Summary:
Summary Statement of Deficiencies D0000 An announced CLIA validation survey was conducted at Sentara Nursing Center-SLC Norfolk Vent Unit on December 19, 2018 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: D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on a review of two (2) randomly selected patient iSTAT blood gas reports, and interviews, the laboratory blood gas reports failed to include the address of the point of care testing facility. Findings include: 1. Review of 2 randomly selected patient blood gas reports from the 2017 and 2018 patient log book revealed, that while the reports included the test site name, the reports did not include the test site address. During the patient log review, at approximately 10:30 AM, the technical consultant stated: "Our final reports at this location have included the test site name as you noted, but we have not included the address to date. We can add the address to the reports." 2. In an interview with the laboratory director, technical consultant, and quality managers at approximately 11:30 AM, it was confirmed that the laboratory failed to include the address of the performing testing facility on patient test results for the twenty-three (23) months reviewed. 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 -- 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 a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), testing personnel records, and interview, the technical consultant failed (TC) to perform the semiannual competency assessment for one (1) of eleven (11) testing personnel (TP) during the twenty-three (23) months reviewed. Findings include: 1. Review of the CMS 209 laboratory personnel form revealed 11 TP. 2. Review of testing personnel records revealed the following: Testing Personnel D - initial training documentation on 11/30/16 and an annual competency record in December 2017 and December 2018. The inspector requested to view the semiannual competency assessment documentation for TP D. The documentation could not be presented for review. (See Personnel Code Sheet) 3. In an interview with the laboratory director, technical consultant, and quality managers at approximately 11:30 AM, it was confirmed that the TC failed to perform the semiannual competency assessment for TP D as outlined above. D6054 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 annually, after the first year. This STANDARD is not met as evidenced by: Based on a review of Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), laboratory personnel files, and an interview, the technical consultant (TC) failed to perform an annual competency evaluation for one (1) of the eleven (11) testing personnel (TP) in calendar year 2017. Findings include: 1. Review of the CMS Form 209: Laboratory Personnel Report revealed 11 TP. 2. Review of the laboratory personnel files revealed that testing personnel A lacked a 2017 annual iSTAT Blood Gas competency evaluation. The inspector requested to review the documentation. No record was available for review. (See Personnel Code Sheet) 3. In an interview with the laboratory director, TC, and quality managers at approximately 11:30 AM, it was confirmed that the TC failed to perform a 2017 iSTAT Blood Gas competency evaluation for TP A as outlined above. -- 2 of 2 --