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The Oregon Administrative Rules contain OARs filed through August 15, 2014
 
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OREGON HEALTH AUTHORITY,
PUBLIC HEALTH DIVISION

 

DIVISION 505

HOSPITAL ORGANIZATION AND MANAGEMENT

333-505-0001

Applicability

These rules apply to all hospitals, regardless of classification.

Stat. Auth.: ORS 441.025
Stats. Implemented:ORS 441.025
Hist.: HD 21-1993, f. & cert. ef. 10-28-93; PH 11-2009, f. & cert. ef. 10-1-09; PH 17-2012, f. 12-20-12, cert. ef. 1-1-13

333-505-0005

Governing Body Responsibility

(1) In a multi-hospital system, one governing body may oversee multiple hospitals.

(2) The governing body of a hospital shall be responsible for the operation of the hospital, the selection of the medical staff and the quality of care rendered in the hospital. The governing body shall ensure that:

(a) All health care personnel for whom a state license or registration is required are currently licensed or registered;

(b) Qualified individuals allowed to practice in the hospital are credentialed and granted privileges consistent with their individual training, experience and other qualifications;

(c) Procedures for granting, restricting and terminating privileges exist and that such procedures are regularly reviewed to assure their conformity to applicable law;

(d) It has an organized medical staff responsible for reviewing the professional practices of the hospital for the purpose of reducing morbidity and mortality and for the improvement of patient care;

(e) A physician is not denied medical staff privileges at the facility solely on the basis that the physician holds medical staff membership or privileges at another health care facility;

(f) Licensed podiatric physicians and surgeons are permitted to use the hospital in accordance with ORS 441.063;

(g) All hospital employees and health care practitioners granted hospital privileges have been tested for tuberculosis in compliance with OAR 333-505-0080; and

(h) A notice, in a form specified by the Division, summarizing the provisions of ORS 441.162, 441.166, 441.168, 441.174, 441.176, 441.178, 441.192 is posted in a place where notices to employees and applicants are customarily displayed.

(3) A hospital may grant privileges to nurse practitioners in accordance with ORS 441.064 and subject to hospital rules governing admissions and staff privileges. The hospital may refuse to grant privileges to nurse practitioners only upon the same basis that privileges are refused to other licensed health care practitioners.

(4) A hospital shall require that every patient admitted shall be and remain under the care of a member of the medical staff as specified under the medical staff by-laws.

Stat. Auth: ORS 441.025
Stats. Implemented: ORS 441.055
Hist.: HD 11-1980, f. & ef. 9-10-80; Renumbered from 333-023-0125; HD 29-1988, f. 12-29-88, cert. ef. 1-1-89, Renumbered from 333-070-0050; HD 21-1993, f. & cert. ef. 10-28-93, Renumbered from 333-505-0000; HD 2-2000, f. & cert. ef. 2-15-00; OHD 20-2002, f. & cert. ef. 12-10-02; PH 11-2009, f. & cert. ef. 10-1-09; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10; PH 17-2012, f. 12-20-12, cert. ef. 1-1-13

333-505-0007

Physician Credentialing, Hospitals, Health Care Service Contractors

Each hospital and health care service contractor shall use the Oregon Practitioner Credentialing Application and the Oregon Practitioner Recredentialing Application adopted pursuant to ORS 442.805 and in accordance with OAR 409-045-0000.

Stat. Auth.: ORS 442.807
Stats. Implemented: ORS 442.805
Hist.: OHD 5-2002, f. & cert. ef. 3-4-02; PH 4-2004, f. & cert. ef. 2-6-04; PH 3-2005, f. & cert. ef. 2-4-05; PH 11-2009, f. & cert. ef. 10-1-09; PH 17-2012, f. 12-20-12, cert. ef. 1-1-13

333-505-0010

Administrator

(1) Each hospital shall employ or contract with a chief executive officer (CEO) or administrator who is responsible for the operation of the hospital and hospital based services in a manner commensurate with the authority conferred by the governing body, supports the delivery of high quality hospital care and services and ensures compliance with all hospital policies and applicable state and federal laws and regulations. In determining the appropriate number of facilities for which a CEO or administrator is responsible, the governing body of the hospital or health system should consider distance between hospitals and the size and complexity of each facility.

(2) For hospitals with attached long-term care facilities, the CEO may function as administrator of both the hospital and the long-term care facility.

(3) The hospital shall notify the Division, in writing, of the voluntary or involuntary termination of the CEO or administrator as well as the appointment of a new CEO or administrator.

Stat. Auth.: ORS 441.025
Stats. Implemented: ORS 441.055
Hist.: HD 29-1988, f. 12-29-88, cert. ef. 1-1-89; HD 21-1993, f. & cert. ef. 10-28-93; HD 2-2000, f. & cert. ef. 2-15-00; PH 11-2009, f. & cert. ef. 10-1-09; PH 17-2012, f. 12-20-12, cert. ef. 1-1-13

333-505-0020

Medical Staff

(1) The medical staff is responsible for reviewing the professional practices of the hospital for the purpose of reducing morbidity and mortality and for the improvement of patient care, and is accountable to the governing body.

(2) The hospital’s medical staff organized pursuant to OAR 333-505-0005(1) shall include Medical Doctors and Doctors of Osteopathy, and may include other licensed health care practitioners as permitted by the governing body.

(3) The medical staff shall adopt and enforce by-laws, medical staff policies, and medical staff rules and regulations to carry out its responsibilities. The by-laws, medical staff policies, and medical staff rules and regulations must be approved by the governing body.

(4) By-laws, medical staff policies, and medical staff rules and regulations shall include but are not limited to:

(a) The organization of the medical staff, including qualifications for serving on the medical staff, nominations, election, appointment or removal of officers, and periodic review of its members;

(b) Criteria for credentialing health care practitioners and the process for applying for credentials;

(c) Criteria for restricting or terminating hospital privileges and the process for restricting or terminating hospital privileges;

(d) A process for periodically reviewing the procedures for granting, restricting, or terminating hospital privileges to ensure that procedures are being followed;

(e) Procedures for insuring that licensed health care practitioners with hospital privileges are acting within their scope of practice and acting consistent with the privileges granted;

(f) Procedures for the acceptance of verbal orders by those individuals authorized by law or their scope of practice to accept verbal orders;

(g) Criteria for tissue specimens and appliances that are subject to a macroscopic or microscopic pathology examination;

(h) Procedures for responding to medical emergencies, including contacting at least one physician in the event of a medical emergency; and

(i) Procedures for notifying patients orally and in writing of any financial interest as required by ORS 441.098.

(5) Amendments to medical staff by-laws shall be accomplished through a cooperative process involving both the medical staff and the governing body. Medical staff by-laws shall be adopted, repealed or amended when approved by the medical staff and the governing body. Approval shall not be unreasonably withheld by either. Neither the medical staff nor the governing body shall withhold approval if such appeal, amendment or adoption is mandated by law, statute or regulation or is necessary to obtain or maintain accreditation or to comply with fiduciary responsibilities or if the failure to approve would subvert the stated moral or ethical purposes of this institution.

(6) Physicians and all other health care practitioners with individual admitting privileges are subject to applicable provisions of the medical staff by-laws and rules governing admission and staff privileges.

Stat. Auth.: ORS 441.025
Stats. Implemented: ORS 441.055, 441.064 & 441.098
Hist.: HD 29-1988, f. 12-29-88, cert. ef. 1-1-89; HD 21-1993, f. & cert. ef. 10-28-93; HD 30-1994, f. & cert. ef. 12-13-94; PH 11-2009, f. & cert. ef. 10-1-09; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10

333-505-0030

Organization, Hospital Policies

(1) A hospital's internal organization shall be structured to include appropriate departments and services consistent with the needs of its defined community.

(2) A hospital shall adopt and maintain clearly written definitions of its organization, authority, responsibility and relationships.

(3) A hospital shall adopt, maintain and follow written patient care policies that include but are not limited to:

(a) Admission, transfer and discharge policies that address:

(A) Types of clinical conditions not acceptable for admission;

(B) Constraints imposed by limitations of services, physical facilities or staff coverage;

(C) Emergency admissions;

(D) Requirements for informed consent signed by the patient or legal representative of the patient for diagnostic and treatment procedures; such policies and procedures shall address informed consent of minors in accordance with provisions in ORS 109.610, 109.640, 109.670, and 109.675;

(E) Requirements for identifying persons responsible for obtaining informed consent and other appropriate disclosures and ensuring that the information provided is accurate and documented appropriately in accordance with these rules and ORS 441.098;

(F) A process for the internal transfer of patients from one level or type of care to another;

(G) Discharge and termination of services; and

(H) Planning for continuity of patient care following discharge.

(b) Patient rights;

(c) Housekeeping;

(d) All patient care services provided by the hospital;

(e) Maintenance of the hospital's physical plant, equipment used in patient care and patient environment; and

(f) Treatment or referral of acute sexual assault patients in accordance with ORS 147.403.

(4) In addition to the policies described in section (3) of this rule, a hospital shall, in accordance with the Patient Self-Determination Act, 42 CFR 489.102, adopt policies and procedures that require (applicable to all capable individuals 18 years of age or older who are receiving health care in the hospital):

(a) Providing to each adult patient, including emancipated minors, not later than five days after an individual is admitted as an inpatient, but in any event before discharge, the following in written form, without recommendation:

(A) Information on the rights of the individual under Oregon law to make health care decisions, including the right to accept or refuse medical or surgical treatment and the right to execute directives and powers of attorney for health care;

(B) Information on the policies of the hospital with respect to the implementation of the rights of the individual under Oregon law to make health care decisions;

(C) A copy of the directive form set forth in ORS 127.531, along with a disclaimer attached to each form in at least 16-point bold type stating "You do not have to fill out and sign this form."; and

(D) The name of a person who can provide additional information concerning the forms for directives.

(b) Documenting in a prominent place in the individual's medical record whether the individual has executed a directive.

(c) Compliance with Oregon law relating to directives for health care.

(d) Educating the staff and the community on issues relating to directives.

(5) A hospital's transfer agreements or contracts shall clearly delineate the responsibilities of parties involved.

(6) Patient care policies shall be evaluated triennially and rewritten as needed, and presented to the governing body or a designated administrative body for approval triennially. Documentation of the evaluation is required.

(7) A hospital shall have a system, described in writing, for the periodic evaluation of programs and services, including contracted services.

Stat. Auth.: ORS 441.025
Stats. Implemented: ORS 147.025 & 441.025
Hist.: HD 29-1988, f. 12-29-88, cert. ef. 1-1-89; PH 11-2009, f. & cert. ef. 10-1-09; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10; PH 17-2012, f. 12-20-12, cert. ef. 1-1-13

333-505-0033

Patient Rights

A hospital shall comply with the requirements for patients rights as set forth in 42 CFR 482.13.

Stat. Auth.: ORS 441.025
Stats. Implemented: ORS 441.025
Hist.: PH 11-2009, f. & cert. ef. 10-1-09; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10; PH 17-2012, f. 12-20-12, cert. ef. 1-1-13

333-505-0040

Personnel

(1) A hospital shall:

(a) Maintain a sufficient number of qualified personnel to provide effective patient care and all other related services.

(b) Have written personnel policies and procedures that are available to personnel.

(c) Provide orientation for new employees.

(d) Have an annual continuing education plan.

(e) Have a job description for each position that delineates the qualifications, duties, authority and responsibilities inherent in each position.

(f) Provide an annual work performance evaluation for each employee with appropriate records maintained.

(g) Have an employee health screening program for the purpose of protecting patients and employees from communicable diseases, including but not limited to requiring tuberculosis testing for employees in accordance with OAR 333-505-0080.

(2) A hospital shall restrict the work of employees with restrictable diseases in accordance with OAR 333-019-0010.

(3) The actions taken by a hospital under this rule shall be fully documented for each employee and made available to Division representatives upon request.

Stat. Auth.: ORS 441.025
Stats. Implemented: ORS 441.025
Hist.: HD 29-1988, f. 12-29-88, cert. ef. 1-1-89; HD 21-1993, f. & cert. ef. 10-28-93; HD 2-2000, f. & cert. ef. 2-15-00; PH 11-2009, f. & cert. ef. 10-1-09

333-505-0050

Medical Records

(1) A medical record shall be maintained for every patient admitted for care in a hospital.

(2) A legible reproducible medical record shall include, but is not limited to (as applicable):

(a) Admitting identification data including date of admission.

(b) Chief complaint.

(c) Pertinent family and personal history.

(d) Medical history, physical examination report and provisional diagnosis as required by OAR 333-510-0010.

(e) Admission notes outlining information crucial to patient care.

(f) All patient admission, treatment, and discharge orders.

(A) All patient orders shall be initiated, dated, timed and authenticated by a licensed health care practitioner in accordance with section (7) of this rule.

(B) Documentation of verbal orders shall include:

(i) The date and time the order was received;

(ii) The name and title of the health care practitioner who gave the order; and

(iii) Authentication by the authorized individual who accepted the order, including the individual’s title.

(C) Verbal orders shall be dated, timed, and authenticated promptly by the ordering health care practitioner or another health care practitioner who is responsible for the care of the patient.

(D) For purposes of this rule, a verbal order includes but is not limited to an order given over the telephone.

(g) Clinical laboratory reports as well as reports on any special examinations. (The original report shall be recorded in the patient's medical record.)

(h) X-ray reports bearing the identification of the originator of the interpretation.

(i) Consultation reports when such services have been obtained.

(j) Records of assessment and intervention, including graphic charts and medication records and appropriate personnel notes.

(k) Discharge summary including final diagnosis.

(l) Discharge order.

(m) Autopsy report if applicable.

(n) Such signed documents as may be required by law.

(o) Informed consent forms that document:

(A) The name of the hospital where the procedure or treatment was undertaken;

(B) The specific procedure or treatment for which consent was given;

(C) The name of the health care practitioner performing the procedure or administering the treatment;

(D) That the procedure or treatment, including the anticipated benefits, material risks, and alternatives was explained to the patient or the patient’s representative or why it would have been materially detrimental to the patient to do so, giving due consideration to the appropriate standards of practice of reasonable health care practitioners in the same or a similar community under the same or similar circumstances;

(E) The manner in which care will be provided in the event that complications occur that require health services beyond what the hospital has the capability to provide;

(F) The signature of the patient or the patient’s legal representative; and

(G) The date and time the informed consent was signed by the patient or the patient’s legal representative.

(p) Documentation of the disclosures required in ORS 441.098.

(3) A medical record of a surgical patient shall include, in addition to other record requirements, but is not limited to:

(a) Preoperative history, physical examination and diagnosis documented prior to operation.

(b) Anesthesia record including preanesthesia assessment and plan for anesthesia, records of anesthesia, analgesia and medications given in the course of the operation and postanesthetic condition.

(c) A record of operation dictated or written immediately following surgery and including a complete description of the operation procedures and findings, postoperative diagnostic impression, and a description of the tissues and appliances, if any, removed. When the dictated operative report is not placed in the medical record immediately after surgery, an operative progress note shall be entered in the medical record after surgery to provide pertinent information for any individual required to provide care to the patient.

(d) Postanesthesia recovery progress notes.

(e) Pathology report on tissues and appliances, if any, removed at the operation.

(4) An obstetrical record for a patient, in addition to the requirements for medical records, shall include but is not limited to:

(a) The prenatal care record containing at least a serologic test result for syphilis, Rh factor determination, and past obstetrical history and physical examination.

(b) The labor and delivery record, including reasons for induction and operative procedures, if any.

(c) Records of anesthesia, analgesia, and medications given in the course of delivery.

(5) A medical record of a newborn or stillborn infant, in addition to the requirement for medical records, shall include but is not limited to:

(a) Date and hour of birth; birth weight and length; period of gestation; sex; and condition of infant on delivery (Apgar rating is recommended).

(b) Mother's name and hospital number.

(c) Record of ophthalmic prophylaxis or refusal of same.

(d) Physical examination at birth and at discharge.

(e) Progress and nurse's notes including temperature; weight and feeding data; number, consistency and color of stools; urinary output; condition of eyes and umbilical cord; condition and color of skin; and motor behavior.

(f) Type of identification placed on infant in delivery room;

(g) Newborn hearing screening tests in accordance with OAR 333-020-0130.

(6) A patient’s emergency room, outpatient and clinic records, in addition to the requirements for medical records, shall be maintained and available to the other professional services of the hospital and shall include but are not limited to:

(a) Patient identification.

(b) Admitting diagnosis, chief complaint and brief history of the disease or injury.

(c) Physical findings.

(d) Laboratory and X-ray reports (if performed), as well as reports on any special examinations. The original report shall be authenticated and recorded in the patient's medical record.

(e) Diagnosis.

(f) Record of treatment, including medications.

(g) Disposition of case with instructions to the patient.

(h) Signature or authentication of attending physician.

(i) A record of the pre-hospital report form (when patient is brought in by ambulance) shall be attached to the emergency room record.

(7) All entries in a patient's medical record shall be dated, timed and authenticated.

(a) Authentication of an entry requires the use of a unique identifier, including but not limited to a written signature or initials, code, password, or by other computer or electronic means that allows identification of the individual responsible for the entry.

(b) Systems for authentication of dictated, computer, or electronically generated documents must ensure that the author of the entry has verified the accuracy of the document after it has been transcribed or generated.

(8) The following records shall be maintained and kept permanently in written or computerized form:

(a) Patient's register, containing admissions and discharges;

(b) Patient's master index;

(c) Register of all deliveries, including live births and stillbirths;

(d) Register of all deaths;

(e) Register of operations;

(f) Register of outpatients (seven years);

(g) Emergency room register (seven years); and

(h) Blood banking register (20 years).

(9) The completion of the medical record shall be the responsibility of the attending qualified member of the medical staff. Any licensed health care practitioner responsible for providing or evaluating the service provided shall complete and authenticate those portions of the record that pertain to their portion of the patient's care. The appropriate individual shall authenticate the history and physical examination, operative report, progress notes, orders and the summary. In a hospital using interns, such orders must be according to policies and protocols established and approved by the medical staff. An authentication of a licensed health care practitioner on the face sheet of the medical record does not suffice to cover the entire content of the record:

(a) Medical records shall be completed by a licensed health care practitioner and closed within four weeks following the patient's discharge.

(b) If a patient is transferred to another health care facility, transfer information shall accompany the patient. Transfer information shall include but is not limited to:

(A) The name of the hospital from which they were transferred;

(B) The name of physician or other health care practitioner to assume care at the receiving facility;

(C) The date and time of discharge;

(D) The current medical findings;

(E) The current nursing assessment;

(F) Current medical history and physical information;

(G) Current diagnosis;

(H) Orders from a physician or other licensed health care practitioner for immediate care of the patient;

(I) Operative report, if applicable;

(J) TB test, if applicable; and

(K) Other information germane to patient's condition.

(c) If the discharge summary is not available at time of transfer, it shall be transmitted to the new facility as soon as it is available.

(10) Diagnoses and operations shall be expressed in standard terminology. Only abbreviations approved by the medical staff may be used in the medical records.

(11) Medical records shall be filed and indexed. Filing shall consist of an alphabetical master file with a number cross-file. Indexing is to be done according to diagnosis, operation, and qualified member of the medical staff, using a system such as the International or Standard nomenclature systems.

(12) Medical records are the property of the hospital. The medical record, either in original, electronic or microfilm form, shall not be removed from the hospital except where necessary for a judicial or administrative proceeding. Treating and attending physicians shall have access to medical records. When a hospital uses off-site storage for medical records, arrangements must be made for delivery of these records to the hospital when needed for patient care or other hospital activities. Precautions must be taken to protect patient confidentiality.

(13) Authorized personnel of the Division shall be permitted to review medical records and patient registers as necessary to determine compliance with health care facility licensing laws.

(14) Medical records shall be kept for a period of at least 10 years after the date of last discharge. Original medical records may be retained on paper, microfilm, electronic or other media.

(15) Medical records shall be protected against unauthorized access, fire, water and theft.

(16) If a hospital changes ownership, all medical records in original, electronic or microfilm form shall remain in the hospital and it shall be the responsibility of the new owner to protect and maintain these records.

(17) If a hospital closes, its medical records and the registers required under section (8) of this rule may be delivered and turned over to any other hospital in the vicinity willing to accept and retain the same as provided in section (12) of this rule. A hospital which closes permanently shall follow the procedure for Division and public notice regarding disposal of medical records under OAR 333-500-0060.

(18) All original clinical records or photographic or electronic facsimile thereof, not otherwise incorporated in the medical record, such as X-rays, electrocardiograms, electroencephalograms, and radiological isotope scans shall be retained for seven years after a patient's last discharge if professional interpretations of such graphics are included in the medical records.

(19) If a qualified medical record practitioner, RHIT (Registered Health Information Technician) or RHIA (Registered Health Information Administrator) is not the Director of the Medical Records Department, periodic and at least annual consultation must be provided by a qualified medical records consultant, RHIT/RHIA. The visits of the medical records consultant shall be of sufficient duration and frequency to review medical record systems and assure quality records of the patients. The contract for such services shall be made available to the Division.

(20) A current written policy on the release of medical record information including a patient's access to his or her medical record shall be maintained in the medical records department.

(21) A hospital is not required to keep a medical record in accordance with this rule for a person referred to a hospital ancillary department for a diagnostic procedure or health screening by a private physician, dentist, or other licensed health care practitioner acting within his or her scope of practice.

(22) Pursuant to ORS 441.059, the rules of a hospital that govern patient access to previously performed X-rays or diagnostic laboratory reports shall not discriminate between patients of chiropractic physicians and patients of other licensed health care practitioners permitted access to such X-rays and diagnostic laboratory reports.

(23) Nothing in this rule is meant to prohibit or discourage a hospital from maintaining its records in electronic form.

Stat. Auth: ORS 441.025
Stats. Implemented: ORS 441.025
Hist.: HB 183, f. & ef. 5-26-66; HB 235, f. 2-5-70, ef. 2-25-70; HB 253, f. 7-22-70, ef. 8-25-70; HB 255, f. 9-15-70, ef. 10-11-70; HD 11-1980, f. & ef. 9-10-80; HD 8-1984, f. & ef. 5-7-84; Renumbered from 333-023-0190; HD 29-1988, f. 12-29-88, cert. ef. 1-1-89, Renumbered from 333-070-0055; HD 21-1993, f. & cert. ef. 10-28-93; HD 2-2000, f. & cert. ef. 2-15-00; OHD 3-2001, f. & cert. ef. 3-16-01; PH 11-2009, f. & cert. ef. 10-1-09; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10; PH 17-2012, f. 12-20-12, cert. ef. 1-1-13

333-505-0060

Quality Assessment and Performance Improvement

(1) The governing body of a hospital must ensure that there is an effective, written, facility-wide quality assessment and performance improvement program to evaluate and monitor the quality and appropriateness of patient care.

(2) All organized services related to patient care, including services furnished by a contractor, must be evaluated.

(3) Written documentation of quality assessment and performance improvement activities shall be recorded at least quarterly.

(4) Healthcare associated infections, adverse drug reactions, errors in administration of drugs, and blood and blood product transfusions must be evaluated.

(5) All medical and surgical services performed in the hospital must be evaluated as they relate to appropriateness of diagnosis and treatment.

(6) The hospital must have an ongoing plan, consistent with available community and hospital resources, to provide and make available social work, psychological, and educational services to meet the medically-related needs of its patients.

Stat. Auth.: ORS 441.055
Stats. Implemented: ORS 441.025
Hist.: HD 29-1988, f. 12-29-88, cert. ef. 1-1-89; HD 21-1993, f. & cert. ef. 10-28-93; HD 2-2000, f. & cert. ef. 2-15-00; PH 11-2009, f. & cert. ef. 10-1-09; PH 17-2012, f. 12-20-12, cert. ef. 1-1-13

333-505-0070

Infection Control and Prevention

(1) A hospital shall establish and maintain an active facility-wide program for the control and prevention of infection. This program shall, at a minimum, include the following:

(a) Identification of existing or potential infections in patients, employees, medical staff, and health care practitioners with hospital privileges;

(b) Control of factors affecting the transmission of infections and communicable diseases;

(c) Provision for orienting and educating all medical staff, health care practitioners with hospital privileges and employees on the cause, transmission and prevention of infections; and

(d) Collection, analysis and use of data relating to infections in the hospital.

(2) A hospital shall be responsible for the development, implementation and periodic review of policies under section (1) of this rule.

(3) In the hospital, the infection control program shall be managed by a qualified individual and overseen by a multidisciplinary committee with responsibility for investigating, controlling and preventing infections in the facility. The composition of the committee may vary but shall include at least representation from major departments and services and shall provide for consultation both from other departments and services and to them.

(4) A hospital shall comply with all rules of the Division for the control of communicable diseases.

(5) A hospital shall have a system of isolation that prevents the transmission of infections in hospitals.

(a) A system of isolation shall:

(A) Follow the principles of epidemiology and disease transmission;

(B) Include precautions to interrupt the spread of infection by all routes that are likely to be encountered in the hospital; and

(C) Be reviewed and approved by a committee responsible for the oversight of the infection control program.

(b) Guidelines for isolation precautions are published periodically by the Hospital Infection Control Practices Advisory Committee (HICPAC) and may be used by a hospital as a reference in order to maintain up-to-date isolation practices.

(6) The hospital multidisciplinary committee shall oversee all aspects of the infection control program, and will ensure that the system of isolation implemented addresses the following fundamentals of infection control:

(a) Handwashing and gloving;

(b) Patient placement;

(c) Transport of infected patients;

(d) Protective apparel;

(e) Patient care equipment and articles;

(f) Linen and laundry;

(g) Dishes, glasses, cups, and eating utensils; and

(h) Routine and terminal cleaning.

(7) A hospital shall have policies and procedures related to cleaning, disinfection, sterilization, and disposal of patient care items.

(a) All instruments or equipment used in patient care should be disinfected or sterilized based on whether the item is critical, semi-critical, or non-critical.

(A) Critical items are those patient care items which enter the vascular system. These items must be sterile and should be sterilized by a Federal Drug Administration (FDA) approved method or purchased sterile for use.

(B) Semi-critical items are those patient care items which come into contact with mucous membranes or nonintact skin. These items must be free of all organisms except spores. Semi-critical items require high level disinfection using wet pasteurization or chemical sterilants which are FDA-approved.

(C) Non-critical items are those items that come into contact only with intact skin. Low level disinfectants may be used which have been approved by the Environmental Protection Agency (EPA) as hospital disinfectants.

(b) All patient care items shall be disposed of properly at discharge or processed according to the categorization of the items, i.e. critical, semi-critical, or non-critical. Single patient use equipment must be disposed of or sent home with the patient at discharge.

Stat. Auth.: ORS 441.025
Stats. Implemented: ORS 441.025
Hist.: HB 183, f. & ef. 5-26-66; HB 212, f. 2-25-69; HB 235, f. 2-5-70, ef. 2-25-70; HD 11-1980, f. & ef. 9-10-80; Renumbered from 333-023-0180; HD 29-1988, f. 12-29-88, cert. ef. 1-1-89, Renumbered from 333-072-0035; HD 21-1993, f. & cert. ef. 10-28-93; OHD 2-2000, f. & cert. ef. 2-15-00, Renumbered from 333-515-0010; PH 11-2009, f. & cert. ef. 10-1-09

333-505-0080

Tuberculosis Control

(1) As used in this rule, "person" means any:

(a) Hospital employee;

(b) Hospital contractor;

(c) Health care practitioner granted privileges by the hospital; or

(d) Hospital volunteer or student.

(2) A hospital shall comply with the Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005, published in the Morbidity and Mortality Weekly Report by the Centers for Disease Control and Prevention (CDC), December 30, 2005, and incorporated by reference.

(3) A hospital shall obtain documentation that tuberculosis (TB) testing has been conducted in a manner consistent with the CDC guidelines for any person who enters a hospital and who has contact with patients, enters rooms that patients may enter, or who handles clinical specimens or other material from patients or their rooms.

(4) A hospital shall require documentation of baseline TB screening conducted in accordance with the CDC Guidelines, within six weeks of the date of hire, date of executed contract or date of being granted hospital credentials.

(5) A hospital that is classified as "potential ongoing transmission" under CDC Guidelines shall consult with the Oregon TB control program within the Division, for guidance on the extent of TB testing required.

(6) If a hospital learns that a person or a patient at the hospital is diagnosed with communicable TB, the hospital shall notify the local public health authority and conduct an investigation to identify contacts. If the Division or local public health authority conducts its own investigation, a hospital shall cooperate with that investigation and provide the Division or local public health authority with any information necessary for it to conduct its investigation.

(7) A hospital shall notify the local public health administrator of its intent to discharge a patient known to have active TB disease.

Stat. Auth.: ORS 441.025
Stats. Implemented: ORS 441.025
Hist.: PH 11-2009, f. & cert. ef. 10-1-09; PH 17-2012, f. 12-20-12, cert. ef. 1-1-13

333-505-0090

Request for Tissues and Organs

(1) A hospital administrator or his or her designee shall contact the appropriate organ or tissue procurement organization when a patient dies at the hospital or when a patient's death is imminent.

(2) After consultation with an organ or tissue procurement organization, the hospital administrator or his or her designee shall communicate with the patient or legal next-of-kin and request that the patient's organs and tissue be donated as an anatomical gift, unless:

(a) The medical record shows that the patient has made an anatomical gift;

(b) The appropriate procurement organizations or the medical examiner has ruled out the potential donor based on accepted medical standards;

(c) The legal next-of-kin are not available because:

(A) They cannot be located in a timely manner after reasonable effort by the procurement organizations or the hospital; or

(B) They are mentally incompetent.

(d) In the opinion of the attending physician after consulting with the procurement organization, it is determined that the request would contribute toward the severe emotional distress of the patient or legal next-of-kin.

(3) For purposes of this rule, "legal next-of-kin" is the class of persons described in ORS 97.965 and in addition to spouse, includes Oregon registered domestic partner.

(4) The hospital shall document the request or the absence of a request, in the medical record of the decedent and provide information on the request and its disposition to the person filing the death certificate.

(5) An anatomical gift by a legal next-of-kin or authorized person may be made by a document of gift signed by the donor or made by his or her telegraphic, recorded telephonic or other recorded message.

(6) A hospital or training requestor who acts or omits to act with probable cause in accord with the terms of ORS 97.951 through 97.978 and these rules is not subject to criminal or civil liability.

Stat. Auth.: ORS 441.025
Stats. Implemented: ORS 441.025
Hist.: PH 11-2009, f. & cert. ef. 10-1-09

333-505-0100

Training for Requestors

(1) All persons making requests for donations of organs, tissues, and eyes shall have received hospital-provided or procurement organization-provided training in accordance with this rule.

(2) Training for requestors shall include but is not limited to:

(a) The legal requirements of ORS 97.951 through 97.978 and these rules, and the necessity for completion of the portion of the death certificate regarding organ, tissue and eye retrieval.

(b) Specifics of organ tissue and eye donation, including: identification of potential donors; medical uses of donated organs, tissues, and eyes; the history and success of transplant programs; reimbursement mechanisms for expenses relating to organ, tissue, and eye retrieval;

(c) A review of the psychological, social, cultural, ethical and religious factors affecting willingness to donate organs, tissues, and eyes, and resistance to organ, tissue, and eye donation, and a review of materials developed to train individuals to request organ, tissue, and eye donation with reasonable discretion and sensitivity;

(d) The family's right to refuse and the need to respect this right;

(e) The effect on funeral arrangements and cost; and

(f) The importance of consulting with the attending physician.

(3) Requestors shall be able to demonstrate knowledge of the training content as defined in this rule.

Stat. Auth.: ORS 441.025
Stats. Implemented: ORS 441.025
Hist.: PH 11-2009, f. & cert. ef. 10-1-09

333-505-0110

Hospital Compliance

(1) A hospital shall demonstrate compliance with OAR 333-505-0090 and 333-505-0100 by maintaining a file, available for Division review, including the following:

(a) Training curriculum;

(b) Hospital policy and procedure regarding request and training for tissues, eyes, and organs;

(c) If not included in policy and procedure, criteria for selection of requestor;

(d) Method by which 24-hour scheduling of requestor(s) is established; and

(e) Policies and procedures for communicating with procurement organizations regarding the availability of donor organs, tissues, and eyes.

(2) Hospitals may provide appropriate procurement organization personnel access to medical records of decedents on a periodic basis. The timing of this review will be mutually agreed to by both the hospital and procurement organizations. Procurement organizations will provide appropriate staff to conduct the review in the hospital. The purpose of this review will be to provide information to the hospital to assist in compliance with state and federal regulations related to organ, tissue and eye donation. If the hospital agrees to the review, all findings will remain strictly confidential.

(3) In the case of a hospital in which organ transplants are performed, the hospital must be a member of the Organ Procurement and Transplantation network established under Section 372 of the Public Health Service Act and abide by its rules and requirements.

Stat. Auth.: ORS 441.025
Stats. Implemented: ORS 441.025
Hist.: PH 11-2009, f. & cert. ef. 10-1-09

333-505-0120

Emergency Contraception

(1) A hospital providing care to a female victim of sexual assault shall:

(a) Promptly provide the victim with unbiased, medically and factually accurate written and oral information about emergency contraception;

(b) Promptly orally inform the victim of her option to be provided emergency contraception at the hospital; and

(c) If requested by the victim and not medically contraindicated, provide the victim of any child bearing age with emergency contraception immediately at the hospital, notwithstanding ORS 147.397 (defining the availability of the Sexual Assault Victims' Emergency Medical Response fund "SAVE Fund").

(d) For purposes of this rule, "emergency contraception" means the use of a drug or device that is approved by the United States Food and Drug Administration to prevent pregnancy after sexual intercourse.

(2) A hospital shall post a written notice, approved by the Division, to inform victims of their right to be provided emergency contraception at the hospital.

(3) Pursuant to ORS 109.640, anyone under the age of 18 has the right to consent to birth control information and services, including emergency contraception.

(4) A hospital shall document in writing that the information required to be given to a female victim of sexual assault in section (1) of this rule, was provided. Failure to have such documentation may result in the issuance of a civil penalty.

(5) A hospital may only provide the victim informational materials about emergency contraception that has been approved by the Division.

(6) The Division shall investigate complaints of violations of sections (1) or (2) of this rule in accordance with ORS 441.057.

(7) In addition to investigating complaints, the Division shall monitor compliance with ORS 435.254 and this rule during scheduled visits to hospitals.

(8) The Division may impose a civil penalty, not to exceed $1000, against a hospital for each violation of ORS 435.254 or these rules. In addition to the assessment of a civil penalty, the Authority will require corrective actions from the hospital.

(a) For the first violation the civil penalty shall be $250;

(b) For the second violation the civil penalty shall be $500;

(c) For the third and any subsequent violations, the civil penalty shall be $1000.

Stat. Auth.: ORS 441.025
Stats. Implemented: ORS 183.745, 441.025, 435.254, 435.256 & 441.057
Hist.: PH 11-2009, f. & cert. ef. 10-1-09

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