Summary:
Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard level deficiencies were cited. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of Centers for Medicare and Medicaid Services (CMS)-209 form, laboratory policy, personnel records, and confirmed in interview, the laboratory failed to follow their own policy for six-month testing person evaluation for one of one testing person in 2022. Findings Included: 1. Review of CMS-209 form submitted at time of survey, 04/17/2024, revealed one testing person (TP-1) performing high complexity testing. 2. Review of laboratory policy, "Competency Assessment" (Approved by the Laboratory Director on 10/13/2020) revealed the following: " ... Procedure: ...2. After the employee's 6 month employment anniversary they will be given a 6 month evaluation. They will have annual competency assessment reviews on or before the anniversary date of their hire." 3. Review of personnel records for TP- 1 revealed no documentation of a six-month evaluation performed. (Date of hire: 05/24 /2022) The surveyor requested the above documentation and it was not provided. 4. In an interview on 04/17/2024 at 10:05 AM, TP-1 confirmed the laboratory failed to follow their own policy for six-month testing person evaluation for one of one testing person in 2022. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) 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 -- The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of laboratory policy, biannual quality improvement reviews, and confirmed in interview, the laboratory failed to follow their own policy for biannual reviews for one of two reviews in 2023. Findings Included: 1. Review of laboratory policy, "Quality Improvement Review Method Accuracy Verification" (Approved by the Laboratory Director on 10/13/2020) revealed the following: " ...Purpose: Each technical employee is [sic] Histology will be evaluated by the Medical Director to ensure that each employee understands and follows all procedures for grossing and slide preparation. Biannual the laboratory staff will pick 5 random cases to review all aspects of grossing, processing, staining and microtomy." 2. Review of 2023 biannual reviews revealed the laboratory failed to document one of two reviews in 2023. The surveyor requested the above second review performed in 2023 and it was not provided. 3. In an interview on 04/17/2024 at 10:14 AM, testing person 1 (TP-1) confirmed the laboratory failed to follow their own policy for biannual reviews for one of two reviews in 2023. -- 2 of 2 --