Bend Dermatology Clinic-Redmond

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 review of the written evidence of bi-annual verification for the potassium hydroxide (KOH) wet mount or the scabies mineral oil microscopy exam and phone interview with the lead Histotechnologist (HT #1) post survey, the laboratory failed to perform bi-annual verification for all personnel listed on the CMS 209 form, performing KOH wet mounts and scabies wet preps with mineral oil procedures. Findings include: 1. Upon review of the documents provided for review during survey, specifically for the KOH procedure, the only documentation of peer review for this procedure presented for review during survey revealed the last documented peer review for these procedures were performed on 03/18/2026 and 4/21/2026. 2. Request for the number of KOH wet mounts and scabies microscopy examinations performed for this facility revealed numbers in 2024 and 2025 too numerous to count. 3. Review of the evidence of bi-annual verification records revealed there was no evidence of bi- annual verification for KOH mounts or Scabies for 2024 and 2025. 4.The number of KOH procedures presented by HT #1 05/12/2026 could not be separated by provider, so it was not possible to count the number of KOH's for each provider in the Bend Dermatology Redmond location. 5. Interview by phone with the lead HT (HT #1) on 05/12/2026 at 2:31 pm confirmed that there was no further evidence of bi-annual verification for KOH wet mounts for 2024 and 2025 for any personnel performing KOH wet mounts at the Redmond location. 6.The number of KOH mounts and scabies oil microscopy could not be determined as referenced in the above findings. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 3 -- 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 the Quality Assurance (QA) policy in place at this location and phone interview with Histotechnician #1, (HT #1), the laboratory failed to ensure an approved QA plan was in place, involved all laboratory testing personnel and included all three (3) phases of testing - pre-analytical, analytical and post analytical phases. Findings include: 1. Interview with the lead HT #1 05/12/2026 at 2:31 pm confirmed that the laboratory failed to ensure a QA plan was in place that included all 3 phases of testing. 2. This is a repeat citation from initial survey. See D5291 citation from 07 /09/2024 initial survey. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of the temperature charts for this lab and interview with Histotechnician (HT #2), the laboratory failed to monitor the room temperature for this clinic each day it is open. Findings include: 1. Upon request for the temperature logs for room temperature, as well as evidence of monitoring the range in which the room temperature is acceptable, none could be produced. 2. Review of the temperature range for the flammables stored within the flammables cabinet at this facility, it was noted that the storage temperature was 15 degrees C - 30 degrees C. 3. Phone interview with lead HT #1 on May 12, 2026 at 2:30 pm confirmed that the lab was not performing daily checks of the room or ambient temperature in this laboratory. 4. This is a repeat citation from 07/09/2024. 5. The laboratory reports performing 928 Mohs dermatologic procedures annually. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on observation of secondary containers in the flammables cabinet containing various chemicals used for Mohs surgery and one unlabeled carboy containing isopropyl alcohol in the laboratory's flammables cabinet, interview with Histotechnician (HT #2) and phone interview with the HT #1, the laboratory failed to ensure secondary containers were labeled with the required safety information and required documentation on secondary containers, including all requiste information as required by regulation. Findings include: 1. Upon observation of the solvents and other organic solutions stored in the flammables cabinet in the laboratory, it was observed that there was a large carboy labeled "Isopropyl Alcohol". 2. The carboy in question did not demonstrate the following: a. Storage requirements b. Lot # and expiration date of the mother container. c. Evidence of who prepared and transferred this solution to the secondary container (carboy), including date of preparation or transfer to the secondary container, that includes the requisite information. 3. Interview with HT #2 on 04/27/2026 at 2:30 pm confirmed the carboy did not have any other information on the body of the container and that HT #2 knew nothing further about the contents of this container/carboy. 4. Interview with HT #1 by phone 05/12/2026 at 2:31 pm revealed that this carboy contained Isopropyl Alcohol for cleaning various devices in the Mohs lab. HT #1 also communicated to me during phone interview that he was unaware of the requirement for seconday container labeling during this phone call. 5. The laboratory reports performing 928 Mohs procedures and an undetermined number of potassium hydroxide (KOH) wet mounts annually. -- 3 of 3 --

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 the procedure manual and interview with HT1, the laboratory failed to establish a procedure for Quality Assessment (QA) and QA monitoring events relative to this laboratory. Findings include: 1. Upon review of the procedure manual for this laboratory, no QA procedure or evidence of QA monitoring events could be found. 2. Interview with HT1 at 1:30 pm confirmed that no QA monitors had been put into place to his knowledge. 3. The laboratory reports performing 127 Mohs cases since 2/20/2024 at date of survey. 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 review of the procedure manual for this laboratory and interview with HT1, the laboratory failed to have a complete and current standard operating procedure (SOP) detailing the Mohs surgical procedure. Findings include: 1. Upon review of the 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 -- procedure manual for this site, no SOP for the Mohs procedure could be found. 2. Interview with HT1 at 1:30 pm confirmed that there was no other procedure outside of the staining procedure for tissue retrieved during Mohs surgery. 3. The laboratory reports performing 127 Mohs cases since 2/20/2024 at date of survey. 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. This STANDARD is not met as evidenced by: Based on review of laboratory temperature records and interview with HT1 during survey, the laboratory failed to ensure the ambient temperature the Cryo-stat, the refrigerator, and ambient temperature and humidity in the lab were recorded each day of patient testing. Findings incude: 1. Upon request for the temperature logs for the Cryo-stat in use for Mohs surgery patients, none could be provided. 2. Upon request for the temperature logs for the refrigerator in use for Mohs surgery patients requiring special immunohistochemical (IHC) stains that require refrigeration, none could be provided. 3. Upon request for the temperature log for ambient room temperature and relative humidity, none could be provided. 4. Interview with HT1 at 1:00 pm confirmed that he did not record/ have written evidence of any of the temperatures for the Cryo-stat, the refrigerator used to store special IHC reagents, ambient room temperature or relative humidity. 5. The laboratory reports performing 127 Mohs cases since 2/20/2024 at date of survey. 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 of fluids in the flammables cabinet on site and interview with HT1, the laboratory failed to discard expired reagents used in the staining process for Mohs surgical patients. Findings include: 1. Upon inspection of reagents contained in the flammables cabinet on site, it was revealed that expired reagents were housed in the cabinet. 1. 3 gallons of FLEX 100, used in the Hematoxylin and Eosin (H&E) staining procedure outdated as of 06/2024. 2. Approximately one half of a 500 ml bottle of Gil Hematoxylin, used in the H&E staining procedure outdated as of 06 /2024. 2. Interview with HT1 at 1:00 pm confirmed that these fluids were all outdated during survey. 3. The laboratory reports performing 127 Mohs cases since 2/20/2024 at date of survey. D5445 CONTROL PROCEDURES -- 2 of 3 -- CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory records for quality control (QC) performed for Hematoxylin and Eosin (H&E) and Immunohistochemical (IHC) stains and interview with HT1, the laboratory failed to follow their standard operating procedure (SOP) for performing and documenting slide QC. Findings include: 1. Upon request for QC records for H&E and IHC stains, none could be produced. 2. Review of the SOP for the IHC stain MART-1, the QC section stated that the QC for this stain would be recorded in the QC log, which was to be kept in the procedure book. 3. Review of the SOP for the H&E stain, the QC section stated that the QC for this stain would be processed and evaluated for stain quality each morning Mohs patients are seen. 4. Interview with HT1 at 12:30 pm confirmed that he had no written record of QC for either stain since the clinic opened 2/20/2024. 5. Interview with the Laboratory Director (LD) at 2:05 pm confirme that she does evaluate QC but that no written record was created for either stain. 6. The laboratory reports performing 127 Mohs cases since 2/20/2024 at date of survey. 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. This STANDARD is not met as evidenced by: Based on review of a patient test report requested during initial survey, the laboratory failed to ensure the address of the site where Mohs surgery was performed, was evident on the patient test report. Findings include: 1. Upon review of the patient report submitted for my review during survey, the correct address/location of the Redmond site, where the Mohs surgery was performed was not present on the patient report. 2. Interview with the HT1 at 1:00 pm confirmed that the address of this site was not on the patient report. 3. The laboratory reports performing 127 Mohs cases since 2/20/2024 at date of survey. -- 3 of 3 --