Commonwealth Extended Care

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Commonwealth Extended Care on 01/22/24 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: The laboratory was not in compliance with the following 42 CFR part 493 CLIA Regulations: D5400 - 42 C.F.R. 493-1250 Condition: Analytic Systems. 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 the review of policy and procedures (P&P), manufacturer package inserts (PI), daily quality control (QC) logs, lack of documentation, and interviews, the lab failed to: 1. Follow the established policy ensuring that the liquid external White Blood Cell (WBC) QC materials were within manufacturer acceptable ranges for 144 days in 24 months reviewed. Refer to D5403. 2. Ensure the correct standard deviation (SD) was used to calculate the acceptable ranges for the white blood cell (BC) QC materials for six of seven lot numbers reviewed. Refer to D5469 A. 3. Verify seven of seven new lot numbers of white blood cell (WBC) QC materials according to manufacturer's instructions. Refer to D5469 B. and 4. Ensure that the established quality assurance (QA) plan identified and addressed analytical issues in the subspecialty of hematology. Refer to D5791. 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 -- 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 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)

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Commonwealth Extended Care on November 5, 2019 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: D6047 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b(8)(i) The procedures for evaluation of the competency of the staff must include, but are not limited to direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), laboratory personnel files, and an interview, the technical consultant (TC) failed to document annual competency assessments that included direct observation of routine White Blood Count (WBC) patient test performance for five (5) of six (6) testing personnel (TP) in 2018 and 2019. Findings include: 1. Review of the CMS 209 form revealed seventeen (17) testing personnel responsible for moderate complexity WBC patient testing: eleven (11) of 17 were identified as new TP in 2019 (initially trained in timeframe of February-October 2019) and six (6) of 17 identified as having performed moderate complexity WBC patient testing during the twenty-four (24) month review timeframe (November 2017 - 11/05/19). 2. Review of personnel files revealed the laboratory's 2018 and 2019 annual Hemocue WBC assessments lacked the required competency procedural element of direct observation of routine patient test performance (patient preparation, specimen handling, and analyzer testing) for: TP A, B, C, D, and E. (See Personnel Code Sheet.) The inspector requested to review additional competency documentation. The TC stated at approximately 2:00 PM: "I give an annual quiz that includes twenty (20) questions for all testing kits in the lab. I have not been able to Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- document direct observation of the staff members performing WBC patient testing for their annual competency assessments." 3. In an exit interview with the TC at approximately 3:30 PM, the above findings were confirmed. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), testing personnel competency assessment records, and interview, the technical consultant (TC) failed to perform the semi-annual competency assessment for one (1) new laboratory testing personnel (TP) in calendar year 2018. Findings include: 1. Review of the CMS 209 revealed seventeen (17) TP identified as responsible for moderate complexity White Blood Count (WBC) patient testing. TP F was identified as being a new TP in calendar year 2018. (See Personnel Code Sheet.) 2. Review of personnel records revealed that TP F was initially trained and started performing WBC patient testing in February 2018. The review of records revealed that no semi-annual competency assessment for TP F was documented in 2018. The inspector requested to view the semi-annual competency assessment documentation for the testing personnel listed above. The documentation could not be presented for review. 3. In an exit interview with the TC at approximately 3:30 PM, the above findings were confirmed. -- 2 of 2 --