Mark E Quiring, Md Pa

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 review of API (American Proficiency Institute) proficiency testing (PT) documentation for 2017 and 2018 and staff interview, the laboratory failed to provide the required attestation signatures for PT performed in the specialty of hematology. Findings: 1. API attestation statements for the second and third events 2017 and the first, second and third events 2018 were reviewed. The form for the second event 2017 was signed only by testing person 1 (CMS fom 209) and the remaining forms unsigned by the laboratory director or the person performing the test. 2. In an interview at the site on 01-30-2019, testing person 1 stated that hematology testing had been suspended in October 2017, and that PT was performed for the third event 2017 and the first event 2018 in anticipation of resuming patient testing. . 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- 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 -- 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 API PT testing documentation for 2017 and 2018, confirmed by staff interview, the laboratory failed to participate successfully in proficiency testing in the specialty of hematology. Findings: 1. API PT testing documentation for 2017 and 2018 showed the following unacceptable scores: 2017 3rd event Platelet Count (x10^9) Sample Reported Expected Grade HEM-14 206 94-159 Unacceptable HEM- 15 108 53-89 Unacceptable 2018 1st event Platelet Count (x10^9) Sample Reported Expected Grade HEM-01 161 50-85 Unacceptable HEM-02 328 167-280 Unacceptable HEM-04 991 257-429 Unacceptable HEM-05 848 89-150 Unacceptable 2. Scores below 60% for two consecutive testing events in the same analyte resulted in a score of "unsuccessful" for Platelet Count. 3. API scores for the second and third events 2018 in the specialty of hematology were all marked "Failure to Participate" resulting in overall scores of "unsuccessful" for all analytes. 4. In an interview at the site on 01-30-2019, testing person 1 stated that hematology testing had been suspended in October 2017 and PT performed through the first event of 2018, when the decision was made to discontinue the specialty. . 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 API PT documentation for 2018 and staff interview, the laboratory failed to notify the proficiency testing program of the suspension of patient testing and the associated circumstances involved in the failure to perform PT in the specialty of hematology. Refer to D2016. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company, American Proficiency Institute (API). The facility was found to be out of compliance with the conditions of participation of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 493.803 successful participation in a proficiency testing program 493.1403 laboratories performing moderate complexity testing; 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: 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 -- Based on a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company, American Proficiency Institute (API), it was determined the laboratory had not successfully participated in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of hematology for the analyte platelets. Refer to D2130 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: Based on a proficiency testing desk review of CMS form 155 and American proficiency Institute API records found that the laboratory failed to attain a satisfactory score of at least 80% of acceptable responses for each analyte in the subspecialty of chemistry. Findings: 1. API 2015 - 2nd event the laboratory received an unsatisfactory scores of 40 % for total bilirubin. 2. API 2015 - 2nd event the laboratory received an unsatisfactory scores of 60 % for sodium. 3. API 2015 - 3rd event the laboratory received an unsatisfactory scores of 60 % for AST. 4. API 2015 - 3rd event the laboratory received an unsatisfactory scores of 60 % for calcium. 5. API 2015 - 3rd event the laboratory received an unsatisfactory scores of 40 % for chloride. 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 a proficiency testing desk review of CMS form 155 and American proficiency Institute API records found that the laboratory failed to attain a satisfactory score of at least 80% of acceptable responses for each analyte in the subspecialty of endocrinology. Findings: 1. API 2015 - 2nd event the laboratory received an unsatisfactory scores of 60 % for thyroid stimulating hormone (TSH). 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 a proficiency testing desk review of CMS form 155 and American Proficiency Institute records found that the laboratory failed to attain a score of at least 80% acceptable responses for each analyte in the subspecialty of hematology for -- 2 of 3 -- the analyte platelets. Findings: 1. API 2017 - 3rd event the laboratory received an unsatisfactory score of 60% for platelets. 3. API 2018 - 1st event the laboratory received an unsatisfactory score of 20% for platelets. 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 desk review of proficiency testing records, it was determined the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two consecutive testing events or two out of three consecutive testing events in the specialty of Hematology. Two out of three unsatisfactory scores results in unsuccessful PT performance. Findings: 1. API 2017 - 3rd event the laboratory received an unsatisfactory score of 60% for platelets. 3. API 2018 - 1st event the laboratory received an unsatisfactory score of 20% for platelets. 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 a desk review of laboratory proficiency testing performance it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services. 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 a desk review of proficiency testing results it was revealed that the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in a HHS approved proficiency testing program. Refer to D2130 -- 3 of 3 --