Chatuge Regional Hosp & Nursing Home

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on March 23, 2023. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following condition deficiencies were cited: D2016 - 42 CFR 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 CFR 493.1403 Condition: Moderate Complex Laboratory Director 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 review of the CASPER 155 report and review of the American Proficiency Institute (API) reports, the laboratory failed to maintain satisfactory proficiency 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 -- testing (PT) participation for Total Bilirubin (TBIL) in 2021 event 3, 2022 event 2 and 2023 event 1, resulting in a non initial unsuccessful participation for TBIL. Refer to D 2096 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 unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid (CMS) CASPER 155 report and review of American Proficiency Institute (API) reports, the laboratory failed to maintain satisfactory participation in three of five testing events ( 3rd event of 2021, 2nd event of 2022 and 1st event of 2023), resulting in a non initial unsuccessful participation for Total Bilirubin (TBIL). Findings: 1. A review of Casper Report 155 revealed the laboratory failed TBIL on the following: 2021 Event 3 TBIL Score 40% 2022 Event 2 TBIL Score 40% 2023 Event 1 TBIL Score 60% 2. A review of the laboratory's API Reports confirmed the laboratory failed T.BIL with the aforementioned scores. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of the CMS CASPER 155 report and review of American Proficiency Institute (API) reports, the laboratory director failed to provide overall management and direction for proficiency testing performance. The laboratory director failed to ensure proficiency testing samples were tested as required. Refer to D 6016 D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of the CMS CASPER Report 155 and the American Proficiency Institute (API) 2021, 2022, and 2023 PT evaluation reports, the laboratory director failed to ensure successful proficiency testing performance in three out of five testing -- 2 of 3 -- events (2021 event 3, 2022 event 2, and 2023 event 1) for Total Bilirubin (TBIL) resulting in the non-initial unsuccessful participation for TBIL. Refer to D2096 -- 3 of 3 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on September 14, 2022. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two of three consecutive events (3rd event of 2021 and 2nd event of 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 -- 2022), resulting in the first unsuccessful occurrence for Chemistry # 0245 including: Total Bilirubin (TBIL) # 305 and P02 Blood Gas # 325. Findings include: Refer to D 2096 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 unsuccessful performance. This STANDARD is not met as evidenced by: Based on proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two of three events (3rd event of 2021 and 2nd event of 2022), resulting in the first unsuccessful performance for T.Bili, analyte # 305 and P02 Blood Gas analyte #325. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte # 305 T.Bili on event 3 of 2021 with a score of 40% and event 2 of 2022 with a score of 40%. 2. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte # 325 P02 Blood Gas on event 3 of 2021 with a score of 60% and event 2 of 2022 with a score of 60%. 2. Desk review of the laboratory's proficiency testing reports from American Proficiency Institute (API) confirmed the laboratory failed the aforementioned analytes on Event 3 of 2021 and Event 2 of 2022 resulting in the first unsuccessful performance. 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two of three consecutive events (3rd event of 2021 and 2nd event of 2022), resulting in the first unsuccessful occurrence for T.Bili #305 and P02 #325. Findings include: See 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 desk review of the Centers for Medicare and Medicaid Casper Report 155D and 153D (CMS 155 and 153) and review of the laboratory's 2021 and 2022 -- 2 of 3 -- proficiency testing (PT) evaluation reports from the American Proficiency Institute (API) , the laboratory director failed to ensure the laboratory maintained satisfactory performance in two of three proficiency testing events for T.Bili #305 and P02 #325 resulting in the first unsuccessful PT occurrence. The findings included: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte # 305 T. Bili on event 3 of 2021 with a score of 40% and event 2 of 2022 with a score of 40%. 2. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte # 325 P02 Blood Gas on event 3 of 2021 with a score of 60% and event 2 of 2022 with a score of 60%. 2. Desk review of the laboratory's proficiency testing reports from American Proficiency Institute (API) confirmed the laboratory failed the aforementioned analytes on Event 3 of 2021 and Event 2 of 2022 resulting in the first unsuccessful performance. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on October 9, 2018. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) report, the laboratory failed to maintain satisfactory performance in event 1 of 2018 resulting in the first 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 -- unsuccessful occurrence for ABO blood group analyte # 865, Rhesus type D(RHO) analyte # 875, and compatibility testing, analyte # 895. Findings include: Refer to D 2155 D2155 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) report, the laboratory failed to maintain satisfactory performance in event 2 of 2018 resulting in the first unsuccessful occurrence for ABO blood group analyte # 865, Rhesus type D(RHO) analyte # 875, and compatibility testing, analyte # 895. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analytes #865 ABO, #875 D(RHO) and #895 compatibility testing on event 1 of 2018 with a score of 0%. 2. Desk review of the laboratory's proficiency testing reports from API confirmed the laboratory failed the three analytes listed above on event 1 of 2018 for failure to participate, resulting in unsuccessful performance. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on an in-office desk review of proficiency testing records, the laboratory director failed to ensure the laboratory maintained compliance with successful performance in event 1 of 2018 resulting in unsuccessful occurrence for ABO blood group analyte # 865, Rhesus type D(RHO) analyte # 875, and compatibility testing, analyte # 895. Findings include: Refer to D 6016 D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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 -- 2 of 3 -- director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) report, the laboratory director failed to ensure the laboratory maintained satisfactory performance in event 1 of 2018 resulting in unsuccessful occurrence for ABO blood group analyte # 865, Rhesus type D(RHO) analyte # 875, and compatibility testing, analyte # 895. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analytes #865 ABO, #875 D(RHO) and #895 compatibility testing on event 1 of 2018 with a score of 0%. 2. Desk review of the laboratory's proficiency testing reports from API confirmed the laboratory failed the three analytes listed above on event 1 of 2018 for failure to participate, resulting in unsuccessful performance. -- 3 of 3 --

Summary Statement of Deficiencies D0000 Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on January 23, 2018. The laboratory was not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiency was cited: D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on policy and procedure manual (SOP) review, the laboratory failed to establish a written procedure for all tests, assays, and examinations performed by the laboratory. Findings include: 1. The laboratory failed to establish a written procedure for a sterility check of the bacteriology media. 2. The laboratory failed to establish a written procedure for quality control (QC) of the bacteriology media. 3. An interview with the laboratory supervisor on 1/23/18 at approximately 3 p.m. in a hospital room confirmed the laboratory SOP did not contain a procedure for bacteriology media sterility check or QC. 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) 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 -- -- (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 calibration document review and staff interview, the lab failed to calibrate the Penta 60 C+ and Pentra 80XL hematology analyzers every six (6) months as required by the manufacturer. Findings include: 1. Review of calibration data revealed the Pentra 60 C+ was calibrated 02/17/16, 04/28/16, 03/31/17, and 07/28/17. A span of 11 months for calibration between 2016 and 2017. 2. Review of calibration data revealed the Pentra 80 XL was calibrated 02/17/16, 05/05/16, 03/31/17, and 07/28/17. A span of 10 months for calibration between 2016 and 2017. 2. Interview with testing personnel #11 (CMS 209 form) on 01/23/18 at approximately 2 PM in a back hospital room, confirmed the time spans. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on quality control (QC) document review and staff interview, the laboratory failed to check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms, and to check each batch for sterility. Findings include: 1. QC document review revealed the laboratory failed to perform a sterility check for each batch of media for 2016, 2017, and 2018 thus far. 2. QC document review revealed the laboratory failed to check each batch of media for its ability to support growth. or, as appropriate, inhibit growth for each batch of media for 2016. 2017, and 2018 thus far. 2. An interview with the laboratory supervisor in a hospital room on 1/23/18 at approximately 3:00 p.m. confirmed a sterility check for each batch of media had not been performed nor a check for each batch of media to support or, as appropriate, inhibit growth for 2016, 2017, and 2018 thus far. -- 2 of 2 --