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 test reports did not identify the location where the technical component was performed for 2 of 4 patients (#1 & 4). Findings: Review of patient test reports from 5/22/16 to 5/22/18. The "Pathology Surgical Report" for patient #1 and patient #4 failed to list where the technical component was performed. During an interview on 5/22/18 at 4 PM, Testing Personnel A acknowledged that the location where the technical component was performed was not listed on the pathology surgical report for patients #1 and #4. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: 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 -- Based on record review and interview, the laboratory's quality assessment program failed to establish and follow a written policy to monitor, access and correct problems in the laboratory's post-analytic system. Findings: Record review of the laboratory's quality assurance logs showed that there was no evidence that a comparison of the patient test requisitions, patient logs and surgical pathology reports was conducted from 5/22/16 to 5/22/18. During an interview on 5/22/18 at 3:07 PM, Testing Personnel A stated that they don't perform any comparisons of the patient test requisitions, patient logs and surgical pathology reports. -- 2 of 2 --