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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 review of laboratory records and interview with staff, the laboratory failed to have a competency assessment policy and failed to perform competency assessments for clinical consultants. 1. Review of the form CMS-209 (Laboratory Personnel Report) signed by the Laboratory Director on August 20, 2025, the laboratory employed three Clinical Consultants. 2. Review of the laboratory's "Staff Competency" binder found no competency assessments for the three Clinical Consultants, nor a policy for competency assessment for Clinical Consultants. 3. During interview on August 26, 2025, at approximately 9:45 am, the Laboratory Director stated the three Clinical Consultants did not have competency assessments, nor did the laboratory have a policy for assessing the competency of Clinical Consultants. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. 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 review of the laboratory's procedure, direct observation, laboratory testing records, and interview with the laboratory director, the laboratory failed to follow their procedure and ensure the conditions of transport were within their temperature ranges for specimens (Glucose and Complete Blood Counts) received from outside laboratories for one of one months reviewed as evidenced by: 1. In review of the the laboratory's procedure titled Glucose Policy and Methodology stated. "the glucose concentration is general stable for as long as 8 hours at 25 degrees C and up to 72 hours at 4 degree C." 2. In review of the laboratory's procedure titled Symex XN-450 Automated Hematology Analyzer stated," If stored at 2-8 within 6 hours of collection. EDTA blood samples with normal results may be analyzed up to 48 hours..." 3. In direct observation at 1144 the laboratory did not take temperature once open the shipping container was opened or recorded temperature environment of the specimens that were being transported. The following patient was observed: a. ETCH0317 4. In review of the laboratory testing records from August 2025 to the date of the survey, the laboratory did not document the conditions of transport for glucose and Complete Blood Counts (CBCs). The laboratory provided no documentation to ensure specimen were within 2-8 degrees C and 4 degree C. 3. In interview with the laboratory director at 1204 she confirmed they did not record temperatures of the specimens when received from outside laboratories. She also stated that all specimens come in with ice packs and should be refrigerated. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with laboratory staff, the laboratory failed to perform maintenance on analyzers as required by the manufacturer for two of two analyzers. I. TOSOH AIA-900 No Serial Number Available 1. Review of the TOSOH AIA-900 immunoassay analyzer maintenance log found the log contained maintenance requirements for daily, weekly, monthly and quarterly tasks. Quarterly maintenance tasks were not documented by the laboratory for seven of seven months (January 2025-July 2025). 2. During interview on August 26, 2025, at approximately 1:30 pm, the Laboratory Director confirmed the laboratory failed to perform quarterly maintenance for the TOSOH AIA-900. II. TOSOH G8 Analyzer Serial Number 15631210 1. Review of the TOSOH G8 HPLC (High Performance Liquid Chromatography) analyzer maintenance log found the laboratory failed to replace the fluid supply line filters as required by the manufacturer for eight months (November 2024-June 2025). 2. Review of the TOSOH Bioscience operator manual on page 162 found the following: "5.9 Suction Filter Replacement - every 6 months ..." 3. During interview on August 26, 2025, at approximately 1:30 pm, the Laboratory Director confirmed the laboratory failed to replace the fluid supply line filters on the TOSOH G8 every six months. -- 2 of 2 --

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 of 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 3 -- Enhanced Reporting (CASPER) 0155 report and American Association of Bioanalysts (AAB) and American Proficiency Institute (API) records, the laboratory had not successfully participated in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the subspecialty of Endocrinology for the Thyroid Stimulating Hormone (TSH) analyte. Refer to D2107. D2107 ENDOCRINOLOGY CFR(s): 493.843(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 a proficiency testing desk review of the CASPER 0155 report and American Association of Bioanalysts (AAB) 2023 records and American Proficiency Institute (API) 2024 proficiency testing records, the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two of two consecutive testing events (2023, Event 3 and 2024, Event 1) in the subspecialty of Endocrinology for the Thyroid Stimulating Hormone (TSH) analyte. Findings included: 1. Review of the CASPER 0155 report revealed the following results: AAB Chemistry 2023 - 3rd Event. T The laboratory received an unsatisfactory score of 60% for the TSH. API Chemistry/Endocrinology 2024 - 1st Event The laboratory received an unsatisfactory score of 20 % for the TSH. 2. A review of AAB 2023 and API 2024 proficiency testing records confirmed the laboratory received the above results. 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 CASPER 0155 report and American Association of Bioanalysts (AAB) 2023 records and American Proficiency Institute (API) 2024 records, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to 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; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of CASPER 0155 report and American Association of Bioanalysts (AAB) 2023 records and American Proficiency Institute (API) 2024 records, the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2107. -- 3 of 3 --

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 the number and severity of the deficiency cited herein, the Condition: Successful [Proficiency Testing] Participation was not met. The laboratory failed to successfully participate in a proficiency testing program approved by CMS for each analyte or test in which the laboratory is certified under CLIA (see D2096). D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on laboratory personnel interviews and proficiency testing record review on August 29, 2023 at 09:30 am, the laboratory failed to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive proficiency testing events. Findings included: a. First Occurrences of Unsuccessful Proficiency Testing Performance: i. For the following analytes or tests, the laboratory failed to achieve satisfactory proficiency testing performance (i.e., obtain a minimum proficiency testing score of 80%) in two consecutive proficiency testing events or two out of three consecutive proficiency testing events constituting first occurrences of unsuccessful proficiency testing performance: ALT (SGPT), Albumin, ALP, AST (SGOT), Bilirubin - total, Calcium - total, Chloride, Cholesterol - total, Creatinine, Glucose (non-waived), Potassium, Sodium, Total Protein, Triglyceride, BUN, and Uric Acid. ii. For these analytes or tests, the laboratory received scores of 0% for the third event of 2022 and scores of 0% for the first event of 2023. b. Subsequent Occurrence of Unsuccessful Proficiency Testing Performance: i. For the following analyte or test, the laboratory failed to achieve satisfactory proficiency testing performance (i.e., obtain a minimum proficiency testing score of 80%) in two consecutive proficiency testing events or two out of three consecutive proficiency testing events constituting a subsequent occurrence of unsuccessful proficiency testing performance: Cholesterol - HDL. ii. For this analyte, the laboratory received a score of 0% for the third event of 2022, a score of 0% for the first event of 2023, and 60% for the second event of 2023. c. According to laboratory records, the laboratory performs and reports approximately 15,500 patient routine chemistry tests annually. 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 the number and severity of the deficiency cited herein, the Condition: Laboratories Performing Moderate Complexity Testing - Laboratory Director was not met. The laboratory director failed to ensure that proficiency testing samples were tested as required under Subpart H of this part (see 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; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on laboratory personnel interviews and proficiency testing record review on August 29, 2023 at 09:30 am, the laboratory director failed to ensure that proficiency testing samples were tested as required under Subpart H of this part. Findings included: The laboratory failed to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive proficiency testing events. See D2016. -- 3 of 3 --

Summary Statement of Deficiencies 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 review of SARS CoV-2 patient test results, interview with the laboratory director and lack of reporting documentation for review, the laboratory failed to report SARS-CoV-2 test results as required for 2 of 2 days reviewed from September 30, 2021 through November 1, 2021. Findings include: 1. The laboratory performs SARS- CoV-2 testing utilizing the Cepheid SARS-CoV-2 Xpert Xpress real time RT-PCR test and since September 30, 2021. 2. SARS-CoV-2 test result from 11/01/21 (#32830) was reviewed during the survey on 11/02/21. 2 SARS-CoV-2 test results were not reported as required during the period of review. 3.No evidence was presented for review during the survey on 11/02/21 to indicate that the laboratory had reported SARS-CoV-2 test results (positive and negative) to the State authorities as required for patient testing performed by the laboratory on 9/30/21 and 11/01/21. 4. The laboratory director confirmed on 11/02/21 at 9.33 a.m. that the laboratory was not aware of SARS-CoV-2 test result reporting requirements and had not reported SARS- CoV-2 test results as required since initiating patient testing on 09/30/21. D5403 PROCEDURE MANUAL 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 -- 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)

Summary Statement of Deficiencies 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 review of SARS CoV-2 patient test results, interview with the laboratory director and lack of reporting documentation for review, the laboratory failed to report SARS-CoV-2 test results as required for 2 of 2 days reviewed from September 30, 2021 through November 1, 2021. Findings include: 1. The laboratory performs SARS- CoV-2 testing utilizing the Cepheid SARS-CoV-2 Xpert Xpress real time RT-PCR test and since September 30, 2021. 2. SARS-CoV-2 test result from 11/01/21 (#32830) was reviewed during the survey on 11/02/21. 2 SARS-CoV-2 test results were not reported as required during the period of review. 3.No evidence was presented for review during the survey on 11/02/21 to indicate that the laboratory had reported SARS-CoV-2 test results (positive and negative) to the State authorities as required for patient testing performed by the laboratory on 9/30/21 and 11/01/21. 4. The laboratory director confirmed on 11/02/21 at 9.33 a.m. that the laboratory was not aware of SARS-CoV-2 test result reporting requirements and had not reported SARS- CoV-2 test results as required since initiating patient testing on 09/30/21. D5403 PROCEDURE MANUAL 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 -- 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)