Skin And Beauty Center - West Hills

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 the surveyor's review of the laboratory's policies and procedures, five patient testing records from 11/21/2024 to 04/02/2026, log sheet, final reports, slides, Mohs map, and an interview with the supervisor on June 16, 2026, it was determined that the laboratory failed to follow their established policies and procedures to 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. The findings include: 1. The surveyor reviewed five patient records for Dermatopathology and identified one discrepancy: a. MRN: MM0000007161 had recorded the patient's last name differently against various records, including the patient log, Mohs map, slides, and patient chart. 2. No

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 surveyors' observation during the laboratory tour and interview with the laboratory's Mohs technician (MT) and laboratory staff (LS); it was determined that the laboratory failed to establish safety procedures to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. The findings include: 1. The laboratory failed to provide a written procedure for laboratory safety. 2. On the day of the survey July 3, 2024, at approximately 1:00 p.m. the surveyors observed that the laboratory lacked an eyewash and spill kits in the area where tissue samples are processed. The surveyor also observed used gloves in the regular trash can. 3. The MT and LS affirmed the lack of safety procedures, eyewash, and spill kits in the testing area. The MT and LS also affirmed presence of the gloves in the regular trash can in the laboratory. 4. Based on the laboratory's annual testing volume declaration signed by the laboratory director on 06/21/2024, the laboratory processes and reports approximately 300 samples annually. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. 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 laboratory written policies and procedures for potassium hydroxide (KOH) and preparation for the detection of Sarcoptes scabiei (scabies) and interviews with the laboratory staff (LS) it was determined that the laboratory failed to have available and follow written procedures for mycology and parasitology test performed in the laboratory. The findings included: 1. On the day of the survey on July 3, 2024, at approximately 11:30 a.m. the laboratory failed to provide written policies and procedures for mycology and parasitology test performed in the laboratory. 2. The LS confirmed on 07/03/2023 at approximately 11:30 a.m. that the laboratory did not have written policies and procedures available for mycology and parasitology tests performed in the laboratory. 3. Based on the laboratory's annual testing volume declaration signed by the laboratory director on 06/21/2024, the laboratory processes and reports 50 mycology and parasitology samples annually. D6011 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(2) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(2) and provide a safe environment in which employees are protected from physical, chemical, and biological hazards. This STANDARD is not met as evidenced by: Based on direct observation during the tour of the laboratory and interviews with the Mohs technician and the laboratory personnel; it was determined that the laboratory director failed to provide a safe environment in which employees are protected from physical, chemical, and biological hazards. See D3011. D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) The laboratory director must ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process. This STANDARD is not met as evidenced by: Based on interview with the laboratory personnel on the day of the survey (July 3, 2024), the laboratory director failed to ensure that an approved, signed, and dated, procedure manual reflecting the current practice is available to all personnel responsible for any aspect of the testing process. Findings include: D5401. -- 2 of 2 --