Watertown Family Practice Associates Sc

Summary Statement of Deficiencies 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 surveyor review of testing records and interview with testing personnel, the laboratory failed to report negative SARS CoV-2 test results for 75 of 75 days when the laboratory performed testing from November 4, 2020 through February 26, 2021. Findings include: 1. Review of laboratory test logs for SARS CoV-2 testing performed on the cobas Liat and the Abbott ID NOW test systems from November 4, 2020 through February 26, 2021 showed the laboratory tested patient samples on 18 days in November and 20 days in December 2020, and 18 days in January and 19 days in February 2021. 2. Review of SARS CoV-2 test results in the WEDSS (Wisconsin Electronic Disease Surveillance System) from this laboratory showed the laboratory entered positive test reports from January 22 and 25, and February 10, 11, and 16. No negative test results from this laboratory were in the system. 3. Interview with testing personnel (staff A) on March 8, 2021 at 1:30 PM revealed the laboratory only entered patient information and results for patients with positive test results. Staff A confirmed the laboratory reported no negative test results to state or local public health entities. 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 -- D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records, observation of reagent storage, and interview with testing personnel, the laboratory did not define criteria consistent with the manufacturer's instructions for the frozen storage of the TriLevel Immunoassay control. Findings include: 1. Review of laboratory records show the laboratory defined acceptable temperature range for the laboratory freezer is negative five to negative fifteen degrees Celsius (C). 2. Observation of the reagents in the laboratory freezer on March 8, 2021 at 2:00 PM revealed a box of TriLevel Immunoassay controls. The box showed the manufacturer's acceptable storage temperature range was less than negative twenty degrees C. 3. Interview with testing personnel (staff F) on March 8, 2021 at 2:15 PM confirmed the laboratory's defined range for acceptable storage of the control was not consistent with the manufacturer's instructions. Further interview confirmed the controls were not stored at less than negative twenty degrees C. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and interview with testing personnel, the technical consultant did not evaluate and document the performance of five of five providers semiannually during the first year of testing. The five providers performed twelve wet mount examinations from January 20, 2020 through March 4, 2021. Findings include: 1. Review of laboratory testing records showed five providers performed wet mount microscopic examinations between January 20, 2020 and March 4, 2021. The identified providers performed testing on the following days: Staff A: May 7, 2020 and March 4, 2021 Staff B: March 5, 2020 Staff C: January 30, 2020 (two tests) and February 26, 2020 Staff D: November 17, 2020 and February 4, 2021 Staff E: January 20, 2020, March 4, 2020, November 18, 2020, and January 25, 2021 2. Interview with testing personnel (staff F) on March 8, 2021 at 2:15 PM confirmed the technical consultant did not evaluate or document competency of the five providers semiannually during the first year the five providers performed wet mount microscopic examinations. -- 2 of 2 --

Summary Statement of Deficiencies 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 surveyor review of testing records and interview with testing personnel, the laboratory failed to report negative SARS CoV-2 test results for 75 of 75 days when the laboratory performed testing from November 4, 2020 through February 26, 2021. Findings include: 1. Review of laboratory test logs for SARS CoV-2 testing performed on the cobas Liat and the Abbott ID NOW test systems from November 4, 2020 through February 26, 2021 showed the laboratory tested patient samples on 18 days in November and 20 days in December 2020, and 18 days in January and 19 days in February 2021. 2. Review of SARS CoV-2 test results in the WEDSS (Wisconsin Electronic Disease Surveillance System) from this laboratory showed the laboratory entered positive test reports from January 22 and 25, and February 10, 11, and 16. No negative test results from this laboratory were in the system. 3. Interview with testing personnel (staff A) on March 8, 2021 at 1:30 PM revealed the laboratory only entered patient information and results for patients with positive test results. Staff A confirmed the laboratory reported no negative test results to state or local public health entities. 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 -- D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records, observation of reagent storage, and interview with testing personnel, the laboratory did not define criteria consistent with the manufacturer's instructions for the frozen storage of the TriLevel Immunoassay control. Findings include: 1. Review of laboratory records show the laboratory defined acceptable temperature range for the laboratory freezer is negative five to negative fifteen degrees Celsius (C). 2. Observation of the reagents in the laboratory freezer on March 8, 2021 at 2:00 PM revealed a box of TriLevel Immunoassay controls. The box showed the manufacturer's acceptable storage temperature range was less than negative twenty degrees C. 3. Interview with testing personnel (staff F) on March 8, 2021 at 2:15 PM confirmed the laboratory's defined range for acceptable storage of the control was not consistent with the manufacturer's instructions. Further interview confirmed the controls were not stored at less than negative twenty degrees C. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and interview with testing personnel, the technical consultant did not evaluate and document the performance of five of five providers semiannually during the first year of testing. The five providers performed twelve wet mount examinations from January 20, 2020 through March 4, 2021. Findings include: 1. Review of laboratory testing records showed five providers performed wet mount microscopic examinations between January 20, 2020 and March 4, 2021. The identified providers performed testing on the following days: Staff A: May 7, 2020 and March 4, 2021 Staff B: March 5, 2020 Staff C: January 30, 2020 (two tests) and February 26, 2020 Staff D: November 17, 2020 and February 4, 2021 Staff E: January 20, 2020, March 4, 2020, November 18, 2020, and January 25, 2021 2. Interview with testing personnel (staff F) on March 8, 2021 at 2:15 PM confirmed the technical consultant did not evaluate or document competency of the five providers semiannually during the first year the five providers performed wet mount microscopic examinations. -- 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 surveyor review of the federal Certification and Survey Provider Enhanced Reports (CASPER) Proficiency Testing (PT) reports, American Association of Bioanalysts (AAB) and American Proficiency Institute (API) PT evaluation reports, the laboratory failed to successfully participate in PT for the Sodium analyte in the Specialty of Chemistry for events 2018-1, 2018-2, 2019-3, and 2020-2. Findings include: 1. Review of PT records in the federal CASPER reporting system shows that the laboratory had unsatisfactory performance for Sodium on events 2018-1, 2018-2, 2019-3, and 2020-2. Event 2018-1, score 40% Event 2018-2, score 60% Event 2019- 3, score 60% Event 2020-2, score 0% 2. Surveyor review of the AAB PT evaluation 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 -- reports confirmed the unsatisfactory scores for Sodium for events 2018-1 and 2018-2. Review of the API PT evaluation reports confirmed the unsatisfactory scores for Sodium for events 2019-3 and 2020-2. This results in subsequent unsuccessful participation in PT for Sodium. 3. Surveyor review of the federal CASPER reporting system on September 14, 2020 shows this is a subsequent unsuccessful PT performance and a repeat deficiency which was previously cited November 1, 2018. See D 2096. 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. This STANDARD is not met as evidenced by: Based on surveyor review of the federal Certification and Survey Provider Enhanced Reports (CASPER) Proficiency Testing (PT) reports, American Association of Bioanalysts (AAB) and American Proficiency Institute (API) Proficiency Testing (PT) evaluation reports, the laboratory failed to successfully participate in PT for the Sodium analyte in the Chemistry Specialty for PT events 2018-1, 2018-2, 2019-3, and 2020-2. Findings include: 1. Review of PT records in the federal CASPER reporting system shows that the laboratory had unsatisfactory performance for Sodium testing on events 2018-1, 2018-2, 2019-3, and 2020-2. Event 2018-1, score 40% Event 2018- 2, score 60% Event 2019-3, score 60% Event 2020-2, score 0% 2. Surveyor review on September 14, 2020 of the AAB PT evaluation reports from events 2018-1 and 2018-2 confirmed the unsatisfactory scores for Sodium. Review of the API PT evaluation reports from events 2019-3 and 2020-2 confirmed the unsatisfactory scores for Sodium. This results in subsequent unsuccessful participation in PT for Sodium testing. This deficiency was previously cited November 1, 2018. 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 surveyor review of the federal Certification and Survey Provider Enhanced Reports (CASPER) Proficiency Testing (PT) reports, American Association of Bioanalysts (AAB) and American Proficiency Institute (API) PT evaluation reports, the laboratory failed to successfully participate in PT for the Sodium analyte in the Specialty of Chemistry for events 2018-1, 2018-2, 2019-3, and 2020-2 which resulted in a subsequent unsuccessful PT performance. The laboratory director has not provided overall management and direction in accordance with 493.1445 of this subpart. Findings include: 1. The laboratory director failed to 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 surveyor review of the federal Certification and Survey Provider Enhanced Reports (CASPER) Proficiency Testing (PT), American Association of Bioanalysts (AAB) Proficiency Testing (PT) records, and interview with testing personnel, the laboratory failed to successfully participate in PT for the Sodium and Chloride analytes in the Subspecialty of Routine Chemistry for events 2018-1, 2018-2 and 2018-3. 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 4 -- 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 surveyor review of the federal Certification and Survey Provider Enhanced Reports (CASPER) Proficiency Testing (PT), American Association of Bioanalysts (AAB) PT records, and interview with testing personnel, the laboratory failed to have successful performance in PT for the Sodium and Chloride analytes in the Subspecialty of Routine Chemistry for events 2018-1, 2018-2 and 2018-3. Findings include: 1. Review of PT records in the federal CASPER reporting system shows that the laboratory failed two consecutive PT events for Sodium in the Subspecialty of Routine Chemistry - Event 2018-1, score 40% and Event 2018-2, score 60%. 2. Review of PT records in the federal CASPER reporting system shows that the laboratory failed two consecutive PT events for Chloride in the Subspecialty of Routine Chemistry - Event 2018-2, score 20% and Event 2018-3, score 60%. 3. Surveyor review of the AAB PT evaluation reports and interview with testing personnel, Staff A, on November 1, 2018 at 11:30 AM confirmed the failed PT scores. This results in a failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events for each analyte which is unsuccessful PT performance. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on surveyor review of microscopy proficiency testing (PT) records and interview with testing personnel, the laboratory has not documented evaluation of not scored or not graded microscopy results for event two in 2017. Findings include: 1. Review of American Academy of Family Physicians (AAFP) PT records for urine microscopy and wet prep microscopy for 2017 show no documented review of "Not graded-lack of referee consensus" samples for event 2017-B. 2. Interview with testing personnel, Staff A, on November 1, 2018 at 11:00 AM confirms the laboratory did not document evaluation of not scored and not graded samples. 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 surveyor review of proficiency testing (PT) records and interview with testing personnel, the laboratory has not verified the accuracy of urine microscopy testing twice annually. Findings include: 1. Review of 2018 PT records showed no -- 2 of 4 -- evidence of evaluation of accuracy of urine microscopy testing. 2. Interview with testing personnel, Staff A, on November 1, 2018 at 11:30 AM confirmed the laboratory did not verify the accuracy of urine microscopy testing twice annually. This is a repeat deficiency previously cited January 13, 2017. 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)