West Tn Univ Med Associates

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review from the Certification and Survey Provider Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Enhanced Reporting (CASPER) 0155 report and the laboratory's AAB Medical Laboratory Evaluation (AAB-MLE) 2025 Proficiency testing (PT) records, the laboratory failed to successfully participate in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in PT for the analyte White Blood Cell (WBC). Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) (f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a PT desk review of the CASPER 0155 report and the laboratory's AAB- MLE PT records, the laboratory failed to achieve an overall satisfactory performance (80% or better) for the WBC analyte for two consecutive testing events. The findings include: 1. A review of the CASPER 0155 report revealed the following results: A score of 0% for the WBC analyte for 2025 Event One. A score of 0% for the WBC analyte for 2025 Event Two. 2. A review of the laboratory's AAB-MLE PT records confirmed the above findings. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 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. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155 report and the laboratory's AAB-MLE 2025 PT records, the laboratory director failed to provide overall management and direction of the laboratory services. The laboratory director failed to ensure proficiency testing samples were tested as required. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155 report and the laboratory's AAB-MLE 2025 PT records, the laboratory director failed to ensure proficiency testing samples were tested as required. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2130. -- 2 of 2 --

Summary Statement of Deficiencies D0000 During a Proficiency Testing (PT) desk review survey conducted on 12/18/24, the laboratory was found out of compliance with the following CONDITIONS: 493.803 Condition: Successful participation 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on surveyor proficiency testing (PT) desk review, a review of the Centers for Medicare and Medicaid Services (CMS) Casper report 0155D (CMS 155), the laboratory's 2024 AAB-Medical Laboratory Evaluation (AAB-MLE) PT records and electronic mail (email) communication with the AAB-MLE PT program Assistant Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Technical Director, the laboratory failed to successfully participate in PT in the specialty of Hematology for the analyte White Blood Cell (WBC) Differential. The laboratory had unsatisfactory scores for 2024 Events One, Two, and Three, resulting in non-initial unsuccessful PT participation. Refer to D2130 D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on surveyor PT desk review, a review of the CMS 155, the laboratory's 2024 PT records, and email communication with the AAB-MLE PT Assistant Technical Director, the laboratory failed to successfully participate in PT for the analyte White Blood Cell (WBC) Differential (WBC DIFF). The laboratory had unsatisfactory scores for 2024 Event One, 2024 Event Two, and 2024 Event Three, resulting in non- initial unsuccessful PT participation. The findings include: 1. A review of the CMS 155 revealed the following for the WBC Differential: 2024 Event One-No scores reported 2024 Event Two=8% 2024 Event Three=24% 2. A review of the laboratory's AAB-MLE PT records revealed the following for the WBC Differential: 2024 Event One: The laboratory failed to submit results for the PT Event. 2024 Event Two Cumulative Report: An overall score of 8% for the WBC Differential. 2024 Event Three Cumulative Report: An overall score of 24% for the WBC Differential for Event Three. Cumulative scores of 0% for 2024 Event One, 8% for 2024 Event Two, 24% for 2024 Event Three. 3. A review of the laboratory's 2024 Event Three PT records revealed that the reporting deadline was 09/27/24. 4. A review of the Allegation of Compliance submitted on 11/25/24 for the initial unsuccessful PT occurrence revealed that the cause of the failures for 2024 Events One and Two was not identified in a timely manner, resulting in failures for the analyte WBC Differential for 2024 Event Three.

Summary Statement of Deficiencies D0000 During a recertification survey performed on 10/22/24, the laboratory was found out of compliance with the following conditions: 493.801 Condition: Enrollment and testing of samples 493.1205 Condition: Virology 493.1441 Condition: Laboratories performing high complexity testing; laboratory director 493.1447 Condition: Laboratories performing high complexity testing; technical supervisor 493.1487 Condition: Laboratories performing high complexity testing; testing personnel D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on laboratory observation, review of the manufacturer's package insert, review of a patient data log, proficiency testing records, and staff interview, the laboratory failed to enroll in proficiency testing for the non-waived Respiratory Syncytial Virus (RSV) test in 2024. The findings include: 1. Laboratory observation on 10/22/24 at 8: 15 a.m. revealed the Quidel Sofia RSV test used for patient testing. During observations, testing person one stated the laboratory primarily tests pediatric patients but occasionally tests adult patients. 2. A review of the Quidel Sophia RSV manufacturer's package insert revealed that the Sophia RSV test was waived for children under seven and moderate for pediatric patients aged seven to less than nineteen. 3. A review of a patient data log spanning 01/01/24 to 10/22/24 revealed that Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 15 -- 59 patients were tested on patients over the age of seven, resulting in the use of the test as a non-waived system. 4. A review of the laboratory proficiency testing records revealed the laboratory was not enrolled in proficiency testing for the non-waived RSV antigen test. 5. The laboratory director confirmed the survey findings during an interview on 10/22/24 at 9:30 a.m. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of the laboratory's proficiency testing records, and staff interview, testing personnel and/or the laboratory director failed to sign the hematology attestation statements for three of four proficiency testing events reviewed from 2023 and 2024. The findings include: 1. A review of the laboratory's AAB/MLE proficiency testing records revealed the testing personnel did not sign the attestation statements for 2024 events one, two, and three. The laboratory director did not sign 2024 events one and two. 2. The laboratory director confirmed the survey findings during an interview on 10/22/24 at 10:30 a.m. Word Key: AAB=American Association of Bioanalysts MLE=Medical Laboratory Evaluation D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a review of the laboratory's 2024 proficiency testing records and staff interview, the laboratory failed to maintain successful participation for two consecutive PT events for the automated White Blood Cell (WBC) Differential, resulting in unsuccessful PT performance (Refer to D2130). D2130 HEMATOLOGY -- 2 of 15 -- CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the laboratory's 2024 proficiency testing records and staff interview, the laboratory failed to maintain successful participation for two consecutive PT events for the automated WBC Differential, resulting in unsuccessful PT performance. The findings include: 1) A review of the laboratory's American Association of Bioanalysts (AAB)/Medical Laboratory Evaluation (MLE) proficiency testing records during a recertification survey conducted on 10/22/24 revealed the following: For 2024 event one, the laboratory did not submit the PT results by the reporting deadline of 02/23/24, resulting in a score of zero for the automated WBC Differential analyte. For 2024 event two, the laboratory's overall score for the WBC Differential was 8%. 2) The laboratory director confirmed the survey findings during an interview on 10/22/24 at 10:30 a.m. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on laboratory observation, review of the laboratory's proficiency testing records, lack of documentation, review of a patient data log, and staff interview, the laboratory failed to verify the accuracy of the RDW, RDW CV, and MPV in 2024. The findings include: 1. Laboratory observation on 10/22/24 at 8:15 a.m. revealed the Sysmex XN 330 used for patient testing for Complete Blood Count with White blood Cell Differential (CBC w/Diff). 2. A review of the laboratory's proficiency testing records revealed the laboratory did not report the RDW, RDW CV and MPV analytes to the proficiency testing program for evaluation. 3.The laboratory did not have documentation of an alternative method for evaluating the accuracy of the RDW, RDW CV, and MPV analytes twice a year in 2024. 4. A review of a patient data log covering the dates of 01/01/24 to 10/22/24 revealed the laboratory reported the RDW, RDW CV and MPV on 41 patients (patient order numbers 8197137, 8966446, 12248738, 13176118, 20346459, 22140391, 23326939, 24164929, 24780441, 25352857, 25431756, 26355330, 28017744, 30064528, 30124714, 30205790, 30286270, 30798706, 30970241, 31004942, 31084174, 31129756, 31179932, 31284262, 31427682, 61427852, 31696160, 31824207, 31946766, 32498341, 33065359, 33364645, 33667651, 34037461, 34815944, 34899341, 35445990, 35920631, 36686481, 37590518, and 38455633). 5. The laboratory director confirmed the survey findings during an interview on 10/22/24 at 9:30 a.m. Word Key RDW=Red Cell Distribution Width CV=Coefficient of Variation MPV=Mean Platelet Volume D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system -- 3 of 15 -- must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on laboratory observation, review of the manufacturer's package insert, review of a patient data log, lack of records, and staff interview, the laboratory failed to verify the performance specifications for using the Quidel Sophia RSV as a moderately complex test with 39 patients tested and reported between 01/01/24 to the date of the survey (10/22/24). The findings include: 1. Laboratory observation on 10/22/24 at 8: 15 a.m. revealed the Quidel Sofia RSV test used for patient testing. During observations, testing person one stated the laboratory primarily tests pediatric patients but occasionally tests adult patients. 2. A review of the manufacturer's package insert revealed that the Sophia RSV test was moderate for pediatric patients aged seven to less than nineteen. 3. A review of a patient data log spanning 01/01/24 to 10/22/24 revealed that 39 patients between the ages of seven and eighteen were tested using the Quidel Sophia RSV test (patient order numbers: 2988933, 3321053, 6641024, 6810146, 11726034, 13808030, 17380675, 18254781, 18753667, 21459182, 22140386, 22913763, 26014467, 26686588, 26701571, 26801574, 27156687, 28194239, 28194245, 29036306, 29183392, 29206155, 29793295, 29793299, 29898871, 30487967, 30509111, 31103538, 31716765, 33054554, 33689680, 33689683, 34519751, 35590475, 37766429, 37831353, 3787335, 41929031, and 55718318). 4. Quidel Sophia RSV verification of manufacturer specifications records were not available on the date of the survey (10/22/24). 5. The laboratory director confirmed the survey findings via an electronic mail communication on 11/01/24 at 8: 10 a.m. D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) 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: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on laboratory observation, review of the manufacturer's package insert, review of a patient data log, lack of records, and staff interview, the laboratory failed to establish the performance specifications for use of the Quidel Sophia RSV in age groups not authorized by the product manufacturer with 20 patients that were outside the authorized age groups tested and reported from 01/01/24 to the survey date (10/22 /24). The findings include: 1. Laboratory observation on 10/22/24 at 8:15 a.m. -- 4 of 15 -- revealed the Quidel Sofia RSV test used for patient testing. During observations, testing person one stated the laboratory primarily tests pediatric patients but occasionally tests adult patients. 2. A review of the Quidel Sophia RSV manufacturer's package insert revealed the following statements: CLIA Complexity: Waived for children less than 7 years of age. CLIA Complexity: Moderate for pediatric patients 7 to less than 19 years of age. 3. A review of a patient data log spanning 01/01/24 to 10/22/24 revealed that 20 patients 19 years and older were tested using the Quidel Sophia RSV test (patient order numbers 9963954, 11877052, 14748258, 22998240, 24728163, 25640464, 26388792, 27004913, 29433868, 30952114, 30973254, 32029012, 32052192, 32056682, 32470911, 33863736, 33880357, 34504770, 35876917, and 36462345). 4. Records for establishing the performance specifications for using the Quidel Sophia RSV outside the manufacturer authorized age groups were not available on the date of the survey (10/22/24). 5. The laboratory director confirmed the survey findings via an electronic mail communication on 11/01/24 at 8:10 a.m. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on a review of final patient test results and a staff interview, two of four final patient test reports failed to include the units of measure for the hemoglobin test. The findings include: 1. A review of patient hemoglobin results in the electronic medical record revealed that two of four results reviewed did not include the units of measure (patient medical record number 200137645 performed on 03/07/24 and patient medical record number 1000000186118 performed on 09/11/24). 2. The laboratory liaison confirmed the survey findings during an interview on 10/22/24 at 1:00 p.m. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 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. This CONDITION is not met as evidenced by: Based on laboratory observation, review of the manufacturer package insert, patient data log, lack of documentation, and staff interview, the laboratory director did not meet the regulatory requirements for directing high-complexity testing (Refer to D6078). D6078 LABORATORY DIRECTOR QUALIFICATIONS -- 5 of 15 -- CFR(s): 493.1443 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-- (b)(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 (b) (1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2) 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 (b)(2)(i) Have at least one year of laboratory training during medical residency (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine); or (b)(2)(ii) Have at least 2 years of experience directing or supervising high complexity testing; or (b)(3) Hold an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution and-- (b)(3)(i) Be certified and continue to be certified by a board approved by HHS; or (b)(3)(ii) Before February 24, 2003, must have served or be serving as director of a laboratory performing high complexity testing and must have at least-- (b)(3)(ii)(A) Two years of laboratory training or experience, or both; and (b)(3)(ii)(B) Two years of laboratory experience directing or supervising high complexity testing. (b)(4) Be serving as a laboratory director and must have previously qualified or could have qualified as a laboratory director under regulations at 42 CFR 493.1415, published March 14, 1990 at 55 FR 9538, on or before February 28, 1992; or (b)(5) On or before February 28, 1992, be qualified under State law to direct a laboratory in the State in which the laboratory is located; or (b)(6) For the subspecialty of oral pathology, be certified by the American Board of Oral Pathology, American Board of Pathology, the American Osteopathic Board of Pathology, or possess qualifications that are equivalent to those required for certification. This STANDARD is not met as evidenced by: Based on laboratory observation, review of the manufacturer package insert, patient data log, lack of documentation, and staff interview, the laboratory director did not meet the regulatory requirements for directing high-complexity testing. The findings include: 1. Observation of the laboratory on 10/22/24 at 8:15 a.m. revealed the Quidel Sophia RSV test used use for patient testing. Testing person one stated during observation that the laboratory primarily tests pediatric patients but occasionally performs the RSV test on adults. 2. A review of the Quidel Sophia RSV manufacturer's package insert revealed that the test is waived when used on patients under seven and moderately complex when used on patients seven to less than nineteen. 3. A review of a patient data log revealed that the Quidel Sophia RSV was reported on patients over the age of eighteen, resulting in the use of the test as a laboratory-developed high-complexity test (Refer to D5423). 4. No documentation that qualified the laboratory director to direct high-complexity testing was available on the date of the survey. 5. The laboratory director confirmed the survey findings during an interview on 10/22/24 at 10:00 a.m. D6108 LABORATORY TECHNICAL SUPERVISOR -- 6 of 15 -- CFR(s): 493.1447 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. This CONDITION is not met as evidenced by: Based on laboratory observation, review of the manufacturer package insert, patient data log, lack of documentation, and staff interview, the laboratory did not have personnel who met the regulatory requirements to perform technical supervision of high-complexity testing in virology (Refer to D6111). D6111 TECHNICAL SUPERVISOR QUALIFICATIONS CFR(s): 493.1449 (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-- (b)(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 (b)(2) Is certified in both anatomic and clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or Possesses qualifications that are equivalent to those required for such certification. (c) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of bacteriology, the individual functioning as the technical supervisor must-- (c)(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 (c)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (c)(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 (c)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology; or (c)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (c)(3)(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 experience in high complexity testing within the subspecialty of bacteriology; or (c)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (c)(4)(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 experience in high complexity testing within the subspecialty of bacteriology; or (c)(5)(i) Have earned a bachelor's degree in a chemical, physical, or biological science or medical technology from an accredited institution; and (c)(5)(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 experience in high complexity testing within the subspecialty of bacteriology. (d) If the requirements of paragraph (b) of this section are not met and -- 7 of 15 -- the laboratory performs tests in the subspecialty of mycobacteriology, the individual functioning as the technical supervisor must-- (d)(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 (d)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (d) (2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor or podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (d)(2)(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 experience in high complexity testing within the subspecialty of mycobacteriology; or (d)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (d)(3)(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 experience in high complexity testing within the subspecialty of mycobacteriology; or (d)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (d)(4)(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 experience in high complexity testing within the subspecialty of mycobacteriology; or (d)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (d)(5)(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 experience in high complexity testing within the subspecialty of mycobacteriology. (e) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of mycology, the individual functioning as the technical supervisor must-- (e)(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 (e)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (e) (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 (e)(2)(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 experience in high complexity testing within the subspecialty of mycology; or (e)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (e)(3)(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 experience in high complexity testing within the subspecialty of mycology; or (e)(4) (i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (e)(4)(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 experience in high complexity testing within the subspecialty of mycology; or (e)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (e)(5)(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 experience in high complexity testing within the subspecialty of mycology. (f) If the requirements of paragraph (b) of -- 8 of 15 -- this section are not met and the laboratory performs tests in the subspecialty of parasitology, the individual functioning as the technical supervisor must-- (f)(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 (f)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (f)(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 (f)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology; (f)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (f)(3)(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 experience in high complexity testing within the subspecialty of parasitology; or (f)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (f)(4)(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 experience in high complexity testing within the subspecialty of parasitology; or (f)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (f)(5)(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 experience in high complexity testing within the subspecialty of parasitology. (g) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of virology, the individual functioning as the technical supervisor must-- (g)(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 (g)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (g) (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 (g)(2)(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 experience in high complexity testing within the subspecialty of virology; or (g)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (g)(3)(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 experience in high complexity testing within the subspecialty of virology; or (g)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (g)(4)(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 experience in high complexity testing within the subspecialty of virology; or (g)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (g)(5)(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 experience in high complexity testing within the subspecialty of virology. (h) If the requirements of paragraph (b) of -- 9 of 15 -- this section are not met and the laboratory performs tests in the specialty of diagnostic immunology, the individual functioning as the technical supervisor must- (h)(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 (h)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (h)(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 (h)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the specialty of diagnostic immunology; or (h)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (h)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of diagnostic immunology; or (h)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (h)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of diagnostic immunology; or (h)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (h)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of diagnostic immunology. (i) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of chemistry, the individual functioning as the technical supervisor must-- (i)(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 (i)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (i)(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 (i)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry; or (i)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (i)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of chemistry; or (i) (4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (i)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry; or (i)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (i)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry. (j) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of hematology, the individual functioning as the technical supervisor must-- (j)(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 (j)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (j)(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 (j)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing for the specialty of hematology (for example, physicians certified either in hematology or -- 10 of 15 -- hematology and medical oncology by the American Board of Internal Medicine); or (j) (3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (j)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of hematology; or (j)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (j)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of hematology; or (j) (5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (j)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of hematology. (k)(1) 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-- (k)(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 (k)(1)(ii) Meet one of the following requirements-- (k)(1)(ii)(A) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (k)(1)(ii) (B) Be certified by the American Society of Cytology to practice cytopathology or possess qualifications that are equivalent to those required for such certification; (l) 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-- (l)(1) Meet one of the following requirements: (l)(1)(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 (l)(1)(i)(B) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; (l)(1)(ii) An individual qualified under 493.1449(b) or paragraph (l)(1) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraph (b) or (l)(1)(i)(B) of this section, the responsibility for examination and interpretation of histopathology specimens. (l)(2) For tests in dermatopathology, meet one of the following requirements: (l)(2)(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-- (l) (2)(i)(B) Meet one of the following requirements: (l)(2)(i)(B)(1) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (l)(2)(i)(B)(2) Be certified in dermatopathology by the American Board of Dermatology and the American Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (l)(2)(i)(B) (3) Be certified in dermatology by the American Board of Dermatology or possess qualifications that are equivalent to those required for such certification; or (l)(2)(ii) An individual qualified under 493.1449(b) or paragraph (l)(2)(i) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (l)(2)(i)(B) of this section, the responsibility for examination and interpretation of dermatopathology specimens. (l) (3) For tests in ophthalmic pathology, meet one of the following requirements: (l)(3)(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-- (l)(3)(i)(B) Must meet one of the following requirements: (l)(3)(i)(B)(1) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or -- 11 of 15 -- (l)(3)(i)(B)(2) Be certified by the American Board of Ophthalmology or possess qualifications that are equivalent to those required for such certification and have successfully completed at least 1 year of formal post-residency fellowship training in ophthalmic pathology; or (l)(3)(ii) An individual qualified under 493.1449(b) or paragraph (1)(3)(i) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (1)(3)(i)(B) of this section, the responsibility for examination and interpretation of ophthalmic specimens; or (m) 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: (m)(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-- (m)(1)(ii) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (m)(2) Be certified in oral pathology by the American Board of Oral Pathology or possess qualifications for such certification; or (m)(3) An individual qualified under 493.1449(b) or paragraph (m)(1) or (2) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (m)(1) or (2) of this section, the responsibility for examination and interpretation of oral pathology specimens. (n) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of radiobioassay, the individual functioning as the technical supervisor must-- (n)(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 (n)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (n)(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 (n)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the specialty of radiobioassay; or (n)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (n)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of radiobioassay; or (n)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (n)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of radiobioassay; or (n)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (n)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of radiobioassay. (o) If the laboratory performs tests in the specialty of histocompatibility, the individual functioning as the technical supervisor must either-- (o)(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 (o)(1)(ii) Have training or experience that meets one of the following requirements: (o)(1)(ii)(A) Have 4 years of laboratory training or experience, or both, within the specialty of histocompatibility; or (o)(1)(ii)(B)(1) Have 2 years of laboratory training or experience, or both, in the specialty of general immunology; and (o)(1)(ii)(B)(2) Have 2 years of laboratory training or experience, or both, in the specialty of histocompatibility; or (o)(2)(i) Have an earned doctoral degree in a biological or clinical laboratory science from an accredited institution; and (o)(2)(ii) Have training or experience that meets one of the following requirements: (o) -- 12 of 15 -- (2)(ii)(A) Have 4 years of laboratory training or experience, or both, within the specialty of histocompatibility; or (o)(2)(ii)(B)(1) Have 2 years of laboratory training or experience, or both, in the specialty of general immunology; and (o)(2)(ii)(B)(2) Have 2 years of laboratory training or experience, or both, in the specialty of histocompatibility. (p) If the laboratory performs tests in the specialty of clinical cytogenetics, the individual functioning as the technical supervisor must-- (p)(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 (p)(1)(ii) Have 4 years of training or experience, or both, in genetics, 2 of which have been in clinical cytogenetics; or (p)(2)(i) Hold an earned doctoral degree in a biological science, including biochemistry, or clinical laboratory science from an accredited institution; and (p)(2)(ii) Have 4 years of training or experience, or both, in genetics, 2 of which have been in clinical cytogenetics. (q) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of immunohematology, the individual functioning as the technical supervisor must-- (q)(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 (q)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (q)(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 (q)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing for the specialty of immunohematology. Note: 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. This STANDARD is not met as evidenced by: Based on laboratory observation, review of the manufacturer package insert, review of a patient data log, a lack of documentation and staff interview, the laboratory did not have personnel who met the regulatory requirement for providing technical supervision in virology. The findings include: 1. Observation of the laboratory on 10 /22/24 at 8:15 a.m. revealed the Quidel Sophia RSV test used use for patient testing. Testing person one stated during observation that the laboratory primarily tests pediatric patients but occasionally performs the RSV test on adults. 2. A review of the Quidel Sophia RSV manufacturer's package insert revealed that the test is waived when used on patients under seven and moderately complex when used on patients seven to eighteen. 3. A review of a patient data log revealed that RSV was reported on patients over the age of eighteen, resulting in a laboratory-developed high-complexity test (Refer to D5423). 4. The laboratory personnel records did not have evidence of high-complexity testing experience in virology to qualify any person as a technical supervisor in virology. 5. The laboratory director confirmed the survey findings during an interview on 10/22/24 at 10:00 a.m. D6168 TESTING PERSONNEL -- 13 of 15 -- CFR(s): 493.1487 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. This CONDITION is not met as evidenced by: Based on laboratory observation, review of the manufacturer package insert, review of a patient data log, a lack of documentation and staff interview, two of two persons performing high-complexity testing did not qualify (Refer to D6171). D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podia

Summary Statement of Deficiencies D0000 During a recertification survey performed on 10/22/24, the laboratory was found out of compliance with the following conditions: 493.801 Condition: Enrollment and testing of samples 493.1205 Condition: Virology 493.1441 Condition: Laboratories performing high complexity testing; laboratory director 493.1447 Condition: Laboratories performing high complexity testing; technical supervisor 493.1487 Condition: Laboratories performing high complexity testing; testing personnel D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on laboratory observation, review of the manufacturer's package insert, review of a patient data log, proficiency testing records, and staff interview, the laboratory failed to enroll in proficiency testing for the non-waived Respiratory Syncytial Virus (RSV) test in 2024. The findings include: 1. Laboratory observation on 10/22/24 at 8: 15 a.m. revealed the Quidel Sofia RSV test used for patient testing. During observations, testing person one stated the laboratory primarily tests pediatric patients but occasionally tests adult patients. 2. A review of the Quidel Sophia RSV manufacturer's package insert revealed that the Sophia RSV test was waived for children under seven and moderate for pediatric patients aged seven to less than nineteen. 3. A review of a patient data log spanning 01/01/24 to 10/22/24 revealed that Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 15 -- 59 patients were tested on patients over the age of seven, resulting in the use of the test as a non-waived system. 4. A review of the laboratory proficiency testing records revealed the laboratory was not enrolled in proficiency testing for the non-waived RSV antigen test. 5. The laboratory director confirmed the survey findings during an interview on 10/22/24 at 9:30 a.m. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of the laboratory's proficiency testing records, and staff interview, testing personnel and/or the laboratory director failed to sign the hematology attestation statements for three of four proficiency testing events reviewed from 2023 and 2024. The findings include: 1. A review of the laboratory's AAB/MLE proficiency testing records revealed the testing personnel did not sign the attestation statements for 2024 events one, two, and three. The laboratory director did not sign 2024 events one and two. 2. The laboratory director confirmed the survey findings during an interview on 10/22/24 at 10:30 a.m. Word Key: AAB=American Association of Bioanalysts MLE=Medical Laboratory Evaluation D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a review of the laboratory's 2024 proficiency testing records and staff interview, the laboratory failed to maintain successful participation for two consecutive PT events for the automated White Blood Cell (WBC) Differential, resulting in unsuccessful PT performance (Refer to D2130). D2130 HEMATOLOGY -- 2 of 15 -- CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the laboratory's 2024 proficiency testing records and staff interview, the laboratory failed to maintain successful participation for two consecutive PT events for the automated WBC Differential, resulting in unsuccessful PT performance. The findings include: 1) A review of the laboratory's American Association of Bioanalysts (AAB)/Medical Laboratory Evaluation (MLE) proficiency testing records during a recertification survey conducted on 10/22/24 revealed the following: For 2024 event one, the laboratory did not submit the PT results by the reporting deadline of 02/23/24, resulting in a score of zero for the automated WBC Differential analyte. For 2024 event two, the laboratory's overall score for the WBC Differential was 8%. 2) The laboratory director confirmed the survey findings during an interview on 10/22/24 at 10:30 a.m. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on laboratory observation, review of the laboratory's proficiency testing records, lack of documentation, review of a patient data log, and staff interview, the laboratory failed to verify the accuracy of the RDW, RDW CV, and MPV in 2024. The findings include: 1. Laboratory observation on 10/22/24 at 8:15 a.m. revealed the Sysmex XN 330 used for patient testing for Complete Blood Count with White blood Cell Differential (CBC w/Diff). 2. A review of the laboratory's proficiency testing records revealed the laboratory did not report the RDW, RDW CV and MPV analytes to the proficiency testing program for evaluation. 3.The laboratory did not have documentation of an alternative method for evaluating the accuracy of the RDW, RDW CV, and MPV analytes twice a year in 2024. 4. A review of a patient data log covering the dates of 01/01/24 to 10/22/24 revealed the laboratory reported the RDW, RDW CV and MPV on 41 patients (patient order numbers 8197137, 8966446, 12248738, 13176118, 20346459, 22140391, 23326939, 24164929, 24780441, 25352857, 25431756, 26355330, 28017744, 30064528, 30124714, 30205790, 30286270, 30798706, 30970241, 31004942, 31084174, 31129756, 31179932, 31284262, 31427682, 61427852, 31696160, 31824207, 31946766, 32498341, 33065359, 33364645, 33667651, 34037461, 34815944, 34899341, 35445990, 35920631, 36686481, 37590518, and 38455633). 5. The laboratory director confirmed the survey findings during an interview on 10/22/24 at 9:30 a.m. Word Key RDW=Red Cell Distribution Width CV=Coefficient of Variation MPV=Mean Platelet Volume D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system -- 3 of 15 -- must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on laboratory observation, review of the manufacturer's package insert, review of a patient data log, lack of records, and staff interview, the laboratory failed to verify the performance specifications for using the Quidel Sophia RSV as a moderately complex test with 39 patients tested and reported between 01/01/24 to the date of the survey (10/22/24). The findings include: 1. Laboratory observation on 10/22/24 at 8: 15 a.m. revealed the Quidel Sofia RSV test used for patient testing. During observations, testing person one stated the laboratory primarily tests pediatric patients but occasionally tests adult patients. 2. A review of the manufacturer's package insert revealed that the Sophia RSV test was moderate for pediatric patients aged seven to less than nineteen. 3. A review of a patient data log spanning 01/01/24 to 10/22/24 revealed that 39 patients between the ages of seven and eighteen were tested using the Quidel Sophia RSV test (patient order numbers: 2988933, 3321053, 6641024, 6810146, 11726034, 13808030, 17380675, 18254781, 18753667, 21459182, 22140386, 22913763, 26014467, 26686588, 26701571, 26801574, 27156687, 28194239, 28194245, 29036306, 29183392, 29206155, 29793295, 29793299, 29898871, 30487967, 30509111, 31103538, 31716765, 33054554, 33689680, 33689683, 34519751, 35590475, 37766429, 37831353, 3787335, 41929031, and 55718318). 4. Quidel Sophia RSV verification of manufacturer specifications records were not available on the date of the survey (10/22/24). 5. The laboratory director confirmed the survey findings via an electronic mail communication on 11/01/24 at 8: 10 a.m. D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) 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: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on laboratory observation, review of the manufacturer's package insert, review of a patient data log, lack of records, and staff interview, the laboratory failed to establish the performance specifications for use of the Quidel Sophia RSV in age groups not authorized by the product manufacturer with 20 patients that were outside the authorized age groups tested and reported from 01/01/24 to the survey date (10/22 /24). The findings include: 1. Laboratory observation on 10/22/24 at 8:15 a.m. -- 4 of 15 -- revealed the Quidel Sofia RSV test used for patient testing. During observations, testing person one stated the laboratory primarily tests pediatric patients but occasionally tests adult patients. 2. A review of the Quidel Sophia RSV manufacturer's package insert revealed the following statements: CLIA Complexity: Waived for children less than 7 years of age. CLIA Complexity: Moderate for pediatric patients 7 to less than 19 years of age. 3. A review of a patient data log spanning 01/01/24 to 10/22/24 revealed that 20 patients 19 years and older were tested using the Quidel Sophia RSV test (patient order numbers 9963954, 11877052, 14748258, 22998240, 24728163, 25640464, 26388792, 27004913, 29433868, 30952114, 30973254, 32029012, 32052192, 32056682, 32470911, 33863736, 33880357, 34504770, 35876917, and 36462345). 4. Records for establishing the performance specifications for using the Quidel Sophia RSV outside the manufacturer authorized age groups were not available on the date of the survey (10/22/24). 5. The laboratory director confirmed the survey findings via an electronic mail communication on 11/01/24 at 8:10 a.m. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on a review of final patient test results and a staff interview, two of four final patient test reports failed to include the units of measure for the hemoglobin test. The findings include: 1. A review of patient hemoglobin results in the electronic medical record revealed that two of four results reviewed did not include the units of measure (patient medical record number 200137645 performed on 03/07/24 and patient medical record number 1000000186118 performed on 09/11/24). 2. The laboratory liaison confirmed the survey findings during an interview on 10/22/24 at 1:00 p.m. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 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. This CONDITION is not met as evidenced by: Based on laboratory observation, review of the manufacturer package insert, patient data log, lack of documentation, and staff interview, the laboratory director did not meet the regulatory requirements for directing high-complexity testing (Refer to D6078). D6078 LABORATORY DIRECTOR QUALIFICATIONS -- 5 of 15 -- CFR(s): 493.1443 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-- (b)(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 (b) (1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2) 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 (b)(2)(i) Have at least one year of laboratory training during medical residency (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine); or (b)(2)(ii) Have at least 2 years of experience directing or supervising high complexity testing; or (b)(3) Hold an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution and-- (b)(3)(i) Be certified and continue to be certified by a board approved by HHS; or (b)(3)(ii) Before February 24, 2003, must have served or be serving as director of a laboratory performing high complexity testing and must have at least-- (b)(3)(ii)(A) Two years of laboratory training or experience, or both; and (b)(3)(ii)(B) Two years of laboratory experience directing or supervising high complexity testing. (b)(4) Be serving as a laboratory director and must have previously qualified or could have qualified as a laboratory director under regulations at 42 CFR 493.1415, published March 14, 1990 at 55 FR 9538, on or before February 28, 1992; or (b)(5) On or before February 28, 1992, be qualified under State law to direct a laboratory in the State in which the laboratory is located; or (b)(6) For the subspecialty of oral pathology, be certified by the American Board of Oral Pathology, American Board of Pathology, the American Osteopathic Board of Pathology, or possess qualifications that are equivalent to those required for certification. This STANDARD is not met as evidenced by: Based on laboratory observation, review of the manufacturer package insert, patient data log, lack of documentation, and staff interview, the laboratory director did not meet the regulatory requirements for directing high-complexity testing. The findings include: 1. Observation of the laboratory on 10/22/24 at 8:15 a.m. revealed the Quidel Sophia RSV test used use for patient testing. Testing person one stated during observation that the laboratory primarily tests pediatric patients but occasionally performs the RSV test on adults. 2. A review of the Quidel Sophia RSV manufacturer's package insert revealed that the test is waived when used on patients under seven and moderately complex when used on patients seven to less than nineteen. 3. A review of a patient data log revealed that the Quidel Sophia RSV was reported on patients over the age of eighteen, resulting in the use of the test as a laboratory-developed high-complexity test (Refer to D5423). 4. No documentation that qualified the laboratory director to direct high-complexity testing was available on the date of the survey. 5. The laboratory director confirmed the survey findings during an interview on 10/22/24 at 10:00 a.m. D6108 LABORATORY TECHNICAL SUPERVISOR -- 6 of 15 -- CFR(s): 493.1447 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. This CONDITION is not met as evidenced by: Based on laboratory observation, review of the manufacturer package insert, patient data log, lack of documentation, and staff interview, the laboratory did not have personnel who met the regulatory requirements to perform technical supervision of high-complexity testing in virology (Refer to D6111). D6111 TECHNICAL SUPERVISOR QUALIFICATIONS CFR(s): 493.1449 (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-- (b)(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 (b)(2) Is certified in both anatomic and clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or Possesses qualifications that are equivalent to those required for such certification. (c) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of bacteriology, the individual functioning as the technical supervisor must-- (c)(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 (c)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (c)(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 (c)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology; or (c)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (c)(3)(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 experience in high complexity testing within the subspecialty of bacteriology; or (c)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (c)(4)(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 experience in high complexity testing within the subspecialty of bacteriology; or (c)(5)(i) Have earned a bachelor's degree in a chemical, physical, or biological science or medical technology from an accredited institution; and (c)(5)(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 experience in high complexity testing within the subspecialty of bacteriology. (d) If the requirements of paragraph (b) of this section are not met and -- 7 of 15 -- the laboratory performs tests in the subspecialty of mycobacteriology, the individual functioning as the technical supervisor must-- (d)(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 (d)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (d) (2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor or podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (d)(2)(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 experience in high complexity testing within the subspecialty of mycobacteriology; or (d)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (d)(3)(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 experience in high complexity testing within the subspecialty of mycobacteriology; or (d)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (d)(4)(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 experience in high complexity testing within the subspecialty of mycobacteriology; or (d)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (d)(5)(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 experience in high complexity testing within the subspecialty of mycobacteriology. (e) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of mycology, the individual functioning as the technical supervisor must-- (e)(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 (e)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (e) (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 (e)(2)(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 experience in high complexity testing within the subspecialty of mycology; or (e)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (e)(3)(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 experience in high complexity testing within the subspecialty of mycology; or (e)(4) (i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (e)(4)(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 experience in high complexity testing within the subspecialty of mycology; or (e)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (e)(5)(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 experience in high complexity testing within the subspecialty of mycology. (f) If the requirements of paragraph (b) of -- 8 of 15 -- this section are not met and the laboratory performs tests in the subspecialty of parasitology, the individual functioning as the technical supervisor must-- (f)(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 (f)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (f)(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 (f)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology; (f)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (f)(3)(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 experience in high complexity testing within the subspecialty of parasitology; or (f)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (f)(4)(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 experience in high complexity testing within the subspecialty of parasitology; or (f)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (f)(5)(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 experience in high complexity testing within the subspecialty of parasitology. (g) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of virology, the individual functioning as the technical supervisor must-- (g)(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 (g)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (g) (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 (g)(2)(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 experience in high complexity testing within the subspecialty of virology; or (g)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (g)(3)(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 experience in high complexity testing within the subspecialty of virology; or (g)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (g)(4)(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 experience in high complexity testing within the subspecialty of virology; or (g)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (g)(5)(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 experience in high complexity testing within the subspecialty of virology. (h) If the requirements of paragraph (b) of -- 9 of 15 -- this section are not met and the laboratory performs tests in the specialty of diagnostic immunology, the individual functioning as the technical supervisor must- (h)(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 (h)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (h)(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 (h)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the specialty of diagnostic immunology; or (h)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (h)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of diagnostic immunology; or (h)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (h)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of diagnostic immunology; or (h)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (h)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of diagnostic immunology. (i) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of chemistry, the individual functioning as the technical supervisor must-- (i)(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 (i)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (i)(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 (i)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry; or (i)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (i)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of chemistry; or (i) (4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (i)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry; or (i)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (i)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry. (j) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of hematology, the individual functioning as the technical supervisor must-- (j)(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 (j)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (j)(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 (j)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing for the specialty of hematology (for example, physicians certified either in hematology or -- 10 of 15 -- hematology and medical oncology by the American Board of Internal Medicine); or (j) (3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (j)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of hematology; or (j)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (j)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of hematology; or (j) (5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (j)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of hematology. (k)(1) 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-- (k)(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 (k)(1)(ii) Meet one of the following requirements-- (k)(1)(ii)(A) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (k)(1)(ii) (B) Be certified by the American Society of Cytology to practice cytopathology or possess qualifications that are equivalent to those required for such certification; (l) 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-- (l)(1) Meet one of the following requirements: (l)(1)(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 (l)(1)(i)(B) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; (l)(1)(ii) An individual qualified under 493.1449(b) or paragraph (l)(1) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraph (b) or (l)(1)(i)(B) of this section, the responsibility for examination and interpretation of histopathology specimens. (l)(2) For tests in dermatopathology, meet one of the following requirements: (l)(2)(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-- (l) (2)(i)(B) Meet one of the following requirements: (l)(2)(i)(B)(1) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (l)(2)(i)(B)(2) Be certified in dermatopathology by the American Board of Dermatology and the American Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (l)(2)(i)(B) (3) Be certified in dermatology by the American Board of Dermatology or possess qualifications that are equivalent to those required for such certification; or (l)(2)(ii) An individual qualified under 493.1449(b) or paragraph (l)(2)(i) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (l)(2)(i)(B) of this section, the responsibility for examination and interpretation of dermatopathology specimens. (l) (3) For tests in ophthalmic pathology, meet one of the following requirements: (l)(3)(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-- (l)(3)(i)(B) Must meet one of the following requirements: (l)(3)(i)(B)(1) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or -- 11 of 15 -- (l)(3)(i)(B)(2) Be certified by the American Board of Ophthalmology or possess qualifications that are equivalent to those required for such certification and have successfully completed at least 1 year of formal post-residency fellowship training in ophthalmic pathology; or (l)(3)(ii) An individual qualified under 493.1449(b) or paragraph (1)(3)(i) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (1)(3)(i)(B) of this section, the responsibility for examination and interpretation of ophthalmic specimens; or (m) 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: (m)(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-- (m)(1)(ii) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (m)(2) Be certified in oral pathology by the American Board of Oral Pathology or possess qualifications for such certification; or (m)(3) An individual qualified under 493.1449(b) or paragraph (m)(1) or (2) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (m)(1) or (2) of this section, the responsibility for examination and interpretation of oral pathology specimens. (n) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of radiobioassay, the individual functioning as the technical supervisor must-- (n)(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 (n)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (n)(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 (n)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the specialty of radiobioassay; or (n)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (n)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of radiobioassay; or (n)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (n)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of radiobioassay; or (n)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (n)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of radiobioassay. (o) If the laboratory performs tests in the specialty of histocompatibility, the individual functioning as the technical supervisor must either-- (o)(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 (o)(1)(ii) Have training or experience that meets one of the following requirements: (o)(1)(ii)(A) Have 4 years of laboratory training or experience, or both, within the specialty of histocompatibility; or (o)(1)(ii)(B)(1) Have 2 years of laboratory training or experience, or both, in the specialty of general immunology; and (o)(1)(ii)(B)(2) Have 2 years of laboratory training or experience, or both, in the specialty of histocompatibility; or (o)(2)(i) Have an earned doctoral degree in a biological or clinical laboratory science from an accredited institution; and (o)(2)(ii) Have training or experience that meets one of the following requirements: (o) -- 12 of 15 -- (2)(ii)(A) Have 4 years of laboratory training or experience, or both, within the specialty of histocompatibility; or (o)(2)(ii)(B)(1) Have 2 years of laboratory training or experience, or both, in the specialty of general immunology; and (o)(2)(ii)(B)(2) Have 2 years of laboratory training or experience, or both, in the specialty of histocompatibility. (p) If the laboratory performs tests in the specialty of clinical cytogenetics, the individual functioning as the technical supervisor must-- (p)(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 (p)(1)(ii) Have 4 years of training or experience, or both, in genetics, 2 of which have been in clinical cytogenetics; or (p)(2)(i) Hold an earned doctoral degree in a biological science, including biochemistry, or clinical laboratory science from an accredited institution; and (p)(2)(ii) Have 4 years of training or experience, or both, in genetics, 2 of which have been in clinical cytogenetics. (q) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of immunohematology, the individual functioning as the technical supervisor must-- (q)(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 (q)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (q)(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 (q)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing for the specialty of immunohematology. Note: 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. This STANDARD is not met as evidenced by: Based on laboratory observation, review of the manufacturer package insert, review of a patient data log, a lack of documentation and staff interview, the laboratory did not have personnel who met the regulatory requirement for providing technical supervision in virology. The findings include: 1. Observation of the laboratory on 10 /22/24 at 8:15 a.m. revealed the Quidel Sophia RSV test used use for patient testing. Testing person one stated during observation that the laboratory primarily tests pediatric patients but occasionally performs the RSV test on adults. 2. A review of the Quidel Sophia RSV manufacturer's package insert revealed that the test is waived when used on patients under seven and moderately complex when used on patients seven to eighteen. 3. A review of a patient data log revealed that RSV was reported on patients over the age of eighteen, resulting in a laboratory-developed high-complexity test (Refer to D5423). 4. The laboratory personnel records did not have evidence of high-complexity testing experience in virology to qualify any person as a technical supervisor in virology. 5. The laboratory director confirmed the survey findings during an interview on 10/22/24 at 10:00 a.m. D6168 TESTING PERSONNEL -- 13 of 15 -- CFR(s): 493.1487 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. This CONDITION is not met as evidenced by: Based on laboratory observation, review of the manufacturer package insert, review of a patient data log, a lack of documentation and staff interview, two of two persons performing high-complexity testing did not qualify (Refer to D6171). D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podia

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 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. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of patient test reports, laboratory procedure manual, testing personnel (TP) records, and staff interview, the laboratory failed to follow its' own policy for testing personnel (TP) assessment when the laboratory began using a new Complete Blood Count (CBC) instrument for patient testing in 2023. The findings include: 1. Observation of the laboratory on 09/26/2023 at 9:10 am revealed a Sysmex XN 330 (serial # 15879) in use for CBC patient testing (new since last survey). 2. Review of patient test reports revealed the first patient CBC for the new Sysmex XN 330 was reported on 07/25/2023 (ID # 200013887). 3. Review of the laboratory policy titled "QUALITY ASSURANCE PROGRAM" section "PERSONNEL" revealed personnel are evaluated initially, at six months, and annually. Policy further stated "Personnel will also be evaluated following the same timeline whenever new tests or methodologies are introduced." 4. Review of TP records revealed that none of the three TP had evaluation of competency for use of the Sysmex XN 330 CBC instrument prior to patient testing which began on 07/25/2023. 5. Interview on 09/25/2023 at 12:30 pm with the Laboratory Director and TP three confirmed the laboratory failed to follow its' own TP policy when it did not perform TP competency assessment prior to patient testing when the methodology for CBC changed in 2023. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing attestation statements and interview with testing personnel number one, the laboratory director failed to sign attestation statements for 2017 events one and three. The findings include: 1. Review of the laboratory's proficiency testing attestation statements for 2017 events one and three revealed no signature by the laboratory director. 2. Interview with testing personnel number one on June 11, 2018 at 3:00 pm confirmed that the laboratory director failed to sign the attestation statements for 2017 events one and three. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 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. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy titled "Personnel Competency" and interview with testing personnel number one, the laboratory failed to establish policies for competency assessment of testing personnel as specified in subpart M. The findings include: 1. Review of the laboratory's policy titled "Personnel Competency" revealed that testing personnel competency is documented by proficiency testing, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- annual evaluations, checklist, color blind test, and employee position description questionnaire. 2. Interview with testing personnel number one on June 11, 2018 at 10: 30 am confirmed that the laboratory's policy for testing personnel competency assessment was not in compliance with Subpart M. The required elements include: Direct observation of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing; Monitoring the recording and reporting of test results; review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records; Direct observation of performance of instrument maintenance and function checks; assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and Assessment of problem solving skills. Evaluating and documenting the performance of individual responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. Thereafter, evaluations must be performed annually. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of 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 or results). This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing evaluation report for 2017 event two, review of the laboratory's policy titled "Quality Assurance Plan," and interview with testing personnel one, the laboratory failed to verify the accuracy of non-graded proficiency testing results for urine sediment and vaginal wet prep for 2017 event two. 1. Review of the laboratory's proficiency testing evaluation report for 2017 event two revealed the following samples were scored as "Pass" with a comment code of "Not Graded-Lack of Referee Consensus" for sample numbers CM-12 and CM-13 for urine microscopy and sample number CM-15 for vaginal wet prep. The report was signed by both the laboratory director and the technical consultant. 2. Review of the laboratory's policy titled "Quality Assurance Plan" revealed that evaluation of non-graded proficiency testing results was not included. 3. Interview with testing personnel number one on June 11, 2018 at 11:00 am confirmed that the laboratory failed to verify the accuracy of non-graded proficiency testing results for sample numbers CM-12, CM-13, and CM-15 for 2017 event two. D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (b) The technical consultant is responsible for-- (b)(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; This STANDARD is not met as evidenced by: -- 2 of 3 -- Based on review of the laboratory's form used for documenting review of complete blood count (CBC) quality control data, the laboratory's quality assurance plan, and interview with testing personnel number one, the technical consultant failed to ensure the quality control program was maintained in 2016 and 2017. The findings include: 1. Review of the form used for documenting technical consultant review of CBC quality control data revealed no signature for review of quality control data for dates 11.7.2016 to 11.23.2016 and 7.22.2017 to 8.28.2017. 2. Review of the laboratory's quality assurance plan revealed the following statement "We will evaluate our quality control program for calibration and control data for each test method used in the lab and determine: a. If calibrators and controls are run according to written policy and procedures; b. If personnel have taken appropriate