Vitalogy Skincare Dba (Bastrop)

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and recertification is recommended. 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 review of the chemical log, patient testing logs, and interview, the laboratory failed to ensure chemicals and stains used in the Hematoxylin and Eosin (H&E) stain used to process Mohs specimens had not exceeded their expiration date by one month out of 14 months reviewed for Eosin. Findings follow. A. Review of the H&E Linear Stainline Log showed at the bottom of the page where chemicals were documented when opened and showed in January 2022 Eosin-y, Lot number 108396, expiration 12/22 was opened, and not logged again until February 2023, Eosin, Lot number 111055, expiration 04/23. B. Review of the Mohs log showed 42 cases, SBA23-001 - SBA23-042 had been processed and tested with Eosin from 01/04/2023 - 01/23/2023. C. Interview with the Laboratory Manager on July 31, 2023 at 1520 hours confirmed there was no documentation showing Eosin had been opened prior to February 2023 showing Eosin wasn't expired. 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 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 -- 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 patient test reports and interview, the laboratory failed to include the correct name and address of the facility where the Mohs testing was performed for one of 11 reports reviewed. Findings follow. A. Review of 11 test reports showed one had the following name and address for the Mohs testing performed at- Vitalogy Skincare GT, 4513 Williams Drive, Georgetown, TX 78633: 1. MRN: 105865 on June 27, 2023. B. Interview with the Laboratory Manager on August 1, 2023 at 1530 hours confirmed the findings. KEY: MRN - Medical Record Number -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of policies and procedures, personnel records, and interview of facility personnel it was revealed that the laboratory failed to have a procedure to assess the competency of the technical consultant and testing personnel . Findings were: 1. A review of policies and procedures found no written policy for assessing the competency of all supervisors, consultants and testing personnel. 2. .Interview of the clinic manager conducted on March 1, 2018 at 11:16 AM confirmed there was no procedure for assessing the competency of the technical consultant or testing personnel. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's quality assurance records from 2016 through 2018 and staff interview, it was revealed the laboratory failed to have documentation of performing twice annual accuracy assessment for KOH preparations in 2017. Findings included: 1. A review of the laboratory's quality assurance records from 2016 through 2018 found no documentation of verification of the accuracy of results for KOH 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 -- preparations in 2017. The last recorded verification of accuracy of results was documented on December 17, 2016. The laboratory was not enrolled in a CMS approved proficiency testing program for Clinical Microscopy. 2. An interview with the clinic manager conducted on March 1, 2018 at 10:58 AM confirmed the laboratory was neither enrolled in a proficiency testing program nor did the laboratory have a method in place to verify the accuracy of the test results for KOH at least twice a year. 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: Review of policies and procedures and interview of facility personnel found that the laboratory director failed to approve, sign and date two of 3 procedures for Bacteriology found in the Competency assessment (new employees) notebook. Findings included: 1. Review of policies and procedures found in the notebook labeled Competency assessment (new employees) contained 3 procedures. Two of the three procedures were not approved signed and dated by the current laboratory director. The procedures titled Wet Prep/KOH and Scabies Prep Procedure had no documentation of approval by the current laboratory director. 2. Interview of the clinic manager conducted on March 1, 2018 at 11:27 AM confirmed the procedures had no documentation of approval by the current laboratory director. D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) 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)(13) 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 review of the laboratory's procedure manual, manufacturer's instructions and interview of facility personnel, the Laboratory Director failed to ensure an approved procedure was available for assessing the competency of all supervisors, consultants and testing personnel and for KOH and Scabies Prep testing . Refer to D 5209 and D5407. -- 2 of 2 --