Clear Lake Pediatric Clinic, Pa

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of the CLIA program The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: 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: Based on a desk review of proficiency testing records obtained from the CMS national 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 -- database and verified with the proficiency testing company American Proficiency Institute (API) found 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 and for six of six regulated analytes in two of three proficiency testing events in 2022. Cell I.D. or WBC Diff RBC HCT (Non- waived) HGB (Non-waived) WBC Platelets Key: CMS=Center for Medicare and Medicaid Services RBC=Red Blood Cell HCT=Hematocrits HGB=Hemoglobin WBC=White Blood Cell 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 desk review of proficiency testing records obtained from the CMS national database and verified with the proficiency testing company American Proficiency Institute (API) found the laboratory failed to attain a score of at least 80% of acceptable responses for six of six regulated analytes resulted in unsatisfactory performance for two of two American Proficiency Institute (API) proficiency testing events in 2022. The findings were: 1. API 2022 Hematology/Coagulation for the second event revealed the laboratory received unsatisfactory scores for the following: Hematology 0% Cell I.D. or WBC Diff 0% RBC 0% HCT (Non-waived) 0% HGB (Non-waived) 0% WBC 0% Platelets 0% 2. API 2022 Hematology/Coagulation for the third event revealed the laboratory received unsatisfactory scores of the following: Hematology 60% Cell I.D. or WBC Diff 60% RBC 60% HCT (Non-waived) 60% HGB (Non-waived) 60% WBC 60% Platelets 60% Key: CMS=Center for Medicare and Medicaid Services RBC=Red Blood Cell HCT=Hematocrits HGB=Hemoglobin WBC=White Blood Cell 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 desk review of proficiency testing records obtained from the CMS national database and verified with the proficiency testing company American Proficiency Institute (API) found the laboratory failed to attain an overall testing event score of at least 80% of acceptance responses for two of three API proficiency testing events in 2022. The findings were: 1. API 2022 Hematology/Coagulation for the second event revealed the laboratory received an overall unsatisfactory score for hematology specialty of 0%. 2. API 2022 Hematology/Coagulation for the third event revealed the laboratory received an overall unsatisfactory score for hematology specialty of 60%. Key: CMS=Center for Medicare and Medicaid Services D2123 HEMATOLOGY CFR(s): 493.851(c) -- 2 of 4 -- 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 records obtained from the CMS national database and verified with the proficiency testing company American Proficiency Institute (API) found the laboratory failed to participate in one of three testing events in 2022 resulted in unsatisfactory performance and a score of 0% for the testing event. API 2022 Hematology/Coagulation for the second event revealed the laboratory received an overall unsatisfactory score for hematology specialty of 0% due to failure to participate. Key: CMS=Center for Medicare and Medicaid Services 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 desk review of proficiency testing records obtained from the CMS national database and verified with the proficiency testing company American Proficiency Institute (API) found the laboratory failed to achieve satisfactory performance (80% or greater) for the same analytes in two consecutive testing events in the specialty of Hematology for six of six regulated analytes for two of three proficiency testing events in 2022. Cell I.D. or WBC Diff RBC HCT (Non-waived) HGB (Non-waived) WBC Platelets Key: CMS=Center for Medicare and Medicaid Services RBC=Red Blood Cell HCT=Hematocrits HGB=Hemoglobin WBC=White Blood Cell 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 desk review of proficiency testing records obtained from the CMS national database and verified with the proficiency testing company American Proficiency Institute (API) found the laboratory failed to achieve an overall satisfactory performance (80% or greater) for two consecutive testing events in the specialty of Hematology for two of three proficiency testing events in 2022. (Refer to D2122) Key: CMS=Center for Medicare and Medicaid Services -- 3 of 4 -- 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 proficiency testing records obtained from the CMS national database and verified with the proficiency testing company American Proficiency Institute (API) found the laboratory director failed to provide overall management and direction of the laboratory services. (Refer to D6016) Key: CMS=Center for Medicare and Medicaid Services 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 records obtained from the CMS national database and verified with the proficiency testing company American Proficiency Institute (API) found the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful testing performances in a HHS approved proficiency testing program. (Refer to D2130). Key: CMS=Center for Medicare and Medicaid Services -- 4 of 4 --

Summary Statement of Deficiencies D0000 An onsite recertification survey was performed on 8/27/21. The laboratory was surveyed and failed to meet the following conditions of the CLIA regulations found at CFR 42 493.1 through 493.1780 resulting in the following IMMEDIATELY JEOPARDY findings: D5400 493.1250 Analytic Systems The immediate jeopardy conditions were abated as evidenced by a letter signed by the laboratory director on 8 /27/21. See the attached letter. and the following CONDITION LEVEL findings: D6076 493.1441 Condition: Laboratories performing high complexity testing; laboratory director D6168 493.1487 Condition: Laboratories performing high complexity testing; testing personnel The facility representative was given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. D2127 HEMATOLOGY CFR(s): 493.851(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on a review of the laboratory's American Proficiency Institute (API) proficiency testing records for 2019 and staff interview, it was revealed that the laboratory failed to return its proficiency testing results to API within the time frame specified by the program for 1 out of 3 testing events in 2019, resulting in unsatisfactory performance for all analytes in the specialty of Hematology. Findings include: 1. A review of the laboratory's API proficiency testing records revealed the laboratory received the following unsatisfactory scores for 2019 Hematology /Coagulation third event: White Blood Cell Differential. - score 0% Erythrocyte Count - score 0% Hematocrit - score 0% Hemoglobin - score 0% Leukocyte Count - score 0% Platelet Count - score 0% 2. Further review of the laboratory's API records for the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- 2019 Hematology/Coagulation third event revealed the following notation: "I mailed the Hematology/Coagulation test on the late date, due to looking at the wrong dates due." 3. An interview with testing person #1 (as indicated on the CMS 209 form) on 8 /27/21 at 1:40 p.m. in the patient exam room, after review of the records, confirmed the above findings. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on a review of the laboratory's test records, a review of the laboratory's policies, and staff interview, it was revealed that the laboratory failed to report a total of 322 SARS-CoV-2 antigen patient test results, that contained both negative and positive antigen test results, as required by 400.200 for 86 of 86 days from November 17, 2020 to August 27, 2021. Findings include: 1. A review of the laboratory's test records from 2020 to 2021 revealed the laboratory started SARS-CoV-2 antigen patient testing using the RapiGEN Biocredit COVID-19 antigen test on November 17, 2020. 2. A review of the laboratory's policies revealed no documentation of a policy /procedure related to SARS-CoV-2 test reporting. 3. A review of the laboratory's SARS-CoV-2 antigen patient test records from November 17, 2020 to August 27, 2021, revealed the laboratory failed to have documentation of reporting 282 negative and 40 positive test records for 86 of 86 days of testing. 4. An interview with the laboratory director on 8/27/21 at 2:00 p.m. in the patient exam room, after review of the records, confirmed the above findings. 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 a review of the laboratory's records from November 2020 to August 2021 and staff interview, it was revealed that the laboratory failed to have documentation of 2 of 2 accuracy assessments in 2020 for SARS-CoV-2 antigen testing using the RapiGEN Biocredit COVID-19 Antigen test. Findings include: 1. A review of the laboratory's test records revealed the laboratory started SARS-CoV-2 antigen testing using the RapiGEN Biocredit COVID-19 Antigen test in November 2020. 2. Further review of the laboratory's records revealed the laboratory failed to have documentation of the twice annual accuracy assessments in 2020 for SARS-CoV-2 antigen testing using the RapiGEN Biocredit COVID-19 Antigen test. 3. An interview -- 2 of 10 -- with the laboratory director on 8/27/21 at 2:00 p.m. in the patient exam room, after review of the records, confirmed the above findings. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on a review of the laboratory's policies, a review of the laboratory's records, a review of patient test records, and staff interview, it was revealed that the laboratory failed to meet the requirements of the analytic systems as evidenced by: 1. The laboratory failed to make available a written procedure for the laboratory personnel to follow for SARS-CoV-2 antigen testing using the RapiGEN Biocredit COVID-19 Antigen test. (Refer to D5403) 2. The laboratory failed to have documentation of establishing the performance specifications for the non-EUA approved RapiGEN Biocredit COVID-19 Antigen test. (Refer to D5423) 3. The laboratory failed to have documentation of verifying the calibration by running quality controls for 3 of 3 calibrations performed on the Beckman Coulter Act Diff 2 hematology analyzer in 2020 and 2021. (Refer to D5437) 4. The laboratory failed to have documentation of running a negative and positive quality control each day of patient testing on the RapiGEN Biocredit COVID-19 Antigen test. (Refer to D5449) D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D0000 An onsite recertification survey was performed on 8/27/21. The laboratory was surveyed and failed to meet the following conditions of the CLIA regulations found at CFR 42 493.1 through 493.1780 resulting in the following IMMEDIATELY JEOPARDY findings: D5400 493.1250 Analytic Systems The immediate jeopardy conditions were abated as evidenced by a letter signed by the laboratory director on 8 /27/21. See the attached letter. and the following CONDITION LEVEL findings: D6076 493.1441 Condition: Laboratories performing high complexity testing; laboratory director D6168 493.1487 Condition: Laboratories performing high complexity testing; testing personnel The facility representative was given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. D2127 HEMATOLOGY CFR(s): 493.851(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on a review of the laboratory's American Proficiency Institute (API) proficiency testing records for 2019 and staff interview, it was revealed that the laboratory failed to return its proficiency testing results to API within the time frame specified by the program for 1 out of 3 testing events in 2019, resulting in unsatisfactory performance for all analytes in the specialty of Hematology. Findings include: 1. A review of the laboratory's API proficiency testing records revealed the laboratory received the following unsatisfactory scores for 2019 Hematology /Coagulation third event: White Blood Cell Differential. - score 0% Erythrocyte Count - score 0% Hematocrit - score 0% Hemoglobin - score 0% Leukocyte Count - score 0% Platelet Count - score 0% 2. Further review of the laboratory's API records for the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- 2019 Hematology/Coagulation third event revealed the following notation: "I mailed the Hematology/Coagulation test on the late date, due to looking at the wrong dates due." 3. An interview with testing person #1 (as indicated on the CMS 209 form) on 8 /27/21 at 1:40 p.m. in the patient exam room, after review of the records, confirmed the above findings. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on a review of the laboratory's test records, a review of the laboratory's policies, and staff interview, it was revealed that the laboratory failed to report a total of 322 SARS-CoV-2 antigen patient test results, that contained both negative and positive antigen test results, as required by 400.200 for 86 of 86 days from November 17, 2020 to August 27, 2021. Findings include: 1. A review of the laboratory's test records from 2020 to 2021 revealed the laboratory started SARS-CoV-2 antigen patient testing using the RapiGEN Biocredit COVID-19 antigen test on November 17, 2020. 2. A review of the laboratory's policies revealed no documentation of a policy /procedure related to SARS-CoV-2 test reporting. 3. A review of the laboratory's SARS-CoV-2 antigen patient test records from November 17, 2020 to August 27, 2021, revealed the laboratory failed to have documentation of reporting 282 negative and 40 positive test records for 86 of 86 days of testing. 4. An interview with the laboratory director on 8/27/21 at 2:00 p.m. in the patient exam room, after review of the records, confirmed the above findings. 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 a review of the laboratory's records from November 2020 to August 2021 and staff interview, it was revealed that the laboratory failed to have documentation of 2 of 2 accuracy assessments in 2020 for SARS-CoV-2 antigen testing using the RapiGEN Biocredit COVID-19 Antigen test. Findings include: 1. A review of the laboratory's test records revealed the laboratory started SARS-CoV-2 antigen testing using the RapiGEN Biocredit COVID-19 Antigen test in November 2020. 2. Further review of the laboratory's records revealed the laboratory failed to have documentation of the twice annual accuracy assessments in 2020 for SARS-CoV-2 antigen testing using the RapiGEN Biocredit COVID-19 Antigen test. 3. An interview -- 2 of 10 -- with the laboratory director on 8/27/21 at 2:00 p.m. in the patient exam room, after review of the records, confirmed the above findings. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on a review of the laboratory's policies, a review of the laboratory's records, a review of patient test records, and staff interview, it was revealed that the laboratory failed to meet the requirements of the analytic systems as evidenced by: 1. The laboratory failed to make available a written procedure for the laboratory personnel to follow for SARS-CoV-2 antigen testing using the RapiGEN Biocredit COVID-19 Antigen test. (Refer to D5403) 2. The laboratory failed to have documentation of establishing the performance specifications for the non-EUA approved RapiGEN Biocredit COVID-19 Antigen test. (Refer to D5423) 3. The laboratory failed to have documentation of verifying the calibration by running quality controls for 3 of 3 calibrations performed on the Beckman Coulter Act Diff 2 hematology analyzer in 2020 and 2021. (Refer to D5437) 4. The laboratory failed to have documentation of running a negative and positive quality control each day of patient testing on the RapiGEN Biocredit COVID-19 Antigen test. (Refer to D5449) D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. 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 No Tags No deficiency details available. 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 --