Summary:
Summary Statement of Deficiencies D3041 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(6) (a)(6) Test reports. Retain or be able to retrieve a copy of the original report (including final, preliminary, and corrected reports) at least 2 years after the date of reporting. In addition, retain the following: (a)(6)(i) Immunohematology reports as specified in 21 CFR 606.160(d). (a)(6)(ii) Pathology test reports for at least 10 years after the date of reporting This STANDARD is not met as evidenced by: Based on the lack of a Procedure Manual (PM) and interview with the Office Manager (OM), the laboratory failed to have a retention policy from 5/29/24 to 3/10/26. The finding includes: 1. There was no procedure to maintain histopathology slides performed in Mohs testing for the required 10 years. 2. The OM confimed on 3/10/26 at 1:30 pm that he was there was no procedure to maintain histopathology slides. 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 the review of the Biannual Assessments (BA) records and interview with the Office Manager (OM) the laboratory failed to verify the accuracy of Histopathology testing biannually in the calendar year 2025. The finding includes: 1. There was no documented evidence the laboratory verified the accuracy of histopathology testing in the calendar year 2025. 2. The OM confirmed on 3/10/26 2pm, the laboratory did not verify the accuracy of Histopathology testing in the calendar year 2025. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- 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 identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on the lack of a Procedure Manual (PM) and interview with the Office Manager (OM), the laboratory failed to establish a detailed procedure for Biannual Assessment (BA) from 5/29/24 to 3/10/26. The findings include: 1. The laboratory did not have a procedure manual. 2 The laboratory did not have a procedure for BA. 3. The OM confirmed on 3/10/26 at 1:15 pm that the laboratory did not have a procedure for BA. D5309 TEST REQUEST CFR(s): 493.1241(e) (e) If the laboratory transcribes or enters test requisition or authorization information into a record system or a laboratory information system, the laboratory must ensure the information is transcribed or entered accurately. This STANDARD is not met as evidenced by: Based on surveyor review of Test Reports (TR), Electronic Medical Records (EMR), lack of a Procedure Manual and interview with the Office Manager (OM), the laboratory failed to have an ongoing mechanism to ensure the accuracy of manual entries by personnel into the EMR from 5/29/24 to 3/10/26. The findings include: 1. The laboratory failed to have a procedure for TR and other pertinent information manually scanned into the EMR. 2. The OM confirmed on 3/10/26 at 1:10pm the laboratory failed to verify the accuracy of manual entries by personnel into the EMR. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on the lack of a Procedure Manual (PM) and interview with Office Manager (OM) the laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems from 5/29/24 to 3/10/26. The OM confirmed on 3 /10/26 at 1:30pm that the laboratory failed to establish the aforementioned procedures. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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 -- 2 of 6 -- 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 lack of Procedure Manual (PM) and interview with the Office Manager (OM), the laboratory failed to have a PM from 5/29/24 to 3/10/26. The OM confirmed on 3/10/26 at 12:45 PM the laboratory did not have a PM for all tests and procedures performed in the laboratory. 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)