Mercy Hospital

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL 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 the review of the laboratory's non-waived test list, lack of approved procedure for the Affirm VPIII testing, patient test reports for 2023, and interview with General Supervisor (GS) #1, the laboratory failed to have a written procedure available to and followed by, laboratory personnel for the operation of the Affirm VP III test system used for the detection of Trichomonas vaginalis, Gardnerella vaginalis and Candida species before reporting patient results. Findings: 1. Review of the non- waived test list included a "Vaginitis Panel" performed on the Affirm VPIII. a. The panel consists of three organisms reported as positive or negative: Trichomonas vaginalis, Gardnerella vaginalis, and Candida species. 2. Request was made for the procedure for the vaginitis panel performed on the Affirm VPIII. No approved procedure was made available at the time of survey. 3. Review of patient results reported from 1/1/23 to 8/22/23 revealed 42 patient reports were released. 4. Interview with GS #1 on 8/22/23 at 2:25 p.m. confirmed, the laboratory failed to have a written procedure available to and followed by, laboratory personnel for the operation of the Affirm VP III test system used for the detection of Trichomonas vaginalis, Gardnerella vaginalis and Candida species before reporting patient results. D5425 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(3) The laboratory must determine the test system's calibration procedures and control 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 -- procedures based upon the performance specifications verified or established under paragraph (b)(1) or (b)(2) of this section. This STANDARD is not met as evidenced by: Based on the review of the Individualized Quality Control Plan (IQCP) for the BD Affirm VPIII test system for Trichomonas vaginalis, Gardnerella vaginalis and Candida species detection and interview with GS #1, the laboratory failed to describe what quality control (QC) was to be used and failed to include the history of the QC frequency (stability study) for the defined QC interval. Findings: 1. Review of the IQCP for the BD Affirm VPIII, signed by the laboratory director 3/20/23 revealed: a. Under "QC plan:", item #4: "QC should be run every new shipment, new lot and every month of the current lot. b. Further review finds the QC material is not defined with any information as to the type of control, manufacturer or expected results (positive control or negative control). c. Item #4 continues with the following: "Past QC data collected and proficiency testing show that QC testing can be run once a month without clinically significant error." d. No QC history to support the defined QC interval was included in the IQCP. The laboratory was not able to provide this documentation at the time of survey. 2. Interview with GS#1 on 8/22/23 at 2:25 p.m. confirmed, the laboratory failed to describe what quality control (QC) was to be used and failed to include the history of the QC frequency (stability study) for the defined QC interval. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the review of the CMS116 test list, QC and patient testing performed from 1 /1/23 to date of survey, package insert for the BD Affirm VPIII test system for Trichomonas vaginalis, Gardnerella vaginalis and Candida species and interview with GS #1, the laboratory failed to perform both a positive and negative control as required before reporting patient results for Trichomonas vaginalis, Gardnerella vaginalis and Candida species. Findings: 1. Review of the 116 test list included a "Vaginitis Panel" performed on the BD Affirm VPIII. a. The panel consists of three organisms reported as positive or negative: Trichomonas vaginalis, Gardnerella vaginalis, and Candida species. It is classified by FDA as moderate complexity. 2. Review of the QC and patient test logs from 1/1/23 to date of survey revealed no external negative control had been performed and a total of 42 patient results have been reported. 3. Review of test system package insert, under Quality Control states: "Quality control requirements must be performed in accordance with applicable local, state and/or federal regulations or accreditation requirements and your laboratory's standard Quality Control procedures." 4. Interview with GS #1 on 8/22/23 at 2:25 p. m. confirmed, the laboratory failed to perform both a positive and negative control as required before reporting patient results for Trichomonas vaginalis, Gardnerella vaginalis and Candida species. -- 2 of 2 --

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, erythrocyte sedimentation rate (ESR) quality control (QC) documentation, patient test logs, and interview with General Supervisor (GS) #1, the laboratory failed to test the ESR proficiency testing samples it received from the proficiency testing (PT) program in the same manner as it tested patient specimens. Findings Include: 1. Review of the laboratory's policy titled "Proficiency Testing", signed by the Laboratory Director (LD) on 09/10/2005, found the following directions: II. Handling of Proficiency Testing Specimens - Specimens received for purposes of proficiency testing will be handled and tested in the same manner as patient samples unless specific handling requirements are specified in the literature. 2. Review of the laboratory's procedure titled "Excite Mini Erythrocyte Sedimentation Rate", signed by the Laboratory Director (LD) on 08/27/2018, found the following directions: Quality Control: ... Control samples both normal and abnormal, need to be run once every month and the values fall within acceptable limits. 3. Review of the laboratory's ESR QC documentation and patient test logs found the laboratory performed extra QC when PT samples were tested as follows: 07/19/2017 Two patient tests were performed. Following the two patient tests, QC and 2 PT samples (API 03 and 04) were Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 22 -- performed. QC was performed again on 07/27/2017. No documentation indicating the reason for the extra QC analysis was present. 4. GS #1 stated they were unsure why testing personnel (TP) had run extra QC with the PT and stated they were unaware that TP were running extra QC with PT samples. GS #1 further stated the laboratory does not run QC with each patient sample. The interview occurred 09/13/2018 at 10: 08 AM. D5026 IMMUNOHEMATOLOGY CFR(s): 493.1217 If the laboratory provides services in the specialty of Immunohematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1271, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: The cumulative deficient practices identified under the specialty of Immunohematology have been determined to constitute an Immediate Jeopardy. Based on review of the laboratory's policies and procedures, quality control documentation, patient test records and final test reports, instrument function check documentation, transfusion records, temperature documentation, and quality assessment documentation, the laboratory failed to meet the requirements specified in 493.1230 through 493.1256, 493.1271, and 493.1281 through 493.1299. Findings Include: 1. The laboratory failed to ensure a written procedures manual for all immunohematology tests, assays, and examinations performed by the laboratory was available to, and followed by, laboratory personnel. (Refer to D5401) 2. The laboratory failed to ensure that the Becton Dickinson (BD) Affirm VPIII, chemistry, immunohematology, erythrocyte sedimentation rate (ESR), hematology complete blood count (CBC) and manual differential, and coagulation procedures included