Pediatric Services, Pa

Summary Statement of Deficiencies D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to perform and document maintenance and function check activities for Microbiology laboratory equipment in 2022 and 2023. Findings are as follows: 1. The laboratory performed Throat Culture and Urine Culture testing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory at 10:05 a.m. on 10/03/23. 2. An incubator with thermometer was observed in the laboratory as present and available for use during the tour. 3. Twice-annual thermometer function checks were required as established in the Incubator Maintenance procedure found in the Incubator and Centrifuge manual. 4. Thermometer function check documentation for 2022 and documentation for the second thermometer function check of 2023 was not found during review of laboratory records. Dates of thermometer verification listed on the maintenance log were July 2021 and January 2023. 5. The laboratory performed approximately 425 cultures annually as indicated on the test volume document provided on date of survey. 6. In an interview at 2:45 p.m. on 10/03/23, TP1 confirmed the above findings. . 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 --

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to investigate unacceptable Hematology proficiency testing (PT) results for 4 analytes in 2021. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory at 9: 05 a.m. on 09/02/21. 2. The laboratory performed PT using the College of American Pathologists (CAP) program. 3. The laboratory received 4 unacceptable PT results for 1 of 5 PT challenges completed for the 2021 Hematology 1st event (FH2-A). See below. Sample Test FH2-04 Red Blood Cell Count FH2-04 Hematocrit FH2-04 Granulocyte % FH2-04 Lymphocyte % 4. Investigation of unacceptable PT results was required as established in the Proficiency Testing procedure located in the Technical Procedure Manual. 5. Investigation of the unacceptable PT results was not found during review of laboratory records. The laboratory was unable to provide investigation documentation upon request. 6. In an interview at 10:00 a.m. on 09/02 /21, TP1 confirmed the above finding. . 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 --

Summary Statement of Deficiencies D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (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. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the technical consultant (TC) failed to evaluate testing personnel for competency in Microbiology (Bacteriology) moderately complex test procedures performed by the laboratory. Findings are as follows: 1. The laboratory performed Microbiology (Bacteriology) testing as confirmed by the Clinic Manager (CM) during a tour of the laboratory on 12 /05/19 at 9:05 a.m. 2. The CM stated the laboratory testing personnel set-up throat and urine cultures and clinic physicians determined the test results. 3. Competency assessments for determining culture test results were not present in 2018 laboratory records for 6 of 6 physicians responsible for this task. 4. The laboratory was unable to provide the competency assessments upon request. 5. In an interview on 12/05/19 at 10:30 a.m., the CM confirmed the above findings. NOTE: this is a repeat deficiency from the 12/08/17 survey. . 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 --

Summary Statement of Deficiencies No Tags No deficiency details available. 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 --