Centra Danville Medical Center

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 --