Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted for MD Express Williamsburg on April 20, 2021 by the Virginia Department of Health's Office of Licensure and Certification. The survey also included an entrance interview and initial record review conducted remotely on 04/12/21. The inspector noted that the laboratory performs SARS-CoV-2 (COVID-19) testing and was in compliance with the applicable COVID-19 reporting requirements. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiencies cited are as follows: D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of the laboratory's proficiency testing (PT) records and an interview, the laboratory failed to retain attestations by the testing personnel (TP) performing Hematology, Chemistry, and Cardiac Marker PT testing on two (2) of six (6) events in the twenty-four months reviewed. Findings include: 1. Review of the laboratory's American Academy of Family Physicians (AAFP) PT documentation (2019 Events A-C, 2020 Events A-C), a total of 6 events, revealed no TP signed attestations for the following 2 hematology and chemistry modules: AAFP 2019 A Hematology, General Chemistry, Cardiac Markers AAFP 2019 B Hematology, General Chemistry, Cardiac Markers The inspector requested to review the TP attestations. The laboratory clinical coordinator stated "Our lab director signed. The testing personnel were assigned but we did not have the personnel sign for those PT reports in 2019." 2. In an interview with the laboratory clinical coordinator on 4/20/21 at 3:30 PM, the above listed findings were confirmed 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 -- D2127 HEMATOLOGY CFR(s): 493.851(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) documentation, and an interview, the laboratory failed to ensure hematology Complete Blood Count (CBC) PT testing results were returned to American Academy of Family Physicians (AAFP) within the program's deadline for one (1) of six (6) events during the twenty-four (24) months reviewed. Findings include: 1. Review of the laboratory's AAFP hematology PT documentation (2019 Events A-C, 2020 Events A-C), a total of 6 events, revealed that the laboratory failed to submit results and received "failure to participate" scores for the following CBC module: Hematology 2019-C: 0% analyte scores for Cell Identification (Lymphocyte, Monocyte, Granulocyte), Red Blood Cell Count, Platelet Count, Hemoglobin, Hematocrit; 20% for White Blood Count. AAFP noted on forty- nine (49) of the fifty (50) hematology analyte challenges "failed, no results received". 2. In an interview with the laboratory clinical coordinator on 4/20/21 at 3:30 PM, the above listed findings were confirmed. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. 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 document evaluation taken for two (2) B-type Natriuretic Peptide (BNP) and one (1) Lymphocyte unacceptable analyte results in calendar year 2020. Findings include: 1. Review of the laboratory's American Academy of Family Physicians (AAFP) PT records (2019 Events A-C, 2020 Events A- C), a total of 6 events, revealed no evidence of remedial action for the following three (3) unacceptable proficiency analyte scores: 2020 AAFP Event A - BNP Cardiac Marker challenge CDM-2N resulted as 3,060 (acceptable range 1,288-3,018); 2020 AAFP Event B - BNP Cardiac Marker challenge sample CDM-10N resulted as 7,121 (acceptable range 364-914) 2020 AAFP Event C- Hematology Lymphocyte percent count challenge HD-11 resulted as 48.70 (acceptable range 49.29-62.10). 2. Review of the laboratory's PT