Cherry Tree Medical Assoc Inc

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 the AAB-Medical Laboratory Evaluation (AAB-MLE) proficiency testing (PT) records and interview with testing personnel #2 (TP), the laboratory director/designee (LD) and TP failed to sign 9 of 11 AAB-MLE PT attestation statement documents for chemistry, and hematology testing performed in 2021 and 2022. Findings Include: 1. On the day of the survey, 07/19/2023 at 08:33 am, the following 9 of 11 AAB-MLE PT attestation statements reviewed were not signed by the LD/designee and TP in 2021 and 2022: - 2021 Event Q2: Chemistry and Non-chemistry - 2021 Event Q3: Non-chemistry - 2022 Event Q1: Chemistry and Non-chemistry - 2022 Event Q2: Chemistry and Non-chemistry - 2022 Event Q3: Chemistry and Non-chemistry 2. TP #2 confirmed the findings above on 07/19/2023 around 12:30 pm. D5405 PROCEDURE MANUAL CFR(s): 493.1251(c) Manufacturer's test system instructions or operator manuals may be used, when applicable, to meet the requirements of paragraphs (b)(1) through (b)(12) of this section. Any of the items under paragraphs (b)(1) through (b)(12) of this section not provided by the manufacturer must be provided by the laboratory. This STANDARD 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 review of the laboratory's procedures, operator manuals, and interview with testing personnel #2 (TP), the laboratory failed to have a complete written procedure manual for hematology and chemistry testing performed that met the requirements of 493.1251 from 08/03/2021 to the date of the survey. Findings include: 1. On the day of the survey, 7/19/2023 at 09:26 am, review of the procedure manuals for hematology and chemistry testing revealed the operators manual were used to perform testing on the following from 01/01/2021 to 07/18/2023: - Ortho Clinical Diagnostics Vitro 350 (chemistry) - Ortho Clinical Diagnostics Vitro ECI (chemistry) - Beckman Coulter Act Diff 2 (hematology) 2. Review of the operators manual revealed that the test system instructions used failed to include the following requirements of 493.1251: - Step by step performance of the procedure including test calculations and interpretation of results - Preparation of slides, solution, calibrators, controls, reagents, stains, and other material used in testing. - Control procedures -

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of Laboratory procedure manuals and interview with testing personnel (TP) #3, the laboratory failed to establish a complete procedure to assess 3 of 3 TP who performed complete blood count (CBC) test in the act diff 2, chemistry tests in the Ortho Vitros ECI, and Ortho Vitros 350 from 08/03/2019 to the date of survey. Findings include: 1. On the day of survey 08/03/2021, the laboratory failed to provide a complete written policy that reviews how to assess the competency of 3 of 3 TP performing complete blood count (CBC) test in the act diff 2, chemistry tests in the Ortho Vitros ECI, and Ortho Vitros 350 in 2019, 2020, and 2021. 2. The TP #3 confirmed the finding above on 08/03/2021 around 09:40 am. 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 --

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 review of the CASPER Report 155 report and graded results from the proficiency testing organization American Association of Bioanalysts (AAB), the laboratory failed to successfully participate in proficiency testing for the analytes T3 Uptake and Hematocrit. Refer to D2017 and 2130. D2107 ENDOCRINOLOGY CFR(s): 493.843(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- 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 review of the CASPER 155 report and graded results from the proficiency testing organization American Association of Bioanalysts (AAB), the laboratory failed to successfully participate in proficiency testing for the analyte: T3 Uptake. The laboratory had unsatisfactory scores for the 2nd event of 2020 and the 3rd event of 2020. Findings include: Analyte Year Event Score T3 2020 2 0%. T3 2020 3 0%. D2108 ENDOCRINOLOGY CFR(s): 493.843(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 review of the CASPER Report 155 report and graded results from the proficiency testing organization American Associations of Bioanalysts (AAB), the laboratory failed to achieve an overall testing score of satisfactory performance in the subspecialty Endocrinology. The laboratory had unsatisfactory scores for the 2nd event of 2020, and 3rd event of 2020. Findings include: Subspecialty Year Event Score Endocrinology 2020 2 0% Endocrinology 2020 3 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 a review of the CASPER 155 report and graded results from the proficiency testing organization American Association of Bioanalysts (AAB), the laboratory failed to successfully participate in proficiency testing for the analyte: Hematocrit (HCT). The laboratory had unsatisfactory scores for the 2nd event of 2020, and 3rd event 2020. Findings include: Analyte Year Event Score Hematocrit 2020 2 60% Hematocrit 2020 3 60% -- 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 review of the CASPER Report 155 report and graded results from the proficiency testing organization American Association of Bioanalysts (AAB), the laboratory failed to successfully participate proficiency testing for the analyte Lactate Dehydrogenase (LDH). Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- 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 review of the CASPER 155 report and graded results from the proficiency testing organization American Association of Bioanalysts (AAB), the laboratory failed to successfully participate in a proficiency testing for the analyte: Lactate Dehydrogenase (LDH), which is in the subspecialty of Routine Chemistry. The laboratory had unsatisfactory scores for the 1st event of 2019 and the 2nd event of 2019. Findings include: Analyte Year Event Score LDH 2019 1 0%. LDH 2019 2 0%. -- 2 of 2 --

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on observation, review of laboratory procedure manuals and interview with Testing Personnel (TP) #1, the laboratory failed to have all procedure manuals in use, signed by the current director. Findings include: 1. On the day of survey, 11/07/2018, review of laboratory procedures manuals revealed, the current laboratory director did not have documentation of acceptance of Ortho Vitros 350 and Beckman Coulter Access 2 operations manuals as the chemistry analyzers policy and procedure manuals. 2. TP#1 confirmed the findings above on 11/07/2018 around 11:30 am. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of serum hCG quality control (QC) records and interview with the Testing Person (TP) #1, the laboratory failed to include two control materials of different concentrations for the Consult Diagnostic serum hCG combo kit, at least once each day of patient testing in 2017. Findings include: 1. On the day of survey, 11 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 -- /07/2018, review of Consult Diagnostic serum hCG combo kit QC records, revealed that QC was performed on a weekly bases and not once each day of patient testing in 2017. 2. In 2017, 1 Serum HCG was performed. 3. TP#1 confirmed the finding above on 11/07/2018 around 12:15 pm. D5781