Summary:
Summary Statement of Deficiencies D0000 An unannounced Clinical Laboratory Improvement Amendments (CLIA) complaint investigation (Complaint #VA00042600) was conducted at Accurate Medical Lab on July 20, 2018 by Medical Facilities Inspectors from the Virginia Department of Health, Office of Licensure and Certification. The laboratory holds a Certificate of Accreditation and operates under CLIA # 34D1106621. Based on review of the documents and interviews, the inspectors found one (1) of the four (4) complainant's allegations to be substantiated. Deficiencies cited are as follows: D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing records and an interview, the laboratory failed to retain instrument printouts of proficiency testing (PT) samples for three (3) of three (3) PT events reviewed from December 2017 until July 2018. Findings include: 1. Review of the laboratory's American Proficiency Institute (API) PT records revealed the laboratory participated in the following: 2017 Chemistry and Hematology Third Event, 2018 Chemistry and Hematology Second Event, 2018 Remedial Proficiency sample. The inspector requested the instrument printouts for the proficiency testing samples for the events listed above. No documentation was available for review. 2. An interview with laboratory director, at approximately 1:30 PM, confirmed that the laboratory did not retain the instrument printouts for the API 2017 Chemistry and Hematology Third Event, 2018 Chemistry and Hematology Second Event and 2018 Remedial Proficiency samples 62R-CH-01, 62R-CH-02, 62R- CH-03, 62R-CH-04 and 62R-CH-05. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- 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 a review of the laboratory's Quality Control (QC) records from April 1, 2018 through July 20, 2018, patient data logs, policies, quality assurance (QA) records, patient test reports and interviews, the laboratory failed to monitor and evaluate analytic quality by: 1. failure to have two levels of QC within acceptable ranges while reporting eleven (11) patient Complete Blood Counts (CBC) and sixteen (16) patient chemistry panels (Cross Reference D5447). 2. failure to follow their written