Summary:
Summary Statement of Deficiencies D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: Based on lack of test requisition documentation for review and interview with the facility personnel, the laboratory failed to have a written or electronic request for patient testing for one out of three patient records reviewed during the survey. Findings include: 1. The laboratory performs Complete Blood Count (CBC) testing in the specialty of Hematology, with an approximate annual test volume of 58,908. 2. No written or electronic request for CBC testing was presented for review for one of three patient records reviewed during the survey, patient# 139237 from 12/05/2018. 3. The facility personnel confirmed that the laboratory did not have an electronic or written test requisition for testing that was performed on the patient indicated above. 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 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. 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 on lack of education credentials and interview with the facility personnel, the laboratory director failed to ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience for the type and complexity of services offered. Findings include: 1. No evidence of education credentials was presented for review for two out of two testing personnel who began patient testing on the Sysmex XS1000-i analyzer in April 2017 and December 2017. 2. The facility personnel confirmed that the laboratory failed to provide a copy of the education credentials for each testing personnel indicated above. -- 2 of 2 --