Summary:
Summary Statement of Deficiencies D0000 An unannounced complaint survey with #2020007077 conducted on 04/22-23/2020 found that Larkin Community Hospital Palm Springs Campus clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. 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: Based on record review and interview, the laboratory failed to create blood specimen tube collection procedure (BC) and specimen incident procedure for redraws in emergency room (ER) station and follow specimen documentation procedures that affected 3 (patient #1, #2 and #3) out 3 patients with hemolyzed samples, reviewed for April 2020. Findings Include: A review of the "Criteria for Specimen Rejection" procedure, revealed that documentation of all unaccepted/rejected specimen will be maintained by this lab including notification of party, time, date and reason for rejection and staff member making the notification. No ER specimen's rejection and redraw incident procedure included. A review of laboratory April 2020 ER specimen log record revealed: Patient #1: required 2 redraws due to hemolyzed blood samples with no documentation for the number of tubes collected and rejected on 4/07/2020 on each draw. Patient #2: required 1 redraw due to hemolyzed blood samples with no documentation for the number of tubes collect and rejected on 4/08/2020. Patient #3: required 1 redraw due to hemolyzed blood samples with no documentation for the number of tubes collect and rejected on 4/9/2020. Patients (#1, #2 and #3) had no 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 -- documentation of nursing staff alerting the laboratory with issues of blood collection. During an interview on 4/22/2020 at 1:57pm, the chief nursing officer stated that the ER staff were using competency assessment as a guideline for BC and confirmed that no procedure in place for BC and incidents. During an interview on 4/22/2020 at 2:10 pm, the laboratory manager confirmed he failed to document the number of tubes rejected for patients #1, #2 and #3. -- 2 of 2 --