Cute Pediatrics, Pllc

Summary Statement of Deficiencies D0000 The laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCY: D6063 - 42 C.F.R. 493.1412 Condition: Testing Personnel; moderate complexity Noted deficiencies and plans of correction were discussed with the laboratory representative at the exit conference. The facility representative was given an opportunity to provide evidence of compliance with noted deficiencies and no such evidence was provided prior to survey exit. Note: The CMS- 2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

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; 493.807 (a) reinstatement after failure; 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 6 -- 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 WBC Differential. D2017 REINSTATEMENT OF NONWAIVED LABORATORIES CFR(s): 493.807(a)(b) (a) If a laboratory's certificate is suspended or limited or its Medicare or Medicaid approval is cancelled or its Medicare or Medicaid payments are suspended because it fails to participate successfully in proficiency testing for one or more specialties, subspecialties, analyte or test, or voluntarily withdraws its certification under CLIA for the failed specialty, subspecialty, or analyte, the laboratory must then demonstrate sustained satisfactory performance on two consecutive proficiency testing events, one of which may be on site, before CMS will consider it for reinstatement for certification and Medicare or Medicaid approval in that specialty, subspecialty, analyte or test. (b) The cancellation period for Medicare and Medicaid approval or period for suspension of Medicare or Medicaid payments or suspension or limitation of certification under CLIA for the failed specialty, subspecialty, or analyte or test is for a period of not less than six months from the date of cancellation, limitation or suspension of the CLIA certificate. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the CMS (Center for Medicare Services) national database, and verified with the American Proficiency Institute (API), the laboratory failed to participate successfully for the analyte WBC Differential. The findings were: 1. The laboratory received the following unsatisfactory scores (passing = >80%) for the analyte WBC Differential: API 2018 (event 2) 73% API 2019 (event 1) 0% API 2019 (event 2) 0% 2. These failures result in a second unsuccessful performance for the analyte WBC Differential. 3. The laboratory must demonstrate sustained satisfactory performance (>80%) on two consecutive testing events for reinstatement. D2056 VIROLOGY CFR(s): 493.831(a) 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 a desk review of proficiency testing scores obtained from the CMS (Center for Medicare and Medicaid Services) national database, and verified with the American Proficiency Institute (API), the laboratory failed to attain an overall testing event score of at least 80% for the second testing event of 2019 for virology resulting in unsatisfactory performance. The findings were: 1. API 2019 (event 2): laboratory received an event score of 0% for virology. D2057 VIROLOGY -- 2 of 6 -- CFR(s): 493.831(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 a desk review of proficiency testing scores obtained from the CMS (Center for Medicare and Medicaid Services) national database and verified with the American Proficiency Institute (API), the laboratory failed to participate in the second event of 2019 for virology resulting in unsatisfactory performance for the overall testing event. The findings were: 1. API 2019 - 2nd event laboratory received an unsatisfactory score of 0% for virology. 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 (API) proficiency testing records found that the laboratory failed to attain a satisfactory score of at least 80% of acceptable responses for each analyte in the specialty of Hematology. The findings were: 1. API 2018 (event 2) - the laboratory received an unsatisfactory score of 73% for WBC Differential. 2. API 2019 (event 1) - the laboratory received an unsatisfactory score of 0% for WBC Differential. 3. API 2019 (event 2) - the laboratory received an unsatisfactory score of 0% for WBC Differential. D2122 HEMATOLOGY CFR(s): 493.851(b) 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 a proficiency testing desk review of CMS Form-155 and American Proficiency Institute (API) proficiency testing records found that the laboratory failed to attain an overall testing event score of at least 80% for 2019 Hematology (events 1 and 2) resulting in unsatisfactory performance. The findings were: 1. API 2019 (event 1) - laboratory received an event score of 0% for hematology. 2. API 2019 (event 2) - laboratory received an event score of 0% for hematology. -- 3 of 6 -- 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 a proficiency testing desk review of CMS Form-155 and American Proficiency Institute (API) proficiency testing records found that the laboratory failed to participate in 2 consecutive testing events in 2019 for hematology resulting in unsatisfactory performance for all analytes in hematology. The findings were: 1. API 2019 (event 1) - laboratory received an unsatisfactory score of 0% for WBC Diff. 2. API 2019 (event 1) - laboratory received an unsatisfactory score of 0% for RBC. 3. API 2019 (event 1) - laboratory received an unsatisfactory score of 0% for Hematocrit. 4. API 2019 (event 1) - laboratory received an unsatisfactory score of 0% for Hemoglobin. 5. API 2019 (event 1) - laboratory received an unsatisfactory score of 0% for WBC. 6. API 2019 (event 1) - laboratory received an unsatisfactory score of 0% for Platelets. 7. API 2019 (event 2) - laboratory received an unsatisfactory score of 0% for WBC Diff. 8. API 2019 (event 2) - laboratory received an unsatisfactory score of 0% for RBC. 9. API 2019 (event 2) - laboratory received an unsatisfactory score of 0% for Hematocrit. 10. API 2019 (event 2) - laboratory received an unsatisfactory score of 0% for Hemoglobin. 11. API 2019 (event 2) - laboratory received an unsatisfactory score of 0% for WBC. 12. API 2019 (event 2) - laboratory received an unsatisfactory score of 0% for Platelets. Key: WBC - White Blood Cells RBC - Red Blood 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 a proficiency testing desk review of CMS Form-155 and American Proficiency Institute (API) proficiency testing records found that the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in the specialty of hematology in two consecutive testing events or two out of three consecutive testing events. Two out of three unsatisfactory scores results in unsuccessful PT performance. The findings were: 1. API 2018 (event 2) - laboratory received an unsatisfactory score of 73% for WBC Diff. API 2019 (event 1) - laboratory received an unsatisfactory score of 0% for WBC Diff. API 2019 (event 2) - laboratory received an unsatisfactory score of 0% for WBC Diff. 2. API 2019 (event 1) - laboratory received an unsatisfactory score of 0% for RBC. API 2019 (event 1) - laboratory received an unsatisfactory score of 0% for RBC. 3. API 2019 (event 1) - -- 4 of 6 -- laboratory received an unsatisfactory score of 0% for Hematocrit. API 2019 (event 2) - laboratory received an unsatisfactory score of 0% for Hematocrit. 4. API 2019 (event 1) - laboratory received an unsatisfactory score of 0% for Hemoglobin. API 2019 (event 2) - laboratory received an unsatisfactory score of 0% for Hemoglobin. 5. API 2019 (event 1) - laboratory received an unsatisfactory score of 0% for Platelets. API 2019 (event 2) - laboratory received an unsatisfactory score of 0% for Platelets. 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 a proficiency testing desk review of CMS Form-155 and American Proficiency Institute (API) proficiency testing records found that the laboratory failed to achieve satisfactory performance (80% or greater) for each event 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. The findings were: 1. API 2019 (event 1)- laboratory received an overall score of 0% for hematology testing event. 2. API 2019 (event ) - laboratory received an overall score of 0% for hematology testing event. 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 service (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 -- 5 of 6 -- 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). -- 6 of 6 --

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 and Medicaid 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 4 -- Based on a desk review of proficiency testing records obtained from the CMS (Center for Medicare and Medicaid 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 WBC Diff (refer to D2130). 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 (PTDR) of CMS Form-155 and American Proficiency Institute (API) 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 the analyte WBC differential (white blood cell), Red Blood Cell (RBC), Hematocrit (HCT), Hemoglobin (HGB), WBC (white blood cell), and Platelet (PLTS). The findings were: 1. API 2018 - 2nd event the laboratory received an unsatisfactory score of 73% for WBC Differential. 2. API 2019 - 1st event the laboratory received an unsatisfactory score of 0% WBC Differential. 3. API 2019 - 1st event the laboratory received an unsatisfactory score of 0% Red Blood Cell (RBC). 4. API 2019 - 1st event the laboratory received an unsatisfactory score of 0% Hemoglobin (HGB). 5. API2019 - 1st event the laboratory received an unsatisfactory of 0% for Hematocrit (HCT). 6. API 2019 - 1st event the laboratory received an unsatisfactory score of 0% for White Blood Cell (WBC). 7. API 2019 - 1st event the laboratory received an unsatisfactory score of 0% for Platelets (PLTS). D2122 HEMATOLOGY CFR(s): 493.851(b) 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 a proficiency testing desk review of CMS Form-155 and API records found that the laboratory failed to attain an overall score of at least 80% for each testing event in the specialty of hematology. The findings were: 1. API 2019 - 1st event the laboratory received an unsatisfactory score of 0% for the hematology event. 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 -- 2 of 4 -- 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 a desk review of proficiency testing (PT) results reported to CMS and records obtained from the PT provider, American Proficiency Institute (API), found the laboratory failed to participate in a testing event resulting in unsatisfactory scores. The findings were: 1. API 2019 - 1st event the laboratory received the unsatisfactory score of 0% due to non-participation for the following analytes: WBC diff 0% RBC 0% HCT 0% HGB (hemoglobin) 0% WBC (white blood cells) 0% PLTS (platelets) 0% 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 (WBC Differential) 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 proficiency testing (PT) performance. The findings were: 1. API 2018 - 2nd event the laboratory received an unsatisfactory score of 73% for WBC Differential. 2. API 2019 - 1st event the laboratory received an unsatisfactory score of 0% for WBC Differential. 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; -- 3 of 4 -- 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) -- 4 of 4 --

Summary Statement of Deficiencies D0000 The laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCY: D6063 - 42 C.F.R. 493.1412 Condition: Testing Personnel; moderate complexity Noted deficiencies and plans of correction were discussed with the laboratory representative at the exit conference. The facility representative was given an opportunity to provide evidence of compliance with noted deficiencies and no such evidence was provided prior to survey exit. Note: The CMS- 2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the