Jay B Herman Md Lab

Summary Statement of Deficiencies 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 laboratory temperature records, lack of documentation and interview with the Laboratory Director (LD), the laboratory failed to monitor and document room temperature and humidity to ensure proper test system operating conditions were met for 1 of 1 Qualigen FastPack IP System used to perform routine chemistry testing from 07/13/2023 to 06/26/2025. Findings include: 1. On the day of survey, 06/26/2025 at 9:10 am, the laboratory failed to provide documentation for monitoring room temperature and humidity to ensure operating conditions were met for 1 of 1 Qualigen FastPack IP System (acceptable room temperature range: 15 to 32 degrees Celsius, humidity range: 10% to 90%) used to perform routine chemistry testing from 07/13/2023 to 06/26/2025. 2. The laboratory performed 491 routine chemistry tests in 2024 (CMS-116 estimated annual volume). 3. The LD confirmed the above findings on 06/26/25 at 9:46 am. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies 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 an observation of the laboratory and interview with the Laboratory Director (LD), the laboratory failed to establish a maintenance policy to assess the maintenance /function of 1 of 1 thermometer used to monitor the temperature of refrigerators in the laboratory where Chemistry reagents and Quality Control Materials were stored from 06/08/2021 to the day of survey. Findings Include: 1. On the day of survey, 07/13 /2023 at 09:00 AM, the laboratory could not provide a maintenance policy for the thermometer used to record refrigerator temperature in the Laboratory. 2. The laboratory could not provide maintenance records for the following thermometers used to store reagents and Quality Controls for Fast Pack Ip system PSA Testing: BGC Analog Vertical Thermometer. 4. LD confirmed the findings above on 07/13 /2023 at 09:10 AM. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following 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 -- for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a lack of laboratory quality control (QC) records, a review of the procedure manual, and an interview with the Laboratory Director (LD), the laboratory failed to perform and document QC for Chemistry Testing from 06/03/2021 to 06/08/2023. Findings include: 1. On the day of the survey, 07/13/2023 at 08:37 AM, the laboratory failed to provide QC documentation for the Prostate Specific Antigen (PSA) performed in Chemistry from 06/03/2021 to 06/08/2023. 2. According to the laboratory's PSA procedure Positive and Negative QC is run each day of patient testing. 3. The laboratory performed 488 PSA tests in 2022 (CMS 116 annual volume). 4. LD confirmed the finding above on 07/13/2023 around 09:00 AM. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies 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 lack of documentation, review of Quality Assessment (QA) procedures, and interview with the Laboratory Director (LD), the laboratory failed to follow their Quality Assessment (QA) program for the Qualigen FastPack Prostate-specific antigen (PSA) testing for 2 of 2 years. Findings include: 1. On the day of survey, 06/08 /2021 at 07:41 a.m. Reviewed of the QA program procedure states: " laboratory assesses the QA plan yearly" 2. the LD could not provide documentation for their yearly QA program for 2019 and 2020 3. The LD confirmed the findings above. *** REPEAT DEFICIENCY *** Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

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 review of patient records and interview with the laboratory director (LD), the laboratory was unable to retrieve 2 years of patient records for Thyroid Stimulating Hormone (TSH) and Testosterone from 2017 to 2018. Findings include: 1. On the day of survey, 11/27/2018, the LD was unable to provide patient preliminary and final report records from 6/22/2017 to 11/27/2018. 2. From 06/22 /2017 to 11/27/2018, the labortaory performed 760 Testosterone and TSH patient tests. 3. The LD confirmed the findings above on 11/27/2018 around 12:30 pm. 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 Quality Assessment record review and interview with the Laboratory Director (LD), the labortaory failed to follow their Quality Assessment (QA) Program for the FastPack testing from 06/22/2018 to the date of survey. Findings include: 1. 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 labortaory's Quality Assessment Program for FastPAck Testing states, "Our lab assesses the QA plan monthly, using the QA checklist". 2. On the day of survey, 11/27 /2018, review of the laboratory's monthly QA checklist revealed that labortaory has not documented monthly quality assessment since December of 2014. 3. The LD confirmed the findings above on 11/27/2018 around 11: 45 am. 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, the review of the labortaory equipment operators manuals, maintenance records and interview with the Laboratory Director (LD), the laboratory failed to, establish a maintenance protocol that ensures equipment performance is accurate and reliable for the Van Guard Compact V6000 Centrifuge and the TriContinent Scientific Inc. 100 microliter pipette used for Testosterone and Thyroid Stimulating Hormone (TSH) testing from 06/22/2017 to the date of survey. Findings Include: 1. The Van Guard Compact V6000 Centrifuge Operator Manual, under Maintenance, point 6 states, "Check rotor periodically for structural integrity". 2. On the day of survey, 11 /27/2018, the LD could not provide maintenance protocols and maintenance records for 1 of 1 Guard Compact V6000 Centrifuge and 1 of 1 TriContinent Scientific Inc. 100 microliter pipette used for Testosterone and TSH testing from 06/22/2017 to 11/27 /2018. 3. From 06/22/2017 to 11/27/2018, the labortaory performed 760 Testosterone and TSH patient tests. 4. The LD confirmed the findings above on 11/27/2018 around 12:45 pm. -- 2 of 2 --