Metro Pediatric Associates

Summary Statement of Deficiencies D0000 A recertification survey was initiated on 11/14/2023. The facility was found not to be in compliance with the laboratory requirements of 42 CFR Part 493 with deficiencies cited. D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on observation, document review, and interview with the Laboratory Director (LD), the laboratory failed to enroll in a Centers for Medicare & Medicaid Services (CMS)-approved proficiency test (PT) program in the specialty of hematology for the regulated analyte complete blood count (CBC) since 2021. Findings included: During a laboratory tour on 11/14/2023, beginning at 2:15 PM, the surveyor observed a Sight Diagnostics OLO hematology analyzer. Review of a "CASPER Report 0096D" dated 10/17/2023, revealed no routine PT scores for the specialty of hematology for 2021, 2022, or 2023. PT records were requested from the Office Manager/Testing Personnel. In an interview on 11/14/2023 at 2:30 PM, the Laboratory Director (LD) confirmed the laboratory was not enrolled in a CMS approved PT program for the regulated CBC analyte. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT 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 -- CFR(s): 493.1239(a) 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 document review and interview, the laboratory failed to establish a written quality assessment (QA) policy and procedure to monitor, assess, and correct problems, when indicated, in the general laboratory system for 3 (2021 through 2023) of 3 years reviewed. Findings included: On 11/14/2023 at 2:30 PM, a written QA policy and procedure was requested for review but was not provided. During an interview on 11/14/2023 at 2:30 PM, the Laboratory Director (LD) stated the laboratory lacked a written QA policy and procedure that encompassed the monitoring and review of proficiency testing (PT). 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 direct observation, document review, and interview with the Laboratory Director (LD) the Laboratory Director failed to enroll in a Centers for Medicare & Medicaid Services (CMS) approved proficiency test (PT) program in the specialty of hematology for the regulated analyte complete blood count (CBC) since 2021. Refer to D6015 D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) 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) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on direct observation, document review, and interview with the Laboratory Director (LD), the Laboratory Director failed to enroll in a Centers for Medicare & Medicaid Services (CMS) approved proficiency test (PT) program in the specialty of hematology for the regulated analyte complete blood count (CBC) since 2021. Refer to D6015 -- 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 desk review of Hematology proficiency testing results from the American Proficiency Institute proficiency testing agency on 02/03/2020, the laboratory failed to successfully participate in the Red Blood Cell (RBC) certified analyte in two consecutive testing events. See D2121 and D2130. D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte 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 -- in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on desk review of Hematology proficiency testing results from American Proficiency Institute testing agency on 02/03/2019, the laboratory failed to achieve satisfactory performance for the Red Blood Cell (RBC) analyte in two consecutive testing events. Findings include: The laboratory scored twenty percent on the RBC in the second testing event of 2019 and scored forty percent on the RBC in the third testing event for an unsatisfactory performance. 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 desk review of Hematology proficiency test results from the American Proficiency Institute testing agency on 02/03/2020, the laboratory failed to successfully achieve satisfactory performance for the Red Blood Cell (RBC) certified analyte in two consecutive testing events. Findings include: The facility scored twenty percent in the second testing event of 2019 and scored forty percent in the third testing event of 2019 for an unsuccessful performance. -- 2 of 2 --