reglab/statecodes huggingface dataset:
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart D - Health Planning › Chapter 301 - LIMITATION ON FEDERAL PARTICIPATION FOR CAPITAL EXPENDITURES › Section 301.4 - Designation; review of proposed capital expenditures

Current through Register Vol. 54, No. 28, July 13, 2024
The Commonwealth has signed an agreement with the Secretary
					 of HHS to designate the Department of Health as the designated planning agency
					 which will submit to the Secretary of HHS, together with the supporting
					 materials as the Secretary of HHS may require, the following
					 information:
(1) With respect to each
				  capital expenditure proposed by or on behalf of a health care facility or
				  health maintenance organization in the Commonwealth, the findings of the
				  designated planning agency as to whether the following has occurred:
(i) The designated planning agency had been
				  given notice of the proposed capital expenditure at least 60 days prior to
				  obligation for the expenditure.
(ii) The expenditure is or is not consistent
				  with the standards, criteria or plans developed under the Public Health Service
				  Act (42 U.C.S.A. §§ 201-300cc-15) or the Mental Retardation
				  Facilities and Community Mental Health Centers Construction Act of 1963, Pub.
				  L. No. 88-64, 77 Stat. 282, to meet the need for adequate health care
				  facilities in the area covered by the plans so developed.
(iii) In reaching the findings, the
				  designated planning agency shall consult with and take into consideration the
				  findings and recommendations of the appropriate health systems
				  agency.
(iv) When the designated
				  planning agency finds that the expenditure is not consistent with the
				  standards, criteria or plans, it shall submit to the Secretary of HHS the
				  findings and recommendations of all other agencies with which it has
				  consulted.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart D - Health Planning › Chapter 301 - LIMITATION ON FEDERAL PARTICIPATION FOR CAPITAL EXPENDITURES › Section 301.5 - Advisory body

Current through Register Vol. 54, No. 28, July 13, 2024
The Statewide Health Coordinating Council, constituted
					 under section 1524 the act (42 U.S.C.A. §
											300m-3), shall
					 serve as the advisory body to the designated planning agency.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart D - Health Planning › Chapter 301 - LIMITATION ON FEDERAL PARTICIPATION FOR CAPITAL EXPENDITURES › Section 301.7 - Fair hearing

Current through Register Vol. 54, No. 28, July 13, 2024
The designated planning agency will grant to an applicant
					 an opportunity for a fair hearing with respect to the findings and
					 recommendations of the designated planning agency. The procedures for a fair
					 hearing shall be as follows:
(1)
Request for hearing.
Requests for hearing shall conform with
				  the following:
(i) Requests for hearing shall
				  be made in writing to the designated planning agency within 30 days after the
				  applicant receives notice of the designated planning agency's findings and
				  recommendations. The request for hearing shall be in the form of a pleading. It
				  shall indicate which of the issues specified in this subsection the applicant
				  wishes to raise and shall set forth the facts and the law upon which the
				  applicant relies. A mere general assertion that the capital expenditure is
				  consistent with standards, criteria or plans or that the designated planning
				  agency committed prejudicial error, or the like, will not be considered as
				  complying with this subsection. The Hearing Officer may strike a portion of a
				  request for hearing which does not comply with this subsection, or, in the
				  alternative, may permit the applicant to make its request more specific. In the
				  latter event, the hearing shall be commenced within 30 days of the filing of
				  the amended request for hearing.
(ii) Subparagraph (i) supplements 1 Pa. Code
				  §
											35.17 (relating to petitions
				  generally).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart D - Health Planning › Chapter 301 - LIMITATION ON FEDERAL PARTICIPATION FOR CAPITAL EXPENDITURES › Section 301.8 - Criteria for agency review

Current through Register Vol. 54, No. 28, July 13, 2024
The criteria under which the designated planning agency and
					 the other agency described in §
										301.4(1)(iii)
					 (relating to designation; review of proposed capital expenditures) evaluates
					 proposals for capital expenditures for purposes of this chapter to determine
					 their conformance with the applicable standards, criteria and plans referred to
					 in § 301.4(1)(ii)-(iv) includes the following:
(1) Whether the proposed project is needed or
				  projected as necessary to meet the needs in the community in terms of health
				  services required; provided, that projects for highly specialized services,
				  such as open-heart surgery, renal transplantation or radiation therapy, which
				  will draw from patient population outside the community in which the project is
				  situated will receive appropriate consideration.
(2) Whether the proposed project can be
				  adequately staffed and operated when completed.
(3) Whether the proposed capital expenditure
				  is economically feasible and can be accommodated in the patient charge
				  structure of the health care facility or health maintenance organization
				  without unreasonable increases.
(4)
				  Whether the project will foster cost containment or improved quality of care
				  through improved efficiency and productivity, including promotion of
				  cost-effective factors such as ambulatory care, preventive health care
				  services, home health care and design and construction economies, or through
				  increased competition between different health services delivery
				  systems.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart D - Health Planning › Chapter 301 - LIMITATION ON FEDERAL PARTICIPATION FOR CAPITAL EXPENDITURES › Section 301.11 - Phase-out of health facilities review program

Current through Register Vol. 54, No. 28, July 13, 2024
(a) No letter of intent required by §
										301.6(a)(1)
				  (relating to procedures for agency review) will be accepted after July 31,
				  1980.
(b) No "Health Facilities
				  Section 1122 Project Form" required by §
										301.6(a)(2) will
				  be accepted after September 30, 1980. No "Health Facilities Section 1122
				  Project Form" will be accepted unless a letter of intent related to that
				  project has been submitted prior to July 31, 1980.
(c) Forms required to be filed under §
										301.6 will be reviewed for
				  completeness in accordance with the procedures established in that section by
				  December 1, 1980. In the event an application is found to be incomplete;
				  required information shall be submitted by December 1, 1980, or the
				  applications will be deemed to be abandoned and no further review will occur.
				  The Department may grant an appropriate extension if unique circumstances
				  require it, but in no event will the extension exceed 3 months.
The provisions of this §
												301.11 issued under section
						2102(a) and (g) of The Administrative Code of 1929 (71 P. S. §
													532(a) and (g)); and section
						904 of the Health Care Facilities Act (35 P. S. §
													448.904).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart D - Health Planning › Chapter 401 - CERTIFICATE OF NEED PROGRAM › Section 401.1 - Applicability

Current through Register Vol. 54, No. 28, July 13, 2024
The provisions of this chapter shall be applicable to
					 persons who propose to undertake to offer, develop, construct or otherwise
					 establish, or to undertake to establish, within the Commonwealth a new
					 institutional health service.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart D - Health Planning › Chapter 401 - CERTIFICATE OF NEED PROGRAM › Section 401.5 - Certificate of Need

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
Letter
				  of intent.
(1) As early as possible,
				  any person desiring to obtain a certificate of need shall submit a letter of
				  intent to the Division of Need Review of the Department and to the Health
				  Systems Agency (HSA) responsible for reviewing applications in the health
				  service area where the proposed project will be located. A letter of intent
				  shall contain at least the following information:
(i) The name and address of the
				  applicant.
(ii) The name and
				  location of the project.
(iii) The
				  reason the project is needed.
(iv)
				  The type of capital expenditure, acquisition, health service, or change in bed
				  capacity involved in the project.
(v) The expected date of project commencement
				  and completion.
(vi) The estimated
				  cost and anticipated source of project financing.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart D - Health Planning › Chapter 401 - CERTIFICATE OF NEED PROGRAM › Section 401.6 - Certificate of need-statement of policy

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
Statewide goals.
(1) Sufficient ambulatory surgery capacity
				  shall be available and accessible in this Commonwealth to meet local community
				  needs.
(2) Ambulatory surgery shall
				  be promoted throughout this Commonwealth whenever it represents a cost
				  effective alternative to inpatient surgery.
(3) Until 50% of total surgical procedures in
				  an HSA region-or whatever alternative percentage is consistent with local
				  health systems plans adopted by the Health Systems Agency and approved by the
				  Statewide Health Coordinating Council are performed on an ambulatory basis, as
				  indicated hereafter, no application for CDN approval of an ambulatory surgical
				  facility or service shall be considered by the Department as in appropriately
				  increasing total community health care costs, provided the project represents
				  the least costly and most effective method of providing services and meets the
				  guidelines set forth in this section.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart D - Health Planning › Chapter 401 - CERTIFICATE OF NEED PROGRAM › Section 401.7 - Simultaneous and comparative review

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
				  The following categories of projects will receive simultaneous and comparative
				  review:
(1) Alcohol and other drug treatment
				  and rehabilitation.
(2) Ambulatory
				  surgical services.
(3) Cardiac
				  catheterization.
(4) Cardiac
				  surgery.
(5) Comprehensive medical
				  rehabilitation.
(6)
				  Lithotripters.
(7) Magnetic
				  resonance imaging devices.
(8)
				  Psychiatric services.
(9) Renal
				  dialysis units.
(10) Skilled
				  nursing and intermediate care services.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart D - Health Planning › Chapter 401 - CERTIFICATE OF NEED PROGRAM › Section 401.11 - Magnetic resonance Certificate of Need-statement of policy

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
Status
				  and trends.
Magnetic resonance (MR) is a category of service that uses
				  the magnetic spin property of certain atomic nuclei to visualize and analyze
				  tissue. Diagnostic techniques include both MR imaging and spectroscopy.
(1) MR imaging has proven to be a useful tool
				  in the diagnosis of the following:
(i) Brain,
				  brain stem, spinal cord disorders and demylenating diseases.
(ii) Diffuse or infiltrating diseases of the
				  liver and kidney.
(iii) Early
				  changes in ischemia and infarction of heart tissue.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart D - Health Planning › Chapter 401 - CERTIFICATE OF NEED PROGRAM › Section 401.12 - Reviewable clinically related health services-statement of policy

Current through Register Vol. 54, No. 28, July 13, 2024
(a) Section 701(d)
				  of the act (35 P. S. §
											448.701(d)), as amended by
				  the act of December 18, 1992 (P. L.____________, No. 179), requires the
				  Department to publish within 30 days of the effective date of the amendment a
				  list of clinically related health services that require a Certificate of
				  Need.
(b) Clinically related health
				  services which require Certificates of Need are as follows:
Alcohol or other drug rehabilitation-inpatient, limited to
					 hospital or nonhospital, inpatient treatment programs lasting less than 60
					 days
Ambulatory surgery-single specialty
Ambulatory surgery-general/multiple specialty
Cardiac catheterization-diagnostic
Cardiac catheterization-therapeutic
Comprehensive medical rehabilitation-inpatient
Emergency department
Intermediate care for the mentally retarded (ICF/MR)
Intermediate or skilled nursing care-inpatient
Lithotripsy-biliary
Lithotripsy-renal
Magnetic resonance imaging
Medical surgical-inpatient
Neonatal intensive care-inpatient
Open heart surgery
Organ transplant-heart/lung
Organ transplant-kidney
Organ transplant-liver
Organ transplant-other
Positron Emission Tomography (P.E.T.)
Psychiatric-inpatient adult
Psychiatric-inpatient child and adolescent
Surgery-inpatient
(c) A health care facility as defined under
				  section 103 of the act (35 P. S. §
											448.103) is automatically reviewable under
				  section 701(a) of the act.
(d) A
				  person proposing to offer a new, high-cost technology as defined in section
				  701(g) of the act and which does not appear in subsection (b) shall consult
				  with the Department regarding the reviewability of the proposal.
This section cited in 28 Pa. Code §
												401.14 (relating to letters of
						interest and filing fees-statement of
						policy).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart D - Health Planning › Chapter 401 - CERTIFICATE OF NEED PROGRAM › Section 401.13 - Examination of Certificate of Need files-statement of policy

Current through Register Vol. 54, No. 28, July 13, 2024
(a) By prior written request and arrangement
				  only, Certificate of Need (CON) applications and materials will normally be
				  available for examination by the public on Tuesdays, Thursdays and Fridays
				  which are official Commonwealth State government business days from 9 a.m. to
				  12 p.m. and from 1 p.m. to 4 p.m. in Room 1027, Health and Welfare Building,
				  Commonwealth and Forster Streets, Harrisburg, Pennsylvania. Parties requesting
				  examination of materials shall make requests in writing by designating the
				  name, address and telephone number of the requesting party, project name and
				  description or CON number or both, and the calendar date on which the party
				  would like the materials to be made available for review. Parties shall make
				  sure that written requests reach the Department at least 2 full business days
				  prior to the calendar date requested for review. Requesting parties will be
				  notified by the Division of Need Review staff by telephone of the date on which
				  materials are available. Requesting parties that walk in without prior contact
				  with the Division of Need Review will be given a date for examination of
				  requested documents within 2 full business days, upon providing the information
				  required by this subsection.
(b)
				  CON records maintained by the Central Office in Harrisburg may be reviewed and
				  copied only at the Division of Need Review Office.
(c) CON records will be made available for
				  review by the Division of Need Review staff in the Division conference area
				  only.
(d) A fee of 50¢ per
				  page for all pages copied will be invoiced payable to the Department of Health
				  by check or money order; however, there will be a minimum copy charge of $5.
				  The requesting party or their representatives are responsible to make the
				  copies, using the copy machine in the Division of Need Review Office.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart D - Health Planning › Chapter 401 - CERTIFICATE OF NEED PROGRAM › Section 401.14 - Letters of intent and filing fees-statement of policy

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A person intending to offer, develop,
				  construct, renovate, expand or otherwise establish or undertake to establish
				  either a clinically related health service that is included in the Department's
				  list of reviewable clinically related health services in §
										401.12 (relating to addition of a
				  health service subject to Certificate of Need review-statement of policy), or a
				  health care facility as defined in section 103 of the act (35 P. S. §
											448.103) shall at the earliest possible time
				  in their planning submit a signed letter of intent to the Department.
(b) Letters of intent shall contain the
				  following information:
(1) The name and
				  address of the applicant.
(2) The
				  name and address of the contact person for the project.
(3) The proposed name and location of the
				  project.
(4) A brief description of
				  the proposed project, including the amount of capital expenditure, the type of
				  health service being proposed or a change in bed capacity involved in the
				  proposed project.
(5) The expected
				  date of project commencement and completion.
(6) The expected capital expenditure,
				  including capital leases or donations as defined in §
											401.15 (relating to Certificate of
				  Need application procedures and filing fees-statement of policy), and
				  anticipated source of project financing.
(7) A statement certifying that the data,
				  information and statements are factual to the best of the applicant's
				  knowledge, information and belief.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart D - Health Planning › Chapter 401 - CERTIFICATE OF NEED PROGRAM › Section 401.15 - Certificate of Need application procedures and filing fees

Current through Register Vol. 54, No. 28, July 13, 2024
(a) An application for a Certificate of Need
				  shall be submitted to the Department on application forms provided by the
				  Department. An applicant shall submit an original and one copy of the completed
				  application to the Department of Health, Division of Need Review, and one copy
				  of the completed application to the appropriate district office of the
				  Department. The copy supplied to the district office is for public review, and
				  copies of the application to persons other than the Department shall be
				  supplied by the applicant in accordance with subsection (o).
(b) An application for a Certificate of Need
				  will be accepted by the Department only on the first 5 business days of each
				  month. Applications received after the fifth day will be returned to the
				  applicant.
(c) Every person who
				  submits to the Department an application for a Certificate of Need shall also
				  file a nonrefundable fee as follows:
(1) For
				  each Certificate of Need application, filed under section 702(b) of the act
				  (35
				  P. S. §
												448.702(b)),
				  $500 plus $3 per $1,000 of proposed capital expenditure. The maximum
				  application fee may not exceed $20,000 for a single proposal.
(2) The letter of intent fee shall be
				  deducted from the required total application fee.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart D - Health Planning › Chapter 401 - CERTIFICATE OF NEED PROGRAM › Section 401.17 - Prohibited communications with the Department-statement of policy

Current through Register Vol. 54, No. 28, July 13, 2024
(a) After the
				  conclusion of a public meeting on a Certificate of Need application held under
				  section 704(b) of the act (35 P. S. §
											448.104(b)), there may be no
				  ex parte contacts with the Department.
(b) For purposes of this section, an ex parte
				  contact is communication between the following individuals and any member of
				  the Department exercising any responsibility for the applicant:
(1) The applicant for a Certificate of
				  Need.
(2) A person acting on behalf
				  of the applicant.
(3) A person who
				  supports or opposes the granting of a Certificate of Need.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart D - Health Planning › Chapter 401 - CERTIFICATE OF NEED PROGRAM › Section 401.18 - Hospital-based skilled nursing facilities-statement of policy

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The Department will apply the relevant
				  criteria contained in Chapter 14 of the State Health Services Plan (SHSP) in
				  the review of Certificate of Need applications to establish hospital-based
				  skilled nursing facilities.
(b) The
				  criteria to be applied will include the long-term care bed need projections
				  contained in Appendix 14-A to Chapter 14 of the SHSP and any updated revisions
				  to that Appendix. If a proposed hospital-based skilled nursing facility is
				  located in a county for which the number of licensed or approved long-term care
				  beds equals or exceeds the projected bed need, the Department will consider
				  approval of the application only if the applicant is able to demonstrate that
				  the approval is otherwise justified under the criteria contained in Chapter 14
				  of the SHSP.
(c) This section
				  applies to Certificate of Need applications for which a completion of
				  preliminary assessment has not been published in the
Pennsylvania
				  Bulletin
.
(d) This section
				  will remain in effect unless it is superseded by specific criteria in the SHSP
				  addressing the issue of bed need projections for hospital-based skilled nursing
				  facilities.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart E - Birth Centers › Chapter 501 - BIRTH CENTERS › GENERAL PROVISIONS › Section 501.1 - Legal base

Current through Register Vol. 54, No. 28, July 13, 2024
(a) This subpart is
					 promulgated by the Department under the powers granted and the duties mandated
					 by Chapter 8 of the Health Care Facilities Act (35 P. S. §§
												448.801a-448.820), and by section 2102(a) and
					 (g) of The Administrative Code of 1929 (71 P. S. §
												532(a) and (g)).
(b) The Department has the power and its duty
					 is to promulgate, after consultation with the Health Care Policy Board, the
					 rules and regulations necessary to carry out Chapter 8 of the Health Care
					 Facilities Act and to assure that the act is enforced.
(c) The purpose of this chapter is to protect
					 and promote the public health and welfare through the establishment and
					 enforcement of regulations setting minimum standards in the construction,
					 maintenance, and operation of health care facilities. The standards are
					 intended by the Department to assure safe, adequate, and efficient facilities
					 and services, and to promote the health, safety, and adequate care of the
					 patients or residents of the facilities. It is also the purpose of this chapter
					 to assure quality health care through appropriate and nonduplicative review and
					 inspection, with regard to the protection of the health and rights of privacy
					 of patients and without unreasonably interfering with the operation of the
					 health care facility.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart E - Birth Centers › Chapter 501 - BIRTH CENTERS › GENERAL PROVISIONS › Section 501.2 - Affected health care facilities

Current through Register Vol. 54, No. 28, July 13, 2024
(a) This
					 subpart shall apply to birth centers, profit or nonprofit, operated within this
					 Commonwealth.
(b) Existing
					 facilities or sections of facilities, which were being used as birth centers
					 prior to June 26, 1985, shall be required to meet the same standards as
					 facilities or sections constructed, converted or remodeled after June 26, 1985,
					 unless an exception is granted by the Department under §
											501.6 (relating to
					 exceptions).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart E - Birth Centers › Chapter 501 - BIRTH CENTERS › GENERAL PROVISIONS › Section 501.3 - Reports/contact person

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The facility
					 shall report regularly to the Department, on forms issued by the Department,
					 statistical information that the Department may request and shall comply with
					 the requirements for recordkeeping in §
											28.41 (relating to recordkeeping
					 requirements).
(b) Data that could
					 lead to the disclosure of the identity of individuals involved will be
					 considered confidential and may not be released without prior authorization of
					 the legal parent, guardian or newborn infant upon obtaining the age of
					 18.
(c) Questions concerning
					 reports required should be addressed to Director, Division of Primary Care and
					 Home Health Services, Department of Health, Post Office Box 90, Harrisburg,
					 Pennsylvania 17108.
The provisions of this §
													501.3 amended under section 16(a)
						  of the Disease Control and Prevention Act of 1955 (35 P. S. §
														521.16(a)); sections 2102(g)
						  and 2111(b) of The Administrative Code of 1929 (71 P. S. §§
														532(g) and
						  541(b)); and sections 3 and 5
						  of the Newborn Child Testing Act (35 P. S. §§
														623 and
						  625).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart E - Birth Centers › Chapter 501 - BIRTH CENTERS › GENERAL PROVISIONS › Section 501.4 - Regulations

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A current copy
					 of this subpart shall be maintained at the facility at all times.
(b) Facilities licensed under this subpart
					 shall comply with environmental, health, sanitation and professional licensure
					 standards which are required by Federal, State and local authorities. This
					 shall include, but not be limited to, standards promulgated by the State Boards
					 of Medicine, Nursing and Pharmacy (49 Pa. Code Chapters 16-18, 21 and 27), and
					 the Department of Environmental Resources (25 Pa. Code Chapters 221-235
					 (relating to radiological health)). Facilities shall also comply with Chapter 1
					 (relating to administration of vital records), Chapter 5 (relating to clinical
					 laboratories) and Chapter 27 (relating to communicable and noncommunicable
					 diseases).
(c) If there is a
					 difference in applicable State or local statutes, the standards established
					 under State statute shall apply for the purposes of compliance with this
					 subpart.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart E - Birth Centers › Chapter 501 - BIRTH CENTERS › GENERAL PROVISIONS › Section 501.5 - Inspections

Current through Register Vol. 54, No. 28, July 13, 2024
All areas of the facility shall be subject to inspection,
						at reasonable times, by authorized representatives of the Department.
						Inspections may be scheduled in advance or be unannounced.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart E - Birth Centers › Chapter 501 - BIRTH CENTERS › GENERAL PROVISIONS › Section 501.6 - Exceptions

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The Department
					 may, within its discretion and for good reason, grant an exception to the
					 standards when the policy objective of those standards is met in existing
					 facilities. The request for an exception shall be made in writing by the
					 facility.
(b) Exceptions will be
					 granted to the standards for physical plant and environment only if the
					 facility is unable to comply because of structural features, which preclude
					 modification, and if the rights, privacy, health and safety of the patients are
					 not jeopardized.
This section cited in 28 Pa. Code §
													501.2 (relating to affected health
						  care facilities); and 28 Pa. Code §
													501.81 (relating to safety from
						  fire).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart E - Birth Centers › Chapter 501 - BIRTH CENTERS › OWNERSHIP › Section 501.11 - General

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The owner of a
					 birth center may be an individual, partnership, association, corporation, or a
					 combination thereof. The following applies to facilities according to the mode
					 of ownership:
(1)
Individual
					 ownership.
A complete list of names and addresses of the persons in
					 charge shall be submitted with the application. When death occurs to a person
					 who was a sole owner of the facility, the executor or administrator of the
					 estate may apply for, and the Department may, after review, grant a license for
					 the facility.
(2)
Partnerships.
A complete list of names and addresses of the
					 persons in charge and all partners responsible for the management of the
					 facility shall be submitted with the application. When a license is issued to a
					 partnership and one or more of the partners dies, the executor or administrator
					 of the deceased's estate, together with the surviving partner, if any, may
					 apply for a license. After review, the Department may grant the
					 license.
(3)
Association or
					 corporation.
A complete list of names and addresses of the officers,
					 directors, principal stockholders, either beneficial or of record, of the
					 corporate owner and of the parent corporation, if applicable, and of the
					 persons in charge who are responsible for the management of the facility, shall
					 be submitted with the application.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart E - Birth Centers › Chapter 501 - BIRTH CENTERS › LICENSURE › Section 501.21 - Licensure process

Current through Register Vol. 54, No. 28, July 13, 2024
(a) An
					 application for license to operate a birth center shall be made under section
					 807 of the Health Care Facilities Act (35 P. S. §
												448.807).
(b) The application form for a license to
					 operate a birth center shall be obtained from the Department of Health,
					 Division of Primary Care and Home Health Services, P.O. Box 90, Harrisburg,
					 Pennsylvania 17108.
(c) Application
					 or renewal forms shall be accompanied by a fee of $50.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart E - Birth Centers › Chapter 501 - BIRTH CENTERS › LICENSURE › Section 501.22 - Issuance of license

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The
					 Department will grant a regular license to operate a birth center after a
					 survey conducted by the Department indicates that the applicant is in
					 substantial compliance with this subpart. The survey shall include an onsite
					 inspection and a review of written approvals by regulatory agencies responsible
					 for building, electric, fire, and environmental safety. New construction,
					 alterations, or renovations that provide space for patient services or rooms
					 shall not be used or occupied until authorization for the occupancy has been
					 received by the birth center from the Department.
(b) A regular license issued by the
					 Department shall expire 1 year from the date of issue. A regular license is
					 issued when, in the judgment of the Department, there is substantial compliance
					 with all applicable regulations.
(c) A provisional license is issued when
					 there are multiple minor deficiencies or a serious specific deficiency, which
					 indicates that the facility is not in compliance with applicable statutes,
					 ordinances, or rules, and the Department finds all of the following:
(1) The applicant is taking appropriate steps
					 to correct the deficiencies in accordance with a timetable submitted by the
					 applicant and agreed upon by the Department.
(2) There is no pattern of deficiencies over
					 a period of 2 or more years.
(3)
					 There is no danger to the health or safety of the patients of the facility or
					 newborn infants.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart E - Birth Centers › Chapter 501 - BIRTH CENTERS › LICENSURE › Section 501.23 - Responsibility of facility owners

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
					 The owner shall be responsible for meeting the minimum standards for the
					 operation of a birth center, as set forth by the Department, and by other State
					 and local agencies responsible for the health, welfare, and safety of the
					 patients therein.
(b) When services
					 for the administration or management of the facility are purchased, the owner
					 shall be responsible for insuring compliance with this title, as well as those
					 of other appropriate agencies.
(c)
					 The owner, or person in charge, shall immediately report, by telephone to the
					 Department and by a written follow-up report as soon as possible, any
					 catastrophic incident, such as fire or flood, or any incident which may cause
					 interruption or cessation of the delivery of services, or another interruption
					 of services which would affect the health and safety of either the patient or
					 newborn infant.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart E - Birth Centers › Chapter 501 - BIRTH CENTERS › LICENSURE › Section 501.24 - Restrictions on a license

Current through Register Vol. 54, No. 28, July 13, 2024
The Department may refuse to renew a license, or may
						suspend, revoke, or limit a license of a birth center or may suspend admissions
						for any of the following reasons:
(1)
					 A serious violation of this subpart, or of the Health Care Facilities Act
					 (35
					 P. S. §§
												448.101-448.904), or of
					 other statutes, which seriously threatens the health, safety, and welfare of
					 patients.
(2) Failure of an owner
					 to submit a reasonable timetable for correction of deficiencies.
(3) The existence of a cyclical pattern of
					 deficiencies that extends over a period of 2 or more years.
(4) Failure, by the holder of a provisional
					 license, to correct deficiencies in accordance with a timetable submitted by
					 the applicant and agreed upon by the Department.
(5) Fraud or deceit in obtaining, or
					 attempting to obtain, a license.
(6) Lending, borrowing, or using the license
					 of another, or in knowingly aiding or abetting the improper granting of a
					 license.
(7) Incompetence,
					 negligence, or misconduct in operating the birth center or in providing
					 services to individuals.
(8)
					 Mistreating or abusing individuals cared for by the birth center.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart E - Birth Centers › Chapter 501 - BIRTH CENTERS › ORGANIZATION › Section 501.31 - General

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The birth
					 center shall develop a written table of organization, which shall be available
					 at the birth center at all times.
(b) The table of organization shall identify
					 a governing body, which has full authority and responsibility for the operation
					 of the birth center.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart E - Birth Centers › Chapter 501 - BIRTH CENTERS › ORGANIZATION › Section 501.32 - Governing body

Current through Register Vol. 54, No. 28, July 13, 2024
The governing body shall be responsible for all of the
						following:
(1) Developing, adopting
					 and enforcing rules and regulations relative to:
(i) The assurance of a safe and
					 professionally acceptable level of comprehensive care at the birth
					 center.
(ii) Protection of personal
					 and property rights of the patient, newborn infant, and support
					 persons.
(iii) The general
					 operation of the birth center.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart E - Birth Centers › Chapter 501 - BIRTH CENTERS › MANAGEMENT › Section 501.41 - Personnel policies

Current through Register Vol. 54, No. 28, July 13, 2024
(a) Personnel
					 policies shall be reviewed, revised, and approved by the governing body
					 periodically, but no less often than once every 2 years.
(b) An individual personnel record shall be
					 maintained for each person employed by the birth center which shall include,
					 but not be limited to, the following:
(1) A
					 current job description for each person, which is reviewed and revised as
					 needed.
(2) Evidence of a
					 pre-employment examination, which shall include the results of a rubella
					 antibody titer, a tuberculin skin test, and, if indicated, a chest
					 x-ray.
(3) Evidence of the
					 education, training, and experience of the individual, in addition to a copy of
					 the current appropriate license or certification credentials, or
					 both.
(4) Records which reflect the
					 orientation, in-service, and out-service educational program of the birth
					 center.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart E - Birth Centers › Chapter 501 - BIRTH CENTERS › MANAGEMENT › Section 501.42 - Use of outside resources

Current through Register Vol. 54, No. 28, July 13, 2024
If the facility does not employ a qualified professional
						for a specific service to be provided by the birth center, the governing body
						shall make arrangements and approve each written policy and procedure for
						services provided by the use of outside resources.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart E - Birth Centers › Chapter 501 - BIRTH CENTERS › MANAGEMENT › Section 501.43 - Agreements

Current through Register Vol. 54, No. 28, July 13, 2024
The governing body, through the person in charge of the
						birth center, shall assume full responsibility for the initiation and
						maintenance of current contracts or agreements.
This section cited in 28 Pa. Code §
													501.75 (relating to laboratory
						  services).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart E - Birth Centers › Chapter 501 - BIRTH CENTERS › MANAGEMENT › Section 501.44 - Transfer agreement with physicians

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The birth center shall have a written
					 transfer agreement with physicians who have admitting privileges to a hospital
					 obstetric/newborn service for the mother and infant when complications or
					 emergencies arise.
(b) The terms of
					 the transfer agreement shall include, but not be limited to, the following:
(1) That the medical necessity for transfer
					 is based upon criteria developed by Director of Midwifery Services and
					 Physician Director of Medical Affairs. The criteria shall be reviewed, revised,
					 and approved annually by the governing body.
(2) In the case of a newborn infant transfer,
					 that a transfer incubator must be available.
(3) That a complete health record, relating
					 to the mother or newborn infant, shall be provided at the time of the transfer
					 to the support person, or authorized individual, for hospital use.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart E - Birth Centers › Chapter 501 - BIRTH CENTERS › MANAGEMENT › Section 501.45 - Emergency transportation agreement

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The birth center shall have a written
					 agreement for emergency transportation of the mother or newborn infant which
					 includes, but is not limited to, the following:
(1) That the transportation service shall
					 provide the birth center information relative to the service's emergency
					 medical service certification status.
(2) The types of services that are to be
					 provided.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart E - Birth Centers › Chapter 501 - BIRTH CENTERS › MANAGEMENT › Section 501.46 - Patient's rights

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The birth
					 center shall have written policies and procedures to assure the individual
					 mother the right to dignity, privacy, and safety and shall include, but not be
					 limited to, the items listed in subsection (b). The policies and procedures
					 shall be developed by the Physician Director of Medical Affairs and Director of
					 Midwifery Services and approved by the governing body. The policies shall be
					 reviewed, revised, and approved anually by the governing body.
(b) It is the right of every mother, or
					 support person, to expect and receive:
(1)
					 Good quality care and high professional standards that are continually
					 maintained and reviewed.
(2)
					 Answers to questions, regarding services and treatment, and the names and
					 functions of the staff person providing services.
(3) Confidentiality, anonymity, and
					 privacy.
(4) Respectful and
					 dignified treatment at all times.
(5) Information regarding cost and counseling
					 on the availability of known financial resources to the service being
					 rendered.
(6) Disclosure and
					 discussion of the nature, purposes, expected effects, and results of the
					 medical treatment under consideration, prior to signing an informed
					 consent.
(7) Control over the
					 release of her health record information. Except in an emergency, a written
					 release, signed by the mother, shall be required, prior to the release of
					 health record information, except as otherwise provided by law or third party
					 contractual arrangements.
(8)
					 Availability of, or actual contact with, a physician, midwife, or registered
					 nurse on a 24 hour per day, 7 day per week basis, as established by the written
					 policies of the birth center.
(9)
					 The right to refuse treatment, at any time, after treatment has
					 begun.
(10) Full information on the
					 medical consequences of refusal of treatment.
(11) A copy of the center's rules that apply
					 to conduct as a mother, spouse, and support person.
(12) A written set of the rights guaranteed
					 by this subpart and by the birth center.
(13) Treatment without discrimination based
					 upon race, color, religion, sex, sexual preference, national origin, or source
					 of payment.
(14) The right to
					 review, or obtain, a copy of the mother's medical records.
(15) The right to expect emergency procedures
					 to be implemented without unnecessary delay.
(16) Full information of the mother's and
					 newborn infant's continuing health care requirements, following discharge and
					 the means for meeting them.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart E - Birth Centers › Chapter 501 - BIRTH CENTERS › MANAGEMENT › Section 501.48 - Birth center policies and procedures

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The birth center policies and procedures
					 shall include but not be limited to the following:
(1) A philosophy of care for the birth
					 center.
(2) Standards, policies and
					 procedures for providing safe and appropriate plans of care to meet the needs
					 of each mother, her family, and her newborn infant. These shall be in keeping
					 with current professional standards for uncomplicated pregnancy, intrapartal
					 care, postpartal care, and newborn care and shall include the following:
(i) Written criteria for the admission of
					 only uncomplicated pregnancies into the birth center system of care.
(ii) Written screening, protocol, and health
					 records which identify high risk and potentially high risk individuals, which
					 shall exclude them from birth center care.
(iii) Written protocols for referral of high
					 risk pregnant women and newborns to appropriate providers of obstetrical and
					 newborn care.
(iv) Program to
					 prevent isoimmunization of Rh-negative mothers and neonatal disease due to Rh
					 incompatibilities.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart E - Birth Centers › Chapter 501 - BIRTH CENTERS › HEALTH RECORDS › Section 501.61 - General

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The birth
					 center, in establishing its policy and procedures for a system of health record
					 keeping, shall take into consideration professional standards and practices
					 appropriate to primary care of the patient and newborn infant as established by
					 the American College of Obstetricians and Gynecologists, 600 Maryland Avenue,
					 SW, Suite 300 East, Washington, DC 20024; American College of Nurse-Midwives,
					 1522 K Street, N.W., Suite 1120, Washington, DC 20005; American Academy of
					 Pediatrics, P.O. Box 1034, 1801 Hinman Avenue, Evanston, Illinois 60204; and
					 other professional standards and practices approved by the Department. The
					 policy and procedures shall be approved by the governing body, at the
					 recommendation of the Physician Director of Medical Affairs, and by the
					 Director of Midwifery Services.
(b)
					 An individual shall be designated who shall have the responsibility for
					 maintaining health record files and developing statistical reports.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart E - Birth Centers › Chapter 501 - BIRTH CENTERS › HEALTH RECORDS › Section 501.62 - Health record transfer, retention and confidentiality

Current through Register Vol. 54, No. 28, July 13, 2024
(a) In the event a referral or transfer to
					 another level of care provider is needed during pregnancy, delivery or
					 post-delivery period, the patient's record, or a complete copy of the record,
					 shall accompany the mother or newborn infant at the time of transfer.
(b) The birth center shall comply with the
					 act of April 29, 1925 (P. L. 358, No. 209) (35 P. S. §§
												351 and
					 352), regarding footprinting
					 and infant identification.
(c)
					 Health records shall be retained by the birth center for the mother and newborn
					 infant, as recommended by the Department for outpatient facilities, as follows:
(1) The mother's entire record shall be
					 retained for 7 years after discharge and date of last entry.
(2) The newborn infant's entire record shall
					 be retained for 7 years after the child reaches 18 years of age.
(3) Health records shall be stored to provide
					 protection from loss, damage, or unauthorized access.
(4) A written authorization for release of
					 health record information, outside the birth center, shall be signed by the
					 mother, prior to the release of health record information.
(5) In the event of a request for newborn
					 infant health record information, authorization shall be signed by the legal
					 parent or guardian except that, if the newborn infant has reached 18 years of
					 age, or is otherwise legally emancipated, the written authorization shall be
					 granted by the person.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart E - Birth Centers › Chapter 501 - BIRTH CENTERS › HEALTH RECORDS › Section 501.63 - Birth certificate

Current through Register Vol. 54, No. 28, July 13, 2024
A certificate of birth shall be filed for each birth,
						within 10 days of the birth, with the local registrar of vital statistics, in
						the district where the birth occurs, under Chapter 1 (relating to
						administration of vital records).