Winfield Neurology Family Medicine

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. 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 the Technical Consultant, the Laboratory Director failed to sign the PT attestation statements. This was noted for two of seven events reviewed in 2024. The findings include: 1. A review of the API PT records revealed no signature by the Laboratory Director (or qualified designee) on attestation statements for the following surveys: a) 2024 Chemistry 1st Event. b) 2024 Chemistry 2nd Event. 2. During an interview on 8/13/24, at 10:22 AM, the Technical Consultant confirmed the above findings. 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 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 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 a review of calibration verification (C-V) records, the Free Thyroxine (FT4) C-V policy and procedure, and an interview with the Technical Consultant, the laboratory failed to ensure C-V was performed and documented on the Qualigen FastPack analyzer for FT4 for the second half of 2023 (one of three 2023-2024 C-V's missed). The findings include: 1. A review of the FT4 C-V records for the Qualigen FastPack analyzer revealed C-V documentation on 5/8/23 and then a year later on 5/16 /24. There was no evidence of a C-V performed and documented the second half of 2023. 2. A further review of the FT4 Calibration Verification Records revealed, "Complete the system method verification every 6 months..." 3. During an interview on 8/13/24 at 3:52 PM, the Technical Consultant confirmed the above findings. D5781

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 a review of QuantStudio Real-Time PCR System procedures, API (American Proficiency Institute) proficiency testing (PT) records, lack of Split Testing records, and interviews with the Testing Personnel #1 and #2, the laboratory failed to verify accuracy for the Respiratory Panel, Urinary Tract Infection Panel, and Wound /Infection Panel on the QuantStudio Real-Time PCR System (a non-regulated high- complexity test) since starting patient testing in December 2019. The findings include: 1. A review of the Med 360 Laboratory Protocol Determination of Respiratory Pathogens using Real-Time Reverse Transcriptase Quantitative Polymerase Chain Reaction (RT-QPCR) and Med 360 Laboratory Protocol Determination of Urinary Tract Infection Pathogens using Real-Time Reverse Transcriptase Quantitative Polymerase Chain Reaction (RT-QPCR) revealed in 12.0 Proficiency Testing "12.1 Enrollment...Further, PT will be performed by Split Sampling of Pathogen with a certified laboratory two times per calendar year for all analytes." 2. A review of the API proficiency testing records revealed that PT was not performed on the QuantStudio Real-Time PCR System for Respiratory, Urinary Tract Infection, and Wound/Infection Pathogens. 3. A review of the Split Testing Records for QuantStudio Real-Time PCR System revealed instrument printouts from Winfield Neurology Family Medicine (3-11-2020) were split testing was performed with Assurance Laboratory. However, there was no evaluation to determine accuracy of the Split Testing Performed. A second split testing for 2020 was not observed by the surveyor. 4. During an interview on 04/08/2021 at 1:52 PM, Testing Personnel #1 and #2 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 -- confirmed they sent their results to Assurance Laboratory for Split Testing but did not receive an evaluation back for the Laboratory Director and laboratory to review results for accuracy. 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 review of QuantStudio Real-Time PCR System procedures, pipettes and centrifuge calibration records, and interviews with the Testing Personnel #1 and #2, the laboratory failed to perform maintenance for pipettes and centrifuges as established in the procedure for the Respiratory Panel and Urinary Tract Infection Panel on the QuantStudio Real-Time PCR System since starting patient testing in December 2019. The findings include: 1. A review of the Med 360 Laboratory Protocol Determination of Respiratory Pathogens using Real-Time Reverse Transcriptase Quantitative Polymerase Chain Reaction (RT-QPCR) and Med 360 Laboratory Protocol Determination of Urinary Tract Infection Pathogens using Real- Time Reverse Transcriptase Quantitative Polymerase Chain Reaction (RT-QPCR) revealed in 13.0 Maintenance "13.1 Pipettes All pipettes in the laboratory are calibrated prior to initial use (by the manufacturer) and every 6 months thereafter..." 2. A review of the Med 360 Laboratory Protocol Determination of Urinary Tract Infection Pathogens using Real-Time Reverse Transcriptase Quantitative Polymerase Chain Reaction (RT-QPCR) revealed in 13.0 Maintenance "13.3 Centrifuges All centrifuges (plate and microcentrifuge) in use in the laboratory are calibrated prior to initial use (by the manufacturer) and every year thereafter." 3. A review of pipette calibration records revealed the calibration was performed 10/09/2019 and 11/11 /2020. A review of centrifuge calibration revealed the laboratory did not have records for the two previous and new centrifuges used for the QuantStudio Real-Time PCR System. 4. During an interview on 04/08/2021 at 2:00 PM, Testing Personnel #1 and #2 confirmed the pipette calibration was not performed every six months. 5. During an interview on 04/08/2021 at 2:00 PM, Testing Personnel #1 confirmed the current centrifuges (two) are new and was not sure if the calibrations were retained from the manufacturer. 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 a review of the procedure manual and an interview with Testing Personnel #2, the laboratory failed to perform calibrations verifications at least every six months as per CLIA regulations and laboratory's procedures for the QuantStudio Real-Time PCR System. The findings include: 1. A review of the Med 360 Laboratory Protocol Determination of Respiratory Pathogens using Real-Time Reverse Transcriptase Quantitative Polymerase Chain Reaction (RT-QPCR) and Med 360 Laboratory Protocol Determination of Urinary Tract Infection Pathogens using Real-Time Reverse Transcriptase Quantitative Polymerase Chain Reaction (RT-QPCR) revealed in 8.3 Qualitative Cut-Off "...The qualitative cutoff will be re-established every six months." 2. During an interview at 1:40 PM on 04/08/2021, Testing Personnel #2 confirmed the laboratory currently uses the cutoff values confirmed during initial validation (12/09/2019) and did not re-establish the cut-off values every six months since validation. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of the personnel records and an interview with Testing Personnel #2, the Technical Supervisor failed to evaluate and document the performance of the individual performing QuantStudio Real-Time PCR System at least semiannually during the first year of patient testing. This was noted on one of one personnel records for QuantStudio Real-Time PCR System reviewed by the surveyor. The finding include: 1. A review of the personnel records revealed Testing Personnel # 2 semiannual evaluation was not performed for QuantStudio Real-Time PCR System. Testing Personnel #2 initial training was documented on 10/07/2019. 2. During an interview conducted on 04/08/2021 at 03:00 PM, Testing Personnel #2 confirmed the semiannual evaluation was not performed for QuantStudio Real-Time PCR System. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the -- 3 of 4 -- performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on a review of the personnel records and an interview with the Testing Personnel #2, the Technical Supervisor failed to evaluate and document the performance of the individual performing QuantStudio Real-Time PCR System at least annually after the first year of patient testing. This was noted on one of one personnel records for QuantStudio Real-Time PCR System reviewed by the surveyor. The finding include: 1. A review of the personnel records revealed Testing Personnel # 2 annual evaluation was not performed for QuantStudio Real-Time PCR System. Testing Personnel #2 initial training was documented 10/07/2019. 2. During an interview conducted on 04/08/2021 at 03:00 PM, Testing Personnel #2 confirmed the annual evaluation was not performed for QuantStudio Real-Time PCR System. -- 4 of 4 --

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a lack of documentation for the validation procedures for the DCA Vantage analyzer (used for Urine Microalbumin/Creatinine, a non-waived moderate- complexity test), patient test records, and an interview with Testing Personnel (TP #1), the surveyor determined the laboratory failed to ensure the verification of the manufacturer's performance specifications was performed, approved, signed and dated by the Laboratory Director before the instrument was used by the testing personnel for patient testing. The findings include: 1. During the entrance tour of the laboratory on 4 /5/2018 at approximately 8:30 AM, TP #1 included Urine Microalbumin/Creatinine performed on the DCA Vantage on the test menu. [The laboratory had this instrument during the previous survey on 5/17/2016, however it was not in use at that time.] 2. A review of the DCA Vantage records revealed no documentation of validation procedures performed to verify the manufacturer's performance specifications. 3. A review of test records stored in the DCA Vantage revealed patient testing began on 6 /13/2016. 4. During an interview on 4/5/2018 at 2:15 PM with TP #1, the surveyor explained new instruments required validation of precision, accuracy and reportable ranges of the tests as stated in the manufacturer's performance specifications, plus verification of the reference ranges for the laboratory's patient population. All validations must be reviewed and approved by the Laboratory Director before 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 -- beginning patient testing. TP #1 stated they had purchased the instrument from another physician's office, and she did not think any validation studies had been performed on the analyzer. Thus the above noted findings were confirmed. . D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of the maintenance procedures in the Operator's Manual for the DCA Vantage analyzer (used for Urine Microalbumin/Creatinine, a non-waived moderate-complexity test), a lack of maintenance records, and an interview with Testing Personnel (TP) #1, the surveyor determined the laboratory failed to perform and document the weekly and quarterly maintenance with the frequency required by the manufacturer for almost two years (from 6/13/2016 when patient testing began till the date of the survey on 4/5/2018). The findings include: 1. A review of the maintenance procedures for the DCA Vantage revealed documentation of the Optical Check performed on 7/20/2016 and 1/2/2017. There was no other documentation of maintenance for this analyzer. 2. A review of the Maintenance procedures on page 97 in the DCA Vantage Operator's Manual, revealed the following: "...Weekly Cleaning the on-board barcode reader window Cleaning the exterior Quarterly Removing and cleaning the cartridge spring and cartridge area Changing the air filter Optical Test" As needed procedures were also listed in the manual. 3. During an interview on 4/5 /2018 at 2:30 PM, the above procedures were reviewed with TP #1, who stated she performed some of the above maintenance, but had not documented it. Thus the above noted finding were confirmed. . D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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 for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on reviews of the quality control records for the DCA Vantage analyzer (used for Urine Microalbumin/Creatinine, a non-waived moderate-complexity test), patient test records and an interview with Testing Personnel (TP) #1, the surveyor determined the laboratory failed to ensure two levels of quality control (QC) were performed each day of patient testing in the absence of an optional IQCP (Individualized Quality Assurance Plan) in 2016 thru 2018. The findings include: 1. A review of the QC records for Urine Microalbumin/Creatinine on the DCA Advantage revealed the Testing Personnel had performed QC seven times in 2016, and ten times in 2017; there was no record of QC performed in 2018. A further review of the records revealed no evidence an optional IQCP had been implemented to allow decreased frequency in QC testing. 2. During an interview on 4/5/2018 at 2:15 PM, when asked -- 2 of 4 -- about the frequency of QC performed on the DCA Advantage, TP #1 stated testing personnel performed QC whenever prompted to do so by the analyzer. TP #1 was then asked if patient testing was performed on other days when QC was not tested. TP #1 answered, "I'm sure we do." When asked if an optional IQCP had been implemented by the laboratory in 2016, TP #1 stated she did not know what an IQCP was. 3. A review of results stored in the DCA Vantage revealed Urine Microalbumin/Creatinine testing on patient samples was performed on days when no QC was run as follows: A) 2016: 101 patient tests performed B) 2017: 106 patient tests performed C) 2018: 22 patient tests performed 4. During the exit interview on 4/5/2018 at approximately 4:00 PM, the surveyor explained that CLIA regulations required two levels of QC each day of patient testing. However if a laboratory chooses to follow a manufacturer's recommendation of performing QC less frequently, the laboratory had the option of implementing an IQCP for the tests. TP #1 stated she was not aware of the requirement to implement an IQCP to allow for decreased QC testing. Thus, the above noted findings were confirmed. . D6036 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413 The technical consultant is responsible for the technical and scientific oversight of the laboratory. This STANDARD is not met as evidenced by: Based on a reviews of quality control (QC), maintenance and analyzer installation and validation records for the DCA Vantage analyzer (used for Urine Microalbumin /Creatinine, a non-waived moderate-complexity test), the Technical Consultant (also the Laboratory Director) failed to provide and document effective technical oversight of the laboratory in the following areas: A) Review of maintenance records to ensure maintenance on the DCA Vantage was performed and documented at the frequency specified by the manufacturer (Refer to D5429) B) Ensuring the development and implementation of an optional Individualized Quality Control Plan (IQCP) or two levels of QC each day of patient testing in 2016-2018 for Urine Microalbumin /Creatinine performed on the DCA Vantage (Refer to D5447) C) Ensuring the verification of the manufacturer's performance specifications was performed, approved, signed and dated before the DCA Vantage was used by the testing personnel for patient testing. (Refer to D5421 and D6040.) 2. During the exit summation on 4/5/2018 at 4:00 PM, these concerns were reviewed and confirmed with Testing Personnel #1. . D6040 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(2) The technical consultant is responsible for-- (b)(2) Verification of the test procedures performed and the establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. This STANDARD is not met as evidenced by: Based on a lack of documentation for the installation and validation procedures for the DCA Vantage analyzer (used for Urine Microalbumin/Creatinine, a non-waived moderate-complexity test), and an interview with Testing Personnel #1, the surveyor determined the Technical Consultant (also the Laboratory Director) failed to ensure -- 3 of 4 -- the verification of the manufacturer's performance specifications was performed, approved, signed and dated before the instrument was used by the testing personnel for patient testing. The findings include: 1. Refer to D5421. SURVEYOR:Laura T. Williams, BS, MT (ASCP)Licensure and Certification Surveyor -- 4 of 4 --