Dermatology Center, Pllc

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: A review of the laboratory's policy and procedure for "QA for KOH testing Addedum", documents for "laboratory personnel competency" and interview determined that the laboratory failed to document laboratory personnel competency on an annual basis for three of five laboratory personnel who perform KOH examinations. Findings follow: A) Review of the laboratory's policy and procedure for "QA for KOH Testing Addendum" revealed "the Dermatology Center will do annual quality assurance KOH testing between physicians in the clinic. Quality Assurance testing was not performed in 2011 or 2012. Action was taken on January 2014 to assure annual QA testing will occur". B) Review of "Laboratory Personnel Competency" forms revealed that KOH competency was documented for laboratory personnel #1 (as listed on a separate laboratory staff list) on 3/15/18, 12/31/19, and 8 /9 22. C) Review of "Laboratory Personnel Competency" forms revealed that KOH competency was documented for laboratory personnel # 2(as listed on a separate laboratory staff list) on 1/3/20, and 8/9/22. D) Review of "Laboratory Personnel Competency" forms revealed that KOH competency was documented for laboratory personnel #3 (as listed on a separate laboratory staff list) on 8/9/22. E) Upon request, the laboratory was unable to provide documentation for performing KOH competency for the personnel identified above for 2021, 2023 and 2024. F) In an interview at 02: 55 p.m. on 5/15/24, laboratory staff (#1 as listed on the form CMS-209) confirmed that KOH cpmpetency was not performed on the personnel identified above and the personnel performed KOH testing during calendar years 2021, 2023 and 2024. 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 -- D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) 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: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: A review of the Mohs Surgery Logs for January through April 2024, a review of Temperature Monitor Logs for January through April 2024 and interviews with laboratory staff, determined the laboratory failed to document cryostat temperatures on one of sixty-four days when Mohs surgery was performed in 2024. Survey findings include: A) A review of the Mohs Surgery logs for April 2024 documented the laboratory performed Mohs Surgery on 4/15/24 ( 7 patients),. B) A review of the Temperature Monitor Logs 2024 ( January through April), revealed the laboratory failed to document cryostat temperatures on 4/15/24 (7 patients tested), C) In an interview at 02:55 p.m. on 5/15/24, laboratory staff (#1 as listed on the form CMS- 209) confirmed that the cryostat temperature was not documented on 4/15/24 and Mohs surgery was performed on that day. -- 2 of 2 --

Summary Statement of 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: Through review of the patient log book, patient reports, cryostat temperature log, lack of documentation, and interview it was determined that the laboratory failed to document the operating temperature of the cryostat in 19 of 700 Mohs surgery patients between 01/01/22 and 07/20/22. Findings follow: A) Review of cryostat temperature records revealed that cryostat temperatures were not documented on 2/21 /22, 5/4/22, 7/6/22, 7/12/22, 7/13/22 and 7/20/22. B) Review of the patient log book and patient reports revealed that Mohs surgeries were performed on: * 2/21/22 ( 1 case patient identified as number one on a separate patient identification list) * 5/4/22 ( 3 cases patients identified as numbers two though four on a separate patient identification list) * 7/6/22 ( 4 cases patients identified as number five through eight on a separate patient identification list) * 7/12/22 ( 1 case patient identified as number nine on a separate patient identification list) * 7/13/22 ( 5 cases patients identified as number ten through fouteen on a separate patient identification list) * 7/20/22 ( 5 cases patients identified as number fifteen through noneteen on a separate patient identification list) C) Upon request the laboratory could not produce documentation of cryostat temperatures for 2/21/22, 5/4/22, 7/6/22, 7/12/22, 7/13/22 or 7/20/22. D) In an interview on 8/11/22 at 12:50 pm, the clinic personnel identified as number one and two on a separate personnel identification list confirmed that Mohs surgeries were 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 -- performed on 2/21/22, 5/4/22, 7/6/22, 7/12/22, 7/13/22 and 7/20/22 and the cryostat temperatures were not documented on those dates. 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: Through observation and interview it was determined that the laboratory failed to assure that supplies were not used when they have exceeded their expiration date. Findings follow: A) During a tour of the laboratory on 8/11/22 at 01:00 pm, three of three bottles of Potassium Hydroxide Solution ( two bottles Lot # 1934524 with an expiration date of 12/12/21, and one bottles lot # K16841 with an expiration date of 2019-11 30) were observed in a supply cabinet and no unexpired Potassium Hydroxide was observed in the cabinet at that time . B) In an interview on 8/11/22 at approximately 01:10 pm, clinic staff members identified as numbers one and two on a separate staff identification list confirmed that the bottles were available for use, and had exceeded the expiration date. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Through a review of Mohs surgery logs, H&E stain quality control log, lack of documentation, as well as interviews with staff, it was determined the laboratory failed to document staining quality for Hematoxylin and Eosin (HE) stain on each day of patient testing. As evidenced by: A) Review of the patient log book and patient reports revealed that Mohs surgeries were performed on: * 2/21/22 ( 1 case patient identified as number one on a separate patient identification list) * 5/4/22 ( 3 cases patients identified as numbers two though four on a separate patient identification list) * 7/6/22 ( 4 cases patients identified as number five through eight on a separate patient identification list) * 7/12/22 ( 1 case patient identified as number nine on a separate patient identification list) * 7/13/22 ( 5 cases patients identified as number ten through fouteen on a separate patient identification list) * 7/20/22 ( 5 cases patients identified as number fifteen through noneteen on a separate patient identification list) B) Review of the H&E stain quality control log revealed that no H&E stain quality control review was documented on 2/21/22, 5/4/22, 7/6/22, 7/12 /22, 7/13/22, or 7/20/22 C) In an interview on 8/11/22 at 12:50 pm, the clinic personnel, identified as numbers one and two on a separate clinic personnel list, confirmed the laboratory did not document H&E stain quality on the days identified above and patients had Mohs surgery with the required H&E stained slides. -- 2 of 2 --