Upper Valley Family Medicine

Summary Statement of Deficiencies 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 review of proficiency testing (PT) documents from the American Association of Bioanalysts (AAB), the Centers for Medicare and Medicaid Services (CMS) CASPER Report 96D and an interview with the technical consultant (TC) on 4 /25/2024, the laboratory failed to participate in one (1) of three (3) testing events in 2023 for the specialty of hematology. The findings include: 1. A review PT documents from AAB and the CMS Report 96D identified that the laboratory failed to participate in testing for event one (1) in 2023 for the specialty of hematology resulting in a score of zero (0). 2. An interview with the TC on 4/25/2024 at 9:52 am confirmed the above finding. 3. The laboratory reports performing 16,110 hematology tests annually. 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, 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 -- consultant competency. This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, laboratory policies, training and competency assessment records and an interview with the technical consultant (TC) on 4/25/2024, the laboratory failed to establish and follow written policies to assess employee competency. The findings include: 1. The CMS 209 identified 12 testing personnel (TP) performing moderate complexity testing. Five (5) of the 12 TP were new since the previous inspection on 6 /24/2022. 2. A review of laboratory policies identified that the laboratory failed to establish in their personnel policy TP assessments semiannually during the first year of employment and competency of the technical consultant (TC). 3. A review of training and competency assessment records identified that the laboratory failed to have an annual competency assessments for one (1) of eight (8) TP in 2023. 4. A review of training and competency assessment records identified that the laboratory failed to have a six month competency assessments for one (1) TP in 2023. 5. A review of training and competency assessment records identified that the laboratory failed to have a competency assessment for the TC. 6. An interview with the TC on 4 /25/2024 at 9:51 am confirmed the above findings. 7. The laboratory reports performing 16,110 moderate tests annually. 8. This is a repeat deficiency from the survey on 2/23/21 for a failure to perform competency assessments of TP in 2019 and 2020. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) documentation from the American Association of Bioanalysts (AAB) and an interview with the technical consultant (TC) on 4/25/2024, the laboratory director failed to review and evaluate PT results for the specialty of hematology. The findings include: 1. A review of PT results for the specialty of hematology from AAB for 2022 identified that the laboratory director failed to review and evaluate PT results for event three (3). 2. A review of PT results for the specialty of hematology from AAB for 2023 identified that the laboratory director failed to review and evaluate PT results for events two (2) and three (3). 3. A review of PT results for the specialty of hematology from AAB for 2024 identified that the laboratory director failed to review and evaluate PT results for event one (1). 4. An interview with the TC on 4/25/2024 at 9:52 am confirmed that the laboratory director failed to review and evaluate PT results for hematology. 5. The laboratory reports performing 16,110 hematology tests annually. 6. This is a repeat deficiency from the previous inspection on 6/24/2022. 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 -- 2 of 6 -- 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 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 of quality control (QC) records for hematology and an interview with the technical consultant (TC) on 6/24/2022, the laboratory failed to retain QC results for two years. The findings include: 1. A review of hematology QC documents identified that the laboratory failed to retain hematology QC results prior to January 1, 2022. 2. An interview with the TC on 6/24/2022 at 11:40 am confirmed the laboratory failed to retain hematology QC results prior to January 1, 2022. 3. The laboratory reports performing 16,015 hematology tests annually. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) documentation and an interview with the technical consultant (TC) on 6/24/2022, the laboratory failed to document the review of PT results for the specialty of hematology. The findings include: 1. A review of PT results for the specialty of hematology from the American Association of Bioanalysts identified that the laboratory failed to document the review and evaluation of PT results by the laboratory director for events 1,2 and 3 in 2021 and 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 -- event 1 in 2022. 2. An interview with the TC on 6/24/2022 at 11:10 am confirmed that the laboratory director failed to review and evaluate PT results for hematology. 3. The laboratory reports performing 16,015 hematology tests annually. -- 2 of 2 --

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 a review of training documentation and competency assessments, the Centers for Medicare and Medicaid Services (CMS) 209 personnel form and an interview on 2/23/2021 with the laboratory lead, the laboratory failed to establish and follow written policies and procedures to assess testing personnel in accordance with 42 C.F.R. 493.1413(b)(8). The findings include: 1. A review of training and competency records identified that two (2) of nine (9) testing personnel listed on the CMS 209 had start days after the previous survey (6/27/2018) that the laboratory failed to have documentation of six (6) month competency which included the six parameters as listed in 42 C.F.R. 493.1413(b)(8). 2. A review of training and competency records identified four (4) of nine (9) testing personnel listed on the CMS 209 for which the laboratory failed to have documentation of annual competency for 2019 which included the six parameters as listed in 42 C.F.R. 493.1413(b)(8). 3. A review of training and competency records identified six (6) of nine (9) testing personnel listed on the CMS 209 for which the laboratory failed to have documentation of annual competency for 2020 which included the six parameters as listed in 42 C.F.R. 493.1413(b)(8). 4. An interview with the laboratory lead on 2/23 /2021 at 9:10 am confirmed that the laboratory failed to document competency assessments for 2019 and 2020. 5. The laboratory reports performing 13,930 tests annually. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) 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 -- For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on observation and interview with the laboratory lead on 2/23/2021, the laboratory failed to ensure their thermometers and timers were calibrated as necessary for accurate and reliable results. The findings include: 1. Based on an observation during a laboratory tour on 2/23/2021 at 11:55 am it was identified that the laboratory failed to have a calibrated thermometer in the refrigerator that stores controls for the Horiba ABX Micros 60, reagents and patient samples to ensure that controls, reagents and samples are stored per manufacturers requirements. 2. Based on an observation during a laboratory tour on 2/23/2021 at 11:55 am it was identified that the laboratory failed to have a calibrated thermometer in the freezer that stores patient samples. 3. Based on an observation during a laboratory tour on 2/23/2021 at 11:56 am it was identified that the laboratory failed to have three (3) of three (3) timers calibrated to ensure accurate timing of patient testing as required by manufacturer. 4. An interview with the laboratory lead on 2/23/2021 at 11:56 confirmed that the laboratory failed to have calibrated thermometers and timers. 5. The laboratory reports performing 16,928 moderate complexity and waived tests annually. -- 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: D2016 Based on a proficiency testing (PT) desk review, the laboratory failed to successfully participate in proficiency testing for the analyte White Blood Cell Differential (WBC Diff). 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 White Blood Cell Differential (WBC Diff) in 2019. Findings: 1. A review of the AAB PT results from 2019 event 1, revealed the laboratory received a score of 0% for the analyte WBC Differentials. 2. A review of the AAB PT results from 2019 event 3, revealed the laboratory received a score of 0% for the analyte White Blood Cell Differential (WBC Diff). -- 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 proficiency testing (PT) desk review, the laboratory failed to successfully participate in proficiency testing for the overall testing events in hematology. Refer to D2131. 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 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 -- unsuccessful performance. This STANDARD is not met as evidenced by: Based on proficiency testing (PT) desk review and the laboratory's graded PT results from American Association of Bioanalysts (AAB), the laboratory failed to achieve an overall testing event score of satisfactory performance for two out of three consecutive testing events for hematology with differential. Findings: Analyte Year Event Score Hematology with differential 2017 3 0 Hematology with differential 2018 1 0 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)