Physicians Quality Care

Summary Statement of Deficiencies D0000 During a recertification survey on 11/03/2023, the laboratory was found out of compliance with the following conditions: 42 CFR 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director 42 CFR 493.1415 Condition: Laboratories performing moderate complexity testing; clinical consultant D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records and staff interview, the laboratory failed to identify testing personnel that performed wet prep proficiency testing in 2022 and 2023 for three of five events reviewed. The findings include: 1. Review of the API PT records revealed the testing person that performed the wet prep PT was not identified on the PT attestation statement or in the PT records for Hematology/Coagulation 2022 events one and two and 2023 event two. 2. Interview on 11/03/2023 at 1:30 pm with the laboratory liaison confirmed the laboratory failed to maintain all PT records when it did not retain the identity or attestation signature of the testing person that performed wet prep PT in 2022 and 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 5 -- D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of the laboratory's API PT records and staff interview, the laboratory failed to evaluate one of one non-graded PT wet prep scores in 2022. The findings include: 1. Review of the API PT records revealed one non-graded wet prep score with no documented evaluation to determine laboratory accuracy (2022 event two, sample VA-02). 2. Interview on 11/03/2023 at 1:30 pm with the laboratory liaison confirmed the laboratory failed to evaluate the non-graded PT score for wet prep testing in 2022. 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 review of the Department of Health and Human Services Centers for Medicare and Medicaid Services Laboratory Personnel Report (CLIA) (FORM CMS- 209), laboratory personnel records, and staff interview, the laboratory failed to employ a laboratory director that met the qualification requirements in subpart M (Refer to D6003) beginning on 09/01/2023. D6003 LABORATORY DIRECTOR QUALIFICATIONS CFR(s): 493.1405 AND 493.1406 The laboratory director must be qualified to manage and direct the laboratory personnel and the performance of moderate complexity tests and must be eligible to be an operator of a laboratory within the requirements of subpart R of this part. (a) The laboratory director must possess a current license as a laboratory director issued by the State in which the laboratory is located, if such licensing is required; and (b) The laboratory director must-- (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)(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 (b)(2)(ii) Have had laboratory training or experience consisting of: (b)(2)(ii)(A) At least one year directing or supervising non- waived laboratory testing; or (b)(2)(ii)(B) Beginning September 1, 1993, have at least 20 continuing medical education credit hours in laboratory practice commensurate with the director responsibilities defined in 493.1407; or (b)(2)(ii)(C) Laboratory training equivalent to paragraph (b)(2)(ii)(B) of this section obtained during medical -- 2 of 5 -- residency. (For example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine); 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 by the American Board of Medical Microbiology, the American Board of Clinical Chemistry, the American Board of Bioanalysis, or the American Board of Medical Laboratory Immunology; or (b)(3)(ii) Have had at least one year experience directing or supervising non-waived laboratory testing; (b)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; (b)(4)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing; and (b)(4)(iii) In addition, have at least one year of supervisory laboratory experience in non-waived testing; or (b)(5)(i) Have earned a bachelor's degree in a chemical, physical, or biological science or medical technology from an accredited institution; (b)(5)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing; and (b)(5)(iii) In addition, have at least 2 years of supervisory laboratory experience in non-waived testing; (b)(6) Be serving as a laboratory director and must have previously qualified or could have qualified as a laboratory director under 493.1406; or (b)(7) On or before February 28, 1992, qualified under State law to direct a laboratory in the State in which the laboratory is located. Laboratory director qualifications on or before February 28, 1992 The laboratory director must be qualified to manage and direct the laboratory personnel and test performance. (a) The laboratory director must possess a current license as a laboratory director issued by the State, if such licensing exists; and (b) The laboratory director must: (b)(1) Be a physician certified in anatomical 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; (b)(2) Be a physician who: (b)(2)(i) Is certified by the American Board of Pathology or the American Osteopathic Board of Pathology in at least one of the laboratory specialties; or (b)(2)(ii) Is certified by the American Board of Medical Microbiology, the American Board of Clinical Chemistry, the American Board of Bioanalysis, or other national accrediting board in one of the laboratory specialties; or (b)(2)(iii) Is certified by the American Society of Cytology to practice cytopathology or possesses qualifications that are equivalent to those required for such certification; or (b)(2)(iv) Subsequent to graduation, has had 4 or more years of full-time general laboratory training and experience of which at least 2 years were spent acquiring proficiency in one of the laboratory specialties; (b)(3) For the subspecialty of oral pathology only, be certified by the American Board of Oral Pathology, American Board of Pathology or the American Osteopathic Board of Pathology or possesses qualifications that are equivalent to those required for certification; (b)(4) Hold an earned doctoral degree from an accredited institution with a chemical, physical, or biological science as a major subject and (b)(4)(i) Is certified by the American Board of Medical Microbiology, the American Board of Clinical Chemistry, the American Board of Bioanalysis, or other national accrediting board acceptable to HHS in one of the laboratory specialties; or (b)(4)(ii) Subsequent to graduation, has had 4 or more years of full-time general laboratory training and experience of which at least 2 years were spent acquiring proficiency in one of the laboratory specialties; (b)(5) With respect to individuals first qualifying before July 1, 1971, have been responsible for the direction of a laboratory for 12 months between July 1, 1961, and January 1, 1968, and, in addition, either: (b)(5)(i) Was a physician and subsequent to graduation had at least 4 years of pertinent full-time laboratory experience; (b)(5)(ii) Held a master's degree from an accredited institution with a chemical, physical, or biological science as a major subject and subsequent to graduation had at least 4 years of pertinent full- time laboratory experience; (b)(5)(iii) Held a bachelor's degree from an accredited -- 3 of 5 -- institution with a chemical, physical, or biological science as a major subject and subsequent to graduation had at least 6 years of pertinent full-time laboratory experience; or (b)(5)(iv) Achieved a satisfactory grade through an examination conducted by or under the sponsorship of the U.S. Public Health Service on or before July 1, 1970; or (b)(6) Qualify under State law to direct the laboratory in the State in which the laboratory is located. Note: The January 1, 1968 date for meeting the 12 months' laboratory direction requirement in paragraph (b)(5) of this section may be extended 1 year for each year of full-time laboratory experience obtained before January 1, 1958 required by State law for a laboratory director license. An exception to the July 1, 1971 qualifying date in paragraph (b)(5) of this section was made provided that the individual requested qualification approval by October 21, 1975 and had been employed in a laboratory for at least 3 years of the 5 years preceding the date of submission of his qualifications. This STANDARD is not met as evidenced by: Based on review of the FORM CMS-209, laboratory personnel records, and staff interview, the person listed on the FORM CMS-209 as the laboratory director did not qualify as a laboratory director due to not possessing a current license to practice medicine. The findings include: 1. Review of the FORM CMS-209 and laboratory personnel records revealed the person listed as the laboratory director on the FORM CMS-209 did not meet the regulatory requirement to perform laboratory director duties due to a medical license that expired on 08/31/2023. 2. Interview on 11/03 /2023 at 9:35 am with the laboratory liaison confirmed the laboratory director listed on the Form CMS-209 did not meet the laboratory director qualification requirements when the license to practice medicine expired on 08/31/2023. D6056 CLINICAL CONSULTANT CFR(s): 493.1415 The laboratory must have a clinical consultant who meets the qualification requirements of 493.1417 of this part and provides clinical consultation in accordance with 493.1419 of this part. This CONDITION is not met as evidenced by: Based on review of the FORM CMS-209, laboratory personnel records, and staff interview, the laboratory failed to employ a clinical consultant that met the qualification requirements (Refer to D6057) beginning on 09/01/2023. D6057 CLINICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1417 The clinical consultant must be qualified to consult with and render opinions to the laboratory's clients concerning the diagnosis, treatment and management of patient care. The clinical consultant must-- (a) Be qualified as a laboratory director under 493. 1405(b)(1), (2), or (3)(i); or (b) Be a doctor of medicine, doctor of osteopathy or doctor of podiatric medicine and possess a license to practice medicine, osteopathy or podiatry in the State in which the laboratory is located. This STANDARD is not met as evidenced by: Based on review of the FORM CMS-209, laboratory personnel records, and staff -- 4 of 5 -- interview, the person listed on the FORM CMS-209 as the clinical consultant did not qualify to perform clinical consultant duties due to not possessing a current license to practice medicine. The findings include: 1. Review of the FORM CMS-209 and laboratory personnel records revealed the person listed as the clinical consultant on the FORM CMS-209 did not meet regulatory requirement to perform clinical consultant duties die to a medical license that expired on 08/31/2023. 2. Interview on 11/03/2023 at 9:35 am with the laboratory liaison confirmed the clinical consultant listed on the FORM CMS-209 did not meet the clinical consultant qualification requirements when the license to practice medicine expired on 08/31/2023. -- 5 of 5 --

Summary Statement of Deficiencies 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 observation of the laboratory, review of package inserts, staff interviews, review of patient test reports, the Centers for Medicare and Medicaid Services regulated analytes, proficiency testing records and interview with the laboratory liaison, the laboratory failed to enroll in proficiency testing for viral antigen detection in 2020 and 2021. The findings include: 1. Observation of the laboratory on 10/6/21 at approximately 8:40 am revealed the BinaxNOW test kit in use for patient testing. 2. Review of the package insert for the BinaxNOW RSV kit revealed the test is waived when used for patients under the age of five. The package insert indicated the test is a qualitative RSV antigen detection. 3. Staff interviews on 10/6/21 at approximately 9: 00 am revealed testing is performed on patients five and older, resulting in a laboratory developed high complexity test system. 4. Review of patient test reports revealed the modified test was used for patient testing in 2020 and 2021. 5. Review of the CMS regulated analyte list revealed that direct viral antigen detection is a regulated analyte. 6. Review of the 2020 and 2021 proficiency testing records revealed no enrollment or participation in proficiency testing for the viral antigen Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- detection. 7. Interview with the laboratory liaison on 10/6/21 at approximately 5:00 pm confirmed the laboratory was not enrolled in proficiency testing for viral antigen detection in 2020 and 2021. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on observation of the laboratory, record review, and staff interviews, the laboratory failed to report negative SARS-CoV-2 test results to public health authorities in 2020 and 2021. The findings include: 1. Observation of the lab on 10/6 /21 at approximately 9:00 am revealed the Accula and QuickVue test kits in use for patient testing for SARS-CoV-2. 2. Review of records for reporting of SARS-CoV-2 results to public health authorities revealed that the laboratory does not report negative SARS-CoV-2 results. For dates selected (10/2/20, 12/10/20, 6/19/21, and 9/24/21) only positive results were reported. 185 of 231 results were not reported. 3. Interview with the lab director on 10/6/21 at approximately 1 pm confirmed negative patient test results have not been reported to public health authorities since 10/1/20. D5010 VIROLOGY CFR(s): 493.1205 If the laboratory provides services in the subspecialty of Virology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1265, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: The laboratory failed to establish performance specifications for use of the laboratory modified, high complexity Respiratory Syncytial Virus test. (Refer to D5423) D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies 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 observation of the laboratory, review of package inserts, staff interviews, review of patient test reports, the Centers for Medicare and Medicaid Services regulated analytes, proficiency testing records and interview with the laboratory liaison, the laboratory failed to enroll in proficiency testing for viral antigen detection in 2020 and 2021. The findings include: 1. Observation of the laboratory on 10/6/21 at approximately 8:40 am revealed the BinaxNOW test kit in use for patient testing. 2. Review of the package insert for the BinaxNOW RSV kit revealed the test is waived when used for patients under the age of five. The package insert indicated the test is a qualitative RSV antigen detection. 3. Staff interviews on 10/6/21 at approximately 9: 00 am revealed testing is performed on patients five and older, resulting in a laboratory developed high complexity test system. 4. Review of patient test reports revealed the modified test was used for patient testing in 2020 and 2021. 5. Review of the CMS regulated analyte list revealed that direct viral antigen detection is a regulated analyte. 6. Review of the 2020 and 2021 proficiency testing records revealed no enrollment or participation in proficiency testing for the viral antigen Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- detection. 7. Interview with the laboratory liaison on 10/6/21 at approximately 5:00 pm confirmed the laboratory was not enrolled in proficiency testing for viral antigen detection in 2020 and 2021. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on observation of the laboratory, record review, and staff interviews, the laboratory failed to report negative SARS-CoV-2 test results to public health authorities in 2020 and 2021. The findings include: 1. Observation of the lab on 10/6 /21 at approximately 9:00 am revealed the Accula and QuickVue test kits in use for patient testing for SARS-CoV-2. 2. Review of records for reporting of SARS-CoV-2 results to public health authorities revealed that the laboratory does not report negative SARS-CoV-2 results. For dates selected (10/2/20, 12/10/20, 6/19/21, and 9/24/21) only positive results were reported. 185 of 231 results were not reported. 3. Interview with the lab director on 10/6/21 at approximately 1 pm confirmed negative patient test results have not been reported to public health authorities since 10/1/20. D5010 VIROLOGY CFR(s): 493.1205 If the laboratory provides services in the subspecialty of Virology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1265, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: The laboratory failed to establish performance specifications for use of the laboratory modified, high complexity Respiratory Syncytial Virus test. (Refer to D5423) D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies 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: The laboratory failed to maintain satisfactory participation in two out of three proficiency testing (PT) events for the the red blood cell and hematocrit analytes. (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. 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 -- This STANDARD is not met as evidenced by: Based on a desk review of the Centers for Medicare and Medicaid Casper Report 155 (CMS 155) and the laboratory's 2018 and 2019 proficiency testing (PT) records, the laboratory failed to maintain satisfactory performance for the red blood cell (RBC) and hematocrit analytes, resulting in the first unsuccessful occurrence. The findings include: 1) Review of the CMS 155 report revealed the following unsatisfactory scores: 2018 event two: RBC 0%, Hematocrit 20%; 2019 event one RBC 20%, Hematocrit 40%. 2) Review of the laboratory's 2018 event two PT performance evaluation report revealed the following: RBC sample numbers HD-6, HD-7, HD-8, HD-9, and HD-10 scored as fail, resulting in an overall score of 0% for the RBC analyte. Hematocrit sample numbers HD-6, HD-7, HD-8, and HD-10 scored as fail resulting in an overall score of 20% for the hematocrit analyte. 3) Review of the laboratory's 2019 event one performance evaluation report revealed the following: RBC sample number HD-1, HD-3, HD-4, and HD-5 scored as fail, resulting in an overall score of 20% for the RBC analyte, and the first unsuccessful PT occurrence for the RBC analyte. Hematocrit sample numbers HD-1, HD-3, and HD-4 scored as fail, resulting in an overall score of 40% for the Hematocrit analyte, and the first unsuccessful PT occurrence for the Hematocrit analyte. -- 2 of 2 --