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 Laboratory Director (LD), the laboratory failed to enter the corresponding specimen source location from the Pathology report onto the patient's Mohs' map and electronic medical record (EMR) report for 9 (17-001, 17-070, 18-002, 18-051, 18-071, 18-105, 19-018, 19-073, and 19- 115) of 10 patient charts audited. Findings include: 1. Record review for 9 of 10 patient chart's audited revealed the specimen source location was not transcribed consistently from the Pathology report to the Mohs' map and the final EMR report as follows: a. 17-001 1. Pathology report - left malar check 2. Mohs' map - left cheek 3. EMR report - left inferior central malar cheek b. 17-070 1. Pathology report - right mid preauricular 2. Lack of documentation of source location 3. EMR report - right lateral zygoma c. 18-002 1. Pathology report - right frontal scalp 2. Mohs' map - right scalp 3. EMR report - right central frontal scalp d. 18-051 1. Pathology report - left lateral extensor forearm 2. Mohs' map - left forearm 3. EMR report - left distal dorsal forearm e. 18-071 1. Pathology report - left inferior antihelix 2. Mohs' map - Lack of documentation of source location 3. EMR report - left antitragus f. 18-105 1. Pathology Report - right med helical rim 2. Mohs' map - lack of documentation of source location 3. EMR report - right inferior posterior helix g. 19-018 1. Pathology 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 -- report - left mid preauricular 2. Mohs' map - lack of documentation of source location 3. EMR report - left superior lateral malar cheek h. 19-073 1. Pathology report - left mid antitragus 2. Mohs' map - lack of documentation of source location 3. EMR report - left antitragus i. 19-115 1. Pathology report - right lower cutaneous lip 2. Mohs' map - lack of documentation of source location 3. EMR report - right lower cutaneous lip 2. During the interview on 11/14/19 at 10:30 am, the LD acknowledged the specimen source location did not correlate between the three reports (Pathology report, Mohs' map and EMR report). 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 with the Laboratory Director (LD), the laboratory failed to ensure the location of the tumor type was maintained as part of the final Mohs' map for 6 (17-070, 18-071, 18-105, 19-018, 19-073, and 19-115) of 10 charts audited. Findings include: 1. Record review revealed for 6 (17-070, 18-071, 18- 105, 19-018, 19-073, and 19-115) of 10 charts audited the final Mohs' map did not state the site of the Mohs' micrographic surgery location. 2. During the interview on 11 /14/19 at 11:00 am, the LD acknowledged the surgery site location was not present on the final Mohs' map. -- 2 of 2 --