Schweiger Dermatology, Pc -

Summary Statement of Deficiencies 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 surveyor review of the Maintenance Records (MR), the Procedure Manual (PM) and interview with the Office Manager (OM), the laboratory failed to ensure the Linistat Linear Stainer maintenance was performed annually from December 2022 to the date of survey. The finding includes: 1. The PM stated " The Laboratory Director will ensure that the periodic maintenance, function checks and calibration verifications will be performed each year as required by the manufacturer. Preventative maintenance is to be performed once a year also." 2. The Linistat Linear Stainer had a maintenance label stating maintenance was due on 12/22. 3. The OM confirmed on 11/1/23 at 3:00 pm that the laboratory did not ensure maintenance was performed annually. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) 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 -- The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on surveyor review of the Mohs Surgical Log (MSL), Test Records (TR), and interview with the Office Manager (OM), the laboratory failed to maintain an accurate information system for Histopathology tests from 10/26/23 to the date of survey. The findings include: 1. A review of the Mohs Surgical log revealed: a. The date on the MSL says the calendar year of 2022, but the tests performed were on 10/26/23. b. The Case # on the MSL starts with the number 22, but should have started with the number 23 for tests performed on 10/26/23. c. Case # 22-211 was documented on the MSL having a testing date of 10/26/23, but the slides and Mohs map were documented as 23-111. d. Case #22-212 was documented on the MSL having at testing date of 10/26/23, but the slides and Mohs map were documented as 23-112. e. Case #22-213 was documented on the MSL having at testing date of 10/26/23, but the slides and Mohs map were documented as 23-113. f. Case #22-214 was documented on the MSL having at testing date of 10/26/23, but the slides and Mohs map were documented as 23-114 g. Case #22-215 was documented on the MSL having at testing date of 10/26/23, but the slides and Mohs map were documented as 23-115. 2. The OM confirmed on 11/1/23 at 2:30pm the laboratory failed to maintain an accurate information system. -- 2 of 2 --

Summary Statement of Deficiencies 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 surveyor review of the Biannual Assessment (BA) records and interview with the Office Manager (OM), the laboratory failed to verify the accuracy of Histopathology testing twice annually in the calendar year 2020. The OM confirmed on 11/9/21 at 1:00 pm that the laboratory did not perform BA for Histopathology testing twice in 2020. 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. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM) and interview with the Office Manager (OM), the laboratory failed to follow the PM for Fume Hood maintenance from May 2020 to the date of the survey. The findings include: 1. The PM stated the "preventive maintenance will be done on the fume hood on the same schedule as the cryostat maintenance" 2. There was no documented evidence that any preventive maintenance was performed. 3. The OM confirmed on 11/9/21 at 12:30 pm that the laboratory did not follow the PM. 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 -- D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on surveyor review of Personnel Records (PR) and interview with the Office Manager (OM), the Laboratory Director failed to ensure that the education records were available for all Testing Personnel (TP) on the date of the survey. The finding includes: 1. Education records were not available for one out of three TP. 2. The OM confirmed on 11/9/21 at 1:15 pm that education records were not available. -- 2 of 2 --