Redwood Family Dermatology

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on the surveyor's observation during the laboratory tour, review of the laboratory's policies and procedure, six (6) randomly selected patient records, and interviews with laboratory supervisor (LS) and testing personnel (TP); it was determined that the laboratory failed to perform and document preventive maintenance (PM) and calibration as defined by the manufacturer and with at least the frequency specified by the manufacturer for small equipment used in the laboratory for sample testing. The findings included: 1. At the time of survey on 2/19/2025, based on the surveyors' observation during the laboratory tour and review of records documentation at approximately 3:30 p.m., it was determined that the laboratory failed to perform PM and calibration on the microtomes, the tissue Tek embedding instrument, and small equipment used in the laboratory for sample processing: hot bath, thermometers, and timers for the years 2023 and 2024. 2. The TS and TP affirmed on February 19, 2025, at approximately 4:00 p.m. that maintenance and calibration was missed for the equipment mentioned in #1 for the years 2023 and 2024. 3. According to the laboratory's testing declaration submitted and signed by the laboratory director; the laboratory performed approximately 8,000 histopathology samples annually for which no preventive maintenance of microtomes, tissue Tek embedding equipment, hot bath, thermometers, and timers for the years 2023 and 2024 for sample processing was performed. D5893 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(b)(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 -- (b) The postanalytic systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: Based on a review of the competency reporting data and interviews with the LP, it was determined that the staff competency reports were missing for 2019. The director is responsible for ensuring that policies and procedures are established for monitoring individuals who conduct testing. Competency reports are required each year for testing personnel if employed longer than one year, and each six months for staff employed less than one year. See D-6127 D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's records for evaluation of competency reporting and an interview with laboratory personnel (LP) on 2/23/2021 between 2 p.m . and 3:30 p.m, it was determined that the staff competency reports for 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 -- 2019 were missing. Findings include: 1. On 2/23/2021, an inspection was conducted between 2 p.m. and 3:30 p.m. 2. During a review of the laboratory documentation for staff competency, the reporting for all personnel was missing for 2019. Competency testing is required for testing personnel once each year for staff employed longer than one year, and every six months for staff employed less than one year. 3. The competency reports were present for 2020. 4. The findings were discussed with the LP, and they verified that the 2019 records were absent. -- 2 of 2 --