Summary:
Summary Statement of Deficiencies D0000 A validation survey was performed on 8/28/2025. A standard level deficiency was cited. 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 review of the laboratory's procedures, review of patient testing records, and interview with general supervisor #1, the laboratory failed to follow their policy in rejecting specimens tested for Direct antiglobulin test (DAT) within the 3 day stability for three of three months reviewed ( March, April, August 2025) as evidenced by: 1. In review of the laboratory policy for DATs stated, "May be tested up to 3 days after collection." 2. In review of patient records for April, May, August 2025, the following patients were past the 3 day time frame: a. patient# 5141538 date drawn: 4-24-2025, date received in laboratory 4-27-2025. Date tested 4-29-2025 b. patient #5189647 date drawn 3-28-2025, date received in laboratory 4-2-2025. c. patient # 5320062 date drawn 8-21-2025, date received in the labroatory 8-24-2025. Date tested on 08-25- 2025. d. patient #5322532 date drawn 8-22-2205 at 1141 date, received in the laboratory 8-25-2025. Tested on 8/25/2025 at 1313 e. patient# 5322521 date drawn 8- 21-2025, date received in the laboratory 8-25-2025. Date tested 8-26-2025 f. patient# 5317974 date drawn 8-20-2025 ,date received in the laboratory 8-25-2025. 3, In an 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 -- interview with genreal supervisor #1 at 1354, she confirmed that they were past their 3 day stability date and had a plan to test future patients within the established time frame. -- 2 of 2 --