Summary:
Summary Statement of Deficiencies D0000 Laboratory representatives were present at the entrance conference conducted 12/17 /2020. The survey process was discussed. An opportunity for questions and comments was given. The exit conference was held with the laboratory representatives on 12/17 /2020. The laboratory was found to be in substantial compliance for the specialties /subspecialties for which it was surveyed. The standard level deficiencies cited were discussed. The process for submitting the corrections was explained. CMS form 2567 will be emailed from the Texas State Health and Human Services Commission, Health Facility Compliance Arlington Group. 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 review of laboratory policy, laboratory proficiency testing (PT) records, and confirmed in staff interview, it was revealed the laboratory failed to have documentation of performing twice annual accuracy assessments for histopathology slide interpretations for 2019. Findings: 1. Review of the laboratory's Proficiency Testing policy stated: "Dr. XX or Dr. XX, Board Certified Dermatopathologists, will do the proficiency testing for Dr. XX. Dr. XX will do proficiency testing for all other providers. Proficiency testing is done Bi-Annual (January and July). One case per physician twice a year (two cases total each year)." 2. Review of laboratory records from 2019 revealed the laboratory performed accuracy assessment for histopathology slide interpretations on 02/25/2019 but failed to perform a second accuracy assessment in 2019. The laboratory did not verify accuracy at least twice annually for histopathology slide interpretations. 3. During an interview on 12/17/2020 at 9:35 am, the histotechnician, regional clinical manager, and office manager confirmed the above findings. 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 -- 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 direct observation, review of laboratory policy, patient records and confirmed in interview, the laboratory failed to follow their own written policy for labeling Mohs slides for 6 of 6 patients in 2019 (random review) and 8 of 8 patients in 2020 (random review). Findings: 1. Review of the laboratory's "Embedding & Cutting Frozen Sections Policy" page 3 stated: "Procedure: 1. After you receive the tissue in the lab, double check to make sure that it matches the map. 2. Take 2 blank slides (one for embedding and one for your cut sections) and place the patients name, mohs [sic] case number, stage, number of tissue and Slide number" 2. A random review of patient Mohs slides from 2019 and 2020 were observed to be labeled with patient last name, stage, number of tissue, slide number, and Mohs case number as follows: 03/08 /2019 Patient IDs: SM19-087, SM19-088, SM19-089 03/14/2019 Patient IDs: SM19- 090, SM19-091, SM19-092 11/13/2020 Patient IDs: SM20-628, SM20-629 The following patient Mohs slides from 2020 were observed to be labeled with patient last name, initial of first name, stage, number of tissue, slide number, and Mohs case number as follows: 11/17/2020 Patient IDs: SM20-630, SM20-631, SM20-632, SM20- 633, SM20-634, SM20-635 The laboratory failed to follow their own written policy for labeling Mohs slides with patient name, Mohs case number, stage, number of tissue and slide number. 3. During an interview on 12/17/2020 at 11:00 am, the histotechnician, regional clinical manager, and office manager confirmed the above findings. -- 2 of 2 --