Pediatric And Adolescent Clinic

Summary Statement of Deficiencies D0000 A Recertification survey was performed on March 12, 2024 at Pediatric & Adolescent Clinic, CLIA ID # 19D1005933. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper 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 review of the laboratory's temperature logs and policies as well as interview with personnel, the laboratory failed to define an acceptable room temperature for the laboratory. Findings: 1. Review of the following laboratory documents revealed the laboratory had different acceptable room temperature limits defined for the laboratory: a) The laboratory's temperature logs defined the acceptable room temperature limits for the laboratory as 68 - 78 degrees Fahrenheit. b) The laboratory's policy "Daily Temperature Monitoring" defined the acceptable room temperature limits for the laboratory as 68 - 90 degrees Fahrenheit. 2. In interview on March 12, 2024 at 12 p. m., the Technical Consultant confirmed the laboratory had different acceptable room temperature limits for the laboratory as identified above. D5783

Summary Statement of Deficiencies D0000 A Recertification survey was performed on June 29, 2022 at Pediatric & Adolescent Clinic, CLIA ID # 19D1005933. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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 installation records, test menu, and interview with personnel, the laboratory failed to have complete performance verification studies for the Abbott Cell-Dyn Emerald Hematology analyzer. Findings: 1. Observation by surveyor during the laboratory tour on June 29, 2022 at 9:30 am revealed the laboratory utilizes the Abbott Cell-Dyn Emerald Hematology analzyer for Complete Blood Count (CBC) patient testing. 2. Review of the laboratory's installation records for the Cell-Dyn Emerald Hematology analyzer revealed that the laboratory started patient testing on September 11, 2021; however, the installation records were not signed as ready for patient testing by the Laboratory Director. 3. In interview on June 29, 2022 at 11:14 am, the Technical Consultant stated that she signed off on the performance verification studies but did not have the Laboratory Director sign as well. 4. Review of the laboratory's installation records revealed the laboratory performed performance verification with raw data to support the studies for 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 -- the following: a) Accuracy: Method Comparison b) Precision: Run to Run and Within Run c) Reportable Range: Linearity 5. Further review of the laboratory's installation records revealed the laboratory did not have raw data to support the studies for the following: a) Complete Precision: Day to Day and Operator Variance b) Reference Range 6. In interview on June 29, 2022 at 11:14 am, the Technical Consultant stated she was unaware the identified raw data was not included with the installation records. The Technical Consultant further stated the reference range studies were carried over from the previous Hematology analyzer since the population has not changed for the facility. 7. Review of the laboratory's test menu revealed the laboratory performs two hundred twenty two (222) CBC tests annually. D5781