Bbh Primary Care Network

Summary Statement of Deficiencies D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on a review of the American Proficiency Institute (API) proficiency testing (PT) records and an interview with Testing Personnel #1, the laboratory failed to submit results by the cutoff date specified by the PT provider on one of seven 2020 - 2022 survey events reviewed. The findings include: 1. A review of the API records revealed the laboratory received a score of zero percent on API 2020 Hematology Event #1 due to failure to participate. A review of instructions for this survey revealed the results were due on March 27, 2020, at 11:59 PM, however the laboratory did not perform the survey until March 30, 2020. 2. During an interview on August 10, 2022 at 1:03 PM, Testing Personnel #1 confirmed the above findings. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing 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 a review of the American Proficiency Institute (API) Hematology proficiency testing (PT) records and an interview with Testing Personnel #1, the laboratory failed to retain API proficiency test records for at least two years. This was noted for five of seven API events reviewed from 2020 to 2022. The findings include: 1. A review of the API Hematology records revealed the following API documentation was not retained by the laboratory for at least two years: a. 2020 Hematology Event #2- no attestation statement b. 2020 Hematology Event #3- no attestation statement c. 2021 Hematology Event #1- no program (results) forms d. 2021 Hematology Event #3- no attestation statement e. 2022 Hematology Event #1- no program forms or attestation statement. 2. A further review of the API attestation page revealed the following instructions, "...retain the signed statement (or a copy) for a minimum of 2 years. ...". 3. During an interview on August 10, 2022, at 12:30 PM, the surveyor reviewed the attestation statement instruction with Testing Personnel #1 who confirmed the laboratory had failed to make copies of results forms and attestation statements mailed to API, and retain the records for at least two years. . 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 a review of the American Proficiency Institute (API) Hematology proficiency testing (PT) records, a review of the Quality Assurance (QA) procedure, and an interview with Testing Personnel #1, the laboratory failed to implement a mechanism to ensure PT results were submitted within the timeframes specified by the PT provider, and failed to ensure QA reviews were performed to ensure PT records were complete and retained for at least two years. This affected six out of seven 2020 - 2022 API PT events reviewed. The findings include: 1. A review of the API PT records revealed the following: A) The laboratory failed to implement a mechanism to ensure PT results were submitted by the cutoff date specified by API (Refer to D2123.) B) The laboratory failed to perform QA reviews of PT records to ensure all required documentation was present and retained for at least two years. (Refer to D3037.) 2. A review of the Proficiency Testing QA records, signed by the Laboratory Director on January 28, 2014, revealed, "PT results are reviewed and retained for a period of at least two years. ...". 3. During an interview on August 10, 2022, at 12:30 PM, Testing Personnel confirmed the above findings. SURVEYOR ID's #32558 and #46291 Licensure and Certification Surveyors -- 2 of 2 --

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 a review of the room temperature logs, a lack of room temperature and humidity records after April 2019, a review of environmental requirements for the Abbott Cell Dyn Emerald Hematology analyzer, and an interview with the Technical Consultant and the Testing Personnel, the surveyor determined the laboratory failed to monitor and document room temperature and humidity in the area of operation for the last eight and a half months. The findings include: 1. A review of the Abbott Cell Dyn Emerald Operator's Manual on page 2-4 (viewed by the surveyor on the Abbott website) revealed: "Installation Environment The following are environmental requirements: ... Temperature range: 64 - 90 degrees F (Fahrenheit) ... Maximum relative humidity 80% (percent) for temperatures up 90 degrees F". 2. A review of the 2018-2020 environmental logs revealed the testing personnel had recorded room temperature (acceptable range: 65-75 degrees F), humidity (acceptable ranges: less than 70%), and refrigerator temperatures on a monthly chart until April 2019. Then in May 2019 the laboratory began using a vaccine refrigerator temperature log each day of patient testing, however, the records did not include the temperature and humidity in the room where the Emerald was operated from May 2019 thru the day of the survey. 3. During an interview on 1/14/2020 at 12:40 PM, the Testing Personnel confirmed she had no longer recorded room temperature and humidity after April 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 -- 2019 because it was not on the new form. The Technical Consultant then explained TPR (the hospital Quality Assurance entity) had required the facilities to use the vaccine refrigerator temperature log. However, the Technical Consultant had failed to ensure the testing personnel continued to monitor and document room temperature and humidity, as per the manufacturer's instructions. 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 a review of a patient results report and interviews with the Technical Consultant and the Testing Personnel, the laboratory failed to ensure the correct name and address of the laboratory performing the testing, and the units of measurement were included on the report. The findings include: 1. On 1/14/2020 at 2:10 PM, the surveyor reviewed the post-analytical process in the facility. Upon the surveyor's request, the Testing Personnel printed a final report from Copia with results for a CBC (Complete Blood Count) she had performed earlier in the day. 2. A review of the Laboratory Report revealed the laboratory name, address, and CLIA number (#) did not belong to this facility (BBH Primary and Specialty Care). The report also failed to include the units of measurement for CBC parameters. 3. As the interview continued on 1/14/2020 at 2:15 PM, the surveyor reviewed the report with the Technical Consultant and the Testing Personnel who confirmed the name, address and CLIA # on the report was the facility with whom this laboratory had merged in August 2018. The Technical Consultant further stated she would investigate why the units of measurement were not printing in the "Units" column of the report. SURVEYOR ID #32558 Licensure and Certification Surveyor -- 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 the laboratory test menu listed during the initial laboratory tour, a review of the proficiency testing records and an interview with the Technical Consultant, the surveyor determined the laboratory failed to ensure accuracy verification of urine sediment microscopy was performed at least twice annually in 2016 and 2017. The findings include: 1. During the initial tour of the laboratory on 3/27/2018 at approximately 9:45 AM, the Technical Consultant listed urine sediment microscopy on the on-site test menu. 2. A review of the API (American Proficiency Institute) proficiency testing (PT) records revealed the laboratory enrolled in surveys that included proficiency for urine sediment microscopy in 2015, however the test was discontinued on the 2016-2017 surveys. 3. During an interview on 3/27/2018 at 11:00 AM, when asked if they had verified the accuracy of urine sediment microscopy by another method, the Technical Consultant confirmed they had not. Thus the above noted findings were confirmed. . D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, 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 -- traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on reviews of the Abbott Cell Dyn Emerald Hematology analyzer "Quick Reference Guide", calibration, and quality control (QC) records, and interviews with the Technical Consultant and testing personnel, the surveyor determined the laboratory failed to follow the manufacturer's instructions in the performance frequency of calibrations, and failed to verify two out of three calibrations performed in 2016-2017. The findings include: 1. A review of the Abbott Cell Dyn Emerald Hematology analyzer "Quick Reference Guide" revealed, on page 51 the following instructions, "When to Calibrate...At least every six months...". The final step of the procedure included instructions for the user to verify the calibration ("calibration verification") using the second calibrator tube. [Laboratories also have the option of running at least two levels of QC to verify their calibration data.] 2. A review of the Hematology records revealed the following: A) 04/28/2016 at 10:38 AM: Documentation of a calibration, however there was no evidence of "calibration verification" or QC afterwards; a review of the records revealed QC was only performed earlier in the morning on this date. B) 05/04/2017 at 1:36 PM: Data from a calibration and three levels of QC performed approximately one year after the previous calibration. C) 10/31/2017 at 11:18 AM: Documentation of a calibration, however there was no evidence of "calibration verification" or QC afterwards; a review of the records revealed QC was only performed earlier in the morning on this date. 3. During an interview on 3/27/2018 at 11:30 AM, the Technical Consultant was asked if the laboratory had any records of Hematology calibrations performed between April 2016 and May 2017. The Consultant said they had been unable to locate the records for the second calibration performed in 2016. When asked how often the Hematology analyzer should be calibrated, the Technical Consultant stated, "Every six months", and further confirmed the testing personnel knew they should perform QC after all calibrations. 4. During a later interview on 3/27/2018 at 1:24 PM, the testing personnel was asked to provide evidence of QC performed after the 4 /28/2016 and 10/31/2017 calibrations. The testing personnel was only able to find QC performed in the mornings on the above dates, thus confirming the above noted findings. SURVEYOR: Laura T. Williams, BS, MT (ASCP) Licensure and Certification Surveyor -- 2 of 2 --