Summary:
Summary Statement of Deficiencies D0000 An initial survey conducted on 05/31/2023 found the ADVANCED DERMATOLOGY AND COSMETIC SURGERY clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to provide documentation that showed that the laboratory director (LD) approved, signed and dated the procedure manual from 01/06/2023. Findings included: Review of the procedure manual showed that there was no documentation that showed that the LD had approved, signed or dated the procedure manual since he was approved as LD on 01 /06/2023. During an interview on 05/31/2023 at 10:40 AM, the Area Clinical Manager acknowledged that the procedure manual was not signed and dated by the laboratory director sinnce 01/06/2023 to 05/31/2023. 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 observation, record review and interview, the laboratory failed to provide 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 -- documentation showing the Alcohol 100% used in the Hematoxylin and Eosin Staining (H&E) was not expired prior to patient testing from 01/31/2023 to 05/31 /2023. Findings included: During laboratory tour on 05/31/2023 at 10:50 AM, the surveyor found an open one-gallon container of 100% Reagent Alcohol with expiration date 01/31/2023 and lot number 114897. Review of the reagent log for 2023 revealed no records and reagent log for 2022 revealed that there was listed a 100% Reagent Alcohol with lot number 146542 and dispose date of 1/19/23. Review of patients log revealed that the laboratory had the following dates after 01/19/2023: -02/23/2023: 5 patients tested -03/23/2023: 6 patients tested -04/20/2023: 3 patients tested -04/24/2023: 5 patients tested -05/13/2023: 5 patients tested -05/18/2023: 4 patients tested. During an interview on 05/31/2023 at 11:00 AM with the Area Clinical Manager she confirmed the laboratory had no documentation that the reagent expired was not used in the testing days listed above. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on record review and interview, the Technical Supervisor (TS) failed to evaluate the initial competency for two out of two testing personnel (TP) since January 2023. Findings included: -Review of the FORM CMS-209 signed by the Laboratory Director (LD) on 05/31/2023 revealed that the Clinical Consultant (CC), TS, General Supervisor (GS) was also TP#A. The laboratory had two TP (TP#A, TP#B). -Review of patient log records revealed that TP#A started testing since January 2023 and TP#B started testing since April 2023. No records of competencies have been found for TP#A and TP#B since the laboratory started testing on January 2023. During an interview on 05/31/2023 at 12:30 PM with the Clinical Area Manager, she confirmed that the TS failed to perform the competencies listed above. -- 2 of 2 --