Hagerstown Reproductive Health Svcs

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on review of the Rhesus (Rh) daily quality control (QC) worksheet for the and interview with testing person (TP), the laboratory failed to ensure that the expiration dates of the QC materials used were not used past the expiration date. Findings: 1. The Rh QC worksheet showed that the Mono clonal QC was tested and recorded on 05 /14/24 and 05/16/24. The Mono clonal QC used expired on 05/11/2024 and patients were tested and reported. 2. During the survey on 05/17/2024 at 2:10 PM, the TP confirmed that the Mono clonal QC testing on 05/14/24 and 05/16/24 had expired on 05/11/2024. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on review of the patient and quality control (QC) worksheets for the 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 -- immunohematology testing and interview with the testing personnel (TP), the laboratory's record system failed to include the identity of the personnel who performed the patient and quality control testing. Findings: 1. Review of the daily patient worksheets showed that the testing person signed the top of the worksheet. The daily patient worksheet included the test results for hemoglobin, Rhesus (Rh) factor and pregnancy test results. When interviewed the TP confirmed that there are times when one TP performs two of the three tests listed on the worksheet and another TP performs the third test. The daily worksheet only has the name of the person who started the worksheet for that date, but not for anyone else who may perform testing that day. 2. Review of the Rh QC worksheet showed that there were no initials of the person who performed the Rh QC each day of testing. 3. During the survey on 05/16 /2024 at 2:00 PM the TP confirmed that the patient and QC worksheets for the immunohematology failed to include the initials of the person who performed the testing. -- 2 of 2 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and interview with the testing personnel (TP), the laboratory director (LD) failed to document the attestation of routine integration of PT samples into the regular patient workload using the laboratory's routine methods in two of six PT events reviewed. Findings: 1. Records from a total of six PT events from 2021 and 2022 were reviewed. 2. The form used to document the attestation statements for routine integration of PT samples into the regular patient workload using the laboratory's routine methods was not signed by the LD in two of six PT events reviewed (2022 1st event and 2021 1st event). 3. During the survey on 01/12/2023 at 3:40 PM, the TP confirmed that attestation statements were not signed by the LD in two of six reviewed PT events. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

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)