Oncology Hematology Care Center Incorporate

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on February 22, 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 CMS Casper 153 and 155 reports and review of Medical Laboratory Evaluation (MLE) reports, the laboratory failed to maintain satisfactory 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 -- proficiency testing (PT) performance for automated hemaglobin (HGB) and red blood cell (RBC) in 2022 events 1 and 3, resulting in the initial unsuccessful performance for HGB and RBC. 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. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid (CMS) Casper 153 and 155 reports and review of Medical Laboratory Evaluation (MLE) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two of three testing events (1st and 3rd events of 2022), resulting in the initial unsuccessful performance for hemaglobin (HGB), and red blood cell count (RBC). Findings: 1. A review of Casper Reports 153 and 155 disclosed the laboratory failed HGB on the following: 2022 Event 1 HGB Score 60% 2022 Event 3 HGB Score 20% 2. A review of Casper Reports 153 and 155 disclosed the laboratory failed RBC on the following: 2022 Event 1 WBC Score 40% 2022 Event 3 WBC Score 0% 3. 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 Centers for Medicare and Medicaid (CMS) Casper 153 and 155 reports and review of Medical Laboratory Evaluation (MLE) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two of three testing events (1st and 3rd events of 2022), resulting in the initial unsuccessful performance for hemaglobin (HGB), and red blood cell count (RBC). Refer to D6016 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 Centers for Medicare and Medicaid (CMS) Casper Reports 153 and 155 and the Medical Laboratory Evaluation (MLE) 2022 proficiency testing (PT) evaluation reports, the laboratory director failed to maintain compliance with -- 2 of 3 -- successful red blood cell (RBC) and hemoglobin (HGB) proficiency testing (PT) for two of three events in 2022, resulting in the initial unsuccessful performance for RBC and HGB. Refer to D2130 -- 3 of 3 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on January 31, 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 CMS CASPER 155 report and review of Medical Laboratory Evaluation (MLE) 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 automated hematocrit (HCT) in 2021 event 2 and 2022 events 1 and 3, resulting in the non-initial unsuccessful participation for HCT. Refer to D 2130 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 review of the Centers for Medicare and Medicaid (CMS) CASPER 155 REPORT and review of the Medical Laboratory Evaluation (MLE) proficiency testing (PT) reports, the laboratory failed to maintain satisfactory participation in three testing events ( 2nd event of 2021 and 1st and 3rd events of 2022), resulting in the non-initial unsuccessful participation for automated hematocrit (HCT). Findings: 1. A review of Casper Reports 153 and 155 revealed the laboratory failed HCT on the following: 2021 Event 2 HCT Score 60% 2022 Event 1 HCT Score 40% 2022 Event 3 HCT Score 20% 2. A review of the laboratory's proficiency testing reports from Medical Laboratory Evaluation (MLE) confirmed the laboratory failed HCT 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 Centers for Medicare and Medicaid (CMS) CASPER 155 report and review of Medical Laboratory Evaluation (MLE) reports, the laboratory director failed to provide overall management and direction for PT performance. The laboratory director failed to ensure PT samples were tested as required. Refer to D6016 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 155 report and the Medical Laboratory Evaluation (MLE) 2021 and 2022 Proficiency testing (PT) evaluation reports, the laboratory director failed to maintain compliance with successful PT for three events -- 2 of 3 -- (2021 event 2 and 2022 events 1 & 3) for hematocrit (HCT) resulting in the non-initial unsuccessful participation for HCT. Refer to D 2130 -- 3 of 3 --

Summary Statement of Deficiencies D0000 A recertification survey was performed on January 17, 2023. An entrance conference was held with the laboratory representatives. The survey process was discussed, along with review of the survey forms that was sent to the facility, previous to the survey. An opportunity for questions and comments was given. Noted deficiencies and plans of correction were discussed with the laboratory representatives at the exit conference. The laboratory representatives were given an opportunity to provide evidence of compliance with the noted deficencies, and no such evidence was provided. The facility was found to be NOT in compliance with all applicable CLIA requirements for specialties/subspecialties for 42 CFR. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of the Quality Assessment (QA)documentation and staff interview, the Laboratory Director(LD) failed to ensure that quality assessment programs were maintained to ensure the quality of laboratory services provided. Findings: 1. Review of the QA documents, available at the time of survey, were last dated December 29, 2020. There were no documents after this date available for review. 2. Staff interview with Testing Personnel #1, #2, and LD, on January 17, 2023, at approximately 2:30 pm, in the front office confirmed the aforementioned statement. D6029 LABORATORY DIRECTOR RESPONSIBILITIES 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): 493.1407(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 the lack of training documents, and confirmed by staff interview, the Laboratory Director (LD) failed to ensure, prior to testing patients' specimens, that 2 out of 2 testing personnel (TP) had initial training documents for moderate complexity testing. Findings: 1. The laboratory did not provide documentation for 2 out of 2 testing personnel, that were listed on the Laboratory Personnel Report (CMS-209 form), had been trained to perform Moderate Complexity Testing on the Beckman Coulter ACTdiff(ACT diff) Hematology Analyzer. 2. Interview with TP#1, TP#2, and the LD on January 17, 2023 in the front office, at approximately 2:35 pm, confirmed that there were no documented training for 2 out of 2 TP prior to testing patients on the ACT diff. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) 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)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on the lack of a job description documents for 2 out of 2 testing personnel (TP), listed on the Laboratory Personnel Report (CMS209), and confirmed by staff interview, the Laboratory Director (LD) failed to specify, in writing, the responsibilities and duties of each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing. The laboratory did not have a policy that identified which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processes, test performance, results reporting, or indicate if director review is required prior to reporting patient test results. Findings: 1. The laboratory could not provide documentation supporting job descriptions for 2 out of 2 TP, listing the responsibilities and duties of each TP. 2. Staff interview with TP#1, TP#2, and the LD, on January 17, 2023, at approximately 2:35 pm in the front office, confirmed the aforementioned statement. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on April 6, 2021. 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 (2nd event of 2021 and 1st 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 Hematology # 760 including: hematocrit(HCT) # 785. Findings include: Refer to D 2130 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 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 from the Medical Laboratory Evaluation (MLE), the laboratory failed to maintain satisfactory performance in two of three consecutive events (2nd event of 2021 and 1st event of 2022), resulting in the first unsuccessful occurrence for hematocrit (HCT), analyte # 785. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte #785 HCT on event 2 of 2021 with a score of 60% and event 1 of 2022 with a score of 40%. 2. Desk review of the laboratory's proficiency testing reports from MLE confirms the laboratory failed HCT on event 2 of 2020 and event 1 of 2022 resulting in the first 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 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 (2nd event 2020 and 1st event of 2022), resulting in the first unsuccessful occurrence for hematocrit (HCT), analyte # 785. 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 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 -- 2 of 3 -- proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two of three consecutive events (2nd event 2021 and 1st event of 2022), resulting in the first unsuccessful occurrence for hematocrit (HCT), analyte # 785. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte # 785 , HCT on event 2 of 2021 with a score of 60% and event 1 of 2022 with a score of 40%. 2. Desk review of the laboratory's proficiency testing reports from Medical Laboratory Evaluation (MLE) confirmed the laboratory failed HC on Event 2 of 2021 and 1 of 2022, resulting in the first unsuccessful performance. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on January 12, 2021. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation during the tour and an interview with the laboratory director, the laboratory failed to implement and established safety procedure to ensure protection from physical, biochemical, and biohazardous materials. Findings include: 1. During the laboratory tour it was observed there was not a maintenance log or eyewash equipment in the phlebotomy or testing area. 2. An interview with the laboratory director during the tour on 01/12/2021 at approximately 09:30 a.m., confirmed the absence of eyewash equipment and maintenance log. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on January 22, 2019. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiency was cited: D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on review of the manufacturer's instruction for use of the hematology controls, review of quality control (QC) records and staff interview, the laboratory continued to use hematology controls after they deteriorated and after they exceeded the expiration date. Findings include: 1. Review of the manufacturer's instructions for use of the Beckman Coulter 4C-ES Cell Control revealed the control material is stable for 90 days but only for a maximum of 20 uses within a 35 day period. 2. Review of QC records including logs and Levey Jennings( LJ) charts revealed many days when control values did not fall within the acceptable range on the first attempt and the laboratory ran controls multiple times in an attempt to get two of the three controls within the acceptable range. 3. Review of QC records revealed the laboratory is using the same vial of controls for up to 90 days and is not opening a new vial after 20 uses. 4. Interview with the testing personnel and laboratory director on January 22, 2019 at 1 pm in the area assigned to the surveyor revealed the laboratory is only ordering one vial of 4C -ES Cell Control per lot number and is using the control material past its deterioration date. D5783