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Order of the Health Officer of the County - Laboratories Conducting COVID-19 Diagnostic Tests

ORDER OF THE HEALTH OFFICER OF THE COUNTY OF SANTA CLARA DIRECTING ALL LABORATORIES CONDUCTING COVID.19 DIAGNOSTIC TESTS TO REPORT COVID-19 TEST INFORMATION-INCLUDING POSITIVE, NEGATIVE, AND INCONCLUSIVE TEST RESULTS-TO LOCAL AND STATE PUBLIC HEALTH AUTHORITIES

DATE OF ORDER: MARCH 24, 2020

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Please read this Order carefully. Violation of or failure to comply with this Order is a misdemeanor punishable by fine, imprisonment, or both. (California Health and Safety Code § 120295, et seq.; California Penal Code §§ 69, 1a8(a)(1); Santa Clara County Ordinance Code § A1-28.)

UNDER THE AUTHORITY OF CALIFORNIA HEALTH AND SAFETY CODE SECTIONS 101040, 101085, AND 120175, THE HEALTH OFFICER OF THE COUNTY OF SANTA CLARA ("HEALTH OFFICER") ORDERS:

  1. The intent of this Order is to ensure that any Laboratory conducting Diagnostic Tests adheres to Reporting Requirements established by the Health Officer as those initially capitahzed terms are defined in Section 4 and to ensure that complete Diagnostic Test data are promptly shared with the individuals from whom the tested samples were taken; their health care providers, if any; and with public health officials, using the California Reportable Disease Information Exchange ("CaIREDIE") system.
  1. Every Laboratory that generates any test result that was collected from a resident of the County of Santa Clara ("County") or was collected or processed in the County from a Diagnostic Test must fully and timely comply with all Reporting Requirements.
  1. Within one hour of receiving Diagnostic test results, Laboratories must report those results to (1) the tested individual's health care provider who ordered the test, if any, and other authorized recipients; and (2) public health officials via the CaIREDIE system in accordance with all Reporting Requirements.
  1. Definitions
    For purposes of this Order, the following terms will have the meaning given below.
    1. "Reporting Requirements" means:
      1. Reporting all positive. negative. and inconclusive Diagnostic Test results in accordance with this Order;
      2. Adhering to any and all California Depattureut of Public Health (CDPH) reporting and notification requirements for Laboratories conducting Diagnostic Tests, including, without limitation: notification requirements of Chapter 17 of the California Code of Regulations section 2505; the March 9,2020 CDPH Letter to Laboratory Directors and Managers, attached to this Order as Exhibit A; and the March 9,2020 CDPH Reportable Conditions: Notification by Laboratories document attached to this Order as Exhibit B, except:
        1. Where a Laboratory promptly submits Diagnostic Test results via electronic laboratory reporting to CaIREDIE, no further reporling is required. Where a Laboratory is unable to report electronically, it must temporarily report to the County Communicable Disease Prevention and Control Program via confidential facsimile or telephone;
      3. Reporting the date the specimen was obtained, the patient identification number, the specimen accession number or other unique specimen identifier, the specimen site, the diagnosis codes, the Laboratory findings for the test performed, and the date that the Laboratory findings were identified;
      4. If provided to the Laboratory, the Laboratory shall report in all test requisitions the name, gender, address including ZIP Code, telephone number, pregnancy status, and date of birth, of the individual who is the subject of the Diagnostic Test; and
      5. All Laboratories are requested, but at this time not required, to report to the Health Officer and CDPH whether a specimen was collected from an inpatient or outpatient individual.
    2. "Diagnostic Test" means nucleic acid amplification testing or serologic testing to determine the presence of SARS-CoY-2 (the virus that causes COVID-l9) or novel coronavirus infection.
    3. "Laboratory" means any facility meeting the requirements to perform testing classified as high complexity under the Clinical Laboratory Improvement Amendments of section 353 of the Public Health Service Act.
  1. This Order is issued based on evidence of increasing occurrence of COVID-19 within the County and throughout the Bay Area, scientific evidence and best practices regarding the most effective approaches to slow the transmission of communicable diseases generally and COVID-19 specifically, and evidence that the age, condition, and health of a significant portion of the population of the County places it at risk for serious health complications, including death, from COVID-I9. Due to the outbreak of the COVID-I9 virus in the general public, which is now a pandemic according to the World Health Organization, there is a public health emergency throughout the County. The scientific evidence shows that at this stage of the emergency, it is essential to slow virus transmission as much as possible to protect the most vulnerable and to prevent the health care system from being overwhelmed. Accurate and precise diagnostic testing is an essential tool for combatting the spread of COVID-19. By sharing high quality test result data at scale, state and local health authorities can better track COVID-19, predict its spread, and better focus public resources to end this global pandemic.
  1. This Order also is issued in light of the existence of 321 cases of COVID-19 in the County, including 13 deaths, as of 5:00 pm on March 22,2020, including a significant and increasing number of suspected cases of community transmission and likely further significant increases in transmission.
  1. This Order is issued in accordance with, and incorporates by reference, the March 4,2020 Proclamation of a State of Emergency issued by Governor Gavin Newsom, the March 12,2020 Executive Order (Executive Order N-25-20) issued by Govemor Gavin Newsom, the February 3,2020 Declaration of a Local Health Emergency Regarding Novel Coronavirus2019 (COVID-I9) issued by the Health Officer, the February 3,2020 Proclamation of a Local Emergency issued by the County Director of Emergency Services, the February 10,2020 Resolution of the Board of Supervisors of the County of Santa ClaraRatifying and Extending the Declaration of a Local Health Emergency, the February 10,2020 Resolution of the Board of Supervisors of the County of Santa Clara Ratifying and Extending the Proclamation of a Local Emergency, and guidance issued by the California Department of Public Health, as each of them have been and may be supplemented.
  1. Pursuant to Govemment Code sections 26602 and 4160I and Health and Safety Code section 101029, the Health Officer requests that the Sheriff and the chiefs of police in the County ensure compliance with and enforce this Order. The violation of any provision of this Order, including any law or regulation cited in this Order, constitutes an imminent threat and creates an immediate menace to public health and may lead to enforcement measures or referral to the relevant enforcement authorities.
  1. This Order shall become effective at 12:01 a.m. on March 25,2020 and will continue to be in effect until it is rescinded, superseded, or amended in writing by the Health Officer.
  1. Copies of this Order shall promptly be: (1) made available at the County Govemment Center at 70 W. Hedding Street, San Jos6, California; (2) posted on the County Public Health Department website (www.sccphd.org); and (3) provided to any member of the public requesting a copy of this Order. In addition, the owner,manager, or operator of any Laboratory that is likely to be impacted by this Order is strongly encouraged to post a copy of this Order onsite and to provide a copy to any number of the public asking for a copy.
  1. If any provision of this Order or its application to any person or circumstance is held to be invalid, then the reminder of the Order, including the application of such part or provision to other persons or circumstances, shall not be affected and shall continue in full force and effect. To this end, the provisions of this Order are severable.

IT IS SO ORDERED:

Sara H. Cody, M.D.
Health Officer of the County of Santa Clara
3/24/20

Approved as to form and legality

James R. Williams
County Counsel
3/24/20

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Last updated: 4/2/2020 1:12 PM