Summary:
Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: Based on direct observation, a review of the laboratory's policies, and manufacturers' instructions and an interview with the Technical Consultant (TC), the laboratory failed to follow the manufacturer's instructions for specimen stability and transport for 19 of 19 bags of specimens received from outside the facility. Findings Include: a. An observation on 07/21/2026 at 11:54 AM in the laboratory revealed 19 specimen bags packed in a soft-sided cooler with four ice packs that were cool to the touch. The specimens were accessioned into the laboratory. No specimen temperature was documented. A sample of specimens and tests received included: Control number PRO1679492; Tests: Triglyceride Control number PRO1680079; Tests: Aspartate Aminotransferase (AST) b. A review of the laboratory policy "Othoalaska/PCA In- House laboratory Tests Menu" revealed Triglyceride and AST specimen stability was listed as "7 days RF [refrigerate]". The refrigerated temperature range was not defined. c. A review of the manufacturer's package insert "Architect Triglyceride", revised June 2018, revealed "Specimen Storage ... Temperature/ Maximum Storage: 20 to 25C [degrees Celsius]/2 days 2 to 8C/7 days" d. A review of the manufacturer's package insert "Architect Aspartate Aminotransferase 2", revised July 2021, revealed "Specimen Storage ... Temperature/ Maximum Storage: Room Temperature (20 to 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 -- 25C)/4 days 2 to 8C/7 days" e. During an interview on 07/21/2026 at 11:11 AM and 11:54 AM, the TC confirmed specimen temperatures are not taken or documented by the laboratory, and the range is not defined. D5783