Clinical Immunology Lab Rosalind Franklin Univ

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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile, American Association of Bioanalysts (AAB) Proficiency Testing (PT) records, and College of Pathologists (CAP) PT records the laboratory failed to successfully participate in PT for the routine chemistry analyte lactate dehydrogenase (LDH) for three of three consecutive events in 2022 resulting in subsequent unsuccessful PT performance. See D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 3 -- 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile, American Association of Bioanalysts (AAB) Proficiency Testing (PT) records, and College of Pathologists (CAP) PT records the laboratory failed to successfully participate in PT for the routine chemistry analyte lactate dehydrogenase (LDH) for three of three consecutive events in 2022 resulting in the subsequent unsuccessful performance for LDH. Findings include: 1. Review of the CASPER Report 0155D ran on 12-1-2022, found the laboratory received the following unsatisfactory PT scores for the analyte LDH. LDH AAB EVENT-1, 2022 = 20% - Unsatisfactory AAB EVENT-2, 2022 = 0% - Unsatisfactory CAP EVENT-3, 2022 = 0% - Unsatisfactory 2. Review of AAB and CAP PT records confirmed the subsequent unsuccessful PT performance for LDH for the three consecutive PT events in 2022. LDH AAB EVENT-1, 2022 = 20% - Unsatisfactory AAB EVENT-2, 2022 = 0% - Unsatisfactory CAP EVENT-3, 2022 = 0% - Unsatisfactory 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile, American Association of Bioanalysts (AAB) Proficiency Testing (PT) records, and College of Pathologists (CAP) PT records the laboratory director failed to ensure successful participation in an Health and Human Services (HHS) approved PT program for the specialty of chemistry (see D6016) resulting in the laboratory's subsequent unsuccessful PT performance for lactate dehydrogenase (LDH). 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile, American Association of -- 2 of 3 -- Bioanalysts (AAB) Proficiency Testing (PT) records, and College of Pathologists (CAP) PT records the laboratory director failed to ensure successful participation in a Health and Human Services (HHS) approved PT program for the specialty of chemistry (see D2096) resulting in the laboratory's subsequent unsuccessful PT performance for lactate dehydrogenase (LDH). -- 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 review of the CASPER Report 0155D and interview with a American Association of Bioanalysts (AAB) representative the laboratory failed to successfully participate in proficiency testing (PT) for the routine chemistry analyte lactate dehydrogenase (LDH), total during events one and two of 2022. See D2096. 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 2 -- 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 CASPER Report 0155D and interview with a American Association of Bioanalysts (AAB) representative; the laboratory failed to successfully participate in proficiency testing (PT) for the routine chemistry analyte lactate dehydrogenase (LDH), total during events one and two of 2022. Findings include: 1. Review of the CASPER Report 0155D ran on 8-1-2022 identified the initial unsuccessful PT performance for the specialty of chemistry for the analyte LDH, total. ROUTINE CHEMISTRY LDH, total - EVENT-1, 2022 = 20% - Unsatisfactory LDH, total - EVENT-2, 2022 = 0% - Unsatisfactory 2. A phone interview with the AAB PT representative on 08/01/2022, at 10:18 AM, confirmed the unsuccessful PT performance for LDH, total during events one and two of 2022. -- 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 surveyor review of CASPER Report 155 Proficiency Testing (PT) records, and phone communication with the PT vendor CAP; it was confirmed that the laboratory failed to successfully participate in the testing of PT samples under the specialty of Diagnostic Immunology. Findings include: 1. Review of PT CASPER Report 155 on November 01, 2019 at 8:54 AM revealed that the unsatisfactory PT performance occurred during events 2 and 3 of calendar year 2019. See D2084. D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(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 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 surveyor review of CASPER Report 155 Proficiency Testing (PT) records, and phone communication with the PT vendor CAP; it was confirmed that the laboratory failed to successfully participate in the testing of PT samples under the subspecialty of General Immunology. Findings include: 1. Review of PT CASPER Report 155 on November 01, 2019 at 8:54 AM, revealed that the unsatisfactory PT performance occurred during calendar year 2019 for events 1 and 2 under the subspecialty of General Immunology for the Anti-HBc diagnostic marker as listed below. GENERAL IMMUNOLOGY Anti-HBc, EVENT-2, 2019 = 0% Anti-HBc, EVENT-3, 2019 = 0% 2. During PT Desk review on November 01, 2019 and phone communication with the PT vendor CAP at 9:40 AM, the PT failing scores were confirmed. -- 2 of 2 --