Summary:
Summary Statement of Deficiencies D0000 A Validation survey was performed on March 13, 2023 through March 15, 2023 at Monroe Surgical Hospital, CLIA ID # 19D0997956. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on observation by surveyor, review of laboratory policies, manufacturer's instrument manual, donor questionnaires, normal patient mean study, and interview with personnel, the laboratory failed to utilize acceptable normal donors per manufacturer requirements for Prothrombin Time (PT) normal donor mean studies. Findings: 1. Observation by the surveyor during the laboratory tour on March 13, 2023 at 09:59 am revealed the laboratory utilizes the Sysmex CA-600 coagulation analyzer for Prothrombin Time (PT) and International Normalized Ratio (INR) patient testing. 2. Review of the laboratory's policy for "Establishment of Reference Interval & Geometric Mean for PT/PTT" under "Requirements" revealed the following: * Donors must be from a healthy population (no known pathological condition) and unanticoagulated. * Donors taking interfering substances and medications should not be included in the study. The medical director will review the donor's medication list to approve those that can be included in the study. * A minimumof 20 donors with a reasonably even distribution of males and females should be included. * Donors should span the adult range. (NOTE: A separate range should be established for pediatric populations if necessary). * Testing should be performed over a period of Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- several days and by different people, if possible, to minimize day to day variation. * A minimum of 4-6 specimens should be drawn each testing day, following the established laboratory protocol for collection, storage, and processing of patient samples. * The test results from the donors should be analyzed statistically and a mean +/- 2sd or 95% confidence limit calculated. 3. Review of the Siemens Sysmex CA-600 analyzer manual under "Verification of Reference Interval" revealed the following: * Donors must be from a healthy population (no known pathological condition; no pre-surgical or hospitalized patients). * Donors should not hake any medications, including aspirin. * A minimum of 20 donors with a reasonably even distribution of males and females should be included. * Donors should span the adult age range. (NOTE: A separate range should be established for pediatric populations). The FDA defines "pediatric" as up to 21 years of age. * Testing should be performed over a period of several days and by different people, if possible, to allow for day to day variation. * A minimum of 4-6 specimens should be drawn each testing day, following the established laboratory protocol for collection, storage, and processing of patient samples. * The test results from the donors should be analyzed statistically and a mean +/- 2sd or 95% confidence limit calculated. 4. Review of the laboratory's "Selection of Individuals for Reference Range Studies" revealed the following: * Do you consider yourself to be healthy? YES NO * Have you recently been ill? YES NO If YES, when _______________ * Are you taking any prescribed or over the counter medications? YES NO * If YES, please list or attach list of all medications _____________________ 5. Review of laboratory's normal donor mean PT study (performed on 10/18/2022) and donor questionnaires for Innovin Lot 564616A revealed the laboratory utilized the following four (4) unacceptable donors: * Donor 524703: The donor answered question of "Do you consider yourself to be healthy? as NO * Donor 523819: The donor listed "Depo-provera" as a prescibed or over-the- counter medication * Donor 523925: The donor listed "Low-Dose Bayer Aspirin" as a prescribed or over-the-counter medication * Donor 526519: The donor listed "Warfarin" as a prescibed or over-the-counter medication 6. In interview on March 14, 2023 at 3:45 pm, the Techincal Consultant stated the Laboratory Director reviews medication lists and decides if donor can be utilized for the study. The Technical Consultant confirmed the laboratory utilized unacceptable donors for the normal mean PT study. D5781