North Branch Dermatology Llc

Summary Statement of Deficiencies D0000 A recertification survey was completed on 01/07/2026. Deficiencies were found resulting in the following condition level deficiencies: D5200 493.1230 Condition: General laboratory systems. D5400 493.1250 Condition: Analytic systems. D6076 493.1441 Condition: Laboratories performing high complexity testing; laboratory director. D6108 493.1447 Condition: Laboratories performing high complexity testing; technical supervisor D6168 493.1487 Condition: Laboratories performing high complexity testing 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 review of laboratory records, the lack of documentation, and interview with the laboratory representative (LR); the laboratory failed to follow written policies and procedures to assess competency for three of three testing personnel (TP) performing microscopic potassium hydroxide (KOH) wet mount testing, microscopic scabies wet mount testing in the specialty of microbiology and Mohs histopathological testing in the subspecialty of histopathology from 2024 through the date of survey, 01/07/2026 (See D5209). The laboratory also failed to follow written policies and procedures to address bi-annual method accuracy evaluations of Mohs micrographic surgery (See D5217-A) and KOH preparations (See D5217-B) from 2024 through the date of survey, 01/07/2026. Likewise, the laboratory failed to follow written policies and procedures to address bi-annual method accuracy evaluations of scabies wet Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 13 -- preparations from 2024 through the date of survey, 01/07/2026 (See D5219). To conclude, the laboratory failed to establish procedures and conduct QA assessments of laboratory testing for microscopic KOH wet mount testing and microscopic scabies wet mount testing in the specialty of microbiology from the beginning of testing to the date of survey 01/07/2026 (See D5291). Repeat Deficiency from previous survey, 09 /10/2024. 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 laboratory's policies and procedures, laboratory records and interview with the laboratory representative (LR); the laboratory failed to follow written policies and procedures to assess competency for three of three testing personnel (TP) performing microscopic potassium hydroxide (KOH) wet mount testing, microscopic scabies wet mount testing in the specialty of microbiology and Mohs histopathological testing in the subspecialty of histopathology from 2024 through the date of survey, 01/07/2026. Findings include: 1. Review of laboratory policies and procedures revealed a document titled "Personnel Competency/ Proficiency Testing Instructions" which stated, "The competency assessment will evaluate the employee's compliance with all policy and procedure within the scope of routine job duties and will include the following methods of assessment. a.) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing, and testing b.) Monitoring the recording and reporting of test results c.) Review of intermediate test results or worksheets, quality control records, proficiency testing results and preventive maintenance records d.) Direct observations of performance of instruments maintenance and function checks e.) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. f.) Assessment of problem-solving skills" "Competency evaluations: [ ...] the lab director will perform an evaluation of the 6 above required competency elements twice in the first year for each testing personnel both for KOH/scabies) (aka PPM) and for the MOHS technicians performing the grossing aspect of testing) and then annually thereafter". 2. Review of laboratory records found 16 instances where the laboratory failed to assess all six elements of competency or perform competency evaluations for three of five TP who perform KOH, scabies, or Mohs testing from 2024 through to the day of survey, 01/07/2026. TP: Date: Test: A 09/24/2024 S* A 11/03/2024 K** A not performed M*** A 01/06/2025 S A 02/03/2025 K A 03/11/2025 M A 10/28/2025 M A 11/11/2025 M A 12/09/2025 M 1 10/28/2024 K 1 11/14/2024 S 1 07/08/2025 K 1 not performed S 2 11/14/2024 S 2 01/07/2025 K 2 06/05/2025 K S* = Scabies K** = KOH M*** = Mohs micrographic surgery 3. Interview with LR on date of survey, 01 /07/2026 at 10:47 pm confirmed the laboratory failed to follow written policies and procedures to assess competency for three of three TP performing microscopic KOH wet mount testing, microscopic scabies wet mount testing in the specialty of microbiology and Mohs histopathological testing in the subspecialty of histopathology from 2024 through the date of survey, 01/07/2026. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE -- 2 of 13 -- 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: A. Based on review of the laboratory's policies and procedures, laboratory records and interview with the laboratory representative (LR); the laboratory failed to follow written policies and procedures to address bi-annual method accuracy evaluations of Mohs micrographic surgery from 2024 through the date of survey, 01/07/2026. Findings Include: 1. Review of the laboratory's policy and procedure manual revealed the policy titled, "Quality Assurance/ Quality Control" which states, "- Semiannually, the Mohs surgeon will review randomly selected Mohs cases with a board certified dermatopathologist for correlation of histologic diagnoses. - A written record of this program shall be maintained for at least 4 years. Any discrepancies of opinion between the doctors shall be noted and discussed fully." 2. Review of laboratory records found the laboratory lacked documentation of bi-annual method accuracy evaluations for Mohs dermatopathology testing. 3. Interview with LR on date of survey, 01/07/2026 at 12:41 pm confirmed the laboratory failed to follow written policies and procedures to address bi-annual method accuracy evaluations of histopathology testing in 2024 through the date of survey, 01/07/2026 B. Based on review of the laboratory's policies and procedures, laboratory records and interview with the laboratory representative (LR); the laboratory failed to follow written policies and procedures to address bi-annual method accuracy evaluations of potassium hydroxide (KOH) preparations from 2024 through the date of survey, 01/07/2026. Findings Include: 1. Review of the laboratory's policy and procedure manual revealed the policy titled, "Personnel Competency/ Proficiency Testing Instructions" which stated, "3). Proficiency testing: (aka biannual method accuracy/verification), 'blind' specimens will be tested twice annually for the facility. This process can be incorporated into competency requirements. b). For PPM (both KOH and scabies), have 2 of the providers go behind the other to verify results and document this. Or provide images to the PPM providers to identify presence/ absence of fungal elements or scabies parasites". 2. Review of laboratory records found the laboratory lacked documentation of biannual method accuracy evaluations for KOH testing. 3. Interview with LR on date of survey, 01/07/2026 at 10:47 am confirmed the laboratory failed follow written policies and procedures to address bi-annual method accuracy evaluations of KOH preparations from 2024 through the date of survey, 01/07/2026. D5219 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(2) (c)(2) Any test or procedure listed in subpart I of this part for which compatible proficiency testing samples are not offered by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, laboratory records and interview with the laboratory representative (LR); the laboratory failed to follow written policies and procedures to address bi-annual method accuracy evaluations of scabies wet preparations from 2024 through the date of survey, 01/07/2026. Findings Include: 1. Review of the laboratory's policy and procedure manual revealed the -- 3 of 13 -- policy titled, "Personnel Competency/ Proficiency Testing Instructions" which states, "3). Proficiency testing: (aka biannual method accuracy/verification), 'blind' specimens will be tested twice annually for the facility. This process can be incorporated into competency requirements. b). For PPM (both KOH and scabies), have 2 of the providers go behind the other to verify results and document this. Or provide images to the PPM providers to identify presence/ absence of fungal elements or scabies parasites". 2. Review of laboratory records found the laboratory lacked documentation of biannual method accuracy evaluations for scabies wet preparation testing. 3. Interview with LR on date of survey, 01/07/2026 at 10:47 am confirmed the laboratory failed to follow written policies and procedures to address bi-annual method accuracy evaluations of scabies wet preparations from 2024 through the date of survey, 01/07/2026. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT 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 laboratory quality assurance (QA) guidelines, laboratory QA records and interview with the laboratory representative; the laboratory failed to establish procedures and conduct QA assessments of laboratory testing for microscopic potassium hydroxide (KOH) wet mount testing and microscopic scabies wet mount testing in the specialty of microbiology from the beginning of testing to the date of survey 01/07/2026. Findings include: 1. Review of laboratory records revealed the laboratory failed to establish and document quality assurance checks from the beginning of testing through the date of survey 01/07/2026 for KOH wet mounts and microscopic scabies examinations. 2. Interview with the LR on the date of survey 01 /07/2026, at 10:45 am, confirmed the laboratory failed to establish and conduct QA assessments of laboratory testing for microscopic KOH wet mount testing and microscopic scabies wet mount testing in the specialty of microbiology from the beginning of testing to the date of survey 01/07/2026. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, 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 analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of the laboratory Policies and procedures, quality control (QC) records, and interview with laboratory representative (LR); the laboratory failed to establish procedures for two of three tests performed, microscopic potassium hydroxide (KOH) wet mount testing and microscopic scabies wet mount testing in the -- 4 of 13 -- specialty of microbiology from the start of testing through the day of survey 01/07 /2026 (See D5401). The laboratory similarly failed to outline all required components of testing procedure for Mohs micrographic surgery post-surgical specimen mapping in the subspecialty of histopathology (See D5403). The laboratory also failed to document temperature and preventative maintenance for the Leica Cryostat CM1510- 3 (serial #: 043631517) used for Mohs histopathology testing on five of eight testing dates reviewed from 2024 through the date of survey, 01/07/2026, affecting five patients reviewed (See D5433). Lastly, the laboratory failed to have an alternative control procedure in place for microscopic KOH wet mount testing in the subspecialty of mycology and microscopic scabies wet mount testing in the subspecialty of parasitology for a total of 94 KOH and 12 scabies examinations during January of 2025 through January of 2026 and three of three patients reviewed (See D5485). D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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 review of laboratory policies and procedures, lack of documentation, and interview with the laboratory representative (LR); the laboratory failed to establish procedures for two of three tests performed, microscopic potassium hydroxide (KOH) wet mount testing and microscopic scabies wet mount testing in the specialty of microbiology from the start of testing through the day of survey 01/07/2026. Findings include: 1. Review of laboratory policies and procedures found the laboratory lacked procedures for: a. microscopic KOH wet mount testing in the subspecialty of mycology, b. microscopic scabies wet mount testing in the subspecialty of parasitology. 2. Interview with the LR on 01/07/2026, at 10:43 am, confirmed the laboratory failed to establish procedures for two of three tests performed, microscopic KOH wet mount testing and microscopic scabies wet mount testing in the specialty of microbiology from the start of testing through the day of survey 01/07/2026. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies 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 review of the laboratory's policy and procedure manual, proficiency testing records, and interview with the laboratory representative, the laboratory failed to establish a competency policy for testing personnel (See D5209) and failed to perform bi-annual method accuracy evaluations for two provider performed microscopy (PPM) tests: potassium hydroxide (KOH) preparations and scabies wet preparations and Mohs dermatopathology testing (See D5217). 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 laboratory policy and procedure manual, and interview with laboratory representative; the laboratory failed to follow the competency policy established by the laboratory. The laboratory failed to ensure competency assessments Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- were performed for nine of nine testing personnel. Findings Include: 1.Review of laboratory policy and procedure manual revealed a document titled "Personnel Competency Testing" which stated "Objective To establish a system where the competency and performance of technical personnel are evaluated and documented upon initial employment, 6 month evaluation and then annually thereafter. Such a system will ensure proper training, skills and will maintain accuracy and consistency of all procedures performed." 2.The competency assessment policy failed to address the following criteria: a) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples, or external proficiency testing samples. 3. Review of competency assessment records found the laboratory lacked documentation of competency assessments for nine of nine testing personnel. 4. On survey date 09-10-24, at 12:24 pm the laboratory representative confirmed the laboratory failed to follow the competency assessment policy for nine of nine TP and the competency policy failed to include an assessment of test performance through previously analyzed samples 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: A.Based on review of laboratory records, lack of documentation, and interview with laboratory representative; the laboratory failed to perform bi-annual evaluations for two of two Provider Performed Microscopy tests performed, potassium hydroxide (KOH) preparations and scabies wet preparations. Findings Include: 1. Review of laboratory records found no bi-annual method accuracy evaluations for (KOH) preparations and scabies wet preparations. 2. Interview with laboratory representative on 09-10-24 at 12:41 pm revealed the facility began KOH and scabies wet preparation testing when the site opened in 2022. 3. Additional interview with the laboratory representative at 12:45 pm on 09-10-2024 confirmed the facility had no procedure for biannual method accuracy evaluation of KOH preparations and scabies wet preparations. B.Based on review of laboratory records, lack of documentation, review laboratory policy and procedure manual and interview with laboratory representative; the laboratory failed to perform bi-annual evaluations for one of one high complexity test system: Mohs dermatopathology testing. Findings Include: 1. Review of laboratory policy and procedure manual titled "Quality Assurance/ Quality Control" stated: "Semiannually, the Mohs surgeon will review randomly selected Mohs cases with a board-certified dermatopathologist for correlation of histologic diagnoses." 2. Review of laboratory records found no bi-annual method accuracy evaluations for Mohs dermatopathology testing. 3. Interview with laboratory representative on 09-10- 24 at 12:41 pm revealed the facility began Mohs dermatopathology testing on 02-14- 2023. The laboratory representative also confirmed that no bi-annual method accuracy had been performed for Mohs as outlined in the laboratories policy and procedure manual. 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 -- 2 of 4 -- 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 direct observation, review of laboratory's policy and procedure manual, preventative maintenance records, lack of documentation, and interview with the laboratory representative the laboratory failed to perform and document annual maintenance for one of one microscope (Nikon - serial number: 247395) to ensure accurate and reliable test performance for potassium hydroxide (KOH) preparations, scabies wet preparation, and Mohs dermatopathology testing in 2023 and 2024. Findings Include: 1. Direct observation on 09-10-2024 at 01:00 PM in the laboratory identified a Nikon microscope, serial number 247395. 2.Interview with the laboratory representative on 09-10-2024 at 1:00 pm, revealed the microscope was used for potassium hydroxide (KOH) preparations, scabies wet preps, and Mohs dermatopathology testing. 3. Review of the laboratory's policy and procedure manual titled " Quality Assurance / Quality Control" stated the following: "Preventive maintenance of microscope is performed annually and such is documented." 4.. Review of the laboratory preventative maintenance records found no documented maintenance as described in the above policy for the microscope in 2023 through the date of the survey,09-10-2024. 5. On survey date 09-10-2024 at 2:07 pm the laboratory representative confirmed the annual microscope maintenance had not been performed for the Nikon microscope serial number 247395. D6045 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(7) (b) The technical consultant is responsible for-- (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; This STANDARD is not met as evidenced by: Based on review of laboratory records, CMS-209 (laboratory Personnel report) form, lack of documentation, and interview with laboratory representative; the laboratory technical consultant (TC) failed to ensure the training needs for five of five testing personnel (TP) authorized to perform potassium hydroxide (KOH) preparations and scabies wet preparations. Findings Include: 1. Review of laboratory personnel records found TP #1, #2, #3, #4 and #5 as identified on the CMS-209, were authorized to perform potassium hydroxide (KOH) and scabies wet preparation. 2. Review of training documentation found TP #1, #2, #3, #4 and #5 had no documented training for potassium hydroxide (KOH) and scabies wet preparations. 3. Interview with the laboratory representative on 09-10-2024, at 01:03 pm, the laboratory representative confirmed five of five TP failed to have documented training for KOH preparations and scabies wet preparations. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) -- 3 of 4 -- (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Review of laboratory personnel records, the CMS-209 (laboratory personnel report), lack of documentation, review of policy and procedure, and interview with the laboratory representative; the technical consultant (TC) failed to ensure competency evaluations were completed for five of five testing personnel (TP) that performed potassium hydroxide (KOH) preparations and scabies wet preparations. Findings Include: 1. Review of the laboratory policy and procedure revealed a document titled "Personnel Competency Testing" that states: "Objective To establish a system where the competency and performance of technical personnel are evaluated and documented upon initial employment, 6 month evaluation and then annually thereafter. Such a system will ensure proper training, skills and will maintain accuracy and consistency of all procedures performed." 2. Review of laboratory personnel records revealed no competency assessments for five of five TP listed on the CMS- 209 as TP #1, #2, #3, #4 and #5 for KOH preparations and scabies wet preparations. 3. On survey date 09-10-24, at 12:41 pm, the laboratory representative confirmed that the laboratory TC failed to perform competency assessments for five of five TP that perform KOH and scabies wet preparations. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of laboratory personnel records, the CMS-209 (laboratory personnel report), lack of documentation, review of laboratory policy and procedure, and interview with laboratory representative; the laboratory technical supervisor (TS) failed to evaluate the competency of four of four testing personnel (TP), for Mohs dermatopathology testing. Findings Include: 1.Review of the laboratory policy and procedure revealed a document titled "Personnel Competency Testing" that states: "Objective To establish a system where the competency and performance of technical personnel are evaluated and documented upon initial employment, 6 month evaluation and then annually thereafter. Such a system will ensure proper training, skills and will maintain accuracy and consistency of all procedures performed." 2. Review of laboratory personnel records revealed no competency assessments for four of four Mohs dermatopathology TP listed on the CMS-209 as TP #6, #7, #8, and #9. 3. On survey date 09-10-2024, at 12:24 pm, the laboratory representative confirmed that the laboratory TS failed to perform competency assessments for four of four Mohs dermatopathology TP. -- 4 of 4 --