Downtown Salem Primary Care Lab

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 review of COVID 19 testing records and discussion with the Technical Consultant (TC), the laboratory failed to report all COVID antigen testing results. Findings include: 1. Upon review of the COVID 19 antigen testing procedure for this laboratory, it was noted that the procedure indicated that only positive results were to be reported to Marion County Public Health. 2. Upon review of the COVID 19 antigen test records for patients tested from December 01, 2020 through February 1, 2021, it was noted that in December 2020, only one (1) out of eight (8) COVID antigen patient tests performed were reported to Marion County Public Health. For the month of January 2021, it was noted that only two (2) out of twenty (20) COVID antigen patient tests performed were reported to Marion County Public Health. For February 1st, 2021, it was noted that two (2) out of two (2) patient test reports were not reported to Marion County Public Health. 3. During survey 02/01/2021 and interview with the TC at approximately 1 pm, she confirmed that the laboratory does not report the negative COVID antigen tests using Care Start COVID antigen test by Access Bio to Marion County Public Health. 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 -- 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 policies and discussion with the Technical Supervisor (TS), the laboratory failed to ensure and follow written policies and procedures for the competency assessment of the TS were in place. Findings include: 1. During survey conducted 02/01/2021, no competency assessments for Hematology or Chemistry could be produced for the TS hired by the lab in August 2020. 2. The TS confirmed that she had had no competency assessment for Hematology or Chemistry by the Laboratory Director (LD) since her hire date in August 2020. 3. No written procedure for the competency of Technical Supervisor could be produced during survey 02/01 /2021. 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 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 review of COVID 19 testing records and discussion with the Technical Consultant (TC), the laboratory failed to report all COVID antigen testing results. Findings include: 1. Upon review of the COVID 19 antigen testing procedure for this laboratory, it was noted that the procedure indicated that only positive results were to be reported to Marion County Public Health. 2. Upon review of the COVID 19 antigen test records for patients tested from December 01, 2020 through February 1, 2021, it was noted that in December 2020, only one (1) out of eight (8) COVID antigen patient tests performed were reported to Marion County Public Health. For the month of January 2021, it was noted that only two (2) out of twenty (20) COVID antigen patient tests performed were reported to Marion County Public Health. For February 1st, 2021, it was noted that two (2) out of two (2) patient test reports were not reported to Marion County Public Health. 3. During survey 02/01/2021 and interview with the TC at approximately 1 pm, she confirmed that the laboratory does not report the negative COVID antigen tests using Care Start COVID antigen test by Access Bio to Marion County Public Health. 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 -- 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 policies and discussion with the Technical Supervisor (TS), the laboratory failed to ensure and follow written policies and procedures for the competency assessment of the TS were in place. Findings include: 1. During survey conducted 02/01/2021, no competency assessments for Hematology or Chemistry could be produced for the TS hired by the lab in August 2020. 2. The TS confirmed that she had had no competency assessment for Hematology or Chemistry by the Laboratory Director (LD) since her hire date in August 2020. 3. No written procedure for the competency of Technical Supervisor could be produced during survey 02/01 /2021. 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 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: Proficiency Testing (PT) desk review of the American Association of Bioanalysts (AAB) proficiency testing (PT) shows the laboratory had unsuccessful participation for the Analyte Human chronic gonadotropin (HCG) in Endocrinology. Refer to D2107. 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: Review of Proficiency testing shows the laboratory failed two consecutive testing events for the analyte Human chronic gonadotropin (HCG). Findings include: 1. 2nd Event 2020 - HCG = 0% 2. 3rd Event 2020 - HCG = 0% -- 2 of 2 --

Summary Statement of Deficiencies D6109 TECHNICAL SUPERVISOR QUALIFICATIONS CFR(s): 493.1449 The laboratory must employ one or more individuals who are qualified by education and either training or experience to provide technical supervision for each of the specialties and subspecialties of service in which the laboratory performs high complexity tests or procedures. The director of a laboratory performing high complexity testing may function as the technical supervisor provided he or she meets the qualifications specified in this section. This STANDARD is not met as evidenced by: Based on review of records and discussion with the currently designated Technical Supervisor (TS) for Hematology, the TS does not qualify to act as a TS for high complexity (HC) Hematology testing. Findings include: 1. The current procedure for performing manual differentials on specimens for Hematology does not require smears with immature cells to be reviewed by a qualified individual or sent out to a facility that has said qualified staffing. 2. The current individual designated as a TS has only 2 of the 4 years of experience in Hematology required for a TS. 3. During an interview with the designated TS on 12/31/2018 at approximately 12:30 pm confirmed that she has only two of the four years required for a HC Hematology TS. 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 --