reglab/statecodes huggingface dataset:
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 29 - MISCELLANEOUS HEALTH PROVISIONS › Subchapter C - TESTING OF BLOOD SPECIMENS TAKEN FROM DEAD BODIES › Section 29.22 - Submission of blood specimens

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
				  Blood specimens shall be mailed as soon as possible to the Department of Health
				  or to another laboratory approved by the Department.
(b) Coroners, medical examiners or their
				  authorized agents shall provide information which is requested by the
				  Department of Health as pertains to any of the following:
(1) The identity, age, sex and race of the
				  deceased, as well as whether the deceased was a driver or pedestrian.
(2) The circumstances of the accident with
				  respect to location, date and time of the accident, and date and time of
				  death.
(3) The circumstances
				  surrounding the collection of the blood specimen with respect to the date and
				  time the sample was taken.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 29 - MISCELLANEOUS HEALTH PROVISIONS › Subchapter D - AMBULATORY GYNECOLOGICAL SURGERY IN HOSPITALS AND CLINICS › Section 29.32 - Scope

Current through Register Vol. 54, No. 28, July 13, 2024
This subchapter applies to the provision of an abortion in
					 a medical facility.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 29 - MISCELLANEOUS HEALTH PROVISIONS › Subchapter D - AMBULATORY GYNECOLOGICAL SURGERY IN HOSPITALS AND CLINICS › Section 29.33 - Requirements for abortion

Current through Register Vol. 54, No. 28, July 13, 2024
Every medical facility shall meet the following
					 requirements with respect to the provision of abortions:
(1) Each medical facility shall have readily
				  available equipment and drugs necessary for resuscitation. If local anesthesia
				  is utilized to perform an abortion in a medical facility during the first
				  trimester, then the following equipment shall be ready to use for resuscitative
				  purposes:
(i) Suction source.
(ii) Oxygen source.
(iii) Assorted size oral airways and
				  endotracheal tubes.
(iv)
				  Laryngoscope.
(v) Bag and mask and
				  bag and endotracheal tube attachments for assisted ventilation.
(vi) Intravenous fluids including blood
				  volume expanders.
(vii) Intravenous
				  catheters and cut-down instrument tray.
(viii) Emergency drugs for shock and
				  metabolic imbalance.
(ix) An
				  individual to monitor respiratory rate, blood pressure and heart
				  rate.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 29 - MISCELLANEOUS HEALTH PROVISIONS › Subchapter D - AMBULATORY GYNECOLOGICAL SURGERY IN HOSPITALS AND CLINICS › Section 29.34 - Abortions not permitted on an ambulatory basis

Current through Register Vol. 54, No. 28, July 13, 2024
All abortions subsequent to the first trimester of
					 pregnancy shall be performed, induced, and completed in a hospital which
					 maintains an obstetrical service in accordance with Chapter 137 (relating to
					 obstetrical services).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 29 - MISCELLANEOUS HEALTH PROVISIONS › Subchapter D - AMBULATORY GYNECOLOGICAL SURGERY IN HOSPITALS AND CLINICS › Section 29.36 - Medical consultation and judgment

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
Abortion prohibited;
				  exceptions.
An abortion may not be performed except by a physician
				  after either one of the following:
(1) He
				  determines that, in his best clinical judgment, the abortion is
				  necessary.
(2) He receives what he
				  reasonably believes to be a written statement signed by another physician,
				  hereinafter called the referring physician, certifying that in this referring
				  physician's best clinical judgment the abortion is
				  necessary.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 29 - MISCELLANEOUS HEALTH PROVISIONS › Subchapter D - AMBULATORY GYNECOLOGICAL SURGERY IN HOSPITALS AND CLINICS › Section 29.37 - Informed consent

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
Rule.
No abortion shall be performed or induced except with
				  the voluntary and informed consent of the woman upon whom the abortion is to be
				  performed or induced.
(b)
Consent.
Except in the case of a medical emergency, consent to
				  an abortion is voluntary and informed if and only if:
(1) The woman is provided, at least 24 hours
				  before the abortion, with the following information by the physician who is to
				  perform the abortion or by the referring physician, but not by the agent or
				  representative of either:
(i) The name of the
				  physician who will perform the abortion.
(ii) The fact that there may be detrimental
				  physical and psychological effects which are not accurately
				  foreseeable.
(iii) The particular
				  medical risks associated with the particular abortion procedure to be employed
				  including, when medically accurate, the risks of infection, hemorrhage, danger
				  to subsequent pregnancies and infertility.
(iv) The probable gestational age of the
				  unborn child at the time the abortion is to be performed.
(v) The medical risks associated with
				  carrying her child to term.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 29 - MISCELLANEOUS HEALTH PROVISIONS › Subchapter D - AMBULATORY GYNECOLOGICAL SURGERY IN HOSPITALS AND CLINICS › Section 29.38 - Reports

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The following
				  information is to be sent to the Department according to the specified time
				  frames on forms prescribed by it:
(1)
Facility information.
(i)
				  Within 30 days of the effective date of this subchapter, every facility at
				  which abortions are performed shall file, and update immediately upon any
				  change, a report with the Department, which shall be open to public inspection
				  and copying, containing the following information:
(A) Name, mailing address, and county of
				  location of the facility.
(B) Name
				  and address of any parent, subsidiary or affiliated organizations,
				  corporations, or associations.
(C)
				  Name and address of any parent, subsidiary or affiliated organizations,
				  corporations or associations having contemporaneous commonality of ownership,
				  beneficial interest, directorship or officership with any other
				  facility.
(D) Date form
				  submitted.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 29 - MISCELLANEOUS HEALTH PROVISIONS › Subchapter D - AMBULATORY GYNECOLOGICAL SURGERY IN HOSPITALS AND CLINICS › Section 29.39 - Penalties

Current through Register Vol. 54, No. 28, July 13, 2024
(a) Any person who
				  willfully delivers or discloses to the Department any report, record or
				  information known by him to be false commits a misdemeanor of the first
				  degree.
(b) In addition to the
				  provisions of subsection (a), any person, organization or facility who
				  willfully violates §
										29.38 (relating to reports) shall
				  upon conviction thereof:
(1) For the first
				  time, have its license suspended for a period of 6 months.
(2) For the second time, have its license
				  suspended for a period of 1 year.
(3) For the third time, have its license
				  revoked.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 29 - MISCELLANEOUS HEALTH PROVISIONS › Subchapter D - AMBULATORY GYNECOLOGICAL SURGERY IN HOSPITALS AND CLINICS › Section 29.40 - Prohibited acts

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
Payment
				  for abortion.
Except in the case of a pregnancy which is not yet
				  clinically diagnosable, any person who intends to perform or induce abortion
				  shall, before accepting payment therefor, make or obtain a determination that
				  the woman is pregnant. Any person who intentionally or knowingly accepts such a
				  payment without first making or obtaining such a determination commits a
				  misdemeanor of the second degree. A person commits a misdemeanor of the second
				  degree if such person makes such a determination erroneously either knowing
				  that it is erroneous or with reckless disregard or negligence as to whether it
				  is erroneous and either:
(1) Thereupon or
				  thereafter intentionally relies upon that determination in soliciting or
				  obtaining any such payment; or
(2)
				  Intentionally conveys that determination to any person or with knowledge that
				  or with reckless disregard as to whether that determination will be relied upon
				  in any solicitation or obtaining of any such payment.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 29 - MISCELLANEOUS HEALTH PROVISIONS › Subchapter D - AMBULATORY GYNECOLOGICAL SURGERY IN HOSPITALS AND CLINICS › Section 29.41 - Fetal experimentation

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
Unborn or live child.
Any person who knowingly performs any
				  type of nontherapeutic experimentation upon any unborn child or upon any child
				  born alive during the course of an abortion commits a felony of the third
				  degree. "Nontherapeutic" means that which is not intended to preserve the
				  child's life or health.
(b)
Dead child.
Experimentation upon children who have died during
				  the course of an abortion may be conducted only upon the written consent of the
				  mother provided that no consideration for such consent is offered or given. Any
				  person who knowingly violates this section commits a misdemeanor of the first
				  degree.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 29 - MISCELLANEOUS HEALTH PROVISIONS › Subchapter D - AMBULATORY GYNECOLOGICAL SURGERY IN HOSPITALS AND CLINICS › Section 29.42 - Exceptions

Current through Register Vol. 54, No. 28, July 13, 2024
The Department may grant an exception to any of the
					 requirements of this subchapter for good cause shown, excepting statutory
					 requirements.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 29 - MISCELLANEOUS HEALTH PROVISIONS › Subchapter D - AMBULATORY GYNECOLOGICAL SURGERY IN HOSPITALS AND CLINICS › Section 29.43 - Facility approval

Current through Register Vol. 54, No. 28, July 13, 2024
(a) Every
				  medical facility which performs abortions within this Commonwealth shall be
				  approved by the Department.
(b) All
				  medical facilities except hospitals may become approved facilities upon
				  submission of an application to the Department from a person authorized to
				  represent such facility and, at the discretion of the Department, satisfactory
				  completion of an onsite survey.
(c)
				  Every hospital licensed or approved by the Department, which has filed with the
				  Department the Abortion Facility Registration form, and which meets the
				  standards set forth in this title, will be deemed to be an approved facility by
				  virtue of its hospital license or approval, unless it has a stated ethical
				  policy to the contrary promulgated in accordance with section
				  5.2 of the Pennsylvania Human
				  Relations Act (43 P. S. §
											955.2) and 16 Pa. Code Part II Subpart A
				  (relating to Human Relations Commission).
(d) Notwithstanding this section, facility
				  approval for performance of abortions may be revoked if this subchapter is not
				  adhered to.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 30 - BLOOD BANKS › GENERAL PROVISIONS › Section 30.1 - Definitions

Current through Register Vol. 54, No. 28, July 13, 2024
The following words and terms, when used in this chapter,
					 have the following meanings, unless the context clearly indicates
					 otherwise:
Act
-The Pennsylvania Blood Bank Act
					 (35
					 P. S. §§
											6501-6523).
Blood bank
-Any place, organization,
					 institution or establishment that is operated wholly or in part for the purpose
					 of obtaining, collecting, storing, processing, preparing for transfusing, or
					 selling human blood or parts or fractions of single blood units or products
					 derived from single blood units, including pools of such single units, whether
					 such procedures are done for direct therapeutic use or for storage for future
					 therapeutic or diagnostic use of such products and whether a place,
					 organization, institution, or establishment is operated on a charitable,
					 commercial, or nonprofit basis.
Blood product
-Any part or fraction of
					 single units of whole human blood, including pools of such single units, or any
					 material derived from single units, including pools of such single units, of
					 such blood which is subsequently prepared for the purpose of administration to
					 human subjects.
Collection
-The obtaining of human blood by
					 the bleeding of donors by a phlebotomy or plasmapheresis.
Department
-The Department of Health of the
					 Commonwealth.
Distribution
-The removal of blood and
					 blood products from a blood bank to any other location for processing or
					 storage for the purpose of providing the blood for diagnostic, therapeutic, or
					 prophylactic purposes.
Licensee
-A person holding a license under
					 the provisions of the act and this chapter.
Person
-Any natural person, partnership,
					 association, corporation, institution, agency, or other similar entity.
Processing
-The standard technical
					 procedures used to prepare blood and blood products, methods of identification,
					 tests for suitability for intended purpose, and performance of tests for
					 communicable diseases.
Screening of donors
-The evaluation of
					 prospective donors by the blood bank to determine the acceptability of the
					 donor by evaluating his past medical history, his present state of health, and
					 laboratory studies.
Secretary
-The Secretary of the
					 Department.
Storage
-The holding of blood and blood
					 products for subsequent distribution and use.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 30 - BLOOD BANKS › GENERAL PROVISIONS › Section 30.2 - Applicability and exemptions

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
				  Except as otherwise provided, this chapter applies to all blood banks operating
				  in this Commonwealth.
(b) The
				  provisions of this chapter shall not apply to blood banks operated by the
				  Federal government, nor to any blood bank operated purely for research and
				  teaching purposes, provided blood or blood products from such research or
				  teaching are not injected into humans.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 30 - BLOOD BANKS › LICENSING, FEES AND INSPECTIONS › Section 30.10 - Licensing

Current through Register Vol. 54, No. 28, July 13, 2024
(a) Any person
				  operating a blood bank in this Commonwealth shall be required to obtain a
				  license in accordance with the provisions of this chapter.
(b) A license is valid for 1 year after
				  issuance and shall be renewed on an annual basis.
(c) A blood bank participating in an
				  inspection and evaluation program other than that of the Department shall be
				  required to remit a fee of $50 per annum, payable to the Department. For all
				  blood banks participating in the inspection and evaluation program of the
				  Department, the fee shall be $200 per annum. A separate fee shall be charged
				  for each permanent blood bank location.
(d) The application for license shall contain
				  the following information:
(1) Name and
				  location of blood bank.
(2) Name
				  and address of person owning the blood bank.
(3) Name and address of person operating the
				  blood bank.
(4) Name, education and
				  experience of all persons having directoral, supervisory or technical duties in
				  the blood bank.
(5) Description of
				  physical facilities and equipment.
(6) Sources of materials and methods of
				  storage and distribution of products.
(7) Description of technical
				  procedures.
(8) Current blood bank
				  licenses, approvals and certifications.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 30 - BLOOD BANKS › LICENSING, FEES AND INSPECTIONS › Section 30.11 - Inspection and evaluation of blood banks

Current through Register Vol. 54, No. 28, July 13, 2024
(a) At least once each year, the blood bank
				  will be inspected and evaluated by a representative of the
				  Department.
(b) The Department may
				  accept the inspection and evaluation of a private or Federal agency. The record
				  of the inspection and evaluation must be made available in its entirety to the
				  Department.
(c) The Department may
				  inspect the blood bank at any time other than at routine annual
				  inspections.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 30 - BLOOD BANKS › LICENSING, FEES AND INSPECTIONS › Section 30.20 - Personnel

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
Required staff.
Each blood bank shall have a blood bank
				  director, medical director, and supervisor. The medical director may also serve
				  as the blood bank director and supervisor.
(b)
Qualifications of medical
				  director.
The medical director must be a physician, licensed to
				  practice in this Commonwealth, with at least 4 years full time postdoctoral
				  clinical laboratory training which includes blood banking and related subjects
				  acceptable to the Department or certified in blood banking by the American
				  Board of Pathology.
(c)
Qualifications of a blood bank director.
A person may not be a
				  director of a blood bank unless the person conforms with one of the following
				  requirements:
(1) The person shall hold a
				  doctoral degree in medicine, osteopathy, or one of the biological sciences, and
				  shall have at least 2 years full time postdoctoral training and experience in
				  blood bank operations and related subjects, acceptable to the
				  Department.
(2) The person shall
				  hold an M.A. or M.S. degree from an accredited institution with a major in
				  medical technology or one of the biological sciences or Blood Bank certificates
				  SBB (ASCP), and shall have at least 4 years' experience in blood bank
				  operations and related subjects, acceptable to the Department.
(3) The person shall hold a baccalaureate
				  degree in medical technology or one of the biological sciences and shall have
				  at least 6 years' experience in blood bank operations and related subjects,
				  acceptable to the Department.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 30 - BLOOD BANKS › LICENSING, FEES AND INSPECTIONS › Section 30.21 - Responsibilities of directors and supervisor

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The medical director shall be responsible
				  for determining and establishing policies and procedures governing all phases
				  of blood banking. The licensee is obliged to demonstrate that the medical
				  director spends sufficient time on the premises to fulfill the requirements of
				  this section.
(b) The blood bank
				  director shall be responsible, under the direction of the medical director, for
				  implementing policies and procedures governing all phases of blood
				  banking.
(c) The supervisor shall
				  be responsible, under the direction of the medical director and blood bank
				  director, for application of policies and procedures governing all phases of
				  blood banking. Depending upon the size and complexity of the establishment,
				  there may be more than one level of technical and nursing
				  supervisors.
(d) Any procedures
				  involving the service of transfusing or injecting of blood products into humans
				  must be under the supervision of the medical director.
(e) The supervisor must be present during the
				  normal working hours of the blood bank, including mobile units.
(f) The medical director or properly
				  qualified designee must be available for consultation at all times outside of
				  regular working hours.
(g) Any time
				  blood is being obtained from a human donor, a physician who is licensed to
				  practice medicine in this Commonwealth shall be available within ten to 15
				  minutes so as to be able to handle emergencies which may arise.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 30 - BLOOD BANKS › LICENSING, FEES AND INSPECTIONS › Section 30.32 - Quality control and proficiency evaluation of testing procedures

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The blood bank
				  shall participate in a continuing proficiency testing program for blood bank
				  laboratory procedures. Private agency programs, or those provided by
				  governmental agencies, shall be used, together with any additional requirements
				  stipulated by the Department. All proficiency evaluation programs will be
				  approved by the Department.
(b) A
				  continuing internal program of quality control shall be maintained by each
				  blood bank to include reagents, equipment, records, and personnel.
(c) All laboratory procedures used in a blood
				  bank shall meet or exceed the standards of The Clinical Laboratory Act of 1951
				  (35
				  P. S. §§
											2151-2164), and
				  regulations promulgated pursuant thereto, and shall be in compliance with
				  applicable Federal regulations.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 30 - BLOOD BANKS › PHYSICAL FACILITIES AND RECORDS › Section 30.40 - Facilities

Current through Register Vol. 54, No. 28, July 13, 2024
The premises and equipment used by any blood bank shall
					 meet the following minimum requirements:
(1) Provide adequate space for the following:
(i) Private and accurate examinations of
				  individuals to determine their suitability as blood donors.
(ii) The withdrawal of blood from donors with
				  minimal risk of contamination and equipment unrelated to blood
				  collection.
(iii) The storage of
				  blood or blood components pending completion of tests.
(iv) The quarantine storage of blood or blood
				  components in a designated location pending repetition of those tests that
				  initially gave questionable serological results.
(v) The storage of finished products prior to
				  distribution.
(vi) The quarantine
				  storage, handling, and disposition of products and reagents not suitable for
				  use.
(vii) The orderly collection,
				  processing, compatibility testing, storage and distribution of blood and blood
				  components to prevent contamination.
(viii) The adequate and proper performance of
				  all steps in plasmapheresis and leukapheresis procedures.
(ix) The orderly conduction of all packaging,
				  labeling and other finishing operations.
(x) Provide adequate lighting, ventilation
				  and screening of open windows and doors.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 30 - BLOOD BANKS › PHYSICAL FACILITIES AND RECORDS › Section 30.41 - Records

Current through Register Vol. 54, No. 28, July 13, 2024
All licensed blood banks shall maintain records which are
					 adequate to identify all data pertinent to donors, handling and testing of
					 units of blood, disposition of blood from the blood bank, and related
					 information. Records should enable tracing of all units from donor bleeding to
					 final disposition. The records shall include the following:
(1) Donor history, physical examination, any
				  reactions, and results of laboratory tests, including a test for
				  hepatitis-associated antigen. Authorization for bleeding and identification of
				  person taking history and performing the phlebotomy must also be
				  included.
(2) Results of all tests
				  performed on each unit of blood.
(3) Requests for transfusion of blood or
				  blood products, including the full name of the recipient, hospital
				  identification number, sex, amount of blood product required, and the name of
				  the requesting physician.
(4)
				  Disposition of all blood not used for transfusion, including persons or
				  organizations receiving such material, dates, and amounts of the
				  material.
(5) Disposition of all
				  units of blood which are found to contain hepatitis-associated antigen or other
				  contaminants.
(6) Record of
				  transfusions.
(7) Records of
				  adverse reactions to transfusions and subsequent investigations.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 30 - BLOOD BANKS › PHYSICAL FACILITIES AND RECORDS › Section 30.42 - Registry of hepatitis cases

Current through Register Vol. 54, No. 28, July 13, 2024
(a) All
				  licensed blood banks shall submit the following information on or before the
				  15th day of each month to the Bureau of Laboratories of the Department.
(1) Identification of all donors whose blood
				  indicates, by a test approved by the Department, the presence of (HBsAg)
				  hepatitis antigen. The identification shall include the name, address and age
				  of donor, and date and place of bleeding and testing.
(2) Names of all donors whose blood was
				  transfused into a recipient who subsequently developed hepatitis. Any related
				  information requested by the Department shall also be supplied. Suitable forms
				  for this purpose will be furnished by the Department.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 30 - BLOOD BANKS › COMPLIANCE WITH FEDERAL LAWS › Section 30.50 - Plasmapheresis laboratories

Current through Register Vol. 54, No. 28, July 13, 2024
Plasmapheresis laboratories shall be in compliance with all
					 requirements of the applicable Federal Food and Drug Administration
					 Regulations.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 30 - BLOOD BANKS › COMPLIANCE WITH FEDERAL LAWS › Section 30.51 - Manufacture of blood products

Current through Register Vol. 54, No. 28, July 13, 2024
Persons and organizations engaged in the preparation of
					 blood fractions or products for subsequent distribution shall show evidence of
					 compliance with all requirements of the United States Public Health Service and
					 applicable Federal and state regulations. Appropriate records of manufacturing
					 procedures shall be provided to the Department upon request.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 30 - BLOOD BANKS › COMPLIANCE WITH FEDERAL LAWS › Section 30.52 - Compliance with other laws

Current through Register Vol. 54, No. 28, July 13, 2024
Blood banks licensed under this chapter shall be required
					 to comply with all pertinent laws and regulations administered by the Federal
					 Food and Drug Administration and any other Federal agency which regulates blood
					 banks and transfusion services, and with The Controlled Substance, Drug, Device
					 and Cosmetic Act (35 P. S. §§
											780-101-780-144), and regulations issued
					 thereunder.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 30 - BLOOD BANKS › PROCEDURE › Section 30.60 - Hearings and appeals

Current through Register Vol. 54, No. 28, July 13, 2024
If a license is denied or revoked, the applicant or holder
					 of such license shall be entitled to the rights of notification hearings and
					 appeals provided for in section 17 of the Pennsylvania Blood Bank Act
					 (35
					 P. S. §
											6517), and the Administrative
					 Agency Law (71 P. S. §§
											1710.1-1710.51) (Repealed), and all the
					 regulations promulgated pursuant to them. The notification provided by section
					 17 of the Pennsylvania Blood Bank Act shall constitute an order to show cause
					 within the meaning of 1 Pa. Code §
										35.14 (relating to orders to show
					 cause).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart A - General Provisions › Chapter 51 - GENERAL INFORMATION › GENERAL PROVISIONS › Section 51.1 - Legal base, scope and definitions

Current through Register Vol. 54, No. 28, July 13, 2024
(a) This
					 subpart implements the act.
(b)
					 This subpart contains standards which are applicable to all entities licensed
					 as health care facilities under the act. It also identifies specific health
					 care services which are restricted to specified health care
					 facilities.
(c) The following words
					 and terms, when used in this subpart have the following meanings, unless the
					 context clearly indicates otherwise:
Act
-The Health Care Facilities Act
						(35
						P.S. §§
													448.101-448.904b.
Department
-The Department of Health of
						the Commonwealth.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart A - General Provisions › Chapter 51 - GENERAL INFORMATION › GENERAL PROVISIONS › Section 51.1a - Clarification of nursing qualifications- statement of policy

Current through Register Vol. 54, No. 28, July 13, 2024
For the purposes of applying statutory and regulatory
						nursing standards and qualifications in this Commonwealth, the following
						applies:
(1) For a licensed practical
					 nurse, the term includes an individual licensed under the laws of this
					 Commonwealth to practice practical nursing or an individual who holds a
					 privilege to practice as a practical nurse under the Nurse Licensure Compact
					 Act (35 P.S. §§
												10291-10295).
(2) For a registered nurse, the term includes
					 an individual licensed under the laws of this Commonwealth to practice
					 professional nursing or an individual who holds a privilege to practice as a
					 registered nurse under the Nurse Licensure Compact Act.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart A - General Provisions › Chapter 51 - GENERAL INFORMATION › GENERAL PROVISIONS › Section 51.2 - Licensed facilities

Current through Register Vol. 54, No. 28, July 13, 2024
The Department licenses the following health care
						facilities under the act:
(1)
					 Ambulatory surgical facilities.
(2)
					 General hospitals.
(3) Special
					 hospitals.
(4) Long-term care
					 nursing facilities.
(5) Birth
					 centers.
(6) Home health care
					 agencies.
(7) Cancer treatment
					 centers.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart A - General Provisions › Chapter 51 - GENERAL INFORMATION › GENERAL PROVISIONS › Section 51.4 - Change in ownership; change in management

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A health care facility shall notify the
					 Department in writing at least 30 days prior to transfer involving 5% or more
					 of the stock or equity of the health care facility.
(b) A health care facility shall notify the
					 Department in writing at least 30 days prior to a change in ownership or a
					 change in the form of ownership or name of the facility. A change in ownership
					 shall mean any transfer of the controlling interest in a health care
					 facility.
(c) A health care
					 facility shall notify the Department in writing within 30 days after a change
					 of management of a health care facility. A change in management occurs when the
					 person responsible for the day to day operation of the health care facility
					 changes.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart A - General Provisions › Chapter 51 - GENERAL INFORMATION › GENERAL PROVISIONS › Section 51.5 - Building occupancy

Current through Register Vol. 54, No. 28, July 13, 2024
(a) New
					 construction, alterations or renovations that provide space for patient or
					 resident rooms or services may not be used or occupied until authorization for
					 the occupancy has been received from the Department.
(b) A health care facility shall request a
					 preoccupancy survey at least 30 days prior to the anticipated occupancy of the
					 facility or an addition or remodeled part thereof. The Department will conduct
					 an onsite survey of the new or remodeled portion of the health care facility
					 prior to granting approval for occupancy. The Department may give the
					 authorization to occupy the new or remodeled portion of the health care
					 facility by an interim written authorization. If interim authorization for
					 occupancy is given, the Department will provide the health care facility with
					 formal authorization within 30 days.
This section cited in 28 Pa. Code §
													571.11 (relating to principle);
						  and 34 Pa. Code §
													403.22 (relating to health care
						  facilities).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart A - General Provisions › Chapter 51 - GENERAL INFORMATION › GENERAL PROVISIONS › Section 51.6 - Identification of personnel

Current through Register Vol. 54, No. 28, July 13, 2024
(a) When
					 working in a health care facility and when clinically feasible, the following
					 individuals shall wear an identification tag which displays that person's name
					 and professional designation:
(1) Health care
					 practitioners licensed or certified by Commonwealth agencies.
(2) Health care providers employed by health
					 care facilities.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart A - General Provisions › Chapter 51 - GENERAL INFORMATION › CIVIL RIGHTS › Section 51.11 - Civil rights compliance

Current through Register Vol. 54, No. 28, July 13, 2024
A health care facility shall comply with all civil rights
						laws. The Department may make onsite visits at its discretion to verify the
						civil rights compliance status of the health care facility.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart A - General Provisions › Chapter 51 - GENERAL INFORMATION › CIVIL RIGHTS › Section 51.12 - Nondiscriminatory policy

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A health
					 care facility shall have a nondiscriminatory policy which applies to all
					 patients or residents and staff. The policy shall include a prohibition on the
					 segregation of buildings, wings, floors and rooms for reasons of race, color,
					 national origin, ancestry, age, sex, religion, handicap or disability. The
					 nondiscriminatory policy shall also address the following:
(1) Inpatient or outpatient admission or
					 care.
(2) Assigning patients or
					 residents to rooms, floors and sections.
(3) Asking patients or residents about
					 roommate preferences.
(4)
					 Assignments of staff to patient or resident services.
(5) Staff privileges of professionally
					 qualified personnel.
(6)
					 Utilization of the health care facility.
(7) Transfers of patients or residents from
					 their rooms.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart A - General Provisions › Chapter 51 - GENERAL INFORMATION › CIVIL RIGHTS › Section 51.13 - Civil rights compliance records

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A
					 health care facility shall maintain the following records to show compliance
					 with §
											51.12 (relating to
					 nondiscriminatory policy):
(1) A copy of the
					 health care facility's admission policy which includes the date of its
					 adoption, which sets forth in clear terms nondiscriminatory practices with
					 regard to race, color, national origin, creed, ancestry, age, sex, religion,
					 handicap or disability.
(2) A copy
					 of a signed and dated notification to employes of the health care facility's
					 nondiscrimination policy.
(3)
					 Evidence that the nondiscriminatory practices of the health care facility have
					 been publicized in the community at least every 3 years by one of the following
					 methods: newspapers, television, radio, brochure or yellow
					 pages.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart A - General Provisions › Chapter 51 - GENERAL INFORMATION › RESTRICTION OF PROVISION OF HEALTH CARE SERVICES › Section 51.21 - Surgery

Current through Register Vol. 54, No. 28, July 13, 2024
Surgery shall be performed only in an acute care hospital
						or in a Class A, Class B or Class C ambulatory surgical
						facility.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart A - General Provisions › Chapter 51 - GENERAL INFORMATION › RESTRICTION OF PROVISION OF HEALTH CARE SERVICES › Section 51.22 - Cardiac catheterization

Current through Register Vol. 54, No. 28, July 13, 2024
Cardiac catheterization shall be performed only in an
						acute care hospital.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart A - General Provisions › Chapter 51 - GENERAL INFORMATION › RESTRICTION OF PROVISION OF HEALTH CARE SERVICES › Section 51.23 - Positron emission tomography

Current through Register Vol. 54, No. 28, July 13, 2024
Positron emission tomography (PET) scanning services
						shall be provided only in a hospital which complies with the regulations of the
						Department governing radiology and nuclear medicine services.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart A - General Provisions › Chapter 51 - GENERAL INFORMATION › RESTRICTION OF PROVISION OF HEALTH CARE SERVICES › Section 51.24 - Lithotripsy

Current through Register Vol. 54, No. 28, July 13, 2024
Lithotripsy services shall be provided only in a hospital
						or ambulatory surgical facility authorized to provide anesthesia services under
						its license.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart A - General Provisions › Chapter 51 - GENERAL INFORMATION › EXCEPTIONS › Section 51.31 - Principle

Current through Register Vol. 54, No. 28, July 13, 2024
The Department may grant exceptions to this part when the
						policy and objectives contained therein are otherwise met, or when compliance
						would create an unreasonable hardship and an exception would not impair or
						endanger the health, safety or welfare of a patient or resident. No exceptions
						or departures from this part will be granted if compliance with the requirement
						is provided for by statute.
This section cited in 28 Pa. Code §
													136.11 (relating to director); 28
						  Pa. Code §
													138.11 (relating to director); 28
						  Pa. Code §
													139.3 (relating to director); and
						  28 Pa. Code §
													158.11 (relating to medical
						  director).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart A - General Provisions › Chapter 51 - GENERAL INFORMATION › EXCEPTIONS › Section 51.32 - Exceptions for innovative programs

Current through Register Vol. 54, No. 28, July 13, 2024
This part is not intended to restrict the efforts of a
						health care facility to develop innovative and improved programs of management,
						clinical practice, physical renovation or structural design. Whenever this part
						appears to preclude a program which may improve the capacity of the health care
						facility to deliver higher quality care and services or to operate more
						efficiently without compromising patient or resident care, the Department
						encourages the health care facility to request appropriate exceptions under
						this chapter.
This section cited in 28 Pa. Code §
													51.13 (relating to civil rights
						  compliance records); 28 Pa. Code §
													136.11 (relating to director); 28
						  Pa. Code §
													138.11 (relating to director); 28
						  Pa. Code §
													139.3 (relating to director); and
						  28 Pa. Code §
													158.11 (relating to medical
						  director).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart A - General Provisions › Chapter 51 - GENERAL INFORMATION › EXCEPTIONS › Section 51.33 - Requests for exceptions

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A
					 health care facility shall make requests for exceptions to the Department in
					 writing.
(b) The Department will
					 retain the requests on file and document whether they have been approved or
					 disapproved.
(c) Upon receipt of a
					 request for exceptions, the request will be published in the
Pennsylvania Bulletin
with a public comment period. The
					 Department will review these comments before making a determination to approve
					 or disapprove an exception. The Department will publish requests for exceptions
					 in emergency situations, but will not include a public comment
					 period.
(d) The Department will
					 publish notice of all approved exceptions in the
Pennsylvania
					 Bulletin
on a periodic basis.
(e) The health care facility shall retain
					 approved requests on file during the period the exception remains in
					 effect.
This section cited in 28 Pa. Code §
													136.11 (relating to director); 28
						  Pa. Code §
													138.11 (relating to director); 28
						  Pa. Code §
													139.3 (relating to director); and
						  28 Pa. Code §
													158.11 (relating to medical
						  director).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart A - General Provisions › Chapter 51 - GENERAL INFORMATION › EXCEPTIONS › Section 51.34 - Revocation of exceptions

Current through Register Vol. 54, No. 28, July 13, 2024
(a) An
					 exception granted under this chapter may be revoked by the Department for
					 justifiable reason. The Department will provide notice of the revocation in
					 writing and will include the reason for the revocation and the date upon which
					 the exception will be terminated.
(b) In revoking an exception, the Department
					 will provide for a reasonable period of time between the date of written notice
					 of the revocation and the date of termination of an exception to afford the
					 health care facility an opportunity to come into compliance with the applicable
					 regulations.
(c) If a health care
					 facility wishes to request a reconsideration of a denial or revocation of an
					 exception, it shall do so in writing to the director of the appropriate
					 division within 30 days after service of the adverse notification.
This section cited in 28 Pa. Code §
													136.11 (relating to director); 28
						  Pa. Code §
													138.11 (relating to director); 28
						  Pa. Code §
													139.3 (relating to director); and
						  28 Pa. Code §
													158.11 (relating to medical
						  director).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart A - General Provisions › Chapter 51 - GENERAL INFORMATION › SANCTIONS › Section 51.41 - Violations, penalties

Current through Register Vol. 54, No. 28, July 13, 2024
(a) When
					 appropriate, the Department will work with the health care facility to rectify
					 a violation of this part.
(b) A
					 health care facility that violates this part may be subject to sanctions by the
					 Department, which include:
(1) Suspension of
					 its license.
(2) Revocation of its
					 license.
(3) Refusal to renew its
					 license.
(4) Limitation of its
					 license as to operation of a portion of the health care facility or to the
					 services which may be provided at the health care facility.
(5) Issuance of a provisional
					 license.
(6) Submission of a plan
					 of correction.
(7) Limitation or
					 suspension of admissions to the health care facility.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart A - General Provisions › Chapter 53 - PHOTO IDENTIFICATION BADGES › Section 53.1 - Legal basis, scope and definitions

Current through Register Vol. 54, No. 28, July 13, 2024
(a) This chapter implements section 809.2 of
				  the act (35 P.S. §
											448.809b).
(b) This chapter contains standards which are
				  applicable to the following:
(1) All entities
				  licensed as health care facilities under the act.
(2) The private practice of a
				  physician.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart A - General Provisions › Chapter 53 - PHOTO IDENTIFICATION BADGES › Section 53.2 - Requirements

Current through Register Vol. 54, No. 28, July 13, 2024
(a) This chapter
				  applies to an employee who delivers direct care as follows:
(1) Outside of a health care facility or
				  employment agency.
(2) In a health
				  care facility.
(3) At the private
				  practice of a physician.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart A - General Provisions › Chapter 53 - PHOTO IDENTIFICATION BADGES › Section 53.3 - Contents of photo identification badge

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
				  An employee's photo identification badge must include the following:
(1) A recent photograph of the employee,
				  updated as provided for in subsection (c).
(2) The employee's full name to include, at a
				  minimum, the full first and last name.
(3) The employee's title.
(4) The name of the employee's health care
				  facility or employment agency.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart A - General Provisions › Chapter 53 - PHOTO IDENTIFICATION BADGES › Section 53.5 - Exceptions

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
Photograph.
A health care facility, health care provider,
				  employment agency or private practice of a physician may permit an employee to
				  wear an identification badge without a photograph if having a photograph taken
				  would violate the tenets of the employee's religion or religious
				  beliefs.
(b)
Policies and
				  procedures for exemption.
A health care facility, health care
				  provider, employment agency or private practice of a physician shall establish
				  policies and procedures in the event that an employee requests an exception
				  under subsection (a), which, at a minimum:
(1)
				  Require the employee to submit a signed and notarized statement that the taking
				  of a photograph would violate the employee's religion or religious
				  beliefs.
(2) Ensure that the
				  employee wears an identification badge that contains the information in §
											53.3(a)(2)-(4)
				  (relating to contents of photo identification badge).
(3) Contain the employee's height and eye
				  color.