Reproductive Resource Center Laboratory

Summary Statement of Deficiencies D6151 GENERAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1463(b)(3)(4) (3) The director or technical supervisor may delegate to the general supervisor the responsiblity for providing orientation to all testing personnel; and (4) Annually evaluating and documenting the performance of all testing personnel. This STANDARD is not met as evidenced by: Based on the review of the CMS 209 personnel form, competency assessment documents, and interview with general supervisor (GS) #1, the GS failed to include competency assessment by direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing; direct observation of performance of instrument maintenance and function checks; and assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples for 2023 and to date of survey 2024. Findings: 1. Review of the CMS209 revealed two high complexity testing personnel (TP) for competency assessment in 2023 and 2024. 2. Review of the competency assessment from 2023 and to date of survey 2024 for the two TP revealed the competencies lacked three of the six required elements: a. Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. b. Direct observation of performance of instrument maintenance and function checks. c. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. 3. Interview with GS #1 on 10/28/24 at 10 a.m. confirmed the GS failed to include competency assessment by direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing; direct observation of performance of instrument maintenance and function checks; and assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples for 2023 and to date of survey 2024. 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 D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of patient test reports and interview, the laboratory failed to include the performing laboratory's address on the patient report. Findings: 1. Review of selected patient test reports for reference laboratory testing showed the reference lab name only. It lacked the referred laboratory street address where the test was performed. These reports are received via system interface and not a scanned report. 2. Interview with the Technical Consultant on 1/18/23 at 10:50 a.m. confirmed the laboratory failed to include the performing laboratory's address on the patient report. 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 D5543 HEMATOLOGY CFR(s): 493.1269(a)(d) (a) For manual cell counts performed using a hemocytometer-- (a)(1) One control material must be tested each 8 hours of operation; and (a)(2) Patient specimens and control materials must be tested in duplicate. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of semen analysis manual cell counts and interview with the general supervisor on October 26, 2018 at 12:30 PM confirmed the laboratory failed to perform semen analysis manual cell counts in duplicate. 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 --