Golden State Dermatology Associates

Summary Statement of Deficiencies 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 observation of Mohs slides prepared onsite, review of 2021-2023 laboratory cryostat temperature records, and interview with laboratory administrative personnel, the laboratory failed to monitor and document the temperature of the cryostat in 2021. Findings included: 1. Mohs slides from 2021 - 2023 were randomly selected for this survey. 2. Laboratory records were reviewed for monitoring and documenting the cryostat temperature each date that Mohs slides were prepared. 3. For 8 out of 8 dates in 2021, the laboratory failed to have cryostat temperature records as follows: 3/19/21 4/13/21 5/06/21 7/21/21 8/11/21 9/07/21 11/24/21 12/21/21 4. Laboratory administrative personnel affirmed (7/19/23 at 4:00pm and 7/27/23 at 6:45 am) the laboratory failed to have cryostat temperature records for the dates in 2021. . D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. 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 the lack of cryostat temperature records for 2021, the laboratory failed to establish a written policy and procedure of ongoing quality assessment to monitor, identify, and correct problems in the laboratory. See D5413. -- 2 of 2 --

Summary Statement of Deficiencies 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 surveyor's review of the laboratory's records for instrument maintenance and an interview with laboratory personnel (LP) on 12/3/2020 between 2:00 p.m. and 3:30 p.m, it was determined that the temperature log for the cryostat had gaps in daily temperature monitoring Findings include: 1. On 12/3/2020, an inspection was conducted between 2:00 p.m. and 3:30 p.m. 2. During a review of the laboratory documentation for equipment maintenance and monitoring , it was noted at approximately 2:45 p.m. that there were gaps in the cryostat temperature log sheet. The laboratory performs MOHS testing Monday-Friday each week. The LP recognized these atypical findings. 3. The Cryostat temperature log had no entries between 9/28/2020 and 11/23/2020, indicating a lack of monitoring and documentation. 4. MOHS services are contracted to MobileMOHS. 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 --