Pediatric Center Of Southwest Louisiana, The

Summary Statement of Deficiencies D0000 A Recertification survey was performed at The Pediatric Center of Southwest Louisiana, CLIA ID 19D1102217, on September 17, 2025. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies, CMS-209 form, personnel competencies, and interview with personnel, the laboratory failed to follow their established competency assessment procedures that included assessment of non-waived test performance for all specialities for two (2) of eight (8) testing personnel reviewed for 2024. Findings: 1. Review of the laboratory's CMS-209 form (Laboratory Personnel Report) revealed Technical Consultant 1 and Technical Consultant 2 also served as testing personnel. 2. In interview on September 17, 2025 at 12:00 pm, Technical Consultant 1 stated herself and Technical Consultant 2 perform complete blood counts (CBC), manual blood cell differentials, urine cultures, urine sediment, KOH, and wet preps if received. 3. Review of the laboratory's "Employee Competency" form revealed "Competencies will take place at designated times after the initial orientation at each location. Upon hire all testing personnel shall undergo an orientation to the laboratory. The initial competency will take place after the 90 days of probationary employment. Another competency will take place after 6 months of employment. A yearly competency will be performed for all testing personnel until the end of their employment. The Laboratory Director or Technical Consultant will conduct the orientation and competency of all personnel that perform moderate and high 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 -- complexity testing." 4. Review of the laboratory's competency assessment forms revealed the following six (6) elements are to be assessed: Direct observation of routine patient test performance; monitor test result recording and reporting; review of worksheets, quality control records, proficiency testing results, maintenance records; direct observation of instrument maintenance; assessment of test performance (PT /blind samples); and assessment of problem-solving skills." 5. Review of the 2024 testing personnel competency assessment for Technical Consultant 1 revealed the laboratory did not perform the semi-annual and annual competency assessments for the following tests: manual blood cell differentials, urine cultures, urine sediment, KOH, and wet preps that included direct observation of routine patient test performance; monitor test result recording and reporting; review of worksheets, quality control records, proficiency testing results, maintenance records; direct observation of instrument maintenance; and assessment of problem-solving skills." 6. Review of the 2024 testing personnel competency assessment for Technical Consultant 2 revealed the laboratory did not perform the annual competency assessments for the following tests: manual blood cell differentials, urine cultures, urine sediment, KOH, and wet preps that included direct observation of routine patient test performance; monitor test result recording and reporting; review of worksheets, quality control records, proficiency testing results, maintenance records; direct observation of instrument maintenance; and assessment of problem-solving skills." 7. In further interview on September 16, 2025 at 12:00 pm, Technical Consultant 1 confirmed semi-annual and annual competencies for the identified microscopic tests were not performed in 2024 for herself and Technical Consultant 2. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) (e)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on review of policies, personnel records, and interview with personnel, the Laboratory Director failed to ensure complete policies and procedures for assessing personnel competency were maintained. Findings: 1. The laboratory failed to follow their established competency assessment procedures that included assessment of non- waived test performance for all specialities for two (2) of eight (8) testing personnel reviewed for 2024. Refer to D5209. 2. The Technical Consultants failed to perform a competency assessment semi-annually during the first year for one (1) of eight (8) testing personnel reviewed. Refer to D6053. 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-- -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's policies, competency assessment records, and interview with personnel, the Technical Consultants failed to perform complete competency assessment procedures for one (1) of eight (8) testing personnel for 2024. Refer to D5209. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies, personnel records, and interview with personnel, the Technical Consultants failed to perform a competency assessment semi- annually during the first year for one (1) of eight (8) testing personnel reviewed. Findings: 1. Review of the laboratory's "Employee Competency" form revealed "Competencies will take place at designated times after the initial orientation at each location. Upon hire all testing personnel shall undergo an orientation to the laboratory. The initial competency will take place after the 90 days of probationary employment. Another competency will take place after 6 months of employment. A yearly competency will be performed for all testing personnel until the end of their employment. The Laboratory Director or Technical Consultant will conduct the orientation and competency of all personnel that perform moderate and high complexity testing." 2. Review of the laboratory's competency assessment forms revealed the following six (6) elements are to be assessed: Direct observation of routine patient test performance; monitor test result recording and reporting; review of worksheets, quality control records, proficiency testing results, maintenance records; direct observation of instrument maintenance; assessment of test performance (PT /blind samples); and assessment of problem-solving skills." 3. Review of personnel records revealed a semi-annual competency assessment was not performed for Technical Consultant 1, due August 2024. The laboratory had the following documented competency assessments: Initial: February 8, 2024 Six (6) month: February 28, 2025, due August 2024 4. In interview on September 17, 2025 at 12:00 pm Technical Consultant 1 and Technical Consultant 3 confirmed the semi-annual competency assessment was not performed as required for Testing Personnel 1. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Recertification survey was conducted September 29, 2023 at The Pediatric Center of Southwest Louisiana, CLIA ID # 19D1102217. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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 review of the laboratory's policy and procedure manual and proficiency test (PT) records and interview with personnel, the laboratory failed to maintain a complete policy for proficiency testing. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory did not include instructions for review and documentation of PT evaluation results that are ungraded and/or educational. 2. Review of the laboratory's PT records revealed the laboratory did not document review of Wisconsin State Laboratory of Hygiene (WSLH) 2023 HemeReg1 sample XIE6 with result status "not scored - non consensus referee." 3. In interview on September 29, 2023 at 10 a.m., Personnel 2 confirmed the laboratory did not have a policy for review of ungraded and/or educational PT evaluation results. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, 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 -- storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D0000 A Recertification survey was performed at The Pediatric Center of Southwest Louisiana, CLIA ID # 19D1102217, on March 23, 2022. The Pediatric Center of Southwest Louisiana was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1250 CONDITION: Analytic systems 42 CFR 493.1403 CONDITION: Laboratories Performing Moderate Complexity Testing, Laboratory Director 42 CFR 493.1409 CONDITION: Laboratories Performing Moderate Complexity Testing, Technical Consultant 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: Based on observation by surveyor, review of patient final test reports, manufacturer's instructions, test menu, and interview with personnel, the laboratory failed to include complete "Fact Sheets" to patients for Emergency Use Authorization (EUA) SARS COV-2 testing. Findings: 1. Observation by surveyor during the laboratory tour on March 23, 2022 at 9:00 am revealed the laboratory utilizes the following kits for SARS COV-2 testing: a) Lumira Dx SARS COV-2 antigen b) Quidel Quickvue SARS COV-2 2. Review of the manufacturers' instructions revealed "Authorized laboratories using your product must include with test result reports, all authorized Fact Sheets. Under exigent circumstances, other appropriate methods for disseminating these Fact Sheets may be used, which may include mass media." 3. Review of the laboratory's patient final test reports for SARS COV-2 revealed the reports are labeled "Fact Sheets For Patients; however, the information provided to patients was not complete. The fact sheet information provided to patients did not match the information provided in the manufacturer's fact sheets. 4. In interview on Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- March 23, 2022 at 9:00 am, Testing Personnel 1 confirmed the SARS COV-2 fact sheets the laboratory provided to patients did not match the manufacturers'. 5. Review of the laboratory's test menu revealed the laboratory performs fourteen (14) Lumira Dx SARS COV-2 antigen tests and 545 Quidel Quickvue SARS COV-2 antigen tests. 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. This STANDARD is not met as evidenced by: I. Based on review of the laboratory's policies, CMS 209 form, personnel records, and interview with personnel, the laboratory failed to establish written policies and procedures to assess competency of the Technical Consultant. Findings: 1. Review of the laboratory's CMS-209 form (Laboratory Personnel Report) revealed one (1) Technical Consultant. 2. Review of the laboratory's "Employee Competency" policy revealed the laboratory did not include performance of competency for the Technical Consultant, to include, but not limited to the frequency. 3. Review of personnel records for the Technical Consultant revealed a competency assessment for her duties as Technical Consultant performed in 2017 by the previous Laboratory Director, not the current. Laboratory Director. 4. In interview on March 23, 2022 at 9:30 am the Technical Consultant confirmed the laboratory's competency policy did not include competency for the Technical Consultant. The Technical Consultant confirmed the current Laboratory Director did not perform a competency assessment for her duties as Technical Consultant. II. Based on review of the laboratory's personnel competency records and interview with personnel, the laboratory failed to perform competency assessments at each specific laboratory testing location for nine (9) Testing Personnel. Findings: 1. In interview on March 23, 2022 at 9:30 am, Testing Personnel 1 stated the laboratory utilizes the same employees at each of their three (3) locations. Testing Personnel 1 stated the competency assessments are performed at whichever location the staff is working at the time and the forms are brought to the main location to sign. Testing Personnel 1 confirmed the competency assessments for testing personnel are not performed on site at each laboratory site. 2. Review of the laboratory's testing personnel competency assessment forms revealed the laboratory's location was not specified. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, 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 analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on observation by surveyor, record review, and interview with personnel, the laboratory failed to ensure the quality of testing within the analytic systems. Findings: -- 2 of 10 -- 1. The laboratory failed to establish written policies for reporting SARS COV-2 results. Refer to D5401. 2. The laboratory failed to perform complete performance verification studies for complete blood count (CBC) testing on the Medonic M series analyzer. Refer to D5421. 3. The laboratory failed to perform quality control (QC) for Group A B-hemolytic Streptococcus (Bacteriology) testing per their IQCP for five (5) of five (5) lot numbers reviewed. Refer to D5445. 4. The laboratory's quality assessment monitors failed to correct issues identified with the analytic system. Refer to D5793. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures and interview with personnel, the laboratory failed to establish written policies for reporting SARS COV- 2 results. Findings: 1. Review of the laboratory's policies and procedures revealed the laboratory did not have written procedures for reporting SARS COV-2 results, to include, but not limited to who is responsible, and frequency of reporting. 2. In interview on March 23, 2022 at 9:30 am, Testing Personnel 1 confirmed the laboratory did not have a written policy for reporting positive and negative SARS COV-2 results to the state. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on observation by surveyor, review of validation studies, test menu, and interview with personnel, the laboratory failed to perform complete performance verification studies for complete blood count (CBC) testing on the Medonic M series analyzer. Findings: 1. Observation by surveyor during the laboratory tour on March 23, 2022 at 9:00 am revealed the laboratory utilizes the Medonic M series analyzer for CBC testing. 2. In interview on March 23, 2022 at 10:50 am, Testing Personnel 1 stated the laboratory replaced their previous Medonic analyzer with a new one in May 2021. 3. Review of the laboratory's "Verification of Performance Specifications" revealed "Each laboratory that introduces a new, non-waived, unmodified, FDA- cleared or approved test is required to check (verify) the manufacturer's performance specifications provided in the package insert for the following before reporting patient test results: Demonstrate that it can obtain performance specifications comparable to -- 3 of 10 -- those established by the manufacturer for the following performance characteristics: a) accuracy b) precision c) reportable range of the test results for the system Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population Quantitative Tests: Precision: Perform five repetitions of at least three samples with different values, spanning the reportable range. Test the samples: In the same run (2 of the 5 repetitions; in a different run on the same day (3rd repetition); and on different days (4th and 5th repetitions performed on different days). If possible have different staff perform the 3rd, 4th, and 5th repetitions to check for operator variance Reportable Range: Using the same process used to evaluate accuracy, evaluate reportable range. If a zero calibrator is available for the analyte, then you may extend the low end of your reportable range down to zero, provided you actually obtain a zero result when you test that sample. Reference Range: Collect specimens from twenty (20) normal patients (a minimum of ten (10) patient specimens my be used if necessary. Test each specimen only once, and spread the testing over a minimum of three days. Calculate the normal patient mean. Calculate the standard deviation (SD) and determine the range of the plus and minus two SD from the mean. Compare this range to the manufacturer's range. 4. Review of the "Medonic M Series Method Validation Evaluation" form revealed the following: "The Lab Director should review the the results of the Reportable Range/Linearity study. No patient results may be reported outside this linear range unless procedures /protocols are developed to use when results are outside the validated linear (reportable) range. Reference Range Validation: The Laboratory Medical Director must examine all reference ranges provided by the manufacturer and determine if they are appropriate for the lab's patient population. This can be done empirically , or by using the methods outlined in the CLSI Document C28-A2E 'How to Define and Determine Reference Intervals in the Clinical Laboratory.' " 5. Review of the laboratory's validation records for the Medonic M series analyzer revealed the laboratory did not include the following: Precision studies: to include run-to run, day to day, within-run, operator variance studies Reference Range studies Reportable Range: to include the range the laboratory verified for each blood cell parameter 6. In interview on March 23, 2022 at 11:11 am, Testing Personnel 1 stated the precision studies were performed all on the same day, May 20, 2021. Testing Personnel 1 further stated she was the only testing personnel that assisted the technical service representative in the studies. 7. In further interview on March 23, 2022 at 11:11 am, the Technical Consultant stated she did not see anything in the laboratory's validation studies concerning what was done for the reference ranges in use. The Technical Consultant stated she thinks the laboratory is using the same ranges as their previous Medonic analyzer. 8. In interview on March 23, 2022 at 1:35 pm, the Technical Consultant stated she did not see anything in the laboratory's validation studies or procedures that stated the laboratory's reportable ranges. 9. Review of the laboratory's test menu revealed the laboratory performs 2,130 CBC tests annually. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. -- 4 of 10 -- This STANDARD is not met as evidenced by: Based on observation by surveyor, review of the laboratory's policies, Individualized Quality Control Plan (IQCP), control records, test menu, and interview with personnel, the laboratory failed to perform quality control (QC) for Group A B- hemolytic Streptococcus (Bacteriology) testing per their IQCP for five (5) of five (5) lot numbers reviewed. Findings: 1. Observation by surveyor during laboratory tour on March 23, 2022 at 9:00 am, the laboratory utilizes the Quidel Solana GAS Assay for Group A B-hemolytic Streptococcus testing 2. Review of the laboratory's "Solana GAS Assay" policy under "Quality Control" section revealed "It is recommended that the reactivity of each new lot and each new shipment of the Solana GAS Assay be verified on receipt and before use. External control tests should be performed thereafter every time patient samples are assayed." 3. In interview on March 23, 2022 at 12:07 pm, Testing Personnel 1 stated external QC for the Solana GAS Assay are tested every new lot and shipment. 4. In interview on March 23, 2022 at 12:07 pm, the Technical Consultant stated the laboratory had an IQCP for the Solana GAS Assay. Testing Personnel 1 stated she was unaware of the laboratory's IQCP. 5 Review of the laboratory's IQCP for the Solana GAS Assay revealed "It is recommended that the reactivity of each new lot and each new shipment of the Solana GAS Assay be verified on receipt and before use and every 30 days." 6. Review of random selection of the laboratory's QC records for the Solana GAS assay revealed the laboratory did not perform QC at least every thirty (30) days for the following five (5) lot numbers: Lot 179486 Lot 173482 Lot 204022 Lot 206627 Lot 180383 7. Review of the laboratory's test menu revealed the laboratory performs 1,271 Group A Streptococcus testing annually on the Solana GAS assay. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D0000 A Certification Survey was performed on September 17, 2019 at The Pediatric Center of Southwest Louisiana, CLIA ID # 19D1102217. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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: Based on record review and interview with personnel, the laboratory failed to ensure the Laboratory Director signed the attestation statement for four (4) of five (5) proficiency testing (PT) events reviewed. Findings: 1. Review of the laboratory's American Academy of Family Physicians (AAFP) proficiency records for 2018 and 2019 revealed the Laboratory Director did not sign the attestation statement for the following events: a) AAFP-PT 2018-A b) AAFP-PT 2018-B c) AAFP-PT 2019-A d) AAFP-PT 2019-B 2. In interview on September 17, 2019 at 10:06 am, Personnel 2 stated that each laboratory under the Pediatric Associates has its own Medical Technologist supervision and that supervisor is responsible for obtaining all signatures on the attestation statements. Personnel 2 further stated that the supervisor for this laboratory is no longer employed. 3. In further interview, Personnel 2 confirmed the Laboratory Director did not sign the attestation statement for the above events. D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons 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 -- other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to perform an assessment for an unacceptable proficiency test (PT) results for 2018 and 2019. Findings: 1. Review of the laboratory's 2018 and 2019 American Academy of Family Physicians (AAFP) PT results revealed the laboratory received the following unacceptable results: a) AAFP-PT 2018-A: Sample HD-3 for Mean Corpuscular Volume (MCV) b) AAFP-PT 2019-B: Sample HCT for Hematocrit (HCT) 3. In interview on September 17, 2019 at 10:06 am, Personnel 2 confirmed the laboratory did not perform