Carilion Clinic Fm -Waynesboro

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Carilion Clinic Family Medicine - Waynesboro on June 4, 2025 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows and includes the Condition under 42 CFR part 493 CLIA Regulation: D2000 - 42 C.F.R. 493-801 Condition: Enrollment and Testing of Samples. 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 a review of the Centers for Medicare and Medicaid Services CASPER 0096D CLIA Application and Survey Summary Report (CMS CASPER 0096D), a tour, proficiency testing (PT) records, patient logs, lack of documentation, and interviews, the laboratory failed to enroll in a hematology PT program for Complete Blood Count (CBC) for five (5) of twenty-three months reviewed while reporting five hundred sixty-one (561) patient CBC panels in 2025 year to date. (Note: survey timeframe: 7/7/23 - 6/4/25, timeframe of non enrollment: 1/1/25-6/4/25). Findings include: 1. Review of the CASPER 0096D report during pre-survey preparation revealed a lack of hematology PT scores reported for the following speciality and related analytes in calendar year 2025: 0760 HEMATOLOGY - Speciality 0765 Cell 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 -- Identification / WBC Differential 0775 Red Blood Cell Count, RBC 0785 Hematocrit, HCT 0795 Hemoglobin, HGB 0805 While Blood Cell Count, WBC 0815 Platelets, PLT 2. During a tour of the laboratory on 6/4/25 at 10 AM, the inspector noted one bench top Sysmex XN-L hematology analyzer. The inspector inquired regarding the operation of the analyzer and the lead tech stated at 10:00 AM, "We have not run CBC's in the last couple of weeks. We have been sending them out." 3. Review of the laboratory's 2024-2025 Wisconsin State Laboratory of Hygiene (WSLH) PT records revealed three hematology events (2024 Events 1-3). No hematology PT records for calendar year 2025 to date (6/4/25) were available. The inspector inquired regarding the lack of PT documentation for Event 1 of 2025 for their Sysmex CBC patient testing. The lead tech stated on 6/4/25 at 1 PM, "Our upper management sent in the PT enrollment for 2025. I was not aware or informed that CBC was not included". The technical consultant (TC) added by statement on 6/4/25 at 1 PM, "I noted that we did not have the 2025 PT records while preparing for this inspection. There was a miscommunication regarding enrollment for hematology between corporate and office laboratory staff." 4. The inspector requested the WSLH PT Enrollment Confirmation documentation. The record (dated 10/24/24) revealed the following PT modules were ordered for 2025 (order number 10034708): Cardiac Markers, INR - CoaguChek, Sedimentation Rate, Point of Care / PPMP Package, Mono Immunoserology, and SARS / Viral Molecular. 5. Review of patient test logs revealed the following number of CBC panels assayed on the Sysmex analyzer in calendar year 2025 year to date: January - 91; February - 74; March - 113; April - 142; May - 141; a total of 561 patient CBC panels were reported while not enrolled for regulated hematology analytes' PT module for 2025. 6. An interview with the lead testing personnel and TC on 6/6/25 at 1:30 PM confirmed the above findings. D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) (e)(4) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed and that-- This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services CASPER 0096D CLIA Application and Survey Summary Report (CMS CASPER 0096D), a tour, proficiency testing (PT) records, lack of documentation, hematology quality control (QC), instrument maintenance, patient test logs, and interviews, the laboratory director (LD) failed to ensure that the laboratory enrolled in a PT program for six of six hematology analytes: White Blood Cell Count (WBC), Red Blood Cell Count (RBC), Hemoglobin (HGB), Hematocrit (HCT), Platelet Count (PLT), and WBC Differential /Cell Identification (Cell ID) from 1/1/25 up to the date of the inspection on June 4, 2025. (Cross Reference D2000.) Findings include: 1. Review of the CMS CASPER 0096D report revealed a lack of PT scores for six of six hematology Complete Blood Count (CBC) analytes: WBC, RBC, HGB, HCT, PLT, and WBC Differential/Cell ID during calendar year 2025 to date of inspection, 6/4/25. 2. During a tour of the laboratory on 6/4/25 at 10 AM, the inspector noted a bench top CBC Sysmex XN-L hematology analyzer. 3. Review of laboratory's Wisconsin State Laboratory of Hygiene (WSLH) hematology PT records, a total of three events (2024 Events 1-3), revealed no records of an expected 2025 WSLH Event 1 for the hematology speciality analytes outlined above. The inspector requested to review 2025 PT Event 1 documentation. The records were not available for review. 4. Review of the 2025 Sysmex XN-L hematology maintenance, QC, and patient test logs -- 2 of 3 -- revealed that the laboratory operated the analyzer for resulting patient CBC panels for the following five months in calendar year 2025 year to date: January, February, March, April, and May. 5. An interview with the lead testing personnel and Technical Consultant on 6/6/25 at 1:30 PM confirmed the above findings. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Carilion Clinic FM- Waynesboro on September 30, 2021 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on interviews, review of manufacturer operator's guide, and patient records, the laboratory failed to have a policy for the collection and processing of an alternative anticoagulant tube type for the analysis of platelet count for one patient on 01/20/20. Findings include: 1. An interview with the primary testing personnel (TP) at approximately 12:00 PM on 09/30/21 revealed the laboratory has practiced an alternative collection and processing sodium citrate anticoagulation tube type for a patient platelet count. The inspector requested to review a policy for the procedure. There was no policy available for review. 2. Review of the Sysmex XN-L Hematology analzyer manufacturer operator's guide revealed the following statement: "4.3 Preparing Sample", "Mix the venous blood with an anticoagulant (EDTA-2k or EDTA-3K). Draw the amount of venous blood that is specified for the amount of EDTA anticoagulant." A call to the Sysmex technical support on 09/30/21 at 1 PM confirmed manufacturer requirements for specimen collection and processing with the EDTA anticoagulant. In addition, the manufacturer did not approve of collection and 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 -- processing of specimen with the sodium citrate anticoagulant. 3. During an interview with the primary TP at approximately 1:15 PM, they confirmed that Patient A sample collected with both the EDTA and sodium citrate tube types for comparison of platelet counts on 01/20/20 and that the platelet count reported from EDTA anticoagulant tube type and not the sodium citrate tube type on 01/20/20. In addition, they were not aware that the manufacturer did not approve of the alternative sodium citrate anticoagulant collection and processing for platelet counts. 4. An exit interview with the primary TP and technical consultant at approximately 1:45 PM on 09/30/21 confirmed the findings. -- 2 of 2 --