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: Through review of laboratory policy and procedure, observation and interview it was determined that the laboratory failed to label one of two specimen collection containers with patient name or unique patient identifier. Findings follow: A) During a tour of the laboratory on 10/23/25 at 10:21 a.m. two urine specimen containers were observed in the laboratory testing area; one labeled on the specimen lid only. B) Review of the laboratory policy and procedure revealed that "patient specimen containers must be labeled with the patient's name and unique identifier". . C) In an interview on 10/23/25 at 10:21 a.m. , the laboratory staff member (#1 on the CMS 209 form) confirmed that the specimen identified above had been analyzed and lacked proper patient identification on the containers as required by policy and procedure. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratorys and, as applicable, the manufacturers test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. 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 -- This STANDARD is not met as evidenced by: Based upon review of laboratory policies and procedures for quality control (QC), review of QC records for Hematology for the month of March 2025, patient results for complete blood cell testing (CBC), lack of documentation, and interview with laboratory staff, the laboratory reported complete blood cell (CBC) results with out performing QC on one of 21 days of patient testing . Findings follow: A) Review of the laboratory's QC policy and procedure for CBC assays revealed that QC was to be performed and acceptable prior to reporting patient results. B) Review of QC records for CBC assays in March 2025 revealed that on 3/20/25 no QC results for CBC assays were presented. C) Review of patient results revealed that CBC assays were performed on 3/20/25 for patient 03776720 at 09:42 a.m., for patient 00299130 at 10: 06 a.m., for patient 03773945 at 10:52 a.m., and for patient 00672018 at 01:40 p.m. D) Upon request, the laboratory was unable to verify QC was performed and acceptable on 3/20/25. E) In an interview on 10/23/25 at 10:10 a.m., the laboratory staff member (# 1 on form CMS 209) confirmed that QC for CBC assays was not performed on 3/20/25 and CBC assays were performed and reported on patients on that day. -- 2 of 2 --