Healthcare Express

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: . Based on review of laboratory policy, instrument printouts, patient final results, and confirmed in interview, the laboratory failed to follow its policy for the processing of hematology CBC (complete blood count) instrument flags for five out of eight patients reviewed from October through December 2021. The findings include: 1. Review of the laboratory procedure "Resolving CBC Flags", section "PLT [platelet] Flags" stated: "PLT FLAGS: PL PU MP DW AG Remix the sample by gentle inversion and repeat. If the flags are still present, DO NOT REPORT RESULTS. Send the sample to the reference laboratory." 2. Random review of patient instrument printouts from October 2021 through December 2021 have the following five patients that had PLT AG flags that weren't resolved with repeat testing, and reported to the provider. 10/5/2021 - Patient ID: 021193 11/5/2021 - Patient ID: 102584 12/9/2021 - Patient ID 052686 12/27/2021 - Patient ID 041568 12/13/2021 - Patient ID 022755 3. On 2/14/2022 at 14:45 hours, surveyor queried for the patient's final reports and documentation that the CBC's were sent to a reference laboratory as described by the policy. The patient final reports listed two separate CBC results: one result set was from the laboratory, and the other result set was from the reference laboratory. 4. In an interview on 2/14/2022 at 14:50 hours in the laboratory, the laboratory operations person confirmed that the patient CBC results were reported to the provider without resolving the instrument flags prior to sending the sample to a reference laboratory. . D5781

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: . Based on review of laboratory policy for cardiac enzyme testing using the Alere Triage Cardiac Panel, confirmed by staff interview, the laboratory failed to follow its own policy for periodic review of the individual quality control plan (IQCP) developed for the system. Findings: 1. Laboratory policies were reviewed. Included was an IQCP section for the Alere Triage Cardiac Panel dated 04-22-15, which contained a sheet titled "IQCP Review Policy" in which was stated the following: "The IQCP and the Quality Control Plan will be reviewed annually in the month of June. The monthly quality control results for the past 12 months along with the results of the last 3 Proficiency Testing events will be reviewed to ensure that the QC plan is sufficient to ensure quality patient results. Any corrections needed will be implemented." 2. Also included was a sheet titled "Triage Quality Assurance," documenting the initial review dated 06-06-2016, signed by the technical consultant (CMS form 209). No documentation of IQCP review for 2017 or 2018 was found. In an interview at the site on 10-31-2018 the technical consultant confirmed that no such documentation could be made available during the survey. 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 --