Endocrinology & Diabetes Center

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Endocrinology and Diabetes Center on June 7, 2022 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) documentation and an interview, the laboratory failed to retain copies of the attestation statement signed by the laboratory director (LD) and testing personnel (TP) for three (3) of five (5) events reviewed. Findings include: 1. Review of the laboratory's American Proficiency Institute chemistry PT records (2020 Events 2-3, 2021 Events 1-3), a total of 5 events, revealed no signed attestation statements by the LD and TP for: 2020 Event 2, 2020 Event 3, 2021 Event 3. The inspector requested to review the attestation documentation for the 3 events outlined above. No documentation was available for review. 2. An exit interview with the office manager at approximately 4:15 PM on 6/7/22 confirmed the above findings. 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 -- 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 tour observations, interviews, and a review of procedures, the laboratory failed to follow established safety protocols that prohibited storage of food and beverages in the laboratory on the date of the survey June 7, 2022. Findings include: 1. During a tour of the laboratory on June 7, 2022 at approximately 2:00 PM, the inspector observed food items and a soft drink beverage stored in a table top refrigerator identified as "send out refrigerator". The inspector noted patient blood samples were stored in the refrigerator adjacent to the food storage. The inspector inquired regarding the presence of the food and beverage stored in the laboratory refrigerator. A laboratory staff member (identified as the phlebotomist), responded to the inquiry on 6/7/22 at approximately 2:01 PM: "It is my food. I will get those out of there." The staff member removed the items (fruit and other various lunch food along with a soft drink) and placed them into her personal bag. The office manager, present during the tour, responded at approximately 2:05 PM: "We have protocols that food is not allowed in the laboratory. It is an elementary safety rule and should be followed by everyone working or visiting the laboratory." 2. Review of the laboratory procedure manual revealed a Qualigen Good Laboratory Practice protocol that stated: "Contamination of food and beverages, is a potential route to toxic chemicals or biological agents through ingestion. Laboratory personnel shall not prepare, store, or consume food or beverages in the laboratory." 3. An exit interview with the office manager at approximately 4:15 PM on 6/7/22 confirmed the above findings. 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 a review of quality assurance (QA) policy, chemistry analyzer user's guide /procedures, lack of documentation, and an interview, the laboratory failed to retain records of monitoring laboratory room temperature and humidity to ensure proper operating specifications for the Qualigen FastPack System analyzer for four (4) of twelve (12) months reviewed in calendar year 2020. Findings include: 1. Review of the laboratory's Qualigen FastPack QA plan revealed a policy to record the daily laboratory room temperature and humidity. 2. Review of the Qualigen chemistry analyzer user's guide and procedure manual revealed instructions to ensure instrument storage and operating specifications: "The instrument's operating temperature should be maintained at 15-32 C and humidity range should be monitored to verify 10-80%". -- 2 of 3 -- 3. Review of the available temperature/humidity logs for calendar year 2020 revealed no records for the months of September, October, November, and December. The inspector requested to review additional log sheets. The office manager stated on 6/7 /22 at approximately 3 PM: "Our lead lab tech left our employment in the timeframe of late October or early November 2020. I will look for the missing logs." 4. An exit interview with the office manager at approximately 4:15 PM on 6/7/22 confirmed the above findings. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Endocrinology and Diabetes Center on March 1, 2018 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: 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 a laboratory tour, review of the laboratory's quality assurance (QA) policy, Qualigen FastPack chemistry analyzer user's guide and procedures, and an interview, the laboratory failed to monitor and record laboratory room temperature and humidity to ensure proper operating specifications for three (3) of three (3) Qualigen FastPack System analyzers from March 2016 to the date of the survey on 3/1/18. Findings include: 1. During a tour at approximately 1:00 PM on 3/1/18, the inspector was unable to locate the devices utilized for monitoring the laboratory room temperature and humidity. The inspector asked to view the thermometer and humidity meters. The primary testing personnel stated: "I do not have a thermometer or humidity meter in the lab. I have to go out to the front lobby and I record the thermostat reading from the front office onto my temperature log sheets. I go to the utility room in the rear of the building to read the humidity meter located in that room." 2. Review of the laboratory's Qualigen QA plan revealed a policy to record the daily laboratory room 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 -- temperature and humidity. 3. Review of the Qualigen User's Guide and procedure manual revealed instructions to ensure instrument storage and operating specifications: "The instrument's operating temperature should be maintained at 15-32 C and humidity range should be monitored to verify 10-80%". 4. In an interview with the office manager at approximately 2 PM on 3/1/18, it was confirmed that the laboratory failed to record and monitor the laboratory room temperature and humidity ensuring proper operating specifications for three (3) of three (3) Qualigen FastPack System analyzers for twenty-four (24) of twenty-four (24) months reviewed. 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 a tour, review of the Qualigen FastPack manufacturer's user guide, the laboratory's equipment maintenance records, patient test log, and an interview, the laboratory failed to follow their calibration maintenance protocols for two (2) of two (2) positive displacement sample pipettes while reporting five thousand six hundred seventeen (5,617) patient test results during the fourteen (14) months reviewed. Findings include: 1. During a laboratory tour on 3/1/18 at approximately 1:00 PM, the inspector noted two (2) Gilson Guest 100 microliter (ul) pipettes in use for patient sample preparation in testing Thyroid Stimulating Hormone (TSH), Thyroxine (FT4), and Vitamin D on the Qualigen FastPack analyzer. The pipette serial numbers (SN) are listed below: Pipette 1 -SN JD 05888, Pipette 2 -SN JD 05887. 2. Review of the Qualigen manufacturer's user guide revealed a policy "Annual Recalibration of the Positive Displacement Sample Pipette" which outlined instructions for pipette calibrations. The policy stated: "Proper performance of pipette is critical to obtain accurate results. The pipette included with the FastPack System is a costly piece of equipment that requires periodic recalibration which must be done by a factory certified dealer". 3. Review of the laboratory's 2016 and 2017 equipment maintenance records revealed: Pipette 1 -SN JD 05888- calibration performed on 1/25/16, calibration expiration date 1/25/17 Pipette 2 -SN JD 05887- calibration performed on 1 /25/16, calibration expiration date 1/25/17 The inspector requested to review the annual pipette calibration documentation for calendar years 2017 and 2018. No documentation was available for review. 4. Review of the laboratory's 2017 Qualigen patient test log revealed the following number of patient tests were reported while utilizing the pipettes listed above: TSH: two thousand five hundred three (2,150); FT4: two thousand one hundred seventy-five (2,175); Vit D: nine hundred thirty-nine (939); a total of five thousand two hundred sixty-four (5,264) patient test results were reported during the lapse in pipette calibration protocols. 5. In an interview with the office manager on 3/1/18, at approximately 2:00 PM, it was confirmed that the laboratory failed to follow the annual calibration maintenance protocols for two (2) of two (2) sample pipettes utilized for Qualigen FastPack TSH, FT4, and Vitamin D patient testing during the fourteen (14) months reviewed as outline above. -- 2 of 3 -- 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