The Pediatric Center Of Southwest Louisiana

Summary Statement of Deficiencies D0000 A Recertification survey was performed on November 7, 2023 at The Pediatric Center of Southwest Louisiana, CLIA ID # 19D2072580. 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 (Laboratory Personnel Report), personnel records, and interview with personnel, the laboratory failed to follow their policy to assess competency of the Technical Consultant for one (1) of three (3) Technical Consultants reviewed. Findings: 1. Review of the laboratory's policy and procedure manual revealed "Technical Consultant Competencies will be evaluated upon initial designation and upon any change in Laboratory Director designation." 2. Review of the laboratory's CMS 209 revealed Personnel 2 served as testing personnel and Technical Consultant. 3. Review of personnel records for Personnel 2 revealed the laboratory did not have documentation of a competency assessment for her role as Technical Consultant. 4. In interview on November 7, 2023 at 2:51 p.m., Personnel 2 confirmed the laboratory did not have documentation of a competency assessment for her role as Technical Consultant. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation, review of the laboratory's temperature records and policy and procedure manual, as well as interview with personnel, the laboratory failed to define acceptable room temperature limits within the manufacturers' required ranges for supplies stored in the laboratory. Findings: 1. Observation by surveyor during the laboratory tour on November 7, 2023 at 1:03 p.m. revealed the laboratory stored BD Microtainer Tubes with K2EDTA (manufacturer's upper temperature limit 25 degrees Celsius) stored in the laboratory. 2. Review of the laboratory's temperature logs revealed the laboratory defined the acceptable room temperature limits as 15-30 degrees Celsius (59-86 degrees Fahrenheit). 4. Review of the laboratory's policy "Temperature Logs Documentation" revealed the acceptable room temperatures defined as 15-30 degrees Celsius (59-86 degrees Fahrenheit). 5. In interview on November 7, 2023 at 4:15 p.m., Technical Consultant 1 confirmed the laboratory's acceptable range was outside of the manufacturer's limits as identified above. D5785

Summary Statement of Deficiencies D0000 A Recertification survey was performed on March 22, 2022 at The Pediatric Center of Southwest Louisiana, CLIA ID # 19D2072580. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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 22, 2022 at 1:00 pm 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 March 22, 2022 at 2:51 pm, Testing Personnel 1 confirmed the SARS COV-2 fact Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- sheets the laboratory provided to patients did not match the manufacturers'. 5. Review of the laboratory's test menu revealed the laboratory performs seven (7) Lumira Dx SARS COV-2 antigen tests and 184 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 22, 2022 at 3:09 pm 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 22, 2022 at 3:09 pm, 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. 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 -- 2 of 8 -- interview on March 22, 2022 at 1:06 pm, the Technical Consultant and Testing Personnel 1 confirmed the laboratory did not have a written policy for reporting positive and negative SARS COV-2 results to the state. 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