Summary:
Summary Statement of Deficiencies D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: . Based on record review and interview with the office manager and staff member, the laboratory failed to enter the corresponding specimen source into the patient's electronic medical record (EMR) dictation from the Mohs' map for 1 (#11) of 11 patient charts reviewed. Findings include: 1. Record review for case F19-12 revealed the scanned Mohs' map labeled the "Clinical Information" as "right superior central malar cheek" and the dictated report in the EMR labeled the specimen source as "Location: right lateral interior eyelid". 2. During the interview on February 11, 2019 at 11:20 AM, a staff member stated "the computer system labels the source location by pressing the area on the map" and confirmed the locations do not always match. 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 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 -- 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: . Name and Address of the laboratory where testing was performed and reported. Based on record review and interview with the office manager, the laboratory failed to ensure the required information of the name and address of the laboratory location performing the Mohs' tissue examination for 11 (#1 - #11) of 11 patient charts reviewed was documented on the final Mohs' map. Findings include: 1. Record review of the following patient final scanned Mohs' map diagram in the patients electronic medical record (EMR) file revealed the laboratory failed to include the name and address of the testing location. a. Mohs' report - F17-03 b. Mohs' report - F17-23 c. Mohs' report - F17-39 d. Mohs' report - F17-68 e. Mohs' report - F17-116 f. Mohs' report - F18-22 g. Mohs' report -F18-67 h. Mohs' report -F18-110A i. Mohs' report -F18-199 j. Mohs' report -F18-149 k. Mohs' report -F19-12 2. During the interview on February 11, 2019 at 11:30 AM, the office manager confirmed the name and address of the testing facility was not included on the Mohs' map. -- 2 of 2 --