Fayetteville Diagnostic Clinic

Summary Statement of Deficiencies D0000 A proficency testing desk review was performed January 14th, 2026 and the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 Code of Federal Regulations (C.F.R.) 493.803 Condition: Successful participation (proficiency testing) D6016 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. The following acronyms will be utilized in this report: API - American Proficiency Institute CASPER - Certification and Survey Provider Enhanced Reporting CLIA - Clinical Laboratory Improvement Act CMS - Centers for Medicare and Medicaid Services HHS - Department of Health and Human Services PT - Prothrombin Time 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. 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 CONDITION is not met as evidenced by: Based on review of the 2025 CMS CASPER Reports 0155D, and API records (2025- 2nd and 2025-3rd), the laboratory failed to achieve satisfactory performance in a proficiency program approved by the HHS for each specialty, subspecialty, and analyte or test in which the laboratory is certified under the CLIA. The laboratory failed to successfully participate in the subspecialty of Hematology for the analyte PT. Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events is unsuccessful performance as cited at D2131. D2130 HEMATOLOGY CFR(s): 493.851(f) (f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the CMS CASPER Reports 0155D and API proficiency testing results, the laboratory failed to achieve satisfactory performance for two of two consecutive testing events (2025-2, 2025-3) proficiency testing for the analyte PT. Survey Findings follow: A. A review of CASPER 0155D reports revealed the following results for two testing events for compatibility testing: 2025-2:60% 2025-3: 40% B. A review of API records confirmed the findings. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of CMS 0155D and API proficiency testing results for 2025, the laboratory director failed to provide overall management and direction of the laboratory services. The laboratory director failed to ensure that the proficiency testing samples are tested as required under Subpart H of this part. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a review of the 2025 Casper CMS 0155D and API proficency testing event results, the laboratory director failed to ensure the laboratory successfully participated in proficiency testing in an HHS approved proficiency testing program for PT. Refer to D2131. -- 2 of 2 --

Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Through a review of 10 patient medical records and an interview with laboratory staff, it was determined the laboratory failed to include all required data on test reports. Survey findings follow: A) One of one arterial blood gas report reviewed on the medical record of patient #1332743 failed to include the name and address of the laboratory location where the test was performed. B) In an interview, at 3:20 p.m. on 11/16/22, laboratory employee #3 (as listed on the form CMS-209) confirmed that there was no laboratory identification on the blood gas report listed ablove. She further stated that arterial blood gas final reports are issued from a system separate from the system used in reporting all other laboratory tests and this would result in all arterial blood gas reports lacking the name and address of the performing laboratory. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Through a review of the Maintenance Logs for the ACL Elite coagulation analyzer, lack of documentation, and interviews with lab staff, it was determined the laboratory failed to perform monthly maintenance on the ACL Elite in June 2020. Survey findings follow: A. The laboratory uses the ACL Elite for moderate complexity coagulation tests (Protime and PTT). The manufacturer's maintenance logs include the following required monthly maintenance: Clean the air filter; back up/archive data; and hard drive maint disk. B. A review of ACL Elite Maintenance Logs for January 2020 through March 2021 revealed the monthly maintenance was not documented in one of fifteen months reviewed. There was no documentation of monthly maintenance in June 2020. C. In an interview, at 9:35 on 4/1/2021, laboratory employee #3 (as listed on the form CMS-209) confirmed the monthly maintenance for June 2020 was not documented. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. 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 -- This STANDARD is not met as evidenced by: Through a review of laboratory policies and procedures, a review of the quality control reports for the MedTox Profile-V drug screens, and interviews with laboratory staff, it was determined the laboratory failed to perform quality control each day for the moderate complexity MedTox Profile-V drug screens. Survey findings include: A. Laboratory policies and procedures were reviewed and it was determined the quality control policy for the MedTox Profile-V drug screens stated that positive and negative quality controls are run weekly and if starting a new lot of test kits. B. Documentation of MedTox Profile-V drug screen quality control was reviewed for July 2020, November 2020, and February 2021. In July 2020, quality control was tested 7/6,7/13, 7/20, 7/27, and 7/31. In November 2020, quality control was documented on 11/2, 11 /9, 11/16, 11/23, and 11/30. In February 2021 drug screen quality control was documented 2/1, 2/8, 2/16, and 2/22. C. In an interview, at 12:48 on 4/1/2021, laboratory employee #3 stated that the laboratory started using the MedTox Profile-V (MedTox Scan) in February 2020 and that the quality control is performed weekly. She further stated that the laboratory had not developed and IQCP for this test. D5537 ROUTINE CHEMISTRY CFR(s): 493.1267(b)(d) For blood gas analyses, the laboratory must perform the following: (b) Test one sample of control material each 8 hours of testing using a combination of control materials that include both low and high values on each day of testing. (d) Document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Through a review of the Laboratory Policies and Procedures, a review of blood gas quality control documentation, and interviews with laboratory staff, it was determined the laboratory failed to perform blood gas quality control each day of testing using a combination of control materials that include both low and high values and cover normal, alkalosis, and acidosis. Survey findings include: A. The policy for quality control of blood gas testing on the iSTAT states, "Run 2 levels of QC rotating between 3 levels (1 and 2, 2 and 3, 3 and 1) each day of testing and after calibration. B. Through a review of blood gas quality control results for July 2020, it was determined that each day of patient testing, the following quality control was documented: On 7/1 levels #1 and #3, on 7/2 levels #1 and #2, on 7/6 levels #2 and #3, on 7/7 levels #1 and #3, on 7/8 levels #1 and #2, on 7/17 levels #2 and #3, on 7/20 levels #1 and #3, on 7/27 levels #1 and #2, and on 7/31 levels #2 and #3. C. Through a review of blood gas quality control results for November 2020, it was determined that each day of patient testing, the following quality control was documented: on 11/2 Level #1 only, on 11/4 levels #2 and #3, on 11/5 levels #2 and #3, on 11/9 levels #2 and #3, on 11/11 levels #1 and #2, 11/13 levels #2 and #3, 11/16 levels #1 and #3, 11 /17 levels #1 and #2, 11/18 levels #2 and #3, 11/20 level #2 only, 11/23 levels #2 and #3, 11/25 levels #1 and #3, 11/30 levels #1 and #2. D. Through a review of blood gas quality control results for February 2021, it was determined that each day of patient testing, the following quality control was documented: on 2/3 levels #2 and #3, on 2 /16 levels #1 and #3, and on 2/25 levels #1 and #2. E. Both low and high were documented on 3 of 9 days of testing in July 2020, 3 of 13 days in November 2020, and 1 of 3 days of testing in February 2021. All three levels of control were documented 0 of 25 days in the three months reviewed. F. In an interview, at 3:39 on 4 /1/2021, laboratory personnel #3 (as listed on the form CMS-209) confirmed the -- 2 of 3 -- laboratory failed to test three levels of quality control covering normal, alkalosis, and acidosis each day of testing. -- 3 of 3 --

Summary Statement of Deficiencies D5783