Summary:
Summary Statement of Deficiencies D3041 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(6) Test reports. Retain or be able to retrieve a copy of the original report (including final, preliminary, and corrected reports) at least 2 years after the date of reporting. (i) In addition, retain immunohematology reports as specified in 21 CFR 606.160(d) (ii) and pathology test reports for at least 10 years after the date of reporting. This STANDARD is not met as evidenced by: . Based on lack of documentation and interview with an office staff member, the laboratory failed to retain a copy of the original histopathology Mohs' map for 18 (October 2017 to March 2019) of 18 months performing Mohs' surgeries for at least ten years. Findings include: 1. Lack of records to review revealed the laboratory did not keep the original Mohs' map for as least ten years from the date of reporting. 2. On March 21, 2019 at approximately 1:30 PM when queried, an office staff member stated that once the map is scanned into the electronic medical record (EMR) file the original copy of the map is discarded. 3. During the interview on March 21, 2019 at approximately 1:30 PM, the office staff member acknowledged that the original Mohs' map is not retained after scanning into the EMR system for at least ten years from the date or reporting. D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- . Based on record review and interview with the office manager, the laboratory failed to have a electronic request for patient testing from an authorized person for the mycology testing for one (#10) of 12 patient charts audited. Findings include: 1. Record review revealed for patient chart audit #10 on April 3, 2018, the laboratory did not have an electronic request for the potassium hydroxide (KOH) testing that was performed. 2. During the interview on March 21, 2019 at approximately 1:00 PM, the office manager acknowledged their was no electronic request for the KOH testing in the patient's electronic medical record file. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: . Based on procedure review, record review, and interview with the histology tech, the laboratory failed to follow the written procedure for the "Maintenance of Eyewash Station" for 15 (2018 and January - March 2019) of 24 months reviewed. Findings include: 1. Procedure review for the "Maintenance of Eyewash Station" revealed the eyewash station was to be activated on a weekly basis. 2. Record review of the eyewash station maintenance log revealed there was no documentation of the weekly maintenance for January - December 2018 and January to March 2019. 3. During the interview on March 21, 2019 at approximately 11:15 AM, the histology tech acknowledged she was unaware of the maintenance requirements for the eyewash station. D5781