Tru North Dermatology

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 record review and interview with Mohs Technician, the laboratory failed to establish competency assessment policies to assess staff competency. Findings include: 1. A record review of the laboratory's policies and procedures revealed that laboratory did not have a competency assessment policy. 2. An interview with Mohs Technician on 08/13/2024 at 4:30 pm confirmed that the laboratory did not establish a competency assessment policy. 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 observation, record review, and interview with the Mohs technician, the laboratory failed to ensure that 1 of 1 bottles of Potassium Hydroxide (KOH) 10% reagent was not used beyond the expiration date. Findings include: 1. The surveyor observed 1 bottle of Potassium Hydroxide (KOH) 10% reagent on 08/13/2024 at 1:15 pm with an expiration date of 3/31/2024. 2. Record review of patient testing reports revealed 1 patient (patient #1) had KOH prep performed on 6/3/2024. 3. An interview 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 -- with Mohs Technician on 8/13/24 at 4:30 pm confirmed the KOH prep testing for patient #1 was performed with the expired KOH reagent currently available for use in the laboratory. -- 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 record review, and interview, the laboratory failed to 1) at least twice annually verify the accuracy of the histopathology Mohs' tissue slide examination for one (2nd six months 2018) of four events reviewed and 2) failed to twice annually verify the accuracy of the microbiology testing for two (2017 and 2018) of two years testing. Findings include: 1. Review of the "Mohs' Micrographic Surgery Skin Specimens" procedure states "two cases" will be sent out two times a year for review by "another physician and/or hospital" for evaluation. 2. On January 16, 2019 at 10:00 AM, record review of the twice a year verification of accuracy for the Mohs' tissue slide examination revealed the laboratory did not have any documentation to show the evaluation was performed during the second six months of 2018. 3. On January 16, 2019 at approximately 12:00 PM, lack of records to show documentation for the twice a year verification of accuracy for the microbiology mycology and parasitology testing was not available. 4. On January 16, 2019 at 10:00 AM and approximately 12: 00 PM when requested, the laboratory was unable to provide the surveyor the documents requested. 5. During the interview on January 16, 2019 at 10:00 AM and 12:00 PM, the office manager confirmed the twice a year verification of accuracy was not performed and documented for the Mohs' tissue slide examination for the second six month evaluation in 2018 and the mycology and parasitology testing for 2017 and 2018. D5301 TEST REQUEST CFR(s): 493.1241(a) 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 laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory failed to have a electronic request for patient testing from an authorized person for the microbiology testing for three (#10 - #12) of 12 patient charts reviewed. Findings include: 1. On January 16, 2019 at 2:15 PM, record review revealed the laboratory did not have a electronic request for the scabies testing that was performed and resulted in the patient's electronic medical record (EMR). 2. On January 16, 2019 at 2:15 PM when requested, the office manager was unable to provide the surveyor the documentation requested. 3. During the interview on January 16, 2019 at 2:15 PM, the office manager confirmed no electronic orders were available in the patient's EMR file. -- 2 of 2 --