Lone Peak Dermatology

Summary Statement of Deficiencies 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 record review and interview with the Laboratory Director, the laboratory failed to verify the accuracy for potassium hydroxide (KOH) preparations twice a year. The laboratory performs approximately 50 mycology tests annually. Finding include: 1. During laboratory record review, the laboratory failed to produce records of accuracy verification since last survey was conducted on 11/01/2019. 2. Interview with the laboratory director on 08/31/2022, at 1:45 PM confirmed the laboratory failed to verify the accuracy of KOH two times per year. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on direct observation and interview with testing personnel, the laboratory failed to ensure that the StatLab tissue marking dyes were not used past their expiration date. The laboratory performs approximately 26 histopathology tests annually. Findings: 1. Direct observation of StatLab tissue marking dyes on 08/31/2022 at 2:08 PM revealed that 4 of 5 StatLab tissue marking dyes had expirations dates of 2019-11-30, 2019-10- 31, 2022-01-31, and 2021-21-31. 2. Interview with the testing personnel on 08/31 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 -- /2022 at 2:10 PM confirmed the StatLab tissue marking dyes were being utilized for patient testing past their expiration date. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview with Laboratory Director, the laboratory failed to perform control procedures each day patient specimens are examined potassium hydroxide (KOH) preparations. The laboratory performs approximately 50 mycology test annually. Findings include: 1. A review of laboratory records failed to include records of positive and negative control procedures being performed for KOH preparations since the last survey on 11/01/2019. 2. An interview on 08/31/2022, at 1: 50 PM, with the LD confirmed the laboratory failed to perform control procedures each day patient specimens are examined for KOH preparations. -- 2 of 2 --

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 procedure manual review, lack of documentation, and interview with staff, the current laboratory director failed to sign and date as approved the procedure manual before use for 1 of 2 tests performed (histopathology). The laboratory began histopathology testing in 07/2017 and had reported approximately 100 cases. Findings include: 1. The laboratory procedure for performing Mohs testing (histopathology) was a copy of a procedure manual used in another Mohs laboratory which had been signed by the technical supervisor in 2011. 2. The technical supervisor confirmed on 04/20/2018 at approximately 10:00 am, the procedure manual had not been customized for Lone Peak Dermatology and had not been approved by the director. 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. 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 -- This STANDARD is not met as evidenced by: Based on Mohs surgery test report and Mohs surgical map review, and interview with staff, the test report for 4 of 4 Mohs surgery cases reviewed failed to include the name and address of the laboratory location where the test was performed. Findings include: 1. Mohs maps for cases 1 and 32 from 2017 and cases 2 and 35 from 2018 have Granger Medical Surgical Dermatology printed on the map. 2. Mohs test reports for cases 1 and 32 of 2017 list the test location as Granger Medical West Valley - Dermatology at 3725 W. 4100 S. West Valley City, UT 84120-5530. 3. Staff confirmed on 04/20/2018 at approximately 11:00 am, the 4 cases had been tested at Lone Peak Dermatology. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on procedure manual review, lack of documentation, and interview with staff, the director failed to establish a quality assessment program to identify failures in quality when they occur in the pre-analytical, analytical, and post-analytical phases of testing for 2 of 2 tests performed (potassium hydroxide preparation and histopathology testing). Findings include: 1. The laboratory lacked a written quality plan to monitor testing from specimen collection to final report. 2. The director confirmed on 04/20/2018 at approximately 11:00 am, the laboratory did not have a written plan or audit process to identify and correct problems in the laboratory. -- 2 of 2 --