California Dermatology Care

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on review of laboratory reports and interview with the Laboratory Director and Medical/Laboratory Assistant-2, the laboratory report failed to clearly indicate where biopsy slides were read and Date reported. Findings included: 1. The laboratory reports titled, "Pathology Report for Biopsy", included three addresses, as follows: a. 2262 Camino Ramon San Ramon, CA 94589 b. 500 Alfred Nobel Dr Ste 185 Hercules, CA 94547 c. 48 Fenton St. Livermore, CA 94550 2. The reports failed to clearly indicate the address and Laboratory Director of the location where the slides were read. Two reports randomly selected for review were as follows: Date of Path # procedure ----------------------------------------------------------------- 3/04/21 WTH--21- 028, WTH--21-029 9/20/23 AI path 23-211 3. The reports had Signature(s) from the Testing person/Physician but failed to have the Date reported. 4. The Laboratory Director and Medical/Laboratory Assistant-2 affirmed (9/29/23 at 3:00pm) the aforementioned omissions on the laboratory reports. . . 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 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. This STANDARD is not met as evidenced by: Based on an audit of 5 patient reports as part of the quality assessment review (in the date range of 1/1/2019-12/1/2020) and the associated tissue slides, the laboratory failed to establish/monitor an ongoing mechanism to detect mistakes of slide labeling (analytic process). The diagnostic abbreviation on one patient slide did not match that on the procedure report. Findings include: 1. On 12/3/2020, an audit was conducted from 10 a.m. to 11:30 a.m. with a review of 5 randomly selected MOHS patients 2. One of the audit cases demonstrated an inconsistency in the slide labelling vs. the diagnosis indicated on the procedure report. The patient under review indicated a procedure logbook diagnosis of SCC, and the slide also indicated SCC. The associated procedure report indicated skin cancer type of BCC. The internal patient ID number, procedure date and name were consistent. 3. A representative of the laboratory (LP) confirmed on (12/3/2020 at 10:45 a.m. that the above descriptions were inconsistent. No

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 patient initial biopsy slides, patient final testing reports (electronic medical records (EMR), slide labeling and interview with the laboratory personnel, it was determined that from 05/05/2017 through 03/16/2018 for one (1) out of eight (8) random patient testing records reviewed, the laboratory failed to follow written policies and procedures for specimen collection, labeling and biopsy reports for each biopsy specimen. The findings included: a. Review of patient slides specimen accession # 17-300 L.P., 09/20/2017, the slide unique identifier (site) found on the slides was incorrectly transcribed on two (2) of the five (5) slides and did not match the final patient testing report (EMR) for the patient site (right lateral neck). It was found that two (2) of the five (5) initial biopsy slides (site identifier) were transcribed as "R lat. Cheek" and did not correspond to the site identifier (right lateral neck) in the final patient testing report. b. On 03/29/2018 12:00 AM (survey date), the laboratory personnel affirmed that the unique slide identifier(s) was incorrectly transcribed on the initial biopsy slides per those denoted in the patient's final testing report (EMR). d. Based on the laboratory's annual test volume declaration (03/20/2018) the laboratory performed 500 histopathology tests annually. 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 --