Arizona Mohs Surgery, Pllc

Summary Statement of Deficiencies 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 review of Mohs test records and interview with the facility personnel, the laboratory failed to ensure positive identification for 1 out of 5 dermatopathology specimens from the time of collection through completion of testing and reporting of test results. Findings include: 1. The laboratory performs testing in conjunction with the Mohs procedure under the subspecialty of histopathology, with an approximate annual test volume of 3,000. It is the practice of the laboratory to assign a unique accession number to each Mohs specimen. The unique accession number is documented on the laboratory's Mohs log, Mohs map, patient's slides and final test report maintained in the patient's Electronic Medical Record (EMR). 2. The laboratory failed to ensure positive identification of a patient's specimen throughout the entire test process for 1 out of 5 Mohs cases reviewed during the survey, MR# MM0000000348 from testing performed on 4/05/23. Direct observation of the test records indicated the following: the patient's slides and Mohs log were labeled with accession# 5636, the original test report maintained in the EMR and the original Mohs map indicated accession# 5654, and the amended test report maintained in the EMR and corrected Mohs map indicated accession# 5436. 3. The corrected Mohs map and final (amended) test report maintained in the EMR for the patient referenced above failed to include the correct accession number at the time of the survey conducted on February 11, 2025. The correct accession number as verified with laboratory personnel during the survey should have been documented as #5636. 4. The facility personnel interviewed on 2/11/25 at 12:50 PM confirmed that the correct case# is Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 5636 as written on the Mohs log and on the slide labels, and also confirmed that the laboratory identified the error, corrected the Mohs map and issued an amended test report on 4/10/23, however an incorrect accession number, #5436, was documented on the corrected map and amended test report. 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 lack of accuracy verification documentation for the microscopic interpretation of Frozen Biopsy specimens and interview with the facility personnel, the laboratory failed to verify the accuracy of testing performed under the subspecialty of Histopathology at least twice annually during 2024. Findings include: 1. No documentation was presented for review to indicate the laboratory verified the accuracy of the microscopic interpretation of Frozen Biopsy specimens at least twice annually during 2024. 2. The facility personnel interviewed on 2/11/25 at 2:05 PM confirmed the laboratory failed to verify the accuracy of histopathology testing at least twice annually during 2024, as indicated above. 3. The laboratory performs approximately 5 frozen biopsies annually. 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 humidity records from 2023 through the survey date of 2/11/2025, review of the manufacturer's specifications for the Leica CM1520 Cryostat and interview with the facility personnel, the laboratory failed to define an operating humidity range which is consistent with the manufacturer's instructions for two of two cryostats. Findings include: 1. The laboratory utilizes two Leica CM1520 cryostats in conjunction with patient testing under the subspecialty of Histopathology. The laboratory reports an annual test volume of 3,000. 2. The manufacturer's specifications for the Leica CM1520 cryostat listed an operating relative humidity range of 20% -60%. 3. Review of the laboratory's humidity records from 2023 through 2/11/2025 indicated the humidity range as 0-100%. 4. The facility personnel interviewed on 2/11 /2025 at 1:55 PM confirmed the laboratory failed to define a humidity range for the two cryostats which is consistent with the manufacturer's requirements. D5787 TEST RECORDS CFR(s): 493.1283(a) -- 2 of 4 -- (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 review of Frozen Biopsy pathology reports and interview with the facility personnel, one out of two frozen biopsy reports failed to include the correct identity of the individual who performed the gross description. Findings include: 1. The laboratory performs the gross description on Frozen Section tissue specimens under the subspecialty of histopathology, with an approximate annual test volume of 5. 2. One out of two Frozen Biopsy pathology reports (MR# MM0000004213 from 9/21 /23) reviewed during the survey listed the individual who performed the gross description as "Gross Description: K.W., MA". 3. The facility personnel interviewed on 2/11/2025 at 1:20 PM stated that only the laboratory director performs the gross description of pathology specimens and confirmed the frozen biopsy test report indicated above listed an employee who did not perform the gross description. D5805 TEST REPORT CFR(s): 493.1291(c) (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 frozen biopsy pathology reports and interview with the facility personnel, the laboratory failed to include the gross description on 2 out of 2 frozen biopsy test reports reviewed during the survey. Findings include: 1. The laboratory performs the microscopic interpretation of frozen biopsy specimens in the subspecialty of histopathology, with an approximate annual test volume of 5. 2. Two out of two frozen biopsy pathology reports (MR# MM0000004213 from 9/21/23 and MM0000005229 from 9/09/24) failed to include the gross description. The gross description (including weighing, measuring, describing color, specific orientation for diagnostic interpretation, and other characteristics of the tissue) must be included on the pathology test report. 3. The facility personnel interviewed on 2/11/2025 at 1:20 PM acknowledged that the gross description was missing from the pathology test reports referenced above. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) (a) The laboratory must establish and follow written policies and procedures for an -- 3 of 4 -- ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on review of a documented lab error form from 4/05/23, review of the amended pathology test report for the error identified on 4/05/23 and interview with the facility personnel, the laboratory failed to ensure resolution of a problem that was identified in the test reporting process for 1 out of 5 Mohs cases reviewed during the survey. Findings include: 1. The laboratory produced documentation of a completed "Lab Error" form from 4/05/23, patient H.E. The form indicated the following information: Accession#: 5436, Date: 4/5/23, Specimen Site: Right Inferior Central Malar Cheek, Error: Wrong accession # in chart, Correction: Corrected to site right #, Future Prevention: Double Check. 2. The facility personnel interviewed on 2/11/25 at 12:50 PM stated that the laboratory identified a reporting/accessioning error for the Mohs case referenced above and documented the error on the Lab Error form. The facility personnel stated that the Mohs log and Mohs slides indicated the correct accession number (#5636). The accession number, which was manually transcribed on the test report (operative note) maintained in the patient's Electronic Medical Record (EMR) and handwritten on the Mohs map, was incorrect and listed as #5654. The laboratory identified the error and amended the test report with the statement, "This amendment changes the case# from 5654 to 5436." The laboratory also corrected the Mohs map to show accession# 5436. The facility personnel acknowledged that the case# was still incorrect on the amended test report and on the Mohs map at the time of the survey, and confirmed that the correct case# should have been entered as #5636. 3. The laboratory failed to monitor and document that the

Summary Statement of Deficiencies D3043 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(7) The laboratory must retain cytology slide preparations for at least 5 years from the date of examination (see 493.1274(f) for proficiency testing exception). The laboratory must retain histopathology slides for at least 10 years from the date of examination. The laboratory must retain pathology specimen blocks for at least 2 years from the date of examination. The laboratory must preserve remnants of tissue for pathology examination until a diagnosis is made on the specimen. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure manual and interview with the laboratory manager on August 12, 2022, the laboratory policies and procedures lacked the requirements for retention of histopathology micrographically oriented hsitographic surgery (Mohs) slides. The findings include: 1. Review of the laboratory's Policies and procedures revealed the lack of retention requirements for the Mohs slides created for patient Dermatopathology testing. 2. The laboratory manager confirmed by interview on August 12, 2022 at 3:00 pm the lack of a policy or procedure for retention of Dermatopathology Mohs slides. 3. The laboratory reports performing 1193 Mohs Dermatopathology patients annually. D3045 RETENTION REQUIREMENTS CFR(s): 493.1105(b) If the laboratory ceases operation, the laboratory must make provisions to ensure that all records and, as applicable, slides, blocks, and tissue are retained and available for the time frames specified in this section. This STANDARD is not met as evidenced by: 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 -- Based on review of the laboratory's policy and procedure manaual, and interview with the laboratory manager, the laboratory failed to have a policy or procedure providing provisions if the laboratory should cease operation for Dermatopathology micrographically oriented hsitographic surgery (Mohs) testing regardng retention of patient records and slides. Findings include: 1. The laboratory is a privatly owned entity performing Dermatopathology Mohs testing since May of 2020. 2. Review of the laboratory's policy's and procedure's revealed the lack of reference to the retention and storage of patient testing records and slides if the laboratory ceased operations. 3. The laboratory manager confirmed by interview on August 12, 2022 at 3:30 pm, the lack of a policy or procedure for retention or patient records and dermatopatholgy slides if the lab ceased operations. 4. The laboratory reports performing 1193 dermatopathology slide reviews annually. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on review of laboratory policy's and procedure's, laboratory mantainence records, observations during labortory tour, and interview with the laboratory manager on August 12, 2022, the laboratory failed to perform and document annual functions checks as outlined in their policy. Findings include: 1. The laboratory performs micrographically oriented hsitographic surgery (Mohs) Dermatopathology staining under a fume hood in the cryostat and nurse computer station area. 2. The laboratory policy "Air Vent/Fume Hood Policy" states the fume hood function check would be performed and documented annually. 3. Review of maintanence records reviewed revealed the lack of documentation of annual fume hood function check being performed for 2021 and 2022 post installation in 2020. 4. Tour of the laboratory revealed the lack of a funtion check sticker of the laboratory fume hood. 5. The laboratory manager confirmed by interview on August 12, 2022 at 3:30 pm the lack of following thier policy for performing and documenting fume hood function checks. 6. The laboratory reports performing 1193 Mohs slides annually. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: Based on personnel record review and the laboratory's policy's and procedure's on August 12, 2022, the laboratory director failed to establish a policy and procedure for monitoring the competency of the micrographically oriented hsitographic surgery -- 2 of 3 -- (Mohs) technician. Findings include: 1. The laboratory has one (1) Mohs technician who is responsible for the operation and maintenance of the laboratory's Cryostat and Dermatopathology Mohs slide stain processing. 2. The laboratory lacked documentation of the competency for the (1) Mohs technician for 2021 and 2022. 3. The laboratory manager confirmed by interview the lack of policy or procedure for performing and documenting competency for the Mohs technician on August 12, 2022 at 4:00 pm. 4. The laboratory performs 1193 Mohs dermatopathology testing annually. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on personnel record review and interview with the laboratory manager on August 12, 2022, the laboratory director failed to specify, in writing, the responsibilities and duties of the micrographically oriented hsitographic surgery (Mohs) Technician and identify which examinations and procedures the Mohs Technician is authorized to perform. Findings include: 1. The laboratory personnel Job description for the Mohs Technician lacks the specification of the responsibilities for the Mohs technician for staining, quality control, retention of Dermatopathology slides and to perform as the Quality Assessment coordinator for the laboratory. 2. The laboratory manager confirmed by interview the lack of delegation of authority, and specifications of responsibilities as cited above. 3. The laboratory reports performing 1193 Dermatopathology patient tests annually. -- 3 of 3 --