Ub Laboratories Inc

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 CMS proficiency testing (PT) records (i.e. CMS CASPER Reports 0155D entitled, "Individual Laboratory Profile" and CMS CASPER Report 0153D entitled, "Unsuccessful (2 of 3) Report"), it was determined that the laboratory failed to successfully participate in a PT program approved by CMS for each analyte or test in which the laboratory is certified under CLIA. The findings included: The laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events in the specialties of Routine Chemistry, Endocrinology, and Hematology constituting unsuccessful PT performances. (See D2016, D2107, and D2130) 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 -- 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 desk review of CMS PT records (CMS CASPER Report 0155D and 0153D, it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT events for the analytes, Iron, Total and Magnesium (Mg), resulting in an subsequest unsuccessful performances. The findings include: a. The laboratory failed to maintain successful performance with the PT program by failing to obtain a score of 80% of acceptable responses in two out of three consecutive PT events for the analytes, Iron, Total and Mg, as follows: 2019 2019 2019 Q1 Q2 Q3 Iron, Total 0% 0% 0% Mg 0% 0% 0% Uric Acid 0% 0% 0% Q1 = First Testing Event Q2 = Second Testing Event Q3 = Third Testing Event b. Failure to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT resulted in an non-initial unsuccessful performance for the analytes, Iron, Total; Mg; and Uric Acid. D2107 ENDOCRINOLOGY CFR(s): 493.843(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 desk review of CMS PT records (CMS CASPER Report 0155D and 0153D, it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT events for the analyte, T3 Uptake, Triiodothyronine (T3), Thyroid Stimulating Hormone (TSH), Thyroxine (T4), resulting in subsequent unsuccessful performances. The findings include: a. The laboratory failed to maintain successful performance with the PT program by failing to obtain a score of 80% of acceptable responses in two out of three consecutive PT events for the analytes, T3 Uptake, T3, TSH, and T4, as follows: 2018 2019 2019 2019 Q2 Q1 Q2 Q3 T3 Uptake 0% 0% 0% T3 0% 0% 0% 0% TSH 0% 0% 0% 2018 2019 2019 2019 Q2 Q1 Q2 Q3 T4 0% 0% 0% Q1 = First Testing Event Q2 = Second Testing Event Q3 = Third Testing Event b. Failure to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT resulted in an non-initial unsuccessful performances for the analytes, T3 Uptake, T3, TSH, and T4. 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. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on desk review of CMS PT records (CMS CASPER Report 0155D and 0153D, it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT events for the analyte, Hematocrit (Hct), resulting in an "initial" (first) unsuccessful performances. The findings include: a. The laboratory failed to maintain successful performance with the PT program by failing to obtain a score of 80% of acceptable responses in two out of three consecutive PT events for the analyte, Hct, as follows: 2019 2019 Q1 Q3 Hct 40% 60% Q1 = First Testing Event Q3 = Third Testing Event b. Failure to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT resulted in an initial unsuccessful performance for the analyte, Hct. 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 the severity of the deficiencies cited herein, the Condition: Laboratories Performing Moderate Complexity Testing: Laboratory director was not met. The laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. (See 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 a desk review of CMS PT records, it was determined the laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under subpart H. of this part. The findings included: For the analytes, Iron, Total; Mg; Uric Acid; T3 Uptake; T3; TSH; and T4, the laboratory repeatedly failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events, resulting in unsuccessful PT performances. (See D2016, D2096, and D2107) For the analyte, Hct, the laboratory repeatedly failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events, resulting an initial unsuccessful PT performance. (See D2130) -- 3 of 3 --

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: D-2087 Based on review of the laboratory's proficiency testing (PT) test result reports, and interview with the laboratory testing consultant (TC) and the laboratory personnel (TP), it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for total Bilirubin (Bili), Sodium (Na), Calcium (CA), Glucose (Glu) and Albumin (Alb) between 2017 thru 2018 PT events were unsatisfactory analyte performance for the testing event. The findings included: a. The laboratory used AU 640 chemistry analyzer to perform routine chemistry and report Basic Metabolic (BMP) panel, and Comprehensive Metabolic (CMP) Panel. b. The laboratory enrolled its proficiency testing (PT) program with College of American Pathologist (CAP) PT provider. c. The laboratory attained scores of 20 % for analyte of Bili and Na in the 2nd 2017 PT event were unsatisfactory analyte performance. d. The laboratory attained scores of 60 % for analyte of CA and Glu in the 2nd 2018 PT event were unsatisfactory analyte performance. e. The laboratory attained a score of 60 % for analyte of Alb in the 3rd 2018 PT event was unsatisfactory analyte performance. f. The laboratory performed routine chemistry for approximately 40 patient specimens monthly. g. The TC and TP affirmed (6/19/19 @ 12:20 PM) that the laboratory failed to attain scores of at least 80 percent of acceptable responses for analyte of Bili, Na, CA, Glu, and Alb between the 2nd 2017 and 3rd 2018 PT events were unsatisfactory analyte performance for the testing events. D2088 ROUTINE CHEMISTRY CFR(s): 493.841(b) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing (PT) test result reports, and interview with the laboratory testing consultant (TC) and the laboratory personnel (TP), it was determined that the laboratory failed to attain an overall testing event score of at least 80 percent for its routine chemistry was unsatisfactory performance. The findings included: a. The laboratory used AU 640 chemistry analyzer to perform routine chemistry in a total of 20 analyte, and report Basic Metabolic (BMP) panel, and Comprehensive Metabolic (CMP) Panel and other analyte including but not limited to Albumin, total protein, Calcium, Glucose, total Bilirubin, AST ... b. The laboratory enrolled its PT program with College of American Pathologist (CAP) PT provider. c. The laboratory attained a score of 47% an overall testing event score for routine chemistry in the 1st 2019 PT event was unsatisfactory performance. d. The laboratory performed routine chemistry panel for approximately 40 patient specimens monthly. e. The TC and TP affirmed (6/19/19 @ 12:20 PM) that the laboratory attained a score of 47% an overall testing event score for routine chemistry in the 1st 2019 PT event was unsatisfactory performance. D2098 ENDOCRINOLOGY CFR(s): 493.843(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 laboratory's proficiency testing (PT) test result reports, and interview with the laboratory testing consultant (TC) and the laboratory personnel (TP), it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for Triiodothyronine (T3), TSH between 2017 and 2018 PT events were unsatisfactory analyte performance for the testing events. The findings included: a. The laboratory performed endocrinology, including, but not limited to Triiodothyronine (T3), TSH testing. b. The laboratory enrolled its PT program with College of American Pathologists (CAP) PT provider. c. The laboratory attained score of 40 % for TSH in the 3rd 2017 PT event was unsatisfactory performance. d. The laboratory attained score of 0 % for T3 in the 2nd 2018 PT event was unsatisfactory performance. e. The laboratory performed TSH for approximately 22 patient specimens monthly. f. The laboratory performed T3 for approximately 2 patient specimens monthly. g. The TC and the TP affirmed (6/19/19 @12:25 PM) that the laboratory failed to attain at least 80% of acceptable responses for T3 and TSH between the 3rd 2017 and the 2nd 2018 PT events were unsatisfactory analyte performance for the testing events. D2109 TOXICOLOGY CFR(s): 493.845(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. -- 2 of 5 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing (PT) test result reports, and interview with the laboratory testing consultant (TC) and the laboratory personnel (TP). it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for TDM (Therapeutic Drug Management) including but not limited to Valproic Acid (VA) and Lithium (Li) between 2017 and 2019 were unsatisfactory analyte performance for the testing events. The findings included: a. The laboratory performed TDM including, but not limited to VA and Li testing. b. The laboratory enrolled its PT program with College of American Pathologists (CAP) PT provider. c. The laboratory attained score of 40 % for VA in the the 2nd 2017 PT event was unsatisfactory performance. d. The laboratory attained score of 0 % for VA in the 1st 2019 PT event was unsatisfactory performance. e. The laboratory attained score of 0 % for Li in the 1st 2019 PT event was unsatisfactory performance f. The laboratory performed VA for approximately 7 patient specimens monthly. g. The laboratory performed Li for approximately 22 patient specimens monthly h. The TC and TP affirmed (6/19/19 @12:25 PM) that the laboratory failed to attain at least 80% of acceptable responses for VA and Li between the 2nd 2017 and the 1st 2019 PT testing events were unsatisfactory analyte performance for the testing events. 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 review of the laboratory's proficiency testing (PT) test result reports, and interview with the laboratory testing consultant (TC) and the laboratory personnel (TP), it was determined that the laboratory failed to attain an overall testing event score of at least 80 percent for complete blood cell counts (CBC) was unsatisfactory performance. The findings included. a. The laboratory used Sysmex XT 1800i to perform CBC, including, but not limited to White blood cell (WBC) with cell differentials, Red blood cells (RBC), Hemoglobin (Hgb), Hematocrit (Hct) and Platelet count (Plt). b. The laboratory enrolled its PT program with College of American Pathologists (CAP) PT provider. c. The laboratory attained a score of 70 % for an overall testing event score in the 1st 2019 CBC PT event was unsatisfactory performance. d. The laboratory performed CBC for approximately 22 patient specimens monthly. e. The TC and TP affirmed (6/19/19 @12:25 PM) that the laboratory failed to attain an overall testing event score of at least 80 percent for CBC in the 1st 2019 PT was unsatisfactory performance. 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