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 laboratory observation, review of the laboratory's policy, and staff interview, the laboratory failed to follow its written policy for specimen labeling for two of two patients' EDTA capillary specimens on the survey date (10.01.2026). The findings include: 1. An Observation of the laboratory on 10.01.2026 at 9:15 a.m. revealed a Medonic M Series hematology analyzer (serial number 62152) used for patient CBC testing. Also observed were two patients' EDTA capillary specimens for CBC patient testing. One was labeled with only one patient identifier, and the other contained no identifying or collection information. 2. A review of the laboratory's policy titled "Specimen Collection" revealed the following statement: "All specimens will be labeled with at least the patient's name, chart number, and date of collection." 3. An interview with the laboratory director on 10.01.2026 at 9:18 a.m. confirmed the above survey findings. Word Key: EDTA = Ethylenediaminetetraacetic Acid CBC = Complete Blood Count D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) 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 -- Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on laboratory observation, review of the manufacturer's control package insert, and staff interview, the laboratory failed to label three of three control vials used to perform quality control on the Medonic M Series hematology analyzer with the opened date and revised expiration date on the survey date (10.01.2026). The findings include: 1. An observation of the laboratory on 10.01.2026 at 9:15 a.m. revealed a Medonic M Series hematology analyzer (serial number 62152) used for complete blood count (CBC) patient testing. Also observed were three levels of Boule Con-Diff Tri-Level hematology controls (lot numbers: low-22605-31, normal-22605-32, high- 22605-33) that lacked the opened date and revised expiration date. 2. A review of the manufacturer's control package insert revealed that "Open vial stability: 14 days." 3. An interview with the laboratory director on 10.01.2026 at 9:25 a.m. confirmed the above survey findings. -- 2 of 2 --