Summary:
Summary Statement of Deficiencies D5803 TEST REPORT CFR(s): 493.1291(b) Test report information maintained as part of the patient's chart or medical record must be readily available to the laboratory and to CMS or a CMS agent upon request. This STANDARD is not met as evidenced by: Based on an attempt to search for a specific patient and interview with Laboratory Director and General Supervisor, test report information was not readily available upon request. Findings include: 1. Test report information for patient associated with Survey ID UT00030006 could not be located at time of survey. 2. In an interview on 4 /13/21 at approximately 2:30 pm, the Laboratory Director confirmed that personnel other than IT personnel can only search for patient results with the QR code associated with the patient sample. IT personnel offsite must be contacted to search for a patient report by name or MRN. 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: 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 with Laboratory Director, the test report does not define the interpretation of an invalid test result. Findings include: 1. Test report reviewed for patient ABS25KK included a test result of "invalid". 2. Test report interpretation included on report for patient ABS25KK did not include an interpretation for an invalid result. The reason for the invalid test result also was not included in the report. 3. In an interview on 4/13/21 at approximately 2:00 pm, the Laboratory Director confirmed that interpretation and reason for an invalid test result is not included in test reports. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on record review and interview with the Technical Supervisor and General Supervisor, documentation of initial training and competency of testing personnel was incomplete. Findings include: 1. Initial training records for 4 of 19 testing personnel were incomplete and not signed by the personnel who performed the training. 2. In an interview on 4/13/21 at approximately 11 am, the Technical Supervisor and General Supervisor confirmed that training documentation was incomplete. -- 2 of 2 --