Summary:
Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor review of the Accession Log and interview with the Testing Personnel (TP), the laboratory failed to retain analytic system records for Mohs testing from 10/27/16 to the date of the survey. The findings include: 1. A review of laboratory records revealed Quality Control results, Instrument Maintenance and Temperature records were not retained in 2017. 2. Patient work records (Mohs maps) were not on site at the time of the survey and had not been received by fax the next day. 3. The TP confirmed at 12:10 pm 7/31/18 analytic system records were not retained. 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 the lack of Competency Assessment (CA) records and interview with the Testing Personnel (TP), the laboratory failed to perform a CA on two out of two Testing Personnel (TP) from 10/27/16 to the date of the survey. The TP confirmed on 7/31/18 at 10:25 am that CA was not performed annually. 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 -- 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 lack of Biannual Assessment (BA) records and interview with the Testing Personnel (TP), the laboratory failed to verify the accuracy of Histopathology testing twice annually from 10/27/16. The findings include: 1. This was cited on the previous survey performed on 10/27/16. 2. The