Summary:
Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to include its address on six of six patient (PT#1-PT#6) test reports reviewed. Findings: 1. Review of six medical records indicated that the test reports for the following patients did not include the address of the laboratory that performed their creatinine test. PT#1 on 02 /12/2021 PT#2 on 03/04/2021 PT#3 on 07/30/2021 PT#4 on 08/31/2021 PT#5 on 12 /31/2021 PT#6 on 12/30/2021 2. On 02/07/2022 at 3:12 pm, SP1 (Administrative Director) and SP2 (Technical Consultant) confirmed that the test reports did not include the address of the laboratory that performed their creatinine test. 3. The annual test volume for creatine testing is approximately 528. 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 --