Medical Arts Laboratory Inc

Summary Statement of Deficiencies D0000 The following deficiencies were 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] . 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 review of the Centers for Medicare and Medicaid Services Casper Report 155, review of the American Proficiency Institute evaluations reports, and staff 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 -- interview, the laboratory failed to achieve satisfactory performance scores on the analyte of thyroid stimulating hormone for 2 consecutive testing events (2025 event #1, 2025 event #2). Refer to D2107. . D2107 ENDOCRINOLOGY CFR(s): 493.843(f) (f) 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 review of the Centers for Medicare and Medicaid Services (CMS) Casper Report 155, review of the API (American Proficiency Institute) evaluation reports, and staff interview, the laboratory failed to achieve satisfactory performance scores on the analyte of thyroid stimulating hormone (TSH) for 2 consecutive testing events (2025 event #1, 2025 event #2). The findings were: 1. Review of the CMS Casper 155 report showed the laboratory failed to successfully obtain a passing score for the analyte of TSH for the following API proficiency testing events: a. 2025 event #1 showed the laboratory scored a 60%. b. 2025 event #2 showed the laboratory scored a 40%. 2. Review of the API proficiency testing evaluations confirmed the laboratory had scored 60% on the 2025 event #1 testing event and a 40% on the 2025 event #2 testing event for the analyte of TSH. 3. Telephone interview with the laboratory manager on 7/21/25 at 2:44 PM confirmed the laboratory had failed 2 consecutive proficiency testing events on the analyte of TSH. -- 2 of 2 --

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 review of the Centers for Medicare and Medicaid Services Casper Report 155, review of the American Proficiency Institute evaluations reports, and staff interview, the laboratory failed to achieve satisfactory performance scores on the analyte of free thyroxine for 2 consecutive testing events (2024 event #3, 2025 event #1). Refer to D2107. D2107 ENDOCRINOLOGY CFR(s): 493.843(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 2 -- (f) 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 review of the Centers for Medicare and Medicaid Services (CMS) Casper Report 155, review of the API (American Proficiency Institute) evaluation reports, and staff interview, the laboratory failed to achieve satisfactory performance scores on the analyte of free thyroxine (FT4) for 2 consecutive testing events (2024 event #3, 2025 event #1). The findings were: 1. Review of the CMS Casper 155 report showed the laboratory failed to successfully obtain a passing score for the analyte of FT4 for the following API proficiency testing events: a. 2024 event #3 showed the laboratory scored a 60%. b. 2025 event #1 showed the laboratory scored a 60%. 2. Telephone interview with the laboratory manager on 3/17/25 at 1:25 PM confirmed the laboratory had failed 2 consecutive proficiency testing events on the analyte of FT4. -- 2 of 2 --

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of proficiency testing records, lack of documentation, and staff interview, the laboratory failed to review and evaluate proficiency testing (PT) results for 4 of 31 proficiency testing events reviewed from June 2022 through August 2024. The findings were: 1. Review of the American Proficiency Institute (API) 2022 Chemistry Core Event #2 PT results showed the laboratory scored an 80% on the serum pregnancy assay. There was no documentation the laboratory had evaluated the proficiency test result. 2. Review of the API 2023 Chemistry Core Event #1 PT results showed the laboratory scored an 80% on carbon dioxide. There was no documentation the laboratory had evaluated the proficiency test result. 3. Review of the API 2024 Chemistry Core Event #1 PT results showed the laboratory scored an 80% on aspartate transaminase. There was no documentation the laboratory had evaluated the proficiency test result. 4. Review of the API 2024 Hematology/Coagulation Event #1 PT results showed the laboratory scored an 80% on the erythrocyte count. There was no documentation the laboratory had evaluated the proficiency test result. 5. Interview with the general supervisor on 9/11/24 at 11:07 AM confirmed an evaluation of the proficiency testing results had not been conducted. 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 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 -- 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 proficiency testing records, lack of documentation, and staff interview, the laboratory failed to have a system in place for reviewing proficiency test results that received an artificial score of 100% for 10 of 31 API (American Proficiency Institute) proficiency testing events reviewed from June 2022 through August 2024. The findings were: 1. Review of the 2022 API Hematology/Coagulation Event #2 proficiency testing evaluation showed the laboratory received an artificial score of 100% on sample VA-02 (vaginal wet prep) and an artificial score on UA-03 (urobilinogen) due to a lack of consensus. There was no documentation a self- evaluation of sample VA-02 or UA-03 had been completed. 2. Review of the 2022 API Hematology/Coagulation Event #3 proficiency testing evaluation showed the laboratory received an artificial score of 100% on BCI-14 (blood cell identification) due to no consensus. There was no documentation a self-evaluation of sample BCI-14 had been completed. 3. Review of the 2022 API Immunology Event #2 proficiency testing evaluation showed the laboratory received an artificial score of 100% on CRP- 04 (C-reactive protein) due to a lack of consensus. There was no documentation a self- evaluation had been completed. 4. Review of the 2023 API Chemistry Core Event #1 proficiency testing evaluation showed the laboratory received an artificial score of 100% on CH-01 (alanine transaminase). There was no documentation a self- evaluation had been completed. 5. Review of the 2023 API Hematology/Coagulation Event #1 proficiency testing evaluation showed the laboratory received an artificial score of 100% on UA-02 (urobilinogen) due to a lack of consensus. There was no documentation a self-evaluation had been completed. 6. Review of the 2023 API Hematology/Coagulation Event #2 proficiency testing evaluation showed the laboratory received an artificial score of 100% on UA-03 (urobilinogen) due to a lack of consensus. There was no documentation a self-evaluation had been completed. 7. Review of the 2023 API Hematology/Coagulation Event #3 proficiency testing evaluation showed the laboratory received an artificial score of 100% on VA-03 (vaginal wet prep) due to a lack of consensus. There was no documentation a self- evaluation had been completed. 8. Review of the 2023 API Immunology Event #3 proficiency testing evaluation showed the laboratory received an artificial score of 100% on CRP-06 (c-reactive protein) due to a lack of consensus. There was no documentation a self-evaluation had been completed. 9. Review of the 2024 API Chemistry Core Event #1 proficiency testing evaluation showed the laboratory received an artificial score of 100% on samples CH-02, CH-03, and CH-05 due to "result variance" on the analyte of total bilirubin. There was no documentation a self- evaluation had been completed. 10. Review of the 2024 API Chemistry Core Event #2 proficiency testing evaluation showed the laboratory received an artificial score of 100% on CH-08 (iron) due to "result variance". There was no documentation a self- evaluation had been completed. 11. Interview with the general supervisor on 9/11/24 at 11:07 AM confirmed a self-evaluation of the non-graded test results had not been conducted. 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 -- 2 of 3 -- 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)

Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: . Based on review of proficiency testing (PT) records, review of the laboratory's criteria for repeat testing, and staff interview, the laboratory failed to test proficiency test samples the same number of times that it routinely tested patient samples for 4 of 28 API (American Proficiency Institute) proficiency testing events reviewed from 2020 Event #3 through 2022 Event #1. The findings were: 1. Review of the PT record for API 2021 Hematology Event #1 showed sample #1 was analyzed on 3/12/21 at 1: 27 PM and again at 1:30 PM. 2. Review of the API 2021 Hematology Event #2 showed sample #6 was analyzed on 7/19/21 at 1:32 PM and again at 1:37 PM. Sample #10 was analyzed at 2:06 PM and again at 2:08 PM. 3. Review of the 2021 API Hematology Event #3 showed sample #13 was analyzed on 11/4/21 at 10:05 AM and again at 10:11 AM. 4. Review of the API 2022 Hematology Event #1 showed sample #1 was analyzed on 3/10/22 at 10:03 AM and again at 10:06 AM. 5. Review of the laboratory's "Hematology Lab Action Limits" criteria for repeat testing showed the results of each of the test samples repeated did not meet the criteria for repeat testing. 6. Interview with the laboratory manager on 5/10/22 at 12:41 PM confirmed the PT samples that were repeated did not meet the criteria. . 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 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 -- 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 the laboratory's COVID-19 patient testing log and staff interview, the laboratory failed to report 1 of 1 SARS-COV-2 patient test results for one month of testing reviewed (April 2022). The findings were: 1. Review of the COVID-19 patient testing log showed 1 patient test had been performed on 4/28/22 using the Mesa BioTech Accula molecular testing platform. There was no evidence the results of the patient's test had been reported to the State of Wyoming Public Health Department. 2. Interview with the laboratory manager on 5/10/22 at 12:41 PM revealed the laboratory had just recently began testing for COVID-19 and she was unaware of the regulation. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: . Based on review of the CMS-116 form, lack of documentation, and staff interview, the laboratory failed to have a written procedure for reporting SARS-CoV-2 positive and negative test results. The laboratory had performed 1 SARS-CoV-2 patient test using a molecular platform since the test was implemented in April 2022. The findings were: 1. Review of the CMS-116 form showed the laboratory performed molecular testing for SARS-CoV-2 using the Mesa Biotech Accula molecular testing procedure. 2. Review of the laboratory's procedure manuals showed no evidence the laboratory had developed a policy and procedure for reporting SARS-CoV-2 positive and negative test results to the appropriate agencies. 3. Interview with the laboratory manager on 5/10/22 at 12:41 PM confirmed the laboratory did not have a written procedure for reporting positive and negative SARS-CoV-2 patient test results. . D6108 LABORATORY TECHNICAL SUPERVISOR 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 review of personnel files, lack of documentation, and staff interview, the laboratory's technical supervisor failed to ensure an annual competency assessment had been completed for 1 of 1 testing personnel (D6128) performing high complexity testing for two consecutive survey cycles (2020, 2022). . -- 2 of 3 -- D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: . Based on review of the CMS-209 Laboratory Personnel Report, review of personnel files, and staff interview, the laboratory technical supervisor failed to evaluate 1 of 1 high complexity testing personnel for competency at least annually for 1 of 2 years of testing reviewed (2021). The findings were. 1. Review of the CMS-209 Laboratory Personnel Report listed 1 testing personnel as performing high complexity patient testing. 2. Review of personnel files showed no evidence a competency assessment was completed in 2021. 3. Interview with the laboratory manager on 5/10/22 at 12:41 PM revealed she unable to locate the competency assessment. THIS IS A REPEAT DEFICIENCY, last cited on 9/2/20. -- 3 of 3 --

Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: . Based on review of proficiency testing (PT) records, review of the laboratory's criteria for repeat testing, and staff interview, the laboratory failed to test proficiency test samples the same number of times that it routinely tested patient samples for 4 of 28 API (American Proficiency Institute) proficiency testing events reviewed from 2020 Event #3 through 2022 Event #1. The findings were: 1. Review of the PT record for API 2021 Hematology Event #1 showed sample #1 was analyzed on 3/12/21 at 1: 27 PM and again at 1:30 PM. 2. Review of the API 2021 Hematology Event #2 showed sample #6 was analyzed on 7/19/21 at 1:32 PM and again at 1:37 PM. Sample #10 was analyzed at 2:06 PM and again at 2:08 PM. 3. Review of the 2021 API Hematology Event #3 showed sample #13 was analyzed on 11/4/21 at 10:05 AM and again at 10:11 AM. 4. Review of the API 2022 Hematology Event #1 showed sample #1 was analyzed on 3/10/22 at 10:03 AM and again at 10:06 AM. 5. Review of the laboratory's "Hematology Lab Action Limits" criteria for repeat testing showed the results of each of the test samples repeated did not meet the criteria for repeat testing. 6. Interview with the laboratory manager on 5/10/22 at 12:41 PM confirmed the PT samples that were repeated did not meet the criteria. . 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 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 -- 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 the laboratory's COVID-19 patient testing log and staff interview, the laboratory failed to report 1 of 1 SARS-COV-2 patient test results for one month of testing reviewed (April 2022). The findings were: 1. Review of the COVID-19 patient testing log showed 1 patient test had been performed on 4/28/22 using the Mesa BioTech Accula molecular testing platform. There was no evidence the results of the patient's test had been reported to the State of Wyoming Public Health Department. 2. Interview with the laboratory manager on 5/10/22 at 12:41 PM revealed the laboratory had just recently began testing for COVID-19 and she was unaware of the regulation. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: . Based on review of the CMS-116 form, lack of documentation, and staff interview, the laboratory failed to have a written procedure for reporting SARS-CoV-2 positive and negative test results. The laboratory had performed 1 SARS-CoV-2 patient test using a molecular platform since the test was implemented in April 2022. The findings were: 1. Review of the CMS-116 form showed the laboratory performed molecular testing for SARS-CoV-2 using the Mesa Biotech Accula molecular testing procedure. 2. Review of the laboratory's procedure manuals showed no evidence the laboratory had developed a policy and procedure for reporting SARS-CoV-2 positive and negative test results to the appropriate agencies. 3. Interview with the laboratory manager on 5/10/22 at 12:41 PM confirmed the laboratory did not have a written procedure for reporting positive and negative SARS-CoV-2 patient test results. . D6108 LABORATORY TECHNICAL SUPERVISOR 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 review of personnel files, lack of documentation, and staff interview, the laboratory's technical supervisor failed to ensure an annual competency assessment had been completed for 1 of 1 testing personnel (D6128) performing high complexity testing for two consecutive survey cycles (2020, 2022). . -- 2 of 3 -- D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: . Based on review of the CMS-209 Laboratory Personnel Report, review of personnel files, and staff interview, the laboratory technical supervisor failed to evaluate 1 of 1 high complexity testing personnel for competency at least annually for 1 of 2 years of testing reviewed (2021). The findings were. 1. Review of the CMS-209 Laboratory Personnel Report listed 1 testing personnel as performing high complexity patient testing. 2. Review of personnel files showed no evidence a competency assessment was completed in 2021. 3. Interview with the laboratory manager on 5/10/22 at 12:41 PM revealed she unable to locate the competency assessment. THIS IS A REPEAT DEFICIENCY, last cited on 9/2/20. -- 3 of 3 --

Summary Statement of Deficiencies D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: Based on patient test requisitions review, lack of documentation, and confirmation by staff, the laboratory failed to have a written or electronic request for patient testing from an authorized person for 1 of 5 test requisitions reviewed. The laboratory performs approximately 95,000 tests per year. Findings include: 1. Patient test requisitions review for specimen number 227948 collected on 11/01/2018 for a Lactate Dehydrogenase (LDH) test failed to include a written or electronic test requisition. 2. In an interview conducted on 09/02/2020 at approximately 3:30 P.M., staff confirmed the laboratory did not collect written or electronic test requisitions for Health Fair specimens. The number of Health Fair tests performed was not determined. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on lack of documentation and confirmation by staff, the laboratory technical 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 -- consultant failed to evaluate 1 of 1 high complexity testing personnel for competency at least annually for 2 of 2 years of testing reviewed (2018 and 2019). 1. The laboratory failed to document testing personnel competency in 2018 and 2019 for Bacteriology, Syphilis Serology, General Immunology, Routine Chemistry, Endocrinology, and Hematology testing for the single testing person employed. 2. In an interview conducted on 09/02/2020 at approximately 5:15 P.M., staff confirmed the competency evaluations were not available on the day of survey for the single testing person. -- 2 of 2 --

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 proficiency testing records review, lack of documentation and interview with staff, the laboratory failed to enroll in proficiency testing for the specialty of Bacteriology for throat culture negative confirmation testing for 2018. The laboratory performed approximately 100 throat culture confirmation tests per month. Findings include: 1. Proficiency testing records review failed to include documentation the laboratory enrolled in an approved proficiency testing program for the specialty of Bacteriology for Throat culture testing to determine the presence or absence of Group A Streptococcus. 2. In an interview with staff on 08/01/2018 at approximately 4:45 P. M., staff confirmed the laboratory had not enrolled in proficiency testing for Bacteriology in 2018. 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 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 -- 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)