Primary Pediatrics Of Macon

Summary Statement of Deficiencies D0000 A recertification survey was performed on April 16, 2024. The facility was found to be NOT in compliance with the CLIA conditions and standards for specialties /subspecialties for 42 CFR. CONDITION LEVEL CITATIONS: D-5400 - Analytic Systems - 493.1250 D-6000 - Moderate Complexity Laboratory Director - 493.1403 NOTE: The CMS-2567 (Statement of Deficiencies) is an official , legal document,. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on May 25, 2022. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. Condition level and standard deficiencies were cited: D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of the Quality Assessment(QA) Policy and QA documents, and staff interview, the laboratory failed to follow their Policy for QA by not documenting monthly QA reviews and assessment activities between 9/2021 thru 5/2022. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems for each specialty and subspecialty of testing performed. Reference: D 5293 D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on June 18, 2021. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two of three consecutive events (2nd event of 2020 and 1st event of 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 -- 2021), resulting in the first unsuccessful occurrence for Hematology # 760 including: cell ID or WBC differential (DIFF) # 765. Findings include: Refer to D 2130 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports from the American Proficiency Institute (API), the laboratory failed to maintain satisfactory performance in two consecutive events (2nd event of 2020 and 1st event of 2021), resulting in the first unsuccessful occurrence for Hematology # 760 including: cell ID or WBC differential (DIFF) # 765. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte WBC differential (DIFF) # 765 with a score of 67% on the 2nd event of 2020 and 0% on the 1st event of 2021. 2. Desk review of the laboratory's proficiency testing reports from API confirms the laboratory failed WBC diff #765 on events 2 of 2020 and 1 of 2021 resulting in the first unsuccessful performance. 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two of three consecutive events (2nd event of 2020 and 1st event of 2021), resulting in the first unsuccessful occurrence for Hematology # 760 including: cell ID or WBC differential (DIFF) # 765. Findings include: Refer to D 6016 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 proficiency testing desk review using the Centers for Medicare and -- 2 of 3 -- Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two of three consecutive events (2nd event of 2020 and 1st event of 2021), resulting in the first unsuccessful occurrence for Hematology # 760 including: cell ID or WBC differential (DIFF) # 765. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte #765 WBC differential (DIFF), on event 2 of 2020 with a score of 67% and event 1 of 2021 with a score of 0%. 2. Desk review of the laboratory's proficiency testing reports from American Proficiency Institute (AP)) confirmed the laboratory failed #765 WBC differential (DIFF), on event #2 of 2020 and event #1 of 2021, resulting in the first unsuccessful performance. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on January 8, 2020. 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: D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on review of the employee competency assessments, and staff interview, the laboratory failed to provide Initial training documents for the four new employees hired in 2019. Findings: 1. Review of the employee competency assessments, 2019 competencies were performed from 12-17-2019 to 12-30-2019. There were four employees hired in 2019 (HIRE DATES: 4-10-19, 4-25-19, 10-26-19, and 3-7-19) that only had competency assessments performed in December of 2019. There was no documentation of an initial training for these 4 employees. 2. Interview with the Laboratory Manager, on January 8, 2020 at approximately 2:45 pm in the training room, confirmed that the four new hires, with the above listed hire dates, did not have initial training documents. 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 -- D6047 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b(8)(i) The procedures for evaluation of the competency of the staff must include, but are not limited to direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. This STANDARD is not met as evidenced by: Based on review of the 2019 Testing personnel Competency evaluations, and staff interview the Laboratory Director (LD), performing the duties of the Technical Consultant (TC), did not perform the competencies for the testing personnel, following the six minimal regulatory requirements for assessment of competency for all personnel performing laboratory testing. There were no 2018 competency assessment documents available. Findings: 1. Review of the competency check off sheets documented for 2019, the sheet consisted of a simple check off sheet. The Six minimal regulatory requirements for assessment of competency was not addressed in the documentation. 2. Interview with the laboratory manager at approximately 2:30 pm, on January 8, 202, in the training room, confirmed that the TC did not evaluate the testing personnel using the Six minimal regulatory requirements of competency as required, and that there were no 2018 competency assessment documents available. D6070 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(1) Each individual performing moderate complexity testing must follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results. This STANDARD is not met as evidenced by: Based on review of the policy and procedure manual (SOP), observation during the lab tour, and staff interview, the laboratory failed follow the policy for labeling specimens collected. Findings include: 1. Observation during the lab tour at 10:15 AM reveals 8 urine specimens on the lab counter to the right of the sink labeled with the patient first name initial and the patient last name. A second unique identifier was not on the labeled specimens. 2. Review if the SOP reveals the lab policy that specimens are to be labeled with two (2) unique identifying factors such as name, date of birth, or patient ID (identification) number. 3. Interview with the lab manager on 1/8 /2020 in the laboratory at approximately 10:20 AM, confirmed the urine specimens were not labeled with 2 unique identifiers. -- 2 of 2 --