Haddonfield Dermatology Associates

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 Biannual Assessment (BA) records and interview with Testing Personnel (TP)), the laboratory failed to verify the accuracy and reliability of Mohs testing twice annually from 3/8/23 to the date of the survey. The findings include: 1. There was no documented evidence that BA was performed in 2023. 2. The TP confirmed on 7/16/24 at 10:30 am that the laboratory did not perform BA as mentioned above. 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), observation of Staining Station (SS) and interview with the Tsting Personnle (TP), the laboratory failed to follow the PM for Hematoxyilin-Eosin (HE) staining from 7/26/22 to the date of the survey. The findings include: 1. The procedure in the PM "Hematoxylin and Eosin Staining Procedure" Does not match the order of the labeled coplin jars in the SS. 2. The OM confirmed on 7/16/24 at 10:30am 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 1 --

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 surveyor review of the Competency Assessment (CA) records and interview with the Office Manager (OM) the laboratory failed to follow its policies and procedures for assessing the competency of Testing Personnel who perform Histopathology testing in the calendar year 2020. The findings include: 1. The CA was not performed on one out of one TP in 2020. 2. The OM confirmed on 9/8/21 at 2: 00 pm that the CA was not performed. 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 in the calendar 2021. The finding includes: 1) Biannual assement has not been performed since June 2020. 2) The OM confirmed on 9/8/21 at 1:00 pm that the laboratory did not perform BA for Histopathology since June 2020. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT 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 -- CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual and interview with the Office Manager (OM), the laboratory failed to establish a detailed procedure for Biannual Assessment (BA) from 4/12/18 to the date of survey. The finding includes: 1. The BA procedure did not include the name of the referring pathologist. 2. The OM confirmed on 9/8/21 at 2:15 pm that the BA procedure was not in detail. 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 surveyor observation of Histology reagents and interview with the Office Manager (OM), the laboratory failed to discard expired Histopathology reagents from 3/1/21 to the date of survey. The findings include: 1. On the date of the survey the laboratory used expired reagents as follows: a. Advantik Tissue marking dye red Lot 11-9002-12 expiration 3/1/21. b. Advantik Tissue marking dye yellow Lot: 11-9004- 12 expiration 8/31//21. 2. The OM confirmed on 9/8/2021 at 1:30 pm that the laboratory used expired reagents. -- 2 of 2 --

Summary Statement of Deficiencies 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: a)Based on surveyor review of the Procedure Manual (PM), observation of the Automated Staining Station (ASS) and interview with the Office Manager (OM), the laboratory failed to follow Mohs Staining Procedure from June 2017 to the date of the survey. The findings include: 1. The ASS in the laboratory did not correspond with the staining procedure in the PM. a) The PM stated Staining Container (SC) # 2 was for 95% Alcohol but ASS had water. b) The ASS had SC # 3 for Hematoxylin but it was water in the PM. c) The ASS had SC # 4 for water but it was Hematoxylin in the PM. d) The ASS had SC # 5 for 95% Alcohol but it was Hematoxylin in the PM. e) The ASS had SC # 6 for Eosin but it was Water in the PM. f) The ASS had SC # 7 for 95% Alcohol but it was water in the PM. g) The ASS had SC # 8 for 100% Alcohol but it was Scott's Bluing in the PM. h) The ASS had SC # 9 for 100% Alcohol but it was water in the PM. i) The ASS had SC # 10 for Xylene Substitute but it was Eosin in the PM. j) The ASS had SC # 11 for Xylene Substitute but it was 95% Alcohol in the PM. k) The ASS had SC # 12 for 100% Alcohol but it was 95% Alcohol in the PM. l) The PM has steps 13-15 but the ASS ends at 12. 2. The OM confirmed on 4/12 /18 at 12:45 pm that PM procedure did not match with ASS. b) Based on surveyor review of the Biannual Assessment (BA) procedure, Procedure Manual (PM) and interview with the Office Manager (OM), the laboratory failed follow the BA procedure for the Calendar year 2016 and 2017. The finding includes: 1.The PM stated that the BA will be submitted for review at a CMS-approved Laboratory. a) There was no evidence that the BA was submitted to a CMS-approved Laboratory. b) 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 -- There was no evidence of physician review of slides c)The BA does not identify the reviewing physician. 2. The PM stated that Mohs Surgeon will "review five categories" a) There was no evidence the five categories were reviewed. 3. The PM stated that 4-10 Mohs cases will be submitted for review. a) Two cases were submitted in BA event 01/10/17 b) Three cases were submitted in BA event 8/9/17 4) The PM stated the BA "will be conducted twice a year"but the laboratory did only once in 2016. 3. The OM confirmed on 4/12/18 at 11:01 am that the BA procedure was not followed. D5781