Rhsc Medical Center Of Jonesborough

Summary Statement of Deficiencies 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) 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 Beckman Coulter DxH520 hematology analyzer with the revised expiration date on the survey date (08.19.2026). The findings include: 1. An observation of the laboratory on 08.19.2026 at 8:50 a.m. revealed a Beckman Coulter DxH520 hematology analyzer (Serial Number: BG060287) used for complete blood count (CBC) patient testing. Observation also revealed three levels of DxH500 Series hematology controls (lot numbers: abnormal low-352618711, normal- 362618712, abnormal high-372618713) that lacked the revised expiration dates. 2. A review of the manufacturer's control package insert revealed that "16* Open Vial Days, *Assumes that the Instructions for Use section of the Consumable IFU/Setting Sheet is performed a maximum of 16 times within 16 days, provided they are handled properly." 3. An interview with the senior sight nursing supervisor on 08.19.2026 at 10:45 a.m. confirmed the above survey findings. Word key: IFU = Instructions for Use Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

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 observation of the laboratory, review of the laboratory's policy, and staff interviews, the laboratory failed to follow its policy for specimen labeling (one of one patient's urine specimen) on the survey date (01.16.2025). The findings include: 1. Observation of the laboratory on 01.16.2025 at 9:50 a.m. revealed one patient's urine specimen on the counter containing no identifying and collection information. 2. A review of the laboratory's policy titled "Specimen Collection" revealed the following statement, "All specimens will be labeled with the patient's name, medical record number or date of birth, along with the date and time of collection." 3. An interview with the technical consultant and lead testing person on 01.16.2025 at 9:55 a.m. confirmed the above survey findings. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --