Mohave Dermatology-Pahrump

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on March 28, 2023. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on a random patient audit of five Mohs patients tested between the dates of July 1, 2021 and January 5, 2023, a review of the director approved Quality Assurance Policy, and an interview with the medical assistant, the laboratory failed to ensure that the written policy and procedure was followed to ensure positive identification of the patient specimens was maintained from the time of collection of the specimen through completion of the testing and reporting of results. Findings include: 1. A random patient audit of five Mohs patients tested between the dates of July 1, 2021 and January 5, 2023 revealed that in the final operative report, the Mohs case number did not match the Mohs case number on the Mohs log, Mohs map, and Mohs slide. The Medical Record Number was incorrectly entered as the Mohs case number on the final operative report for five of five patients reviewed. 2. A random patient audit of five Mohs patients tested between the dates of July 1, 2021 and January 5, 2023 revealed that the date of service was not written on the slide label for two of five patients reviewed. The date of service was not on the slides for the patient tested on 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 -- May 5, 2023 and for the patient tested on January 5, 2023. 3. A review of the Mohs patient logs between the months of July, 2021 and February, 2023 revealed that the laboratory failed to document the Mohs surgeon and the Mohs tech on the logs for three of 20 months. 4. A review of a Mohs patient records tested on July 1, 2021 revealed that the Mohs case number P21-84 was not written on the Mohs map. 5. A review of the Mohs log for July 1, 2021 revealed that the patient medical record numbers were not written on the Mohs log for 17 of 17 patients tested on that date. 6. A review of the Mohs log for November 4, 2021 revealed that the full Mohs case numbers were not written on the Mohs log for 23 of 23 patients tested on that date. The case numbers were missing the prefix P21. 7. A review of a Mohs patient records tested on November 4, 2021 revealed that the Mohs case number written on the Mohs slide did not match the Mohs case number written on the log. The Mohs case number on the log for the patient with the initials KC was "197." The Mohs case number on the slides for the patient was "P21-196." 8. A review of a Mohs patient records tested on October 6, 2022 revealed that the section numbers for the tissue do not match on the slides and on the Mohs map. The Mohs map indicated that for Stage II, there were two sections cut, numbered 3 and 4, examined. On the slide, the label for stage II did not not include section number 4 on the label.. 9. A review of a Mohs patient records tested on January 5, 2023 revealed that on the Mohs map, the number of stages, slides and sections was left blank. A review of the Mohs log indicated that for the patient identified by case number P23-003, there was one slide, and one stage, with two sections examined. 10. The laboratory policy entitled, "Quality Assurance Policy" stated, "A log will also be created by MOHS (sic) Technician so that he/she can maintain an accurate record of specimens he/she has been processing on each MOHS day. This log will include the following information; Patient (Last, first) name, DOB, Unique Identifier (DOB), MOHS date, & Site being performed. The same information that is presented on the log, will also need to be on the patient MOHS Map and Slides." 11. The findings were confirmed during an interview with the medical assistant on March 28, 2023 at approximately 10:00 AM. The laboratory performs approximately 300 histopathology procedures annually. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on a random patient audit of five Mohs patients tested between the dates of July 1, 2021 and January 5, 2023, a review of the Mohs logs between the months of May, 2021 and February, 2023, a review of the laboratory policy entitled, "Quality Assurance Policy," a review of the laboratory quality assurance records, and an interview with the medical assistant, the director failed to ensure that the established quality assessment program detected and corrected errors when they occurred. Findings include: 1. The laboratory policy entitled, "Quality Assurance Policy," in the section entitled, "Post-Analytic" stated, "After MOHS (sic) has been completed for the day, Medical Assistant and Office Manager will review all documents and patient charts to assure that everything is input correctly." It goes on to state, "If any mistakes are found, responsible employee will be counseled & this will be documented in a

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on June 22, 2021. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on a random patient audit between the dates of March 14, 2019 and April 1, 2021, a review of the director approved policy and procedure entitled "Quality Assurance Policy," and an interview with the Office Manager, the laboratory failed to ensure that positive patient identification was maintained throughout the testing process for one of ten patient records reviewed. Findings include: 1. A random patient audit between the dates of March 14, 2019 and April 1, 2021 revealed that for the April 1, 2021 Mohs case number P21-62, the labels on two of two slides did not include the date of birth in accordance with the director approved policy entitled "Quality Assurance Policy." 2. The director approved policy entitled "Quality Assurance Policy," in the section entitled "Analytic" stated, "A log will be created by the Mohs Technician so that he/she can maintain an accurate record of specimens he /she has been processing on each Mohs day. This log will include the following information; Patient (Last, First) name, Date of Birth (DOB), Unique Identifier (DOB), Mohs date, and site being performed. The same information that is presented 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 -- on the log will also need to be on the patient Mohs map and slides." 3. The Office Manager confirmed the findings during an interview conducted on June 22, 2021 at approximately 10:00 AM. The laboratory performs approximately 96 Histopathology tests annually. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on a review of the laboratory records of the annual preventative maintenance for the microscope, and an interview with the Office manager, the laboratory failed to retain records of the annual preventative maintenance for the microscope for the years of 2018, 2019 and 2020. Findings include: 1. There were no records for the annual preventative maintenance for the laboratory microscope between the dates of August 7, 2017 and March 1, 2021. 2. The Office Manager confirmed the findings during an interview conducted on June 22, 2021 at approximately 9:30 AM. The laboratory performs approximately 96 Histopathology tests annually. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on a random patient audit between the dates of March 14, 2019 and April 1, 2021, a review of the laboratory quality assessment daily checklist records, a review of the director approved policy entitled "Quality Assurance Policy" and an interview with the Office manager, the director failed to ensure that the established quality assessment program was maintained to detect and correct failures in quality when they occur. Findings include: 1. A random patient audit between the dates of March 14, 2019 and April 1, 2021 revealed that for the April 1, 2021 Mohs case number P21-62, the quality assessment review conducted did not detect the failure to include the patient Date of Birth (DOB) on the labels of two of two patient slides as the unique patient identifier in accordance with the director approved policy entitled "Quality Assurance Policy." 2. The director approved policy entitled "Quality Assurance Policy," in the section entitled "Analytic" stated, "A log will be created by the Mohs Technician so that he/she can maintain an accurate record of specimens he/she has been processing on each Mohs day. This log will include the following information; Patient (Last, First) name, Date of Birth (DOB), Unique Identifier (DOB), Mohs date, and site being performed. The same information that is presented on the log will also need to be on the patient Mohs map and slides." 3. The director approved policy -- 2 of 3 -- entitled "Quality Assurance Policy," in the section entitled "Post-Analytic" stated, "After Mohs has been completed for the day, Medical Assistant and Office Manager will review all documents and patient charts to assure that everything is input correctly. A check-list will be created every Mohs day to ensure that all patient information has been checked thoroughly." 4. The Quality Assurance checklist created on April 2, 2021 for the Mohs procedure date of April 1, 2021, in the section entitled "Slides," the failure to include the patient DOB on the slides was not detected and corrected. 5. The Office Manager confirmed the findings during an interview conducted on June 22, 2021 at approximately 10:00 AM. The laboratory performs approximately 96 Histopathology tests annually. -- 3 of 3 --

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on January 30, 2019. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. 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 review of the twice a year verification of accuracy documentation for dermatologists performing Mohs histopathology testing and an interview with the office manager, the laboratory failed to perform and document the accuracy of dermatologists performing Mohs procedures at least twice per testing year. Findings include: 1. There was no performance and documentation of twice a year verification of accuracy for testing person number one from the Centers for Medicare & Medicaid Services (CMS) 209 form for testing year 2017. 2. There was no performance and documentation of twice a year verification of accuracy for testing person number two from the (CMS) 209 form for testing year 2018. This was confirmed by the office manager on January 30, 2019 at approximately 10:00 AM. The laboratory performs approximately 96 histopathology tests annually. 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 --