Gabrail Cancer Center

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 record review and an interview with the sole Testing Personnel (TP), the laboratory failed to successfully participate in a Proficiency Testing (PT) program for the non-waived automated white blood cell (WBC) differential (diff) testing performed under the specialty of Hematology. This deficient practice had the potential to affect 1179 out of 1179 patient WBC diff testing performed in this laboratory between the first and second PT testing events of 2023. Findings Include: 1. The laboratory failed to achieve a PT score of 80% (percent) for WBC diff testing in the first PT event in 2023 in the specialty of Hematology. (Refer to D2121) 2. The laboratory failed to achieve satisfactory performance for the same analytes; white 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 -- blood cell (WBC) differential (diff) and percent monocyte in two consecutive events for first and second PT events in 2023, in the specialty of Hematology. (Refer to D2130) D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on record review, phone and electronic mail (email) interviews with the sole Testing Personnel (TP), the laboratory failed to achieve a proficiency testing (PT) score of 80% (percent) for white blood cell (WBC) differential (diff) in the second PT event in 2023, in the specialty of Hematology. This deficient practice had the potential to affect 1179 out of 1179 patient WBC diff testing performed in this laboratory between the first and second PT testing events of 2023. Findings Include: 1. Review of the laboratory's second American Proficiency Institute (API) Hematology /Coagulation PT testing event of 2023 documentation, provided for the PT desk review, revealed the following unsatisfactory analyte testing scores: Second PT Event 2023 WBC diff; 56% % mono; 60%; DXH-07, DXH-09 % lymph; 40%; DXH-06, DXH-07, DXH-08 % neut; 20%; DXH-06, DXH-07, DXH-08, DXH-09 % eos; 60%; DXH-07, DXH-08 2. Review of the laboratory's PT evaluation documentation revealed the laboratory ran the PT event samples under the incorrect software version and also ran them in the quality control (QC) mode under "other" as the source when API instructed the PT samples to be run in the QC mode under "patient" as the source. 3. Further review of the laboratory's PT evaluation documentation found the following statements: "QC, machine operation, calibrations and start up logs were all reverified by the lab director. At random 15 patient results were pulled from the month of Mar - Aug 2023 prior to the 2nd event...'(the Laboratory Director)' seen no discrepancies and determined the API failures had no effect on patient results...API advised that if samples were run under the correct source they would have passed." 4. The TP confirmed the unsatisfactory PT scores for the analytes indicated above. The interviews occurred on 07/28/2023 at 12:57 PM. % mono; percent monocyte % lymph; percent lymphocyte % neut; percent neutrophil % eos; percent eosinophil 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 record review, phone and electronic mail (email) interviews with the sole Testing Personnel (TP), the laboratory failed to achieve satisfactory performance for the same analyte, white blood cell (WBC) differential (diff) and percent monocyte, in two consecutive events for first and second PT events in 2023 in the specialty of Hematology. This deficient practice had the potential to affect 1179 out of 1179 patient WBC diff testing performed in this laboratory between the first and second PT testing events of 2023. Findings Include: 1. Review of the laboratory's second American Proficiency Institute (API) Hematology/Coagulation PT testing event of -- 2 of 3 -- 2023 documentation, provided for the PT desk review, revealed the following unsatisfactory analyte testing scores: First PT Event 2023 WBC diff; 76% % mono; 0%; Second PT Event 2023 WBC diff; 56% % mono; 60%; 2. Review of the laboratory's PT evaluation documentation revealed the laboratory ran both the first and second PT event samples under the incorrect software version and also ran them in the quality control (QC) mode under "other" as the source when API instructed the PT samples to be run in the QC mode under "patient" as the source. 3. Further review of the laboratory's PT evaluation documentation found the following statements: "QC, machine operation, calibrations and start up logs were all reverified by the lab director. At random 15 patient results were pulled from the month of Mar -Aug 2023 prior to the 2nd event...'(the Laboratory Director)' seen no discrepancies and determined the API failures had no effect on patient results...API advised that if samples were run under the correct source they would have passed." 4. The TP confirmed the unsatisfactory PT scores for the analytes indicated above. The interviews occurred on 07/28/2023 at 12:57 PM. % mono; percent monocyte -- 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 record review and an interview with the sole Testing Personnel (TP), the laboratory failed to successfully participate in a Proficiency Testing (PT) program for the non-waived glucose testing performed under the subspecialty of routine chemistry. All patients who had glucose testing in this laboratory from the first testing event of 2022 to current date had the potential to be affected by this deficient practice. Findings Include: 1. The laboratory failed to achieve a PT score of 80% (percent) for the analyte glucose in the first PT event in 2022 in the specialty of Chemistry. (Refer to D2087) 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 -- D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on record review and an interview with the sole Testing Personnel (TP), the laboratory failed to achieve a proficiency testing (PT) score of 80% (percent) for the analyte glucose in the first PT event in 2022 in the specialty of chemistry. All patients tested for glucose from the first testing event in 2022 to current date had the potential to be affected by this deficient practice. Findings Include: 1. Review of the laboratory's "QUALITY ASSURANCE PROCEDURE MANUAL FOR ACE AXCEL", approved by the Laboratory Director via signature and date on 01/03/2022 and provided on the date of the inspection found the following statement: "Unsuccessful or unsatisfactory Proficiency testing events are to be reported to the lab manager and lab director. Retests on the specific test are to be done and the

Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on record review and interviews with the Chief Operations Officer (COO) and Testing Personnel (TP) #3, the laboratory failed to achieve a proficiency testing (PT) score of 80% (percent) for the analytes creatinine (creat) in the first PT event in 2019 and phosphorus (phos) and total iron binding capacity (TIBC) in the third PT event in 2019, all in the specialty of Chemistry. Patient creat, phos and TIBC testing had the potential to be affected by this deficient practice during the first and third quarters in 2019. Findings Include: 1. Review of the laboratory's 2019 American Proficiency Institute (API) Chemistry PT documentation, provided on the date of the inspection, revealed the following unsatisfactory analyte testing scores: First PT Event 2019 Creat; 40% unacceptable; CH-02, CH-03, CH-05 Third PT Event 2019 Phos; 60% unacceptable; CH-11, CH-12 TIBC; 20% unacceptable; CH-11, CH-13, CH-14, CH- 15 2. The COO and TP#3 confirmed the unsatisfactory PT scores for the analytes indicated above. The interviews occurred on 01/16/2020 at 3:01 PM. D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in 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 6 -- proficiency testing event. This STANDARD is not met as evidenced by: Based on record review and interviews with the Chief Operations Officer (COO) and Testing Personnel (TP) #3, the laboratory failed to conduct and document appropriate training activities and employ the technical assistance necessary to correct the unacceptable problems associated with creatinine (creat), phosphorus (phos) and total iron binding capacity (TIBC) proficiency testing (PT) failures in 2019, all in the specialty of Chemistry. Patient creat, phos and TIBC testing had the potential to be affected by this deficient practice during the first and third quarters in 2019. Findings Include: 1. Review of the laboratory's 2019 American Proficiency Institute (API) Chemistry PT documentation, provided on the date of the inspection, revealed the following unsatisfactory analyte testing scores: First PT Event 2019 Creat; 40% unacceptable; CH-02, CH-03, CH-05 Third PT Event 2019 Phos; 60% unacceptable; CH-11, CH-12 TIBC; 20% unacceptable; CH-11, CH-13, CH-14, CH-15 2. Review of the laboratory's 2019 "API Analyte Testing Form - Chemistry" PT review and

Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on record review and an interview with the Laboratory Supervisor (LS), the laboratory failed to attain a proficiency testing (PT) score of at least 80 percent of acceptable responses for the analyte creatinine for the second testing event of 2017. Findings Include: 1. Review of six of the laboratory's 2016 and 2017 American Proficiency Institute (API) Chemistry PT records, provided on the date of the inspection, revealed a creatinine analyte testing score of 20% for the second testing event of 2017. 2. The LS confirmed the laboratory did not achieve a PT analyte testing score of at least 80% for creatinine and received a score of 20% for the analyte creatinine for the second testing event of 2017. The interview occurred on 01/29/2018 at 10:44 AM. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on record review and an interview with the Laboratory Supervisor (LS), 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 verify the accuracy of ungraded triglyceride and low density lipoprotein (LDL) results not assigned a proficiency testing (PT) score. Findings Include: 1. Review of six of the laboratory's 2016 and 2017 American Proficiency Institute (API) Chemistry PT records, provided on the date of the inspection, revealed the submitted triglyceride and LDL results for sample CH-01 in the first testing event of 2017 were not graded by API. 2. The Surveyor requested the laboratory's API PT verification documentation of the ungraded triglyceride and LDL results for sample CH-01 in the first testing event of 2017 from the LS. The LS was unable to provide any verification documentation for the ungraded PT results on the date of the inspection. The interview occurred on 01/29/2018 at 10:44 AM. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on record review and an interview with the Laboratory Supervisor (LS), the laboratory failed to document evaluation activities of ungraded and unacceptable proficiency testing (PT) results. Findings Include: 1. Review of six of the laboratory's 2016 and 2017 American Proficiency Institute (API) Chemistry PT records, provided on the date of the inspection, revealed the submitted triglyceride and LDL results for sample CH-01 in the first testing event of 2017 were not graded by API and the Alanine Aminotransferase (ALT) result for sample CH-09 in the second testing event of 2016 was unacceptable. Documentation of the laboratory's result evaluations were not found. 2. The Surveyor requested the laboratory's API PT evaluation documentation of the ungraded triglyceride and LDL results and the unacceptable ALT result from the LS. The LS was unable to provide any evaluation documentation for the ungraded and unacceptable PT results on the date of the inspection. The interview occurred on 01/29/2018 at 10:44 AM. D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(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 record review and an interview with the Lab Supervisor (LS), the Technical Consultant (TC) failed to include the assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing (PT) samples for testing personnel (TP) #1, who routinely performed the testing in the laboratory, in 2016. Findings Include: 1. Review of six out of six of the laboratory's 2016 and 2017 API Chemistry PT records, provided on the date of the inspection, did not find that TP#1 participated in any chemistry PT testing in 2016. 2. The Surveyor requested the laboratory's 2016 documentation indicating that TP#1 tested previously analyzed specimens, internal blind samples or external PT in 2016 from the LS. The LS confirmed that TP#1 did not participate in testing previously -- 2 of 3 -- analyzed specimens, internal blind samples or external PT activities in 2016, as required, and was unable to provide the requested documentation on the date of the inspection. The interview occurred on 01/29/2018 at 10:45 AM. D6053 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 semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on record review and an interview with the Lab Supervisor (LS), the Technical Consultant (TC) failed to evaluate and document the 12 month competency assessments of testing personnel (TP) #1 and TP#2, who were responsible for moderate complexity testing procedures on the newly installed chemistry and hematology analyzers. Findings Include: 1. Review of the laboratory's "Lab Personnel Evaluation" policy and procedure, provided on the date of the inspection, found instructions to assess the competency of testing personnel semiannually during the first year. 2. Review of the laboratory's instrument installation records revealed the ACE Axcel Chemistry analyzer was installed in 11/2016 and the Beckman Coulter AcT 5Diff AL Hematology analyzer was installed in 12/2016 with documented training by the manufacturer's of both analyzers on 12/12/2016 for TP#1 and TP#2. 3. Review of the laboratory's 2017 and 2018 competency assessment records, provided on the date of the inspection, did not find the 12 month competency assessment documentation for TP#1 and TP#2 who tested patient samples on the newly installed Chemistry and Hematology analyzers since 12/2016. 4. The Surveyor requested the laboratory's ACE Axcel Chemistry analyzer and Beckman Coulter AcT 5Diff AL Hematology analyzer 12 month competency assessment documentation for TP#1 and TP#2 from the LS. The LS confirmed that TP#1 and TP#2 did not have their 12 month competency assessments conducted, as required, on the newly installed Chemistry and Hematology analyzers and was unable to provide the requested documentation on the date of the inspection. The interview occurred on 01/29/2018 at 8:53 AM. -- 3 of 3 --