Jefferson County Hospital

Summary Statement of Deficiencies D6092 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iv) The laboratory director must ensure an approved

Summary Statement of Deficiencies D0000 The following condition level deficiencies were cited: D2016 - 42 C.F.R. 493.803 Condition: Successful participation, proficiency testing D6076 - 42 C.F.R. 493.1441 Condition: Laboratory Director, high complexity 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 surveyor desk review of the laboratory proficiency testing records (graded copies from the American Proficiency Institute and the CASPER report 0155D from the Centers for Medicare and Medicaid Services data system) on 6/14/2023, the 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 -- laboratory failed to maintain satisfactory performance in three of three testing events (2022-Event 2, 2022-Event 3, and 2023-Event 1) resulting in unsuccessful participation in Immunohematology for Compatibility Testing. Refer to D2181. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory for 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 surveyor desk review of the laboratory proficiency testing records (graded copies from the American Proficiency Institute and the CASPER report 0155D from the Centers for Medicare and Medicaid Services data system) on 6/14/2023, the laboratory has not successfully performed proficiency testing for Compatibility Testing in three of three testing events. Findings include: A review of the laboratory records from the American Proficiency Institute and the CMS CASPER report 0155D revealed the laboratory scored the following for three of three testing events for Compatibility Testing: : Year 2022-2nd Event: 80% Year 2022-3rd Event: 80% Year 2023-1st Event: 80% 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 surveyor desk review of the laboratory proficiency testing records (graded copies from the American Proficiency Institute and the CASPER report 0155D from the Centers for Medicare and Medicaid Services data system) on 6/14/2023, the laboratory director failed to provide overall management and direction for ensuring Immunohematology proficiency testing was tested for three of three events as required under Subpart H. 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 surveyor desk review of the laboratory proficiency testing records (graded copies from the American Proficiency Institute and the CASPER report 0155D from the Centers for Medicare and Medicaid Services data system) on 6/14/2023, the laboratory director failed to ensure Immunohematology proficiency testing was tested as required under subpart H. The laboratory failed to maintain satisfactory performance in three of three testing events (2022-Event 2, 2022-Event 3 and 2023- -- 2 of 3 -- Event 1) resulting in the subsequent unsuccessful participation for Compatibility Testing. Refer to 2181. -- 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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the American Proficiency Institute and the CASPER reports 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 2 /13/2023, the laboratory failed to maintain satisfactory performance in two of two testing events (2022 - Events 2 & 3) resulting in unsuccessful performance in Immunohematology for Compatibility Testing. Refer to D2181. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) 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 an overall testing event score of satisfactory for 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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the American Proficiency Institute and CASPER reports 0153D /0155D from the Centers for Medicare and Medicaid Services data system) on 2/13 /2023, the laboratory has not successfully performed proficiency testing for Compatibility Testing in two of two testing events. Findings include: A review of the laboratory records from the American Proficiency Institute and the CMS CASPER reports 0153D/0155D revealed the laboratory scored the following for Compatibility Testing: Year 2022 - 2nd Event: 80% Year 2022 - 3rd Event: 80% -- 2 of 2 --

Summary Statement of Deficiencies D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of personnel records since the last survey on 12/3/20, the CMS 209 personnel form, and lack of documentation of training, the laboratory director failed to ensure Testing Personnel #10, #11, #13, #14, #15, and #17 received appropriate training for performing blood gas testing with the Opti CCA-TS blood gas analyzer, prior to testing patients' blood gas specimens. Findings include: Review of personnel records since the last survey on 12/3/20 and the CMS 209 personnel form revealed the following testing personnel had no documentation of training for performing blood gas testing on the Opti CCA-TS blood gas analyzer, prior to testing patients' blood gas specimens: Testing Personnel #10 (date of hire 5/9/22) Testing Personnel #11 (date of hire 6/1/21) Testing Personnel #13 (date of hire 12/6/21) Testing Personnel #14 (date of hire 11/1/21) Testing Personnel #15 (date of hire 5/13/22) Testing Personnel #17 (date of hire 7/11/22) D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the 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 -- performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of personnel records since the last survey on 12/3/20, the CMS 209 personnel form, and lack of documentation of semiannual evaluations, the technical consultant failed to evaluate and document the performance of Testing Personnel #11, #12, #13, and #14, responsible for moderate-complexity blood gas testing, at least semiannually during the first year these individuals tested patients' blood gas specimens. Findings include: Review of personnel records since the last survey on 12 /3/20 and the CMS 209 personnel form revealed the technical consultant failed to evaluate and document the performance of the following testing personnel for blood gas testing on the Opti CCA-TS blood gas analyzer at least semiannually during the first year these individuals tested patients' blood gas specimens: Testing Personnel #11 (date of hire 6/1/21) Testing Personnel #12 (date of hire 8/2/21) Testing Personnel #13 (date of hire 12/6/21) Testing Personnel #14 (date of hire 11/1/21) D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of personnel records since the last survey on 12/3/20, the CMS 209 personnel form, and lack of documentation of annual evaluations, the technical consultant failed to evaluate and document the performance of Testing Personnel #11 and #12, responsible for moderate-complexity blood gas testing, at least annually. Findings include: Review of personnel records since the last survey on 12/3/20 and the CMS 209 personnel form revealed the technical consultant failed to evaluate and document the performance of the following testing personnel for blood gas testing on the Opti CCA-TS blood gas analyzer at least annually: Testing Personnel #11 (date of hire 6/1/21) Testing Personnel #12 (date of hire 8/2/21) -- 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: 1. Based on review of calibration verification records for the Triage Meter Pro analyzer since installation on 3-23-17, interview with the technical consultant on 7-17- 18 at 9:30 a.m., and review of quality control and patient test logs, the laboratory failed to document, as performed, calibration verification for D-dimer testing at least once every six months since 3-23-17. A total of fifteen patient D-dimer results were reported from 9-23-17, when D-dimer calibration verification was due, through 7-15- 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 -- 18. Findings include: Review of calibration verification records since installation of the Triage Meter Pro analyzer on 3-23-17 revealed no documentation of performance of calibration verification for D-dimer testing since 3-23-17. In an interview on 7-17- 18 at 9:30 a.m., the technical consultant, listed on the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, confirmed calibration verification has not been performed for D-dimer testing on the Triage Meter Pro analyzer since 3-23- 17. Review of D-dimer quality control and patient test logs revealed a total of fifteen patient D-dimer results were reported from 9-23-17, when D-dimer calibration verification was due, through 7-15-18. 2. Based on review of calibration verification records for Hemoglobin A1C testing performed on the Siemens Dimension EXL 200 analyzer since the last survey on 9-21-16 and interview with the technical consultant on 7-17-18 at 11:10 a.m., the laboratory failed to document, as performed, calibration verification for Hemoglobin A1C testing at least once every six months since 7-21-17. Findings include: Review of calibration verification records for Hemoglobin A1C testing performed on the Siemens Dimension EXL 200 analyzer since 9-21-16 revealed no documentation of performance of calibration verification since 7-21-17. In an interview on 7-17-18 at 11:10 a.m., the technical consultant confirmed calibration verification has not been performed for Hemoglobin A1C testing on the Siemens Dimension EXL 200 analyzer since 7-21-17. 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 review of quality control and patient test logs, patient test reports, instrument printouts for D-dimer testing with the Alere Triage Meter Pro from 5-10- 17 through 7-15-18, lack of documentation of an Individualized Quality Control Plan (IQCP), and interview with the technical consultant on 7-17-18 at 9:30 a.m., the laboratory failed to include two levels of control material each day of patient testing from 5-10-17 through 7-15-18, when a total of twenty-six patient D-dimer results were reported. Findings include: Review of quality control and patient test logs, patient test reports, and instrument printouts for D-dimer testing with the Alere Triage Meter Pro from 5-10-17 through 7-15-18 revealed a total of twenty-six patient D- dimer results were reported on the following days with no documentation of performance of two levels of control each day of patient testing: 5-10-17--Patient #29210 5-18-17--Patient #1031728 5-19-17--Patient #10027244 5-20-17--Patient #10027271 6-14-17--Patient #1036407 9-14-17--Patients #0008763 and #1033962 9- 15-17--Patient #0010545 9-20-17--Patient #10030858 9-21-17--Patients #213698 and #213665 10-18-17--Patient #1042996 10-26-17--Patient #10032101 11-30-17--Patient #10033285 12-18-17--Patients #1032272 and #1037385 1-5-18--Patient #1032817 1- 17-18--Patient #1043184 1-24-18--Patient #1043184 2-17-18--Patients #1043269 and #1036710 2-19-18--Patient #1034564 3-3-18--Patient #1043293 7-12-18--Patient #1043531 7-15-18--Patients #1040193 and #1036266 There was no documentation of establishment of an IQCP, required after 1-1-16 if two levels of control are not included each day of patient testing. In an interview on 7-17-18 at 9:30 a.m., the technical consultant confirmed an IQCP was not developed for D-dimer testing. -- 2 of 2 --