Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Monument Avenue Pediatrics, PC on August 18, 2021 by the Virginia Department of Health's Office of Licensure and Certification. 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: D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a review of Centers for Medicare and Medicaid Services CLIA Application and Survey Summary (CMS CASPER 96D), proficiency testing (PT) records, and an interview, the laboratory failed to attain a score of at least eighty (80) percent of acceptable responses for Hematocrit (HCT) in one (1) out of six (6) Hematology testing events reviewed. Findings include: 1. On 08/08/21, prior to the on-site survey, the inspector's review of the laboratory's CMS CASPER 96D report revealed the laboratory received a 40 % score for HCT in the first event of calendar year 2021. 2. During the onsite survey on 08/18/21, the inspector reviewed 6 American Proficiency Institute (API) hematology PT records (2019 Events 2-3, 2020 Events 1-3, 2021 Event 1). The review revealed the following failed HCT challenge scores on the 2021 1st Event: HEM-02 resulted as 14, acceptable range 15-18; HEM-03 resulted as 49, acceptable range 50-57, HEM-04 resulted as 24, acceptable range 25-30; resulting in unsatisfactory analyte performance for the testing event. 2. An exit interview with the nurse coordinator at approximately 11:15 AM confirmed the above findings D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE 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 -- 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 of unsatisfactory scores for three (3) of five (5) Hematocrit (HCT) and one (1) of 5 Platelet (PLT) challenges reported on the 2021 Hematology Event 1 report. Findings include: 1. Review of the laboratory's American Proficiency Institute (API) PT records (2019 Events 2-3, 2020 Events 1-3, 2021 Event 1) revealed no evidence of evaluation for each of the following failed analyte scores: 2021 API Event 1: HCT (HEM-02, HEM-03, HEM- 04), PLT (HEM-02). The inspector requested to review documentation that the laboratory evaluated the 4 unacceptable challenge results outlined above. Documentation was not available for review. 2. An exit interview with the nurse coordinator at approximately 11:15 AM confirmed the above findings 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 a laboratory tour, review of procedures, and interviews, the laboratory failed to follow their policy for specimen labeling for two (2) of 2 collected COVID-19 Polymerase Chain Reaction molecular (PCR) patient specimens observed in the reference laboratory send out box on August 18, 2021 at 9:15 AM. Findings: 1. During a laboratory tour with the nurse coordinator at approximately 9:15 AM on 08 /18/21, the inspector noted 2 patient specimen swabs in transport media tubes with requisitions for COVID-19 PCR (dated 8/18/21) packaged in clear plastic bags and racked in a box labeled as reference lab send out testing. The inspector noted/inquired regarding the observation that neither of the 2 collected specimen tubes were labeled. The nurse coordinator stated" "our electronic medical record zebra printer is malfunctioning today and the staff plans to label the tubes once it is repaired. I will have someone label the tubes as soon as possible." 2. Review of the laboratory procedure manual revealed a policy which defined specimen identification/labeling criteria that stated: "Label all specimens with two identifiers using a sharpie pen once collected, before leaving the exam room". 3. An exit interview with the nurse coordinator at approximately 11:15 AM confirmed the above findings D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for -- 2 of 4 -- specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)