Tri-State Clearwater Medical Clinic

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 a Proficiency Testing (PT) desk review of graded PT results from the American Association of Bioanalysts (AAB) and an interview with the laboratory manager on 1/19/2023, the laboratory failed to successfully participate in PT for the analyte creatinine for one event in 2020 and two (2) consecutive testing events in 2021 and 2022. See D2096 D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 3 -- Failure to achieve satisfactory performance for the same analyte or test in 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 (PT) desk review of graded PT results from the American Association of Bioanalysts (AAB) and an interview with the laboratory manager on 1/19/2023, the laboratory failed to achieve an overall score of satisfactory performance for two (2) consecutive testing events for the analyte creatinine in 2022. The findings include: 1. A PT desk review of graded PT results from AAB identified that the laboratory failed to achieve satisfactory results for the following analyte: Analyte Year Event Score Creatinine 2020 3 20% Creatinine 2021 1 0% Creatinine 2021 2 20% Creatinine 2022 2 20% Creatinine 2022 3 20% 2. A rolling review of the laboratory's graded PT results from AAB identified the subsequent occurrence of unsuccessful PT participation for the analyte creatinine in 2020 event three (20%), and in 2021 for events one (0%) and two (20%) for which the laboratory submitted an allegation of compliance (AOC) on 11/26/2021 which resulted in the reinstatement of testing of the analyte creatinine on 6/15/2021. 3. A PT desk review performed on 1/24 /2023 identified the additional subsequent occurrence of unsuccessful PT participation for the analyte creatinine in 2022 for event two (20%) and event three (20%). 4. An interview with the Clinic manager on 1/19/2023 at 2:08 pm confirmed the PT failures in 2020, 2021 and 2022 for creatinine. 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 Proficiency Testing (PT) desk review of graded PT results from the American Association of Bioanalysts (AAB), the subsequent occurrence of unsuccessful participation for the analyte creatinine (event three in 2020, events one and two in 2021), the corresponding allegation of compliance (AOC) and evidence of compliance (EOC) which provided the basis for reinstatement of testing on 6/15/2022 for the analyte creatinine, the laboratory director failed to ensure the plan of remedial action, training, or technical assistance was successful from previous proficiency testing failures and sanction for the analyte creatinine to ensure that the laboratory maintained successful participation for the analyte creatinine for two (2) consecutive proficiency testing events in 2022. See D6019 D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved

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 a Proficiency Testing (PT) desk review of graded PT results from the American Association of Bioanalysts (AAB) and an interview with the clinic manager on 11/1/2021, the laboratory failed to successfully participate in PT for the subspecialty of routine chemistry for the analyte creatinine for three (3) of three (3) consecutive testing events. See D2096 D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 3 -- Failure to achieve satisfactory performance for the same analyte or test in 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 (PT) desk review of graded PT results from the American Association of Bioanalysts (AAB) and an interview with the Clinic manager on 11/1/2021, the laboratory failed to achieve an overall testing event score of satisfactory performance for three (3) consecutive testing events for the subspecialty of routine chemistry for the analyte creatinine. The findings include: 1. A PT desk review of graded PT results from AAB revealed the laboratory failed to achieve satisfactory results for the subspecialty of routine chemistry for the following analyte: Analyte Year Event Score Creatinine 2020 3 20% Creatinine 2021 1 0% Creatinine 2021 2 20% 2. An interview with the Clinic manager on 11/1/2021 at 2:33 pm confirmed the PT failures. 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 Proficiency Testing (PT) desk review of graded PT results from the American Association of Bioanalysts (AAB) and the previous CMS-2567 for unsuccessfully participation dated 6/3/2021 and its corresponding Allegation of Compliance (AOC)/ Evidence of compliance (EOC) dated 6/9/2021, the laboratory director failed to ensure the plan of remedial action, training,or technical assistance was successful from previous proficiency testing failure for the analyte creatinine and failed to ensure that the laboratory maintained successful participation for the analyte creatinine for three (3) of three (3) consecutive proficiency testing events. (D6019) The laboratory director failed to ensure that the laboratory submit PT results for creatinine for 2021 event one (1). (D6017) D6017 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(ii) 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)(ii) Ensure that results are returned within the timeframes established by the proficiency testing program. This STANDARD is not met as evidenced by: Based on a Proficiency Testing (PT) desk review of graded PT results from the American Association of Bioanalysts (AAB) and an interview with the Clinic manager on 11/1/2021, the laboratory director failed to ensure that the laboratory submitted PT results for analytes in the subspecialty of routine chemistry for 2021 -- 2 of 3 -- event one (1) . The findings include: 1. A PT desk review of graded PT results from AAB revealed the laboratory failed to submit PT results for 19 analytes in the subspecialty of routine chemistry, including creatinine for 2021 event one (1). 2. An interview with the Clinic manager on 11/1/2021 at 2:33 pm confirmed the failure to submit PT results. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved

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 a Proficiency Testing (PT) desk review of the CASPER 0155D report and graded results from the American Association of Bioanalysts (AAB), the laboratory failed to successfully participate and achieve an overall satisfactory score for two consecutive testing events for the specialty of Routine Chemistry and the subspecialty of Endocrinology. See D2096 and D2107. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 or test in 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 (PT) desk review of the CASPER 0155D report and graded results from the American Association of Bioanalysts(AAB), the laboratory failed to achieve an overall satisfactory score for two consecutive testing events for the following analytes: Aspartate Aminotransferase (AST), Chloride, Creatinine, Urea Nitrogen (BUN). The findings include: 1. A PT desk review of graded results from AAB revealed that the laboratory failed to achieve satisfactory scores in the specialty of Routine Chemistry for the following analytes: Aspartate Aminotransferase (AST), Chloride, Creatinine, Urea Nitrogen (BUN). Analyte Year Event Score AST 2020 3 40 AST 2021 1 0 Chloride 2020 3 40 Chloride 2021 1 0 Creatinine 2020 3 20 Creatinine 2021 1 0 BUN 2020 3 40 BUN 2021 1 0 D2107 ENDOCRINOLOGY CFR(s): 493.843(f) Failure to achieve satisfactory performance for the same analyte or test in 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 (PT) desk review of the CASPER 0155D report and graded results from the American Association of Bioanalysts(AAB), the laboratory failed to achieve an overall satisfactory score for two consecutive testing events for the following analytes: Thyroid Stimulating Hormone (TSH) and Thyroxine, Free (FT4). The findings include: 1. A PT desk review of graded results from AAB revealed that the laboratory failed to achieve satisfactory scores for two consecutive testing events in the subspecialty of Endocrinology for the analytes Thyroid Stimulating Hormone (TSH), and Thyroxine, Free (FT4). Analyte Year Event Score TSH 2020 3 20 TSH 2021 1 0 FT4 2020 3 40 FT4 2021 1 0 -- 2 of 2 --

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 a proficiency testing (PT) desk review, the laboratory failed to successfully participate in proficiency testing for the analyte Hematocrit (HCT). Refer to D2130. 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. 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 -- This STANDARD is not met as evidenced by: Based on a proficiency testing (PT) desk review and the laboratory's graded PT results from the American Association of Bioanalysts (AAB), the laboratory failed to achieve satisfactory performance in two out of three consecutive testing events for Hematocrit (HCT) in 2019. Findings: 1. A review of the AAB PT results from 2019 event 1, revealed the laboratory received a score of 60% for the analyte Hematocrit (HCT). 2. A review of the AAB PT results from 2019 event 3, revealed the laboratory received a score of 60% for the analyte Hematocrit (HCT). -- 2 of 2 --

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 a proficiency testing (PT) desk review, the laboratory failed to successfully participate in proficiency testing for the analyte Chloride. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. 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 -- This STANDARD is not met as evidenced by: Based on a proficiency testing (PT) desk review and the laboratory's graded PT results from the American Association of Bioanalysts (AAB), the laboratory failed to achieve satisfactory performance in two out of three consecutive testing events for Chloride in 2019. Findings: 1. A review of the AAB PT results from 2019 event 2, revealed the laboratory received a score of '0' for the analyte Chloride. 2. A review of the AAB PT results from 2019 event 1, revealed the laboratory received a score of '60' for the analyte Chloride. -- 2 of 2 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on a record review and an interview with the laboratory manager, the laboratory failed to retain calibration records from the Cobas Integra 400 Plus chemistry analyzer for all 23 chemistry analytes. Findings: 1. A calibration record review for the Cobas Integra 400 revealed the laboratory failed to retain the chemistry calibration print-outs from the dates requested for December 2017. 2. An interview on July 26, 2018 at 10:45 AM, with the laboratory manager, confirmed the laboratory failed to retain the chemistry calibration instrument print-outs from 2017 because the lab only keeps the most current calibration records onboard the instrument computer. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. 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 -- This STANDARD is not met as evidenced by: Based on a record review and an interview with the laboratory manager, the laboratory director failed to ensure two phlebotomists receive appropriate training and demonstrate they can perform testing on the Sysmex pocH-100i complete blood count (CBC) analyzer prior to testing patient samples since the last survey on February 18, 2016. Findings: 1. A record review revealed two phlebotomists failed to have documentation of training prior to testing patient CBC samples since 2016. 2. An interview on July 26, 2018 at 10:05 AM, with the laboratory manager, confirmed the laboratory director failed to ensure the phlebotomists receive appropriate training and demonstrate they can reliably perform CBC tests for patient samples. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on competency assessment records and an interview with the laboratory manager, the laboratory director who is the technical consultant failed to have a qualified individual perform competency assessments for 3 out of 5 testing personnel performing complete blood counts (CBCs), chemistry, endocrinology, and microscopic examinations since the last accreditation survey on February 18, 2016. The technical consultant also failed to assess the competency for 2 out of 5 phlebotomists performing CBCs since 2016. Findings: 1. A review of personnel records revealed the laboratory director failed to have a qualified individual perform competency assessments on the 5 testing personnel listed on the CMS-209 Personnel Report form. 2. An interview on July 26, 2018 at 8:15 AM, with the laboratory manager, confirmed the laboratory director failed to have a qualified individual perform competency assessments since 2016. D6047 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b(8)(i) The procedures for evaluation of the competency of the staff must include, but are not limited to direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. This STANDARD is not met as evidenced by: Based on competency assessment records and an interview with the laboratory manager, the laboratory director who is the technical consultant failed to perform direct observations of patient test performance including handling and processing of samples since the last survey on February 18, 2016. Findings: 1. A review of the Competency Based Assessment forms for the laboratory manager and the medical technologists revealed the forms failed to include the direct observation of routine patient test performance since 2016. 2. An interview on July 26, 2018 at 8:15 AM, with the laboratory manager, confirmed the laboratory assessment forms in use failed to include the direct observation of test performance. D6050 TECHNICAL CONSULTANT RESPONSIBILITIES -- 2 of 3 -- CFR(s): 493.1413(b)(8)(iv) The procedures for evaluation of the competency of the staff must include, but are not limited to direct observation of performance of instrument maintenance and function checks. This STANDARD is not met as evidenced by: Based on competency assessment records and an interview with the laboratory manager, the laboratory director who is the technical consultant failed to perform direct observations of instrument maintenance performance including function checks since the last survey on February 18, 2016. Findings: 1. A review of the Competency Based Assessment forms for the laboratory manager and the medical technologists revealed the forms failed to include the direct observation of instrument maintenance performance including function checks since 2016. 2. An interview on July 26, 2018 at 8:15 AM, with the laboratory manager, confirmed the laboratory assessment forms in use failed to include the direct observation of instrument maintenance and function checks. -- 3 of 3 --