Johnny Gurgen Do Pa

Summary Statement of Deficiencies D0000 A recertification survey was conducted on December 16, 2024. Johnny Gurgen DO PA clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D0000 A recertification survey was conducted on June 22, 2022. Johnny Gurgen DO PA clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D5609 HISTOPATHOLOGY CFR(s): 493.1273(e)(f) (e) The laboratory must use acceptable terminology of a recognized system of disease nomenclature in reporting results. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on record review, observation, and interview, the laboratory failed to document quality control information including the expiration dates, open dates and lot numbers for all reagents used in their Hematoxylin & Eosin (H & E) stains from 03/19/2021 to 06/22/2022. Findings: Review of the procedure titled, "Quality Control Policies and Documentation" noted "Reagent lot numbers and expiration dates must be recorded. The laboratory used the following reagents in their laboratory: Acid Alcohol Solution 0.5%, 100% Reagent Alcohol, 95% Reagent Alcohol, 80% Reagent Alcohol, 70% Reagent Alcohol, Hematoxylin, Eosin, Scott's Tap Water Substitute, 10% Formalin Fixative, Xylene, and Xylene Substitute. Review of the Chemical Log showed the log did not include the opened date or expiration date listed for the following reagents: Received date 03/19/2021 Acid Alcohol Solution 0.5% lot #59975 Received date 03 /24/2021 100% Reagent Alcohol lot #2106301 Received date 04/07/2021 Xylene lot #2106206 Received date 05/12/2021 10% Formalin Fixative #2107614 Received date 05/12/2021 100% Reagent Alcohol lot #2107614 Received date 05/12/2021 100% Xylene lot #2108902 Received date 05/12/2021 Hematoxylin lot #120579 Received date 05/12/2021 Eosin lot #108615 Received date 05/12/2021 80% Reagent Alcohol lot #2109216 Received date 05/12/2021 70% Reagent Alcohol lot #2109214 Received date 06/01/2021 Xylene Substitute lot #2112701 Received date 07/06/2021 100% 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 -- Reagent Alcohol lot #2113017 Received date 08/06/2021 100% Reagent Alcohol lot #2117648 Received date 08/06/2021 95% Reagent Alcohol lot #2111110 Received date 08/06/2021 70% Reagent Alcohol lot #2116607 Received date 08/06/2021 Xylene lot #2116537 Received date 08/06/2021 80% Reagent Alcohol lot #2116006 Received date 11/01/2021 Eosin lot #124485 Review of the Chemical Log showed the log did not have the opened date for the following reagents: Received date 08/06/2021 Hematoxylin lot #121679 Received date 09/09/2021 100% Reagent Alcohol lot #2120219 Received date 09/09/2021 95% Reagent Alcohol lot #2119419 Received date 10/13/2021 Xylene lot # 2124209 Received date 10/13/2021 100% Reagent Alcohol lot #2125021 Received date 01/11/2022 Xylene lot #2130021 Received date 03/04/2022 100% Reagent Alcohol lot #2205201 Received date 05/0402022 100% Reagent Alcohol lot # 2206205 Observations on 06/22/2022 at 10:45 showed the following reagent were in the flammable cabinet and labeled with the following information: 95% Reagent Alcohol lot #2111110 open date 04/22/2022 70% Reagent Alcohol lot #2102109 open date 05/05/2022 Scott's Tap Water Substitute lot #2131703 open date 03/09/2022 Review of the chemical log showed the above mentioned chemical were not listed in the Chemical Log. On 06/22/2022 at 10:58 AM, the Office Manager acknowledged the chemical log did not contain all the required information. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on June 8, 2020. Johnny Gurgen DO PA clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to retain quality control (QC) records from June 8 - 30, 2018 and October 1 - 31, 2018. Findings: Review of the laboratory's histology QC records showed that there were not any records from June 8 - 30, 2018 and October 1 - 31, 2018. The following monthly QC records were missing: Slide Dryer/Oven Daily Maintenance QC, Floatation Bath Daily Maintenance QC, Manual H&E Stain Daily Maintenance QC, Microtome Daily Maintenance QC, Tissue Processor Daily Maintenance QC, and Embedding Center Daily Maintenance QC. Review of the Grossing Sheet for Specimens listed 173 patients specimens processed from June 8 - 30, 2018, and 225 patients specimens processed from October 1 - 31, 2018. During an interview on 6/8/20 at 12:10 PM, the Mohs Technician stated she did not know where the QC records for June 2018 and October 2018 were. D3039 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(5) Quality system assessment records. Retain all laboratory quality system assessment records for at least 2 years. 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 record review and interview, the laboratory failed to retain quality assessment (QA) records from June through August 2018, October through December 2018 and January through June 2019. Findings: Review of the laboratory's histology QA records showed that there were not any records from June through August 2018, October through December 2018 and January through June 2019. The following monthly QA checklists were missing: Monthly Quality Assurance Checklist and Monthly Patient Quality Assurance Checklist. Review of the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification form signed by the Laboratory Director on 5/20/20 noted the estimated testing volume for histology biopsies was 4,320 per year. During an interview on 6/8/20 at 12:10 PM, the Mohs Technician stated she did not know where the QA records were. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to verify the accuracy of the reading and interpretation of the Hematoxylin and Eosin (H&E) stain at least twice annually in 2019. Findings: The laboratory used peer review to verify the accuracy of the reading and interpretation of H&E stains. Review of the laboratory's records for 2019 showed that all the peer reviews were signed and dated by the reviewing doctor on 9/19/19. During an interview on 6/8/20 at 11:30 AM, the Mohs Technician stated that peer review was performed only once during 2019. -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to establish a written procedure on the assessment of employee competency. Findings: Review of the laboratory's procedure manual did not show a procedure on the assessment of employee competency. During an interview on 6/05/18 at 11:55 AM, Mohs Tech acknowledged that they did not have a procedure on employee competency. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory failed to monitor, evaluate and correct problems in the over quality of the analytic system. The laboratory failed to Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- have a procedure manual for the histology testing performed in the laboratory (D5401), and failed to maintain documents for quality control and maintenance for equipment used in the histology section of the laboratory (D5433). 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 record review and interview, the laboratory failed to have a procedure manual for the histology testing performed in the laboratory from 1/31/17 to 6/05/18. Findings: Review of the "Leesburg Dermatology and Mohs Surgery Chemical Hygiene Plan" contained a document titled "Histology Procedure". The "Histology Procedure" document contained a flow chart and a description of specimen accessioning, gross examination, tissue fixation, tissue processing, tissue embedding, tissue sectioning and slide staining. The "Histology Procedure" did not contain the necessary information to be considered a procedure manual. No other histology procedure manual was found. During an interview on 6/05/18 at 11:45 AM, Mohs Technician acknowledged that the "Histology Procedure" document was not a procedure manual. 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 record review and interview, the laboratory failed to maintain documents for quality control and maintenance for equipment used in the histology section of the laboratory. Findings: Review of the histology quality control and maintenance logs showed that the laboratory failed to maintain documentation of quality control and maintenance performed on the equipment used from 1/31/17 through 3/31/17. Quality control and maintenance records for the microtome, tissue processor, embedding center, slide dryer/oven, floatation bath and auto stainer are missing. During an interview on 6/05/18 at 12:15 AM, Mohs Technician acknowledged that the maintenance logs were missing. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an -- 2 of 5 -- 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 record review and interview, the histology laboratory failed to establish a quality assessment (QA) program to monitor, access and correct problems, and the Mohs laboratory failed to follow a written policy to monitor, access and correct problems for their QA program. Findings: 1. Review of the "Leesburg Dermatology and Mohs Surgery Chemical Hygiene Plan" showed that the laboratory failed to have a QA program. Review of the Histology Logs showed that there was no "Monthly Quality Assurance Checklist" or "Monthly Patient Quality Assurance Checklist" performed for histology section of the laboratory from when histology testing started on 1/31/17 through 6/05/18. During an interview on 6/05/18 at 12:30 PM, Mohs Technician (Tech) stated that the she did not know if the histology technologist filed out any quality assurance checklists. 2. Review of Mohs procedure titled "Quality Assurance" stated "Monthly the nurse or tech will check off the Monthly Quality Assurance Checklist". Review of the "Monthly Quality Assurance Checklist" showed that the checklists for August 2017 through May 2018 were missing. During an interview on 6/05/18 at 9:50 AM, Mohs Tech stated she did not know where the "Monthly Quality Assurance Checklist" for 8/01/17 through 12/31/17 were located. Mohs Tech also stated at 10:13 AM that the "Monthly Quality Assurance Checklist" for 2018 was not done. 3. Review of the Mohs "Monthly Quality Assurance Checklist" in the section for patient test management system states the laboratory checks to ensure "Lab reports contain correct information". To ensure the laboratory reports contain the correct information the laboratory has a "Monthly Patient Quality Assurance Checklist". Review of the "Monthly Patient Quality Assurance Checklist" showed that the checklists for 5/01/17 through 12/31/17 were missing. During an interview on 6/05/18 at 9:50 AM, Mohs Tech stated she did not know where the "Monthly Patient Quality Assurance Checklist" for 5/01/17 through 12/31/17 were located. 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 record review and interview, the laboratory director failed to provide overall management and direction. The laboratory director failed to identify that documentation of quality control and maintenance for equipment used in the histology laboratory was not maintained (D6093), failed to establish and maintain a quality assessment (QA) program for the histology section of the laboratory, and failed to identify failures in the Mohs QA program (D6094), failed to establish a written procedure on the assessment of employee competency (D6103), and failed to ensure that the laboratory had a procedure manual for the histology testing performed in the laboratory (D6106). D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) -- 3 of 5 -- The laboratory director must ensure that the quality control 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 record review and interview, the laboratory directory failed to identify that documentation of quality control and maintenance for equipment used in the histology laboratory was not maintained. Findings: Review of the histology quality control and maintenance logs showed that the laboratory failed to maintain documentation of quality control and maintenance performed on the equipment used from 1/31/17 through 3/31/17. Quality control and maintenance records for the microtome, tissue processor, embedding center, slide dryer/oven, floatation bath and auto stainer were missing. During an interview on 6/05/18 at 12:15 AM, Mohs Technician acknowledged that the maintenance logs were missing. 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 record review and interview, the laboratory director failed to establish and maintain a quality assessment (QA) program for the histology section of the laboratory, and failed to identify failures in the Mohs QA program. Findings: 1. Review of the "Leesburg Dermatology and Mohs Surgery Chemical Hygiene Plan" showed that the laboratory failed to have a QA program. Review of the Histology Logs showed that there was no "Monthly Quality Assurance Checklist" or "Monthly Patient Quality Assurance Checklist" performed for histology section of the laboratory from when histology testing started on 1/31/17 through 6/05/18. During an interview on 6/5/18 at 12:30 PM, Mohs Technician (Tech) stated that the she did not know if the histology technologist filed out any quality assurance checklists. 2. Review of Mohs procedure titled "Quality Assurance" stated "Monthly the nurse or tech will check off the Monthly Quality Assurance Checklist." Review of the "Monthly Quality Assurance Checklist" showed that the checklists for August 2017 through May 2018 were missing. During an interview on 6/05/18 at 9:50 AM, Mohs Tech stated she did not know where the "Monthly Quality Assurance Checklist" for 8 /01/17 through 12/31/17 were located. Mohs Tech also stated at 10:13 AM that the "Monthly Quality Assurance Checklist" for 2018 was not done. 3. Review of the Mohs "Monthly Quality Assurance Checklist" in the section for patient test management system states the laboratory checks to ensure "Lab reports contain correct information". To ensure the laboratory reports contain the correct information the laboratory has a "Monthly Patient Quality Assurance Checklist". Review of the "Monthly Patient Quality Assurance Checklist" showed that the checklists for 5/01/17 through 12/31/17 were missing. During an interview on 6/05/18 at 9:50 AM, Mohs Tech stated she did not know where the "Monthly Patient Quality Assurance Checklist" for 5/01/17 through 12/31/17 were located. D6103 LABORATORY DIRECTOR RESPONSIBILITIES -- 4 of 5 -- 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 record review and interview, the laboratory directory failed to establish a written procedure on the assessment of employee competency. Findings: Review of the laboratory's procedure manual showed that there was no procedure on the assessment of employee competency. During an interview on 6/05/18 at 11:55 AM, Mohs Technician acknowledged that they did not have a procedure on employee competency. D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) The laboratory director must ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory directory failed to ensure that the laboratory had a procedure manual for the histology testing performed in the laboratory from 1/31/17 to 6/05/18. Findings include: Review of the "Leesburg Dermatology and Mohs Surgery Chemical Hygiene Plan" contained a document titled "Histology Procedure". The "Histology Procedure" document contained a flow chart and a description of specimen accessioning, gross examination, tissue fixation, tissue processing, tissue embedding, tissue sectioning and slide staining. The "Histology Procedure" did not contain the necessary information to be considered a procedure manual. No other histology procedure manual was found. During an interview on 6/05 /18 at 11:45 AM, Mohs Technician acknowledged that the "Histology Procedure" document was not a procedure manual. -- 5 of 5 --