing from an accredited institution meets the requirement for moderate complexity testing personnel at §493.1423(b)(2). The laboratory may show a PSV report verifying that a bachelor’s degree in nursing was earned, a diploma with the type of degree earned, or transcripts as evidence of meeting the education personnel requirement. An associate degree in nursing from an accredited institution meets the requirement for moderate complexity testing personnel at §493.1423(b)(4). The laboratory may show a PSV report verifying that an associate degree in nursing was earned, a diploma with the type of degree earned, or transcripts as evidence of meeting the education personnel requirement. • Federal Laboratories - The regulation at 42 CFR 493.3(c) states that “laboratories under the jurisdiction of an agency of the Federal Government are subject to the rules of this part, except that the Secretary may modify the application of such requirements as appropriate.” Therefore, with respect to the employment of physicians and similar medical and scientific professionals in federal laboratories, the Secretary’s noted discretion in applying CLIA regulations to federal laboratories would offer other federal agencies a means for adopting hiring criteria that only require possession of a valid license in one state in order to work in any federally operated laboratory. • Home Schooling - There is no standardized approach to home schooling across the country. Should a surveyor be presented with a home school diploma, in general, they would accept the home school diploma at face value and focus on the employee’s training and competency. At this time, CMS is not aware of any primary source verification company that verifies home school programs. • Military Training - Primary source verification companies are able to verify most military schooling and training. If the PSV company is unable to provide verification of the successful completion of an official U.S. Military medical laboratory procedures training course of at least 50 weeks duration and that the applicant has held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician), (42 CFR 493.1423(b)(5) for moderate complexity testing and 42 CFR 493.1489(b)(4) for high complexity testing), the laboratory must present documentation that the testing personnel has the qualifications to meet the CLIA personnel requirements. • Regents Bachelor’s Degree (RBD) - The RBD, which is a baccalaureate degree program designed for adult students, is one example of a non-traditional degree which would be evaluated using the education algorithm. The basic principle of RBD is that credit is awarded for what students know regardless of how that knowledge was obtained. In other words, students may earn college- equivalent credit for work and life experiences that can be equated to college courses. It is designed to provide students with a comprehensive general education. Many times, no specific courses are required for graduation, allowing students to design their own programs of study. This degree is usually awarded by a Board of Regents of an accredited institution. CLIA regulations require that a bachelor’s degree be from an accredited institution. The RBD may meet this requirement. However, CLIA also requires that the bachelor’s degree be in a “chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution.” Compliance with Personnel Requirements If the surveyor identifies potentially serious isolated or pervasive test quality problems that may be attributed to unqualified or untrained individuals performing or directing the laboratory’s testing, the surveyor may request such documentation as may be necessary for the surveyor to confirm compliance with the personnel requirements. Mandatory Citations A laboratory is considered to be non-compliant if: a required position is not filled, if an individual does not meet the required qualifications for that position (such as education, training and experience). Noncompliance with personnel regulations must be cited at the condition level if not met; i.e., the individual does not meet the required education, training, or experience, the position is not filled. The list of mandatory citations is at section 6130.5. As indicated in the list, both the condition level AND standard level deficiencies must be cited. Practical Application of the Personnel Qualification Determinations Surveyors are instructed to cite the most appropriate mandatory deficiency(s) if the laboratory does not meet the personnel requirements for the CLIA position categories which are included on Form CMS-209. Some examples are included here, though this is not an exhaustive list. Example 1: A CLIA surveyor is evaluating a sample of TP qualifications in a moderate complexity laboratory and is presented with a home school diploma as evidence of compliance. What would the surveyor do? Answer: Surveyor would accept the diploma at face value and focus on the testing personnel’s training and competency. Example 2: A CLIA surveyor is evaluating a sample of TP qualifications in a high complexity laboratory and is presented with proof of a medical technology degree from an accredited institution. Does this degree satisfy the personnel requirement or are transcripts needed? Answer: Yes, a medical technology degree from an accredited institution is sufficient. A PSV report verifying a medical technology degree from an accredited institution would also meet the requirement. Example 3: If a laboratory is applying for a CLIA certificate and the LD is not board certified, but is board eligible, what evidence is needed for CMS to issue a Certificate of Registration? Answer: If an LD is only eligible to be board certified, the PSV Company may not be able to verify eligibility status. The LD would need to provide the documentation of training and experience required by the board to be eligible to take such examinations. Example 4: A laboratory is hiring a military trained medical laboratory technician. What evidence is needed for the laboratory to maintain compliance with CLIA personnel qualifications? Answer: Primary source verification companies are able to verify most military schooling and training. If the PSV company cannot verify the successful completion of an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and that the applicant has held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician), the laboratory must present documentation that the testing personnel has the qualifications to meet the requirement. Example 5: A CLIA surveyor evaluating qualifications of a nurse performing moderate complexity laboratory testing is presented with a nursing license as evidence of compliance. What would the surveyor do? Answer: CLIA surveyors do not accept nursing licenses as evidence of compliance. The laboratory must provide the surveyor with a PSV report verifying the type of degree earned, a diploma showing the type of degree earned, or transcripts as evidence of meeting the personnel requirement. Example 6: A CLIA surveyor is evaluating a sample of TP qualifications in a high complexity laboratory and is presented with a report from a primary source verification company. The report verifies that the TP has a degree in Medical Technology from an accredited university and that the TP has worked for 3 years as a medical technologist at a hospital. Does this report satisfy the personnel requirement or are transcripts needed? Answer: Yes, the PSV company report is sufficient; no further evidence is needed. Example 7: A CLIA surveyor is evaluating a sample of TP qualifications in a high complexity laboratory located in a state that requires licensure for medical technologists. The surveyor is presented with a PSV company report that verifies the TP’s State license as evidence of meeting the personnel requirement. Does the surveyor also need to see further evidence of education, such as degrees or transcripts? Answer: No. It is acceptable for the laboratory to present the surveyor with a PSV report verifying State licensure. The State license would also be acceptable. For laboratories in states that require licensure, no further academic documentation, such as diploma or transcripts, is required. Example 8a: A CLIA surveyor is evaluating LD qualifications in a high complexity laboratory located in a state that requires licensure. The surveyor is presented with a PSV report verifying the LD’s State license as evidence of meeting the personnel requirement. Does the surveyor also need to see further evidence of education, such as degrees or transcripts? Answer: No. It is acceptable for the laboratory to present the surveyor with only a PSV report verifying State licensure. The State license would also meet the requirement. For laboratories in states that require licensure, no further academic documentation, such as diploma or transcripts, is required. Example 8b: A CLIA surveyor is evaluating LD qualifications in a high complexity laboratory located in a state that requires licensure. The LD is a foreign trained physician. The surveyor is presented with a PSV company report verifying the LD’s State medical license as evidence of meeting the personnel requirement. Does the LD also need to produce foreign educational equivalencies? Answer: No. It is acceptable for the laboratory to present the surveyor with only a PSV report verifying State medical licensure. The State medical license would also meet the requirement. Foreign trained physicians (MD, DO, DPM or DDS) who are licensed to practice medicine in the State in which the laboratory is located do not need to produce educational equivalencies. The state medical license is also sufficient proof of academic achievement. Example 9: A CLIA surveyor is evaluating TP qualifications in a high complexity laboratory. The surveyor is presented with a PSV report verifying that the TP received a bachelor’s degree from an accredited university in 2008. Is this sufficient evidence of meeting the personnel requirement? Answer: No. Regulation §493.1489(b)(2)(i) states that high complexity testing personnel will have earned a “…bachelor’s degree in a chemical, biological, clinical or medical laboratory science, or medical technology…” The documentation in the PSV report did not state the type of bachelor’s degree earned. The surveyor would need to look for additional evidence of the type of bachelor’s degree earned, a diploma showing the type of degree earned, or transcripts. Just having evidence of a bachelor’s degree does not meet the personnel requirement.