Small Business Economic Impact Statement

Draft Rule – Laboratory Cost Questionnaire Chapter 246-101 WAC Notifiable Conditions

The Washington State Board of Health (Board) and the Washington State Department of Health (Department) are proposing updates to chapter 246-101 WAC, Notifiable Conditions. This chapter of rules includes notification requirements for a number of entities including health care providers, health care facilities, and laboratories. As part of rule making, the Board and Department are required to prepare a cost-benefit analysis that includes the probable cost of complying with requirements deemed “significant” under the Administrative Procedure Act, chapter 34.05 RCW.

You are receiving this questionnaire because we need your help in gathering the probable costs associated with the significant changes in the draft rules. You can help us by answering the questions below related to the specified draft rule sections. Each table below contains categories of information to help us identify potential costs associated with each “significant” draft rule change. Simplified examples of responses are included in the first table for assistance in completing it and the other tables in this questionnaire. Space is provided below each table for additional comments related to that section of rule. While only requirements deemed “significant” are included in this questionnaire, you may include additional information on any change in the draft rules at the end of the questionnaire.

If you have any questions or need help completing the questionnaire, please contact Vicki Bouvier at [email protected] or 360.701.8092. You may submit your responses via email to [email protected] or [email protected].

The draft Notifiable Conditions rules and other information is online at https://www.doh.wa.gov/ForPublicHealthandHealthcareProviders/NotifiableConditions/RuleMaking.

General Information

Name of Laboratory: Name of person completing questionnaire: Phone number: Email: Number of employees: Is your business independent or affiliated with another business:

WAC 246-101-201, Notifiable conditions: Laboratories (Significant changes only) The draft rule would: A. Establish notification of laboratory results, notification timeframes, specimen types, and specimen submission timeframes for 19 new agents (conditions) B. Change notification of laboratory results, notification timeframes, specimen types, or specimen submission timeframes for 46 existing agents (conditions) C. Add notification of de-identified negative screening results at least annually for five named conditions using an electronic form provided by the Department

The draft rule continues the standard that laboratories must submit laboratory test results and related specimens only if the laboratory conducts the test as part of their normal testing protocols. The draft rule does not require laboratories to perform tests on any conditions or change their testing methods for any conditions if it is not part of their normal testing protocols.

Under the draft rule, when a laboratory performs a test for an agent (condition) that provides a result identified in Table Lab-1 as part of its normal testing protocols, the laboratory must: 1. Submit laboratory test results to the public health authority within the timeframe specified 2. Submit specimens to the public health laboratory within the timeframe specified

A. Establish notification of laboratory results, notification timeframes, specimen types, and specimen submission timeframes for 19 new agents (conditions) Please identify in the table below whether these draft changes would increase costs, decrease costs, or would be cost neutral. [See Table Lab-1 of the draft rules for notification and specimen submission requirements for new agents (conditions) listed below). The Board and Department assume cost increases and decreases for this activity will be related to labor, professional services, or administrative tasks. For each estimate, include the unit for each cost, e.g., cost per case, cost per hour, annual ongoing cost, one time cost, etc.

New Agent (Condition) Currently test Estimated Cost change with brief If increased or neutral cost, provide the information below. for agent number explanation: using method of test  Increased cost Equipment Supplies (Type, Labor (Type, purpose, Professional Services (Type, Administrative Lost sales specified in results  Cost neutral (Type, purpose, purpose, and cost) and cost) purpose, and cost) (Type, purpose, or revenue draft rule: submitted cost) and cost)  Yes per year  No EXAMPLE: Agent (Condition) W Yes 20 Cost neutral: 0 0 0 0 0 0 Agent (condition) already in laboratory information management system (LIMS) and no specimen submission requirement EXAMPLE: Agent (Condition) Y Yes 134 Cost increase: Agent 0 Packaging per Lab technician prepare  IT costs to build out Contract 0 (condition) not in LIMS and specimen: $100 specimen: 1 hour per LIMS to include new management: specimen submission specimen package, condition: $5,000 $500 required $35/hour  Transportation per specimen: $50 EXAMPLE: Agent (Condition) X No 0 Cost neutral: Rule does not 0 0 0 0 0 0 apply because current test used for agent (condition) does not provide result identified in draft rule Amoebic meningitis Anaplasma species (Anaplasmosis) Babesia species (Babesiosis)

Ehrlichia species (Ehrlichiosis) Histoplasma capsulatum (histoplasmosis) Human prion disease MERS  Rickettsia rickettsii,  Rickettsia africae  Rickettsia conorii  Rickettsia typhi  Rickettsia parkeri  Rickettsia philipii  Other Rickettsia species Rubella Taenia solium (Taeniasis or Cysticercosis) Trypanosoma cruzi (Chagas disease) Vaccinia (vaccine-acquired smallpox) Zika virus, acute (Arbovirus)

Additional Comments:

B. Change notification of laboratory results, notification timeframes, specimen types, or specimen submission timeframes for 46 existing agents (conditions) Please identify in the table below whether these draft changes would increase costs, decrease costs, or would be cost neutral. [See Summary of Changes to Laboratory Reporting Tables to for changes to existing agents (conditions) listed below]. The Board and Department assume cost increases and decreases for this activity will be related to labor, professional services, or administrative tasks. For each estimate, include the unit for each cost, e.g., cost per case, cost per hour, annual ongoing cost, one time cost, etc.

Agent (Condition) with New Currently Change in number of Cost change with brief If increased, decreased, or neutral cost, provide the information below. Notification or Specimen test for test results to submit explanation: Submission Requirements agent using with brief  Increased cost Equipment Supplies (Type, Labor (Type, purpose, Professional Services Administrative (Type, Lost sales or method explanation:  Decreased cost (Type, purpose, purpose, and cost) and cost) (Type, purpose, and purpose, and cost) revenue specified in  None  Cost neutral and cost) cost) draft rule:  Increase  Yes  Decrease  No Bacillus anthracis (Anthrax) Blood lead level Bordetella pertussis (Pertussis) Borrelia hermsii, miyamotoi, or recurrentis (Relapsing fever, tick- or louse-borne) Brucella species (Brucellosis) Burkholderia mallei (Glanders) Burkholderia pseudomallei (Melioidosis)  California serogroup viruses, acute (Arbovirus)  Chikungunya virus, acute (Arbovirus)  Dengue, acute (Arbovirus)  Eastern and western equine encephalitis, acute (Arbovirus)  Japanese encephalitis, acute (Arbovirus)  La Crosse encephalitis, acute (Arbovirus)  Powassan virus, acute (Arbovirus)  St. Louis encephalitis, acute (Arbovirus)  West Nile virus, acute (Arbovirus) Chlamydophila psittaci (Psittacosis) Chlamydia trachomatis Clostridium botulinum (Botulism) Corynebacterium Diphtheria (Diphtheria) Coxiella burnetii (Q fever)

Agent (Condition) with New Currently Change in number of Cost change with brief If increased, decreased, or neutral cost, provide the information below. Notification or Specimen test for test results to submit explanation: Submission Requirements agent using with brief  Increased cost Equipment Supplies (Type, Labor (Type, purpose, Professional Services Administrative (Type, Lost sales or method explanation:  Decreased cost (Type, purpose, purpose, and cost) and cost) (Type, purpose, and purpose, and cost) revenue specified in  None  Cost neutral and cost) cost) draft rule:  Increase  Yes  Decrease  No  Crimean-Congo hemorrhagic fever virus (Viral hemorrhagic fever)  Ebola virus (Viral hemorrhagic fever)  Guanarito virus (Viral hemorrhagic fever)  Junin virus (Viral hemorrhagic fever)  Lassa virus (Viral hemorrhagic fever)  Lujo virus (Viral hemorrhagic fever)  Machupo virus (Viral hemorrhagic fever)  Marburg virus (Viral hemorrhagic fever)  Sabia virus (Viral hemorrhagic fever)  Cryptococcus gattii  Undifferentiated Cryptococcus species [i.e. Cryptococcus not identified as C. neoformans] Cyclospora cayetanensis (Cyclosporiasis) Francisella tularensis (Tularemia) Haemophilus influenzae (children < 5 years of age)  Andes virus (Hantaviral infection)  Bayou virus (Hantaviral infection)  Black Creek Canal virus (Hantaviral infection)  Dobrava-Belgrade virus (Hantaviral infection)  Haantan virus (Hantaviral infection)  Seoul virus (Hantaviral infection)  Sin nombre virus (Hantaviral infection)  Other (Hantaviral infection) Hepatitis A virus Hepatitis B Virus Hepatitis C Virus Hepatitis D Virus Hepatitis E Virus

Agent (Condition) with New Currently Change in number of Cost change with brief If increased, decreased, or neutral cost, provide the information below. Notification or Specimen test for test results to submit explanation: Submission Requirements agent using with brief  Increased cost Equipment Supplies (Type, Labor (Type, purpose, Professional Services Administrative (Type, Lost sales or method explanation:  Decreased cost (Type, purpose, purpose, and cost) and cost) (Type, purpose, and purpose, and cost) revenue specified in  None  Cost neutral and cost) cost) draft rule:  Increase  Yes  Decrease  No Human immunodeficiency virus (HIV) Legionella species (Legionellosis) Leptospira species (Leptospirosis) Listeria monocytogenes (Listeriosis) Mumps virus Mycobacterium tuberculosis complex Neisseria gonorrhoeae (Gonorrhea) Neisseria meningitides (Meningococcal disease) Plasmodium species (Malaria) Rubeola (measles virus) Salmonella species (Salmonellosis, typhoid fever)  Shiga toxin-producing E. coli  Enterohemorrhagic E. coli (STEC) Shigella species (Shigellosis) Treponema pallidum (Syphilis) Trichinella species (Trichinellosis) Vancomycin-resistant Staphylococcus aureus Variola virus (smallpox) Vibrio cholerae O1 or O139 (Cholera) Vibrio species (Vibriosis) not including Vibrio cholerae O1 or O139 (Cholera) Yellow fever virus  Yersinia enterocolitica (Yersiniosis)  Yersinia pseudotuberculosis (Yersiniosis)  Yersinia intermedia (Yersiniosis)  Yersinia fredericksenii (Yersiniosis)  Yersinia kristensenii (Yersiniosis) Yersinia pestis (Plague)

Additional Comments:

C. Add notification of de-identified negative screening results at least annually for five named conditions using an electronic form provided by the Department of Health. This requirement could be met by compiling and submitting a cumulative report for up to one year’s worth of de-identified screening results, or by submitting de-identified negative screening results individually throughout the year. The Department will provide an electronic form to submit de-identified negatives for those who need it. The form must be submitted using secure electronic data transmission (see changes for WAC 246-101-220), excluding secure electronic data transmission systems that require identifiable information as part of the data set for submission, e.g., the Health Care Authority Health Information Exchange, and the Department secure electronic disease surveillance system.

The draft rule defines "De-identified negative screening result" as an initial test result that indicates the absence of disease, and that has personally identifiable information removed from it using the Health Insurance Portability and Accountability Act of 1996 (HIPAA) safe harbor method defined in 45 C.F.R. 164.514. For purposes of this rule, a de-identified negative screening result does not include a negative test result associated with a previous positive test result, such as a negative nucleic acid or viral load test that is performed after a positive antibody or antigen test.

Please identify in the table below whether the changes above would increase costs, decrease costs, or would be cost neutral. The Board and Department assume cost increases and decreases for this activity will be related to labor, professional services, or administrative tasks. For each estimate, include the unit for each cost, e.g., cost per case, cost per hour, annual ongoing cost, one time cost, etc.

Agent (Condition) with New Currently test Estimated Cost change with brief If increased, decreased, or neutral cost, provide the information below. Notification or Specimen for agent: number explanation: Submission Requirements  Yes of test  Increased cost Equipment Supplies (Type, Labor (Type, purpose, Professional Services Administrative (Type, Lost sales or  No results  Decreased cost (Type, purpose, purpose, and cost) and cost) (Type, purpose, and purpose, and cost) revenue submitted  Cost neutral and cost) cost) per year Chlamydia trachomatis Hepatitis C virus Human immunodeficiency virus (HIV) Neisseria gonorrhoeae (Gonorrhea) Treponema pallidum (Syphilis)

In order to fully understand the potential impacts of submitting de-identified negatives relative to other options, and to inform the development of the rule, we ask that you identify costs for submitting identifiable negative screening results for chlamydia, hepatitis C, HIV, gonorrhea, and syphilis.

Would you anticipate a reduction in screening requests as a result of a requirement to submit identifiable negative screening results? Yes / No Reason:

Do you prefer identifiable or de-identified screening results? Reason:

WAC 246-101-205, Duties: Laboratory directors (Significant changes only) A. The draft rule would require laboratories to submit presumptive and final test results to the Department of Health for a patient residing outside and visiting Washington State.

B. The draft rule would make the following changes to the data components a Laboratory Director must send to a reference laboratory when referring a specimen to another laboratory for testing:  Revises patient address: Removes allowance to use only a zip code and removes language “when available in laboratory database”  Revises patient date of birth: Removes allowance to use patient age and removes language “when available in laboratory database”  Revises patient sex: Removes language “when available in laboratory database”  Adds “For hepatitis B tests only, pregnancy status (pregnant/not pregnant/unknown), for patients fourteen to fifty years of age only”  Adds “Patient best contact telephone number”  Adds “Patient Medicaid status, for blood lead tests for patients less than 72 months of age only”  Revises “Name of the principal health care provider” to “Requesting health care provider’s name”  Revises “Telephone number of the principal health care provider” to “Requesting health care provider’s phone number”  Revises “Address of principal health care provider” to “Address where patient received care” and removes the language “when available”  Adds “Name of submitting laboratory”  Adds “Telephone number of submitting laboratory”  Adds “Date laboratory received specimen”  Revises “Test type requested” to “Test method requested”

Note: WAC 246-101-105 of the draft rule would also require health care providers and health care facilities to submit these data components to laboratories with each notifiable condition test ordered.

A. Submitting presumptive and final test result for an out-of-state patient Please identify in the table below whether the submitting presumptive and final test results for an out-of-state patient would increase costs, decrease costs, or would be cost neutral. The Board and Department assume cost increases and decreases for this activity will be related to labor, professional services, or administrative tasks. For each estimate, include the unit for each cost, e.g., cost per case, cost per hour, annual ongoing cost, one time cost, etc.

Estimated Cost change with brief explanation: If increased, decreased, or neutral cost, provide the information below. number of test  Increased cost results  Decreased cost Equipment (Type, Supplies (Type, purpose, Labor (Type, purpose, and Professional Services (Type, Administrative (Type, Lost sales or submitted per  Cost neutral purpose, cost) and cost) cost) purpose, and cost) purpose, and cost) revenue year

Additional comments:

B. Data components for reference laboratory referral Please identify in the table below whether the draft changes to reference laboratory referral data components would increase costs, decrease costs, or would be cost neutral. The Board and Department assume cost increases and decreases for this activity will be related to labor, professional services, or administrative tasks. For each estimate, include the unit for each cost, e.g., cost per case, cost per hour, annual ongoing cost, one time cost, etc.

Estimated Cost change with brief explanation: If increased, decreased, or neutral cost, provide the information below. number of  Increased cost referrals made  Decreased cost Equipment (Type, Supplies (Type, purpose, Labor (Type, purpose, and Professional Services (Type, Administrative (Type, Lost sales or per year  Cost neutral purpose, cost) and cost) cost) purpose, and cost) purpose, and cost) revenue

Additional comments:

WAC 246-101-215, Content of documentation accompanying specimen submission: Laboratory directors (Significant changes only) The draft rule would make the following changes to the content of documentation required when submitting specimens:  Revises patient address: Removes allowance to use only a zip code and removes language “when available in laboratory database”  Revises patient date of birth: Removes allowance to use patient age and removes language “when available in laboratory database”  Revises patient sex: Removes language “when available in laboratory database”  Adds “For hepatitis B tests only, pregnancy status (pregnant/not pregnant/unknown), for patients fourteen to fifty years of age only”  Revises patient telephone number: Removes language “when available in laboratory database”  Revises “Requesting health care providers address” to “Address where patient received care” and removes the language “when available”  Adds “Date laboratory received specimen”  Adds “Test method used”  Removes “other information of epidemiological value, when available”

Content of documentation accompanying specimen submission Please identify in the table below whether the draft changes to specimen submission documentation would increase costs, decrease costs, or would be cost neutral. The Board and Department assume cost increases and decreases for this activity will be related to labor, professional services, or administrative tasks. For each estimate, include the unit for each cost, e.g., cost per case, cost per hour, annual ongoing cost, one time cost, etc.

Estimated Cost change with brief explanation: If increased, decreased, or neutral cost, provide the information below. number of  Increased cost specimen  Decreased cost Equipment (Type, Supplies (Type, purpose, Labor (Type, purpose, and Professional Services (Type, Administrative (Type, Lost sales or submissions per  Cost neutral purpose, cost) and cost) cost) purpose, and cost) purpose, and cost) revenue year

Additional comments:

WAC 246-101-220, Means of notification: Laboratory directors (Significant changes only) The draft rule would require all presumptive and final test results be submitted via secure electronic data transmission. This change would eliminate:  Hand-written presumptive and final test results  Non-electronic mail submission (e.g. USPS, FedEx, UPS, etc.)

The draft rule defines “secure electronic data transmission” as electronic communication and accounts developed and maintained to prevent unauthorized access, loss, or compromise of sensitive information, including, but not limited to, secure file transfer, secure email, secure facsimile, the health care authority’s health information exchange, and the Department secure electronic disease surveillance system.

The draft rule defines “secure electronic disease surveillance system” as the secure electronic data transmission system maintained by the Department to submit notifications, case reports, and outbreak reports under this chapter.

Means of presumptive and final test result notification Please identify in the table below whether changing from hand-written or non-electronic mail submission to secure electronic data transmission would increase costs, decrease costs, or would be cost neutral. The Board and Department assume cost increases and decreases for this activity will be related to labor, professional services, or administrative tasks. For each estimate, include the unit for each cost, e.g., cost per case, cost per hour, annual ongoing cost, one time cost, etc.

Estimate number Cost change with brief explanation: If increased, decreased, or neutral cost, provide the information below. of test results  Increased cost submitted per  Decreased cost Equipment (Type, Supplies (Type, purpose, Labor (Type, purpose, and Professional Services (Type, Administrative (Type, Lost sales or year  Cost neutral purpose, cost) and cost) cost) purpose, and cost) purpose, and cost) revenue

Additional comments:

WAC 246-101-225, Content of presumptive and final test result notification: Laboratory directors (Significant changes only) The draft rule would make the following changes to the content of documentation required when submitting specimens:  Revises patient address: Removes allowance to use only a zip code and removes language “when available in laboratory database”  Revises patient date of birth: Removes allowance to use patient age and removes language “when available in laboratory database”  Revises patient sex: Removes language “when available in laboratory database”  Adds “For hepatitis B tests only, pregnancy status (pregnant/not pregnant/unknown), for patients fourteen to fifty years of age only”  Adds patient telephone number  Adds “Patient Medicaid status, for blood lead tests for patients less than 72 months of age only”  Revises “Requesting health care providers address” to “Address where patient received care” and removes the language “when available”  Adds “Test method used”

Content of presumptive and final test result notification The Department and Board assume all costs associated with the changes to WAC 246-101-225 are already identified above for WAC 246-101-205 and -215. However, please identify in the table below whether additional costs would be related to the draft changes to the content of presumptive and final test result notification. For each estimate, include the unit for each cost, e.g., cost per case, cost per hour, annual ongoing cost, one time cost, etc.

Estimated Cost change with brief explanation: If increased, decreased, or neutral cost, provide the information below. number of  Increased cost notifications  Decreased cost Equipment (Type, Supplies (Type, purpose, Labor (Type, purpose, and Professional Services (Type, Administrative (Type, Lost sales or submitted per  Cost neutral purpose, cost) and cost) cost) purpose, and cost) purpose, and cost) revenue year

Additional comments:

Summary questions

Overall how will the draft rules impact your business?

What are your estimated total costs per year of the draft rules?