Grace Medical Clinics, Pa

Summary Statement of Deficiencies D6040 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(2) The technical consultant is responsible for-- (b)(2) Verification of the test procedures performed and the establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. This STANDARD is not met as evidenced by: Based upon the review of verification records and interview with the TC (Technical Consultant) on 12/13/23, the TC failed to verify the performance characteristics of the Medonic hematology analyzer implemented in the laboratory in November of 2023. Findings: Review of verification records for the Medonic Hematology analyzer revealed the performance of a calibration and one run of external quality controls prior to patient testing. There was no documentation of a study to verify the accuracy, precision and reportable range of the instrument at this laboratory. In interview at approximately 10:45 a.m., the TC confirmed that prior to patient testing, he calibrated the instrument and ran external quality controls. The TC also stated that the analyzer was previously in use at a different laboratory and the verifications that were performed at the other laboratory have been retained. 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 D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on review of laboratory procedures, review of 2017, 2018, and 2019 American Proficiency Institute (API) proficiency testing (PT) records, and testing personnel (TP) interview 11/21/19, the laboratory failed to test PT specimens the same number of times as they test patient specimens. Findings: The laboratory's "Proficiency Testing" procedure states, "The laboratory shall test PT samples using the same procedures/methodologies used for patient testing..." The Procedure also states under "PT Specimen Processing", "PT specimens are processed identical to patient specimens." Review of the laboratory's procedure, "Cell-Dyn Emerald Hematology Analyzer", under section "Critical Values Critical/Alert Values", revealed the following: "Critical values are those results demonstrating such variance from normal as to represent a pathophysiological state with potential of being life threatening unless action is taken quickly. Results should be verified by repeat testing...." The laboratory's procedure, "Cell-Dyn Emerald Hematology Analyzer", also revealed the following hematology critical values: a. White Blood Cell (WBC) (K/mm 3)- less than or equal to 2.0, or greater than or equal to 20.0. b. Hemoglobin (HGB) (g/dL)- less than or equal to 7.0, or greater than or equal to 20.0. c. Hematocrit (HCT)(%)- less than or equal to 20.0, or greater than or equal to 60.0. d. Platelet (PLT) (K/mm 3) - less than or equal to 30.0. Review of 2017, 2018, and 2019 API PT records revealed the following PT specimens had critical values that were not repeated. 1. 2017 API 3rd event: Sample HEM-13, WBC result 20.7 and Sample HEM-15, WBC result 1.9, HGB result 5.2, and HCT result 17.3. 2. 2018 API 1st event: Sample HEM-01, HGB result 5.5 and HCT result 18.2. 3. 2018 API 2nd event: Sample HEM-08, HGB result 5.5, and HCT result 19.7. 4. 2019 API 1st event: Sample HEM-01, WBC result 20.2 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 -- and Sample HEM-02, HGB result 5.4, and HCT result 19.3. During interview at approximately 11:20am, TP#3 confirmed it is the laboratory's policy to repeat critical values on patient specimens before reporting the results to the provider. She also stated PT specimens are not always repeated for Critical Values. Deficiency previously cited 11/18/2015. -- 2 of 2 --