Summary:
Summary Statement of Deficiencies D2003 ENROLLMENT CFR(s): 493.801(a)(2)(ii) For those tests performed by the laboratory that are not included in subpart I of this part, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1) This STANDARD is not met as evidenced by: Based on of proficiency records for 2021, 2022 and to date February 6, 2023, review of patient reports and interview with the testing personnel (TP) #3, the laboratory failed to establish a means to verify the accuracy of the non-regulated analyte for urine microscopic testing twice a year. Findings: 1. Review of proficiency records for 2021, 2022 and to date February 6, 2023, showed the laboratory failed to prove accuracy on the non-regulated analyte urine microscopic exam since April 8, 2021. 2. Review of patient results confirmed the laboratory reports out results for urine microscopic exams. 3. Interview with the TP #3 on February 6, 2023 at 2:00 PM confirmed the laboratory failed to establish a means to verify the accuracy of the non- regulated analyte for urine microscopic testing twice a year. D6045 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(7) (b) The technical consultant is responsible for-- (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; This STANDARD is not met as evidenced by: Based on review of competencies and interview with testing personnel # 3, the 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 -- technical consultant (whom is also the laboratory director) failed to identify training needs for one of one testing personnel in 2022. Findings: 1. Review of laboratory competencies showed no documentation of initial training for testing personnel # 4. 2. Interview with testing personnel #3 on February 6, 2023 at 2:00 PM confirmed the technical consultant failed to identify initial training needs for one testing personnel in 2022. 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 performance evaluations and interview with testing personnel #3, the technical consultant (whom is also the laboratory director) failed to evaluate and document performance evaluations at least semiannually during the first year for one of one testing personnel. Findings: 1. Review of performance evaluations showed no semiannual performance evaluation was documented for testing personnel #4. 2. Interview with testing personnel #3 on February 6, 2023 at 2:00 PM confirmed the technical consultant did not evaluate and document the semiannual performance evaluation for testing personnel #4. 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 review of performance evaluations and interview with testing personnel #3, the technical consultant (whom is also the laboratory director) failed to evaluate and document annual performance evaluations for three of three testing personnel in 2021 and 2022. Findings: 1. Review of performance evaluations showed no annual performance evaluation for testing personnel #1, #2 and #3 in 2021 and 2022. 2. Interview with testing personnel #3 on February 6, 2023 at 2:00 PM confirmed the technical consultant failed to evaluate and document annual performance evaluation for testing personnel #1, #2 and #3 in 2021 and 2022. -- 2 of 2 --