Summary:
Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on surveyor review of the Competency Assessment (CA) records and interview with the Clinical Coordinator (CC), the laboratory failed to include how CA was performed and what records were reviewed on one of one Testing Personnel from 4/18 /17 to the date of the survey. The CC confirmed on 3/19/19 at 10:15 am that the CA did not include details. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on surveyor review of the Biannual Assessment (BA) records and interview with the Clinical Coordinator (CC), the laboratory failed to verify the accuracy and reliability of Histopathology testing twice a year in the calendar years 2017 and 2018. The CC confirmed on 3/19/19 at 10:30 am that BA was not performed. D5805 TEST REPORT CFR(s): 493.1291(c) 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 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 surveyor review of the Final Report (FR) and interview with the Clinical Coordinator (CC), the laboratory failed to ensure that the FR included the address of the laboratory location where testing was performed from 1/10/18 to the date of survey. The findings include: 1. A review of ten Mohs Map FR revealed the FR did not have the address of the laboratory location where the test was performed but 20 Prospect Ave., Hackensack, NJ. 2. The CC confirmed on 3/19/19 at 10:50 am that FR did not have all the required information. -- 2 of 2 --