Indian River Memorial Hospital Inc

Summary Statement of Deficiencies D0000 Recertification survey was conducted from 1/11/2024 to 1/31/2024. Indian River Memorial Hospital Inc clinical laboratory was not in compliance with 42 CFR Part 493, requirements for clinical laboratories. 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 observation, record review and interview, the laboratory failed to locate Potassium Hydroxide (KOH) patient records for 2022 and 2023. Findings Included: On 1/11/2024 at 1:10 PM, a bottle of KOH 10% with expiration date of 10/31/2025 was located in the lab. Review of KOH log indicated there was no documentation of patients recorded for KOH testing in 2022 and 2023. Review of Mycology Slide examination SOP signed by Laboratory Director on 4/19/2023 revealed no written policy on how patient records would be monitored for KOH. On 1/11/2024 at 2:45 PM , the Director of Lab Operations and Practice Manager confirmed the lab could not locate KOH patients in their laboratory record computer system as physician wrote patient results in notes not easily traced. Annual testing volume for Mycology is 15. D5219 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(2) At least twice annually, the laboratory must verify the accuracy of any test or procedure listed in subpart I of this part for which compatible proficiency testing samples are not offered by a CMS-approved proficiency testing program. 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 record review, and interview, the laboratory failed to perform twice annual peer- review verifications for micrographically oriented histographic surgery (MOHS) testing in 2023. Finding included: Review of Peer Reviews revealed no documentation for 2 out of 2 MOHS peer review verifications in 2023. Review of MOHS Lab Surgery Proficiency Monitoring Program (Peer Reviews) SOP signed by the Laboratory Director on 1/5/2024 read, "All peer reviews will be selected at random for physicians. A total of 5 cases will be reviewed annually. The cases will be read by another MOHS surgeon (annually) to assure that both physicians concur that tumor has been removed. (This process is known as peer-review)." The policy did not contain documentation of twice annual reviews. On 1/11/2024 at 2:44 PM the Director of Lab Operations confirmed 2 out of 2 MOHS peer- review verifications were not completed in 2023. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on record review, and interview, the technical consultant failed to perform annual Potassium Hydroxide (KOH) competency assessments for 1 out of 3 Testing Personnel in 2022 and 2023, (C). Findings Included: The Laboratory Personnel Report revealed employee C was Testing Personnel C. Review of Competency assessments revealed no documentation of annual KOH competency assessments performed for Testing Personnel C in 2022 and 2023. Review of MOHS Lab Competency Assessment of Testing Personnel SOP signed by Laboratory Director on 4/19/2023 read, "Annually: with the calendar year. Competency: the ability of the employee to apply their skill knowledge, and experience to perform their job duties correctly and as they were initially trained." On 1/11/2024 at 2:44 PM the Director of Lab Operations confirmed the technical consultant failed to perform annual KOH competency assessment for 1 out of 3 Testing Personnel, C in 2022 and 2023. -- 2 of 2 --

Summary Statement of Deficiencies D0000 (Amended) An initial certification survey was conducted on March 29, 2022. Indian River Memorial Hospital Inc clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. 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 record review and interview, the laboratory failed to establish and follow written policies and procedures to assess employee initial training that included six month, and annual competency assessment for one of one testing personnel from 10/04 /2021 to 03/29/2022. Findings: Review of the laboratory's procedure manual showed there was no procedure for competency assessments. Review of the laboratory personnel records showed there was no record of an initial competency assessment on the histology technologist. Review of the laboratory's quality control logs with the current location of the laboratory listed, noted the first date the quality control logs were completed was 10/04/2021. On 03/29/2022 at 3:11 PM, the Histology Technologist stated there was no initial training competency assessment performed on him. On 03/29/2022 at 3:59 PM, the Histology Technologist said there was no policy for competency assessments. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on record review, and interview, the laboratory did not have a written quality assessment procedure that described the laboratory's process for proficiency testing from 09/21/2021 to 03/29/2022. Findings: Review of the procedure manual showed the manual was signed by the Laboratory Director on 09/21/2021. The procedure manual failed to include a procedure on the performance of proficiency testing for the reading of the Hematoxylin & Eosin (H & E) stains performed by the Mohs Surgeon and the Potassium Hydroxide (KOH) testing performed by the Laboratory Director. On 03/29/2022 at 3:58 PM, the Histology Technologist stated there was no procedure on the proficiency testing for the H&E stains. On 03/29/2022 at 4:18 PM, the Histology Technologist said there was no procedure on the proficiency testing for the KOH testing. 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)