Summary:
Summary Statement of Deficiencies D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on review of two instrument printouts and electronic medical record (EMR) patient final reports, and interview with the laboratory liaison, the laboratory failed to maintain a record system for identification of the testing personnel performing complete blood count (CBC) in 2018. The findings include: 1) Review of two CBC instrument printouts and EMR patient final reports (patient numbers five-dated 11.20.18 and seven-dated 12.3.18) revealed no testing personnel identification. 2) Interview on December 7, 2018 at 11:00 a.m. with the laboratory liaison confirmed that neither the instrument printouts nor the final patient report in the EMR contained the identification of the testing personnel that performed patient samples for CBC (patient numbers five and seven). D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(11) Ensure that prior to testing patients' specimens, all personnel 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 -- have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services (CMS) form 209, personnel records for testing personnel number three, and interview with the laboratory liaison, the laboratory director failed to ensure testing personnel number three had appropriate education prior to performing patient testing in 2018. The findings include: 1. Review of the CMS 209 revealed the name of testing personnel number three. 2. Review of the personnel records for testing personnel number three revealed no documentation of education. 3. Interview with the laboratory liaison on December 7, 2018 at 11:00 am confirmed testing personnel number three performs patient testing for complete blood count and there was no documentation of highest level of education for testing personnel number three. The laboratory director failed to ensure testing personnel number three had the appropriate level of education prior to patient testing in 2018. -- 2 of 2 --