St Joseph Dermatology And Vein Clinic

Summary Statement of Deficiencies D3029 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(2) Test procedures. Retain a copy of each test procedure for at least 2 years after a procedure has been discontinued. Each test procedure must include the dates of initial use and discontinuance. This STANDARD is not met as evidenced by: . Based on record review and interview with testing personnel #3, the laboratory failed to include the date of discontinuance for its hair morphology testing for two (December 2022 to December 2024) of two years reviewed. Findings include: 1. A review of the laboratory's "Tests Performed in this Clinical Laboratory" policy revealed "Hair Morphology" was listed. 2. An interview with testing personnel #3 on 12/18/24 at 11:05 am revealed the laboratory had not performed hair morphology testing. 3. A review of the laboratory's "Hair Morphology" test procedure revealed a lack of discontinuation date. 4. An interview on 12/18/24 at 12:06 pm with testing personnel #3 confirmed the laboratory had not included the date of discontinuation of the hair morphology test procedure. 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 D3027 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(1) Test requisitions and authorizations. Retain records of test requisitions and test authorizations, including the patient's chart or medical record if used as the test requisition or authorization, for at least 2 years. This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel #4 (TP4), the laboratory failed to retain test requisitions for at least 2 years for 2 (Patients CH1 and PJ4) of 10 patient test records reviewed. Findings include: 1. A review of patient test records revealed a lack of documentation of test requests for the following patients: a. Patient CH1 had a Potassium Hydroxide (KOH) preparation test performed on 3/16 /21. b. Patient PJ4 had a KOH preparation test performed on 2/22/21. 2. An interview on 4/15/21 at 10:23 am with TP4 confirmed the laboratory did not retain test requisitions for the patients listed above. D3041 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(6) Test reports. Retain or be able to retrieve a copy of the original report (including final, preliminary, and corrected reports) at least 2 years after the date of reporting. (i) In addition, retain immunohematology reports as specified in 21 CFR 606.160(d) (ii) and pathology test reports for at least 10 years after the date of reporting. This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel #4 (TP4), the laboratory failed to retain test reports for at least 2 years for 2 (Patients CH1 and PJ4) of 10 patient test records reviewed. Findings include: 1. A review of patient test 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 -- records revealed a lack of documentation of test reports for the following patients: a. Patient CH1 had a Potassium Hydroxide (KOH) preparation test performed on 3/16 /21. b. Patient PJ4 had a KOH preparation test performed on 2/22/21. 2. An interview on 4/15/21 at 10:23 am with TP4 confirmed the laboratory did not retain test reports for the patients listed above. 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 Testing Personnel #4, the laboratory failed to evaluate for testing personnel performing Potassium Hydroxide (KOH) and Scabies preparations for 2 (April 2019 to April 2021) of 2 years reviewed. Findings include: 1. A review of the laboratory's competency records revealed a lack of a documented competency assessment for the following testing personnel in performing KOH and Scabies preparations between April 2019 to April 2021: a. Testing Personnel #1 b. Testing Personnel #2 c. Testing Personnel #3 3. An interview on 4/15 /21 at 10:05 am with TP4 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 record review and interview with Testing Personnel #4 (TP4), the laboratory failed to verify the accuracy of its Potassium Hydroxide (KOH) and Scabies preparations at least twice annually for 2 (April 2019 to April 2021) of 2 years reviewed. Findings include: 1. A review of the laboratory's records revealed a lack of documentation of two verification of accuracy testing events performed for KOH and Scabies preparations between April 2019 and April 2021. 2. An interview on 4/15/21 at 10:05 am with TP4 confirmed the laboratory did not verify the accuracy of its testing twice annually for the tests listed above. D6122 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(ii) The procedures for evaluation of the competency of the staff must include, but are not limited to monitoring the recording and reporting of test results. This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel #4, the technical supervisor failed to include monitoring the recording and reporting of test results in staff competency assessments for 2 (Testing Personnel #4 and #5) of 5 testing personnel listed on the CMS-209 form. Findings include: 1. A review of the -- 2 of 3 -- laboratory's competency assessment records revealed a lack of documentation of monitoring the recording and reporting of test results on the competency assessments for Testing Personnel #4 and #5. 2. An interview on 4/15/21 at 9:51 am with Testing Personnel #4 confirmed the Technical Supervisor did not document the monitoring of recording and reporting of test results on competency assessments. D6126 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(vi) The procedures for evaluation of the competency of the staff must include, but are not limted to assessment of problem solving skills. This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel #4, the technical supervisor failed to include the assessment of problem-solving skills in staff competency assessments for 2 (Testing Personnel #4 and #5) of 5 testing personnel listed on the CMS-209 form. Findings include: 1. A review of the laboratory's competency assessment records revealed a lack of documentation of the assessment of problem-solving skills on the competency assessments for Testing Personnel #4 and #5. 2. An interview on 4/15/21 at 9:51 am with Testing Personnel #4 confirmed the Technical Supervisor did not document the assessment of problem-solving skills on competency assessments. -- 3 of 3 --

Summary Statement of Deficiencies D5787 TEST RECORDS CFR(s): 493.1283(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 record review and interview with testing personnel #1 and #2 (TP1 and TP2), the laboratory failed to record the time of specimen receipt into the laboratory for the Mohs' tissue specimens for two (S17-466 and S18-001) of 26 patient charts audited. Findings include: 1. Record review of the Mohs' map in the patients charts and the retained hard copy of the map revealed the laboratory did not include the time the Mohs' tissue specimen was received into the laboratory for examination. 2. During the interview on February 27, 2019 at 12:10 PM, TP1 and TP2 confirmed the specimen receipt time was not documented on the Mohs' map. 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 --