Summary:
Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (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 1 of 13 urine specimen collection containers with patient name and unique patient identifier. Findings follow: A) During a tour of the laboratory on 6/19/24 at 2:02pm one of thirteen urine specimen cups was observed on the laboratory bench labeled with the patients initials only. B) Review of the laboratory policy and procedure revealed that specimen containers are to be labeled with the patient's first and last names and the patient's date of birth or unique identifier. C) In an interview on 6/19/24 at 2:03pm, the laboratory staff member (testing personel #1 on the CMS 209 form) confirmed that the specimen identified above lacked proper patient identification on the container as required by policy and procedure. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. 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: Through review of the laboratory's policy and procedure for "Quality Control" (QC), review of quality control Levy-Jennings charts for April through October of 2023 , review of the technical consultants QA review notes, lack of documentation and interview it was determined that the laboratory failed to recognize or take