Heartland Diagnostic Services Llc

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 American Proficiency Institute proficiency testing record review and laboratory director communication, the laboratory failed to achieve satisfactory performance in white blood cell differential proficiency testing for two consecutive testing events in 2019 (Event 1 and Event 2), resulting in unsuccessful performance. (Refer to D2130) D2130 HEMATOLOGY CFR(s): 493.851(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 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 record review and laboratory director communication, the laboratory failed to achieve satisfactory performance in proficiency testing for white blood cell differential for two consecutive events in 2019 (Event 1 and Event 2), resulting in unsuccessful performance. Findings include: 1. Review of 2019 American Proficiency Institute (API) proficiency testing reports on 09/05/19 for the analyte white blood cell differential revealed the following results: Event 1 - 0% Basophils % Sample Lab results Acceptable Range #1 0.0 4.6 - 7.8 #2 0.0 4.1 - 7.2 #3 0.0 5.2 - 8.6 #4 0.0 4.7 - 7.9 #5 0.0 4.5 - 7.6 Eosinophils % Sample Lab results Acceptable Range #1 0.0 7.7 - 12.3 #2 0.0 6.8 - 11.2 #3 0.0 8.2 - 13.0 #4 0.0 7.5 - 12.0 #5 0.0 7.6 - 12.0 Lymphocytes % Sample Lab results Acceptable Range #1 1.7 31.1 - 35.4 #2 0.7 35.3 - 41.6 #3 3.1 27.6 - 30.6 #4 0.7 31.1 - 37.6 #5 1.6 31.5 - 35.6 Monocytes % Sample Lab results Acceptable Range #1 0.2 7.7 - 11.1 #2 0.0 7.4 - 11.7 #3 0.8 8.4 - 11.0 #4 0.2 7.3 - 11.9 #5 1.1 8.2 - 11.5 Neutrophils % Sample Lab results Acceptable Range #1 4.8 38.2 - 44.1 #2 2.2 34.1 - 40.7 #3 14.1 40.8 - 46.6 #4 2.4 36.7 - 43.3 #5 5.6 38.0 - 43.6 Event 2 - 4% Basophils % Sample Lab results Acceptable Range #6 0.0 4.5 - 7.4 #7 0.0 4.0 - 7.1 #8 0.0 5.3 - 8.5 #9 0.0 4.4 - 7.5 #10 0.0 4.6 - 7.8 Eosinophils % Sample Lab results Acceptable Range #6 0.1 7.4 - 11.9 #7 0.7 6.8 - 10.9 #8 0.0 8.4 - 13.0 #9 0.1 7.4 - 11.9 #10 0.0 7.4 - 11.9 Lymphocytes % Sample Lab results Acceptable Range #6 21.6 33.0 - 36.8 #7 23.1 36.6 - 42.6 #8 16.5 27.8 - 31.1 #9 26.0 33.3 - 37.7 #10 27.2 32.7 - 39.0 Monocytes % Sample Lab results Acceptable Range #6 13.5 7.8 - 10.8 #7 10.2 7.0 - 11.3 #8 0.1 7.6 - 10.4 #9 2.5 7.6 - 10.8 #10 1.2 6.8 - 11.0 Neutrophils % Sample Lab results Acceptable Range #6 64.8 37.4 - 43.0 #7 66.0 33.7 - 40.0 #8 83.4 41.3 - 46.7 #9 71.4 36.8 - 42.6 #10 71.6 36.1 - 42.8 The specialty of hematology requires a score of 80% or greater for satisfactory performance. 2. Through electronic communication received at 10:03 a.m. on 08/20/19 and written communication received on 09/05/19, the laboratory director (#1) stated the laboratory had failed hematology proficiency testing for the second time. -- 2 of 2 --

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review, staff interview, and policy review, the laboratory failed to twice annually verify the accuracy of 4 of 4 non-regulated microscopy analytes (vaginal wet preparation [wet prep], potassium hydroxide preparation [KOH], sperm absence/presence, and urine sediment) in 2017. The laboratory performed approximately 580 microscopy patient tests in 2017. Findings include: 1. Reviewed at approximately 10:30 a.m. on 09/17/18, the laboratory's test menu listed wet prep, KOH, post vas semen analysis (sperm absence/presence), and urinalysis microscopic examination (urine sediment) available for patient testing. 2. Reviewed at approximately 10:40 a.m. on 09/17/18, the 2017 proficiency testing records indicated the laboratory did not participate in proficiency testing for wet prep, KOH, sperm absence/presence, and urine sediment. 3. Upon request on 09/17/18, the laboratory failed to provide evidence of twice annual accuracy verification for wet prep, KOH, sperm absence/presence, and urine sediment in 2017. 4. During interview at approximately 12:00 p.m. on 09/17/18, a technical consultant (#1) confirmed the laboratory did not twice annually verify the accuracy of wet prep, KOH, sperm absence/presence, and urine sediment in 2017. 5. Reviewed at 1:15 p.m. on 09/17/18 the policy"Laboratory Quality Assurance (Assessment) Plan," approved 05/27/15, stated, ". . . V. Monitoring of Standards as Defined by CLIA [Clinical Laboratory Improvement Amendment] '88: . . . D. Comparison of Test Results . . . 2. Any test done that is not included in a proficiency testing program is verified for accuracy and reliability twice a year. . . ." 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 --