Rsb Dermatology Inc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at RSB DERMATOLOGY INC from 08/14/2025 to 08/20/2025. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (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. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to have documentation of the acceptability of the Quality Control (QC) slide for Hematoxylin & Eosin (H&E) stain for frozen sections for two out of six testing dates in two months (July and August) reviewed in 2025. Based on record review and staff interview, the laboratory failed to have documentation of the acceptability of the Quality Control (QC) slide for Hematoxylin & Eosin (H&E) stain for pathology sections for nine out of nine months (April, May, June, July, August, September, October, November and December) reviewed in 2024 and for 2025 41 out of 52 testing dates from January to August 2025. Findings included: 1-Review of the procedure manual signed by the Laboratory Director (LD) on 01/08/2025, revealed that on policy "Quality Control Testing" stated: "You must maintain records of daily control of patient's specimen testing. These records must be on hand for a minimum of two years. Completed forms are maintained in laboratory QA log filed by month." 2-The laboratory used the "MOHS DAILY QC WORKSHEET" to record the acceptability of the daily H&E stain for the frozen section testing. Review of the MOHS DAILY QC WORKSHEET log for July and August 2025 revealed that on 07/23/ 2025 and 08/06/2025, there was no record of H&E QC slide approval. 3-Review of pathology section "H&E Quality 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 -- Control" log from 04/2025 to 12/2024, the laboratory failed to have documentation of the acceptability of the H&E quality control slide. Review of "HEMATOXYLIN & EOSIN STAINING QUALITY CONTROL WORKSHEET" for year 2025, revealed that the laboratory failed to have documentation of acceptability of the daily QC slide for the following dates: 01/08/2025, 01/13/2025, 01/16/2025, 01/27/2025, 02/03/2025, 02/05/2025, 02/11/2025, 02/17/2025, 02/19/2025, 02/24/2025, 02/26/2025, 03/05 /2025, 03/10/2025, 03/12/2025, 03/17/2025, 03/19/2025, 03/24/2025, 03/26/2025, 04 /07/2025, 04/09/2025, 04/14/2025, 04/16/2025, 04/21/2025, 04/23/2025, 04/28/2025, 05/05/2025, 05/07/2025, 05/12/2025, 05/14/2025, 05/19/2025, 05/21/2025, 05/26 /2025, 05/28/2025, 06/04/2025, 06/09/2025, 06/30/2025, 07/09/2025, 07/14/2025, 07 /16/2025, 07/21/2025, 07/23/2025, 07/28/2025, 07/30/2025, 08/06/2025 and 08/11 /2025. 4-Based on review of Form CMS-116 signed by the LD on 08/14/2025, revealed that the annual test volume was 2,500 tests performed. 5-During an interview on 08/14/2025 at 03:00 PM the Office Consultant confirmed that the TP failed to document the acceptability of the Daily QC slide for H& E Stain for the days and months of reference listed above. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory Quality Assessment (QA) failed to identify and correct that the laboratory failed to have documentation of the approval of the daily Quality Control (QC) slide Hematoxylin and Eosin (H&E) stain from April 2024 to August 2025. Based on record review the QA failed to identify and correct that the laboratory failed to document the daily log for Hematoxylin and Eosin Maintenance log and temperature records for the Pathology section during one out of seven months in 2025 (January, February, March, April, May, June, July and August). Findings included: 1-Review of daily QC slide for H&E stain from April 2024 to August 2025, revealed that the laboratory failed to have documentation of the approval. Refer to D5473. 2-Review of procedure manual signed by the Laboratory Director (LD) on 01/08/2025, revealed that the policy "QUALITY ASSURANCE FORM" stated that the QA form will be used to monitor the ongoing and overall quality. The form will document the overall quality of the total testing process and if problems have been identified." The laboratory listed the monitored parameters, Daily: H&E Quality Control, Functions verifications: Microscope, Fume Hood, Eye Wash, Embedding Center, Refrigerator, Humidity, Room temperature, Hematoxylin & Eosin Maintenance Log, QC Logs: Microtome, Oven and water bath. 3-Review of maintenance records for 2024 and 2025, revealed that for May 2025 the laboratory had 8 testing dates and failed to document the Hematoxylin & Eosin staining Maintenance Log, Path daily Quality Control. Function Verification 1 (included Oven temperature, Waterbath temperature, Embedding Center temperature, room temperature, room humidity) and Daily Quality Control. Function Verification 2 ( included Coverslipper, Eyewash, Fume Hood, Microscope and Microtome). 4-Review of "PATHOLOGY MONTHLY QUALITY ASSURANCE CHECKLIST" for May 2025 signed by the LD on 05/28/2025, revealed that the laboratory failed to identify and correct the lack of documentation. 5-During an interview on 08/14/2025 at 03:30 PM, the laboratory consultant representative confirmed that the QA plan failed to -- 2 of 3 -- ensure that the laboratory documented the approval of daily QC slide for H&E stain for the period reviewed and failed to correct the missing documentation for May 2025. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; This STANDARD is not met as evidenced by: Based on record review and staff interview, the LD failed to ensure the laboratory documented the approval of the daily Quality control slide for Hematoxylin & Eosin (H&E) stain since April 2024. (Refer D5473) and failed to ensure the Quality Assurance detected and corrected the missing documentation for daily quality control for pathology in May 2025. (Refer to 5793) -- 3 of 3 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on March 14, 2024. RSB Dermatology Inc clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation, review of the procedure manual and quality control documents, and interview, the laboratory failed to document the making of the 70 %, 90 %, and 95 % alcohol solutions used in the processing and staining for biopsy and Mohs surgery tissue samples from 01/19/2022 to 03/14/2024. Findings: Examination of the Miles Tissue Tek VIP on 03/14/2024 at 9:40 PM, showed the processor used 70 %, and 90 % Alcohol. Examination of the flammable cabinet 03/14/2024 at 9:45 AM revealed it only contained bottles of 100 % Alcohol. Review of the procedure manual noted the biopsy stain line used 70 %, 90 %, and 95 % alcohol solutions. Review of the procedure manual noted the Mohs stain line used 95 % alcohol solution. Review of the laboratory's quality control documents revealed the laboratory did not have documentation of the preparation of the 70 %, 90 %, and 95 % alcohol solutions On 03 /14/2024 at 11:37 AM, Testing Personnel A stated they did not document the making of the 70 %, 90 %, and 95 % alcohol solutions. 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 D0000 A recertification survey was completed on 1/18/2022 at RSB Dermatology. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following Conditions were not Met : 5200- General Laboratory Systems D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory failed to perform peer-review twice a year for KOH and Scabies in 2020 and 2021.(See 5217) 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 record review and interview, the laboratory failed to perform peer-review twice a year for KOH and Scabies in 2020 and 2021. Findings included: This a repeated deficiency from 1/28/2020. Review of American Association of Bioanalyst 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 -- (AAB) Proficiency Testing Service revealed there was no records of peer-view performed twice a year for KOH in 2020. Review of Peer-Review records for Scabies revealed there was no documentation of peer-review performed for Scabies twice a year in 2020 and 2021. During an interview on 1/18/2022 at 2:34 PM, the office consultant confirmed peer-review had not been performed twice annually in 2020 for KOH and Scabies in 2020 and 2021. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey conducted on 01-28-2020, found RSB Dermatology Inc clinical laboratory not incompliance with 42 CFR Part 493, Requirements for Laboratories. D3039 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(5) Quality system assessment records. Retain all laboratory quality system assessment records for at least 2 years. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to ensure a two-year record retention for potassium hydroxide preparation (KOH) and Scabies quality assessment (QA) records for 2018 and 2019. Findings Include: A review of the KOH quality assessment record displayed that KOH QA forms were missing for 2018 and 2019. A review of the Scabies quality assessment record revealed the Scabies QA forms were missing for 2018. During an interview on 1- 28-2020 at 11:30 am, The laboratory director and office manger confirmed that the record were missing from KOH QA records for the period of 2018-2019. 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 record review and staff interview, the laboratory failed to perform potassium hydroxide preparation (KOH) proficiency testing (PT) twice annually for 2018 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 -- 2019. Findings Include: A review of Peer-Review Proficiency Testing record revealed that KOH PT was not preformed twice annually for 2018 and 2019. During an interview on 1-28-2020 at 11:30 am, the laboratory director confirmed that the KOH PT was not performed twice annually for 2018 and 2019. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

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 record review and interview with laboratory director, the laboratory failed to verify the accuracy of Mohs slides for 1 out of 2 years and histopathology 2 out of 2 years. Findings include: Review of laboratory's verification accuracy records showed there is no documentation for year 2016 for Mohs slides and for histopathology, there is no documentation for years 2016 and 2017. Interview with the laboratory director at 11:00 a.m. on 04/09/2018 confirmed that there is no documentation of the accuracy verification for Mohs during 2017 and for histopathology for 2016 and 2017. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of