Akron Clinic - Hrh

Summary Statement of Deficiencies 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)

Summary Statement of Deficiencies D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of personnel records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 8:30 am on 03/11/2020, the laboratory director failed to ensure that prior to testing patients' specimens, all testing personnel performing moderate complexity testing received the appropriate training for one out of one new testing personnel (laboratory personnel identifier #2) hired in August 2019. The findings include: 1. Personnel identifier #2 began complete blood count (CBC) patient testing in August 2019. 2. At the time of the survey, the laboratory did not have documented training for personnel identifier #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 1 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on the lack of Sysmex XP-300 patient test records, review of patient electronic health records (EHR) and confirmed by laboratory personnel, identifier #1 (refer to the Laboratory Personnel Report) at approximately 9:45 am on 5/17/2018; the laboratory failed to retain a copy of Sysmex XP-300 patient test records for three out of three patient (identifiers A, B, and C) with hematology testing performed in February 2018. The findings include: 1. Patient identifier A had a complete blood cell count (CBC) performed and reported in the EHR on 2/1/2018. 2. Patient identifier B had a CBC performed and reported in the EHR on 2/7/2018. 3. Patient identifier C had a CBC performed and reported in the EHR on 2/15/2018. 4. Laboratory personnel, identifier #1, confirmed that the laboratory manually entered patient test results from the Sysmex XP-300 instrument printout into the EHR. 5. At the time of the survey, the laboratory did not retain the Sysmex XP-300 instrument printouts for patient identifiers A, B, and C. 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 --