New Market Medical Center

Summary Statement of Deficiencies D0000 An announced on-site CLIA recertification survey was conducted at New Market Medical Center on December 4, 2020 by the Virginia Department of Health's Office of Licensure and Certification. The survey included an entrance interview and virtual record review conducted on 12/3/2020. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiencies cited are as follows: D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records, lack of documentation, and an interview, the laboratory failed to evaluate non-graded microscopy PT results for one (1) of three (3) events reviewed for calendar year 2019. Findings include: 1. Review of the laboratory's 2019 American Proficiency Institute (API) PT documentation (Events 1-3) revealed no evaluation or verification of accuracy for the non-graded responses of: 2019 Event 1 Urine Sediment - challenge sample US-02 -not graded due to lack of consensus, 2019 Event 1 Vaginal Wet Prep (KOH)- challenge sample VKP- 01-not graded due to lack of consensus. The inspector requested to review evaluation documentation for the microscopy PT samples listed above. No additional documentation was available for review. 2. In an exit interview with the primary testing personnel on 12/4/20 at approximately 10:00 AM, the above findings were confirmed. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT 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 -- 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. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies and procedures, monthly hematology quality control (QC) records, lack of documentation, and an interview, the laboratory failed to follow their policy to monitor, assess/correct problems with the Abbott Cell Dyn analyzer with QC statistical review for three (3) of twelve (12) months reviewed in calendar year 2019. Findings include: 1. Review of the laboratory's policies and procedures revealed a quality assurance (QA) plan to monitor, assess and correct problems with the Abbott Cell Dyn hematology analyzer via a monthly QA checklist with a review of printed Levy-Jennings (LJ) charts. 2. During a review of the laboratory's monthly QA reports from calendar year 2019, the inspector noted no hematology LJ charts were reviewed on the monthly reports during the timeframe of October 1, 2019 to December 31, 2019. The inspector requested to review the three month timeframe of LJ records. No additional hematology QC statistics were available for review. The primary testing personnel stated on 12/3/20 at approximately 3:30 PM: "I do not have those QC print outs. I am not sure where they are at this time." 3. In an exit interview with the primary testing personnel on 12/4/20 at approximately 10:00 AM, the above findings were confirmed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at New Market Medical Center on August 23, 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: D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on review of procedures, a laboratory tour, and an interview, the laboratory failed to ensure that their Potassium Hydroxide (KOH) 20% and fungal stain reagents, stored in the microscopy area, were within the manufacturer's stated expiration dates for three (3) lot numbers of reagents. Findings include: 1. Review of the laboratory's policy and procedure manual revealed a General Laboratory Operations Policy for Reagents and Supplies that stated: "No reagent will be used beyond the expiration date". 2. During a laboratory tour at approximately 3:30 PM, the inspector noted the following three (3) expired reagents (stored beside the microscope): One (1) bottle of Accuderm DMSO Potassium Hydroxide (KOH) 20% with manufacturer's printed expiration date of 5/06/2015; Two (2) bottles of Delasco Fungal Stain (Lot K11A44 manufacturer's printed expiration date October 2014 and Lot K154M3 manufacturer's printed expiration date April 2016); The laboratory inspector asked if the KOH and fungal stain reagents were used for patient testing and the primary testing personnel stated: "Yes, the KOH is used rarely for wet prep and KOH slides". The inspector asked it the fungal stain reagents were used for patient testing and the primary testing personnel indicated that they were used. 3. During an interview with the primary testing personnel at approximately 3:45 PM, it was confirmed that the 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 2 -- failed to ensure that the reagents listed above were not used beyond the expiration dates. -- 2 of 2 --