Bielinski Dermatology Group, L L C/Skin Md

Summary Statement of Deficiencies 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 review of laboratory policies and procedures, laboratory records, CMS-209 (Laboratory Personnel Report), and interview with testing personnel (TP) #4; the laboratory failed to follow written policies and procedures regarding performance of bi-annual method accuracy evaluations for Provider-Performed Microscopy (PPM) testing at the laboratory facility for three of four TP in the years of 2023 through the date of survey, 05/23/2025, affecting 69 patients. Findings include: 1. Review of the CMS-209 (Laboratory Personnel Report) revealed four TP performing PPM testing of Potassium hydroxide (KOH) and scabies (TP #1, 2, 3, and 7) at the laboratory testing facility. 2. Review of laboratory policies and procedures revealed the procedure titled, "Potassium Hydroxide (KOH)", which stated, under "Quality Control Procedures:", "Semi-Annually - a visual test will be given to each provider." 3. Review of laboratory policies and procedures revealed the procedure titled, "Ectoparasites", which stated, under "Quality Control Procedures:", "A visual identification test will be given to each provider semi-annually." 4. Review of laboratory competency evaluation records revealed that three of four TP performing PPM testing (TP #1, 3, and 7) lacked documentation of bi-annual method accuracy evaluations performed at the testing laboratory. 5. Review of laboratory records revealed 69 KOH patients had been testing from 2023 through the date of survey, 05/23/2025. 6. Interview with TP #4 on 05/23/2025, at 10:22 am, confirmed the laboratory failed to follow written 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 -- policies and procedures regarding performance of bi-annual method accuracy evaluations for PPM testing at the laboratory facility for three of four TP in the years of 2023 through the date of survey, 05/23/2025. D5787 TEST RECORDS CFR(s): 493.1283(a) (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) 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 review of laboratory policies and procedures, laboratory records, patient test reports, and interview with testing personnel (TP) #4; the laboratory failed to accurately correlate pertinent information of patient specimen identification regarding the Mohs histopathology surgical specimen source for one of four patients reviewed between the specimen tracking log, the surgical map, and the final patient test report. Findings include: 1. Review of laboratory policies and procedures revealed the policy titled, "Policy on Quality Assurance and Procedure - Mohs Surgery", which stated, under "Procedure", "ii. The specimen is given an accession number and logged into the Mohs logbook with patient name, date, site, diagnosis, stage or layer, and number of quadrants per stage." 2. Review of laboratory records revealed the Mohs logbook, which stated, for patient EP25-126 (tested on 05/21/2025), under Specimen Source, "right inferior forehead". 3. Review of laboratory records revealed Mohs histopathology surgical map document for patient EP25-126, which indicated the location of Mohs surgical testing site as "left central temple". 4. Review of the patient test report for patient EP25-126, from 05/21/2025, revealed, under "Impression/Plan: .... located on the left central temple." 5. Interview with TP #4 on 05/23/2025, at 11:51 am, confirmed the laboratory failed to have a reliable system in place to ensure test results, including Mohs histopathology surgical specimen source, for one of four patients reviewed between the specimen tracking log, the surgical map, and the final patient test report. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (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; (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: Based on review of laboratory policies and procedures, laboratory records, CMS-209 (Laboratory Personnel Report), and interview with testing personnel (TP) #4; the technical supervisor (TS) failed to ensure competency evaluations for three of four TP performing Provider-Performed Microscopy (PPM) testing and one of one TP performing histopathology tissue grossing were performed at the laboratory testing -- 2 of 3 -- facility in the years of 2023 through the date of survey, 05/23/2025. Findings include: 1. Review of laboratory policies and procedures revealed the policy titled, "Policy for Personnell Competency", which stated, under "Principle", "Personnel must not report test results for patient specimens until training is complete and competency is verified for each test procedure they perform." 2. Review of the CMS-209 (Laboratory Personnel Report) revealed four TP performing PPM testing of Potassium hydroxide (KOH) and scabies (TP #1, 2, 3, and 7) and one TP performing histopathology tissue grossing (TP #4). 3. Review of laboratory competency evaluation records revealed that three of four TP performing PPM testing (TP #1, 3, and 7) lacked documentation of competency evaluations performed at the testing laboratory. 4. Review of laboratory competency evaluation records revealed that one of one TP performing histopathology tissue grossing (TP #4) lacked documentation of competency evaluations performed at the testing laboratory. 5. Interviews with TP #4 on 05/23 /2025, at 09:31 am and 10:22 am, confirmed the TS failed to ensure competency evaluations for three of four TP performing PPM testing and one of one TP performing histopathology tissue grossing were performed at the laboratory testing facility in the years of 2023 through the date of survey, 05/23/2025. -- 3 of 3 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's manual, records and an interview with the laboratory staff, the laboratory failed to retain analytic systems records for the Mycology testing conducted on patients during the years of 2016 and 2017. Findings: 1. On 09/27/2018 at 9:45 AM, the surveyor requested the quality control records and patients' test logs for the fungal culture and Potassium Hydroxide (KOH) testing performed in the laboratory for the period of October 1, 2016 through 09/27 /2018 (date of survey). In response, the laboratory staff stated that the new owner and laboratory director (LD) took over the practice on 12/15/2017 and that they could not find any test or quality control records from the previous owner/LD prior to that time. 2. The following documents were not available for review at the time of survey for patient testing performed prior to 12/15/2017: Patients' test logs for KOH and fungal cultures; Media check records for fungal media used in testing; Quality control records for fungal and KOH testing; The twice annual accuracy verification of the the Fungal testing and KOH procedure; and Environmental/maintenance records, (incubators, refrigerator, microscope, etc.) 3. On a Recertification survey conducted on 09/27/2018 at 11:30 AM, the laboratory staff confirmed the above findings. 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, 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 -- consultant competency. This STANDARD is not met as evidenced by: Based on the surveyor's review of the Laboratory Personnel Report (CMS 209), the laboratory's manual, records, and an interview with the laboratory staff; the laboratory failed to establish written policies and procedures that meet the personnel requirements in subpart M to assess employees performing Potassium Hydroxide (KOH) preparations (Preps) and fungal testing, affecting 4 out of 4 testing personnel (TP). Findings: 1. The CMS 209 lists 2 licensed practitioners and 2 licensed physicians performing fungal cultures using dermatophyte test media (DTM) and KOH Preps (a moderately complex test) in the laboratory. 2. The personnel documents revealed that 4 out of 4 TP had not received competencies or training since the new laboratory director (LD)/owner and new laboratory personnel began in December 15, 2017 thru the date of survey 09/27/2018, but were authorized to perform patient testing during this period. 3. The laboratory's manual does not include an established competency policy and step-by-step procedures for assessing TP performing fungal and KOH testing. 4. On a Recertification survey conducted on 09 /27/2018 at 11:30 AM, the laboratory staff confirmed the above findings. 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 the surveyor's review of the laboratory's manuals, test records, and an interview with the laboratory staff; the laboratory failed to verify the accuracy of tests performed in the specialty of Microbiology at least twice annually. Findings: 1. The manual and test records reveal that the laboratory performs the following tests: Dermatophyte test media (DTM) fungal test, the Potassium Hydroxide (KOH) preparations (Preps), Swartz-Lamkins and Chlorazol Black E Preps. 2. The laboratory's manual does not define the method and procedure the laboratory will use to verify the accuracy of its fungal test, KOH, Swartz-Lamkins, and Chlorazol Black E Preps testing. 3. The records reveal that fungal cultures and KOH preps were performed on patients during the period of 12/15/2017 to 09/20/2018 by laboratory personnel. 4. On a Recertification survey conducted on 09/27/2018 at 11:30 AM, the laboratory staff confirmed the above findings. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's manual, final report, the Clinical Laboratory Improvement Amendments (CLIA) application (CMS 116), and an interview with the laboratory staff; the laboratory failed to ensure test reports include all information as specified in 493.1291(c)(1)- (c)(6), affecting 50 patients. Findings: 1. The laboratory's manual does not include a step-by-step process to manually enter patients' fungal and Potassium Hydroxide (KOH) prep results into the patients' chart in the electronic medical records (EMR) system. 2. The "final report" printed from selected patients' EMR chart fail to include the "date of testing" for the test performed. 3. On the CMS 116, the LD documents that 50 patients were tested during the year of 2017 to 09/20/2018. 4. On a Recertification survey conducted on 09/27/2017 at 11:35 AM, the laboratory staff confirmed the above findings. -- 3 of 3 --