Desert Mountain Skin Cancer Surgery

Summary Statement of Deficiencies D0000 An onsite recertification survey conducted on December 13, 2023 , at Desert Mountain Skin Cancer Surgery found the laboratory to be in compliance with the CLIA regulations found at 42 CFR, Part 493 Laboratory Requirements, with standard deficiencies cited. 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 Proficiency Testing Procedure, Proficiency Testing Forms, and staff interview, the laboratory failed to verify the accuracy of non-regulated analytes for 1 of 2 events in 2023. Findings Included: 1. A review of Proficiency Testing Procedure states lab tech or risk manager is to send two cases semi-annually for peer review. 2. A review of Proficiency Testing forms revealed only one peer review was done for 2023. 3. Laboratory director was asked to provide documentation for second peer review. None were provided. 4. Interview on 12/13/2023 at 12:22 pm with laboratory director confirmed the findings. 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: 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 -- Based on direct observation, manufacturer's instructions and staff interview, the laboratory failed to ensure Hematoxylin reagent was not used for testing beyond expiration dates for 3 of 3 reagents. Findings included: 1. During a tour of the laboratory on 12/13/2023 at 1:30 PM the following expired reagents were observed: A. 3 Bottles of Avantik Gil 3 Hematoxylin, Lot Number: 141098, Exp: 2023-07-31. B. One bottle was opened and labeled in use 12-13-23. 2 .Interview on 12/13/2023 at 1:40 PM with laboratory director confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The following deficiency was cited as the result of a recertification survey on 02/20 /19 for 42 CFR part 493 Laboratory Requirements. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on the review of 2019 temperature records and patient logs, the laboratory failed to document the cryostat (a device used to freeze and cut surgical tissue for mounting on glass slides) temperature each day of use. 100 Moh's (a type of surgery for treating skin cancer) cases (SF1901 - SF19100) were processed in 2019. Findings are: A. Review of 2019 temperature records revealed no documentation of the cryostat temperature each day the cryostat was used for processing tissues collected during Moh's surgeries. The histotechnologist (a person trained to cut, mount, and stain tissue for examination) had initialed each day of use instead of recording the temperature. B. Review of patient test logs indicated patient samples were processed on the following dates: 01/09/19 12 cases, SF1901 - 12 01/12/19 11 cases, SF1913 - 23 01/16/19 8 cases, SF1924 - 32 01/19/19 8 cases, SF1933 - 41 01/23/19 9 cases, SF1942 - 51 01/30 /19 10 cases, SF1952 - 62 02/02/19 8 cases, SF1963 - 71 02/06/19 9 cases, SF1972 - 81 02/13/19 8 cases, SF1982 - 90 02/16/19 9 cases, SF1991 - 100 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 --