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 review on random patient sampling test results, the lack of documentation for a test order, and interview with the testing personnel, it was determined that the laboratory failed to have a written or electronic request for patient testing from an authorized person. The findings included: a. The laboratory did not have an order for Complete Blood Count (CBC), but was analyzed and resulted. b. For one (1) out of seven (7) random patient sampling test results reviewed covering period from 2/18 /2016 to 1/9/2018, one (1) patient did not have an order/requisition on 2/18/2016. c. The testing personnel affirmed (2/1/2018, 1300) that the laboratory failed to have written or electronic request for patient testing from an authorized person. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(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 preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on review on random patient sampling test results, the lack of documentation for a test order, and interview with the testing personnel, it was determined that the laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems 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 -- identified in the preanalytic systems. The findings included: a. The laboratory has not established written policy and procedure to have a mechanism in order to assess problem of no requisition or order from provider on a patient chart. b. For one (1) out of seven (7) random patient sampling test results reviewed covering period from 2/18 /2016 to 1/9/2018, one (1) patient did not have an order/requisition on 2/18/2016. c. The testing personnel affirmed (2/1/2018, 1300) that the laboratory has not established and follow written policy and procedure to assess, monitor and correct problem in the preanalytical systems. -- 2 of 2 --