Centra Danville Medical Center

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Centra Danville Medical Center on August 4 - 5, 2026 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: D2014 TESTING OF PROFICIENCY TESTING SAMPLES (b)(6) 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. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records, lack of documentation, and interviews, the laboratory failed to retain PT records to document their processing and testing/reporting of iSTAT PT results for two of five Core Chemistry PT modules during the 23 months of review (August 28, 2024 to August 5, 2026). Findings include: 1. Review of Core Chemistry PT records (2025 Events 1-3, 2026 Events 1-2) a total of five events, revealed that the laboratory utilized American Proficiency Institute (API) Core Chemistry module enrollment for their point of care moderate complexity iSTAT Chem8 patient testing. 2. Review of the laboratory's PT records for the module outlined above revealed that the records lacked the following: API 2025 Event 2 - iSTAT Chem8 results from analyzer; API 2025 Event 3 - copy of the proficiency testing program report forms, testing personnel and lab director (LD) attestation statements, iSTAT Chem8 results from analyzer, API scored report, nor review of PT results; API 2026 Event 2 - iSTAT Chem8 results from analyzer; The Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- inspector requested to review the PT records outlined above, noting that the PT binder tab for API 2025 Event 3 was empty. The requested documentation was not available for review. The Point of Care Testing (POCT) supervisors stated on 8/4/26 at 3 PM, "We have looked and cannot locate those records. There have been staff changes and we cannot reach out to the previous laboratory lead to ask. We can print the results for the 2025 3rd event from API site and review retroactively." 3. An interview with the two POCT supervisors, Director of Urgent Care, and Lab Director on 8/4/26 at 5 PM, and the Practice Administrator on 8/5/26 at 2 PM confirmed the above findings. 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: A. Based on a review of procedures, analyzer maintenance records, lack of documentation, and interviews, the laboratory failed to document performance of required monthly iSTAT Electronic Simulator maintenance per protocol for 11 of 23 months reviewed (timeframe: September 2024 to August 5, 2026). Findings include: 1. Review of the laboratory's procedure manual revealed an iSTAT protocol (under heading: iSTAT Monthly Procedures) which stated, "The External Electronic Simulator will be run monthly and with software updates. Print the results and place in the iSTAT maintenance records." 2. Review of the laboratory's monthly iSTAT Daily/Monthly logs for September 2024 to the inspection date of 8/5/26 revealed the following months lacked the External Electronic Simulator check: September 2024; October 2024; November 2024; December 2024; May 2025; June 2025; August 2025; November 2025; March 2026; June 2026; July 2026; 11 of 23 months reviewed lacked External Electronic Simulator check documentation. The inspector requested to review documentation of the required iSTAT monthly maintenance checks outlined above. No additional records were available. 3. An interview with the two Point of Care Testing (POCT) supervisors, Director of Urgent Care, Lab Director (LD) on 8/4 /26 at 5 PM, and the Practice Administrator on 8/5/26 at 2 PM confirmed the above findings. B. Based on a review of procedures, analyzer maintenance records, lack of documentation, and interviews, the laboratory failed to document every six month iSTAT Thermal Probe Check maintenance per protocol for three of four due dates during the 23 months reviewed (timeframe: September 2024 to August 5, 2026). Findings include: 1. Review of the laboratory's procedure manual revealed an iSTAT protocol (under heading: iSTAT Bi-Annual / Every Six Months Procedures) which stated, "The Thermal Probe Check is performed every six months on the iSTAT analyzer and should be documented on the maintenance log." 2. Review of the laboratory's iSTAT Daily/Monthly logs for September 2024 to the inspection date of 8 /5/26 revealed that the Thermal Probe Check was documented as performed once in October 2025. The inspector requested to review additional documentation of the iSTAT Thermal Probe checks. The inspector inquired regarding the expected due timeframes of September 2024 to December 2024, any additional check in calendar year 2025, and January 2026 to the date of the inspection. No additional Thermal Probe records were available. 3. An interview with the two POCT supervisors, Director of Urgent Care, and LD on 8/4/26 at 5 PM, and the Practice Administrator on 8/5/26 at 2 PM confirmed the above findings. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT -- 2 of 4 -- CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. This STANDARD is not met as evidenced by: Based on a review of Centers of Medicaid and Medicare Services CLIA Survey Summary Report (CMS CASPER 0096D), tour, review of proficiency testing (PT) and patient result logs, quality control (QC) reports, lack of documentation, policies, and interviews, the laboratory failed to document monthly chemistry QC statistics and failed to identify the lapse in reviews during 6 of 23 months reviewed for their Vitros analyzer (timeframe: September 2026 to August 2026). Findings include: 1. During a pre-survey review, the CMS CASPER 0096D revealed enrollment with scores reported on Events 1-3 in calendar year 2025 for the following speciality of chemistry and regulated analytes: 0245 ROUTINE CHEMISTRY 0255 Alanine Aminotranserase (ALT) 0265 Albumin 0275 Alkaline Phosphatase (Alk Phos) 0285 Amylase 0295 Aspartate Aminotransferase (AST) 0305 Bilirubin, Total 0345 Calcium (Ca) 0351 Carbon Dioxide (CO2) 0355 Chloride (CL) 0365 Cholesterol, Total 0375 Cholesterol, High Density (HDL) 0405 Creatinine 0415 Glucose 0455 Magnesium, (Mg) 0460 Phosphorus 0465 Potassium (K) 0475 Sodium (Na) 0485 Total Protein 0495 Triglyceride 0505 Blood Urea Nitrogen (BUN) 0515 Uric Acid 2. During a tour of the laboratory on 8/4/26 at 1 PM, the inspector noted a Vitros chemistry analyzer stored in the laboratory's record room not in use. The inspector inquired when the laboratory discontinued testing on the analyzer. The Point of Care Testing (POCT) Supervisors stated that they had moved the analyzer from the laboratory on 8/3/26 prior to the inspection. The POCT supervisor stated, "I am not sure what date that the laboratory discontinued testing on the Vitros but it was in early 2025. As of June 29, 2026 the only chemistry in use is the Abbott iSTAT per our hospital lab manager." 3. Review of the laboratory's American Proficiency Testing (API) Core Chemistry PT module records for 2025 Events 1-3 revealed: API Event 1 - the laboratory reported "Instrument Not in Use" for all analytes of speciality 0245 ROUTINE CHEMISTRY outlined on the CASPER report above- for Vitros analyzer; API Event 2 - the laboratory reported "Instrument Not in Use" for all analytes of speciality 0245 ROUTINE CHEMISTRY outlined on the CASPER report above- for Vitros analyzer; API Event 3 - The inspector noted that the records for API 2025 Event 3 were missing (**Cross Reference D2014). The inspector requested that the laboratory print out 2025 Event 3 from the API site. Review of the printed API scores revealed that the laboratory had reported Vitros results for the 21 analytes outlined on the CASPER report for 2025 3rd event and received score of 100%. 4. Review of patient data log for the Vitros analyzer with the IT Laboratory Information Systems Manager on 8/5 /26 at 2 PM, revealed that the last date that patient results transmission was completed from the Vitros was 2/27/2025. 5. Review of the Vitros chemistry QC records for the 6 month timeframe of September 2024 to the last date of patient transmission on 2/27 /25, the inspector noted no monthly Levey Jennings (LJ) statistical reports for the onboard analytes: Albumin, Alk Phos, ALT, Amylase, AST, Direct Bilirubin, Total Bilirubin, BUN, Ca, Cholesterol, HDL, CL, CO2, Creatinine, Glucose, Mg, Phosphorus, K, Na, Total Protein, Triglyceride, Uric Acid. The inspector requested to review the LJ QC documentation for the Vitros analytes. The six months' QC records were not available for review. The inspector inquired regarding

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Centra Danville Medical Center on 08/27/24 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. The laboratory was not in compliance with the following 42 CFR part 493 CLIA Regulations: 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 review of the Centers for Medicare and Medicaid Services CLIA Laboratory Application for Certification form (CMS 116), CASPER Survey Summary (Report 0096D), tour of the laboratory testing room, proficiency testing (PT) records, lack of documentation, and interviews, the laboratory failed to enroll in PT for 14 of 14 non- waived regulated chemistry analytes from 04/08/24 up to the date of survey on 08/27 /24. Findings include, 1. Review of the CMS 116 form and a tour of the laboratory testing area on 08/27/24 at 09:45 AM revealed the laboratory uses the Ortho Vitros 350 (serial number J27004851) to perform patient testing in the specialty of chemistry. 2. An interview with the technical consultant and the Lab Manager on 08 /27/24 at 10:00 AM revealed that the site ceased testing with the Ortho Vitros 350 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 -- chemistry analyzer on 04/28/23 due to staff shortages. The laboratory implemented chemistry testing with the Abbott i-STAT Chem 8+ cartridges at that time for patient testing. The laboratory obtained full staff and re-implemented patient testing with the Ortho Virtros 350 chemistry analyzer on 04/08/24. 3. Review of the American Proficiency Institute (API) calendar for shipping dates for 2024 revealed that the second core chemistry modules was shipped on 05/13/24 and the third core chemistry modules was shipped on 08/19/24. 4. Review of the API PT records and the CASPER Report 0096D revealed lack of scores for the following 14 non-waived regulated analytes for the second event in 2024: Alanine Aminotransferase (ALT), Albumin, Alkaline phosphatase (ALK PHOS), Amylase, Asparate Trasferase (AST), total bilirubin, total calcium, total cholesterol, high density level (HDL) cholesterol, creatinine, magnesium (MG), total protein, triglycerides (TRIG), and uric acid. 5. In an interview with the Lab Manager on 08/27/24 at 11:45 AM, the surveyor requested to review proficiency testing records for the above-specified analytes performed on the Ortho Vitros 350 chemistry analyzer for the second event in 2024 or enrollment for the third event in 2024. They stated, "we are enrolled for the i-STAT but we haven't enrolled for the Vitros yet; I don't have the enrollment." 6. In an exit interview with the laboratory director, technical consultant, Lab Manager on 08/27/24 at 1445, the findings were confirmed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification on-site survey was conducted at Centra Danville Medical on February 10, 2021 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. The initial contact and entrance interview with laboratory conducted on January 21, 2021 with off-site record review of documentation and a follow-up email on February 5 & 8, 2021. Specific deficiencies cited are as follows: 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: Based on the review of laboratory maintenance logs, manufacturer operator's guide, lack of documentation and interview with the primary testing personnel and technical consultant, the lab failed to perform the thermal probe checks for the iSTAT hand- held analyzer twice a year in 2019 and 2020. Findings include: 1. The laboratory utilizes the iSTAT hand-held analyzer to perform Troponin I and B-type Natiureic Peptide (BNP) chemistry tests, categorized as moderate complexity testing. 2. Review of the laboratory maintenance logs on February 5, 2021 revealed lack of documentation of the thermal probe checks for the analyzer. The inspector requested to review documentation of thermal probe checks and the lab provided documentation of the specified maintenance performed on 09/16/20 at the date of on-site survey on February 10, 2021. No other documentation was available for review. In an interview with the primary testing personnel and technical consultant on February 10, 2021 at approximately 10 AM, they stated that the lab staff did not realize that the thermal probe checks were required and that the policy was updated to include the procedure for performing the checks on 05/22/20. 3. Review of the manufacturer operator's 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 -- guide revealed the following statement, "Procedures- Quality Control- Thermal Probe Check (14-19): Check the thermal probes on each analyzer twice a year." 4. An interview with the technical consultant on February 10, 2021 at approximately 11:20 AM confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at Centra Danville Medical on September 18, 2018 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: D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of calibration records for the chemistry analyzer and interviews, the 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 -- laboratory failed to perform the calibration verification twice a year for the Sodium (NA), Postassium (K+) and Chloride (CL) analytes for the sixteen (16) of the sixteen (16) months reviewed. Findings include: 1. Review of calibration records for the Vitros 350 chemistry analyzer from October 1, 2016 and up to the date of survey (a total of 16 months) revealed that the NA, K+, and CL analyte calibrations were a 2- point calibration. The inspector requested to review calibration verification documentation for the above-listed analytes. The documentation was not available for review. 2. An interview with the technical consultant and primary testing personnel at approximately 5:20 PM confirmed the findings. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on a tour of the laboratory, review of policies and procedures, hematology records, and interviews, the laboratory failed to establish and follow a policy for the comparison of hematology Complete Blood Count (CBC) test results performed on the two (2) Abbott Cell Dyn Emerald instruments for sixteen (16) of the sixteen (16) months reviewed. Findings include: 1. Tour of the laboratory at approximately 10: 15 AM revealed that the laboratory has 2 Abbott Cell Dyn Emerald instruments. The instruments are identified as EM2 (Serial Number 031013) and EM6 (Serial Number 030614). 2. Review of the policies and procedures revealed no documentation of a policy or procedure to evaluate a comparison of CBC test results assayed on the 2 hematology analyzers. 3. Review of the hematology records, to include Quality Control and instrument maintenance, from October 1, 2016 and up to the date of survey revealed no documentation or evaluation of CBC result comparison records for the 2 hematology instruments listed above. 4. An interview with the technical consultant and primary testing personnel at approximately 5:20 PM confirmed the findings. -- 2 of 2 --