Treasure Valley Dermatology & Skin Cancer Center

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 a lack of documents and an interview with the laboratory lead on 10/04 /2022, the laboratory failed to document, at least twice annually, the verification of accuracy for Mohs in 2021 . The findings include: 1. A lack of documentation for bi- annual verification identified that the laboratory failed to document verification of accuracy for Mohs surgery procedures twice annually in 2021. 2. An interview with the laboratory lead on 10/04/2022 at 9:09 am confirmed that the laboratory had not performed verification of accuracy for Mohs surgery procedures in 2021 . 3. The laboratory reports performing 750 Mohs surgery procedures annually. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (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. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the laboratory quality control (QC) log and an interview with the laboratory lead on 10/04/2021, the laboratory failed to have a qualified testing person document the quality of Hematoxylin and Eosin (H&E) stain daily. The findings 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 -- include: 1. A review of the laboratory's Mohs QC H&E stain log identified that the laboratory failed to have a qualified testing person review and document the quality of the H&E stain daily for Mohs surgery procedures. 2. An interview with the laboratory lead on 10/04/2021 at 9:13 am confirmed the above finding. 3. The laboratory reports performing 750 Mohs surgery procedures annually. -- 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 of biannual verification documentation and an interview with the laboratory technician on 03/29/2021, the laboratory failed to document the verification of accuracy for potassium hydroxide (KOH) examinations, at least twice annually. The findings include: 1. A record review of biannual verification documentation on 03/29/2021 revealed that the laboratory failed to document the verification of accuracy for KOH examinations, at least twice annually, since the last survey on 03/04/2019. 2. An interview with the laboratory technician on 03/29/2021 at 1:40 PM confirmed that the laboratory failed to document verification of accuracy for KOH examinations. 3. The laboratory reports performing 20 KOH examinations annually. 4. This is a repeat deficiency from the previous survey on 03/04/2019. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. 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 -- This STANDARD is not met as evidenced by: Based on a record review of the laboratory's temperature logs, Avantik QS12 Cryostat Instruction Manual, and an interview with the laboratory technician on 03/29/2021, the laboratory failed to monitor and document room temperature in the laboratory for acceptable temperature ranges. The findings include: 1. A record review of the laboratory's cryostat log sheets revealed that the laboratory failed to document that room temperature was being monitored each day of patient testing when operating the Avantik QS12 Cryostat. 2. A record review of the Avantik QS12 Cryostat Manual, page 12, indicated the environmental temperature operating limits of +5C to +35C, in which the laboratory failed to monitor and document. 3. An interview with the laboratory technician on 03/29/2021 at 2:10 PM confirmed that room temperature, where the cryostat is located has never been documented. 4. The laboratory reports performing 275 Moh's slide examinations annually. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on record review of the laboratory's maintenance logs, Avantik QS12 Cryostat Instruction Manual, and an interview with the laboratory technician on 03/29/2021, the laboratory failed to follow the Avantik QS12 Cryostat Instruction Manual and perform maintenance as specified by the manufacturer. The findings include: 1. A record review of the laboratory's maintenance logs revealed that the laboratory failed to document performing maintenance as specified by the manufacturer on pages 53-54 of the Avantik QS12 Cryostat Instruction Manual. 2. An interview with the laboratory technician on 03/29/2021 at 2:10 PM confirmed that the laboratory failed to document performing maintenance specified by the manufacturer for the Avantik QS12 Cryostat. 3. The laboratory reports performing 275 Moh's slide examinations annually. -- 2 of 2 --

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 a record review of personnel documents and an interview with the laboratory director, the laboratory failed to establish and follow a policy or procedure to evaluate the competency of testing personnel performing microscopic fungal examinations since May 2018. Findings: 1. A review of documents for the testing personnel competency assessments and laboratory procedures and policies, revealed the laboratory failed to establish and document the competency evaluations for 1 out of 2 testing personnel listed on the CMS-209 Personnel Report form. 2. An interview on March 4, 2019 at 9:15 AM, with the laboratory director, confirmed the laboratory failed to establish and follow written policies and procedures to assess the competency of 1 out of 2 testing personnel. 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 a record review and an interview with the laboratory director, the laboratory failed to verify the accuracy of microscopic fungal examinations at least twice a year since May 2018. Findings: 1. A document review revealed the laboratory failed to 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 -- verify the accuracy of microscopic fungal examinations at least twice a year. 2. The laboratory performs approximately 100 tests per year. 3. An interview on March 4, 2019 at 9:35 AM, with the laboratory director, confirmed the laboratory failed to document the accuracy of microscopic examinations at least twice a year. D5401 PROCEDURE MANUAL CFR(s): 493.1251(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 a record review and an interview with the laboratory director, the laboratory failed to write a procedure for the microscopic examination of skin scrapings for the presence of fungal elements used with potassium hydroxide (KOH) since May 2018. Findings: 1. A review of the laboratory's procedure manual revealed the laboratory failed to write a procedure for the presence or absence of fungal elements using KOH. 2. The laboratory performs approximately 100 tests per year. 3. An interview on March 4, 2019 at 9:25 AM, with the laboratory director, confirmed the laboratory failed to write a procedure for the KOH examinations. -- 2 of 2 --