First Care Medical Clinic

Summary Statement of Deficiencies D0000 An initial certification survey was conducted May 18-19, 2022. Based on the survey findings, Immediate Jeopardy was identified and the laboratory was notified May 19, 2022 at approximately 4:10 p.m. The laboratory failed to identify and correct problems in the specialty of hematology and the subspecialties of bacteriology, mycology, parasitology, routine chemistry, and endocrinology. The laboratory performs approximately 203,980 tests per year. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on review of manufacturer's IFU (Instructions for Use), review of personnel records, review of the FDA (Food and Drug Administration) website, review of the laboratory's policies and procedures, and interview with TP (testing personnel) #2 on 5 /18/22, the laboratory failed to follow manufacturer's instructions for performing the Sienna-Clarity COVID-19 Antigen Rapid Test Cassette. Findings: 1. The laboratory failed to follow manufacturer's IFU to ensure 5 of 5 TP were trained prior to testing patients for SARS-CoV-2 using the Sienna-Clarity COVID-19 Antigen Rapid Test Cassette test kit. Manufacturer's IFU printed from the FDA website state "INTENDED USE ... The Sienna-Clarity COVID-19 Antigen Rapid Test Cassette is intended for use by trained clinical laboratory personnel and individuals trained in point of care. The Sienna-Clarity COVID-19 Antigen Rapid Test Cassette is only for use under the Food and Drug Administration's Emergency Use Authorization. ... CONDITIONS OF AUTHORIZATION FOR THE LABORATORY ... F. All operators using your product must be appropriately trained in performing and interpreting the results of your product. Use appropriate personal protective Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 23 -- equipment when handling this kit, and use your product in accordance with the labeling. ..." During interview at approximately 12:10 p.m., TP #2 stated that in addition to the two laboratory personnel (TP #1 and TP #2), 3 medical assistants also perform COVID testing. He confirmed there were no training records available for any of the 5 testing personnel who perform COVID testing. 2. The laboratory failed to follow manufacturer's IFU to include Fact Sheets with patient test results. Manufacturer's IFU printed from the FDA website state "... CONDITIONS OF AUTHORIZATION FOR THE LABORATORY ... A. Authorized laboratories using your product must include, with test reports, all Fact Sheets. ..." Review of the FDA website revealed a "FACT SHEET FOR PATIENTS" and a "FACT SHEET FOR HEALTHCARE PROVIDERS". During interview at approximately 12:30 p.m., TP #2 confirmed that Fact Sheets were not given to patients with their COVID test results. 3. The laboratory failed to follow manufacturer's IFU to establish a process for reporting patient test results to state and/or local public health authorities. Manufacturer's IFU printed from the FDA website state "... D. Authorized laboratories using your product must have a process in place for reporting test results to healthcare providers and relevant public health authorities, as appropriate. ..." Review of the laboratory's "COVID-19 Antigen Rapid Test Policy" revealed it did not include instructions for reporting patient SARS-CoV-2 antigen test results to state and/or local public health authorities. During interview at approximately 12:30 p.m., TP #2 stated positive results are faxed to the health department. He verified the laboratory did not have a written procedure for reporting patient SARS-CoV-2 antigen test results to state and/or local public health authorities. 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 review of CMS (Centers for Medicare and Medicaid Services) Casper report 155D, review of 2019, 2020, 2021, and 2022 API (American Proficiency Institute) PT (proficiency testing) records, and interview with TP #2 on 5/18/22, the laboratory failed to enroll in an approved PT program for the BD (Becton Dickinson) Affirm VPIII testing in the subspecialty of Bacteriology. Findings: The laboratory performs testing for Gardnerella, Trichomonas, and Candida using the BD Affirm VPIII test. Review of the CMS Casper report 155D and 2019, 2020, 2021, and 2022 API proficiency testing records revealed the laboratory had not enrolled in PT for the regulated subspecialty of Bacteriology for 2019, 2020, 2021, and 2022. During interview at approximately 10:30 a.m on 5/18/22, TP #2 confirmed the laboratory was not enrolled in PT for the BD Affirm testing. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) -- 2 of 23 -- (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 policies, review of 2019, 2020, 2021, and 2022 API PT records, and absence of documentation 5/18/22, the laboratory failed to maintain all PT records and failed to ensure the LD (laboratory director) and TP signed the attestation statements for testing events in 2019, 2020, and 2021. Findings: The laboratory's "Proficiency Testing & Split Testing Policy" states, "...Proficiency Testing Guidelines....The lab director or designee and testing personnel should sign the attestation page prior to submitting results... Primary records related to PT and alternate testing should be retained for two years unless longer retention is required for specific analytes...." Review of 2019, 2020, 2021, and 2022 API PT records revealed: 1. The laboratory failed to maintain the PT evaluation reports for 2019 3rd Hematology testing event and 2020 Chemistry Core and Hematology 2nd testing events. Review of records revealed the laboratory had only the API performance summary on file but no documentation of the evaluation reports for all analytes tested. 2. The laboratory failed to ensure the LD and/or TP signed the attestation for 2019 Chemistry Miscellaneous 2nd testing event, 2019 Hematology 3rd testing event, 2020 Chemistry Core and Hematology 3rd testing events, 2021 Hematology 1st testing event, and 2021 Chemistry Core 2nd testing event. 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 random review of SARS-CoV-2 patient logs and interview with TP (testing personnel) #2 on 5/18/22, the laboratory failed to report all positive and negative SARS-CoV-2 test results to state or local public health authorities. The laboratory performs SARS-CoV-2 antigen testing using the Sienna-Clarity COVID-19 Antigen Rapid Test Cassette. Random review of SARS-CoV-2 patient logs revealed: 1. On 12 /1/21, the laboratory tested 12 patients. The 2 patients that tested positive had "Faxed" written beside their names on the log. There was no documentation that public health -- 3 of 23 -- authorities were notified of the 10 negative results. 2. On 12/30/21, the laboratory tested 75 patients. 25 patients tested positive and 50 patients tested negative. There was no documentation that public health authorities were notified of any of the results. 3. On 1/22/22, the laboratory tested 47 patients. 9 patients tested positive and 38 patients tested negative. There was no documentation that public health authorities were notified of any of the results. 4. On 2/1/22, the laboratory tested 24 patients. 2 patients tested positive and 22 patients tested negative. There was no documentation that public health authorities were notified of any of the results. 5. On 5/4/22, the laboratory tested 5 patients. The 2 patients that tested positive had "Faxed Results" written beside their names on the log. There was no documentation that public health authorities were notified of the 3 negative results. Review of SARS-CoV-2 patient logs revealed the following statement printed at the bottom of each log sheet with a fax number: "Fax positive Covid to Health Department". Random review of SARS- CoV-2 patient logs also revealed multiple logs that did not include a test date and multiple logs which included only the first names of patients with no other identifier. During interview 5/18/22 at approximately 2:15 p.m., TP #2 stated that they fax positive results to the health department. He stated that TP #1 usually documents on the patient log if she faxes the result to the health department, but nobody else documents faxing results. He stated they do not keep fax confirmations or any other documentation to verify that the results were transmitted. He confirmed it was difficult to determine which patients were tested on which dates based on the documentation available. 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 review of the laboratory's policies, review of 2019, 2020, 2021, and 2022 API PT records and alternate PT records 5/18/22, the laboratory failed to verify accuracy of testing twice a year for the Qualitative urine drug screen in 2021 and for HA1c (glycosylated hemoglobin) in 2019, 2020, 2021, and 2022. Findings: The laboratory's "Alternate Proficiency/ Split Testing Program" policy states, "Alternate Proficiency Testing/Split Testing is required if the lab is not participating in CAP/API or other participating PT agency....This Alternate PT or Split testing should be performed at least twice (2) a year or Semi-annually..." Review of the 2019, 2020, 2021, and 2022 API PT records revealed the laboratory performed API Chemistry Miscellaneous 1st event in 2021 for the Qualitative Urine drug screen. There was no documentation that the laboratory participated or verified accuracy of the Qualitative urine drug screen for the 2nd event of 2021. Review of API PT records and alternate PT records revealed the laboratory had not verified accuracy for the HA1c test in 2019, 2020, 2021, and 2022. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: -- 4 of 23 -- Based on review of the laboratory's policies, review of the 2019, 2020, 2021, and 2022 API PT, and absence of documentation 5/18/22, the laboratory failed to document evaluation and

Summary Statement of Deficiencies D0000 An initial certification survey was conducted May 18-19, 2022. Based on the survey findings, Immediate Jeopardy was identified and the laboratory was notified May 19, 2022 at approximately 4:10 p.m. The laboratory failed to identify and correct problems in the specialty of hematology and the subspecialties of bacteriology, mycology, parasitology, routine chemistry, and endocrinology. The laboratory performs approximately 203,980 tests per year. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on review of manufacturer's IFU (Instructions for Use), review of personnel records, review of the FDA (Food and Drug Administration) website, review of the laboratory's policies and procedures, and interview with TP (testing personnel) #2 on 5 /18/22, the laboratory failed to follow manufacturer's instructions for performing the Sienna-Clarity COVID-19 Antigen Rapid Test Cassette. Findings: 1. The laboratory failed to follow manufacturer's IFU to ensure 5 of 5 TP were trained prior to testing patients for SARS-CoV-2 using the Sienna-Clarity COVID-19 Antigen Rapid Test Cassette test kit. Manufacturer's IFU printed from the FDA website state "INTENDED USE ... The Sienna-Clarity COVID-19 Antigen Rapid Test Cassette is intended for use by trained clinical laboratory personnel and individuals trained in point of care. The Sienna-Clarity COVID-19 Antigen Rapid Test Cassette is only for use under the Food and Drug Administration's Emergency Use Authorization. ... CONDITIONS OF AUTHORIZATION FOR THE LABORATORY ... F. All operators using your product must be appropriately trained in performing and interpreting the results of your product. Use appropriate personal protective Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 23 -- equipment when handling this kit, and use your product in accordance with the labeling. ..." During interview at approximately 12:10 p.m., TP #2 stated that in addition to the two laboratory personnel (TP #1 and TP #2), 3 medical assistants also perform COVID testing. He confirmed there were no training records available for any of the 5 testing personnel who perform COVID testing. 2. The laboratory failed to follow manufacturer's IFU to include Fact Sheets with patient test results. Manufacturer's IFU printed from the FDA website state "... CONDITIONS OF AUTHORIZATION FOR THE LABORATORY ... A. Authorized laboratories using your product must include, with test reports, all Fact Sheets. ..." Review of the FDA website revealed a "FACT SHEET FOR PATIENTS" and a "FACT SHEET FOR HEALTHCARE PROVIDERS". During interview at approximately 12:30 p.m., TP #2 confirmed that Fact Sheets were not given to patients with their COVID test results. 3. The laboratory failed to follow manufacturer's IFU to establish a process for reporting patient test results to state and/or local public health authorities. Manufacturer's IFU printed from the FDA website state "... D. Authorized laboratories using your product must have a process in place for reporting test results to healthcare providers and relevant public health authorities, as appropriate. ..." Review of the laboratory's "COVID-19 Antigen Rapid Test Policy" revealed it did not include instructions for reporting patient SARS-CoV-2 antigen test results to state and/or local public health authorities. During interview at approximately 12:30 p.m., TP #2 stated positive results are faxed to the health department. He verified the laboratory did not have a written procedure for reporting patient SARS-CoV-2 antigen test results to state and/or local public health authorities. 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 review of CMS (Centers for Medicare and Medicaid Services) Casper report 155D, review of 2019, 2020, 2021, and 2022 API (American Proficiency Institute) PT (proficiency testing) records, and interview with TP #2 on 5/18/22, the laboratory failed to enroll in an approved PT program for the BD (Becton Dickinson) Affirm VPIII testing in the subspecialty of Bacteriology. Findings: The laboratory performs testing for Gardnerella, Trichomonas, and Candida using the BD Affirm VPIII test. Review of the CMS Casper report 155D and 2019, 2020, 2021, and 2022 API proficiency testing records revealed the laboratory had not enrolled in PT for the regulated subspecialty of Bacteriology for 2019, 2020, 2021, and 2022. During interview at approximately 10:30 a.m on 5/18/22, TP #2 confirmed the laboratory was not enrolled in PT for the BD Affirm testing. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) -- 2 of 23 -- (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 policies, review of 2019, 2020, 2021, and 2022 API PT records, and absence of documentation 5/18/22, the laboratory failed to maintain all PT records and failed to ensure the LD (laboratory director) and TP signed the attestation statements for testing events in 2019, 2020, and 2021. Findings: The laboratory's "Proficiency Testing & Split Testing Policy" states, "...Proficiency Testing Guidelines....The lab director or designee and testing personnel should sign the attestation page prior to submitting results... Primary records related to PT and alternate testing should be retained for two years unless longer retention is required for specific analytes...." Review of 2019, 2020, 2021, and 2022 API PT records revealed: 1. The laboratory failed to maintain the PT evaluation reports for 2019 3rd Hematology testing event and 2020 Chemistry Core and Hematology 2nd testing events. Review of records revealed the laboratory had only the API performance summary on file but no documentation of the evaluation reports for all analytes tested. 2. The laboratory failed to ensure the LD and/or TP signed the attestation for 2019 Chemistry Miscellaneous 2nd testing event, 2019 Hematology 3rd testing event, 2020 Chemistry Core and Hematology 3rd testing events, 2021 Hematology 1st testing event, and 2021 Chemistry Core 2nd testing event. 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 random review of SARS-CoV-2 patient logs and interview with TP (testing personnel) #2 on 5/18/22, the laboratory failed to report all positive and negative SARS-CoV-2 test results to state or local public health authorities. The laboratory performs SARS-CoV-2 antigen testing using the Sienna-Clarity COVID-19 Antigen Rapid Test Cassette. Random review of SARS-CoV-2 patient logs revealed: 1. On 12 /1/21, the laboratory tested 12 patients. The 2 patients that tested positive had "Faxed" written beside their names on the log. There was no documentation that public health -- 3 of 23 -- authorities were notified of the 10 negative results. 2. On 12/30/21, the laboratory tested 75 patients. 25 patients tested positive and 50 patients tested negative. There was no documentation that public health authorities were notified of any of the results. 3. On 1/22/22, the laboratory tested 47 patients. 9 patients tested positive and 38 patients tested negative. There was no documentation that public health authorities were notified of any of the results. 4. On 2/1/22, the laboratory tested 24 patients. 2 patients tested positive and 22 patients tested negative. There was no documentation that public health authorities were notified of any of the results. 5. On 5/4/22, the laboratory tested 5 patients. The 2 patients that tested positive had "Faxed Results" written beside their names on the log. There was no documentation that public health authorities were notified of the 3 negative results. Review of SARS-CoV-2 patient logs revealed the following statement printed at the bottom of each log sheet with a fax number: "Fax positive Covid to Health Department". Random review of SARS- CoV-2 patient logs also revealed multiple logs that did not include a test date and multiple logs which included only the first names of patients with no other identifier. During interview 5/18/22 at approximately 2:15 p.m., TP #2 stated that they fax positive results to the health department. He stated that TP #1 usually documents on the patient log if she faxes the result to the health department, but nobody else documents faxing results. He stated they do not keep fax confirmations or any other documentation to verify that the results were transmitted. He confirmed it was difficult to determine which patients were tested on which dates based on the documentation available. 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 review of the laboratory's policies, review of 2019, 2020, 2021, and 2022 API PT records and alternate PT records 5/18/22, the laboratory failed to verify accuracy of testing twice a year for the Qualitative urine drug screen in 2021 and for HA1c (glycosylated hemoglobin) in 2019, 2020, 2021, and 2022. Findings: The laboratory's "Alternate Proficiency/ Split Testing Program" policy states, "Alternate Proficiency Testing/Split Testing is required if the lab is not participating in CAP/API or other participating PT agency....This Alternate PT or Split testing should be performed at least twice (2) a year or Semi-annually..." Review of the 2019, 2020, 2021, and 2022 API PT records revealed the laboratory performed API Chemistry Miscellaneous 1st event in 2021 for the Qualitative Urine drug screen. There was no documentation that the laboratory participated or verified accuracy of the Qualitative urine drug screen for the 2nd event of 2021. Review of API PT records and alternate PT records revealed the laboratory had not verified accuracy for the HA1c test in 2019, 2020, 2021, and 2022. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: -- 4 of 23 -- Based on review of the laboratory's policies, review of the 2019, 2020, 2021, and 2022 API PT, and absence of documentation 5/18/22, the laboratory failed to document evaluation and

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: Based on desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D 9/5/19 and desk review of 2018 and 2019 API (American Proficiency Institute) proficiency testing results 11/5/19, the laboratory failed to successfully participate in proficiency testing for Total Protein in two consecutive testing events. See the deficiency cited at D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D 9/5/19 and desk review of 2018 and 2019 API (American Proficiency Institute) proficiency testing results 11/5/19, the laboratory failed to achieve satisfactory performance for Total Protein in two consecutive testing events, resulting in unsuccessful performance. Findings: 1. Desk review of 2018 API proficiency testing results revealed the laboratory provided unacceptable responses for 2 of 5 samples and received a score of 60% for Total Protein on the 2018 Chemistry Core 3rd event. 2. Desk review of 2019 API proficiency testing results revealed the laboratory provided unacceptable responses for 2 of 5 samples and received a score of 60% for Total Protein on the 2019 Chemistry Core 1st event. 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 desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D 9/5/19 and desk review of 2018 and 2019 API (American Proficiency Institute) proficiency testing results 11/5/19, the laboratory director failed to provide overall management and direction to ensure successful participation in proficiency testing. See the deficiency cited at D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D 9/5/19 and desk review of 2018 and 2019 API (American Proficiency Institute) proficiency testing results 11/5/19, the laboratory director failed to ensure successful participation in proficiency testing as required in Subpart H. Findings: 1. Desk review of 2018 API proficiency testing results revealed the laboratory provided unacceptable responses for 2 of 5 samples and received a score of 60% for Total Protein on the 2018 Chemistry Core 3rd event. 2. Desk review of 2019 -- 2 of 3 -- API proficiency testing results revealed the laboratory provided unacceptable responses for 2 of 5 samples and received a score of 60% for Total Protein on the 2019 Chemistry Core 1st event. -- 3 of 3 --

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)