Southern Illinois Univ - School Of Dental Med

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, laboratory records, and interview with the laboratory director (LD); the laboratory failed to perform bi-annual method accuracy verification of oral pathology specimens in 2024 through date of survey 07/03/2025. Findings include: 1. Review of the laboratory's "Quality Assessment" policy/protocol stated, "For quality assurance and assessment purposes, one to two slides will be sent to another bord certified oral pathologist annually for review". Regulation 493.1236 requires accuracy verification at least twice annually. 2. Review of laboratory records found no bi-annual method accuracy verification for oral pathology testing in 2024 through the date of survey 07/03/2025. 3. On survey date 07/03/2025, at 09:43 am interview with the LD confirmed the laboratory failed to complete bi-annual method accuracy comparisons in 2024 or 2025 for oral pathology testing. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) (b)(1)(i) Establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(1)(ii) Perform and document the maintenance activities specified in paragraph b(1)(i) of this section. This STANDARD is not met as evidenced by: 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 -- Based on direct observation, review of the laboratory's records, lack of documentation, and interview with the laboratory director (LD); the laboratory failed to define and document performance of microscope preventative maintenance (PM) as required per 493.1254. Findings include: 1. During the tour of the laboratory on 07/03 /2025 at 10:30 am, the surveyor identified an Olympus BX 46 microscope (Serial Number: 0D47332) used for oral pathology testing. 2. Review of the laboratory procedure manual, entitled "Biopsy Policies and Procedures", failed to outline the PM methods for the laboratories microscope. 3. A lack of documentation revealed no preventative maintenance had been completed for the Olympus BX 46 microscope used for oral pathology testing from the start of testing in September of 2021 through the survey date of 07/03/2025. 4. On survey date 07/03/2025, at 10:30 am, interview with the LD confirmed the laboratory failed to have preventative maintenance records for the Olympus BX 46 microscope (Serial Number: 0D47332). -- 2 of 2 --

Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and interview with laboratory director (LD); the laboratory failed to establish written policies and procedures for specimen handling, receiving, and referral, prior to receiving patient specimens for Oral Pathology affecting 14 of 14 patients' reported. Findings include: 1. The laboratory procedures manual was reviewed. 2. The laboratory received Oral Pathology specimens for slide interpretation. 3. The manual failed to include the following written policies and procedures: -Patient preparation. -Specimen collection. - Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. -Specimen storage and preservation. -Conditions for specimen transportation. -Specimen processing. -Specimen acceptability and rejection. -Specimen referral. 4. Further review of the manual showed the laboratory failed to include the step-by-step procedure detailing how patients' slides are to be received and documented from the tissue processing laboratory. 5. The laboratory director confirmed the above findings on 03/30/2022 at 11:15 AM. D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must 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 -- be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and interview, the laboratory failed to document all control procedures performed affecting for 14 of 14 patients tests. Findings Include: 1. The laboratory's manual and patient log sheet were reviewed. 2. The procedures manual revealed the following: *The laboratory director (LD) performed Oral pathology slide interpretations only. *Patients' specimens were sent to SEMC Pathology (14D0982965) for tissue processing and pathology slide production. 3. The patient log sheet revealed the LD began reading Oral Pathology slides on 08/30 /2021; 4. Interview on 03/30/2022 at 10:50 AM; LD stated the quality of the slides received from SEMC were assessed during the reading of patients. slides, however these evaluations were not documented. 5. The patient log revealed that 14 patients Oral Pathology slides have been read and reported since testing began in 08/30/2021. 6. The log and manual further showed that the laboratory failed to document the reactivity the Hematoxylin and eosin (H&E) stains and special stains, if applicable, for 14 of 14 reported patient cases. 7. The laboratory failed to document all tissue staining quality controls and failed to establish procedures which would ensure the tissue stain quality of all processed tissue are assessed and documented when received from SEMC laboratory, prior to reading patients' Oral Pathology slides. 8. The LD confirmed the above findings on March 30, 2022 at 11:00 AM. -- 2 of 2 --