Center For Skin Wellness Llc, The

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at The Center for Skin Wellness LLC on 12/10/20. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level 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 review of the CMS Laboratory Personnel Report (Form CMS 209), competency record review, and interview with the Office Manager, the laboratory failed to perform a six month competency evaluation for 1 (Testing Personnel #B) of 1 new employee. Findings included: Record review of the Form CMS 209 revealed that Staff #B worked as Testing Personnel. Record review of the procedure manual revealed the undated procedure titled, "PROFICIENCY TESTING Competency and CLIA competency assessment." The procedure stated "Evaluation and documenting competency of personnel responsible for testing is required at least semi-annually during the first year" When competency records were requested for Testing Personnel #B who had started 3/2020, the laboratory stated they did not have competency records for Testing Personnel #B. Interview on December 10, 2020 at 11:20 AM, the office manager confirmed that competency had not been performed on Testing Personnel #B and stated she did not know that a Moh's surgeon needed competency evaluations. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- 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 record review and interview with the Office Manager, the laboratory failed to verify the accuracy of testing twice a year for 1 of 1 years (2020) reviewed for subspecialty of Mycology (fungi), and Parasitology (scabies) Findings Included: Review of the procedure manual revealed that the laboratory did not have a procedure for verifying the accuracy of testing for fungi and scabies. Interview on 12/10/2020 at 11:15 AM, the Office Manager confirmed that the peer reviews for fungi and scabies had not been performed in 2020. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with the Office Manager, the laboratory failed to perform preventative maintenance on the cryostat used in the Histopathology laboratory since the date of the last on-site survey, 08/27/2019. Findings included: Observation during the laboratory tour on 12/10/20 at 10:20 AM revealed a sticker on the Leica cryostat that stated the preventive maintenance was due 04/2020. Record review of the laboratory's "Cryostat Maintenance" procedure revealed that "preventative maintenance and grounding checks are done and documented annually." On 12/10/20 at 10:25 AM, the Office Manager stated that the preventative maintenance had been missed due to Coronavirus. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview with the Office Manager, the facility failed to ensure Histopathology Hematoxylin and Eosin (H&E) quality control (QC) stain was documented and acceptable before reporting patient results from 09/20/19 to 12/9 /2020. Findings included: Record review of the procedure manual revealed a procedure titled "Stain Maintenance Auto-Stainer." The procedure stated "A QC worksheet is documented daily on the stain quality and any corrections or changes made." Record review of the "Quality Control Staining" revealed that the H&E QC -- 2 of 3 -- had not been documented from 09/20/19 to 12/9/20. On 12/10/20 at 11:25 PM, the Office Manager confirmed the H&E quality control documentation was missing. This is a repeat deficiency. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced CLIA initial certification survey was conducted at The Center for Skin Wellness LLC on 08/27/19. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on record review and interview with the Office Manager, the laboratory failed to record the room humidity for 5 of 5 days (04/23/19, 04/24/2019, 05/31/19, 06/28 /19, and 07/26/19) and failed to record room temperature for 2 (06/28/19 and 07/26 /19) of 5 days (04/23/19, 04/24/2019, 05/31/19, 06/28/19, and 07/26/19) when Histopathology Hematoxylin and Eosin (H&E) staining was being performed. Findings Included: Record review of the Leica CM1850 Cryostat Instruction Manual dated 12/2003 showed the maximum room temperature should be 35 degrees Celsius and the air humidity should not exceed 60%. A review of the Moh's log showed patient's specimens for H & E stain had been performed on 04/23/19, 04/24/19, 05/31 /19, 06/28/19 and 07/26/19. A review of the "2019 Room Temperature" log revealed no temperatures were recorded on 06/28/19 and 07/26/19. In addition, there was no record or log that documented room humidity for any of the dates when staining was performed. Interview on 08/27/19 at 11:00 AM with the Office Manager confirmed 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 -- that room temperatures were not recorded for 06/28/19 and 07/26/19, and the humidity for 04/23/19, 04/24/19, 05/31/19, 06/28/19, and 07/26/19 had not been documented. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and staff interview, the facility failed to ensure Histopathology Hematoxylin and Eosin (H&E) quality control (QC) stain was documented and acceptable before reporting patient results for 3 ( 05/31/19, 06/28/19, and 07/26/19) out of 5 (04/23/19, 04/24/19, 05/31/19, 06/28/19, and 07/26/19) days. Findings included: Record review of the Moh's log showed patient's specimens for H & E stain had been logged on 04/23/19, 04/24/19, 05/31/19, 06/28/19, and 07/26/19. A total of 38 patients' specimens for H & E had been stained since 04/23/19. Record review of the procedure revealed a procedure titled "Quality Assurance for Routine Stains" and stated "Each QC will be logged on the stain QC chart. Record review of the "Quality Control Staining "revealed that the H & E QC had not been documented on 05/31/19, 06/28/19, and 07/26/19. On 08/27/19 at 12:00 PM, the Office Manager confirmed the H & E quality control documentation was missing. -- 2 of 2 --