WSR 20-06-061

PROPOSED RULES

DEPARTMENT OF HEALTH

STATE BOARD OF HEALTH

[Filed March 3, 2020, 11:23 a.m.]

Original Notice.

Preproposal statement of inquiry was filed as WSR 18-11-089.

Title of Rule and Other Identifying Information: Chapter 246-101 WAC, Notifiable conditions, proposed changes to add notification and specimen submission requirements; change notification and specimen submission requirements for existing conditions; clarify notification requirements for suspected cases; revise reporting requirements for veterinarians and the Washington state department of agriculture; update references; and improve clarity and usability of the rule.

Hearing Location(s): On April 8, 2020, at 1:30 p.m., at the Cowlitz County Event Center, 1900 7th Avenue, Longview, WA 98632.

Date of Intended Adoption: April 8, 2020.

Submit Written Comments to: Alexandra Montano, P.O. Box 47811, Olympia, WA 98504-7811, email https://fortress.wa.gov/doh/policyreview, by March 25, 2020.

Assistance for Persons with Disabilities: Contact Alexandra Montano, phone 360-236-4205, TTY 711, email alexandra.montano@doh.wa.gov, by April 3, 2020.

Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The purpose [of] the chapter is to provide critical information to public health authorities to aid them in protecting and improving public health through prevention and control of infectious and noninfectious conditions as required under law. Public health authorities use the information gathered under this chapter to take appropriate action, including, but not limited to: Treating ill people; providing preventive therapies for individuals who came into contact with infectious agents; investigating and halting outbreaks; removing harmful health exposures from the environment; assessing broader health-related patterns, including historical trends, geographic clustering, and risk factors; and redirecting program activities and developing policies based on broader health-related patterns. The chapter establishes notification requirements and standards for conditions that pose a threat to public health consistent with this purpose and the authorizing statutes it is adopted under.

The current rules require health care providers, health care facilities, laboratories, veterinarians, food service establishments, child care facilities, and schools to notify public health authorities of cases of notifiable conditions identified in this chapter, cooperate with public health authorities when conducting case investigations, and follow infection control measures when necessary to control the spread of disease.

The proposed rules significantly amend notification requirements applicable to health care providers, health care facilities, laboratories, and veterinarians; create notification requirements for the Washington state department of agriculture; and clarify requirements for food service establishments, schools, child care facilities, and the general public. Proposed changes to the rules include: (1) Adding or revising notification and specimen submission requirements for seventy-four new or existing conditions; (2) eliminating three categories of conditions (other rare diseases of public health significance, emerging conditions with outbreak potential and disease of suspected bioterrorism origin); (3) eliminating notification requirements for veterinarians and clarifying requirements for veterinarians to cooperate with public health authorities during case investigations; (4) establishing notification requirements for the Washington state department of agriculture; (5) updating local health jurisdiction duties to reflect current technology used for notifying the department of health (department), clarifying existing and establishing new notification timelines, and clarifying notification, case report, and outbreak report content requirements; (6) updating reference to the Security and Confidentiality Guidelines developed by the Centers for Disease Control and Prevention; (7) updating statutory references throughout the chapter; and (8) improving overall clarity and usability of the chapter by merging health care provider and facility rules, repealing unnecessary rules, clarifying requirements for suspected cases of notifiable conditions, and revising language consistent with clear rule writing standards.

Reasons Supporting Proposal: The rules were last revised in 2011. Since then, there have been a number of advances and developments which can only be addressed in rule. The state board of health and department have proposed changes to chapter 246-101 WAC to better protect public health by improving our understanding of emerging conditions, allowing more thorough case investigations, and improving the public health response to infectious and noninfectious conditions. The public health goals for these changes are to reduce the risk of transmission of disease and prevent serious complications and fatalities.

Statutory Authority for Adoption: RCW 43.20.050, 70.104.055, 43.70.545, 70.24.125, 70.104.030, 70.24.130, 70.24.380, and 70.28.032.

Statute Being Implemented: RCW 70.104.055, 43.70.545, 70.28.010, and 70.05.060.

Rule is not necessitated by federal law, federal or state court decision.

Name of Proponent: Washington state board of health and Washington state department of health, governmental.

Name of Agency Personnel Responsible for Drafting, Implementation, and Enforcement: Alexandra Montano, 101 Israel Road S.E., Tumwater, WA, 98504-7990, 360-236-4205.

A school district fiscal impact statement is not required under RCW 28A.305.135.

A cost-benefit analysis is required under RCW 34.05.328. A preliminary cost-benefit analysis may be obtained by contacting Alexandra Montano, P.O. Box 47811, Olympia, WA 98504-7811, phone 360-236-4205, TTY 711, email alexandra.montano@doh.wa.gov.

The proposed rule does impose more-than-minor costs on businesses.

Small Business Economic Impact Statement

The purpose of chapter 246-101 WAC, Notifiable conditions, is to provide critical information to public health authorities to aid them in protecting and improving public health through prevention and control of infectious and noninfectious conditions as required under RCW 43.20.050, 70.104.055, and 43.70.545. Public health authorities use the information gathered under this chapter to take appropriate action, including, but not limited to, treating ill people; providing preventive therapies for individuals who came into contact with infectious agents; investigating and halting outbreaks; removing harmful health exposures from the environment; assessing broader health-related patterns, including historical trends, geographic clustering, and risk factors; and redirecting program activities and developing policies based on broader health-related patterns. The chapter establishes notification requirements and standards for conditions that pose a threat to public health consistent with this purpose and the authorizing statutes it is adopted under.

The current rules require health care providers, health care facilities, laboratories, veterinarians, food service establishments, child care facilities, and schools to notify public health authorities of cases of notifiable conditions identified in chapter 246-101 WAC, cooperate with public health authorities when conducting case investigations, and follow infection control measures when necessary to control the spread of disease.

The rules were last revised in 2011. Since then, there have been a number of advances and developments which can only be addressed in rule. The state board of health (board) and department of health (department), through joint rule making, have proposed changes to Chapter 246-101 WAC, Notifiable conditions, to better protect public health by improving our understanding of emerging conditions, allowing more thorough case investigations, and improving the public health response to infectious and noninfectious conditions. The public health goals for these changes are to reduce the risk of transmission of disease and prevent serious complications and fatalities.

On April 17, 2017, the department and board filed a preproposal statement of inquiry (CR-101) to begin joint rule making to consider adopting notification requirements for seven new conditions and classes of conditions, and notification and specimen submission requirements for three conditions identified in the current rules under the definition of "Other Rare Disease of Public Health Significance." After further review by department subject matter experts, the department and board withdrew the original CR-101 and filed a new preproposal statement of inquiry on May 18, 2018, to clarify and expand the scope of rule making. The new CR-101 expanded the list of new conditions and classes of conditions for consideration to twenty-one, and expanded to four the number of specific conditions identified in the definition of "Other Rare Disease of Public Health Significance" considered for adoption.

Over the course of rule development, the department and board consulted with more than fifty subject matter experts at the department of health, department of labor and industries, and Washington state department of agriculture, and formed a technical advisory committee (TAC) to gather information in 2018. Members of the TAC represented a variety of stakeholders including health care providers, health care facilities, laboratories, local health jurisdictions, professional associations, health equity organizations, and state agencies. The draft rules were broadly distributed in May 2019 to gather informal comments from interested parties. Further comments were sought in June and July 2019 from local health jurisdictions. Members of the regulated community and the TAC were asked to complete a cost questionnaire for the significant changes in the draft rules in November 2019 to complete the proposed rules and required analyses.

If adopted, the proposed rules would significantly amend notification requirements applicable to health care providers, health care facilities, laboratories, and veterinarians; create notification requirements for the Washington state department of agriculture; and clarify requirements for food service establishments, schools, child care facilities, and the general public. Proposed changes to the rules include:

The proposed rules require health care providers, health care facilities, and laboratories to submit case reports and specimens to public health authorities for specified conditions, within specified time frames, with specified information, and using a specified format. The rules do not require health care providers, health care facilities, or laboratories to provide service or conduct laboratory tests that they do not include as a part of their business practices. Table 1 outlines the probable costs by condition (per case) along with the total annual costs by condition. Table 2 outlines the additional probable one-time costs for providers, facilities, and laboratories for training and for updating Standard Operating Procedures, Laboratory Information Management Systems (LIMS), and Electronic Laboratory Reporting (ELR) systems.

WAC 246-101-105: Duties: Health care providers and facilities, 246-101-115: Content of Case Reports: Health care providers and health care facilities, and 246-101-205: Duties: Laboratory directors: The proposed rules amend multiple sections in order to establish consistent content of health care provider, facility, and laboratory case reports and specimen submission forms. The only exception to this proposed standard is WAC 246-101-118, content of case reports for occupational traumatic injury hospitalizations: Health care facilities. The costs of these changes are included in Table 1: Probable Annual Costs (WAC 246-101-101, 246-101-105, 246-101-115, 246-101-201, 246-101-205, 246-101-215, 246-101-225), and Table 2: Probable One-time Costs (WAC 246-101-101, 246-101-105, 246-101-115, 246-101-201, 246-101-205, 246-101-215, 246-101-225) above.

WAC 246-101-110, Means of notification: Health care providers and health care facilities: The proposed rule requires all case reports be type written. This change would eliminate hand-written case reports. The department assumes that by providing electronic forms on its website, the proposed change is cost neutral for health care providers and facilities.

WAC 246-101-205, Duties: Laboratory directors: The proposed rule requires laboratories to submit presumptive and final test results to the department of health for a patient residing outside and visiting Washington state. The department assumes the probable cost for a laboratory to prepare and submit case reports for patients visiting Washington state are included in costs identified in Table 1 and Table 2 for updating laboratory LIMS and ELR systems, updating standard operating procedures for each notifiable condition, and confirming receipt for case reports for conditions notifiable immediately or within twenty-four hours.

WAC 246-101-220, Means of notification: Laboratory directors: The proposed rule requires all presumptive and final test results be submitted via secure electronic data transmission. This change would eliminate hand-written presumptive and final test results, and nonelectronic mail submission (e.g. USPS, FedEx, UPS, etc.). The department assumes that by providing electronic forms on its website, the proposed change to eliminate hand-written test results is cost neutral for health care providers and facilities. The department also assumes the proposed requirement to use secure electronic data submission of test results is the standard for laboratories to share sensitive data and the probable cost for this change is negligible.

WAC 246-101-405, Duties: Veterinarians and the state department of agriculture: The proposed rule eliminates the requirement for veterinarians to notify the department of suspected human cases of specifically named zoonotic diseases that poses a high risk of transmission to humans. The department has historically received no case reports from veterinarians under this requirement and assumes there will be no increased or decreased cost for this proposed change.

Probable Benefit and Cost Conclusion: The department of health and state board of health evaluated the qualitative [quantitative] and qualitative costs and benefits of the proposed rules, taking into account the general goals and specific objectives of the statute being implemented.

Benefit Summary: The proposed rules establish a surveillance system that includes notification, investigation, and collection and distribution of data related to infectious and noninfectious conditions. This data is critical to local health jurisdictions, the department, and other public health authorities tasked with preventing and controlling the spread of disease. Public health authorities also use the data to assess broader patterns, including historical trends and geographic clustering of disease. Based on these assessments, officials are able to take appropriate actions such as conducting outbreak investigations, redirecting program activities, and developing new policies to prevent and control infectious and noninfectious conditions.

Public health surveillance plays an essential role in disease control by providing public health authorities with information and data necessary to take public health action. Surveillance provides data and information to assess the burden and distribution of adverse health events, prioritize public health actions, implement disease control measures to reduce the number and severity of cases, monitor the impact of control measures, identify reservoirs or vectors of disease, identify emerging health conditions that may have a significant impact upon population health, and contribute to surveillance activities at the national and international level to implement more effective control measures on a broader scale6.

Public health surveillance plays a key role in identifying, controlling, and preventing the spread of zoonotic disease and can also play a role in promoting equity. Many of the new conditions in the proposed rules disproportionality [disproportionately] impact subpopulations who are already experiencing health disparities as documented in this analysis.

The proposed rules establish notification requirements for new conditions and revised notification and specimen submission requirements for some current conditions. These changes help to avoid the costs associated with the burden on an individual with a case of a condition, the public health system, and the population as a whole.

Cost Summary: The proposed rules impose new costs for health care providers, health care facilities, and laboratories for new requirements related to case reports and specimens submitted under the proposed rules. Below is a summary of the costs described in the preceding section-by-section analysis.

The probable one-time cost per entity is $0 for providers/facilities and $49,768 for non-CLIA waived laboratories (Table 2). The estimate for each laboratory is likely inflated due to the fact that some laboratories do not test for many of the conditions and will not include the one-time costs of updating their systems. In addition, some one-time costs are specific to laboratories using ELR (not exclusively, but primarily large labs). The department assumes that some laboratories will incur zero one-time costs associated with the proposed amendments, with any one lab incurring no more than $49,768 in one-time costs.

In addition to these one-time costs, the probable annual costs for all regulated entities in Washington state combined (Table 1) range from $1,720,451.50 - $1,860,721.50. No one entity will absorb all of these costs. As noted above, the department assumes some regulated entities (e.g. laboratories who do not test for notifiable conditions, or health care providers who do not diagnose notifiable conditions) will incur zero costs. The annual costs of the rules statewide will be distributed among the remaining businesses, with larger entities likely to incur the largest costs due to higher testing volumes. Three healthcare providers/facilities provided annual cost estimates in the cost questionnaires. These estimates were $72.80, $100 (respondent did not indicate number of employees), and $574 annually. One laboratory (>5000 employees) estimated that the proposed changes would cost them $12,000 - $15,000 in one-time costs and $2,500 - $5,000 in annual costs.

Analysis of whether the proposed rule may impose more than minor costs on businesses in the industry: Based on the minor cost thresholds and the summary of costs identified above, the department and board assume that the proposed rules will impose more than minor costs on the businesses in the industry.

Determination of whether the proposed rule may have a disproportionate impact on small businesses as compared to the ten percent of businesses that are the largest businesses required to comply with the proposed rule: Based on the minor cost thresholds and the summary of costs identified above, the department and board assume that the proposed rules will have a disproportionate impact on small businesses as compared to the ten percent of businesses that are the largest required to comply with the proposed rules.

Alternative 1: Mandatory Electronic Laboratory Reporting using HL7 Messaging with Mitigating Measures for Small Laboratories: The board and department considered mandating laboratory submission of test results using HL7 messaging, and including mitigating measures for small laboratories that allow those businesses to submit results using a less costly method. The benefit of this approach is that it would move a majority of the reporting to HL7 messaging, which would improve timelines of reporting and reduce the burden on local health jurisdictions and the department, freeing up limited public health resources to promote public health. This approach would simultaneously mitigate the costs for small laboratories that do not have capacity to acquire and maintain a costly HL7 system.

However, there are a number of barriers to using this approach. This alternative would require the board and department to define a small laboratory based on income or number of employees. This is not necessarily a proxy for the number of notifiable conditions a laboratory reports each year, so this approach could require a laboratory to invest in an expensive ELR system even if they only submit a small number of notifiable conditions each year. In addition, some laboratories are part of hospitals which have a large number of employees, but the board and department heard from the TAC that this does not mean that the laboratory itself has a large staff or operating budget. Using the number of notifiable conditions reported each year as a way to define small laboratories versus large laboratories would be an inaccurate measure of a laboratory's budget and their ability to absorb the costs of mandatory HL7 as a small lab could report a large number of cases each year. Using number of case reports to define laboratory size is not only inaccurate and unenforceable (because the decentralized reporting system in Washington state makes it challenging to track how many cases are submitted by any one laboratory to determine if they meet the definition of a large business), but also creates a potential incentive for labs to underreport in order to stay below the large laboratory threshold. The fact that health care providers and others conducting rapid screening tests (RST) are also laboratories under the rule further complicates this alternative.

Alternative 2: Mandatory Electronic Laboratory Reporting with Three Reporting Options: In order to maintain the benefits outlined above while addressing the challenges, the board and department considered allowing all laboratories to choose reporting methods from the following options:

While this alternative would provide a less costly option for small laboratories or laboratories who report a small number of cases each year, there was no way to guarantee that the web-submitter would be operational by the time the rule went into effect. Without the web-submitter, this alternative would not have provided adequate mitigation for small businesses.

Alternative 3: Maintain the Status Quo: The status quo allows laboratories to submit case reports using HL7 or using other formats (e.g. postal service). While this would be the least burdensome alternative for laboratories, this option would not allow the public health benefits outlined above (e.g. increased timeless and accuracy of reporting) and would continue to allow hand-written case reports, which create issues with legibility and increased risk of data entry errors. This alternative does not provided the needed public health benefits.

Alternative 4: Remove Secure Facsimile, Postal Mail, and Handwritten Case Report as Options for Submitting Case Reports, but Do Not Mandate Electronic Lab Reporting Using HL7 Messaging:This option has potential to improve timeliness of notification and data accuracy for laboratory reports, particularly for those submitting RST results, (e.g., fewer legibility issues and manual data entry errors; more complete information; more usable and consistent information due to the use of department standardized tools) and to reduce the burden on local health jurisdictions and the department of processing paper reports thereby freeing up limited public health resources to promote public health.

However, we learned that many laboratories who have not already moved to ELR through HL7, including the state public health laboratories and those reporting using RST (such as ECEAP programs which submit large volumes of lead tests) still rely heavily on facsimile to submit case reports. The lead program at the department has had great success in helping laboratories move away from facsimile toward other electronic methods of submission (e.g. secure email using a standardized spreadsheet format provided by the department) through relationship-building and technical assistance. There are opportunities to work with laboratories to help them voluntarily move away from facsimile, and to continue to pursue a web-submitter resource, before removing this frequently used reporting method through rule. The board and department determined that removing the postal mail and handwritten case reports as options at this time, but allowing the continued use of secure facsimile, was the least burdensome alternative that still created the benefits of increased timeliness and accuracy of reporting.

Description of how small businesses were involved in the development of the proposed rule: The department and board requested participation from small business on the TAC that provided professional expertise and recommendations for revision of the chapter. In addition, the Association of Community and Migrant Health Centers and the commission on Hispanic affairs participated in the TAC.

The department and board also requested comments and cost estimates on the draft rules from licensed health care providers, health care facilities, and laboratories. In addition, staff contacted small laboratories and facilitates via email and phone in an effort to receive feedback on the rules, both content and cost.

The estimated number of jobs that will be created or lost as the result of compliance with the proposed rule: The department and board estimate no jobs will be created or lost as the result of compliance with the proposed rules.

A copy of the statement may be obtained by contacting Alexandra Montano, P.O. Box 47811, Olympia, WA 98504-7811, phone 360-236-4205, TTY 711, email alexandra.montano@doh.wa.gov.

February 28, 2020

Michelle A. Davis and Jessica Todorovich

for John Wiesman

State Board of Health Executive Director

and Chief of Staff for Secretary of Health