Summary:
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 Proficiency Testing (PT) desk review of the American Proficiency Institute (API) proficiency testing revealed the laboratory failed to participate in two (2) out of three (3) consecutive testing events for the following specialties. Mycology, Parasitology, Routine Chemistry and Hematology. Refer to D2039, D2048, D2089, and D2123. D2039 MYCOLOGY CFR(s): 493.827(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 3 -- 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 Proficiency Testing (PT) desk review of the American Proficiency Institute (API) and phone conversation with the Practice Administrator (PA) the laboratory failed to participate in two (2) out of three (3) consecutive events for the following analytes in Mycology. Findings include. 1. API 3rd event 2021 a) Vaginal Wet Prep - 0% b) Vaginal Wet Prep KOH - 0% 2. API 2nd event 2022 a) Vaginal Wet Prep - 0% b) Vaginal Wet Prep (KOH) - 0% 3. The laboratory performs approximately 40 test per year. 4. The PA confirmed these findings during the phone conversation on 10/10 /2022 @ 10:15 AM. D2048 PARASITOLOGY CFR(s): 493.829(b) 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 Proficiency Testing (PT) desk review of the American Proficiency Institute (API) and phone conversation with the Practice Administrator (PA) the laboratory failed to participate in two (2) out of three (3) consecutive events for the following analytes in Parasitology. Findings include. 1. API 3rd event 2021 a) Pinworm Prep - 0% 2. API 2nd event 2022 a) Pinworm Prep - 0% 3. The laboratory performs approximately 40 test per year. 4. The PA confirmed these findings during the phone conversation on 10/10/2022 @ 10:15 AM. D2089 ROUTINE CHEMISTRY CFR(s): 493.841(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 -- 2 of 3 -- 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 Proficiency Testing (PT) desk review of the American Proficiency Institute (API) and phone conversation with the Practice Administrator (PA) the laboratory failed to participate in two (2) out of three (3) consecutive events for the following analytes in Routine Chemistry subspecialty Urinalysis. Findings include. 1. API 3rd event 2021 a) Urine Sediments - 0% 2. API 2nd event 2022 a) Urine Sediments - 0% 3. The laboratory performs approximately 6982 test per year. 4. The PA confirmed these findings during the phone conversation on 10/10/2022 @ 10:15 AM. 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 Proficiency Testing (PT) desk review of the American Proficiency Institute (API) and phone conversation with the Practice Administrator (PA) the laboratory failed to participate in two (2) out of three (3) consecutive events for the following analytes in Hematology. Findings include. 1. API 3rd event 2021 a) Cell Identification - 0% b) Red Blood Cell - 0% c) Hematocrit- 0% d) Hemoglobin - 0% e) White Blood Cell - 0% f) Platelets - 0% 2. API 2nd event 2022 a) Cell Identification - 0% b) Red Blood Cell - 0% c) Hematocrit- 0% d) Hemoglobin - 0% e) White Blood Cell - 0% f) Platelets - 0% 3. The laboratory performs approximately 69.000 hematology test per year. 4. The PA confirmed these findings during the phone conversation on 10/10 /2022 @ 10:15 AM. -- 3 of 3 --