Rocky Mountain Dermatology

Summary Statement of Deficiencies D3043 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(7) The laboratory must retain cytology slide preparations for at least 5 years from the date of examination (see 493.1274(f) for proficiency testing exception). The laboratory must retain histopathology slides for at least 10 years from the date of examination. The laboratory must retain pathology specimen blocks for at least 2 years from the date of examination. The laboratory must preserve remnants of tissue for pathology examination until a diagnosis is made on the specimen. This STANDARD is not met as evidenced by: Based on patient test records review, lack of one slide, and interview with staff, the laboratory failed to retain 1 of 26 histopathology slides reviewed from 03/19/2018 to 10/14/2019 for at least 10 years's . The laboratory performed approximately four Mohs frozen section histopathology cases one day per week. Findings include: 1. Patient test records included documentation the laboratory performed frozen section histopathology testing for patient M18-213 on 03/19/2018. Records included there were 3 slides prepared from one stage of Mohs surgery performed on a left radial dorsal hand specimen. 2. In an interview on 01/16/2020 at approximately 5:15 P.M., the laboratory manager stated they were unable to locate the 3rd slide from the case. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on new Mohs procedure review, test report review and direct observation, the procedure for Mohs frozen section testing failed to include the signature and date the director approved the frozen section testing procedure. The laboratory started testing in July 2016 and performs from 3 to 9 frozen section tests per day. Findings include: 1. The new Mohs frozen section method used to determine the presence or absence of tumor cells in micrographic surgery specimens failed to include the director's signature and date the process was approved. 2. In an interview with staff on 02/05 /2018 at approximately 12:30 P.M. staff confirmed the director had not signed and dated the procedure as approved. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on patient test record review, lack of documentation, and confirmation by staff, the laboratory technical consultant failed to ensure testing personnel performing moderate complexity potassium hydroxide, (KOH), testing were evaluated annually after the first year of testing to ensure they could accurately test and report KOH test 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 -- results for 2 of 5 testing personnel in 2016 and 2017. The laboratory performed approximately 50 KOH tests per year. Findings include: 1. Patient test records review included documentation moderate complexity testing personnel performed KOH testing for patient #1801469 on 08/03/2017 by test person D, and on 01/30/2016 for patient date of birth 11/20/1980 by test person E. 2. Competency records failed to include documentation the two testing personnel performing the KOH tests listed in finding #1 (D and E) were evaluated for competency in 2016 or 2017. 3. In an interview with staff on 02/05/2018 at approximately 11 :00 A.M. staff confirmed they did not have competency documentation for two testing personnel who performed KOH tests. -- 2 of 2 --