St Margaret's Health - Spring Valley

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, lack of laboratory records and interview it was determined that the laboratory failed to establish written policies and procedures to assess and document the competency of two of two Technical Supervisors for 2020 and to the date of the survey in 2021. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to describe the laboratory's process for assessing the competency of two of two Technical Supervisors. 2. The Survey Team requested and the laboratory failed to provide documentation of the evaluation of the competency of two of two Technical Supervisors for 2020 and to the date of the survey in 2021. Technical Supervisors include: - Laboratory Director/Technical Supervisor #1 - Technical Supervisor #2 3. During an interview with the Survey Team at 9:00 AM on November 3, 2021 the Laboratory Director/Technical Supervisor #1 confirmed these findings. D5619 CYTOLOGY CFR(s): 493.1274(b)(3) (b) Staining. The laboratory must have available and follow written policies and procedures for each of the following, if applicable: (b)(3) Nongynecologic specimens that have a high potential for cross-contamination must be stained separately from other nongynecologic specimens, and the stains must be filtered or changed following staining. 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 -- This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, lack of laboratory records and interview it was determined that the laboratory failed to establish written policies and procedures for identifying nongynecologic specimens with a high potential for cross- contamination and staining them separately from other nongynecologic specimens and filtering or changing the stains following staining. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures for identifying nongynecologic specimens with a high potential for cross- contamination and staining them separately from other nongynecologic specimens and filtering or changing the stains following staining. 2. The Survey Team requested and the laboratory failed to provide records documenting that stains were filtered or changed following staining of specimens with a high potential for cross- contamination. 3. During an interview with the Survey Team at 3:30 PM on November 2 , 2021 the Laboratory Director/Technical Supervisor #1 confirmed these findings. D9999 By agreement between ASCT Services, Inc. and CMS, information provided for CMS's completion of CMS Form 670 are ASCT Services, Inc. averages only. This information is confidential and proprietary to ASCT Services, Inc., is exempt under the Freedom of Information Act (5 U.S.C. 552 et seq.), and shall be used for federal government purposes only. -- 2 of 2 --

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 record review and an interview with the testing personnel (TP1) and laboratory director (LD); the laboratory failed to ensure test reports indicate *the name and address of the laboratory where the tests were performed. Findings include: 1. The Histopathology specimen logs, slides, and final reports from 2018, 2019 and 2020 were reviewed. 2. Slide review of 14 patients showed 4 patients' tissues (patients F1, F2, F3, and F4) were processed and stained at another laboratory (Methodist Medical Center). 3. Further review revealed the laboratory failed to include the name and location of the laboratory which performed the processing and staining of the slides on the final reports for 4 out of 4 patients. 4. TP1 and LD confirmed the findings on 09/29/2020 at 2:15 PM. 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 --