Summary:
Summary Statement of Deficiencies D0000 The initial survey was performed on 07/12/2024. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director at the conclusion of the survey. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory director, the laboratory failed to ensure a proficiency testing attestation statement had been signed by the laboratory director or designee for one of three Hematology events reviewed in 2023 and 2024. Findings include: (1) A review of the second and third 2023, and first 2024 Hematology proficiency testing records identified the following for one of three events: (a) First 2024 Event - The attestation statement had not been signed by the laboratory director or designee. (2) The records were reviewed with the laboratory director who stated on 07/12/2024 at 11:48 am, the attestation statement had not been signed. D5401 PROCEDURE MANUAL 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 -- CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a review of records, policies and procedures, and interview with the laboratory director, the laboratory failed to follow their written policy for verifying the stated values of control materials prior to implementation for six of 30 lot numbers used during the review period of 05/01/2023 through 05/29/2024. Findings include: (1) On 07/12/2024 at 09:30 am, the laboratory director stated the following: (a) The laboratory performed CBC (Complete Blood Count) testing using the Medonic M- Series analyzer; (b) Three levels of Boule Con-Diff Tri-Level (Quality Control) materials were tested each day of patient testing; (c) The manufacturer's provided ranges were used to determine acceptability of quality control results. (2) A review of the "Laboratory Procedure Manual" identified a policy titled "CBC new Lot Verification" which stated "Before New lot of CBC control can be used, they must be verified, and the new lot will be run alongside of current lot until (3) runs of each Low, Normal and High control has been ran. The new lot must be in range with new lot reportable ranges in order to use them as verification of this lot." (3) A review of records for 30 control lot numbers used from 05/01/2023 through 05/29/2024 identified no documentation to prove six of the 30 lot numbers had been implemented per policy: (a) Low-level lot #22306-01, normal-level lot #22306-02, and high-level lot #22306-03 used from 09/27/2023 through 10/26/2023 - The controls had been tested as follows: (i) The new lots were tested three times on 09/27/2023, after the current lot expired. (b) Low-level lot #22307-31, normal-level lot #22307-32, and high-level lot #22307-33 used from 11/14/2023 through 12/07/2023 - The controls had been tested as follows: (i) The new lots were tested three times on 11/14/2023, after the current lot expired. (4) The findings were reviewed with the laboratory director who stated on 07/12/2024 at 3:25 pm, the laboratory did not follow their written policy. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)