Monroe Pediatrics

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on March 8, 2022. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were 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 Proficiency Testing document review and staff interview, the laboratory failed to enroll Hematology in an approved proficiency testing program. The Findings include: 1. PT document review revealed that the laboratory failed to enroll into the speciality of hematology for years 2020 and 2021. 2. During an interview on March 8, 2022 at 11:10 AM with Testing Personnel#1(CMS 209), in the laboratory, confirmed that the laboratory failed to enroll into an approved PT program, in the speciality of hematology, for years 2020 and 2021. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: A review of personnel records and staff interview confirmed that the laboratory failed to establish a written policy to assess the six CLIA required criteria for employee competency for the specialty of hematology. The findings include: 1. The laboratory failed to have a written competency policy and procedure that include the six required criteria for testing personnel for years 2020 and 2021. 2. An annual competency assessment was not performed for any of the staff for 2020 or 2021 in the specialty of hematology. 3. During an interview with the Testing Personnel#1(CMS 209) on March 8, 2022 at 12: 10 PM, confirmed that the laboratory did not have a policy to assess the required six competency criteria for the testing personnel in the laboratory. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT 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 surveyor review of the standard procedure manual(SOP) document records (Pre-analytic, analytic, and post analytic) and interview with the Testing Personnel (TP), the laboratory failed to establish a written quality assessment (QA) to monitor, assess, and correct problems in the general laboratory system for quality assessment. 1. The laboratory failed to have QA policy to assess patient confidentially, specimen integrity and identification, complaints,

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on August 27, 2019. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on proficiency test (PT) document review and staff interview, the laboratory failed to test the PT samples with the laboratory's regular patient workload by testing personnel (TP) who routinely perform the testing as required. Findings include: 1. American Academy of Family Physicians (AAFP) PT document review revealed Staff #4 (CMS 209) tested all PT samples for all three 2018 Hematology events and 2019 Hematology events 1 and 2. 2. An interview withe Staff #4 (CMS 209) on 8/27/2019 in the breakroom at approximately 11:00 a.m. confirmed she performed PT samples testing for the aforementioned Hematology PT events. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- This STANDARD is not met as evidenced by: Based on review of the laboratory policy and procedure manual (SOP) and staff interview, the laboratory failed to establish and follow written policies and procedures to assess employee competency. Findings include: 1. SOP review revealed the absence of the CLIA six-procedure competency policy and procedure for assessing employee competency. 2. An interview with Staff #4 (CMS 209) in the breakroom on 8/27/2019 at approximately 11:00 a.m. confirmed the SOP did not contain a competency policy and procedure. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on proficiency test (PT) document review and staff interview, the laboratory failed to document required