Um Oral Pathology Biopsy Service

Summary Statement of Deficiencies D5030 ORAL PATHOLOGY CFR(s): 493.1220 If the laboratory provides services in the subspecialty of Oral pathology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: . Based on record review and interview with the Laboratory Coordinator (LC), the laboratory failed to establish policies and procedures for assessing competency of laboratory personnel (refer to D5209), failed to include control procedures for Periodic Acid-Schiff (PAS) stain in the laboratory procedure manual (refer to D5403), and failed to ensure document negative reactivity for Periodic Acid-Schiff (PAS) staining (refer to D5473). 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 with the Laboratory Coordinator (LC), the laboratory failed to establish policies and procedures for assessing laboratory personnel competency for 2 (September 2023 to September 2025) of 2 years. Findings include: 1. A review of staff personnel records revealed that competency assessments were not performed for the following laboratory personnel: a. Testing Personnel: TP1, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- TP2, TP3, TP4 b. Clinical Consultants: CC1, CC2, CC3, CC4 c. Technical Consult: TS1 d. General Supervisor: GS1 2. A request was made to the LC on 9/8/2025 at 11: 56 am for the missing competency assessments and documentation was not provided. 3. A request was made to the LC on 9/8/2025 at 11:56 am for the competency assessment policy and documentation was not provided. 4. An interview was conducted with the LC on 9/8/2025 at 11:57 am which confirmed that the competency assessments had not been performed for the above laboratory personnel. ***Repeat Deficiency from June 10, 2015 and September 19, 2019 Surveys*** D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

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 record review and interview with the Laboratory Coordinator, the laboratory failed to verify the accuracy of its oral pathology testing at least twice annually for 2 (August 2021 and August 2023) of 2 years reviewed. Findings include: 1. A review of the laboratory's records revealed a lack of verification of accuracy documentation for its oral pathology testing between August 2021 to August 2023. 2. The surveyor requested the laboratory's verification of accuracy documentation for its oral pathology testing between August 2021 to August 2023 on 8/1/23 at 10:30 am and it was not made available. 3. An interview on 8/1/23 at 12:37 pm with the Laboratory Coordinator confirmed verification of accuracy documentation for its oral pathology testing between August 2021 to August 2023 was not available. 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) 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 -- The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: . Based on lack of documentation of competency assessments and interview with the Laboratory Director (LD), the director failed to ensure that competency assessments were completed for Testing Personnel #2 (TP2) for 2 (September 2017 to September 2019) of 2 years as the grossing fill-in position during vacations. Findings include: 1. Review of the CMS-209 signed by the director on 09/16/2019 listed 2 TP performing the highly complex oral pathology grossing. 2. On 09/16/2019 at approximately 11:45 pm when requested, the laboratory was unable to provide the surveyor with competency assessments for TP2 for 2 years. 3. During the interview on 09/16/2019 at 12:00 pm, the LD confirmed no competency assessments were performed and documented for TP2. ***Repeat Deficiency from June 10, 2015 survey*** 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 --