reglab/statecodes huggingface dataset:
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 1 - Controlled Substances › Section 19 CSR 30-1.052 - Records for Long-Term Care Facilities (LTCF)

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule sets requirements for record
				  keeping by long-term care facility registrants.
(1) Long-term care facilities (LTCFs) and
				their suppliers shall maintain written records of transfers of controlled
				substances from the supplier to the LTCF emergency kit.
(2) The records shall include the date of
				transfer; the name of each controlled substance, the strength, dosage form and
				quantity; the name, address and controlled substance registration number of the
				supplier and the name, address and controlled substance registration number of
				the LTCF. Federal Drug Enforcement Administration (DEA) official order forms
				shall not be used to record transfers of controlled substances to LTCF
				emergency kits.
(3) No physician's
				order or prescription shall be used for initial stocking or replacement of
				controlled substances in the emergency kit. Controlled substances contained in
				the kit shall be obtained from a pharmacy, hospital or practitioner who holds a
				controlled substances registration.
(4) The administration and medical staff of
				the LTCF, in conjunction with the primary supplier, shall designate in written
				protocols and procedures who may have access to the emergency kit, who may
				administer controlled substances from the emergency kit and under what
				circumstances and a list of the controlled substances it intends to maintain in
				the emergency kit. These protocols and procedures shall be subject to review
				and approval by the Department of Health. Only those individuals designated in
				the LTCF's written policies and procedures shall have access to or administer
				controlled substances from the emergency kit.
(5) Each administration of controlled
				substances from the emergency kit shall be based upon a practitioner's order
				and shall be recorded in an administration record separate from the patient's
				medical record. This administration record shall include: the date, patient's
				name, drug name, drug strength, dosage, ordering practitioner's name and name
				of the person administering the controlled substance.
*Original authority: 195.050, RSMo 1939, amended 1971, 1989
					 and 195.195, RSMo 1957, amended 1971, 1989,
					 1993.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 1 - Controlled Substances › Section 19 CSR 30-1.060 - Determining Lawful Prescribing, Dispensing and Administering of Controlled Substances

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule defines the statutory and
				  regulatory basis for determining what is lawful prescribing, dispensing and
				  administering of controlled substances.
When determining if controlled substances are being lawfully
				  prescribed, dispensed and administered by practitioners, the Department of
				  Health shall enforce Chapter 195, RSMo, the Department of Health rules in 19
				  CSR 30 pertaining to controlled substances, and the federal Controlled
				  Substances Act
				  21
				  U.S.C. 801 -
				  966,
				  and its regulations, 21 CFR 1300 - 1399. In determining lawful prescribing,
				  dispensing and administering of controlled substances, the Department of Health
				  also shall consider the provisions of Chapters 330, 332, 334, 335, 336, 338 and
				  340, RSMo, the rules in 4 CSR 110, 4 CSR 150, 4 CSR 200, 4 CSR 210, 4 CSR 220,
				  4 CSR 230 and 4 CSR 270, and protocols relating to the respective practitioners
				  established and on file at the respective licensing boards.
*Original authority: 195.030, RSMo 1939, amended 1971,
					 1989, 1993, 1995, 1999 and 195.195, RSMo 1957, amended 1971, 1989,
					 1993.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 1 - Controlled Substances › Section 19 CSR 30-1.062 - Transmission of Prescriptions

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This amendment establishes specific
				  requirements and restrictions governing transmission of prescription
				  information.
(1)
				Prescriptions in Schedule II. A pharmacist may dispense a controlled substance
				in Schedule II only under a written prescription signed by the practitioner,
				except as provided in section 195.060.3, RSMo. A prescription for a Schedule II
				controlled substance may be transmitted from the prescribing practitioner to a
				pharmacy by facsimile equipment, provided the original written, signed
				prescription is presented to the pharmacist for review prior to the actual
				dispensing of the controlled substance, except that-
(A) A prescription written for a Schedule II
				narcotic substance to be compounded for the direct administration to a patient
				by parenteral, intravenous, intramuscular, subcutaneous, or intraspinal
				infusion may be transmitted by the practitioner or the practitioner's agent to
				the pharmacy by facsimile. The facsimile which has been reduced to writing
				shall serve as and shall be maintained in the same manner as an original
				written prescription.
(B) A
				prescription written for a Schedule II substance for a resident of a long-term
				care facility may be transmitted by the practitioner or the practitioner's
				agent to the pharmacy by facsimile. The facsimile which has been reduced to
				writing shall serve as, and shall be maintained in the same manner, as an
				original written prescription.
(C)
				A prescription written for a Schedule II substance for a patient of a hospice
				may be transmitted by the practitioner or the practitioner's agent to the
				pharmacy by facsimile. The practitioner or the practitioner's agent shall note
				on the prescription that the patient is a hospice patient. The facsimile which
				has been reduced to writing shall serve as, and shall be maintained in the same
				manner, as an original written prescription.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 1 - Controlled Substances › Section 19 CSR 30-1.064 - Separate Registrations

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This amendment allows Schedule II drugs to
				  be partially filled for up to sixty (60) days after the date the original
				  prescription was issued.
(1)
				The partial filling of a prescription for a controlled substance listed in
				Schedule II is permissible, if the pharmacist is unable to supply the full
				quantity called for in a written or emergency oral prescription, and s/he makes
				a notation of the quantity supplied on the face of the written prescription (or
				written record of the emergency oral prescription), or in the electronic
				record. The remaining portion of the prescription may be filled within
				seventy-two (72) hours of the first partial filling; however, if the remaining
				portion is not or cannot be filled within the seventy-two (72) hour period, the
				pharmacist shall so notify the prescribing individual practitioner. No further
				quantity may be supplied beyond seventy-two (72) hours without a new
				prescription.
(2) The partial
				filling of a prescription for controlled substances listed in Schedules II,
				III, IV, or V is permissible, provided that-
(A) Partial filling may occur at the request
				of a patient or it may be directed by the prescriber, unless the prescription
				is written for a patient in a long-term care facility (LTCF) or for a patient
				with a medical diagnosis documenting a terminal illness, in which case the
				pharmacist must record on the prescription whether the patient is "terminally
				ill" or "LTCF patient.";
(B) Each
				partial dispensing is recorded in the same manner as a refilling would
				be;
(C) With each partial
				dispensing, the pharmacy must document the date and quantity dispensed on the
				original prescription record or their electronic computer applications,
				provided that the electronic system meets all of the federal requirements for
				handling of electronic prescriptions for controlled substances, including the
				ability to retrieve the information pertaining to partially filled controlled
				substances;
(D) The total quantity
				dispensed in all partial fillings cannot exceed the total quantity
				prescribed;
(E) No dispensing
				occurs-
1. For controlled substances listed in
				Schedule II, after sixty (60) days after the date on which the original
				prescription was issued; and
2. For
				controlled substances listed in Schedules III and IV after six (6) months after
				the date on which the original prescription was issued;
(F) A partial dispensing is not considered a
				"refill" if the patient does not receive the full authorized amount at one (1)
				time; and
(G) The prescription was
				written and filled in accordance with all other applicable laws and
				regulations.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 1 - Controlled Substances › Section 19 CSR 30-1.066 - Dispensing by Individual Practitioners

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule sets requirements for individual
				  practitioners who dispense controlled substances.
(1) An individual practitioner who dispenses
				controlled substances shall-
(A) Provide
				direct supervision to employees or agents who assist in the administering or
				dispensing of controlled substances. Controlled substances shall not be
				dispensed from an individual practitioner's inventory unless a practitioner is
				physically in the registered location except pursuant to the provisions of
				section (2) of this rule;
(B)
				Package all controlled substances dispensed from an individual practitioner's
				inventory in compliance with the Poison Prevention Packaging Act of 1970,
				15
				U.S.C. 1471 -
				1476;
(C) Permanently affix a label to the exterior
				of the drug container which includes: the date, the name and address of the
				dispensing practitioner, the name of the patient, directions for use, and the
				exact name and strength of the drug dispensed for all controlled substances
				dispensed;
(D) Dispense only to
				individuals with whom the practitioner has established and documented a
				practitioner/patient relationship. An individual practitioner shall not
				dispense under the order of another practitioner not practicing at that
				location.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 1 - Controlled Substances › Section 19 CSR 30-1.068 - Administering In Emergency Rooms

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule sets requirements for
				  administering controlled substances in hospital emergency
				  rooms.
(1) Controlled
				substances may be administered to a hospital emergency room patient under a
				verbal order of a registered practitioner who is not physically present if-
(A) The order is for a legitimate medical
				purpose and the practitioner who orders the administration of a controlled
				substance is acting in the usual course of his/her medical practice, after
				sufficient examination and establishment of a practitioner/patient
				relationship;
(B) The practitioner
				who orders the administration of a controlled substance is a medical staff
				member of the hospital;
(C) The
				administration of a controlled substance is documented in a formal medical
				record for the patient;
(D) The
				patient is assessed in the hospital by a practitioner, when available, or a
				registered nurse. If the patient is not assessed by a practitioner in the
				hospital, a registered nurse shall assess the patient and confirm and document
				in the patient's medical record the existence of a preestablished
				practitioner/patient relationship with the practitioner who ordered
				administration of a controlled substance;
(E) The order is written in the patient's
				medical record and is authenticated by the ordering practitioner within a time
				frame and manner as defined by the medical staff in cooperation with nursing
				and administration. This policy shall be included in the hospital's written
				policies and procedures.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 1 - Controlled Substances › Section 19 CSR 30-1.070 - Emergency Dispensing of Schedule II Substances

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule provides for the prescribing and
				  dispensing of Schedule II drugs in an emergency situation.
(1) In the case of a bona fide emergency
				situation, as defined by the Department of Health, a pharmacist may dispense a
				Schedule II controlled substance upon receiving oral authorization of a
				prescribing practitioner; provided, that-
(A)
				The quantity prescribed and dispensed is limited to the amount adequate to
				treat the patient during the emergency period. Prescribing or dispensing beyond
				the emergency period must be pursuant to a written prescription;
(B) The prescription immediately shall be
				reduced to writing by the pharmacist and shall contain all information, except
				for the prescribing practitioner's signature;
(C) If the prescribing practitioner is not
				known to the pharmacist, s/he must make reasonable effort to determine that the
				oral authorization came from a practitioner, by verifying his/her phone number
				against that listed in the directory and other good faith efforts to insure
				his/her identity;
(D) Within seven
				days after authorizing an emergency oral prescription, the prescribing
				practitioner must cause a written prescription for the emergency quantity
				prescribed to be delivered to the dispensing pharmacist. The prescription shall
				have written on its face authorization for emergency dispensing. The written
				prescription may be delivered to the pharmacist in person or by mail, but if
				delivered by mail it must be postmarked within the seven-day period. Upon
				receipt, the dispensing pharmacist shall attach this prescription to the oral
				emergency prescription which had earlier been reduced to writing. The
				pharmacist shall notify the Department of Health if the prescribing
				practitioner fails to deliver a written prescription to him/her; failure of the
				pharmacist to do so shall void the authority conferred by this section to
				dispense without a written prescription of a prescribing
				practitioner.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 1 - Controlled Substances › Section 19 CSR 30-1.072 - Dispensing of Schedule V Substances

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule provides for the prescribing,
				  administering and dispensing of Schedule V drugs.
(1) A pharmacist may dispense directly a
				controlled substance listed in Schedule V pursuant to a prescription. A
				prescription for a controlled substance listed in Schedule V may be refilled
				only as expressly authorized by the prescribing individual practitioner. If
				this authorization is not given, the prescription may not be refilled. A
				pharmacist dispensing those substances pursuant to a prescription shall label
				the substance and file the prescription.
(2) An individual practitioner may administer
				or dispense directly a controlled substance listed in Schedule V in the course
				of his/her professional practice without a prescription.
(3) An institutional practitioner may
				administer or dispense directly (but not prescribe) a controlled substance
				listed in Schedule V only pursuant to a written prescription signed by the
				prescribing individual practitioner or pursuant to an oral prescription made by
				a prescribing individual practitioner and promptly reduced to writing by the
				pharmacist (containing all information required except for the signature of the
				prescribing individual practitioner) or pursuant to an order for medication
				made by an individual practitioner which is dispensed for immediate
				administration to the ultimate user.
*Original authority: 195.195, RSMo 1957, amended 1971,
					 1989, 1993.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 1 - Controlled Substances › Section 19 CSR 30-1.074 - Dispensing Without a Prescription

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This amendment updates the requirements for
				  the sale, dispensation, or distribution of methamphetamine precursor products
				  to be consistent with section
				  195.417,
				  RSMo.
(1) Definitions. For
				the purposes of this rule, the following terms shall apply:
(A) "Dispenser" means a pharmacist, intern
				pharmacist, or registered pharmacy technician who sells, dispenses, or
				otherwise provides methamphetamine precursor products to purchasers.
(B)"Methamphetamine precursor products" means
				both Schedule V pseudoephedrine products and any other drug product containing
				any detectable amount of ephedrine, pseudoephedrine, or phenylpropanolamine,
				including the salts or optical isomers or salts of optical isomers or
				ephedrine, its salts or optical isomers, or salts of optical isomers of
				ephedrine, pseudoephedrine, or phenylpropanolamine.
(C) "Valid photo identification" means a
				photo identification that is issued by a state or the federal government or a
				document that, with respect to identification, is considered acceptable and
				showing the date of birth of the person, including forms of identification
				acceptable under federal regulations
				8 CFR
				274a.2(b)(1)(v)(A) and
				(B).
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 1 - Controlled Substances › Section 19 CSR 30-1.076 - Emergency Distribution by a Pharmacy

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule provides for dispensing of
				  controlled substances by a pharmacy in emergency situations.
(1) An emergency means a situation where a
				quantity of a controlled substance must be dispensed by a pharmacy to a patient
				who does not have an alternative source for that substance reasonably available
				to him/her and the pharmacy cannot obtain that substance through its normal
				distribution channels within the time required to meet the immediate needs of
				the patient for that substance. In the event of an emergency, a pharmacy may
				distribute (without being registered as a distributor) a controlled substance
				in Schedule III, IV or V to a second pharmacy in order for that pharmacy to
				dispense the substance; provided, that-
(A)
				The amount distributed does not exceed the amount required by the second
				pharmacy for his/her immediate dispensing;
(B) The distribution is recorded as being
				dispensed by the first pharmacy and the second pharmacy records the substance
				as being received. Each pharmacy will retain a signed receipt of the
				distribution;
(C) The second
				pharmacy is registered to dispense the controlled substance to be distributed
				to him/her;
(D) If the substance is
				a Schedule II controlled substance, the official order form designated by the
				federal Drug Enforcement Administration must be used to document the
				transfer.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 1 - Controlled Substances › Section 19 CSR 30-1.078 - Disposing of Unwanted Controlled Substances

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This amendment establishes the process for
				  authorized registrants to collect unwanted controlled substances through
				  collection receptacles or a mail-back program and amends requirements for
				  destruction of controlled substances by registrants.
(1) A registrant in possession of any
				controlled substance(s) and desiring or required to dispose of such
				substance(s) shall:
(A) Return the controlled
				substance(s) to the original supplier;
(B) Transfer the controlled substance(s) to a
				distributor authorized to accept controlled substance(s) for the purpose of
				disposal;
(C) Retain a DEA Form 41
				in compliance with federal regulations;
(D) Become an Authorized Collector of
				Controlled Substances. Registrants shall dispose of all unwanted controlled
				substances and keep records in accordance with federal regulations. Only
				manufacturers, distributors, reverse distributors, narcotic treatment programs,
				hospitals/clinics with an on-site pharmacy, and retail pharmacies that have
				modified their state and federal controlled substances registrations may
				possess a collection receptacle for medication disposal or participate in the
				DEA approved mail-back system
(E)
				Contact the Bureau of Narcotics and Dangerous Drugs (BNDD), Department of
				Health and Senior Services for information pertaining to subsections (1)(A),
				(B), (C), or (D) of this rule.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 1 - Controlled Substances › Section 19 CSR 30-1.080 - Electronic Prescribing Waiver

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule establishes the process for
				  practitioners to obtain waivers to the electronic prescribing requirements
				  established by section
				  195.550,
				  RSMo.
(1) Practitioners
				required to utilize electronic prescribing pursuant to section
				195.550,
				RSMo may request a waiver of this requirement from the Department of Health and
				Senior Services.
(A) Applications shall only
				be submitted by practitioners with active Missouri Controlled Substance
				Registrations. Applications shall not be submitted by a registrant's designee
				or representative.
(B) Applicants
				requesting a waiver shall submit an application for a waiver by sending their
				application to BNDDRxWaiver@health.mo.gov. A sample application may be found on
				the Department's website,
www.health.mo.gov/safety/bndd
.
(C) The application shall include:
1. Applicant's first and last name;
2. Applicant's licensure type;
3. Applicant's Missouri Controlled Substance
				Registration number;
4. Applicant's
				email address;
5. The Applicant
				shall indicate for which of the following reasons they are seeking a waiver:
A. Economic hardship;
B. Technological limitations; or
C. Other exceptional circumstances;
6. The Applicant shall provide any
				additional details they consider necessary to support their waiver
				request;
7. The Applicant shall
				certify that the information included in their application is true and
				accurate; and
8. The Applicant
				shall sign and date the application. An electronic signature will satisfy this
				requirement.
(D) Waivers
				granted by the department shall be valid for one (1) year after the date on
				which they are issued.
(E) Waivers
				shall be kept on file at the practitioner's primary, principle practice
				location and available for review by the department.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 11 - Rules for Mammography › Section 19 CSR 30-11.010 - Mammography Authorization

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule establishes requirements for
				  mammography authorization and payment of fees by mammography
				  suppliers.
(1) All
				mammography suppliers shall meet the requirements of applicable rules of
				Chapter 10 of 19 CSR 20.
(2) Each
				applicant for mammography authorization shall submit a registration fee to the
				Department of Health prior to issuance of the mammography authorization. Fees
				are as follows: three (3)-year authorization, six hundred dollars ($600);
				temporary authorization for twelve (12) months, two hundred dollars ($200); and
				temporary authorization for six (6) months, one hundred dollars ($100).
(A) Each radiation machine shall be
				individually registered for mammography authorization.
(B) Application for authorization renewal
				shall be submitted not more than ninety (90) days and not less than thirty (30)
				days prior to the expiration date of the current authorization.
(C) Registration fees shall not be required
				for reinstatement of a mammography authorization which has been withdrawn by
				the Department of Health; reinstatement shall be effective only for the
				remainder of the original period of authorization.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 11 - Rules for Mammography › Section 19 CSR 30-11.020 - Requirements for Suppliers of Mammography Services

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule establishes requirements for
				  suppliers of mammography services, including responsibility for the quality of
				  mammographic examinations.
(1) The supplier shall be responsible for the
				overall quality of mammography examinations conducted in each facility. The
				supplier shall have available the services of a physician consultant and a
				radiation physicist, either on staff or through arrangement.
(2) The supplier shall provide satisfactory
				assurances, as documented in its medical records, that the images or films of
				the first and subsequent mammography procedures and the related written reports
				of the physicians' interpretations for each patient are either placed in the
				patient's medical record kept by the supplier or sent to another person-
				including the patient-for placement in the patient's medical record as directed
				by the patient or by the patient's physician. If the records of the examination
				are retained by the supplier, they shall be retained for at least sixty (60)
				months following the date of service. If the supplier should cease to exist
				before the end of the sixty (60)-month period, the records shall be transferred
				to the patient or the patient's primary care provider.
(3) With the consent of the patient,
				reasonable efforts shall be made by the supplier of the current examination to
				obtain any of the patient's previous mammography records- including original
				images and films-copies of written reports prepared by interpreting physicians,
				and other relevant information pertinent to previous mammographies that might
				be available from others, for comparison with the current mammography records.
				Records of previous mammographies obtained and of current mammographies
				performed by the supplier shall be properly preserved and made available to
				other qualified mammography suppliers or others who submit a written request
				authorized by the patient.
(4) The
				supplier shall make a record for each patient of the mammography services it
				provides. This record shall include:
(A) The
				date the mammography procedure was performed and the date of the
				interpretation;
(B) The name of the
				patient;
(C) The names of the
				supplier, the interpreting physician and the equipment operator;
(D) A description of the procedures
				performed;
(E) The name of the
				referring physician, if any, or other physician, if any, identified by the
				patient to receive the interpreting physician's written report; and
(F) The date the physician's written report
				was sent to the appropriate physician or patient.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 11 - Rules for Mammography › Section 19 CSR 30-11.030 - Requirements and Responsibilities for Physician Consultants

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule establishes requirements for
				  physician consultants including qualifications and supervisory
				  responsibilities.
(1) The
				physician consultant shall meet the requirements for the interpreting physician
				as specified in 19 CSR 20-11.040(1) and (2).
(2) The physician consultant shall document
				in writing annually that-
(A) S/he has
				checked the procedural manuals and observed, at least monthly, the operator's
				performance;
(B) S/he has verified
				that equipment and personnel meet applicable rules of this chapter;
(C) Safe operating procedures are used;
				and
(D) All other requirements of
				this chapter are being met.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 11 - Rules for Mammography › Section 19 CSR 30-11.040 - Requirements and Responsibilities for Interpreting Physicians

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule establishes requirements for
				  interpreting physicians including qualifications, the mammography reporting
				  process and responsibility to the patient.
(1) The results of all mammography procedures
				shall be interpreted by a qualified physician who is licensed to practice
				medicine in Missouri and-
(A) Has completed
				two (2) months of documented, formal training in reading mammograms with
				instruction in medical radiation physics, radiation effects and radiation
				protection; or is certified by the American Board of Radiology (ABR) or the
				American Osteopathic Board of Radiology (AOBR); and
(B) Has completed forty (40) hours of
				documented continuing medical education credits in mammography. Time spent in
				residency specifically devoted to mammography shall be accepted, if documented
				in writing.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 11 - Rules for Mammography › Section 19 CSR 30-11.050 - Requirements for Operators of Mammography Equipment

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule establishes requirements for
				  operators of mammography equipment, including qualifications, certification and
				  continuing education.
(1)
				Operators of mammography equipment shall be certified by the American Registry
				of Radiological Technologists (ARRT), the American Registry of Clinical
				Radiographic Technologists (ARCRT), Missouri or shall possess equivalent
				certification. Operators also shall meet the following requirements:
(A) Shall have completed a minimum of forty
				(40) hours of documented formal mammography instruction or on-the-job training
				as outlined in Appendix A, "Topics to be Covered in Mammography Instruction."
				On-the-job training shall be documented to include the business address and
				qualifications of the instructor, a brief description of the training, the date
				and length of the training, and an evaluation of the student's performance
				signed and dated by the instructor; and
(B) Shall obtain at least fifteen (15) hours
				of continuing education in technical aspects of mammography and related
				subjects every three (3) years.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 11 - Rules for Mammography › Section 19 CSR 30-11.060 - Requirements for Individuals Who Provide X-ray Physics Support

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule establishes requirements for
				  radiation physicists including qualifications and responsibilities for quality
				  assurance.
(1) A radiation
				physicist who provides diagnostic X-ray physics support to a supplier of
				mammography services shall be certified by the American Board of Radiology as a
				radiation physicist or shall possess other qualifications acceptable to the
				Department of Health.-
(2) Under
				the direction of the physician consultant, a radiation physicist shall
				establish a mammography quality assurance program.
(3) At least annually, a radiation physicist
				shall provide on-site consultation to the supplier, including, but not limited
				to, a complete evaluation of the entire mammography system to ensure compliance
				with 19 CSR 20-11.070 and 19 CSR 20-11.080.
*Original authority
					 1992.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 11 - Rules for Mammography › Section 19 CSR 30-11.070 - Mammography Equipment Requirements

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule establishes requirements for
				  mammography equipment, including radiation machines and other components of
				  mammography systems.
(1) The
				equipment used for mammography shall be specifically designed for mammogra-phy
				and shall meet the following requirements:
(A)
				Equipment shall meet the Food and Drug Administration (FDA) performance
				standards for diagnostic X-ray systems and their major components in
				21 CFR
				1020.30 and FDA standards for radiographic
				equipment in
				21 CFR
				1020.31 upon installation and while in
				use;
(B) The image receptor systems
				and all their individual components shall be designed specifically for
				mammography and shall function properly;
(C) The equipment shall be limited to
				providing kilovoltage (kV)-target-filter combinations appropriate to image
				receptors meeting the requirements of subsection (1)(B);
(D) The half value layer (HVL) in millimeters
				of aluminum of the useful beam for systems operating at X-ray tube potentials
				of less than thirty-five kilovoltage potential (35 kVp) shall be equal to or
				greater than the product of the tube potential in kilovolts multiplied by
				one-hundredth (0.01) and shall not exceed this calculated product by more than
				plus one-tenth millimeter (+0.1 mm) of aluminum;
(E) Devices parallel to the imaging plane
				shall be available to adequately immobilize and compress the breast;
(F) Film-screen units shall have the
				capability for using anti-scatter grids;
(G) Film-screen units shall have the
				capability of automatic exposure control;
(H) The equipment shall have a control panel
				that includes a device, usually a mil-liammeter, or a means for an audible
				signal to give positive indication of the production of X rays whenever the
				X-ray tube is energized. The control panel shall include appropriate
				indicators-labeled control settings or meters that show the physical factors,
				such as kVp, milliamperes (mA), milliampere-seconds (mAs), exposure time or
				whether timing is automatic-when used for exposure;
(I) The developer temperature of the
				photographic processor shall be maintained as specified by the film
				manufacturer for the particular film-developer-processor-development time
				combination; and
(J) The focal spot
				size and source-to-image receptor distances shall be limited to those
				appropriate for mammography.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 11 - Rules for Mammography › Section 19 CSR 30-11.080 - Quality Assurance

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule establishes requirements for
				  calibration of mammography equipment and monitoring of the mammography
				  system.
(1) All variable
				parameters of the equipment shall be calibrated as follows:
(A) When the equipment is first
				installed;
(B) After any major
				changes or replacement of parts;
(C) At least annually while in use;
				and
(D) When quality assurance
				tests indicate that calibration is needed.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 11 - Rules for Mammography › Section 19 CSR 30-11.090 - Maintenance of mammography Records

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule establishes requirements for
				  maintenance of quality assurance records by the supplier.
(1) Records of all quality assurance tests
				for mammography X-ray equipment shall include the following:
(A) The initial mammographic equipment
				performance evaluation and subsequent evaluations and testing;
(B) Verification that the mammographic X-ray
				equipment is in safe operating order; and
(C) Quality assurance test results.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 11 - Rules for Mammography › Section 19 CSR 30-11.100 - Right of Entry to mammography Suppliers for Enforcement

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule authorizes the right of entry by
				  agents of the Department of Health.
(1) Agents of the Department of Health
				charged with the enforcement of the provisions of this chapter shall have the
				right of entry and free access during normal business hours to any building or
				structure for the purposes of inspection, evaluation and examination of records
				and equipment.
Appendix A
Topics to be Covered in
Mammography Instruction
A. Anatomy and Physiology of the Female
				Breast
1. Mammary glands
2. External anatomy
3. Subdivision for localization
4. Retromammary space
5. Central portion
6. Cooper's ligament
7. Vessels, nerves, lymphatics
8. Breast tissue
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 20 - Hospitals › Section 19 CSR 30-20.001

Current through Register Vol. 49, No. 14, July 15, 2024
*Original authority: 192.006, RSMo 1993, amended 1995 and
					 197.080, RSMo 1953, amended 1993, 1995.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 20 - Hospitals › Section 19 CSR 30-20.011 - Definitions Relating to Hospitals

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This amendment modifies the definition of
				  the term "hospital" as used in Chapter 20 to include "rural emergency
				  hospitals."
(1) Automated
				Dispensing System-An automated system that is used to dispense medication to
				patients pursuant to a patient-specific prescription or patient-specific
				medication order using an electronic verification system. An automated
				dispensing system does not include an automated system used for compounding
				medication or an automated filling system governed by
				20 CSR
				2220-2.950.
(2) Chemical Restraint-A drug or medication
				when it is used as a restriction to manage the patient's behavior or restrict
				the patient's freedom of movement and is not a standard treatment or dosage for
				the patient's condition.
(3) Chief
				executive officer-The individual appointed by the governing body to act in its
				behalf in the overall management of the hospital.
(4) Chief operating officer-The individual
				appointed by the chief executive officer on behalf of the governing body or the
				individual who is responsible for the management of one (1) hospital in a
				multi-hospital organization under the direction of the chief executive officer
				of the organization.
(5)
				Compounding-The preparation, incorporation, mixing and packaging or labeling of
				a drug or device as the result of a prescriber's prescription or prescription
				drug order based on the prescriber/patient/pharmacist relationship in the
				course of professional practice. Compounding may also be defined as the
				preparation, incorporation, mixing and packaging or labeling of a drug or
				device, for the purpose of, or as an incident to, research, teaching or
				chemical analysis and not for sale or dispensing purposes.
(6) Defined service area-The geographic area
				served by a defined group of hospitals and emergency services.
(7) Department-Missouri Department of Health
				and Senior Services.
(8)
				Diversion-Temporary closure of a hospital emergency department to ambulance
				traffic.
(A) Defined service area-The
				geographic area served by a defined group of hospitals and emergency services.
				In areas where there is a community-based emergency medical services diversion
				plan, the service area(s) defined as the catchment area by the plan will be the
				defined service area(s). In areas where there is not a community-based
				emergency medical services diversion plan, the defined service area will be a
				twenty (20)-mile radius from a hospital.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 20 - Hospitals › Section 19 CSR 30-20.040

Current through Register Vol. 49, No. 14, July 15, 2024
*Original authority: 192.005.2, RSMo 1985 and 197.080, RSMo
					 1953.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 20 - Hospitals › Section 19 CSR 30-20.050 - Standards for the Operation of Long-Term Care Units

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This amendment updates language throughout
				  and eliminates the language regarding nurse assistant orientation and training.
				  This amendment also updates referenced rule numbers throughout and places
				  additional requirements on the frequency of physician visits to
				  residents.
(1) Swing beds
				located in the hospital which may be used intermittently for long-term care are
				exempt from the requirements of this rule.
(2) Administration.
(A) A long-term care unit shall be licensed
				as part of the hospital in which it is located or attached. The hospital
				governing body shall be the legal authority for the long-term care unit and
				shall be responsible for the overall planning, directing, control, and
				management of the activities and functions of the long-term care
				unit.
(B) The administration of the
				long-term care unit shall be the responsibility of the chief executive officer
				of the hospital. This authority may be delegated to a qualified assistant in
				accordance with the governing body bylaws of the hospital.
(C) Visiting Hours.
1. Regular daily visiting hours shall be
				established.
2. Relatives or
				guardians and clergy, if requested by the resident or family, shall be allowed
				to see critically-ill residents at any time in keeping with the orders of the
				physician.
(D) Medical
				records shall comply with
				19 CSR
				30-20.015. All medical orders shall be renewed at
				least monthly.
(E) All residents
				shall have a comprehensive, accurate, standardized assessment completed within
				fourteen (14) days of admission utilizing the resident assessment instrument
				developed by the Centers for Medicare and Medicaid Services (CMS) for use in
				long-term care facilities. The assessment shall be documented and become the
				basis for the care and treatment to be provided.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 20 - Hospitals › Section 19 CSR 30-20.060

Current through Register Vol. 49, No. 14, July 15, 2024
*Original authority: 192.005.2, RSMo 1985 and 197.080, RSMo
					 1953.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 20 - Hospitals › Section 19 CSR 30-20.070 - Registration as a Hospital Infectious Waste Generator

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule establishes standards and
				  procedures for the registration of hospitals to ensure a high level of public
				  safety in the handling and disposal of infectious waste.
(1) Application for Registration as a
				Hospital Infectious Waste Generator.
(A)
				Annually every hospital shall submit to the Department of Health and Senior
				Services an application for registration as an infectious waste generator. The
				application shall be furnished by the Department of Health and Senior Services
				and are included herein.
(B) Each
				application shall include:
1. An operational
				plan for the handling and treatment of infectious waste as specified in 19 CSR
				30-20.114(1)(C);
2. A statement
				that the applicant understands and complies with sections 260.200-260.345,
				RSMo; 19 CSR 30-20.011; 19 CSR 30-20.114(1)(C); 10 CSR 80-2.010; and 10 CSR
				80-7.010; and
3. The signature of
				the hospital's chief executive officer and the director of the infectious waste
				management program.
(C)
				The application shall be submitted annually. It shall be reviewed and denial or
				acceptance given within thirty (30) days after the Department of Health and
				Senior Services receives the application. If denied, specific reasons, with
				references, shall be given for the denial.
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Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 20 - Hospitals › Section 19 CSR 30-20.080

Current through Register Vol. 49, No. 14, July 15, 2024
*Original authority: 192.006, RSMo 1993, amended 1995 and
					 197.080, RSMo 1953, amended 1993, 1995.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 20 - Hospitals › Section 19 CSR 30-20.082

Current through Register Vol. 49, No. 14, July 15, 2024
*Original authority: 192.006, RSMo 1993, amended 1995 and
					 197.080, RSMo 1953, amended 1993, 1995.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 20 - Hospitals › Section 19 CSR 30-20.084

Current through Register Vol. 49, No. 14, July 15, 2024
*Original authority: 192.006, RSMo 1993, amended 1995 and
					 197.080, RSMo 1953, amended 1993, 1995.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 20 - Hospitals › Section 19 CSR 30-20.086

Current through Register Vol. 49, No. 14, July 15, 2024
*Original authority: 192.006, RSMo 1993, amended 1995;
					 197.080, RSMo 1953, amended 1993, 1995; and 197.154, RSMo
					 2004.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 20 - Hospitals › Section 19 CSR 30-20.088

Current through Register Vol. 49, No. 14, July 15, 2024
*Original authority: 192.006, RSMo 1993, amended 1995;
					 197.080, RSMo 1953, amended 1993, 1995; and 197.154, RSMo
					 2004.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 20 - Hospitals › Section 19 CSR 30-20.090

Current through Register Vol. 49, No. 14, July 15, 2024
*Original authority: 192.006, RSMo 1993, amended 1995;
					 197.080, RSMo 1953, amended 1993, 1995; and 197.154, RSMo
					 2004.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 20 - Hospitals › Section 19 CSR 30-20.092

Current through Register Vol. 49, No. 14, July 15, 2024
*Original authority: 192.006, RSMo 1993, amended 1995;
					 197.080, RSMo 1953, amended 1993, 1995; and 197.154, RSMo
					 2004.