Shady Grove Pediatric Associates

Summary Statement of Deficiencies 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 the "Laboratory Personnel Report (CLIA) (CMS-209), annual evaluation documentation and interview with the testing person (TP), the technical consultant failed to ensure that all of the TP received an annual evaluation as required. Findings: 1. The CMS-209 lists six TP. One of the TP is the laboratory director. 2. The annual evaluations for 2019 through 2021 were reviewed. The records showed that two of the five TP listed on the CMS-209 did not have an annual evaluation performed during that time period. 3. During the survey on 09/13/2021 at 10:45 AM, the TP confirmed that the records did not include an annual evaluation of two of the five TP listed on the CMS-209. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of the written procedure manual and interview with the testing person, the laboratory director (LD) did not perform quality assessment (QA) procedures for the overall quality of laboratory services. Findings: 1. The LD did not have QA procedures performed for the year 2017 and only performed one QA check for the year 2018 in December. 2. The laboratory had a QA procedure and QA checklist outlining the steps for performing the QA checks. 3. The testing person confirmed that QA procedures were only performed for December 2018. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --