NOTICES
INDEPENDENT REGULATORY REVIEW COMMISSION
Notice of Comments Issued
[30 Pa.B. 4313] Section 5(d) and (g) of the Regulatory Review Act (71 P. S. § 745.5(d) and (g)) provide that the designated standing committees may issue comments within 20 days of the close of the public comment period, and the Commission may issue comments within 10 days of the close of the committee comment period. The Commission comments are based upon the criteria contained in subsections 5.1(h) and (i) of the Regulatory Review Act (75 P. S. § 745.5a(h) and (i)).
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 regulations must be submitted by the dates indicated.
Final-Form Submission Reg. No. Agency/Title Issued Deadline 16-17 Department of State
Boxing and Wrestling7/27/00 6/26/02 10-156 Department of Health
Reporting of
Communicable and
Noncommunicable
Diseases7/27/00 6/26/02
State Athletic Commission Regulation No. 16-17
Boxing and Wrestling
July 27, 2000 We submit for consideration the following objections and recommendations regarding this regulation. Each objection or recommendation includes a reference to the criteria in the Regulatory Review Act (71 P. S. § 745.5a(h) and (i)) which have not been met. The State Athletic Commission (SAC) must respond to these Comments when it submits the final-form regulation. If the final-form regulation is not delivered by June 26, 2002, the regulation will be deemed withdrawn.
1. General.--Clarity.
References to the Athletic Code
In several places, the regulation uses a general reference to the entire ''Athletic Code.'' Rather than referencing the entire Athletic Code, each statutory citation or reference in the regulation should refer to the specific statutory sections or subsections that are pertinent to the particular regulatory provision. For example, the licensing of physicians in section 3.3(a) of the regulation should provide a complete citation to sections 905(a) and 910 of the Athletic Code (5 Pa.C.S. §§ 905(a) and 910).
Functions of a SAC Commissioner or the Executive Director
Various provisions throughout the regulation state that ''the Commission [SAC] or Executive Director'' will perform a certain duty or function. For example, section 3.2(a) states that inspectors ''shall be appointed by the Commission [SAC] or Executive Director and approved by the Secretary.'' It is our understanding that SAC's intent is to allow one member of the SAC or the Executive Director to appoint or nominate a person to be an inspector. There was no intent to involve the entire SAC in the hiring of each inspector. The SAC counsel identified other provisions where the intent was for one SAC Commissioner or the Executive to perform a function or duty.
To clearly state the SAC's intent, the regulation should replace the phrase ''the Commission or Executive Director'' with ''a Commissioner or the Executive Director.'' In addition, section 1.1 of the regulation should include a definition of the term ''Commissioner'' as a member of the SAC.
Forms, Manuals and Procedures
In certain provisions, the regulation refers to forms or procedures approved or prescribed by the SAC. For example, section 3.3(b) refers to both a physician's report on a form prescribed by the SAC and ''procedures prescribed by the SAC as approved by the Medical Advisory Board.'' According to SAC staff, these procedures are set forth in a document entitled the ''Medical/Safety Manual'' which SAC publishes for the physicians assigned to contests. In addition, SAC publishes manuals for judges and referees, contract forms for boxers, managers and promoters, and other prescribed forms.
The regulation should include information on how copies of these forms and manuals may be obtained. This information could be a SAC address or telephone number that people could use to request a form or manual.
2. Section 1.1. Definitions.--Consistency with Statute; Clarity.
Commission credentials
The definition of this term contains the phrase ''in furtherance of the Commission's official duties.'' This phrase does not add anything to the meaning of the term. The phrase should be deleted from this definition in the final-form regulation.
Bout
The term ''bout'' is not defined in this section; however, the term is used throughout the regulation. For example, section 3.1(j) states that the SAC may videotape a ''bout'' to review action. Additionally, section 5.2(c) speaks to rescheduling a ''bout'' or ''main bout.'' In the final-form regulation, SAC should define ''bout'' and ''main bout'' and use the terms consistently throughout the regulation.
Event
The regulation defines this term as ''one or more boxing contests, as defined in section 302 of the Athletic Code . . . .'' However, the term ''boxing contest'' does not appear in section 302 of the Athletic Code. Instead, the term ''contest'' in section 302 of the Athletic Code is defined as ''a boxing engagement . . . .''
It is our understanding that the term ''event'' is intended to mean an engagement including one or more bouts or contests. This definition needs to be modified to clearly match SAC's intent and the term should be used consistently throughout the regulation.
Subsection (b)--Incorporation by reference
This subsection incorporates by reference the definitions in section 302 of the Athletic Code pertaining to boxing and the definitions in section 1902 of the Athletic Code pertaining to wrestling. However, it is our understanding that SAC's intent was to incorporate all the statutory definitions. The phrases ''pertaining to boxing'' and ''pertaining to wrestling'' were meant to identify pertinent sections of this regulation, not the applicable statutory definitions.
To enhance clarity, this subsection should be divided into two paragraphs. The first subparagraph should clearly state that all the definitions in section 302 of the Athletic Code are incorporated for the provisions of the regulation related to boxing which include Subparts A and B. The second would state that all the definitions in section 1902 of the Athletic Code are incorporated for the regulatory provisions related to wrestling which include Subpart C of the regulation.
3. Section 3.1. Executive Director.--Clarity.
Attending a representative number of events
Subsection (b) states that the Executive Director shall attend a ''representative number'' of athletic events. The SAC should clarify what constitutes a ''representative number'' by specifying a minimum number or percentage of bouts or events that the Executive Director will attend.
Approval of proposed matches
Subsection (h) gives the Executive Director ''the authority to approve or prohibit each proposed matching of boxers within this Commonwealth.'' The regulation should clearly state the criteria or processes the Executive Director will use in deciding which matches would be approved or prohibited. For example, the criteria could include references to statutory requirements such as section 708 of the Athletic Code related to suspension and revocation for injuries, or section 711 of the Athletic Code related to limitation on difference in weights.
Circumstances not addressed by this part
Subsection (i) states ''Circumstances arising that are not addressed by this part shall be ruled on by the Executive Director.'' What is meant by the word ''circumstances''? Are these ''circumstances'' limited to situations relating to the SAC's duties under the Athletic Code?
Reviewing videotape
Subsection (j) states: ''The Executive Director and the Commission may use a videotape of a bout to review actions taken relating to a bout.'' It is our understanding that the intent of this subsection is to state that a single Commissioner, the Commission as a whole, or the Executive Director has the option of reviewing a videotape. To clearly state this intent, this phrase should be revised to state ''The Executive Director, a Commissioner or the Commission...''
Right of appeal
Subsection (k) indicates that actions by the Executive Director are subject to the right of appeal to the SAC. There are two concerns.
First, it is our understanding that in practice there are two levels of appeal and review. Initially, the Executive Director may meet with concerned parties to discuss one of his actions and informally work toward resolution of differences in opinion. If the issues are not resolved by the informal review, parties may appeal to the SAC. The subsection should reflect the actual practices of the Executive Director and SAC. It should outline the two-tier process which includes informal review and the right of appeal. The regulation should also include references to the appropriate regulatory or statutory rules of procedure for appeals such as 1 Pa. Code Chapter 35 or 2 Pa.C.S. §§ 501--508.
Second, sections 1301--1305 of the Athletic Code specifically outline the procedures for SAC to consider recommendations by the Executive Director that a permit or license be suspended or revoked. For example, a person has the right to a hearing before SAC ''within ten business days after the date on which the license or permit is suspended or revoked'' under section 1304(b) of the Athletic Code. This subsection should include a reference to sections 1301--1305 of the Athletic Code.
4. Section 3.2. Inspectors.--Statutory authority; Clarity.
Nomination of inspectors
Subsection (a) indicates that inspectors will be ''appointed by'' a SAC Commissioner or the Executive Director and ''approved by the Secretary.'' Since the Secretary has the authority to make appointments, this provision should state that an inspector will be ''nominated by'' a SAC Commissioner or the Executive Director.
Agents of the Department of Revenue
Subsection (d) identifies the inspectors as agents of the Department of Revenue. Section 210 of the Fiscal Code (72 P. S. § 210) states that the Department of Revenue has the authority to appoint agents to ''facilitate collection of money from persons . . . who have business with administrative departments, boards or commissions . . . .'' Since the Department of Revenue, not the SAC, has the authority to appoint its agents, the phrase ''as agents of the Department of Revenue'' should be deleted.
The subsection also states that it is the inspector's duty to ''enforce legislative and regulatory provisions pertaining to the collection of revenues'' due to the Commonwealth. This language is vague. The SAC should include a specific reference to section 916 of the Athletic Code and any other specific regulatory or statutory provisions that relate to collection of revenues.
5. Section 3.3. Physicians.--Clarity.
Procedures
Subsection (b) requires examinations to be ''conducted in accordance with procedures prescribed by the SAC as approved by the Medical Advisory Board . . . .'' It is not clear what ''procedures'' are to be used by the physician. The regulation should state that the approved procedures are set forth in the ''Medical/Safety Manual'' published by SAC.
Designee
Subsection (c) refers to a ''designee.'' The term ''designee'' is not defined. It is not clear whether a designee would be employed by the SAC. The regulation should define the term ''designee'' or it should be deleted from the final-form regulation.
Follow up ministrations and postbout physical report
Subsection (h) requires ''follow up ministrations'' by the attending physician when there is a knockout or technical knockout. New language in this subsection requires the attending physician to complete a ''postbout physical report on each boxer.'' The SAC's ''Medical/Safety Manual'' contains a form entitled ''Post Fight Check'' for the attending physician. This subsection should state that the report will be completed on a form prescribed by SAC.
6. Section 3.4. Announcers.--Clarity.
Subsection (j) states: ''Only an assigned announcer may make an announcement from the ring unless another person is specifically authorized.'' Announcers for professional events must be licensed by the SAC and assigned by the promoter or sponsor of the event. However, it is not clear who would ''specifically authorize'' another person to make an announcement from the ring. The regulation should indicate who has the authority to authorize ''another person'' to make announcements.
7. Section 5.1. Tickets.--Statutory authority; Reasonableness.
As proposed, subsection (e) requires ''ticket holders to events under the jurisdiction of the Commission to surrender their tickets or the appropriate stubs at the admission gates . . . .'' Since ticket holders are not licensees, the burden of the requirement ''to collect the tickets from the ticket holders'' should be placed upon the promoter who is a licensee. The SAC should restate the requirement for ticket collection in subsection (i) accordingly.
8. Section 5.2. Postponements and cancellations.--Implementation procedure; Clarity.
Subsection (e) states that ticket holders will be entitled to a refund in cases of postponement or cancellation of the main event or the entire program ''under the conditions of time, place and procedure that the Commission [SAC] approves and announces in each instances.'' How will this information be announced? What media will be used to notify ticket holders of how, when and where they can obtain a refund?
9. Section 13.3. Additional license fees.--Clarity.
This section requires that ''license fees or taxes due to the Commonwealth within a maximum of 48 hours after each promotion.'' The term ''promotion'' is not defined, however, the regulation does define the term ''event'' and the Athletic Code defines the term ''contest.'' The SAC should replace the term ''promotion'' with the defined term ''event'' or ''contest.''
10. Section 21.1. Contracts.--Clarity.
Subsection (n) indicates that a promoter may not advertise or announce a boxing contest until the event has been approved. Is this a reference to approval by the Executive Director? If appropriate, this subsection should cross-reference subsection 3.1(h) of this regulation.
11. Section 21.3. Ring and ring equipment.--Clarity.
Paragraph (7) reads: ''The ring shall be amply illuminated if needed, as determined by the Commission [SAC].'' Existing language that describes the type of illumination required is being deleted. Why? What standards will the SAC use to determine the need for ample illumination?
12. Section 21.4. Conduct of bouts.--Clarity.
Part of subsection (c) and all of subsection (e) prescribe clothing and glove requirements for boxers. However, the title and other subsections of this section address ''conduct of bouts.'' To be consistent with the headings of the sections, the SAC should move the clothing and glove requirements in subsections (c) and (e) to section 21.8 relating to ''boxers.''
13. Section 21.10. Seconds.--Clarity.
Subsection (j) provides that ''a manager, second or another person having received ample warnings to stop an offending conduct may be ejected from the corner.'' There are four issues pertaining to the language in this subsection.
First, it is not clear who ''another person'' would be. Only individuals licensed by the SAC are allowed in the boxer's corner of the ring. The regulation should clearly specify who is allowed in a boxer's corner and delete ''another person'' from the final-form regulation.
Second, the regulation should address situations when ''another person'' who is not licensed but is a spectator or ticket holder disrupts the bout or impedes the boxers. Since this section relates to seconds or licensees in each boxer's corner, provisions for situations involving spectators should be added to section 21.4 relating to ''conduct of bouts'' or section 21.11 relating to ''referees.''
Third, it is not clear how many warnings are ''ample.'' Existing language that the SAC has proposed be deleted from the regulation indicated two warnings. The SAC should delete ''ample'' and replace it with a specific number of warnings in the final-form regulation. For example, the SAC could state ''having received two or more warnings . . . .''
Fourth, the phrase ''offending conduct'' has not been defined. If the phrase is not defined, then what may be offensive to one referee may not be offensive to another. The SAC should define ''offending conduct'' and include examples in the final-form regulation.
14. Section 21.11. Referees.--Clarity.
Subsection (c)(7) establishes that a referee is to determine whether an injury resulted from an ''accidental foul'' or an ''intentional foul.'' The word ''foul'' is not defined. However, section 21.16(b) includes a comprehensive list of fouls and other practices prohibited in boxing bouts by the SAC. Section 21.11(c)(7) should include a cross-reference to the activities or actions that constitute a foul in section 21.16(b).
15. Section 21.12. Judges.--Clarity.
Subsection (c) contains the phrase ''generally recognized rules of boxing.'' In section 21.11(c)(8), the reference to the rules generally recognized in the sport under the traditional title of the ''Marquis of Queensbury Rules'' is being deleted. The reference to ''generally recognized rules of boxing'' is vague. It is our understanding that the Association of Boxing Commissions (ABC) has established rules which the SAC uses for championship events. Whether it is the ABC's rules or another source, the regulation should specify the rules that apply to the sport in Pennsylvania. The SAC should consider incorporating a specific reference in the regulation, or the term ''generally recognized rules of boxing'' should be defined.
16. Miscellaneous Clarity Issues.
Typographical errors
Section 3.2(e), as published in the Pennsylvania Bulletin, states:
Subject only to the direction of the Commission, an inspector or the Executive Director shall have authority over the following . . . .However, section 3.2(e) of the proposed regulation submitted by the SAC states:
Subject only to the direction of the Commission or the Executive Director, an inspector shall have authority over the following . . . .The meaning of the two versions is very different and the SAC should include the correct version in the final-form regulation and ensure the correct version is published by the Pennsylvania Bulletin.
Missing parenthesis
In the version of the regulation published in the Pennsylvania Bulletin, section 21.4, relating to ''conduct of bouts,'' is missing a closing parenthesis after subsection (a). This should be corrected in the final-form regulation.
Reversed bracket
Also in the version published in the Pennsylvania Bulletin, section 21.4(c) has a bracket that should be a closing bracket after the words ''their seconds.'' Instead the bracket is facing the wrong direction. This should be corrected in the final-form regulation.
Department of Health Regulation No. 10-156
Reporting of Communicable and
Noncommunicable Diseases
July 27, 2000 We submit for consideration the following objections and recommendations regarding this regulation. Each objection or recommendation includes a reference to the criteria in the Regulatory Review Act (71 P. S. § 745.5a(h) and (i)) which has not been met. The Department of Health (Department) must respond to these Comments when it submits the final-form regulation. If the final-form regulation is not delivered by June 26, 2002, the regulation will be deemed withdrawn.
1. General--Statutory authority, Protection of the public health, Reasonableness and Clarity.
Authorized departures from the regulations
Section 27.9 would allow the Department to authorize an exception to any regulation in Chapter 27. Section 27.151(a)(1) would allow the Department to specify additional diseases that would prohibit donation of blood. The exception or addition expires after 90 days unless the Advisory Health Board (Board) acts to affirm it. These sections do not state what happens after the Board affirms an exception or addition.
A provision of the regulation may only be amended by promulgation of a new regulation. The Department should add language to state that if the Board affirms the Department's action, the Department will amend the regulation. In the alternative, the Board should explain its statutory authority for amending the regulation without going through the rulemaking process.
Additionally, the Department should consider incorporating by reference the Morbidity and Mortality Weekly Report's ''Case Definitions for Infectious Conditions Under Public Health Surveillance'' for the list of communicable diseases contained in the proposed rulemaking. This would be a viable alternative to authorizing an exception to any regulation in this chapter, if the regulation becomes outdated. Guidelines for documents that can be incorporated by reference can be found at 45 Pa.C.S. § 727 and 1 Pa. Code § 3.41.
Scope of reporting
As defined in section 27.1, the individuals responsible for reporting are ''health care practitioners.'' Section 27.23 assigns the same reporting responsibility as health care practitioners to institutions, orphanages and child care groups. Section 27.21a(a) contains the list of specific diseases, infections and conditions that a health care practitioner must report.
The proposed regulation assigns the same reporting responsibility to a number of different persons, who have varying degrees of skill, to identify diseases, infections and conditions. While physicians have the necessary expertise to diagnose, commentators stated that other persons included under the definition of ''health care practitioner'' and section 27.23 could only provide a layman's identification. What does the Department expect in reports from laymen? Can the reports be based on symptoms and suspicions, rather than identification?
Suggested additions and deletions of diseases
Commentators suggested additions and deletions of diseases to several sections, including sections 27.22(b), 27.43a(b)(2) and 27.201. We recommend that the Department review the commentators' concerns, and explain in the Comment and Response document why each of those specific diseases was not included or was deleted.
Subchapter A. GENERAL PROVISIONS 2. Section 27.1. Definitions.--Consistency with statute, Reasonableness and Clarity.
General
This section defines six terms that are also defined in 35 P. S. § 521.2. We object to the definitions of the following terms that differ from the definitions contained in the statute: ''communicable disease,'' ''isolation,'' ''local health officer,'' ''quarantine'' and ''reportable disease.'' If the Department does not use the statutory definitions in the final-form regulation, it should justify the changes.
Child
This regulation defines ''child'' as ''[A] person 15 years of age or younger.'' As many different definitions for ''child'' exist in this Commonwealth, the Department should clarify how the use of this specific definition was determined. How is a person between the ages of 16 to 21 classified?
Isolation
The definition of ''isolation'' requires the ''separation for the communicable period of an infected person or animal from other persons or animals . . . .'' Commentators have asked whether the Department should clarify ''separation'' because the definition, as written, could be interpreted to require any patient or resident with any infection to be isolated.
We understand that many different factors are considered to determine whether a patient, resident or animal should be separated, and what degree of separation is required. There are a number of factors for separation, including the disease, patient, resident or animal's behavior, and current situation at the facility. Likewise, separation could entail complete isolation or simply moving the patient to a single-patient room.
These factors and situations are substantive and should be in the body of the regulation, not in the definition of ''isolation.'' Therefore, to avoid confusion over implementation of ''separation,'' the Department should include the factors involved in making a decision to separate, and what form separation could take, in section 27.61, relating to isolation.
Local health department
This definition states ''[T]he Department will maintain a list of local health departments and revise the list when new local health departments are established.'' That information is substantive, and should not be included in the term's definition. The Department should consider moving that portion of the definition to section 27.4, relating to reporting cases.
Additionally, will the list of local health departments be revised if a local health department is relocated, or closed? If so, the Department should amend the final-form regulation to reflect that intent.
Undefined terms
The terms ''pupil,'' ''school,'' ''school employee,'' ''clinically related health care service'' and ''child care provider'' are used in this proposed rulemaking. To eliminate any confusion, the Department should consider defining these terms in either section 27.1, relating to definitions, or within the sections where they are used.
3. Section 27.4. Reporting cases.--Reasonableness and Clarity.
Subsection (a) outlines how and where cases should be reported. Will the Department provide a list of addresses and phone numbers if one of the locations mentioned in subsections (a)(1)--(7) changes? If so, how will the Department notify health care practitioners and clinical laboratories of a change in location?
4. Section 27.7. Cooperation between clinical laboratories and persons who order laboratory tests.--Reasonableness and Clarity.
Testing
Section 27.7 requires clinical laboratories and ''persons who request (and order) the testing . . . .'' to share information. We have two concerns with this section. First, the term ''the person who requests the testing'' is unclear. Is that person the practitioner, or the individual (who may be a nurse, physician's assistant or a member of the support staff) who actually contacts the clinical laboratory? The Department should resolve this ambiguity in the final-form regulation.
Second, paragraph (1) uses the term ''person who requests the testing.'' Paragraph (2) uses ''[A] person who orders testing.'' Is there a difference between a person who ''requests'' and a person who ''orders'' testing? If not, the Department should use a uniform term throughout this section.
5. Section 27.8. Criminal penalties for violating the act or this chapter.--Protection of public health and safety.
This section outlines penalties for persons who violate any provision of this chapter. However, the regulation does not address the immediate measures a healthcare facility should take if a patient under the facility's care leaves the facility and exposes the public to disease. The Department should explain what a healthcare facility should do in this situation.
Subchapter B. REPORTING OF DISEASES, INFECTIONS AND CONDITIONS 6. General.--Economic impact, Need and Clarity.
Hepatitis C
Commentators, including Representative Dennis O'Brien, Majority Chairperson of the House Health and Welfare Committee, stated there is a need for more comprehensive reporting of viral Hepatitis C cases, including chronic as well as acute. The lists of diseases in sections 27.21a, 27.22 and 27.43a require reporting of viral Hepatitis C. These sections do not specify whether the disease must be chronic or acute for reporting purposes. To have the appropriate information reported, the Department should clarify the reporting of Hepatitis C cases.
Duplicative reporting requirements
Subchapter B requires multiple reporting of a single incidence of disease. Commentators outlined the following examples:
* Section 27.21a(b)(1) provides that a health care facility is not required to report a case if it reported the case previously. A clinical laboratory is also required to report under section 27.22, even if it is part of the health care facility. In this instance, the regulations require two reports on one diagnosis within the same facility.
* Section 27.22(a) requires clinical laboratories to report. The regulation appears to require duplicative reporting when one clinical laboratory refers a case to another laboratory.
The Department should clarify whether only one report is required in these situations, or explain why duplicative reporting is needed and how the benefits outweigh the costs.
Complexity of reporting process
Commentators believe the reporting requirements in Subchapter B are burdensome in two ways. First, the reporter is required to determine the appropriate local agency for the patient's residence, or which local agency is able to intervene. Second, when reporting to the Department, the point of submittal varies by the disease being reported. Commentators suggest simplifying the reporting process to improve the appropriate filing of reports. Among the suggestions is reporting to a single point that distributes the reports to the appropriate agencies. The Department should review the process for submitting reports, and explain why the current system is necessary.
7. Section 27.21a. Reporting of cases by health care practitioners and health care facilities.--Clarity.
Section 27.22. Reporting of cases by clinical laboratories.--Clarity.Sections 27.21a(a)(2) and 27.22(b) require reporting of several diseases ''in children up to 5 years or 60 months of age.'' Why are both phrases ''5 years'' and ''60 months'' needed? For clarity, the Department should use the phrase ''under 5 years of age.''
Under section 27.21(a)(2), Chickenpox will become reportable 3 years after the adoption of the final-form regulation. The Department explains in the Preamble that Chickenpox has not been reportable since 1984. The 3 year delay is to allow the Department to obtain data before requiring reporting of Chickenpox. We question why the Department is including Chickenpox in this rulemaking before the data is available. The Department should consider including Chickenpox in a future rulemaking.
8. Section 27.22. Reporting of cases by clinical laboratories.--Protection of the public health.
Subsection (c) lists the content of reports. Commentators suggest adding ''the source of specimen, results and range of normal values for the specific test.'' The Department should consider adding these items to the reports.
9. Section 27.32. Reporting AIDS.--Protection of the public health and Need.
Section 27.32 is being deleted. Therefore, AIDS reporting will no longer be required from hospitals, healthcare facilities and institutions. Representative O'Brien expressed concern that, under the language of the proposed regulation, AIDS would no longer be a reportable disease. Because section 27.21 requires physicians to report cases of AIDS, section 27.32 should be retained in the final-form regulation.
10. Section 27.34. Reporting cases of lead poisoning.--Duplication and Clarity.
Subsection (a)
A commentator stated clinical laboratories do not always determine whether the patient is pregnant. As the regulation is written, pregnancy is a criteria for reporting cases of lead poisoning. The Department should explain how a clinical laboratory would know or determine whether the patient is pregnant.
Why is the Department using the phrase ''those persons under 16 years of age,'' instead of the defined term ''child'' which includes persons 15 years of age or younger?
Subsection (i)
Paragraph (5) is a broad requirement for ''[O]ther information as requested by the Department.'' The Department should limit the scope of this information to the information needed to complete the form, as explained in subsection (i).
Subsection (j)
Subsection (j) ends with the phrase ''or other disciplinary action.'' What other disciplinary action is the Department authorized to take under the statute?
Subchapter C. QUARANTINE AND ISOLATION 11. Section 27.60. Disease control measures.--Clarity.
The last sentence of this section states that under certain circumstances a local health authority shall consult with and receive approval from the Department prior to taking disease control measures. The regulation should state how to request the Department's approval, and whether the Department's approval is in writing.
12. Section 27.71. Exclusion of pupils and staff for specified diseases and infectious conditions.--Economic and fiscal impact, Need, Reasonableness and Clarity.
Children and staff attending schools and child care group settings
Prior to section 27.71, the regulation is subtitled ''Communicable diseases in children and staff attending schools and child care group settings.'' However, the title and text of sections 27.71, 27.72, 27.73 and 27.74 use other terms such as ''pupils.'' For clarity, the Department should review these sections and use defined terms consistently, including the subtitle.
Staff person who has contact with pupils; verification for readmission
Section 27.71 requires pupils and staff persons who have contact with pupils that are suspected of having one of the listed diseases to receive verification from a school nurse or physician that the criteria for readmission has been satisfied. We have three questions regarding this section.
First, the term ''staff person who has contact with pupils'' is unclear. Who is included in this term? The Department should define this term in either this section or in section 27.1, relating to definitions.
Second, if the timeframe for readmission has been satisfied (as noted in paragraphs (1)--(15)), is it necessary for pupils and staff persons who have contact with pupils to receive verification for readmission from a school nurse or physician?
Finally, the regulation is limited to ''school nurse'' or physician verification for readmission. Commentators stated that not all schools have a ''school nurse'' readily available. Why is verification limited to a school nurse or a physician? Would verification from other medical personnel, such as a registered nurse or physician's assistant, meet this requirement? We have the same concern in section 27.73, relating to readmission of excluded pupils and staff.
13. Section 27.72. Exclusion of pupils and staff showing symptoms.--Reasonableness and Clarity.
Staff person and staff person who has contact with pupils
This section requires persons in charge of a school to immediately exclude pupils or staff persons who show a number of different symptoms that could denote the onset or infection of a communicable disease. In subsection (a), why is the phrase ''pupil or staff person'' used instead of ''pupil or a staff person who has contact with pupils''? For consistency with the rest of the rulemaking, the Department should choose one of the two phrases, define it and use it consistently.
Inclusion of Diarrhea
Also in subsection (a), commentators have suggested including ''diarrhea'' in the list of symptoms that require persons in charge of a school to exclude pupils or staff members. They argue that the addition of ''diarrhea'' in this subsection would be consistent with other provisions in the regulation, specifically: Sections 27.76(a)(3) relating to exclusion and readmission of children and staff in child care group settings; section 27.154(6) relating to restrictions on caregivers in a child care group setting; and section 27.155(6) relating to restrictions on health care practitioners. The Department should include ''diarrhea'' in subsection (a)(1)--(7), or explain this inconsistency.
Subsection (b)
Subsection (b) states: ''[T]he Department will periodically determine and publish . . . what increase in absenteeism constitutes an unusual rate of absenteeism.'' The term ''periodically'' is unclear. Will the Department publish such information quarterly, annually or monthly? Will the information be published in the Pennsylvania Bulletin? The Department should establish a timeframe for ''periodically,'' and state where the publication will occur.
This subsection also requires schools to maintain records of exclusions and review these records to determine when unreasonable rates of absenteeism occur. Is the school then required to forward that information to the Department? If so, what forms and procedures are required to report this information? The final-form regulation should clearly state that schools need to submit this information, and should specify the reporting process.
14. Section 27.76. Exclusion and readmission of children and staff in child care group settings.--Reasonableness and Clarity.
Invasive H. influenza disease
Commentators have noted that the Department should delete subsection (a)(8), which deals specifically with ''invasive H. influenza disease.'' As noted in Issue #1, we understand that the Department utilizes the Morbidity and Mortality Weekly Report's ''Case Definitions for Infectious Conditions Under Public Health Surveillance'' (Report), for determining which communicable diseases need to be reported. As ''invasive H. influenza disease'' is not included in the Report, we question its inclusion here. The Department should explain.
Screening
Subsection (b)(3) requires caregivers at child care group settings: to screen ''each child by staff at the time the child is brought to the child care group setting for the presence of a condition which requires exclusion.'' We have three concerns with this subsection.
First, does this requirement mandate that caregivers at a child care group examine every child every day for the presence of an exclusionary disease, or only if the child is suspected of having an exclusionary disease? The Department should clarify its intention in the final-form regulation.
Second, the regulation states that caregivers should screen each child for ''the presence of a condition which requires exclusion.'' Does this mean that the caregiver is responsible for making an accurate diagnosis of a child's condition, or that the caregiver should screen for symptoms of exclusionary diseases? The Department should explain.
Finally, how will the caregiver report the presence of an exclusionary disease to the Department? Will there be a form approved by the Department? Is there a process the caregiver must follow? The Department should fully explain the process for caregivers to report exclusionary diseases in the final-form regulation.
15. Section 27.77. Immunization requirements for children in child care group settings.--Clarity.
Certificates of immunization
Subsection (a)(4) requires certificates of immunization to be completed and signed for each child enrolled in a child care group setting. This subsection also requires that these certificates be ''periodically updated by the caregiver.'' The term ''periodically'' is unclear. The Department should include a timeframe.
Subchapter D. SEXUALLY TRANSMITTED DISEASES, TUBERCULOSIS AND OTHER COMMUNICABLE DISEASES 16. Section 27.87. Refusal to submit to treatment for communicable diseases.--Clarity.
The second sentence of subsection (b) is long and complex. The Department should amend this sentence to make it clearer.
17. Section 27.89. Examinations for syphilis.--Consistency with the statute, Protection of the public health and Clarity.
Subsections (a)(1) and (c) state that the Department will publish the rate of syphilis in the Pennsylvania Bulletin ''as necessary.'' What is the purpose of publishing the rate of syphilis, why is publication necessary and what criteria will be used to determine when it is necessary?
Subchapter E. SELECTED PROCEDURES FOR PREVENTING DISEASE TRANSMISSION 18. Section 27.151. Restrictions on the donation of blood, blood products, tissue, sperm and ova.--Consistency with statute and Clarity.
Subsection (a) states that, ''a person who is known to be infected with a causative agent of a reportable disease is not allowed to donate.'' The Department should add ''or suspected'' in accordance with 35 P. S. § 521.4(a).
19. Section 27.152. Investigation of cases and outbreaks.--Clarity.
In subsection (b), a representative may be required to present ''documentation to establish that he is an authorized representative of the Department or local health authority.'' What kind of documentation is required? Would a nametag meet this requirement?
20. Section 27.158. Special requirements for shigellosis.--Protection of the public health and Clarity.
This section begins with the phrase ''[A] household contact of a case of shigellosis.'' This phrase is unclear. The Department should either provide examples or define the term ''household contact'' in this section of the final- form regulation.
21. Section 27.161. Special requirements for tuberculosis.--Clarity.
In subsection (b) the term ''substantial'' is used to describe a timeframe. The Department should provide a specific timeframe and delete the term ''substantial.''
Subchapter F. MISCELLANEOUS PROVISIONS 22. Section 27.201. Disposition of articles exposed to contamination.--Protection of the public health and Clarity.
This section provides an exception for when the transmission of articles is made ''with proper precaution.'' The regulation should explain or reference what ''proper precaution'' must be taken.
23. Section 27.202. Lease of premises occupied by a person with communicable disease.--Clarity.
The phrase ''[cleaned] to the satisfaction of health authorities'' is being deleted. What standard must be met?
24. Other clarity issues.
Portions of the regulation use vague phrases or have typographical errors. The Department should review the following:
Section 27.4(c) requires that ''[A] case shall be reported using the appropriate case format.'' The Department should explain what the ''appropriate case format'' is, and how reporters will be made aware of the proper format for reporting.
Section 27.23 begins with the phrase ''[E]xcept as otherwise set forth in this section.'' Why is this phrase needed?
If the Department retains ''invasive H. influenza disease,'' ''influenza'' should be replaced with ''influenzae'' in section 27.76.
Section 27.84(a) and (b) reference an ''appropriate'' remedy. Section 27.87(b) references an ''appropriate'' institution. The Department should clarify what is considered ''appropriate.''
Section 27.203 requires ''appropriate precautions'' to prevent the spread of disease. This phrase is vague. The Department should give examples of what it considers to be ''appropriate precautions'' in the final-form regulation.
JOHN R. MCGINLEY, Jr.,
Chairperson
[Pa.B. Doc. No. 00-1402. Filed for public inspection August 11, 2000, 9:00 a.m.]
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