Elliot Urgent Care Lab At Bedford

Summary Statement of Deficiencies 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 record review and staff interview, the laboratory failed to verify performance specifications for the hematology analyzer after receiving the instrument from the manufacturer for service repairs in November 2021. Findings include: 1. Review on 3/31/2022 of service records for the POCH-100i hematology analyzer revealed the instrument was serviced at the manufacturer and shipped back to the laboratory on 11/3/2021. 2. Review on 3/31/2022 of calibration records for the POCH- 100i hematology analyzer revealed the laboratory performed a 1 point calibration upon receiving the instrument back from the manufacturer. There were no records that the laboratory verified accuracy, precision and reportable range after receiving the instrument back from the manufacturer. 3. Interview with the Technical Consultants on 3/31/2022 at 10:00 a.m. confirmed the laboratory did not verify performance specifications for accuracy, precision and reportable range after receiving the instrument back from the manufacturer. The Technical Consultants revealed that instrument was down from 10/18/2021 to 11/5/2021. The laboratory performs 1,100 complete blood counts on the POCH-100i analyzer annually. 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 D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on record review the laboratory director failed to sign and date a revised hematology procedure before being put into use on November 30, 2018. Findings include: 1) Review on 1/4/2019 of the "I-Stat Testing" procedure received on January 4, 2019 revealed the procedure had been revised in October 2018. The laboratory director's signature and date of approval were not on the revised procedure. 2) Review on 1/4/2019 of the laboratory's

Summary Statement of Deficiencies D5425 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(3) The laboratory must determine the test system's calibration procedures and control procedures based upon the performance specifications verified or established under paragraph (b)(1) or (b)(2) of this section. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to determine hematology test system's control procedures based upon the performance specifications established by the laboratory in 2018. Findings include: 1) Review on 10 /26/2018 the laboratory's control procedure for prothrombin/international normalized ratio (PT/INR) revealed instruction to test two levels of PT/INR controls for each new lot or shipment of reagent test cartridges and every 30 days. 2) Review on 10/26/2018 of the i-STAT manufacturer's instructions revealed instruction to perform control testing on each new lot and shipment of PT/INR test cartridges. 3) Review on 10/26 /2018 of the laboratory individualized quality control procedure for PT/INR revealed the data used to determine the quality control procedure (QCP) was obtained in 2015 and 2016 by other laboratories. This laboratory did not establish its own performance specifications using its own i-STAT analyzers to determine the QCP for PT/INR. 4) Interview on 10/26/2018 at 11:30 a.m. with the technical consultants confirmed the above findings. 5) The laboratory has performed two PT/INR tests since opening in July 2018. 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 --