Birmingham Internal Medicine Associates

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) 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 Urgent Care Hematology maintenance records, the Sysmex XP-300 user manual, and an interview with the Technical Consultant (TC), the Urgent Care Laboratory failed to document weekly maintenance on the Sysmex XP-300 Hematology analyzer as per the manufacturer's requirements for twelve of twelve months in 2023. The findings include: 1. A review of the Sysmex XP-300 Hematology analyzer records revealed no documentation of weekly maintenance for the year of 2023. 2. A further review of the Sysmex XP-300 Hematology user manual revealed, "Weekly: Clean the SRV tray." 3. During an interview on 1/30/2025, at 1: 10 PM, the TC confirmed the above findings. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) (a )Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (a)(1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (a)(2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (a)(2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (a) (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (a)(3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration 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 -- verification. This STANDARD is not met as evidenced by: Based on a review of the Hematology records, the Quality Assurance (QA) plan, and an interview with the Technical Consultant (TC), the Laboratory failed to perform calibrations on the Sysmex XP-300 Hematology analyzer every six months as per the QA policy. The laboratory failed to perform one of two calibrations due in 2024. The findings include: 1. A review of the Hematology calibration records revealed the Sysmex XP-300 was last verified on 4/3/2024. There was no evidence of documentation for a calibration the second half of 2024. 2. A further review of the QA plan revealed on page 3 "Calibrations are done according to manufacturer's recommendations and at least every six months." 3. During an interview on 1/30 /2025, at 2:15 PM, TC confirmed the calibration due in the second half of 2024 was not performed. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) (d) 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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493. 1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (d)(3) At least once each day patient specimens are assayed or examined perform the following for: This STANDARD is not met as evidenced by: Based on a review of the Urgent Care Cardiac and D-dimer Triage QC (Quality Control) records, the Triage IQCP (Individualized Quality Control Plan), and an interview with the Technical Consultant, the Laboratory failed to ensure testing personnel performed the Triage QC every 30 days as per the IQCP. The surveyor noted 2 out of 12 months in 2023 when QC was not performed as required by the IQCP. The findings include: 1. A review of the Urgent Care Triage records for #83311 and #83646 revealed the laboratory exceeded the 30-day requirements for external Cardiac and D-dimer QC for November and December 2023. 2. A review of the Triage IQCP revealed, "Assay a high and low QC material.... every 30 days." 3. During an interview on 1/30/25 at 1:10 PM, the Technical Consultant confirmed the above findings. D5781

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 a review of API (American Proficiency Institute) Proficiency Testing (PT) and API Hematology Verification survey records, Quality Assurance (QA) Policies and Procedures (P&P), and an interview with Testing Personnel #1, the laboratory failed to: (I) document Hematology Verification survey evaluations, and (II) implement a QA policy specifying how to perform Hematology Verification surveys evaluations and how acceptable parameters were determined. This was noted from the previous survey on 4/22/2021 to the current survey on 1/5/2023. The findings include: 1. During the entrance tour on 1/4/2023 from 10:30 to 11:00 AM, Testing Personnel #1 (also the QA Supervisor) stated CBC's (Complete Blood Counts) were performed in the main lab on the Sysmex XS-1000i, and in the Urgent Care area on the Sysmex XP-300. 2. A review of PT records revealed the laboratory elected to utilize API PT surveys compatible with the Sysmex XS-1000i analyzer in the main lab, and Hematology Verification surveys on the Sysmex XP-300 in Urgent Care. 3. A review of the API evaluations revealed scores, expected ranges and participant comparison statistics for the Sysmex XS-1000i analyzer, however the API Hematology Verification survey "evaluations" did not include this information on the Sysmex XP- 300 for 2021-Events 1 and 3 or 2022 Events-1, 2, and 3. (The laboratory failed to run 2021-Event 2.) The laboratory failed to document what results were used for comparisons, the accuracy of the Sysmex XP-300, or if any problems were noted. 4. During an interview on 1/4/2023 at 1:45 PM, the surveyor asked how the API Hematology Verification surveys on the Sysmex XP-300 were evaluated. Testing Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- Personnel #1 explained the Hematology Verification surveys were run as per instructions from API, and she reviewed and compared the results with scores on line from the affiliated laboratories in Moody, Trussville and Springville, which also utilize the Sysmex XP-300. Testing Personnel #1 further stated she utilized Hematology Verification surveys for the Sysmex XP-300 because this was what API suggested. 5. As the interview continued on 1/4/2023 at approximately 2:00 PM, Testing Personnel #1 printed the API 2021-Event #3 PT results from the Moody laboratory as an example of how she evaluated the Hematology Verification surveys. The surveyor then explained the Hematology Verification evaluations must be documented. The laboratory must also have a QA policy specifying the laboratory uses the Hematology Verification surveys for their proficiency testing, how the surveys are evaluated and what constituted acceptable parameters. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based a review of Abbott i-Stat records and an interview with Testing Personnel #1 (also the Quality Assurance Supervisor), the laboratory failed to perform and/or document software updates and function checks required by the manufacturer on the i- Stat instrument from the previous survey on 4/22/2021 to the current survey on 1/5 /2023. The findings include: 1. A review of the Abbott manufacturer's instructions revealed the following: A) A review of the i-Stat Technical Bulletin revealed "...it is necessary to update standardization values .. to maintain long-term consistency of performance. ...New CLEW software--delivered twice a year ...re-establishes these standardization values ...". B) A review of the Abbott i-Stat System Manual revealed "...A quality check is performed on the thermal probes each time the external Electronic Simulator is used. ...Therefore [Abbott] recommends that the thermal probe check be verified ever six months". 2. The laboratory was unable to provide documentation of the CLEW software updates, the external Electronic Simulator checks or the thermal probes checks during the survey. 3. During an interview on 1/5 /2023 at 2:20 PM Testing Personnel #1 stated she always performed the CLEW updates and function checks, however she did not realize she needed to document it. . 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, 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. -- 2 of 5 -- This STANDARD is not met as evidenced by: Based on a review of Hematology calibration records and an interview with Testing Personnel #1 (also the Quality Assurance Supervisor), the laboratory failed to ensure one of two Hematology analyzers was calibrated every six months as per the manufacturer's instructions. This affected one of two calibrations due in 2022 on the Sysmex XP-300. The findings include: 1. A review of Hematology calibration records revealed Sysmex calibrated the two Hematology analyzers during service calls every six months, and provided a "Certificate of Calibration Verification". 2. A review of records for the Sysmex XP-300 (located in the Urgent Care area) revealed a Certificate of Calibration Verification with the Certificate Date: May 4, 2022, and the Certificate Exp [Expiration] Date: October 31, 2022. However, there was no documentation of a second calibration performed in November 2022. 3. During an interview in 1/5/2023 at 10:00 AM, Testing Personnel #1 confirmed Sysmex had not performed the second calibration due in November 2022 because the Clinic Administration was negotiating a new service contract with one renewal period for all the instruments in multiple labs. Thus, Administration did not approve the estimate for the cost of a second calibration the end of 2022 on the Sysmex XP-300. . 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 Abbott i-Stat calibration verification records, a review of the calibration information in the on-line Abbott i-Stat System Manual, the laboratory's SOP (Standard Operating Procedure) and an interview with Testing Personnel #1(also the Quality Assurance Supervisor), the laboratory failed to perform calibration verification on the Abbott i-Stat CHEM8+ cartridges twice a year as required by CLIA regulations. This was noted from the previous survey (4/22/2021) to the current survey (1/5/2023). The findings include: 1. A review of the calibration information in the on-line Abbott i-Stat System Manual on page 41 of 659 revealed, "A one-point -- 3 of 5 -- calibration is performed each time a cartridge requiring calibration is used". Tests calibrated with less than three calibrators require calibration verification every six months, as per CLIA regulations. 2. A review of the Abbott i-Stat CHEM8+ SOP under "CALIBRATION:" revealed, "Calibration Verification procedure is intended to verify the accuracy of results over the entire measurement range of a test as may be required by regulatory ... bodies". The surveyor noted the procedure failed to specify the required frequency of calibration verification. 3. During an interview on 1/5/2023 at 10:32 AM, when the surveyor requested calibration verification (C-V) records for the Abbott i-Stat, Testing Personnel #1 stated she did not know C-V on the Abbott i- Stat CHEM8+ cartridges was required, and confirmed the laboratory had not performed the procedure since the initial installation (3/17 to 3/18/2020). . D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of Quality Control (QC) records from the Sysmex XP-300 Hematology analyzer and an interview with Testing Personnel #1 (also the Quality Assurance Supervisor), the laboratory failed to have a mechanism in place to allow review of the CBC (Complete Blood Count) QC for shifts and trends for the previous two months. This affected QC performed from 11/17/2022 to the date of the survey on 1/5/2023. The findings include: 1. A review of 2021-2022 Sysmex XP-300 records revealed the laboratory utilized Levy-Jennings (L-J) charts printed from the LaB DaQ Laboratory Information System (LIS) and Sysmex Insight reports to monitor for shifts and trends in the CBC QC until 11/17/2022. 2. During an interview on 1/5/2023 at 2: 05 PM the surveyor asked how the laboratory monitored for shifts and trends in the Sysmex XP-300 QC after 11/17/2022; Testing Personnel #1 explained as of 11/17 /2022 the computer configuration in the Urgent Care area (where the Sysmex XP-300 is located) changed from the LaB DaQ LIS to Relay Med. The laboratory can no longer print the QC data with the L-J charts. Testing Personnel #1 and the the Laboratory Consultant confirmed the laboratory had not implemented a new mechanism to track CBC QC shifts and trends. . D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. -- 4 of 5 -- This STANDARD is not met as evidenced by: Based on a review of the test menu and analyzers, and an interview with Testing Personnel #1 (also the Quality Assurance Supervisor), the laboratory failed to implement procedures to ensure test results from the two Hematology analyzers were compared and evaluated twice a year. This affected CBC's (Complete Blood Counts) from the previous survey (4/22/2021) to the current survey (1/5/2023). The findings include: 1. During the entrance tour on 1/4/2023 from 10:30 to 11:00 AM, Testing Personnel #1 stated CBC's were performed in the main laboratory on the Sysmex XS- 1000i, and in the Urgent Care area on the Sysmex XP-300. 2. During an interview on 1 /5/2023 at 10:30 AM Testing Personnel #1 confirmed the laboratory had not implemented a mechanism to compare results on the two Hematology instruments. SURVEYOR ID# 32558 Licensure and Certification Surveyor -- 5 of 5 --

Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on a review of the test menu with the Laboratory Manager, record reviews and interviews, the surveyor determined the laboratory failed to report SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronovirus 2) test results for negative Coronovirus Disease 2019 (COVID-19), performed using Abbott ID NOW COVID - rapid antigen testing. The laboratory begin testing for COVID-19 on 11/02/2020 and performed 2230 tests from date of implementation. The laboratory failed to report 1727 negative results for SARS-CoV-2 for the COVID-19 antigen test results to the Alabama Department of Public Health (ADPH); although positive results were reported to the Report Card for (ADPH). Findings include: 1. During the tour of the laboratory at 9:30 AM on April 21, 2021, the laboratory manager stated the laboratory used the rapid antigen testing by Abbott ID Now to perform COVID testing. From the start date of this testing, 11/02/2020, to April 21, 2021, the laboratory staff performed and resulted 2230 total tests, with 1727 of these tests being negative, which were not reported to the State Health Department. These totals were received via fax on 4/28 /2021. 2. At 10:29 AM on April 21, 2021, the Laboratory Manager (LM) stated another employee said the laboratory was not required to report the negative test 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 -- results, only the positives. The surveyor discussed with the LM the separate mechanism, than the REPORT CARD, to ensure all negative test results are reported. During the exit interview, at 4:56 - 5:30 PM, the office staff confirmed the negative COVID results were not reported, and confirmed only positive results were submitted to ADPH via the REPORT CARD. The surveyor discussed the requirement to report positive and negative COVID test results. Note: The Report Card has the following statement "If you are a Laboratorian, reporting on behalf of a laboratory, blood bank, or plasma center, the REPORT Card is not the mechanism you should use to report a patient that has a reportable disease or health condition." 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 a review of the Chemistry calibration verification records (a lack of documentation for 2018 and 2019) and interviews with Testing Personnel (TP) #1, who is also the Laboratory Manager, and the Quality Assurance Manager, the surveyor determined the laboratory failed to perform calibration verifications for Hemoglobin A1c (Hgb A1c), tested on the Tosoh G8, in 2018 and 2019; and failed to perform calibration verifications for analytes tested on the Beckman Coulter AU 680, at least every 6 months, between June, 2018 and June of 2019. This is a repeat deficiency. The findings include: 1. The laboratory failed to provide documentation the staff performed calibration verifications for Hgb A1c, performed on the Tosoh G8, for 2018 and 2019. A routine calibration for this analyte requires only two calibrators, hence, a calibration verification should be performed at least every six months. 2. The laboratory failed to provide documentation the staff performed a calibration verification for Chemistry analytes tested on the AU 680, at a six-months interval between June 25, 2018 and June 3, 2019. The analytes are routinely calibrated using one or two calibrators. 3. In an interview on April 21, 2021 at 3:00 PM, the surveyor requested the calibration verifications for the AU 680 from the laboratory manager and the Tosoh for 2018 and 2019. The laboratory manager believed the records may have been stored in an offsite ware-house. The surveyor discussed the missing records -- 2 of 3 -- with the Laboratory Manager and Quality Assurance Manager, again during the exit interview at 4:56 - 5:30 PM. The records were not provided during the survey, and the surveyor requested the laboratory staff send the records to the State Agency by noon on Friday, April 23, 2021. The records were not received. The cover-sheet of the fax indicated the laboratory staff did not find the calibration records for the Tosoh for 2018 and 2019, and nothing was indicated for the AU 680. -- 3 of 3 --

Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on a review of the test menu with the Laboratory Manager, record reviews and interviews, the surveyor determined the laboratory failed to report SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronovirus 2) test results for negative Coronovirus Disease 2019 (COVID-19), performed using Abbott ID NOW COVID - rapid antigen testing. The laboratory begin testing for COVID-19 on 11/02/2020 and performed 2230 tests from date of implementation. The laboratory failed to report 1727 negative results for SARS-CoV-2 for the COVID-19 antigen test results to the Alabama Department of Public Health (ADPH); although positive results were reported to the Report Card for (ADPH). Findings include: 1. During the tour of the laboratory at 9:30 AM on April 21, 2021, the laboratory manager stated the laboratory used the rapid antigen testing by Abbott ID Now to perform COVID testing. From the start date of this testing, 11/02/2020, to April 21, 2021, the laboratory staff performed and resulted 2230 total tests, with 1727 of these tests being negative, which were not reported to the State Health Department. These totals were received via fax on 4/28 /2021. 2. At 10:29 AM on April 21, 2021, the Laboratory Manager (LM) stated another employee said the laboratory was not required to report the negative test 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 -- results, only the positives. The surveyor discussed with the LM the separate mechanism, than the REPORT CARD, to ensure all negative test results are reported. During the exit interview, at 4:56 - 5:30 PM, the office staff confirmed the negative COVID results were not reported, and confirmed only positive results were submitted to ADPH via the REPORT CARD. The surveyor discussed the requirement to report positive and negative COVID test results. Note: The Report Card has the following statement "If you are a Laboratorian, reporting on behalf of a laboratory, blood bank, or plasma center, the REPORT Card is not the mechanism you should use to report a patient that has a reportable disease or health condition." 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 a review of the Chemistry calibration verification records (a lack of documentation for 2018 and 2019) and interviews with Testing Personnel (TP) #1, who is also the Laboratory Manager, and the Quality Assurance Manager, the surveyor determined the laboratory failed to perform calibration verifications for Hemoglobin A1c (Hgb A1c), tested on the Tosoh G8, in 2018 and 2019; and failed to perform calibration verifications for analytes tested on the Beckman Coulter AU 680, at least every 6 months, between June, 2018 and June of 2019. This is a repeat deficiency. The findings include: 1. The laboratory failed to provide documentation the staff performed calibration verifications for Hgb A1c, performed on the Tosoh G8, for 2018 and 2019. A routine calibration for this analyte requires only two calibrators, hence, a calibration verification should be performed at least every six months. 2. The laboratory failed to provide documentation the staff performed a calibration verification for Chemistry analytes tested on the AU 680, at a six-months interval between June 25, 2018 and June 3, 2019. The analytes are routinely calibrated using one or two calibrators. 3. In an interview on April 21, 2021 at 3:00 PM, the surveyor requested the calibration verifications for the AU 680 from the laboratory manager and the Tosoh for 2018 and 2019. The laboratory manager believed the records may have been stored in an offsite ware-house. The surveyor discussed the missing records -- 2 of 3 -- with the Laboratory Manager and Quality Assurance Manager, again during the exit interview at 4:56 - 5:30 PM. The records were not provided during the survey, and the surveyor requested the laboratory staff send the records to the State Agency by noon on Friday, April 23, 2021. The records were not received. The cover-sheet of the fax indicated the laboratory staff did not find the calibration records for the Tosoh for 2018 and 2019, and nothing was indicated for the AU 680. -- 3 of 3 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a review of the API (American Proficiency Institute) Proficiency Testing records, and an interview with Testing Personnel #1 (also the Quality Coordinator), the surveyor determined the laboratory failed proficiency testing for CK-MB Isoenzymes in the 2017-Event #3 and the 2018-Event #1 Chemistry surveys, resulting in "Initial Unsuccessful Performance" for this analyte. (Refer to D2096.) . D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the API (American Proficiency Institute) Proficiency Testing records, and an interview with Testing Personnel #1 (also the Quality Coordinator), the surveyor determined the laboratory failed proficiency testing for two consecutive testing events for CK-MB Isoenzymes in the 2017-Event #3 and the 2018-Event #1 Chemistry surveys, resulting in "Initial Unsuccessful Performance" for this analyte. The findings include: 1. A review of the API (American Proficiency Institute) Proficiency Testing records revealed the following failing scores for CK-MB Isoenzymes: A) 2017-Event #3: 40% B) 2018-Event #1: 20% 2. In an interview on 8/2 /2018 at 8:30 AM, Testing Personnel #2 reviewed and confirmed the above noted 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 reviews of the temperature/humidity records, environmental requirements for the Sysmex XP-300 Hematology analyzer as stated in the Operator's Manual, and an interview with Testing Personnel (TP) #2 (also the Quality Coordinator), the surveyor determined the laboratory failed to monitor and document room temperature and humidity within the satellite laboratory each day patient CBC (Complete Blood Count) testing for February thru April 2018. The findings include: 1. A review of the temperature/humidity records revealed logs for the Building 1 satellite laboratory for May-July 2018. Testing Personnel performed CBC testing at that location using the Sysmex XP-300 Hematology analyzer. 2. A review of the Sysmex XP-300 Instructions for Use manual on page 2-2 under "Installation" revealed, "...Use the instrument in places where ambient temperatures ranges between 15 degrees C (Celsius) and 30 degrees C...", and "...relative humidity ranges between 30 - 85%." 3. During an interview on 8/2/2018 at 10:45 AM, TP #2 was asked about the timeline for the laboratory relocation and the opening of the satellite laboratory. TP #2 explained the main laboratory was in Building 1 until November 2017, and then they moved to a larger space in Building 3. However, to accommodate physician still in Building 1, the laboratory reopened a "satellite lab", installed a new Sysmex XP-300, and began patient testing in February 2018. When asked if the laboratory had monitored the temperature and humidity to ensure the analyzer was operated within the environmental parameters specified by the manufacturer, TP #2 confirmed they had not implemented monitoring until May 2018. Thus the above noted finding were confirmed. . -- 2 of 4 -- 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, 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 installation and calibration records for the Sysmex XP-300 Hematology analyzer (used in the Building 1 satellite lab for Complete Blood Count testing), the Sysmex XS-1000i records, and an interview with Testing Personnel (TP) #2 (also the Quality Coordinator), the laboratory failed to perform a calibration in April 2018 after the six-month expiration of the previous calibration, performed during the installation of the instrument. The findings include: 1. A review of records for the Sysmex XP-300 Hematology analyzer revealed the instrument was calibrated during the installation procedures on 10/26/2017. A review of the "Calibration Certificate" revealed the expiration date for the calibration was 4/24/2018, however there was no documentation of a second calibration until 7/22/2018. 2. A review of the records for the Sysmex XS-1000i Hematology analyzer (in the Building 3 main Laboratory) revealed Sysmex Technical Support had performed a calibration on the XS-1000i on 4/23/2018. 3. During an interview on 8/2/2018 at 9:30 AM, TP #2 was asked if the Sysmex Technician had also performed a calibration on the Sysmex XP- 300 on 4/23/2018 when he was on site for the Sysmex XS-1000i maintenance. TP #2 reviewed the calibration records, and stated she did not know why the Sysmex tech had not performed the calibration on the XP-300 at the same time. She stated the XP- 300 was not calibrated until 7/22/2018, thus confirming the above noted 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 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 -- 3 of 4 -- 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 reviews of the calibration and calibration verification (C-V) records for the Tosoh G8 and the Beckman Coulter AU 680 Chemistry analyzers, and an interview with Testing Personnel (TP) #2 (also the Quality Coordinator), the laboratory failed to perform and document calibration verifications every six months as required by the laboratory policy. The findings include: 1. A review of the calibration records for the Tosoh G8 analyzer (which performs Glycohemoglobin or Hemoglobin A1c testing) revealed the tests were calibrated using two calibrators. A review of the calibration records for the AU 680 Chemistry analyzer revealed all analytes were calibrated using kits with only one or two calibrators. Tests using less than three calibrators require a C-V every six months. 2. A review of the records for the Tosoh G8 revealed a C-V was performed on the following dates: A) 6/02/2016 (reviewed during the previous survey) B) 7/25/2017 (more than one year after the previous C-V) C) 6/25/2018 (eleven months after the previous C-V) 3. A review of the records for the AU 680 Chemistry analyzer revealed a C-V for all analytes was performed on the following dates: A) 10/17/2016 B) 10/18/2017 (one year after the previous C-V) C) 6/12/2018 (eight months after the previous C-V) 4. During an interview on 8/2/2018 at 9:25 AM, when asked how often a CV should be performed, TP #2 stated, "We are supposed to run a C-V every six months". TP #2 further explained some C-V's had been missed in 2017 due to a period with no Laboratory Manager, high employee turnover, and poorly organized records. Thus the above noted findings were substantiated. 5. This is a repeat deficiency. SURVEYOR:Laura T. Williams, BS, MT (ASCP) Licensure and Certification Surveyor -- 4 of 4 --