Gary Karakashian Md Pa

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on surveyor review of the Operators Manual (OM) for the Zeiss Axioskop microscope, review of the Temperature Logs and interview with the Testing Personnel (TP) the laboratory failed to monitor and document the humidity range where the Professional Component (PC) for Histopathology tests are performed from 6/24/21 to the date of the survey. The finding include: 1. The OM defined the operating environment maximum relative humidity as 80% for the Zeiss Axioskop microscope. 2. The TP confirmed on 8/28/23 at 2:35 pm the laboratory failed to monitor and document the humidity where the PC for Histopathology tests are performed. 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. (c) The laboratory must document all analytic systems assessment activities. 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 surveyor review of the Procedure Manual, a lack of a Reagent Tracking Log and interview with Testing Personnel (TP) the laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic system from 6/24/21 to the date of survey. The finding includes: 1. The laboratory failed to have a procedure for tracking reagents used in Histopathology testing. 2. The TP confirmed on 8/28/23 at 2:15 pm that the laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems. -- 2 of 2 --

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on surveyor review of the Biannual Assessment (BA) records and interview with the Laboratory Director (LD), the laboratory failed to verify the accuracy of Histopathology testing twice annually in the Calendar year 2019. The LD confirmed on 6/24/21 at 9:45 am that the laboratory did not verify the accuracy of Histopathology testing. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual and interview with the Laboratory Director (LD), the laboratory failed to establish a written procedure for Biannual Assessment (BA) from 9/13/18 to the date of survey. The LD confirmed on 6/24/21 at 9:45 am that a BA procedure was not established. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) 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 -- The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on surveyor review of the Temperature Charts (TC) and interview with the Laboratory Director (LD), the laboratory failed to monitor and document room temperature on each day of Mohs testing from 9/13/18 to the date of the survey. The finding includes: 1. Review of TC revealed that the laboratory did not monitor and record room temperature from 9/13/18 to the date of the survey on days patient testing was performed. 2. The LD confirmed on 6/24/21 at 9:30 am that the room temperature was not monitored and recorded each day of Mohs testing. -- 2 of 2 --

Summary Statement of Deficiencies D3041 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(6) Test reports. Retain or be able to retrieve a copy of the original report (including final, preliminary, and corrected reports) at least 2 years after the date of reporting. (i) In addition, retain immunohematology reports as specified in 21 CFR 606.160(d) (ii) and pathology test reports for at least 10 years after the date of reporting. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM) and interview with the Laboratory Director (LD), the laboratory failed to have accurate retention policy from 9/27/16 to the date of survey. The finding includes: 1. The Biopsy PM stated to retain pathology reports for seven years but the regulation requires for 10 years. 2. The LD stated on 9/13/18 at 10:00 am that he was not aware of retention requirements. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on surveyor review of the Final Report (FR) and interview with the Laboratory 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 -- Director (LD), the laboratory failed to ensure that the FR included all the required information from 9/27/16 to the date of survey. The findings include: 1. The Mohs maps and Biopsy reports in the patients' charts did not have the address of the facility where testing was performed. 2. The Biopsy reports did not have the "Report Date". 3. The LDconfirmed on 9/13/18 at 10:30 am that FR did not have all the required information. -- 2 of 2 --