Summary:
Summary Statement of Deficiencies D0000 An announced initial CLIA survey was conducted at Carient Heart & Vascular on March 14, 2023 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. During the course of the initial survey, Immediate Jeopardy (IJ) was identified. The Immediate Jeopardy was removed when Carient Heart & Vascular voluntarily ceased testing in the specialty of Hematology. The laboratory was not in compliance with the following 42 CFR part 493 CLIA CONDITION Regulations: D2000 - 42 C.F.R. 493-801 Condition: Enrollment and testing of samples, D5400 - 42 C.F.R. 493-1250 Condition: Analytic Systems-Immediate Jeopardy; D6000 - 42 C.F. R. 493-1403 Condition: Moderate Complexity, Laboratory Director-Immediate Jeopardy, and D6063 - 42 C.F.R. 493-1421 Condition: Moderate Complexity, Testing Personnel. Specific deficiencies cited are as follows. D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of instrument and patient records, lack of documentation and interviews, the laboratory failed to enroll in a Proficiency Testing (PT) program for Activated Clotting Time (ACT) from August 10, 2022 until the date of the survey on March 14, 2023. Findings include: 1. During an entrance interview with the Clinical Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 13 -- Manager (CM) on March 14, 2023 at approximately 11:05 AM, the CM stated the laboratory uses the Hemochron Signature Elite Whole Blood Microcoagulation System to perform Low Range Activated Clotting Time (ACT-LR) on patient specimens during procedures. The surveyor inquired when the laboratory began patient testing. The CM stated they started working at the facility in October 2022 and the laboratory was using the Hemochron ACT for patients at that time. 2. Review of the Hemochron Signature Elite instrument (serial number 21354 7/31/2021) database revealed the first patient specimen ACT results recorded were on August 10, 2022. 3. A review of the laboratory's records revealed a lack of documentation of PT testing enrollment for ACT from August 10, 2022 until the date of the survey on March 14, 2023. During an interview with the Clinical Manager on March 14, 2023 at approximately 2:00 PM, the surveyor requested documentation of the laboratory's enrollment in a PT program from August 2022 until March 14, 2023. The laboratory provided no proof of enrollment for the surveyor to review. 4. In exit interviews with the Laboratory Director on March 14, 2023 at approximately 3:00 PM and Clinical Manager on March 14, 2023 at approximately 3:30 PM, the findings were confirmed. 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 a tour, review of the laboratory's policies and procedures, laboratory records, instrument records, patient records, lack of documentation and interviews, the laboratory failed to: 1. include in their Low Range Activated Clotting Time (ACT- LR) procedure requirements for specimen labeling, criteria for acceptability and rejection, preparation of quality control materials, interpretation of results, reportable range, quality control procedures (QC),