Community Physicians/Sager Pediatric

Summary Statement of Deficiencies D0000 A desk review of proficiency testing was performed on October 28, 2023. The laboratory was found to be not in compliance with the following conditions: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director 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 2022 and 2023 CMS Casper Reports 096D, 0153D, and the American Proficiency Institute (API) proficiency testing results, the laboratory failed to have successfully participate in proficiency testing in the specialty of Hematology 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 -- for the analyte White Blood Cell Differential (WBC DIFF). Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance as cited at D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of 2022 and 2023 CMS Casper Reports 096D, 0153D, and the American Proficiency Institute (API) proficiency testing results, the laboratory failed to achieve satisfactory perfomance for the analyte WBC DIFF in three of four testing events. A. A review of the proficiency testing results revealed the laboratory received a score of 0% for the test of WBC DIFF in the second proficiency testing event of 2022. B. A review of the proficiency testing results revealed the laboratory received a score of 0% for the test of WBC DIFF in the third proficiency testing event of 2022. C. A review of the proficiency testing results revealed the laboratory received a score of 0% for the test of WBC DIFF in the second proficiency testing event of 2023. 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 2022 and 2023 proficiency testing events, laboratory director failed to ensure the overall management and direction of laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of the 2022 and 2023 proficiency testing events, the laboratory director failed to ensure successful participation in aproficiency testing program for the Hematology test of WBC DIFF. Refer to D2130. -- 2 of 2 --

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 2022 CMS Casper Reports 155D, 153D and American Proficiency Institute (API) proficiency testing results, it was determined the laboratory failed to have successful participation in proficiency testing for the test of White Blood Cell Differential (WBC DIFF) as evidenced by: Failure to achieve satisfactory performance for test of WBC DIFF in two out of three proficiency testing events is unsuccessful performance, as cited at D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- Failure to achieve satisfactory performance for the same analyte in two consecutive 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 2022 CMS Casper Reports 155D and 153D and API proficiency testing results, it was determined the laboratory failed to successfully participate in the second proficiency testing event of 2022 and the third proficiency testing events of 2022, resulting in a score of 0% for the test of White Blood Cell Differential (WBC DIFF), as evidenced by: A. A review of proficiency test scores for 2022 revealed the laboratory received a score of 0% for the test of WBC DIFF in the second proficiency testing event of 2022. B. A review of proficiency test scores for 2022 revealed the laboratory received a score of 0% for the test of WBC DIFF, in the third proficiency testing events of 2022. 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 2022 proficiency testing scores, it was determined the laboratory director failed to provide overall management and direction as evidence by: A. Failure to achieve satisfactory performance for the analyte of WBC DIFF in two consecutive testing events, as cited at D2130. 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 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. This STANDARD is not met as evidenced by: Through review of proficiency testing attestation forms for 2018 and 2019 and interview it was determined that the laboratory director did not attest that the proficiency testing was performed in the same manner as patient testing in one of six events reviewed. Survey findings follow: A) Review of API proficiency testing Hematology/Coagulation third event 2019 revealed the laboratory director or designee did not sign the statement attesting that testing was performed in the same manner as patient testing . B) In an interview at approximately 04:45 PM on 1/16/20, the laboratory staff member, identified as number two on the CMS 209 form, confirmed that the laboratory director or designee signature were not present on the proficiency testing event attestation identified above. 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 D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Through observations made during a tour of the laboratory and interviews with laboratory staff, it was determined the laboratory failed to follow manufacturer's instructions for performing the Osom Mono Test. Survey findings include: A. During a tour of the laboratory at 8:35 a.m. on 5/24/2018 the surveyor observed one kit of Osom Mono Test (lot #171225) on the laboratory counter. The manufacturer's expiration date of the test kit was 4/30/2018 (24 days prior to the survey). B. In an interview at 8:35 a.m. on 5/24/2018, the technical consultant (as listed on the form CMS-209) confirmed the Osom Mono Test was available for use when it had exceeded the manufacturer's expiration date. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Through a review of the Diatron Abacus manufacturer's instructions, lack of documentation, and interviews with laboratory staff, it was determined the laboratory failed to document daily maintenance for Diatron Abacus as specified by 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 -- manufacturer. Survey findings include: A. The Diatron Abacus manufacturer's instructions include the following daily maintenance: Check reagent condition; Check the contents of the waste tank; run blank measurement; run required daily cleaning at the end of the day. B. Through a review of the January 2018 through May 2018 Problem Log (used by the laboratory to document start up and maintenance) it was determined the laboratory had no documentation of checking the reagent condition, or running the daily cleaning at the end of the day. C. In an interview, at 9:52 a.m. on 5 /24/2018, the technical consultant confirmed the lack of documented daily maintenance for the Diatron Abacus. -- 2 of 2 --