St Luke's Jerome Laboratory

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 Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D) and graded results from the College of American Pathologists (CAP), the laboratory failed to successfully participate and achieve an overall satisfactory score for two (2) of three (3) testing events in 2021 for the specialty of immunohematology. See D2162 D2162 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(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 2 -- Failure to achieve satisfactory performance for the same analyte 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 Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D), graded PT results from the College of American Pathologists (CAP) and telephone interview with the laboratory manager on 3/10/2022, the laboratory failed to achieve a satisfactory score in two (2) of three (3) consecutive testing events in 2021 for the specialty of immunohematology. The findings include: 1. A PT desk review of Report 155D and graded PT results from CAP identified that the laboratory failed to achieve a satisfactory score of 100 percent for the analyte D (Rho) typing. Analyte Year Event Score D (Rho) 2021 2 80% D (Rho) 2021 3 80% 2. A telephone interview with the laboratory manager on 3/10/2022 at 1:48 pm confirmed the above findings. -- 2 of 2 --

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 Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D) and graded results from the College of American Pathologists (CAP), the laboratory failed to successfully participate in PT for the analyte free thyroxine (freeT4) for two (2) of three (3) consecutive testing events. The findings include: 1. A PT desk review revealed the laboratory had unsatisfactory scores for the 2nd event of 2020 and the 3rd event of 2020 for free T4. See D2107. D2107 ENDOCRINOLOGY 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 -- CFR(s): 493.843(f) 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 Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D) and graded results from the College of American Pathologists (CAP), the laboratory failed to achieve satisfactory performance for the analyte free thyroxine (freeT4) in two (2) consecutive testing events. The findings include: 1. A PT desk review of report 155D and CAP graded results revealed that the laboratory failed to achieve satisfactory performance for the analyte free T4 in two (2) consecutive testing events. Subspecialty Year Event Score free T4 2020 2 0% free T4 2020 3 0% 2. The laboratory reports performing 320 free T4 test annually. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on a Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D) and graded results from the College of American Pathologists (CAP), the laboratory director failed to ensure the proficiency testing samples are tested as required under subpart H of this part. The finding include: 1. A PT desk review of report 155D and CAP graded results revealed that the laboratory failed to achieve satisfactory performance for the analyte free T4 in two (2) consecutive testing events. See D2016, D2107 2. The laboratory reports performing 320 free T4 test annually. -- 2 of 2 --

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 proficiency testing (PT) review and the laboratory's PT results from the American Association of Bioanalysts (AAB), the laboratory repeatedly failed to successfully participate in proficiency testing for the analytes Lactate Dehydrogenase and Partial Thromboplastin Time. Refer to D2096 and 2130. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- 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 proficiency testing (PT) review and the laboratory's PT results from the American Association of Bioanalysts (AAB), the laboratory failed to achieve satisfactory performance for the analyte Lactate Dehydrogenase (LDH) and has sustained a subsequent occurrence of unsuccessful participation in PT. Findings: Analyte Year Event Score LDH 2017 3 0 LDH 2018 1 0 LDH 2018 2 0 D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a proficiency testing (PT) review and the laboratory's PT results from the American Association of Bioanalysts (AAB), the laboratory failed to achieve satisfactory performance for the analyte Partial Thromboplastin Time (PTT) and has sustained a subsequent occurrence of unsuccessful participation in PT. Findings: Analyte Year Event Score PTT 2017 2 60 PTT 2017 3 40 PTT 2018 1 0 PTT 2018 2 20 D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on the deficiencies cited for subsequent unsuccessful performance in proficiency testing, the laboratory director failed to provide overall management and direction for the laboratory. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on a proficiency testing (PT) review and the laboratory's PT results from the American Association of Bioanalysts (AAB), the laboratory director failed to ensure that the laboratory maintained successful participation in proficiency testing for the analytes Lactate Dehydrogenase (LDH) and Partial Thromboplastin Time (PTT). -- 2 of 3 -- Findings: Analyte Year Event Score LDH 2017 3 0 LDH 2018 1 0 LDH 2018 2 0 Analyte Year Event Score PTT 2017 2 60 PTT 2017 3 40 PTT 2018 1 0 PTT 2018 2 20 -- 3 of 3 --

Summary Statement of Deficiencies 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 record review and an interview with the laboratory supervisor, the laboratory failed to establish and document unscheduled maintenance activities for the analyzers in the laboratory since the last survey on September 22, 2016. Findings: 1. A review of instrument maintenance and trouble-shooting logs revealed the laboratory failed to have a system in place to document unscheduled maintenance and trouble- shooting activities for the Sysmex CA-600, Sysmex XN-1000, and the Ortho Vitros analyzer. 2. An interview on August 14, 2018 at 3:45 PM, with the laboratory supervisor, confirmed the laboratory failed to establish and document unscheduled maintenance activities in for the analyzers in the laboratory. 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 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 -- 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 record review and an interview with the laboratory supervisor, the laboratory failed to perform and document calibration verification procedures at least once every 6 months for the D-dimer test performed on the Sysmex CA-600 coagulation analyzer since the last survey on September 22, 2016. Findings: 1. A record review of calibration reports for the D-dimer revealed the laboratory failed to perform calibration verification at least once every 6 months since the last survey. 2. An interview on August 15, 2018, at 1:30 PM, with the laboratory supervisor, confirmed the laboratory failed to perform calibration verifications on the D-dimer test. D5503 BACTERIOLOGY CFR(s): 493.1261(a)(2) (a) The laboratory must check the following for positive and negative reactivity using control organisms: (a)(2) Each week of use for gram stains. This STANDARD is not met as evidenced by: Based on a record review and an interview with the laboratory testing personnel, the laboratory failed to perform and document quality control at least each week of use for gram stain tests since the last survey on September 22, 2016. Findings: 1. A record review of the gram stains performed revealed the laboratory failed to perform and document quality control at least once per week or to write an Individualized Quality Control Plan. 2. An interview with the testing personnel on August 14, 2018 at 3:15 PM, confirmed the laboratory failed to perform quality control for gram stains. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a record review and an interview with the laboratory supervisor, the laboratory failed to perform and document alarm system inspections for the blood -- 2 of 4 -- storage refrigerator since the last survey on September 22, 2016. Findings: 1. A record review of the laboratory procedure manual and worksheets in the laboratory revealed the laboratory failed to perform and document alarm system checks for the blood storage refrigerator. 2. An interview on August 14, 2018 at 3:15 PM with the laboratory supervisor, confirmed the laboratory failed to perform inspections of the alarm system where blood products are stored. D6122 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(ii) The procedures for evaluation of the competency of the staff must include, but are not limited to monitoring the recording and reporting of test results. This STANDARD is not met as evidenced by: Based on a record review and an interview with the laboratory testing personnel, the technical supervisor failed to include the monitoring of reporting of test results in the competency evaluation for tests performed on the I-Stat Point-of -Care (POC) device since the last survey on September 22, 2016. Findings: 1. A review of the personnel competency evaluations for 2017 revealed the assessments failed to include monitoring of test results for 21 out of 21 POC testing personnel. 2. An interview on August 14, 2018 at 10:00 AM, with the laboratory testing personnel, confirmed the assessment forms failed to include the monitoring of test results. D6123 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Based on a record review and an interview with the laboratory testing personnel, the technical supervisor failed to include the review of intermediate test results or worksheets, quality control, proficiency testing, and preventative maintenance records in the competency evaluation for tests performed on the I-Stat Point-of -Care (POC) device since the last survey on September 22, 2016. Findings: 1. A review of the personnel competency evaluations for 2017 revealed the assessments failed to include the review of intermediate test results or worksheets, quality control, proficiency testing, and preventative maintenance records for 21 out of 21 POC testing personnel. 2. An interview on August 14, 2018 at 10:00 AM, with the laboratory testing personnel, confirmed the assessment forms failed to include the review of intermediate test results or worksheets, quality control, proficiency testing, and preventative maintenance records. D6124 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(iv) The procedures for evaluation of the competency of the staff must include, but are not limited to direct observation of performance of instrument maintenance and function checks. -- 3 of 4 -- This STANDARD is not met as evidenced by: Based on a record review and an interview with the laboratory testing personnel, the technical supervisor failed to include the direct observation of performance of instrument maintenance in the competency evaluations for tests performed on the I- Stat Point-of -Care (POC) device since the last survey on September 22, 2016. Findings: 1. A review of the personnel competency evaluations for 2017 revealed the assessments failed to include the direct observation of performance of instrument maintenance for 21 out of 21 POC testing personnel. 2. An interview on August 14, 2018 at 10:00 AM, with the laboratory testing personnel, confirmed the assessment forms failed to include the direct observation of performance of instrument maintenance. D6125 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on a record review and an interview with the laboratory testing personnel, the technical supervisor failed to include the test performance through blind testing or proficiency testing in the competency evaluations for tests performed on the I-Stat Point-of -Care (POC) device since the last survey on September 22, 2016. Findings: 1. A review of the personnel competency evaluations for 2017 revealed the assessments failed to include test performance through blind testing or proficiency testing for 21 out of 21 POC testing personnel. 2. An interview on August 14, 2018 at 10:00 AM, with the laboratory testing personnel, confirmed the assessment forms failed to include the test performance through blind testing or proficiency testing. -- 4 of 4 --

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 proficiency testing (PT) desk review, the laboratory failed to successfully participate in proficiency testing for the analyte Lactate Dehydrogenase, Total. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 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 -- unsuccessful performance. This STANDARD is not met as evidenced by: Based on proficiency testing (PT) desk review and the laboratory's graded PT results from the American Association of Bioanalysts (AAB), the laboratory failed to achieve successful performance for the analyte Lactate dehydrogenase, total (LDH) in two out of three testing events. Findings: Analyte Year Event Score LDH 2017 3 0% LDH 2018 1 0% -- 2 of 2 --

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 proficiency testing desk review, the laboratory failed to successfully participate in proficiency testing for the analyte Partial Thromboplastin time (PTT). Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful 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 proficiency testing (PT) desk review and the laboratory's graded PT results American Association of Bioanalysts (AAB), the laboratory failed to achieve successful performance for the analyte Partial Thromboplastin time (PTT) in two out of three testing events. Findings: Analyte Year Event Score PTT 2017 2 60% PTT 2017 3 40% -- 2 of 2 --