Quasar Laboratory

Summary Statement of Deficiencies D3007 FACILITIES CFR(s): 493.1101(b) The laboratory must have appropriate and sufficient equipment, instruments, reagents, materials, and supplies for the type and volume of testing it performs. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview with the testing personnel, the laboratory failed to have sufficient equipment for the testing it performs for 2 (November 2018 to November 2020) of 2 years. Findings include: 1. An observation on 11/5/20 at 8:54 am by the surveyor revealed a Sterling Diagnostics IsoComp I. 2. An interview on 11/5/20 at 8:54 am with the testing personnel revealed the printer on the Sterling Diagnostics IsoComp I analyzer was broken. 3. A review of the Sterling Diagnostics IsoComp I analyzer data revealed a lack of instrument printouts to verify transcribed data from November 2018 to November 2020 for the following processes: a. Background counts b. Quality control c. Calibrations d. Patient test results Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

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 CMS database and review of the American Association of Bioanalysts (AAB) proficiency testing reports, it was determined the laboratory failed to successfully participate in a CMS approved proficiency testing program for the hematology analytes: white blood cell differential, white blood cell, red blood cell, hematocrit, hemoglobin, and platelets. Findings include: Review of the CMS database and the AAB proficiency testing reports showed unsatisfactory performance for two (2nd and 3rd 2018) consecutive proficiency testing events for the hematology analytes: white blood cell differential, white blood cell, red blood cell, hematocrit, hemoglobin, and platelets Refer to D2123 and D2131. 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 -- D2123 HEMATOLOGY CFR(s): 493.851(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 review of the CMS database and review of the American Association of Bioanalysts (AAB) proficiency testing reports, the laboratory failed to participate and achieve a satisfactory performance for the hematology analytes: white blood cell differential (WBC diff), white blood cell (WBC), red blood cell (RBC), hematocrit (HCT), hemoglobin (HGB), and platelets (PLTS) in two consecutive testing events. Findings include: WBC diff PT Event Score 2nd event 2018 0% 3rd event 2018 0% WBC PT Event Score 2nd event 2018 0% 3rd event 2018 0% RBC PT Event Score 2nd event 2018 0% 3rd event 2018 0% HCT PT Event Score 2nd event 2018 0% 3rd event 2018 0% HGB PT Event Score 2nd event 2018 0% 3rd event 2018 0% PLT PT Event Score 2nd event 2018 0% 3rd event 2018 0% D2131 HEMATOLOGY CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance 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 review of the CMS database and review of the American Association of Bioanalysts (AAB) proficiency testing reports, the laboratory failed to achieve a satisfactory overall performance for the specialty of hematology. Findings include: Unsatisfactory performance for two (2nd and 3rd 2018) consecutive overall testing events constitutes unsuccessful performance for the specialty of hematology: Findings include. Hematology PT Events Score 2nd event 2018 0% 3rd event 2018 0% -- 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 review of the CMS database and review of the American Association of Bioanalysts (AAB) graded proficiency testing reports, it was determined that the laboratory failed to successfully participate in a CMS approved proficiency testing program for the chemistry analyte: cholesterol high density lipoprotein (HDL). Findings include: Review of the CMS database and the AAB proficiency testing reports showed unsatisfactory chemistry performance for three of four events for the following analyte: cholesterol HDL. Refer to D2096. D2096 ROUTINE CHEMISTRY 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): 493.841(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 CMS database and the American Association of Bioanalysts (AAB) proficiency testing reports, the laboratory failed to achieve satisfactory performance for the chemistry analyte: cholesterol high density lipoprotein (HDL) in three of four consecutive testing events. Findings include: Unsatisfactory performance for three of four consecutive proficiency testing events constitutes subsequent unsuccessful performance for cholesterol HDL: HDL PT event Score 2nd event 2018 40% 1st event 2018 40% 3rd event 2017 60% -- 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 review of the CMS database and review of the American Association of Bioanalysts (AAB) proficiency testing reports, it was determined that the laboratory failed to successfully participate in a CMS approved proficiency testing program for the chemistry analyte: cholesterol high density lipoprotein (HDL). Findings include: Review of the CMS database and the AAB proficiency testing reports showed unsatisfactory performance for two of two proficiency testing events for the chemistry analyte: cholesterol HDL. Refer to D2087 and D2096. D2087 ROUTINE CHEMISTRY 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): 493.841(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 review of the CMS database and the American Association of Bioanalysts (AAB) proficiency testing reports, the laboratory failed to attain a score of at least 80% of acceptable responses for the cholesterol high density lipoprotein (HDL), which is unsatisfactory performance for the testing events. Findings include: cholesterol HDL PT Event Score 3rd event 2017 60% 1st event 2018 40% 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 CMS database and the American Association of Bioanalysts (AAB) proficiency testing reports, the laboratory failed to achieve satisfactory performance for the chemistry analyte cholesterol high density lipoprotein (HDL) in two of two consecutive testing events. Findings include: Unsatisfactory performance for two of two consecutive proficiency testing events constitutes unsuccessful performance for cholesterol HDL: cholesterol HDL PT event Score 3rd event 2017 60% 1st event 2018 40% -- 2 of 2 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory director and/or testing personnel failed to attest to the routine integration of the non-chemistry (hematology) proficiency testing samples into the patient workload for three (event #2 and #3 of 2016, event #1 of 2017) of six events in 2016 and 2017. Findings include: 1. On January 18, 2018 at 12:20 p.m., record review of the American Association of Bioanalysts (AAB) final graded proficiency testing reports revealed the laboratory director and testing personnel did not sign the attestation statement sheets as follows: a. 2016 - 2nd event b. 2016 - 3rd event c. 2017 - 1st event 2. During the interview on January 18, 2018 at 12:20 p.m., testing personnel #1 as listed on the CMS-209 confirmed the laboratory did not attest to the routine integration of the testing samples into the patient workload. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory failed to ensure written Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- competency policies were established and implemented for three (testing personnel #2, #5, and #6) of six testing personnel. Findings include: 1. On January 18, 2018 at 9: 38 a.m., record review of the annual competency revealed there was no documentation as follows: a. testing personnel #2 - no annual competency for 2016, and 2017 b. testing personnel #5 - no six month competency for 2017 c. testing personnel #6 - no six month competency for 2017 2. During the interview on January 18, 2018 at 9:38 a.m., testing personnel #1 confirmed the annual competency was not completed as required in 2016 and 2017. ***Repeat Deficiency from February 4, 2016 survey*** D5781