Summary:
Summary Statement of Deficiencies D0000 An announced CLIA validation survey was conducted at Premier Healthcare Associates, INC on June 1, 2022 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 and include the Condition under 42 CFR part 493 CLIA Regulation: D5400 -42 CFR. 493.1250 Analytic Systems. 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 module results were returned to American Proficiency Institute (API) within the program's deadline for one (1) of four (4) events reviewed. Findings include: 1. Review of the laboratory's API hematology PT documentation (2020 Event 3, 2021 Events 1-3), a total of 4 events, revealed that the laboratory failed to submit and received failure to participate scores for the following CBC module: Hematology 2021 Event 2: receiving 0% scores for Cell Identification (Lymphocyte, Monocyte, Granulocyte), Red Blood Cell Count, White Blood Cell Count, Platelet Count, Hemoglobin, and Hematocrit. API noted: "Failure to participate" on the PT results. 2. An exit interview with the general supervisor on 6/1/22 at approximately 3:30 PM confirmed the above findings. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records, procedures, and interviews, the laboratory failed to document evaluation of non-graded PT results per established policy for hematology and immunology analyte challenges on two (2) of four (4) American Proficiency Institute (API) testing events reviewed. Findings include: 1. Review of the laboratory's procedure manual revealed a Quality Assurance policy that stated, "When a PT challenge receives a score of non-graded, we will conduct a self- evaluation of performance". 2. Review of the laboratory's API PT documentation (2020 Event 3, 2021 Events 1-3), a total of 4 events, revealed no evaluation or verification of accuracy for the non-graded responses for the following 4 analyte challenge samples: 2020 Hematology Module Event 3 - Blood Cell ID one (1) of five (5) responses (BCI-11), Urine Sediment 1 of two (2) responses US-06; API 2021 Immunology Module Event 1 - Anti-CCP 2 of 2 responses (CCP-01 and CCP-02). The inspector requested to review evaluation documentation for the non-graded analyte challenges BCI-11, US-06, CCP-01 and CCP-02 outlined on the 2 PT events listed above. No additional documentation was available for review. 3. An exit interview with the general supervisor on 6/1/22 at approximately 3:30 PM confirmed the above findings. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of analyzers' user guides, maintenance records, tour, review of policies, hematology calibration records, chemistry calibration verification records, lack of documentation, and interviews, the laboratory failed to: 1. document required monthly maintenance protocols for the Beckman Coulter DxH 520 hematology analyzer for six (6) of the twenty-four (24) months reviewed (timeframe: June 2020 to the time of the inspection June 1, 2022) - Cross Reference D5429 A; 2. document required monthly maintenance protocols for the Beckman Coulter AU480 chemistry analyzer for one (1) of 6 months reviewed in calendar year 2020 and failed to document required quarterly maintenance tasks for five (5) of the (8) quarters during the 24 months reviewed - Cross Reference D5429 B; 3. document required monthly maintenance protocols for the TOSOH A1A 360 chemistry analyzer for thirteen (13) of 24 months reviewed - Cross Reference D5429 C; 4. document annual function checks for centrifuge revolutions per minute for the urinalysis Thermo Biofuge centrifuge serial number (SN 41329853) in calendar year 2021 - Cross Reference D5435; 5. document every 6 months calibration procedures for Complete Blood Count testing on the Beckman Coulter DxH 520 hematology analyzer during the 24 -- 2 of 8 -- month review timeframe - Cross Reference D5437; 6. perform every 6 month chemistry calibration verification studies per established policy for Beckman Coulter AU480 analytes Albumin, Urease, Calcium, Cholesterol, Chloride, Creatinine, Glucose, Potassium, Sodium, Total Protein, Triglyceride, CO2, Alkaline Phoshatase, Alanine Transaminase, Aspartate Aminotransferase, Creatine Kinase, Total Bilirubin, High-density Lipoprotein and TOSOH A1A 360's Prostate Specific Antigen in calendar years 2020 and 2021 - Cross Reference D5439. 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: A. Based on review of analyzer's user guide, available maintenance records, lack of documentation, and an interview, the laboratory failed to document required monthly preventative maintenance protocols for the hematology analyzer for six (6) of the twenty-four (24) months reviewed (timeframe: June 2020 to the time of the inspection June 1, 2022). Findings include: 1. Review of the laboratory's Beckman Coulter DxH 520 hematology procedures and maintenance guidelines revealed the following two required monthly maintenance protocols (outlined in "Hematology Maintenance Binder"): Perform Bleach Cycle, Clean the WBC Bath Filter. 2. Review of the laboratory's available DxH 520 maintenance log records from June 2020 to 6/1/22 revealed lack of documentation for: Monthly Task "Perform bleach cycle" - in November 2021, January 2022; Monthly Task "Clean WBC Bath Filter" - in July, September, October, and December of calendar year 2020, November 2021, and January 2022. A total of 6 months lacked documentation of one (1) or both of the 2 monthly maintenance tasks as outlined above during the 24 months reviewed. The inspector requested to review additional documentation of monthly maintenance for the 6 months noted. No records or