Pinnacle Dermatology

Summary Statement of Deficiencies D3043 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(7) (a)(7) Slide, block, and tissue retention-- (a)(7)(i) Slides. (a)(7)(i)(A) Retain cytology slide preparations for at least 5 years from the date of examination (see 493.1274(f) for proficiency testing exception). (a)(7)(i)(B) Retain histopathology slides for at least 10 years from the date of examination. (a)(7)(ii) Blocks. Retain pathology specimen blocks for at least 2 years from the date of examination. (a)(7)(iii) Tissue. 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 laboratory records, direct observation, and interview with testing personnel (TP) # 4; the laboratory failed to retain all documented histopathology slides for one of seven patients reviewed for ten years from the date of the Mohs micrographic surgery histopathologic examination. Findings include: 1. Review of the patient log for Mohs micrographic surgery histopathologic examination indicated a total number of three slides were created for the following patient: Date: Accession #: # of slides: 03/11/2024 OP24-0185 3 2. Upon review of patient testing on 09/22/2025, at 2:35 pm, surveyors observed the above mentioned patient only had one of three histopathology slides retained. 3. Interview with TP #3 on 09/22/2025, at 3:31 pm, confirmed the laboratory failed to retain all documented histopathology slides for one of seven patients reviewed for ten years from the date of the Mohs surgical histopathology examination. D5028 HISTOPATHOLOGY CFR(s): 493.1219 If the laboratory provides services in the subspecialty of Histopathology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- 1273, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on direct observation, review of the CMS-209 (Laboratory Personnel Report), laboratory policies and procedures, laboratory records, manufacturer operating instructions, lack of documentation, and interview with testing personnel #4; the laboratory failed to retain all documented histopathology slides for one of seven patients reviewed for ten years from the date of the Mohs micrographic surgery histopathologic examination (see D3043), failed to follow the written policy for bi- annual method accuracy (proficiency testing/peer reviewed histopathology interpretations) for Mohs micrographic histopathology testing for five of five events and failed to follow written policies and procedures for monitoring, assessing, and correcting problems identified for 24 of 24 months (see D5291), failed to follow its policy and procedure for slide labeling for seven of seven Mohs micrographic surgery patients reviewed (see D5311), failed to document the discontinuance of seven of seven procedures not utilized at upon the date of survey (see D5409), and failed to follow written policies and procedures for an ongoing mechanism to monitor assess, and when indicated, correct problems identified in the analytic systems by ensuring laboratory preventative maintenance logs were documented and temperature and humidity was recorded for two of seven patient testing dates reviewed (see D5791) in the subspecialty of histopathology from 2023 through the date of survey, 09/22/2025. 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: A) Repeat standard level deficiency from 08/24/2023 recertification survey. Based on review of the CMS-209 (Laboratory Personnel Report), laboratory policies and procedures, laboratory records, lack of documentation, and interview with testing personnel (TP) #4; the laboratory failed to follow the written policy for bi-annual method accuracy (proficiency testing/peer reviewed histopathology interpretations) for Mohs micrographic histopathology testing for five of five events from 2023 through the date of survey, 09/22/2025. Findings include: 1. Review of the CMS-209 (Laboratory Personnel Report) revealed three TP (TP #1, #2, and #3) performing Mohs micrographic histopathology testing. 2. Review of laboratory policies and procedures revealed the policy titled "Quality Assurance-Proficiency Testing", which stated, under "Procedure": "A. Proficiency Testing "1. Mohs Micrographic Surgery "a .... In compliance with section 493.1709, each Mohs surgeon will have 6 slides from each year (3 from Jan[uary]-June and 3 from July-Dec[ember]) in which Mohs surgery is performed pulled at random. These slides will be checked for accuracy ...." 3. Review of bi-annual method accuracy (proficiency testing/peer reviewed histopathology interpretations) for Mohs micrographic histopathology testing revealed the following: i. July-December 2023 TP: # of cases reviewed: #1 0 #2 3 #3 3 ii. January-June 2024 TP: # of cases reviewed: #1 0 #2 6 #3 0 iii. July-December 2024 TP: # of cases reviewed: #1 4 #2 0 #3 1 iv. January-June 2025 TP: # of cases reviewed: #1 3 #2 0 #3 3 4. Interview with TP #4 on 09/22/2025, at 3:41 pm, -- 2 of 5 -- confirmed the laboratory failed to follow the written policy for bi-annual method accuracy (proficiency testing/peer reviewed histopathology interpretations) for Mohs micrographic histopathology testing for five of five events from 2023 through the date of survey, 09/22/2025. B) Based on review of laboratory policies and procedures, laboratory records, lack of documentation, and interview with testing personnel (TP) #4; the laboratory failed to follow written policies and procedures for monitoring, assessing, and correcting problems identified for 24 of 24 months in the subspecialty of histopathology from 2023 through the date of survey, 09/22/2025. Findings include: 1. Review of laboratory policies and procedures revealed the policy titled "Quality Assurance", which stated, "Monthly the nurse or tech will check off the Monthly Quality Assurance Checklist .... The lab director will also review and sign off the checklist monthly." 2. Review of laboratory records revealed the document titled "Job Description - Laboratory Director", which stated, "(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratories services provided and to identify failures in quality as they occur." 3. Review of laboratory records revealed a lack of documentation of monthly quality assurance checks performed in the laboratory for the previous 24 months reviewed. 4. Interview with TP #4 on 09/22/2025, at 3:01 pm, confirmed the laboratory failed to follow written policies and procedures for monitoring, assessing, and correcting problems identified for 24 of 24 months in the subspecialty of histopathology from 2023 through the date of survey, 09/22/2025. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: Repeat standard level deficiency from 08/24/2023 recertification survey. Based on review of the laboratory's Allegation of Compliance (AoC) response regarding citations from the 08/24/2023 recertification survey, direct observation, and interview with testing personnel (TP) #4; the laboratory failed to follow its policy and procedure for slide labeling in the subspecialty of histopathology for seven of seven Mohs micrographic surgery patients reviewed from 2023 through the date of survey, 09/22 /2025. Findings include: 1. Review of the laboratory's AoC response regarding citations from the 08/24/2023 recertification survey revealed the procedure titled "Mohs Slide Labeling", which stated, under "Current Policy", "All offices has been updated to the 'M' for mohs, the Year, dash and then the accession with four number sequence...Example 'M23-0001'". 2. Direct observation of Mohs micrographic surgical slides upon patient review on 09/22/2025, at 2:35 pm, revealed the following label on the seven patient slides reviewed: Date: Slide Label: 10/02/2023 OP23-0782 12/19/2023 OP23-1092 01/26/2024 OP24-0057 03/11/2024 OP24-0185 01/14/2025 OP25-0054 04/11/2025 OP25-0357 07/18/2025 OP25-0769 3. Interview with TP #4 on 09/22/2025, at 3:02 pm, confirmed the laboratory's policy and procedure for slide labeling was out of date and the most current procedure for slide labeling was not being followed up to the date of survey, 09/22/2025. -- 3 of 5 -- D5409 PROCEDURE MANUAL CFR(s): 493.1251(e) (e) The laboratory must maintain a copy of each procedure with the dates of initial use and discontinuance as described in 493.1105(a)(2). This STANDARD is not met as evidenced by: Repeat standard level deficiency from 08/24/2023 recertification survey. Based on review of laboratory policies and procedures, lack of documentation, and interview with testing personnel (TP) #4; the laboratory failed to document the discontinuance of seven of seven procedures not utilized at upon the date of survey, 09/22/2025. Findings include: 1. Review of laboratory policy and procedures manual revealed the following procedures of which the laboratory director (LD) failed to indicate the date of last use: i. "Ectoparasites [Scabies]" ii. "KOH [Potassium hydroxide]/Scabies Annual Competency Assessment" iii. "KOH/Scabies Initial Training Checklist" iv. "Mohs Slide Labeling" - dated 01/10/2020. v. "Slide Labeling" vi. "Frozen Section Procedure" vii. "Urine Pregnancy test" 2. Interview with TP #4, on 09/22/2025, at 3: 02 pm, confirmed the laboratory does not perform the above mentioned/outdated procedures found in the laboratory's policy and procedure manual but the LD failed to document when the procedures were discontinued. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, manufacturer operating instructions, laboratory records, lack of documentation, and interview with testing personnel (TP) #4; the laboratory failed to follow written policies and procedures for an ongoing mechanism to monitor assess, and when indicated, correct problems identified in the analytic systems by ensuring laboratory preventative maintenance logs were documented and temperature and humidity was recorded for two of seven patient testing dates reviewed in the subspecialty of histopathology. Findings include: 1. Review of laboratory policies and procedures revealed the following procedures" i. "Daily Laboratory Maintenance", which stated the following: "8. Temperature charts, chemical, and other logs are checked daily or whenever in use. "9. Follow procedure for microscope care and document. "10. Follow procedure for eyewash and document. "11. Document that daily maintenance has been completed by initialing daily maintenance logs." ii. "Daily Routine", which stated the following: "1. Check and log temperature on cryostat.", "4. Check and log al[l] paperwork in log workbook.", "11. At the end of the day, clean cryostat according to maintenance log, and document.", "12. Wipe down counters and clean lab according to daily log and document." 2. Review of manufacturer operating instructions for the Leica CM Cryostat (Serial Number: 1156) revealed, under "Environmental specification", "Operating temperature 18[degrees Celsius] to 35[degrees Celsius]" and "Relative humidity [RH] (operation) 20 to 60 % RH non-condensing". 3. Review of laboratory records revealed the following preventative maintenance and temperature/humidity monitoring logs: i. "Cryostat Temperature Log and Maintenance Instructions" ii. "Microscope -- 4 of 5 -- Maintenance" iii. "Eye Wash Station" iv. "Daily Routine Maintenance" v. "Room Temp[erature] & Humidity" 4. Review of above mentioned preventative maintenance and temperature/humidity monitoring logs revealed a lack of documentation on the following dates of patient testing: i. 10/02/2023 ii. 03/11/2024 5. Interview with TP #4 on 09/22/2025, at 3:38 pm, confirmed the laboratory failed to follow written policies and procedures for an ongoing mechanism to monitor assess, and when indicated, correct problems identified in the analytic systems by ensuring laboratory preventative maintenance logs were documented and temperature and humidity was recorded for two of seven patient testing dates reviewed in the subspecialty of histopathology. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) (e)(5) Ensure that the quality control and 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 review of laboratory policies and procedures, laboratory records, lack of documentation, and interview with testing personnel (TP) #4; the laboratory director failed to follow the written policy for bi-annual method accuracy (proficiency testing /peer reviewed histopathology interpretations) for Mohs micrographic histopathology testing for five of five events reviewed (see D5219a) and failed to ensure the quality assurance program was maintained to assure the quality of laboratory services for 24 of 24 months in the subspecialty of histopathology from 2023 through the date of survey, 09/22/2025 (see D5291b). -- 5 of 5 --

Summary Statement of Deficiencies D5028 HISTOPATHOLOGY CFR(s): 493.1219 If the laboratory provides services in the subspecialty of Histopathology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1273, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of the laboratory procedure manual, Mohs accessioning logs, Mohs maps, patient slides, proficiency testing (PT) records, CMS-209 (Laboratory personnel Report), the laboratory's quality assurance documents for Mohs Micrographic Surgery, Mohs "Quality Control Staining" log, lack of documentation, and interview with a laboratory representative, the laboratory failed to meet the requirements of this condition. The laboratory failed to ensure positive identification of patient specimens throughout the testing process by failing to properly label histopathology slides for two of nine cases reviewed (See D5203). The laboratory failed to follow the written policy for bi-annual method accuracy of Mohs histopathology testing for one of one events performed in 2023 (See D5291 part A). The laboratory failed to follow the written policy for bi-annual method accuracy for Mohs histopathology for two of two events in 2022 (See D5291 part B). The laboratory failed to follow the "Mohs Slide Labeling" procedure for Mohs histopathology testing for five of five Mohs histopathology cases reviewed in 2023 (See D5311). The laboratory failed to check hematoxylin and eosin (H&E) staining material for intended reactivity each day of use for one of seven patient testing dates reviewed for Mohs histopathology testing (See D5473). D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- 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: REPEAT DEFICIENCY Based on review of Mohs accessioning logs, Mohs maps, patient slides, and interview with a laboratory representative, the laboratory failed to ensure positive identification of patient specimens throughout the testing process by failing to properly label histopathology slides for two of nine cases reviewed. Findings Include: 1. Patient testing records were reviewed for nine patients that had a Mohs surgery performed. a. Medical Record Numbers (MRN):749627, 611171, 665768, 9254411, 664239, 637074, 747738, 629570, and 658329. 2. Review of the Mohs accessioning log for 1-18-2023 and the corresponding Mohs maps identified the following information for the slide accession numbers (SAN) for the three patients reviewed on this date. MRN SAN 9254411 OP23-0040 747738 OP23-0039 629570 OP23-0041 3. Review of the corresponding patient slides from the Mohs procedures found the following: MRN SAN on Mohs Map SAN On Slide 9254411 OP23-0040 OP23-0039 747738 OP23-0039 OP23-0040 629570 OP23-0041 OP23-0041 4. On survey date 8-14-2023, at 1:35 pm, the laboratory representative confirmed two of three sets of patients slides from Mohs testing performed on 1-18-2023 were mislabeled according to the information found on the Mohs accession log and Mohs maps. 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: A. Based on review of proficiency testing (PT) records, CMS-209 (Laboratory personnel Report), the laboratory's quality assurance documents for Mohs Micrographic Surgery, and interview with the laboratory representative, the laboratory failed to follow the written policy for bi-annual method accuracy for Mohs histopathology testing for one of one events performed in 2023. Findings Include: 1. Review of the laboratory's policy and procedure manual identified the policy, "Quality Assurance-Proficiency Testing", which stated the following under the sub section for Mohs Micrographic Surgery: "In compliance with section 493.1709, each Mohs surgeon will have 6 slides from each year (3 from Jan-June and 3 from July-Dec) in which Mohs surgery is performed pulled at random...A reviewing Mohs surgeon will verify the diagnosis and sign off on the paperwork." 2. Review of the CMS-209 (Laboratory Personnel Report) identified three testing personnel (TP#1, TP#2, and TP#3) performing Mohs micrographic surgeries. 3. Review of PT testing records for Mohs Micrographic Surgy found for the first bi-annual method accuracy evaluation of 2023 (January through June) a total of 3 patient cases were reviewed. a. TP#1 - Zero cases selected (Zero slides) b. TP#2 - One case selected (Two total slides) c. TP#3 - Two cases selected (Four total slides) 4. Interview with the laboratory representative on 8-24-2023 at 1:35 pm confirmed the laboratory failed to follow the "Quality Assurance-Proficiency Testing" policy for Mohs micrographic surgery for the first -- 2 of 6 -- event of 2023. B. Based on review of proficiency testing (PT) records, the laboratory's quality assurance documents for Mohs Micrographic Surgery, lack of documentation, and interview with the laboratory representative, the laboratory failed to follow the written policy for bi-annual method accuracy for Mohs histopathology for two of two method accuracy assessments in 2022. Findings Include: 1. Review of the laboratory's policy and procedure manual identified the policy, "Quality Assurance-Proficiency Testing", stated the following under for Mohs Micrographic Surgery: "If the reviewing Mohs surgeon and the performing Mohs surgeon disagree on the diagnosis a full review will be done of the case. First, we will check to make sure that there are no additional notes in the operation note stating why a positive case would be called clear. If there are no such notes both Mohs surgeons will re-read the case with notes from the other to see if they agree. If no agreement can be achieved a third Mohs surgeon will read the slides. If two surgeons agree that the case is still positive, they will work on a plan to get the information to the patient with a plan of action on how to take care of the remaining cancer. All the steps along this process will be documented. All quality assurance documentation is maintained in the laboratory Quality Assurance section of the Mohs Manual." 2. Review of 2022 PT testing records for Mohs micrographic surgery found for the following disagreements: a. Event Two of 2022 - One of six cases reviewed had a differing diagnosis by the reviewing dermatopathologist. i. MRN:730445 b. Event One of 2022 - Two of six cases reviewed had a differing diagnosis by the reviewing dermatopathologist. i. MRN: 9076815 ii. MRN: 674706 3. Review of the laboratory Quality Assurance section of the Mohs Manual found no documentation of reviews for the three cases identified in the above finding as outlined in the "Quality Assurance-Proficiency Testing" procedure. 4. Interview with the laboratory representative on 8-24-2023, at 1: 35 pm, confirmed the laboratory failed to follow the "Quality Assurance-Proficiency Testing" policy for Mohs micrographic surgery and identify and investigate diagnostic discrepancies for Mohs cases reviewed in 2022. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of the "Mohs Slide Labeling" procedure, patient slides, and interview with a laboratory representative, the laboratory failed to follow the "Mohs Slide Labeling" procedure for Mohs histopathology testing for five of five Mohs histopathology cases reviewed in 2023. Findings include: 1. Review of the laboratory procedure, "Mohs Slide Labeling", stated the following: "Slides will be labeled according to office location they originate from: ...followed by the Mohs Surgeon performing the procedure:" 2. Review of five of five Mohs histopathology cases performed in 2023 found the slides failed to include the Mohs surgeon performing the procedure. Medical Record Numbers 9254411 664239 637074 747738 629570 3. Interview with the laboratory representative on 8-24-2023, at 1:35 pm, confirmed in September of 2022 the laboratory changed how Mohs slides were labeled but the slide labeling procedure failed to be updated. -- 3 of 6 -- D5409 PROCEDURE MANUAL CFR(s): 493.1251(e) The laboratory must maintain a copy of each procedure with the dates of initial use and discontinuance as described in 493.1105(a)(2). This STANDARD is not met as evidenced by: Based on review of the laboratory procedures manual and interview with a laboratory representative, the laboratory failed to document the discontinuance of two of two microbiology procedures, "Potassium Hydroxide (KOH)" and "Ectoparasites". Findings Include: 1. Review of the laboratory procedure manual identified the procedures, "Potassium Hydroxide (KOH)" and "Ectoparasites" 2. On survey date 8- 24-2023, at 1:35 pm, the laboratory representative confirmed that KOH and ectoparasite testing were not performed at this location but had not been discontinued by the laboratory director. 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: REPEAT DEFICIENCY Based on review of laboratory procedures, Mohs accession logs, Mohs "Quality Control Staining" log, and interview with a laboratory representative; the laboratory failed to check hematoxylin and eosin (H&E) staining material for intended reactivity each day of use for one of seven patient testing dates reviewed for Mohs histopathology testing. Findings Include: 1. Review of the laboratory's policy, "Policy On Quality Assurance and Procedure -Mohs Surgery", revealed that the laboratory will produce a control slide each day of testing for H&E staining and is assessed for the quality of staining and technique. 2. A random review of patient testing dates for Mohs histopathology found for one of seven patient testing dates reviewed the Mohs surgeon failed to document the acceptability of H&E stain reactivity on the Mohs "Quality Control Staining" log for 4-22-2022. 3. Review of the Mohs accession log identified five patients who had Mohs histopathology testing performed on 4-22-2022. 4. On survey date 8-24-2023, at 1:35 pm, the laboratory representative confirmed the laboratory director or Mohs surgeon failed to sign off on the H&E control for 4-22-2022. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: -- 4 of 6 -- Based on review of proficiency testing (PT) records, the laboratory's quality assurance documents for Mohs Micrographic Surgery, lack of documentation, the laboratory policy "Policy on Quality Assurance-Quarterly Checklist", competency assessment records, and interview with the laboratory representative, the laboratory director failed to meet the requirements of this condition. The laboratory director failed to identify problems that required

Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on direct observation, review of laboratory records, and interview with a laboratory representative; the laboratory failed to ensure established safety procedures were observed to ensure protection from chemical hazards as no material safety data sheets (MSDS) were available for hazardous chemicals used in the processing of histopathology specimens. Findings include: 1. Direct observation of the laboratory facility on 1-14-2020, at 12:20 pm, found no MSDS were available to review for chemicals used to process Mohs histopathology specimens. 2. Review of the laboratory's chemical hygiene plan identified the following chemicals used in this laboratory which should have had MSDS available for review: Hematoxylin, Eosin-y, Alcohol, Xylene, Xylene Substitute, and Formalin. 3. Interview with a laboratory representative at 4:15 pm, on 1-14-2020, confirmed the laboratory failed to have MSDS materials available for review for the chemicals identified in the chemical hygiene plan. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with a laboratory representative; the laboratory failed to ensure positive identification of patient specimens throughout the testing process by failing to follow histopathology slide labeling procedures for 1 of 7 dates reviewed for 4 of 4 sets of patient slides. Findings Include: 1. The laboratory's Mohs accession log was reviewed for 7 patient testing dates. 2. Review of patient slides for 01-03-2020 found the slides for 4 of 4 patients' were mislabeled according to the Mohs accession log. Patient Identification Accession # On Log Accession # On Slide M1 0002 0143 M8 0001 0142 M9 0003 0144 M10 0004 0145 3. On survey date 1-14-2020, at 4:15 pm, the laboratory representative confirmed 4 of 4 sets of patient slides identified above were mislabeled according to the Mohs accession log. 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 direct observation, review of the laboratory records, and interview with laboratory personnel; the laboratory failed to check hematoxylin and eosin (H&E) staining material for intended reactivity each day of use for 1 of 7 patient testing dates reviewed for Mohs histopathology testing. Findings Include: 1. Review of the laboratory's policy, "Quality Assurance for Routine Stains", revealed that the laboratory will produce a control slide each day of testing for H&E staining, the laboratory director will determine if the staining is acceptable, and this information will be documented on the quality control log. 2. Review of patient test results for Mohs histopathology testing found for 1of 7 patient testing dates reviewed the laboratory failed to document H&E stain reactivity on the quality control log. Patient Identification Date M7 12-30-2019 3. Direct observation of laboratory slides on 1-14- 2020, at 3:30 pm, found the laboratory failed to retain a quality control slide of normal skin stained on 12-30-2019 with H&E, as outlined in the laboratory policy, "Quality Assurance for Routine Stains". 4. Review of the Mohs accession log identified 10 additional patients who had Mohs histopathology testing performed on 12-30-2019. 5. During survey date 01-14-2020, at 4:15 pm, the laboratory representative confirmed H&E stain quality for Mohs histopathology testing failed to be documented on 12-30- 2019 and no quality control slide was found for 12-30-2019. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically -- 2 of 6 -- transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with a laboratory representative; the laboratory failed to have a reliable system to ensure that test results are accurately transferred to the final report destination for 3 of 7 patient test records reviewed for Mohs histopathology testing. Findings include: 1. Review of patient test records for Mohs histopathology testing revealed for 3 of 7 patients' the laboratory failed to ensure results indicated on the Mohs maps were correctly transcribed to final report destination (the patient chart - procedure details). Patient Identifier Mohs Map Procedure Detail M3 Stage 1 - Negative Stage 1 - Microscopic tumor was found persisting in 1 of the specimens. M4 Stage 4 - Negative Stage 4 - Microscopic tumor found persisting in "X" of the specimens (No number of specimens provided) M5 Stage 1 - Positive Stage 1 - Microscopic tumor was found persisting in none of the sections of the specimens. 2. Review of the Mohs map and patient chart for patient M4 also found the laboratory failed to identify the number of total specimens and the number of positive specimens for each Mohs stage reviewed and subsequently this information failed to be documented in the procedure detail for each stage in the patient chart. 3. On survey date 1-14-2020, at 4:15 pm, the above findings were confirmed by the laboratory representative. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of the laboratory records and interview with a laboratory representative the laboratory director failed to provide the overall management and direction to maintain proper laboratory operation. The laboratory director must meet the overall management and direction in accordance with 493.1445. Findings include: 1. The laboratory director failed to ensure 3 of 4 testing personnel who conducted high complexity grossing of histopathology specimens met the educational requirements. See D6102. 2. The laboratory director failed to ensure the competency policy was maintained 4 of 4 testing personnel reviewed that perform the grossing of Mohs histopathology specimen. See D6103. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: -- 3 of 6 -- Based on review of laboratory records and interview with a laboratory representative; the laboratory director failed to ensure 3 of 4 testing personnel who conducted high complexity grossing of histopathology specimens met the educational requirements. Findings Include: 1. Review of the CMS-209 (Laboratory Personnel Report) identified 3 new testing personnel performing high complexity histopathology testing. 2. Review of personnel records found no qualifying education documentation for 3 of 3 testing personnel performing high complexity grossing of histopathology specimens. See D6171. 3. Review of test volume records revealed of the 866 Mohs blocks documented in the laboratory accession logs in 2019, 772 of those blocks were grossed by personnel that failed to meet the qualification requirements for high complexity testing. 4. On survey date 1-14-2020, at 4:15 pm, the surveyor's findings were confirmed by the laboratory representative. 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 review of laboratory records and interview with a laboratory representative; the laboratory director failed to ensure the competency policy was maintained 4 of 4 testing personnel reviewed that perform the grossing of Mohs histopathology specimens. Findings Include: 1. Review of the document, "Laboratory Competency Assessment Policy", outlined the competency procedure for testing personnel in the specialty of pathology. The policy states the following: "For a new employee, competency assessment evaluation will be performed upon hire, and will be repeated at 6 months, then annually thereafter. All personnel will have annual competency evaluation performed by the laboratory director." 2. Review of competency assessment records for TP#4, 5, 6, and 7 found the following: TP#4 - No annual competency assessment in 2019. TP#5 - Initial training was documented in July of 2018 but no 6 month or 1 year competency assessment was completed in 2019. TP#6 - Initial training was documented in December of 2018 but no 6 month competency assessment was completed in 2019. TP#7 - No training or competency assessment was documented. 3. On survey date 1-14-2020, at 4:15 pm, the above findings were confirmed by a laboratory representative. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Based on review of laboratory records and interview with the laboratory director (LD); the laboratory failed to have a sufficient number of individuals who meet the -- 4 of 6 -- qualification requirements of 493.1489 of this subpart to perform the functions specified in 493.1495 of this subpart for the volume and complexity of testing performed. Findings Include: 1. The laboratory failed to ensure 3 of 3 new testing personnel (TP) were qualified for high complexity histopathology testing. See D6171. D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high -- 5 of 6 -- complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with a laboratory representative; the laboratory failed to ensure 3 of 3 new testing personnel (TP) were qualified for high complexity histopathology testing. Findings Include: 1. Review of the CMS-209 (Laboratory Personnel Report), identified 3 new testing personnel performing high complexity histopathology testing: TP#5, 6, and 7. 2. Review of educational documentation for 3 of 3 new high complexity TP identified on the CMS-209 failed to meet the minimum education requirements for high complexity testing. a. TP#5 - No qualifying educational documentation for high complexity histopathology grossing found. b. TP#6 - HS diploma and college course work failed to meet the minimum qualification requirements for high complexity histopathology grossing. c. TP#7 - No qualifying educational documentation for high complexity histopathology grossing found. 3. On survey date 01-14-2020, at 4:15 pm, the above findings were confirmed by the laboratory representative. -- 6 of 6 --

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 laboratory records and interview with the laboratory director (LD); the laboratory failed to ensure positive identification of patient specimens throughout the testing process by failing to follow histopathology slide labeling procedures for 6 of 20 sets of patient slides reviewed. Findings Include: 1. Review of the laboratory's policy and procedure manual identified the procedure, "Mohs Slide Labeling", which stated: "Slides will be labeled according to office location they originate from:", "...followed by the Mohs Surgeon performing the procedure:", and "...followed by the Year and Accession Number" 2. Review of the patient slides for 6 of 20 sets of slides reviewed found the slides failed to be labeled as described in the laboratory procedure. The following patient's slides were improperly labeled: Patient Identification Test Date P3 06-04-2018 P4 06-04-2018 P5 06-08-2018 P6 06-08-2018 P7 06-08-2018 P8 06-08-2018 3. On survey date 6-27-2018, at 12:00 pm the above findings were confirmed by the LD. 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. 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 review of the laboratory records and interviews with the laboratory director (LD); the laboratory failed to establish policies and procedures to assess employee competency. Findings Include: 1. Review of the laboratory's policy and procedure manual found no policy had been established to assess the competency of personnel listed on the CMS-209. 2. On survey date 06-27-2018, at 12:00 pm, the LD confirmed the laboratory failed to establish a competency assessment policy. -- 2 of 2 --