Foothill Dermatology Medical Center

Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on the surveyor's observation during the laboratory tour, lack of laboratory's policies and procedures, and interviews with office manager (OM) and laboratory technician (LT), the laboratory failed to: A) Establish safety procedures to ensure protection from physical, chemical, and biochemical materials. B) Establish formaldehyde and xylene exposure limits by providing testing performed by an outside company. No exposure testing for formaldehyde and xylene records were found. C) Have an eye wash solution/area up to date and ready to use. The findings include: 1. Based on the survey on October 17, 2025, at approximately 11:30 a.m. the laboratory failed to provide a written policy and procedure for laboratory safety; including environmental testing for formaldehyde and xylene exposure in the laboratory for testing personnel. 2. Based on the observations during the laboratory tour, where the Mohs processing and staining of samples took place, it was found that the laboratory lacked an eye wash that was ready to use. 3. The OM and LT affirmed by interviews October 17, 2025, at approximately 11:45 a.m., that the laboratory lacked safety procedures, formaldehyde and xylene exposure testing records, and ready to use eyewash in the Mohs processing area. 4. Based on the laboratory's annual testing volume declaration signed by the laboratory director on 10/16/ 2025, the laboratory processed and reported annually approximately 8,000 Mohs patients' test samples. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on severity of the deficiencies cited herein, the Condition for Analytic Systems was not met. The findings included: The laboratory failed to: A) Establish policies and procedures for the laboratory such as: Mohs procedure, quality assurance, peer review, retention and storage of slides, quality control, turn-around time, microscope and equipment preventive maintenance, safety plan, reagent log,

Summary Statement of Deficiencies D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review and the lack of documentation for H & E quality control (QC) slides, random patient test results and interview with the laboratory staff, it was determined that; the laboratory failed to each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. The findings included: a. The laboratory's policy and procedure under the title, " Policy and Procedure for acceptance or rejection of control slide" stated, " Step 2: The quality of H&E stain, control slide will be reviewed by the lab director Dr. Sidhu and he will accept or reject the control slide. Step 3: If the Control slide is rejected all tissue slides will be returned immediately and re-cuts will be ordered. Which will be documented in our quality control log book." b. There was no documentation (daily QC slide and log book records) presented on the day of the survey (11/1/2019, 1330). c. For seven (7) out of eight (8) random patient test results reviewed covering period from 11/17/2017 to 9/27/2019, seven (7) have no documentation shown for the QC slides and on the laboratory's log book. d. The laboratory staff confirmed (11/1/2019, 1330) that the laboratory has no documentation to show for the QC slide and records. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) 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 -- (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. This STANDARD is not met as evidenced by: Based on review and the lack of documentation for H&E QC slides, patient test reports, and interview with the laboratory staff it was determined that the laboratory failed to follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems. The findings included: a. See D 5473 b. See D 5803 D5803 TEST REPORT CFR(s): 493.1291(b) Test report information maintained as part of the patient's chart or medical record must be readily available to the laboratory and to CMS or a CMS agent upon request. This STANDARD is not met as evidenced by: Based on review and the lack of documentation for a test report, random patient test results and interview with the laboratory staff, it was determined that; the laboratory failed to have a test report information maintained as part of the patient's chart or medical record must be readily available to the laboratory and to CMS or a CMS agent upon request. The findings included: a. The laboratory's policy and procedure under the title, "Collection of Specimens" stated: " Dr Sidhu will then process to read the slide and dictate microscopic description, which will be transcribed, and make into a patient report." b. For seven (7) out of eight (8) random patient test results reviewed covering period from 11/17/2017 to 9/27/2019, seven (7) patients have no report maintained as part of the patient's chart. d. The laboratory staff confirmed (11/1/2019, 1330) that the laboratory has no documentation to show of patient test reports. -- 2 of 2 --