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 review of patients' test records and reports and interview, the test report did not indicate the following: *For positive patient identification, both the patient's name and identification number, or a unique patient identifier and identification number. Findings: 1. Patients' test records consisted of patients testing logs and Mohs Surgery Maps. The following information was included on both the patients testing log and Mohs Surgery Map: a. Date of service b. Patient's first and last name c. Patient's Date of Birth d. Diagnosis e. Site f. Case # (Unique Identifier) 2. Review of 4 patients' test records and their corresponding test reports revealed that there was no documentation to show that the Case #s were recorded on the test reports of 4 of 4 patients' test reports reviewed. 3. During survey date 1/17/18 at 2:00 PM, the laboratory director confirmed the surveyor' findings. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical 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 -- phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: Based on observation; review of Laboratory Personnel Report - CLIA (CMS 209); policies and procedures; and personnel records, the laboratory director failed to ensure that policies and procedures are established for monitoring individuals who conduct preanalytic, analytic, and post analytic phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results, and whenever necessary, identify needs for remedial training or continuing education to improve skills. Findings: 1. During survey date 01/17/18 at 1:00 PM, the surveyor performed a patient look back. The surveyor requested patients' test reports, along with the corresponding patients' slides and quality control (QC) slides. The surveyor observed that the Mohs Tech filed all slides (patient and QC) on their horizontally, where the dates; patients names; and Case #s were not easily viewable. Also, the slides were not stored in chronological order. The Mohs Tech had to remove all slides from the storage box in order to see their identifiers. Later, the Mohs Tech asked the surveyor how she should store the patient's slides. 2. There were only 2 personnel listed on the CMS 209, which included the laboratory director who also fulfils the positions of Clinical Consultant, Technical Supervisor, General Supervisor, and Testing Personnel. The 2nd person (Mohs Tech) was listed as Testing Personnel. 3. Review of policies and procedures revealed that there was a form that is used for assessing the competency of testing personnel. 4. Review of personnel records revealed that there was no documentation to show the laboratory director assessed the competency of testing personnel (Mohs Tech). 5. During survey date 01/17/18 at 2:00 PM, the laboratory director confirmed the surveyors' findings. -- 2 of 2 --