Premier Medical Group Laboratory

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 review of established Quality Assessment (QA) policies and procedures and interview with the testing personnel, the laboratory failed to follow QA policies and procedures to monitor, assess, and when indicated, correct problems identified in the general laboratory systems. Findings include: 1. The laboratory's established QA policy and form titled 'Quality Assessment Review Form and Checklist' states, "Annually, one activity for each of the following processes will be reviewed for the patient testing process. A detailed account of a problem may also be documented on the Monitoring Quality Assessment form." The QA form monitors the following: Patient Test Management, Quality Control, Proficiency Testing, Comparison of Test Results, Personnel, Complaint Investigations, and QA Review. 2. No QA documentation was provided for review during the survey conducted on 12/15/2022 to indicate the laboratory documented QA activities on an annual basis during 2020, 2021 and 2022 (through the date of the survey) to monitor, assess and, when indicated, correct problems identified in the general laboratory systems. 3. The testing personnel interviewed on 12/15/22 at 12:50pm confirmed the laboratory failed to provide documentation of annual QA reports to monitor, assess and correct problems identified with the general laboratory systems. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on direct observation of control and calibration material and interview with the testing personnel, the laboratory used controls and calibrators past the expiration date. Findings include: 1. The laboratory performs patient testing in the specialties of Diagnostic Immunology and Chemistry, with an approximate annual test volume of 126,240 in those specialties. The laboratory utilizes the Beckman Coulter AU680 and DXI600 analyzers for the testing. 2. During the survey conducted on December 15, 2022, direct inspection of the reagents, control and calibration materials in use at the time of the survey for the analyzers indicated above revealed the following expiration dates: - ISE Reference Solution, lot# M104520, expiration date of 9/30/22 - Access SARS-CoV-2 IgG II reagent boat, lot# 234088, expiration date of 11/30/22 - DRI pH Detect control pH 3.6, lot# 74394022, expiration date of 11/30/22 - DRI pH Detect control pH 11.5, lot# 74394023, expiration date of 11/30/22 - DRI Creatinine Detect 20.0 mg/dL Calibrator, lot# 74437068, expiration date of 9/30/22 - DRI pH Detect pH 11.0 Calibrator, lot# 74186499, expiration date of 4/30/22 - DRI Creatinine Detect Calibrator, lot# 74437067, expiration date of 9/30/22 - DRI Opiate Urine Calibrator 1, lot# 74229258, expiration date of 8/31/22 - DRI Opiate Urine Calibrator 3, lot# 74229262, expiration date of 8/31/22 - DRI Negative Urine Calibrator, lot# 73980992, expiration date of 6/30/22 - Cedia Multi-Drug Calibrator, lot# 74174431, expiration date of 8/31/22 - Cedia DAU Negative Calibrator, lot# 73939225, expiration date of 6 /30/22 3. The total number of patients tested using the expired reagents, controls and calibrators could not be determined at the time of the survey. 4. At approximately 11: 45am on 12/15/22, the testing personnel interviewed confirmed that the expired reagents, controls and calibrators indicated above were in use at the time of the survey 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. This STANDARD is not met as evidenced by: Based on review of quality assessment (QA) policies and procedures and interview with the testing personnel, the laboratory failed to follow established QA policies and procedures to monitor, assess, and when indicated, correct problems identified in the analytic systems, specifically problems identified with the using reagents, controls and calibrators past the expiration date. Findings include: 1. During the survey conducted on 12/15/22, the laboratory presented a binder for review labeled, "AU680 Drug Screen Tests". It is the practice of the laboratory to complete a log in the binder to track the name, lot#, and expiration dates of reagents, controls and calibrators used by the laboratory on the Beckman Coulter AU680 analyzer. 2. The laboratory failed to document any information in the log referenced above after 5/23/2019 with regard to the reagents, controls and calibrators used for the drug screen tests performed on the AU680 analyzer. 3. The laboratory failed to follow their established QA process indicated above to monitor, assess and correct problems identified in the analytic -- 2 of 4 -- systems, as evidenced by the number of expired test materials in use on the AU680 analyzer at the time of the survey. See D5417 for findings. 4. The testing personnel interviewed on 12/15/22 at 12:40pm confirmed the laboratory failed to follow established QA policies and procedures to monitor, assess and correct problems identified with the analytic systems. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on review of patient test reports and interview with the testing personnel, the laboratory failed to have a system in place to ensure the accuracy of test results that are electronically interfaced into the laboratory's information system (LIS). Findings include: 1. The laboratory performs patient testing using the Sysmex XS-1000i hematology analyzer, Beckman Coulter AU680 and DXI 600 chemistry and immunology analyzers, TOSOH analyzer, and the Applied Science Quant Studio 3 analyzer, with an approximate annual test volume of 160,038. 2. The test results from the analyzers listed above are electronically interfaced into the Laboratory Information System (LIS), LabDaq. 3. No documentation was presented for review during the survey conducted on December 15, 2022 to indicate the laboratory has a system in place to ensure the accuracy of patient test results that are electronically interfaced into the LIS. 4. The testing personnel interviewed on 12/15/22 at 12:15pm confirmed the laboratory failed to have a system in place to verify the accuracy of the patient test results that are electronically sent from the analyzers to the LIS. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on lack of initial training documentation for one testing personnel who performs testing in the specialties of Diagnostic Immunology, Chemistry and Hematology and interview with the general supervisor, the laboratory director failed to ensure that all testing personnel receive the appropriate training and demonstrate that they can perform all testing operations reliably and accurately prior to testing patients' specimens. Findings include: 1. No initial training documentation was presented for review for one testing personnel who performs patient testing in the -- 3 of 4 -- specialties of Diagnostic Immunology, Chemistry and Hematology. 2. The general supervisor interviewed on 12/15/22 at 9:20am confirmed the laboratory failed to have documentation of initial training for the testing personnel indicated above. -- 4 of 4 --

Summary Statement of Deficiencies 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 lack of written procedures for review and interview with the facility personnel, the laboratory failed to have written procedures for testing performed under the specialty of Hematology and the sub-specialties of Routine Chemistry, Endocrinology and Toxicology. Findings include: 1. The laboratory performs approximately 230,000 tests per year under the specialty and sub-specialties listed above. 2. No evidence of an approved procedure manual was presented for review during the survey. 3. The facility personnel acknowledged that they were unaware of the location of the procedure manual. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- This STANDARD is not met as evidenced by: Based on review of the manufacturer's criteria for relative humidity requirements for the environment where the Sysmex hematology analyzer is operated, the humidity range indicated on the laboratory's log sheets and interview with the facility personnel, the laboratory failed to follow manufacturer's instructions for the humidity levels where the Sysmex hematology analyzer is operated. Findings include: 1. The manufacturer's specifications for the relative humidity (RH) are between 40% and 80% with no condensation. 2. The laboratory's logs indicated an acceptable humidity range of between 0% and 80%. 3. The recorded daily humidity range for the laboratory was consistently below 40%; although it could not be determined at the time of the survey how many days in 2019 that the humidity was below the manufacturer's range. 4. The facility personnel acknowledged that they were unaware of the manufacturer's requirements. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) 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: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on review of analyzer function check records and interview with the facility personnel, the laboratory failed to perform and document background counts on the Sysmex XS 1000i hematology analyzer each day prior to patient testing. Findings include: 1. The laboratory performs patient testing on the Sysmex XS 1000i hematology analyzer, with an approximate annual test volume of 63,995. 2. No documentation was presented for review during the survey conducted on February 11, 2020 to indicate the laboratory performed and documented the background count performed on the Sysmex XS 1000i analyzer each day prior to patient testing. The laboratory failed to maintain record of the background counts that were performed prior to 2/14/2019. 3. No documentation of the background count was presented for review for patient records reviewed during the survey from 11/07/2018. 4. The laboratory director confirmed that the laboratory failed to produce evidence of background counts performed each day of patient testing that occurred prior to 2/14 /19. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit -- 2 of 4 -- of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on lack of calibration verification documentation for the Beckman Coulter AU680 chemistry analyzer and interview with the facility personnel, the laboratory failed to perform and document calibration verification procedures as required during 2018. Findings include: 1. The laboratory uses a Beckman Coulter AU680 analyzer to conduct patient testing in the sub-specialty of Routine Chemistry, with an approximate annual test volume of 153,412. 2. No documentation was presented for review to indicate the laboratory performed a calibration verification at least once every six months during 2018, including at least a minimal (or zero) value, a mid- point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results. 3. Review of calibration verification documentation revealed the laboratory performed a calibration verification in May 2018, but no other documentation was provided for review to indicate the laboratory performed another calibration verification in 2018. 4. The facility personnel confirmed that the laboratory did not perform a calibration verification every six months in 2018 as required. 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. This STANDARD is not met as evidenced by: Based on review of test performance verification documentation for the Tosoh analyzer and interview with the facility personnel, the laboratory failed to identify errors found in the analytic systems. Findings include: 1. The laboratory began patient testing on the Tosoh analyzer in January 2020. 2. During the survey, review of performance verification documentation for the Tosoh analyzer revealed the laboratory name was listed as "Commonwealth Primary Care Laboratory" on all test validation documentation. 3. No

Summary Statement of Deficiencies D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on lack of calibration verification documentation for the Beckman AU680 chemistry analyzer and interview with the facility personnel, the laboratory failed to perform and document calibration verification procedures as required. Findings include: 1. The electrolytes included in testing of chemistry panels only include a two point calibration 2. No documentation was presented for review for October or November of 2017 to indicate the laboratory performed a calibration verification at 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 -- least once every six months for the electrolytes tested under routine chemistry, including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results. The laboratory provided documentation of a calibration verification performed in April 2017 as part of the performance verification study and in May 2018, but no other documentation was presented for review. 3. The facility personnel confirmed that the laboratory did not perform a calibration verification every six months as required. -- 2 of 2 --