Southeastern Pediatric Associates Pa

Summary Statement of Deficiencies D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. The procedures for evaluation of the competency of the staff must include, but are not limited to-- This STANDARD is not met as evidenced by: Based on a review of the personnel records and an interview with Testing Personnel 1 (TP1) and Testing Personnel 2 (TP2), the Technical Consultant failed to ensure competency assessments for Testing Personnel (TP) listed on the CMS 209 (Laboratory Personnel Report) included the six CLIA minimal regulatory requirements. The surveyor noted two of the six requirements were missing on the annual competencies from 2023-2025. The findings include: 1. A review of the 2023- 2025 personnel records revealed TP competency assessments for Bacteriology and Hematology specialties did not include two of the six CLIA minimal regulatory requirements. The surveyor noted the missing two requirements were as follows: (1) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. (2) Assessment of problem-solving skills. 2. The TP1 and TP2 confirmed the above findings during the exit conference on 2-12-2025 at 3:30 PM. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually This STANDARD is not met as evidenced by: 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 -- Based on a review of personnel records and an interview with Testing Personnel 1 (TP1) and Testing Personnel 2 (TP2), the Technical Consultant failed to assess and document the annual competency of individuals responsible for moderate complexity testing. This was noted for three of the four Testing Personnel (TP) from the date of the last survey, 3-22-2023 to the date of the current survey, 2-12-2025. The findings include: 1. A review of personnel records revealed the Technical Consultant failed to perform and document the annual Bacteriology and Hematology competency assessments for three of the four TP from 2023-2025. 2. During the exit conference on 2-12-2025 at 3:30 PM, the TP1 and TP2 confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies 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 a review of CAP (College of American Pathologists) Proficiency Testing (PT) records, and an interview with General Supervisor #1, the laboratory failed to implement a mechanism to ensure all PT results were submitted and received by the PT provider. The surveyor noted results for one of three 2022 Urine Culture surveys were not submitted to CAP. The findings include: 1. A review of the Routine Microbiology Combination (RMC)-Event C survey results revealed scores for the Throat Culture survey, however there were no scores for the Urine Culture survey. The surveyor requested the scores from General Supervisor #1 who stated the laboratory missed printing the pages with the Urine Culture Scores, and she needed to check the CAP website. 2. During an interview on 3/22/2023 at 11:48 AM, General Supervisor #1 stated there were no results for the 2022 RMC-C Urine Culture survey, however she had confirmed it was performed. General Supervisor #1 believed the results may not have been submitted on line correctly. The surveyor then asked if the laboratory had Quality Assurance reviews to ensure accurate and complete results were submitted to CAP; the Supervisor confirmed this was not usually done. . D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) 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 -- laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the Medonic M Series Hematology Quality Control (QC) records, and an interview with General Supervisor #1, the laboratory failed to ensure data from each day of QC was included on Levy Jennings (L-J) charts or the Interlaboratory Quality Assurance Program (IQAP) reports to track for shifts and trends over time. The laboratory failed to include 59 days of QC data from August 2021 through March 2022. The findings include: 1. A review of the Medonic M Series Hematology QC records revealed the laboratory printed cumulative monthly reports with the daily QC data, and the L-J charts attached. However, the surveyor noted six months with a total of 59 days of missing QC results, as follows: A) 8/1--8/9/2021 (9 days) B) 8/26--8/31/2021 (5 days) C) 10/26--11/9/2021 (15 days) D) 12/1--12/11 /2021 (11 days) E) 2/1--2/7/2022 (7 days) F) 3/1--3/12/2022 (12 days) 2. A further review of the CDS (Clinical Diagnostic Solution) IQAP data revealed QC from the above dates in 2021 were not included in the laboratory's monthly statistics reports. 3. During an interview on 3/22/2023 at 3:00 PM, the surveyor asked General Supervisor #1 about the the process for printing the cumulative monthly QC from the Medonic, and submitting the data to CDS for inclusion in the IQAP statistics. The Supervisor explained the problems were occurring when they implemented a new lot # (number) of QC in the middle of a month. Staff sometimes forgot to print the cumulative data and L-J charts from the previous lot number of QC, or they forgot to print and submit the end of the month QC for the new lot # to the CDS IQAP. SURVEYOR ID# 32558 Licensure and Certification Surveyor -- 2 of 2 --

Summary Statement of Deficiencies D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a reviews of the Medonic M Series Hematology analyzer quality control (QC) records, patient test records, and an interview with the General Supervisor, the surveyor determined the laboratory failed to ensure at least two levels of Hematology QC were within acceptable limits before patient testing began. This was noted on two days of patient CBC (Complete Blood Count) testing in June 2017. The findings include: 1. A review of the Hematology cumulative QC report revealed the following days when patient samples were tested and resulted without at least two levels of QC within acceptable ranges: A) 6/14/2017: No QC was run in the MC (Microtainer) mode; one patient CBC was performed in the MC mode. B) 6/16/2017: No QC performed; 14 patient CBCs were tested. 2. During an interview and review of the QC and patient records on 6/26/2018 at 4:00 PM, the General Supervisor was asked if the manufacturer required QC to be run in both the OT (Open Tube) and MC modes each day of patient testing. The Supervisor answered, "Yes", and confirmed the Testing Personnel performing testing on the above dates had not followed the laboratory's QC policies. Thus the above noted findings were confirmed. SURVEYOR:Laura T. Williams, BS, MT (ASCP)Licensure and Certification Surveyor 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 --