NOTICES

Notice of Comments Issued

[37 Pa.B. 5953]
[Saturday, November 3, 2007]

   Section 5(g) of the Regulatory Review Act (71 P. S. § 745.5(g)) provides that the Independent Regulatory Review Commission (Commission) may issue comments within 30 days of the close of the public comment period. The Commission comments are based upon the criteria contained in section 5.2 of the Regulatory Review Act (71 P. S. § 745.5b).

   The Commission has issued comments on the following proposed regulations. The agency must consider these comments in preparing the final-form regulation. The final-form regulation must be submitted within 2 years of the close of the public comment period or it will be deemed withdrawn.

Reg. No.	Agency/Title	Close of the Public Comments Period	IRRC Comment Issued
16-A-5418	State Board of Pharmacy Sales of Hypodermic Needles and Syringes 37 Pa.B. 4652 (August 25, 2007)	9/24/07	10/24/07
16A-4314	State Board of Chiropractic Reactivation of Lapsed License 37 Pa.B. 4627 (August 25, 2007)	9/24/07	10/24/07
16A-4815	State Board of Funeral Directors Preneed Funeral Arrangements 37 Pa.B. 4643 (August 25, 2007)	9/24/07	10/24/07
16A-4514	State Board of Cosmetology General Revisions 37 Pa.B. 4628 (August 25, 2007)	9/24/07	10/24/07
16A-419	State Architects Licensure Board Requirements for Examination Eligibility 37 Pa.B. 4625 (August 25, 2007)	9/24/07	10/24/07
16A-4923	State Board of Medicine Expect Witness 37 Pa.B. 4647 (August 25, 2007)	9/24/07	10/24/07
16A-5131	State Board of Nursing Faculty Requirements for Nursing Education    Programs 37 Pa.B. 4649 (August 25, 2007)	9/24/07	10/24/07

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State Board of Pharmacy
Regulation #16A-5418 (IRRC #2625)

Sales of Hypodermic Needles and Syringes

October 24, 2007

   We submit for your consideration the following comments on the proposed rulemaking published in the August 25, 2007 Pennsylvania Bulletin. Our comments are based on criteria in section 5.2 of the Regulatory Review Act (71 P. S. § 745.5b). Section 5.1(a) of the Regulatory Review Act (71 P. S. § 745.5a(a)) directs the State Board of Pharmacy (Board) to respond to all comments received from us or any other source.

1.  Section 27.18.--Protection of the public health, safety and welfare; Need.

   Subsection (s)(1) limits the number of hypodermic needles and syringes that may be sold to a person 18 years of age or older without a prescription to 30. In the Regulatory Analysis Form (RAF) submitted with the proposed rulemaking, the Board has indicated that they considered not placing a limit on the number of needles and syringes but decided to place a limit of 30 needles and syringes because each sale is a ''teachable moment where counseling can be provided for drug rehabilitation.''

   Subsection (s)(3) prohibits the sale of needles and syringes to persons under the age of 18 without a prescription. Several commentators, including Representative Babette Josephs, have questioned the need for this provision. We note that the Board has not provided an explanation for this provision in the RAF or the Preamble to the regulation. We request that the Board explain why the prohibition on sales to persons under the age of 18 is needed and how it protects the health of all citizens of the Commonwealth.

2.  Fiscal impact.

   The Preamble to the proposed rulemaking notes the following: ''It is anticipated that many patients will continue to present a prescription to obtain prescription benefits in paying for hypodermic needles and syringes.'' The Pennsylvania Medical Society has suggested a study to determine whether insurers should be mandated to preserve reimbursement for diabetics and people with other medical conditions requiring injected medications. We question how this rulemaking will affect people who currently obtain needles and syringes with a prescription and the assistance of some type of medical insurance. We urge the Board to work with necessary authorities to ensure that this rulemaking does not have a negative fiscal impact on people who obtain needles and syringes with a prescription and the assistance of medical insurance.

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State Board of Chiropractic
Regulation #16A-4314 (IRRC #2626)

Reactivation of Lapsed License

October 24, 2007

   We submit for your consideration the following comments on the proposed rulemaking published in the August 25, 2007 Pennsylvania Bulletin. Our comments are based on criteria in section 5.2 of the Regulatory Review Act (71 P. S. § 745.5b). Section 5.1(a) of the Regulatory Review Act (71 P. S. § 745.5a(a)) directs the State Board of Chiropractic (Board) to respond to all comments received from us or any other source.

Section 5.17.  Biennial registration; unregistered status and inactive status; failure to renew; address of record.--Clarity.

   Subsection (m)(3) permits an individual to reactivate a license by proving ''continuous licensed practice of chiropractic in one or more other jurisdictions . . . for at least 5 years immediately preceding application for reactivation.'' Board staff has explained that the individual must also remain current with Pennsylvania's continuing education requirements in order to qualify for reactivation. This requirement should be clearly stated in the final-form regulation.

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State Board of Funeral Directors
Regulation #16A-4815 (IRRC #2627)

Preneed Funeral Arrangements

October 24, 2007

   We submit for your consideration the following comments on the proposed rulemaking published in the August 25, 2007 Pennsylvania Bulletin. Our comments are based on criteria in section 5.2 of the Regulatory Review Act (71 P. S. § 745.5b). Section 5.1(a) of the Regulatory Review Act (71 P. S. § 745.5a(a)) directs the State Board of Funeral Directors (Board) to respond to all comments received from us or any other source.

1.  Section 13.1. Definitions.--Reasonableness; Consistency with other regulations; Need; Clarity.

Preneed funeral contract--

   We have questions in two areas concerning this definition.

   First, why does this definition only include the term ''funeral entity''? In addition to ''funeral entity,'' the term ''licensed funeral director'' is defined in section 13.1 of the existing regulations. Why not include both ''funeral entity'' and ''licensed funeral director'' in the definition for preneed funeral contract?

   Second, what is the intent of including the phrase ''whether or not the funeral entity receives preneed funeral funds''? Why would a business enter into such a contract without receiving funds?

   Furthermore, a significant focus of both section 13(c) of the Funeral Director Law (Law) (63 P. S. § 479.13(c)) and this proposed regulation is the money received for such contracts. What type of review or oversight would the Board exercise in a situation where there is no monetary transaction? Unless the Board can justify the inclusion of this phrase, it should be deleted from the final-form regulation.

Preneed funeral funds--

   In Paragraph (i) of this definition, what is the purpose of the last phrase, ''whether or not a contract to provide specified funeral services or merchandise exists''? How could the Board verify that money held by a licensee or funeral entity was related to ''preneed'' monies if no contract existed? If a customer has not finalized her or his decisions concerning which services to select but gives money to a funeral director or funeral entity, is the funeral director or entity required to document the transaction?

   Finally, Paragraphs (iii) and (iv) may be inconsistent or incompatible with the proposed regulation since they involve insurance policies and not just contracts. An assignment of an insurance policy may exist with or without a preneed contract. If there is no contract, the transfer clause required by Section 13.228(a) will not apply. If an insurance policy includes a provision requiring assignment to a particular funeral entity, the Board needs to review and explain how it will regulate a change in the policy. The Board may need to develop separate provisions to address insurance policies.

2.  Section 13.224. Depositing and reporting preneed funeral funds.--Fiscal impact; Reasonableness; Consistency with the statute and regulations; Implementation procedure; Feasibility; Clarity.

   Subsection (a) contains new language. For example, there is a new rule that all the preneed funds received by the funeral director or entity must be deposited within ten days of receipt. We identified questions in two areas.

   First, why is the ten-day rule necessary? Is there any record or history of problems with the timeliness of deposits? The Board should explain the need for the new language in this subsection or delete it from the final-form regulation.

   Second, it is unclear if Subsection (a) applies to a funeral entity that receives a preneed fund transfer from another entity at the request of a customer. If this subsection does apply to such a transfer, what happens to any accumulated earnings or interest? The earnings or interest are not mentioned in the definition of ''preneed funeral fund.'' However, Section 13.228(b) in this proposed regulation specifically requires the transfer of ''accumulated interest and earnings'' with preneed funeral funds. If the first funeral entity must transfer both the preneed funds (the original money given by the customer) and any accumulated interest and earnings, then the receiving entity should be required by the final-form regulation to deposit the interest and earnings with the customer's preneed funeral funds.

   Subsection (b) mandates quarterly reporting of the information described in Subsection (c). There are four concerns.

   First, why is mandated reporting necessary? What will the Board do with this information? The Board needs to explain how it plans to review and utilize these reports.

   Next, what will be the costs for the Board in processing and reviewing the reports, and for funeral entities or funeral directors to transmit or submit the reports? Does the Board have adequate staff to process and review these records on a regular and timely basis? Commentators report that there are thousands of preneed contracts across the state. The Board should examine these costs and provide cost estimates when it submits the final-form regulation. If the Board opts to retain the reporting requirement, the costs for both the Board and the regulated community may be reduced significantly by requiring annual or biennial reporting, rather than quarterly.

   Third, the Preamble indicates that changes are necessary because the existing provisions ''do not address the transferability of funds when a funeral director other than the contracting funeral director provides funeral services and merchandise or the ability of a customer to change funeral directors or transfer funds in the event of a change of funeral directors.'' However, quarterly or periodic reporting is not necessary to monitor these transactions. The existing regulations require a licensee to submit a report every time the funeral director enters into a preneed contract or provides the services required by a preneed contract. The final-form regulation could mirror the current rules by requiring reports whenever there is a change or an end to the contract, a switch to another funeral entity or funeral director, or a transfer of funds.

   Fourth, what is the definition of the term ''rollover'' in Subsection (b)? As noted by the House Professional Licensure Committee (House Committee) on October 3, 2007, the final-form regulation should include a definition for this term. In addition, the intent of the last sentence of Subsection (b) is unclear. The need for this sentence should be clarified in the final-form regulation.

   Regarding Subsection (c)(2), please explain the need for deleting the phrase ''100% of the money received by the funeral director on account of the contract had been deposited.'' This language is consistent with Section 13(c) of the Law and should be retained.

3.  Section 13.227. Limitations on preneed funeral contracts.--Fiscal impact; Consistency with the statute; Reasonableness; Clarity.

   Commentators for the Pennsylvania Cemetery, Cremation and Funeral Association and the Funeral Consumers Alliance of Greater Philadelphia expressed concerns with provisions in this section. We share three concerns.

   First, the new language in Subsection (b) reads:

A funeral director or funeral entity may not charge or collect any fees under a preneed funeral contract for funeral goods and services that exceed the fees for the goods and services as set forth on the funeral entity's general price list at the time the goods or services are provided. [Emphasis added.]

   This provision could possibly negate a benefit of preneed contracts. Price lists may be guaranteed in preneed contracts at the time when the contracts are signed. The consumer gets the benefit of the prices available at the time of the contract, and the funeral entity gets the benefit of accepting funds before they are needed. With promulgation of Subsection (b), would funeral entities be able to increase costs charged to customers based on price lists at the time of service? What happens if the preneed funds in an account do not cover the price list at the time of service? What impact would this provision have on irrevocable contracts? Should the subsection state ''at the time the contract is initiated''? The Board must explain the need for this subsection or delete it from the final-form regulation.

   Second, Subsection (b) refers to a ''funeral entity's general price list.'' Is there any situation when a funeral director would maintain a ''general price list''?

   Third, we question the rationale and need for Subsection (c), which reads:

A preneed funeral contract may not incorporate a contract for funeral merchandise entered into by a person or entity other than a funeral director.

   The Law does not identify any restrictions on the source of the merchandise included in a funeral director's contract. In addition, it is our understanding that the National Funeral Directors Association recommends that ''a funeral home should never refuse to service a family because they indicate that they will be using a third-party casket.'' This provision appears to limit the ability of a consumer to select from a variety of products. The Board should justify this provision or delete it from the final-form regulation.

4.  Section 13.228. Transfer of a preneed funeral contract by customer.--Fiscal impact; Consistency with statute; Reasonableness; Feasibility; Clarity.

   Pursuant to Subsection (a), every preneed contract initiated after the effective date of this regulation must expressly permit the customer to transfer the account and funds to another funeral director or funeral entity. The Preamble offers no explanation for this change beyond generic references to protection of consumers and updating regulations to match current practices in the profession.

   The statute gives the Board the authority to adopt regulations. Section 16(a) of the Law (63 P. S. § 479.16(a)) reads:

The board shall be charged with the enforcement of this act. It shall be empowered to formulate necessary rules and regulations not inconsistent with this act for the proper conduct of the business or profession of funeral directing and as may be deemed necessary or proper to safeguard the interests of the public and the standards of the profession. (Emphasis added.)

   The Board has not demonstrated the need for this proposed regulation. Specifically, the Board has not explained how this proposed regulation will ''safeguard the interests of the public.'' Additionally, the Board has disclosed no record indicating a high level of consumer complaints or significant harm to consumers related to preneed contracts. In the final-form regulation submittal, the Board should explain the need for this regulation, and how it will protect consumers.

   In its comments, the House Committee expressed concerns with the impact of this regulation on the calculation of resources in determining eligibility for benefits from Social Security or Medical Assistance (MA) programs. The Board claims that customers will be able to set aside the preneed funds and avoid having them calculated as a resource because the account, money or trust remains ''irrevocable.'' Subsection (b) directs the transfer of the preneed funds from one funeral entity to another at the direction of the customer. However, nothing in this section states that the funds are ''irrevocable'' or that none of the funds may be returned to the customer. In fact, the words ''revocable,'' ''irrevocable'' or ''irrevocability'' do not appear in the proposed regulation or the Preamble. In the final-form regulation, the Board should clarify whether preneed funds would be irrevocable, and how the funds would be protected from classification as an asset for the purposes of Social Security or MA programs.

   The provisions of this section are very clear that the current funeral entity must transfer all the preneed funds, interest and earnings to the new funeral entity as requested by the customer. However, there is nothing that directs the actions of the new entity or what it may do with the funds. Nothing in the proposed regulation requires that the new funeral entity honor the terms and conditions of the original contract or that it use all the preneed funds, interest and earnings for funeral services. For example, what would prevent the new funeral entity from giving a portion of the funds to the customer and reducing the list of services? The Board should clarify how the new funeral entity must treat the original contract and the funds.

   The Board should also respond to the questions raised by the House Committee as to whether the preneed funds can be irrevocable yet still transferable. There is also a concern with the Law. Section 13(c) of the Law includes the following sentence:

. . . If any such licensed funeral entity shall accept any money for such contracts, he shall, forthwith, either deposit the same in an escrow account in, or transfer the same in trust to, a banking institution in this Commonwealth, conditioned upon its withdrawal or disbursement only for the purposes for which such money was accepted . . . .  (Emphasis added.)

   It is unclear how the proposed regulation is consistent with the Law since none of its provisions guarantee that the money will be used for the purposes for which it was accepted. These purposes are set forth in the original preneed contract. The final-form regulation should ensure that the purposes in the original contract are fulfilled.

   In its comments, the House Committee also requested further information concerning regulations or laws in other states pertaining to the portability of preneed contracts. Portability is an important issue for both the House Committee and commentators. The difficult question appears to be providing for portability while simultaneously maintaining the irrevocability of preneed funds, especially for income and asset determinations in Social Security or MA programs.

   If it was only a question of portability, it is available under the existing regulations. The Board submitted a copy of the Commonwealth Court decision Bean v. Department of State, State Board of Funeral Directors (855 A.2d 148, 2004) with this proposed regulation. The Bean decision reported that Board-approved contract forms allowed customers to select an irrevocable or revocable contract. With a revocable contract, the customer can transfer preneed funds at a later date. This is portability. If the Board believes these options are insufficient, then it could establish an additional option for these forms that is based on this section.

   If the goal is to combine both portability and irrevocability, the Board needs to thoroughly review options that ensure irrevocability while allowing for consumer choice. This would allow the marketplace to provide what consumers want and need. The Board should investigate a variety of options to allow for portability when needed while also guaranteeing irrevocability of the funds and terms in the contract.

5.  Section 13.229. Sale or transfer of preneed funeral contracts or preneed funeral funds by funeral director.--Fiscal impact; Consistency with statute; Reasonableness; Feasibility; Clarity.

   Under Subsection (a), why is it necessary to notify each customer of a transfer within 30 days? The Board should explain the basis for the 30-day period or consider extending the time period.

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State Board of Cosmetology
Regulation #16A-4514 (IRRC #2628)

General Revisions

October 24, 2007

   We submit for your consideration the following comments on the proposed rulemaking published in the August 25, 2007 Pennsylvania Bulletin. Our comments are based on criteria in section 5.2 of the Regulatory Review Act (71 P. S. § 745.5b). Section 5.1(a) of the Regulatory Review Act (71 P. S. § 745.5a(a)) directs the State Board of Cosmetology (Board) to respond to all comments received from us or any other source.

1.  Section 7.1. Definitions.--Implementation procedures; Clarity.

   The definition of ''school of cosmetology'' mirrors the statutory definition of the same term found in the Cosmetology Law (63 P. S. §§ 507--526) (Law). Both definitions list a school district as an entity that could be considered a ''school of cosmetology.'' We have two concerns.

   First, what is meant by the term ''school district''? We understand that the Board intends a school district to include an area vocational-technical school. We recommend that the final-form regulation include a definition of ''school district.''

   Second, section 7.113a, pertaining to accreditation by a nationally-recognized accrediting agency, requires all schools to be accredited. Is there a process available for school districts to become accredited? Is there a need for school districts to become accredited? We ask the Board to consider how it will implement Section 7.113a as it relates to school districts and make the necessary adjustments to its regulations.

2.  Section 7.31. Examination prerequisite for licensure; exceptions.--Implementation procedures.

   Subsection (c) allows applicants to obtain a natural hair braider license without examination if certain conditions are met. The exemption from examination will expire one year after the effective date of the regulation. Subsection (c)(ii) states that the Board will accept certain information without penalty for failure to comply with the licensing provisions prior to September 5, 2006, the effective date of Act 99 of 2006. It is our understanding that the Board is not imposing penalties for non-compliance at this time, but penalties will be imposed one year from the effective date of the final-form rulemaking. We recommend that the regulation be amended to provide the regulated community with notice of the nature of these penalties.

3.  Section 7.32. Deadline for examination applications.--Clarity.

   Subsection (c) states that a first-time examinee must complete and pass both the theoretical and practical portions of the exam within one year. Does the phrase ''within 1 year'' mean within 1 year of completing the necessary course work or within 1 year of passing one portion of the exam? This issue should be clarified in the final-form regulation.

4.  Section 7.32.d. Requirements for cosmetologist examination.--Reasonableness.

   Subsection (d) requires applicants seeking credits for educational credit to complete the total 1,250 training hours, including those completed in the field for which the applicant is seeking credit, within four consecutive years. What is the need for this provision?

5.  Sections 7.32e. Requirements for esthetician examination.--Clarity.

   Subsection (a)(2)(ii) states that applicants who, among other things, have ''received training from or under the auspices of the Bureau of Rehabilitation in the Department of Labor and Industry'' would be eligible to take the examination. We are aware that this language comes directly from the Law and that the existing regulation found at § 7.32d, pertaining to requirements for cosmetologist examination, contains identical language. What is meant by ''under the auspices''? This language also appears in §§ 7.32f(a)(2)(ii) and 7.32h(a)(2)(ii).

6.  Section 7.41. Display of licenses.--Clarity.

   Subsection (b) states that: ''[a]n individual license shall be readily available for inspection . . . ,'' however it does not specifically state whose license should be available: the salon owner, the individual working in the salon, or both. In addition, it is unclear from this language whether a school also would be required to display its license. The final-form regulation should clarify these issues.

7.  Section 7.43. Expiration and renewal of licenses.--Implementation procedures.

   Subsection (c) requires a natural hair braider licensee to provide proof that certain requirements have been met. What kind of proof would be necessary? This should be explained in the final-form regulation.

8.  Section 7.94. Sanitary use of supplies.--Reasonableness; Clarity.

   Subsection (c) adds language that prohibits a spatula or similar utensil from coming in contact with the hair of a client. With various existing methods of color treatment that may require spatulas to administer the product, the Board should clarify how it is possible for these tools to avoid contact with hair.

9.  Section 7.111. Application for a school license.--Clarity.

   Subsection (a)(2)(ii)(B) requires an owner-applicant for a school license to acquire 1,250 hours of ''satisfactory experience'' and 1,800 hours of ''satisfactory work experience'' and deletes language that states the experience relates to being in charge of a cosmetology shop. (Emphasis added.) The quoted terms are vague. We recommend that the final-form regulation specify the type of experience that would be considered acceptable.

10.  Section 7.120. Work done by students on the public.--Fiscal impact; Reasonableness; Implementation procedures.

   Subsection (a) states the following:

A school may permit students who have completed at least 300 hours of instruction to work on the public, if the charges for the students' services are based on the reasonable cost of materials used on the client only.

   We have two concerns. First, commentators believe the language being added to this subsection, ''used on the client,'' will have a significant fiscal impact on cosmetology schools because it will prevent them from incorporating any overhead costs into the prices charged. According to the Pennsylvania Association of Private School Administrators: ''[s]tudent clinic overhead costs have always been covered by the clients who use the clinic services.'' Commentators believe this change will lead to higher tuition prices for students. It is also noted that a decrease in clinic revenue could result in the loss of accreditation and Federal grant eligibility for students.

   We acknowledge that the new language, if enforced, will have a significant impact on the regulated community. We recommend that the Board work with the regulated community on the development and implementation of the final-form regulation to mitigate potential effects it may have.

   Our second concern pertains to the 300-hour requirement. Has the Board considered revising the 300-hour requirement of this section to accommodate the limited licensure categories included in the proposed rulemaking? Why or why not?

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State Architects Licensure Board
Regulation #16A-419 (IRRC #2629)

Requirements for Examination Eligibililty

October 24, 2007

   We submit for your consideration the following comments on the proposed rulemaking published in the August 25, 2007 Pennsylvania Bulletin. Our comments are based on criteria in section 5.2 of the Regulatory Review Act (71 P. S. § 745.5b). Section 5.1(a) of the Regulatory Review Act (71 P. S. § 745.5a(a)) directs the State Architects Licensure Board (Board) to respond to all comments received from us or any other source.

1.  Section 9.27. Inactive records.--Clarity.

   The proposed rulemaking changes this Section to require that a record of a candidate for licensure will only be considered ''inactive'' if an applicant does not correct a deficient application within five years. Originally, the regulation also required applicants to pass the entire examination within five years, or their record would be considered ''inactive.'' What effect does the rolling clock period have on the calculation of when a record becomes ''inactive''?

2.  Section 9.46. Requirements for examination eligibility.--Implementation procedures; Clarity.

Rolling clock requirement

   Subsection (b) explains the Board's new ''rolling clock'' requirement, which states that: ''[i]f an applicant for licensure fails to pass all remaining divisions within a 5-year period, the applicant will automatically be given a new 5-year period . . . .'' We have two concerns.

   First, the proposed rulemaking indicates that with the ''rolling clock'': ''[t]he applicant will automatically be given a new 5-year period measured from the date of administration of the next oldest passed division . . . to pass all divisions . . . and this rolling clock will continue to automatically renew until all divisions . . . are passed . . . .'' However, the last sentence added to this Section states that: ''[t]he Board will only consider the divisions of the examination passed within the 5-year time period immediately preceding the date of the latest administered division passed . . . .'' (Emphasis added.) Therefore, based on these varying sentences, it is unclear if once the rolling clock expires, the applicant will have to take only the remaining divisions needed to pass, or all divisions administered within the new rolling clock period. The Board should clarify this issue in the final-form regulation.

   Second, the Preamble mentions that the Board will adopt the National Council for Architectural Registration Boards rolling clock standards with one exception. This exception relates to candidates who had passed at least one division of the Architect Registration Exam by January 1, 2006. Has the Board considered including the January date in the final-form regulation?

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State Board of Medicine
Regulation #16A-4923 (IRRC #2630)

Expert Witness

October 24, 2007

   We submit for your consideration the following comments on the proposed rulemaking published in the August 25, 2007 Pennsylvania Bulletin. Our comments are based on criteria in section 5.2 of the Regulatory Review Act (71 P. S. § 745.5b). Section 5.1(a) of the Regulatory Review Act (71 P. S. § 745.5a(a)) directs the State Board of Medicine (Board) to respond to all comments received from us or any other source.

Section 16.52 Expert witnesses.--Reasonableness; Implementation procedures; Clarity.

   The proposed rulemaking adopts the criteria for expert qualifications established by the Medical Care Availability and Reduction of Error Act (Mcare Act) (40 P. S. § 1303.512). While we recognize that the majority of the language contained in the proposed regulation is similar to provisions in the Mcare Act, we have four concerns.

Formatting of the Subsections

   It appears that the titles of the subsections for the proposed rulemaking do not follow the appropriate alpha-numeric order. For example, Subsection (c) refers to ''subsections (a) and (b),'' but these sections are not included in the proposed regulation. We note that the following comments reference the Pennsylvania Bulletin version of the proposed rulemaking. In the submittal and publication of the final-form regulation, this formatting should be reviewed.

Paragraph (1) General rule

   This paragraph states that: ''[a] person will not be competent to offer an expert medical opinion in a disciplinary action before the Board unless that person possesses sufficient education, training, knowledge, and experience . . . .'' (Emphasis added.) How will the Board determine what is ''sufficient?''

Waiver requirements

   The proposed regulation provides that the Board may waive the requisite qualifications for an expert. However, the waiver language is vague. For example, Paragraph (2)(ii) states that the Board may waive the requirements for an expert if the Board determines the expert is ''otherwise competent'' to testify. (Emphasis added.) How the Board will make such a determination?

   In Subsection (e), the Board may waive various requirements for an expert if the Board determines that the expert possesses: ''sufficient training, experience and knowledge to provide the testimony'' as a result of ''active involvement'' in or full-time teaching of medicine. (Emphasis added.) The final-form regulation should specify how the Board will determine what is ''sufficient.'' Additionally, we note that Paragraph (1) includes ''education'' as one of the qualifications the Board must determine as ''sufficient'' before a person can offer an expert medical opinion. Why isn't ''education'' a criterion for waiver in Subsection (e)? Finally, the Board should clarify what would constitute ''active involvement.''

Subsection (f)

   This subsection allows the Board to apply ''its own expertise in determining the applicable standard of care in disciplinary matters before the Board.'' A commentator raised the issue of what qualifies Board members as ''experts'' in individual cases. Like the commentator, we question not only whether permitting the Board to make such determinations would render the proposed expert witness requirements moot, but also how this application would impact a respondent physician's right to cross-examine the expert against him/her. The Board should explain these concerns in the final-form regulation. It should be noted that the language contained in Subsection (f) is not included in the Mcare Act.

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State Board of Nursing
Regulation #16A-5131 (IRRC #2631)

Faculty Requirements for Nursing Education Programs

October 24, 2007

   We submit for your consideration the following comments on the proposed rulemaking published in the August 25, 2007 Pennsylvania Bulletin. Our comments are based on criteria in section 5.2 of the Regulatory Review Act (71 P. S. § 745.5b). Section 5.1(a) of the Regulatory Review Act (71 P. S. § 745.5a(a)) directs the State Board of Nursing (Board) to respond to all comments received from us or any other source.

1.  General.--Statutory authority; Clarity.

   In the Preamble, the Board states that its statutory authority to promulgate this regulation is found in section 6.1 of the Professional Nursing Law (Law) (63 P. S. § 216.1). This provision gives the Board the authority to develop standards, which are different from regulations. See Main Line Health, Inc. v. CAT Fund, 738 A.2d 66 (Pa. Cmwlth. 1999), aff'd 777 A.2d 1048 (Pa. 2001). The authority to promulgate this regulation is actually located in 63 P. S. § 212.1(k). The Board should include a reference to section 2.1 of the Law in the Preamble of the final-form regulation.

2.  Section 21.71. Nurse administrator, faculty and staff requirements.--Fiscal impact; Reasonableness; Implementation procedure; Clarity.

Subsection (a)--Nurse administrator, faculty and staff requirements

   Subsection (a) includes new language which reads:

A nursing education program shall employ a sufficient number of qualified faculty, faculty assistants, allied faculty and staff to accomplish the program objectives. [Emphasis added.]

   The House Professional Licensure Committee (House Committee) submitted comments dated September 26, 2007, questioning the use of the phrase ''sufficient number'' and requesting information on how this amount would be quantified. If a national standard exists that provides guidance, the House Committee recommended that the regulation reference the standard. We agree that the phrase is vague and needs to be clarified in the final-form regulation.

   The main paragraph of Subsection (a) ends with the sentence: ''The minimum faculty and staff requirements are as follows.'' Subsections (a)(1)--(5) describe these minimum requirements.

   Subsection (a)(1) lists a ''full-time nurse administrator'' as a minimum requirement for a nursing education program. This is a new term which replaces the existing term ''director of the program.'' The House Committee requested more information concerning the basis for this change. The Board should explain the need for this change and whether it is a substantive change in direction for this position. Another question is if the nursing program is a school or college, then is the nurse administrator also the head of the school or college? The Board should consider adding a definition for this term in the final-form regulation.

   Subsection (a)(3) reads: ''Additional faculty members as needed.'' In the existing regulations, the word ''needed'' is followed by phrase ''to insure an educationally effective student-faculty ratio.'' However, the latter phrase is being deleted by the proposed regulation. How will programs determine when additional faculty members are needed? While we understand the need for flexibility, the regulation should provide some guidance. Rather than note a possible need for additional faculty, this subsection in the final-form regulation should address student-faculty ratios. If the Board does not want to establish a minimum ratio, then it should require that nursing education programs submit their ratios to the Board and document the rationale for, and the effectiveness of, their approach to student-faculty ratios.

   Another new term appears in Subsection (a)(4), which reads: ''Allied faculty members as needed.'' Based on the requirements for this position and discussion of the term in the Preamble, it appears that members of the ''allied faculty'' do not need to have degrees in nursing. They are required by Subsection (c)(3) to have ''at least one graduate degree in a subject area pertinent to their area of teaching'' and ''may teach basic sciences or specialized areas of nursing practice.'' Unlike the other faculty positions, there is no requirement that ''allied faculty'' hold a license as a registered nurse (RN) in Pennsylvania. The Preamble offers an example of this term by stating:

. . . this amendment will permit a nursing education program to employ an individual with a graduate degree in chemistry to teach chemistry courses and will allow a program to employ an individual with a doctoral degree in pharmacy to teach pharmacology.

   If members of the ''allied faculty'' are not required to hold degrees in nursing or RN licenses, this should be clarified in the final-form regulation.

   There is another question concerning ''allied faculty.'' What is meant by ''as needed'' in this subsection? Are allied faculty ''needed'' only when an RN with the appropriate degree is unavailable? Does the Board intend that there be a preference for faculty candidates who are also licensed RNs? The Board should specify which areas of the curriculum must be taught by faculty with RN licenses and which areas may be taught by others.

   Subsection (a)(5) reads: ''Program support services, including administrative and clerical services.'' Commentators expressed concern with this change since it replaces existing language in Subsection (a)(4) which required a minimum of one full-time secretary. In addition, there is a concern with the deletion of a similar requirement in Section 21.74(a)(4). The new language does not set a minimum standard and provides no direction concerning the level of support services. In addition, there is no guidance concerning library, financial aid, or admissions services. A nursing program associated with an accredited college or university may be able to obtain services from the other institution. However, a diploma program in a hospital or other facility may not have similar access. The minimum requirements for these services should be set forth in the final-form regulation.

Subsection (b)--Nurse administrator qualifications

   The Hospital and Healthsystems Association of Pennsylvania (HAP) expressed concern with the administrative functions and other responsibilities of the nurse administrator. Subsections (b)(1) and (2) describe the qualifications for this position. They mention the need for ''experience in nursing practice, nursing education and administration.'' However, there is no indication of the level of experience necessary. In addition, there is no indication of the need for training or education in administrative or managerial functions. The House Committee also noted a concern over the lack of detail in the experience requirements for this position. The final-form regulation should provide more detail regarding the administrative duties, functions, qualifications and experience requirements for nurse administrators.

Subsection (c)--Faculty qualifications

   Commentators expressed concerns with two basic changes in this subsection.

   First, current faculty at two different college nursing programs and the House Committee expressed concern with the provisions for ''faculty assistants'' in the proposed regulation. The two commentators from the education programs expressed grave concern and warn that strict enforcement of the ''five-year rule'' will only exacerbate the shortages in faculty and new licensees. The new language maintains the existing requirement that these assistants can only teach for a cumulative period of five years without obtaining a graduate degree. The commentators claim that this requirement will force many experienced and qualified people out of these positions, especially in clinical courses. If a person is content as a faculty assistant, why must he or she be forced to enroll for additional degrees? The Board needs to justify retaining the five-year rule or delete it from the regulation.

   Second, Subsection (c)(5) introduces the term ''preceptor'' into this segment of the Board's existing regulations. Previously, the term ''preceptor'' was only used in the Board's regulations for certified registered nurse practitioners (see Sections 21.334(e) and 21.373(c)(3)(ii) and (iii)). Generally, a preceptor is defined as a teacher or instructor. Why is the Board using the term ''preceptor'' rather than ''instructor'' or ''teacher''?

   In addition, the Pennsylvania State Nurses Association, HAP and other commentators express serious concerns with the lack of details in the language describing ''clinical preceptors.'' Many commentators express confusion over the purpose of this position. The Board should work with the commentators and regulated community in resolving these concerns. The education and experience requirements for this position need to be specified in the final-form regulation.

   Finally, Subsection (c)(5) includes this sentence: ''A clinical preceptor shall hold a current license to practice professional nursing in the state of the clinical experience.'' The intent of this sentence is unclear. Would programs be allowed to hire out-of-state nurses to be preceptors? Would they need temporary practice permits?

3.  General.--Fiscal impact; Protection of the public health, safety and welfare; Reasonableness; Clarity.

   The House Committee expressed concern with an ''overall lowering of standards'' in nursing education programs via this proposed regulation. The Board needs to review each provision in the regulation and develop a detailed explanation of how the provisions provide additional flexibility and more opportunities for greater enrollment of new nursing students while not lowering the quality of nursing education programs.

4.  Miscellaneous.--Clarity.

   Other sections of the Board's existing regulations include the term ''director of the school'' with language relating to schools for RNs. The meaning of the term ''director of the school'' appears to be similar to the meaning of ''director of program,'' which is being replaced in this proposed regulation by the term ''nurse administrator.'' For example, Section 21.75(e) reads:

The director of the school and nursing faculty shall be afforded the time and opportunity to engage in leadership activities within their profession, commensurate with their responsibilities.

   In addition, Section 21.124(b) includes these requirements for documentation:

Upon completion of the entire program, a transcript or photocopy of the final record of the student shall be submitted along with the application for admission to the licensing examination. The transcript shall bear the impression of the school seal and signature of the director of the school or authorized representative.

   If the term ''director of the school'' in these sections is equivalent to ''nurse administrator'' in the proposed regulation, then the term ''director of the school'' should be replaced with the new term in the final-form regulation to ensure that terms are used consistently in the Board's regulations.

ARTHUR COCCODRILLI,   
Chairperson

[Pa.B. Doc. No. 07-2042. Filed for public inspection November 2, 2007, 9:00 a.m.]

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