Summary:
Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard level deficiencies were cited. 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 review of laboratory policy, patient test records, and confirmed in interview, the laboratory failed to ensure patient histopathology (Mohs) slides were labeled with at least two unique patient identifiers for 24 of 24 slides in 2023 (December random review) and 24 of 24 slides in 2024 (May random review). Findings included: 1. Review of the laboratory policy titled "Embedding, Cutting, and Cover-slipping Frozen Sections" revealed: "Procedure ... 3. The reverse slide mount method is used for embedding. Each slide will be labeled with the patient name, Mohs accession number, stage, date, slide number. a. Mohs accession number is assigned by location and year (ex. S17-001) b. Stages numbered c. Piece number is the number of piece(s) the surgeon divides the tissue into d. Slide level is an alphanumeric number: Examples: A- first slide, B- second slide, C- third slide, etc." An example of how to label a slide was illustrated in the policy: "NAME ACCESION#-STAGE Date Piece#slidelevel" [sic] The laboratory policy did not include labeling instructions to reliably identify patients using at least 2 unique patient identifiers to distinguish between specimens. 2. The following 48 patient slides from December 2023 and May 2024 were observed to be labeled with a patient last name and first initial, Mohs 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 -- accession number, piece number, slide number, and date of service: 12/28/203 Patient ID: S23-070; 6 slides Patient ID: S23-071; 4 slides Patient ID: S23-072; 5 slides Patient ID: S23-073; 5 slides Patient ID: S23-074; 4 slides 05/31/2024 Patient ID: S24- 446; 3 slides Patient ID: S24-447; 4 slides Patient ID: S24-448; 4 slides Patient ID: S24-449; 3 slides Patient ID: S24-450; 10 slides The laboratory failed to ensure patient histopathology (Mohs) slides were labeled with at least 2 unique patient identifiers. 3. During an interview on 06/05/2024 at 10:38 a.m., the Histology Technician and Regional Clinical Manager confirmed the above findings. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy, potassium hydroxide (KOH) patient logs, patient charts and in interview with staff, the laboratory failed to ensure one of two patients KOH results were transcribed accurately to the final test report in December 2023. Findings included: 1. Review of the laboratory's policy "Potassium Hydroxide (KOH)" stated: "Reporting Results Results are reported along with patient identification information, physician, date test performed, results, and comments that indicate the diagnosis and/or any abnormalities found." 2. A review of "KOH/Scabies Log" from December 2023 revealed the following patient KOH results documented: Patient #1 "Date: 12/11/2023; PT MRN: 6089173; Patient Name: [XX]; BODY LOCATION: Rt upper arm; TEST PERFORMED: KOH; DIAGNOSIS (Needs to match chart) Tinea Corporis; PROVIDER: [XX]; MA: [XX]" The laboratory's practice was documenting the patient's result in the log and then transcribing it into the patient's medical record ("Visit Note"). The laboratory was asked to provide the above-mentioned patient medical record to review the KOH results for that date. The chart was provided, and KOH results were transcribed in the patient's medical record as follows: Patient #1: MRN (medical record number): 6089173; Visit Note date: 12 /11/2023 "Plan: KOH Prep. A KOH prep was ordered and evaluated from the right anterior proximal upper arm. A 15-blade scalpel was used to scrape the skin. The skin scrapings were placed on a glass slide, covered with a coverslip and a KOH solution was applied. Examination of the slide showed: branching hyphae." The laboratory failed to accurately transcribe results of KOH preparations to the final reports. 3. During an interview on 06/05/2024 at 10:38 a.m., the Histology Technician and Regional Clinical Manager, after a review of records confirmed the above findings. Word Key: PT- patient MRN- medical record number RT- right MA- medical assistant -- 2 of 2 --