CR_13-020 Hearing to consider rule revising Sections A-E 2.02 (7) (a), 2.02 (7) (b), and 2.02 (7) (b) 2., relating to electronic seals and signatures.

Sections 15.08 (5) (b) and 450.02 (3) (a) , Stats.

Explanation of agency authority

Section 15,08 (5) (b), allows each examining board to "promulgate rules for its own guidance and for the guidance of the trade or profession to which it pertains and define and enforce professional conduct and unethical practices not inconsistent with the law relating to the particular trade or profession."

Section 450.02 (3) (a) , Stats., authorizes the Board to promulgate rules "[r]elating to the … distribution and dispensing of prescription drugs."

Related statute or rule

Chapter Phar 7 .

Plain language analysis

The proposed amendment to S. Phar 7.01 (1) (e) allows the delivery of the prescription medication(s) to be delivered to a location of the patient's choice. The consultation requirement is met by the pharmacist providing a notice that consultation is available relative to the prescription(s) being delivered. In these cases directions and a means of contacting the pharmacist must accompany the delivery.

Summary of, and comparison with, existing or proposed federal regulation

None.

Comparison with rules in adjacent states

Illinois: Under Illinois law, dispensing does not mean the physical delivery to a patient or a patient's representative in a home or institution by a designee of a pharmacist by a common carrier [Pharmacy Practice Act, 225 ILCS 85/sec. 3(m)].

Under Ill. Admin. Code title 68, s. 1330.70: "Oral counseling is not practicable for the patient or patient's agent, the pharmacist shall use alternative forms of patient information. When used in place of oral counseling, alternative forms of patient information shall advise the patient or agent that the pharmacist may be contacted for consultation in person at the pharmacy or by toll-free or collect telephone service."

Iowa: Under Iowa law, there is a requirement that pharmacists be responsible for delivery of prescription drugs to the patient or patient's agent; no specific location of such delivery is mentioned. If in the pharmacist's professional judgment oral counseling is not practicable, the pharmacist may use alternative forms of patient information. "Not practicable" refers to patient variables including, but not limited to, the absence of the patient or patient's caregiver. When used in place of oral counseling, alternative forms of patient information shall advise the patient or caregiver that the pharmacist may be contacted for consultation in person at the pharmacy by toll-free telephone or collect telephone call. [Iowa Admin. Code 657-6.2(7); 657-6.14(4)]

Michigan: Under Michigan administrative rules, a prescription is dispensed to the patient or the patient's caregiver. A caregiver is defined as the parent, guardian or other individual who has assumed responsibility for providing a patient's care. A pharmacist shall communicate to the patient or the patient's caregiver, necessary and appropriate information regarding safe and effective medication use at the time a prescription is dispensed. The information shall be communicated orally and in person, except when the patient or patient's caregiver is not at the pharmacy or when a specific communication barrier prohibits oral communication. In either situation, providing printed material designed to help the patient use the medication safely and effectively satisfies the requirements. A consultation is not required if a patient or a patient's caregiver refuses a consultation. [Mich. Admin. Code r 338.490]

Minnesota: Under Minnesota administrative rules, when a new filled prescription or a refilled prescription for which counseling is required is being mailed or delivered to the patient by common carrier or delivery services, the consultation must still be provided but may be accomplished by providing written information to the patient regarding the medication being dispensed and the availability of the pharmacist to answer questions and through a toll-free phone number for long distance calls.. There is nothing in the administrative code which indicates a specific location for a delivery. [Minn. R. 6800.0910]

Summary of factual data and analytical methodologies

Pharmacy Examining Board receives and grants many requests for variances to Phar 7.01 (1) (e). The Pharmacy Examining Board determined that permitting the delivery to a location of a patient's choice would be beneficial to patients and to pharmacies without negatively impacting public safety.

Analysis and supporting documents used to determine effect on small business or in preparation of economic impact analysis

This rule was posted for public comment on the economic impact of the proposed rule, including how this proposed rule may affect businesses, local government units and individuals, for a period of 14 days. No comments were received relating to the economic impact of the rule.

Fiscal Estimate and Economic Impact Analysis

The Fiscal Estimate and Economic Impact Analysis is attached.

Initial Regulatory Flexibility Analysis or Summary

Delivery of prescriptions is already allowed by rule. The location of the delivery will not have an impact on small business. This rule change will not have an effect on small business.

Agency Contact Person

Sharon Henes, Paralegal, Department of Safety and Professional Services, Division of Policy Development, 1400 East Washington Avenue, Room 151, P.O. Box 8935, Madison, Wisconsin 53708; telephone [phone]; email at [e-mail] .

STATE OF WISCONSIN DEPARTMENT OF ADMINISTRATION DOA-2049 (R03/2012)	Division of Executive Budget and Finance 101 East Wilson Street, 10th Floor P.O. Box 7864 Madison, WI 53707-7864 FAX: [phone]
ADMINISTRATIVE RULES Fiscal Estimate & Economic Impact Analysis

1. Type of Estimate and Analysis
X Original   ⍽ Updated   ⍽ Corrected
2. Administrative Rule Chapter, Title and Number
Section Phar 7.01 (1) (e)
3. Subject
Prescription drug delivery.
4. Fund Sources Affected			5. Chapter 20, Stats. Appropriations Affected
⍽ GPR   FED   X PRO   PRS   SEG   SEG-S
6. Fiscal Effect of Implementing the Rule
X No Fiscal Effect ⍽ Indeterminate	⍽ Increase Existing Revenues ⍽ Decrease Existing Revenues		⍽ Increase Costs ⍽ Could Absorb Within Agency's Budget ⍽ Decrease Cost
7. The Rule Will Impact the Following (Check All That Apply)
⍽ State's Economy ⍽ Local Government Units		⍽ Specific Businesses/Sectors ⍽ Public Utility Rate Payers ⍽ Small Businesses (if checked, complete Attachment A)
8. Would Implementation and Compliance Costs Be Greater Than $20 million? ⍽ Yes   X No
9. Policy Problem Addressed by the Rule
The current rule does not provide enough flexibility for patients to have their prescription medication delivered to a location of their choice due to the limitation of delivery only to the patient's residence.
10. Summary of the businesses, business sectors, associations representing business, local governmental units, and individuals that may be affected by the proposed rule that were contacted for comments.
This rule was posted for 14 days for economic comments and none were received.
11. Identify the local governmental units that participated in the development of this EIA.
None. This rule does not affect local governmental units.
12. Summary of Rule's Economic and Fiscal Impact on Specific Businesses, Business Sectors, Public Utility Rate Payers, Local Governmental Units and the State's Economy as a Whole (Include Implementation and Compliance Costs Expected to be Incurred)
This rule will not have an economic or fiscal impact on specific businesses, business sectors, public utility rate payers, local governmental units or the state's economy as a whole. Delivery of prescriptions is already allowed by rule. The location of the delivery will not have an impact.
13. Benefits of Implementing the Rule and Alternative(s) to Implementing the Rule
The benefit of implementing the proposed rule would allow patients to have their prescriptions delivered to a location of their choice. In addition, pharmacies would no longer have to request the Pharmacy Examining Board to grant a delivery variance. The Pharmacy Examining Board has determined that permitting the delivery to a location of a patient's choice would be beneficial to patients and to pharmacies without negatively impacting public safety. When prescriptions are delivered, the prescription will be accompanied by appropriate directions and an indication that consultation is available by contacting the pharmacist. The alternative to the proposed change is for the rule to remain as it currently is which would limit the delivery to a patient's residence only unless a variance is granted by the Pharmacy Examining Board.
14. Long Range Implications of Implementing the Rule
The long range implication is patients will be better served by having their prescriptions delivered to more locations than just their place of residence and pharmacies will no longer have to request and wait for the next Board meeting in order to receive delivery variances.
15. Compare With Approaches Being Used by Federal Government
None.
16. Compare With Approaches Being Used by Neighboring States (Illinois, Iowa, Michigan and Minnesota )
Our four neighboring states do not indicate a limitation on delivery to only the patient's residence. In all four states, the consultation requirement is met by providing printed information, including directions on contacting the pharmacist by phone if a consultation is desired.
17. Contact Name				18. Contact Phone Number
Sharon Henes				[phone]

This document can be made available in alternate formats to individuals with disabilities upon request.

Notice of Hearing

Safety and Professional Services —
Examining Board of Architects, Landscape Architects, Professional Engineers, Designers and Land Surveyors

CR 13-020

NOTICE IS HEREBY GIVEN that pursuant to authority vested in the Examining Board of Architects, Landscape Architects, Professional Engineers, Designers, and Land Surveyors in ss. 15.08 (5) (b) , 227.11 (2) (a) , and 443.17 , Wis. Stats., and interpreting s.443.17, Wis. Stats., the Examining Board of Architects, Landscape Architects, Professional Engineers, Designers and Land Surveyors will hold a public hearing at the time and place indicated below to consider an order to amend ss. A-E 2.02 (7) (a) , 2.02 (7) (b) , and 2.02 (7) (b) 2. , relating to electronic seals and signatures.

Hearing Information

Date:   Thursday, April 25, 2013
Time:   9:00 a.m.
Location:   1400 East Washington Avenue, Room 121
  Madison, WI

Appearances at the Hearing

Interested persons are invited to present information at the hearing. Persons appearing may make an oral presentation but are urged to submit facts, opinions and argument in writing as well. Facts, opinions and argument may also be submitted in writing without a personal appearance by mail addressed to the Department of Safety and Professional Services, Division of Policy Development, P.O. Box 8935, Madison, Wisconsin 53708. Written comments must be received at or before the public hearing to be included in the record of rule-making proceedings.

Place where Comments are to be Submitted and Deadline for Submission

Comments may be submitted to Shawn Leatherwood Department of Safety and Professional Services, Division of Policy Development, 1400 East Washington Avenue, Room 151, P.O. Box 8935, Madison, WI 53708-8935, or by email to [e-mail] . Comments must be received at or before the public hearing to be held on April 23, 2013 to be included in the record of rule-making proceedings.

Copies of Rule

Copies of this proposed rule are available upon request to Shawn Leatherwood Department of Safety and Professional Services, Division of Policy and Development, 1400 East Washington Avenue, P.O. Box 8935, Madison, Wisconsin 53708, or by email at Shancethea.Leatherwood@ wisconsin.gov .

Analysis Prepared by the Department of Safety and Professional Services

Statutes interpreted

Section 443.17 , Stats.

Statutory authority

Sections 15.08 (5) (b) , 227.11 (2) (a) , and 443.17 , Stats.

Explanation of agency authority

The Examining Board of Architects, Landscape Architects, Professional Engineers, Designers and Land Surveyors has general power, pursuant to s. 15.08 (5) (b) , Stats., to promulgate rules for guidance within its profession. The Boards may also promulgate rules that interpret statutes they enforce or administer per s. 227.11 (2) (a) , Stats. Section 443.17 , Stats., regulates the use of seals and is administered by the Board. Therefore, the Board is authorized to promulgate rules that give guidance on the use of seals or signatures.

Related statute or rule

Wis. Admin. Code s. A-E 2.02

Plain language analysis

Registration seals and signatures must be utilized in the production of plans, drawings, documents, specifications, and reports generated by architects, landscape architects, professional engineers, designers and land surveyors. The proposed rule would allow the afore mentioned professionals to use an electronic seal or signature on documents submitted to governmental agencies as long as the electronic seal or signature conformed to the requirements of subch. II, ch. 137 , Stats. and the governmental agency accepts such documents.

Summary of, and comparison with, existing or proposed federal regulation

There are no comparable or existing proposed federal regulations

Comparison with rules in adjacent states

Illinois: Architects, Engineers and Land Surveyors must have a reproducible seal or facsimile, which may be computer generated. Ill. Admin. Code tit. 68 ss. 1150, 1380.295 and 1270.58 Illinois code expressly prohibits the use of signatures generated by computers. Illinois requires original signatures only.

Iowa: Professional Engineers and Professional Land Surveyors must use a certification block on original documents. The certification block requires a seal and a signature. A legible rubber stamp or facsimile of a seal may be used 193C IAC 6.1 (3) (542B) Computer generated seals may be used on final documents. Iowa Professional Engineers and Professional Land Surveyor licensees may affix a handwritten or secure electronic signature to the certification block as long as the signature is protected by a procedure that is, "adequate to (1) verify the signature is that of a specific person and (2) detect any changes that may be made or attempted after the signature of the specific person is affixed." 193C IAC 6.9 (542B)

Michigan: Architects, professional engineers, and professional land surveyors may use an embossed seal or a rubber stamp and an original signature only. MICH. ADMIN. Code r.339.15301, 339.16024, 339.17301 (2012).

Minnesota: Licensed architects, professional engineers, land surveyors, professional landscape architects, professional geologist, or professional soil scientists may use a seal on all plans, specifications, plats, and reports and other documents. Minn. R. 1800.4300 (2012) Furthermore, a signature is required for all plans, specifications, plats reports or other documents. The signature may be stamped, handwritten, or electronically created as long as it creates an accurate representation of the licensee's actual signature. Minn. Stats. Ann. § 326.12 (2012)

Summary of factual data and analytical methodologies

Both the Engineering Section and the A-E Rules committee reviewed similar rules in other states regarding electronic signatures and seals. Discussions were held regarding how to secure electronic seals and signatures in order to avoid misuse or misrepresentation and how to bring the rules in line with subch. II of chapter 137, Stats. regarding electronic signatures. The Board ensures the accuracy, integrity, objectivity and consistency of the data used in preparing the proposed rule and related analysis.

Analysis and supporting documents used to determine effect on small business or in preparation of economic impact analysis

The proposed rule will not have any impact on small business as defined in s. 227.114 (1) , Stats.

Fiscal Estimate and Economic Impact Analysis

The Fiscal Estimate and Economic Impact Analysis are attached.

Initial Regulatory Flexibility Analysis or Summary

Not applicable.

Environmental Assessment/Statement

Not applicable.

Agency Contact Person

Shawn Leatherwood Department of Safety and Professional Services, Division of Board Services, 1400 East Washington Avenue, Room 151, P.O. Box 8935, Madison, Wisconsin 53708; telephone [phone]; email at Shancethea.Leatherwood @wisconsin.gov .

STATE OF WISCONSIN DEPARTMENT OF ADMINISTRATION DOA-2049 (R03/2012)	Division of Executive Budget and Finance 101 East Wilson Street, 10th Floor P.O. Box 7864 Madison, WI 53707-7864 FAX: [phone]
ADMINISTRATIVE RULES Fiscal Estimate & Economic Impact Analysis

1. Type of Estimate and Analysis
X Original   ⍽ Updated   ⍽ Corrected
2. Administrative Rule Chapter, Title and Number
Section A-E 2.02, Wis. Admin. Code
3. Subject
Electronic seals and signatures.
4. Fund Sources Affected			5. Chapter 20, Stats. Appropriations Affected
⍽ GPR   ⍽ FED   X PRO   ⍽ PRS   ⍽ SEG   ⍽ SEG-S
6. Fiscal Effect of Implementing the Rule
X No Fiscal Effect ⍽ Indeterminate	⍽ Increase Existing Revenues ⍽ Decrease Existing Revenues		⍽ Increase Costs ⍽ Could Absorb Within Agency's Budget ⍽ Decrease Cost
7. The Rule Will Impact the Following (Check All That Apply)
⍽ State's Economy ⍽ Local Government Units		⍽ Specific Businesses/Sectors ⍽ Public Utility Rate Payers ⍽ Small Businesses (if checked, complete Attachment A)
8. Would Implementation and Compliance Costs Be Greater Than $20 million? ⍽ Yes   X No
9. Policy Problem Addressed by the Rule
The proposed rule would allow architects, landscape architects, professional engineers, designers and land surveyors to use electronic seals or signatures on all plans, drawings, documents, specifications and reports. Currently, all seals and stamps on drawings and specifications to be filed as public documents are required to be original. However, there is a provision that allows for electronic signatures in Wis. Admin Code A-E 2.02 (7) (b) 2.; but the provision is outdated. The proposed rule draft would allow broader use of electronic signatures to be filed as public documents and update the corresponding citation to subch. II, ch. 137, Stats.
10. Summary of the businesses, business sectors, associations representing business, local governmental units, and individuals that may be affected by the proposed rule that were contacted for comments.
This proposed rule was posted on the Department of Safety and Professional Services website and on the Wisconsin government website for 14 business days to solicit comments from the public. No businesses, business sectors, associations representing business local governmental units or individuals contacted the department about the proposed rule.
11. Identify the local governmental units that participated in the development of this EIA.
No local governmental units participated in the development of this EIA.
12. Summary of Rule's Economic and Fiscal Impact on Specific Businesses, Business Sectors, Public Utility Rate Payers, Local Governmental Units and the State's Economy as a Whole (Include Implementation and Compliance Costs Expected to be Incurred)
The proposed rule will not impact business sectors, public utility rate payers, local governmental units or the state's economy as a whole.
13. Benefits of Implementing the Rule and Alternative(s) to Implementing the Rule
Electronic seals and signatures will allow greater flexibility in filing plans, specifications, plats, and reports and other documents. The benefit will go towards architects, landscape architects, professional engineers, designers and land surveyors who will be able to choose between electronic seals and signatures or stamped seals and hand written signatures.
14. Long Range Implications of Implementing the Rule
Long range implications of the proposed rule will result in greater efficiency in maintaining records and keeping the affected professions up to date with current advancements in technology.
15. Compare With Approaches Being Used by Federal Government
There are no comparable federal rules.
16. Compare With Approaches Being Used by Neighboring States (Illinois, Iowa, Michigan and Minnesota )
Illinois: Architects, Engineers and Land Surveyors must have a reproducible seal or facsimile, which may be computer generated. Ill. Admin. Code tit. 68 ss. 1150, 1380.295 and 1270.58 Illinois code expressly prohibits the use of signatures generated by computers. Illinois requires original seals only. Iowa: Professional Engineers and Professional Land Surveyors must use a certification block on original documents. The certification block requires a seal and a signature. A legible rubber stamp or facsimile of a seal may be used. 193C IAC 6.1 (3) (542B) Computer generated seals may be used on final documents. Iowa Professional Engineers and Professional Land Surveyor licensees may affix a handwritten or secure electronic signature to the certification block as long as the signature is protected by a procedure that is, "adequate to (1) verify the signature is that of a specific person and (2) detect any changes that may be made or attempted after the signature of the specific person is affixed." 193C IAC 6.9 (542B) Michigan: Architects, professional engineers, and professional land surveyors may use an embossed seal or a rubber stamp and an original signature only. MICH. ADMIN. Code r.339.15301, 339.16024, 339.17301 Minnesota: Licensed architects, professional engineers, land surveyors, professional landscape architects, professional geologist, or professional soil scientists may use a seal on all plans, specifications, plats, and reports and other documents. Minn. R. 1800.4300 (2012) Furthermore, a signature is required for all plans, specifications, plats reports or other documents. The signature may be stamped, handwritten, or electronically created as long as it creates an accurate representation of the licensee's actual signature. Minn. Stats. Ann. § 326.12
17. Contact Name				18. Contact Phone Number
Shawn Leatherwood				608-261-4438

This document can be made available in alternate formats to individuals with disabilities upon request.