Children's National Pediatrician Assocs Chevy Chas

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the federal proficiency testing data report and review of the comparative evaluation summery from WSLH proficiency testing (PT) program, the laboratory failed to successfully participate in the WSLH PT program for bacteriology testing, in which the laboratory is certified under CLIA. (Refer to D2028) D2028 BACTERIOLOGY CFR(s): 493.823(e) Failure to achieve an overall testing event score of satisfactory performance for two 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 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the federal proficiency testing data report and review of the comparative evaluation summery from WSLH proficiency testing (PT) program, the laboratory failed to successfully participate in the WSLH PT program for bacteriology testing, in which the laboratory is certified under CLIA. The following analyte was noted as failed in the 2020 2nd event and the 2019 3rd event. Findings: 1. WSLH proficiency testing 2020 2nd event Bacteriology 60% 2. WSLH proficiency testing 2019 3rd event Bacteriology 60% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of the federal proficiency testing data report and review of the comparative evaluation summery from WSLH proficiency testing (PT) program, the laboratory director failed to ensure that the laboroatry successfully participated in the WSLH PT program for bacteriology testing, in which the laboratory is certified under CLIA. (Refer to D2028) D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(4)(iv) Ensure that an approved

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of the microbiology patient log and interview with the office manager, the laboratory failed record the proficiency testing (PT) samples on the patient log in the same manner as the patient specimens. Findings: 1. Review of the microbiology patient logs for 2017 through May 2019 showed that the laboratory was not listing the PT samples on the microbiology patient log in the same manner as the patient specimens. 2. During the survey on 05/24/19 at 11:15 AM the office manager confirmed that the PT samples were not listed on the microbiology patient log in the same manner as the patient specimens. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: Based on review of the proficiency testing (PT) records and interview with the office manager, the laboratory did not ensure that each testing person who performed the test signed the attestation worksheet showing that PT samples were reviewed in the same manner at the patients. Findings: 1. According to the office manager there are 3 physicians and one nurse practitioner who perform the final interpretation of the urine colony count testing. 2. The PT records from 2017 and 2018 (6 events) were reviewed. The PT attestation worksheets revealed that only the initials of the laboratory director was present. 3. The office manager explained that the PT interpretations are reviewed by the laboratory director along with the one of the physicians or the nurse practitioner prior to submission to the PT agency. 4. During the survey on 05/24/19 at 11:15 AM the office manager confirmed that the PT attestation worksheets failed to have the signature of each physicians or nurse practitioner involved in the interpretation of the PT result. 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: I. Based on review of the Quality Assurance (QA) policy and interview with the office manager, the laboratory director failed to ensure that all QA activities were documented. Findings: 1. The pre-analytical portion of the QA policy that covers test tracking requires the laboratory to randomly select 10 requisitions on a quarterly basis for review. 2. The surveyor asked to review the documentation of the quarterly review. According to the office manager the patients listed on the patient log that are highlighted with yellow, pink or blue are the randomly selected patients for review. 3. The QA policy failed to include written instructions for how to identify the randomly selected 10 requisitions that were reviewed quarterly. The QA policy failed to identify where to document that the random review was 100% for each quarter and