San Diego Family Dermatology

Summary Statement of Deficiencies 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 the surveyor's review of the laboratory's records and an examination of laboratory reagents, along with an interview with laboratory personnel (LP) on 9/10 /2020 between 2 pm and 3:30 pm, it was determined that the laboratory failed to not use a reagent when the expiration date had passed. Findings include: 1. On 9/10/2020, an inspection was conducted between 2 pm and 3:30 pm. 2. During a review of the laboratory documentation and an examination of the KOH reagent, it was noted at approximately 3 pm that the expiration date on the reagent bottle had passed. The LP recognized that the reagent date had passed. 3. The reagent was KOH from McKesson, and the expiration date on the bottle was 10/2/2018. 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 D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on review of laboratory documents for Mohs procedures, histopathology slides, and patients test records; and interview with laboratory personnel, the laboratory failed to follow written policies and procedures to ensure accurate specimen identification from the time of collection through completion of testing and reporting of results. Findings include: a. The laboratory log book of Mohs procedures performed included the following records: Date Patient Site M16# --------------------------------------------------------- 9/22/16 H, J R mid Helix 133 " W, B L med Shin 134 b. M16-133 1) The Mohs Flow Sheet documented the Location as R mid helix. 2) 3 out of 7 slides for patient H, J were mislabeled as "M16-134, L med Shin" c. M16-134 1) The Mohs Flow Sheet documented the Location as L medial shin, but was crossed out and re-stated as "Temple". 2) The Mohs Micrographic Operative Report documented that the procedure was performed on "L Temple". 3) 2 out of 2 slides for patient W, B were mislabeled as "L Med Shin". d. Laboratory personnel affirmed (2/15/18) the aforementioned discrepancies in the Mohs records and slides; and thus, the failure to ensure accurate identifications from time of collection through completion of testing and reporting of Mohs procedures. e. The accuracy and quality of Mohs records and slides could not be assured. The laboratory stated the estimated volume of Mohs procedures performed annually as 252. . 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 survey findings and deficiency cited (D5203), the laboratory failed to establish a written policy and maintain the practice to monitor and assess all Mohs records and histopathology slides from time of specimen collection through completion of testing and reporting of results to ensure accuracy and correct problems as they occur. Findings include: a. Errors occurring on 9/22/2016 were not identified in the laboratory's routine random reviews for quality assessment. The errors were identified 17 months later during this CLIA onsite survey/inspection. See D5203. b. The accuracy and quality of Mohs records and slides could not be assured. The laboratory stated the estimated volume of 252 Mohs procedures performed annually for 2016 and 2017. -- 2 of 2 --