Saint Francis Physician Network, Llc

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: The laboratory failed to maintain satisfactory participation in two out of three proficiency testing (PT) events for the White Blood Cell Differential (WBC Diff) analyte resulting in the first unsuccessful proficiency testing (PT) occurrence for the WBC Diff analyte. (Refer to D2130) D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 -- events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services Casper report 155 (CMS 155) and the laboratory's 2021 event two and 2022 event one proficiency testing (PT) evaluation reports, the laboratory failed to maintain a satisfactory performance the White Blood Cell Differential (WBC Diff) analyte in two out of three PT events, resulting in the first unsuccessful PT occurrence for the WBC Diff analyte. The finding include: 1) Review of the CMS 155 revealed the following unsatisfactory PT scores for the WBC Diff analyte: 2021 Event two = 0% 2022 Event one = 40% 2) Review of the laboratory's 2021 PT evaluation report for event two revealed a score of 0% for 'Failure to Participate. 3) Review of the laboratory's 2022 PT evaluation report for event one revealed the following: a. Granulocytes: samples numbers HEM-02, HEM-03, HEM-04, HEM-05 scored as unacceptable in a score of 20%. b. Lymphocytes: sample numbers HEM-02, Hem-03, and HEM-05 scored as unacceptable in a score of 40%. c. Monocytes: sample numbers HEM-01 and HEM- 03 scored as unacceptable with a score of 60%, resulting in an overall score for the WBC Diff analyte of 40% and the first unsuccessful PT occurrence. -- 2 of 2 --

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 observation of the laboratory, review of the complete blood count (CBC) instrument records and interview with the technical consultant, the laboratory failed to perform calibration every six months, in 2019. The findings include: 1) Observation on July 29, 2019 at 1:20 p.m. of the laboratory revealed the Beckman Coulter AcT diff2 CBC instrument (serial number BB44317) in use for patient testing. 2) Review of the CBC instrument records revealed installation of the CBC instrument on 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 -- December 4, 2018, with no calibration performance at the six month due date, June 2019. 3) Interview on July 29, 2019 at 4:00 p.m. with the technical consultant confirmed the CBC instrument calibration due date was in June 2019, which was not performed. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on review of patient number one final complete blood count (CBC) report, the CBC instrument printout, the quality assessment (QA) plan, interview with testing personnel number two and the technical consultant, the laboratory failed to have an effective quality assessment plan for review of patient reports containing the date of performance, in 2019. The findings include: 1) Review of patient number one final CBC report revealed no date of performance on the electronic medical record (EMR) "In-House CBC w/Auto Diff" form. The "CBC w/auto diff flowsheet" for patient number one stated the date of performance as 07-02-19. 2) Review of the CBC instrument printout for patient number one revealed the date of performance as 06-27- 19. 3) Review of the QA plan revealed the patient test management does not include a review for date of performance and date of reporting. 4) Interview on July 29, 2019 at 3:45 p.m. with testing personnel number two confirmed patient number one CBC sample was collected on June 27, 2019, performed on June 27, 2019 and recorded on the EMR CBC records as performed on July 2, 2019 during the patient office visit. The patient CBC results are manually typed into the patient EMR and the CBC instrument printout is not scanned into the patient EMR. 5) Interview on July 29, 2019 at 4:00 p.m. with the technical consultant confirmed the date of performance for CBC testing is not reviewed with the patient test management review. The quality assessment plan does not include to review for date of performance and date of reporting. D6072 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(3) Each individual performing moderate complexity testing must adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. This STANDARD is not met as evidenced by: Based on review of the complete blood count (CBC) quality control (QC) records and interview with testing personnel number one, the testing personnel failed to follow the CBC QC policies when the CBC QC lot number changes, in 2019. The findings include: 1) Review of the CBC QC records revealed that from July 2, 2019 to July 24, 2019 the correct lot numbers, expiration dates, and acceptable limits were not entered into the CBC instrument with the new QC lot number change. The daily CBC QC instrument printouts were reviewed daily by testing personnel numbers one and two with no reorganization of incorrect lot numbers, expired dates and incorrect limits. 2) Interview on July 29, 2019 at 4:10 p.m. with testing personnel number one confirmed -- 2 of 3 -- that on July 2, 2019 to July 24, 2019, the CBC QC lot number samples were changed but the correct lot numbers, expiration dates and acceptable limits were not entered into the CBC instrument. The daily CBC QC instrument printouts were reviewed daily by testing personnel numbers one or two, but didn't clearly understand that the CBC QC lot numbers, expiration dates and acceptable limits needed to be updated with each shipment of new lot numbers. -- 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: The laboratory failed to maintain satisfactory participation for two out of three proficiency testing events for the hematology specialty resulting in the first unsuccessful proficiency testing (PT) occurrence for hematology. (Refer to D2122) D2122 HEMATOLOGY CFR(s): 493.851(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. 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 desk review of the Centers for Medicare and Medicaid Oscar Report 155 (CMS 155) and the laboratory's 2017 proficiency testing (PT) evaluation reports, the laboratory failed to maintain satisfactory performance for two out of three test events for the hematology specialty. The findings include: 1. Review of the CMS 155 report revealed the following unsatisfactory event scores for the hematology specialty: 2017 event one=0%, 2017 event 3=0%. 2. Review of the 2017 PT event one evaluation report revealed an event score of 0% for failure to participate. 3. Review of the 2017 PT event three evaluation report revealed an event score of 0% for failure to participate. -- 2 of 2 --