Summary:
Summary Statement of Deficiencies D0000 An onsite initial certification survey conducted February 13, 2024, found the laboratory in compliance with 42 CFR Part 493, Requirements for Laboratories. 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 the laboratory's policies, surveyor observations, and staff interview, the laboratory failed to have a mechanism in place to ensure samples were maintained at the required temperature during transport for three of three months between November 2023 and January 2024. The findings included: 1. A review of the laboratory's policy titled "Laboratory Operations Manual for DNA/RNA Based Pathogen Testing" (approved by the laboratory director on 09/01/2023) under the section titled Pre-analytical Error Root Causes (page 4), stated: "The pre-analytical system shall take care of the following aspects, as each can have a major effect on the accuracy of the result: Patient preparation Request Forms Specimen Collection, containers, labeling, and phlebotomy equipment and procedure - Specimen transport Specimen preparation Specimen storage" Under "Stability of Samples and Storage" (page 5), the policy stated: "Samples are collected by swab and placed in Copen eSwab Media or collected as a cutting and placed in Copen eSwab Media for storage or shipping. The eSwabs are stored in their original container at 5-25C until used. Specimens are to be held at room temperature at 20-25C and processed within 3 days." Under Shipping Specimens (page 6), the policy stated: "Specimen should be Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- shipped overnight to ensure temperatures do not reach above 25C. While bacteria and fungi often grown well in warmer environments, it is important to maintain sample integrity. Specimens transported to the lab on the same day should be kept in the refrigerator until transported and transported in a cooler with ice packs to prevent overheating." 2. A review of the laboratory's policy titled "Client Manual - Pre- analytical" (approved by the laboratory director on 09/01/2023) determined: "Specimens should be refrigerated at 4-8C or stored at room temperature at 20-25C and processed within 72 hours. Specimens can be stored frozen (below 2C) for 30 days, or in the fridge (4-8C) for 72 hours. (Room temperature specimens should not be tested after 72 hours)." 3. During a tour of the laboratory on 2/13/2024 at 10:00 a. m., Testing Person 2 (as listed on the CMS 209 Laboratory Personnel report) demonstrated that specimens were sent overnight in Lab Paks, a leak-resistant packs designed with tough material, a tight seal and an absorbent pad. 4. In an interview conducted 2/13/2024 at 10:57 a.m. in the conference room, Testing Person number 2 confirmed the laboratory did not have a process in place to ensure that specimens shipped at room temperature did not exceed extremes in temperature when shipped. D5401 PROCEDURE MANUAL CFR(s): 493.1251(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 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 review of the laboratory's policies, and staff interview, the laboratory failed to have documentation of performing monthly wipe tests for two of two months. The findings include: 1. The laboratory's policy titled "Laboratory Operations Manual for DNA/RNA Based Pathology Testing" (approved by the laboratory director on 09/01 /2023) under the section titled "Wipe Test" (page 10) stated: "Once every month, take a patient sample swab and swab the area where sample preparation is performed. Run this sample as if it were a patient sample on ALL panels. Name the sample "YEARMONTHDAY Panel Name Wipe Test." Results should be negative for all targets. If they are not, perform complete decontamination by soaking the area in a 1: 10 bleach solution for five minutes, followed by a water wipe down. Repeat the test to confirm decontamination is completed. Record the test and any