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 Testing Personnel (TP), the laboratory failed to perform CA correctly on three of three TP in December 2017. The findings include: 1. The laboratory did not document what records were reviewed and how CA was assessed. 2. The CA was not assessed for problem solving skills. 3. The TP # 1 listed on CMS form 209 confirmed on 9/19/18 at 1:00 pm that CA was not performed correctly. 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 surveyor review of the Final Report (FR) and interview with the Testing 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 -- Personnel (TP), the laboratory failed to ensure that the FR included all the required information from 12/20/16 to the date of survey. The findings include: 1. The FR did not include the address of the facility where Mohs testing was performed. 2. There was no 'Repot Date" on the FR. 3. The TP # 2 and 3 listed on CMS form 209 confirmed on 9/19/18 at 1:00 pm that FR did not have all the required information. -- 2 of 2 --