ration in a school approved by the Council on Education of the American Medical Association or by the American Osteopathic Association, or have earned a bachelor's or associate degree in radiologic technology from an accredited college or university.

(2) For those whose training was completed prior to July 1, 1966, but on or after July 1, 1960: Successful completion of 24 full months of training and/ or experience under the direct supervision of a physician who is certified in radiology by the American College of Radiology or who possesses qualifications which are equivalent to those required for such certification, and at least 12 full months of pertinent portable X-ray equipment operation experience in the 5 years prior to January 1, 1968.

(3) For those whose training was completed prior to July 1, 1960: Successful completion of 24 full months of training and/or experience of which at least 12 full months were under the direct supervision of a physician who is certified in radiology by the American College of Radiology or who possesses qualifications which are equivalent to those required for such certification, and at least 12 full months of pertinent portable X-ray equipment operation experience in the 5 years prior to January 1, 1968.

Standard-personnel

orientation.

(b) The supplier of portable X-ray services has an orientation program for personnel, based on a procedural manual which is: Available to all members of the staff, incorporates relevant portions of professionally recognized documents, and includes instruction in all of the following:

(1) Precautions to be followed to protect the patient from unnecessary exposure to radiation;

(2) Precautions to be followed to protect an individual supporting the patient during X-ray procedures from unnecessary exposure to radiation;

(3) Precautions to be followed to protect other individuals in the surrounding environment from exposure to radiation;

(4) Precautions to be followed to protect the operator of portable X-ray equipment from unnecessary exposure to radiation;

(5) Considerations in determining the area which will receive the primary beam;

(6) Determination of the time interval at which to check personnel radiation monitors;

(7) Use of the personnel radiation monitor in providing an additional check on safety of equipment;

(8) Proper use and maintenance of equipment;

(9) Proper maintenance of records; (10) Technical problems which may arise and methods of solution;

(11) Protection against electrical hazards;

(12) Hazards of excessive exposure to radiation.

(c) Standard: Employee records. Records are maintained and include evidence that

(1) Each employee is qualified for his or her position by means of training and experience; and

(2) Employees health supervision.

receive adequate

[34 FR 388, Jan. 10, 1969. Redesignated at 42 FR 52826, Sept. 30, 1977, and amended at 53 FR 12015, Apr. 12, 1988]

8 405.1414 Condition for coverage-referral for service and preservation of records.

All portable X-ray services performed for Medicare beneficiaries are ordered by a doctor of medicine or doctor of osteopathy and records are properly preserved.

(a) Standard-referral by a physician. Portable X-ray examinations are performed only on the order of a doctor of medicine or doctor of osteopathy licensed to practice in the State. The supplier's records show that:

(1) The X-ray test was ordered by a licensed doctor of medicine or doctor of osteopathy, and

(2) Such physician's written, signed order specifies the reason an X-ray test is required, the area of the body to be exposed, the number of radiographs to be obtained, and the views needed; it also includes a statement concerning the condition of the patient which indicates why portable X-ray services are necessary.

(b) Standard-records of examinations performed. The supplier makes for each patient a record of the date of the X

ray examination, the name of the patient, a description of the procedures ordered and performed, the referring physician, the operator(s) of the portable X-ray equipment who performed the examination, the physician to whom the radiograph was sent, and the date it was sent.

(c) Standard-preservation of records. Such reports are maintained for a period of at least 2 years, or for the period of time required by State law for such records (as distinguished from requirements as to the radiograph itself), whichever is longer.

$405.1415 Condition for coveragesafety standards.

X-ray examinations are conducted through the use of equipment which is free of unnecessary hazards for patients, personnel, and other persons in the immediate environment, and through operating procedures which provide minimum radiation exposure to patients, personnel, and other persons in the immediate environment.

(a) Standard-tube housing and devices to restrict the useful beam. The tube housing is of diagnostic type. Diaphragms, cones, or adjustable collimators capable of restricting the useful beam to the area of clinical interest are used and provide the same degree of protection as is required of the housing.

(b) Standard-total filtration. (1) The aluminum equivalent of the total filtration in the primary beam is not less than that shown in the following table except when contraindicated for a particular diagnostic procedure.

(d) Standard-control panel. The control panel provides a device (usually a milliammeter 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 includes appropriate indicators (labelled control settings and/or meters) which show the physical factors (such as kVp, mA, exposure time or whether timing is automatic) used for the exposure.

(e) Standard-exposure control switch. The exposure control switch is of the dead-man type and is so arranged that the operator can stand at least 6 feet from the patient and well away from the useful beam.

(f) Standard-protection against electrical hazards. Only shockproof equipment is used. All electrical equipment is grounded.

(g) Standard-mechanical supporting or restraining devices. Mechanical supporting or restraining devices are provided so that such devices can be used when a patient must be held in position for radiography.

(h) Standard-protective gloves and aprons. Protective gloves and aprons are provided so that when the patient must be held by an individual, that individual is protected with these shielding devices.

(i) Standard-restriction of the useful beam. Diaphragms, cones, or adjustable collimators are used to restrict the useful beam to the area of clinical interest.

(j) Standard-personnel monitoring. A device which can be worn to monitor radiation exposure (e.g., a film badge) is provided to each individual who operates portable X-ray equipment. The device is evaluated for radiation exposure to the operator at least monthly and appropriate records are maintained by the supplier of portable X-ray services of radiation exposure measured by such a device for each individual.

(k) Standard-personnel and public protection. No individual occupationally exposed to radiation is permitted to hold patients during exposures except during emergencies, nor is any other individual regularly used for this service. Care is taken to assure that pregnant women do not assist in portable X-ray examinations.

§ 405.1416 Condition for coverage—inspection of equipment.

Inspections of all X-ray equipment and shielding are made by qualified individuals at intervals not greater than every 24 months.

(a) Standard-qualified inspectors. Inspections are made at least every 24 months by a radiation health specialist who is on the staff of or approved by an appropriate State or local government agency.

(b) Standard-records of inspection and scope of inspection. The supplier maintains records of current inspections which include the extent to which equipment and shielding are in compliance with the safety standards outlined in § 405.1415.

Subparts O and P (Reserved)

Subpart Q-Conditions of Participation: Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and/ or Speech Pathology Services; and Conditions for CovOutpatient Physical erage: Therapy Services furnished by Physical Therapists in Independent Practice

AUTHORITY: Secs. 1102, 1861(p), and 1871 of the Social Security Act (42 U.S.C. 1302, 1395x(p), 1395hh).

SOURCE: 41 FR 20865, May 21, 1976, unless otherwise noted. Redesignated at 42 FR 52826, Sept. 30, 1977.

(a) In order to participate in the program of health insurance for the aged and disabled as a provider of outpatient physical therapy and/or speech pathology services, a clinic, rehabilitation agency, or public health agency (other than a provider of services as defined in section 1861(u) of the Social Security Act, 42 U.S.C. 1395x(u)) must meet the requirements set forth in section 1861(p)(4) thereof, 42 U.S.C. 1395x(p)(4). This section of the law states a number of specific requirements which must be met by such participating providers and authorizes the Secretary of Health and Human Services to prescribe by regulation other requirements relating to the health and safety of beneficiaries as may be found necessary.

(b) Section 1861(p) provides in pertinent part as follows:

(p) The term outpatient physical therapy services means physical therapy services furnished by a provider of services, a clinic, a rehabilitation agency, or a public health agency, or by others under an arrangement with, and under the supervision of, such provider, clinic, rehabilitation agency, or public health agency to an individual as an outpatient

excluding, however

(3) Any item or service if it would not be included under subsection (b) if furnished to an inpatient of a hospital; and

(4) Any such service

(A) If furnished by a clinic or rehabilitation agency, or by others under arrangements with such clinic or agency, unless such clinic or rehabilitation agency

(1) Provides an adequate program of physical therapy services for outpatients and has the facilities and personnel required for such program or required for the supervision of such program, in accordance with such requirements as the Secretary may specify,

(ii) Has policies, established by a group of professional personnel, including one or more physicians (associated with the clinic or rehabilitation agency) and one or more

qualified physical therapists, to govern the services (referred to in clause (i)) it provides, (iii) Maintains clinical records on all patients,

(iv) If such clinic or agency is situated in a State in which State or applicable local law provides for the licensing of institutions of this nature, (I) is licensed pursuant to such law, or (II) is approved by the agency of such State or locality responsible for licensing institutions of this nature, as meeting the standards established for such licensing; and

(v) Meets such other conditions relating to the health and safety of individuals who are furnished services by such clinic or agency on an outpatient basis, as the Secretary may find necessary, or

(B) If furnished by a public health agency, unless such agency meets such other conditions relating to health and safety of individuals who are furnished services by such agency on an outpatient basis, as the Secretary may find necessary.

The term outpatient physical therapy services also includes speech pathology services furnished by a provider of services, a clinic, rehabilitation agency, or by a public health agency, or by others under an arrangement with, and under the supervision of, such provider, clinic, rehabilitation agency, or public health agency to an individual as an outpatient, subject to the conditions prescribed in this subsection.

(c) The specific requirements included in the statute and the additional health and safety requirements prescribed by the Secretary are set forth in the following Conditions of Participation for Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and/or Speech Pathology Services.

physicians' services. To meet this definition, an organization must meet the following test of physician participation:

(1) The medical services of the clinic are provided by a group of physicians (i.e., more than two) practicing medicine together; and

(2) A physician is present in the clinic at all times during hours of operation to perform medical services (rather than only administrative services).

(c) Organization. A clinic, rehabilitation agency, or public health agency.

(d) Physical therapist. A person who is licensed as a physical therapist by the State in which he or she is practicing if the State licenses physical therapists, and

(1) Has graduated from a physical therapy curriculum approved by the American Physical Therapy Association, or by the Council on Medical Education and Hospitals of the American Medical Association, or jointly by the Council on Medical Education of the American Medical Association and the American Physical Therapy Association; or

(2) Prior to January 1, 1966:

(i) Was admitted to membership by the American Physical Therapy Association; or

(ii) Was admitted to registration by the American Registry of Physical Therapists; or

(iii) Has graduated from a physical therapy curriculum in a 4-year college or university approved by a State department of education; or

(3) Has 2 years of appropriate experience as a physical therapist and has achieved a satisfactory grade on a proficiency examination approved by the Secretary, except that such determinations of proficiency shall not apply with respect to persons initially licensed by a State after December 31, 1977, or seeking qualification as a physical therapist after such date; or

(4) (i) Was licensed or registered prior to January 1, 1966, and

(ii) Prior to January 1, 1970, had 15 years of full-time experience in the treatment of illness or injury through the practice of physical therapy in which services were rendered under the order and direction of attending and re

ferring doctors of medicine or osteopathy; or

(5) If trained outside the United States;

(i) Was graduated since 1928 from a physical therapy curriculum approved in the country in which the curriculum was located and in which there is a member organization of the World Confederation for Physical Therapy.

(ii) Meets the requirements for membership in a member organization of the World Confederation for Physical Therapy,

(iii) Has 1 year of experience under the supervision of an active member of the American Physical Therapy Association, and

(iv) Has successfully completed a qualifying examination as prescribed by the American Physical Therapy Association.

(e) Physical therapist assistant. A person who is licensed as a physical therapist assistant by the State in which he is practicing, if the State licenses such assistants, and has graduated from a 2year college-level program approved by the American Physical Therapy Association.

(f) Physician. A person who is—

(1) A doctor of medicine or osteopathy legally authorized to practice medicine and surgery by the State in which he or she performs those functions or actions; or

(2) A doctor of podiatric medicine, but only with respect to the functions which he or she is legally authorized to perform by the State in which he or she performs them.

(g) Psychologist. A person who:

(1) Holds a doctoral degree in psychology from a training program approved by the American Psychological Association; or

(2) Has attained certification or licensing by the State, or non-statutory certification by the State psychological association.

(h) Public health agency. An official agency established by a State or local government, the primary function of which is to maintain the health of the population served by performing environmental health services, preventive medical services, and in certain cases, therapeutic services.

(i) Rehabilitation agency. An agency which provides an integrated multidisciplinary program designed to upgrade the physical function of handicapped, disabled individuals by bringing together as a team specialized rehabilitation personnel. At a minimum, a rehabilitation agency must provide physical therapy or speech pathology services, and a rehabilitation program which in addition to physical therapy or speech pathology services, includes social or vocational adjustment services.

(j) Social worker. A person who is licensed by the State in which he is practicing if the State licenses social workers, is a graduate of a school of social work accredited or approved by the Council on Social Work Education, and has 1 year of social work experience in a health-care setting.

(k) Speech pathologist. A person who is licensed by the State in which he is practicing, if the State licenses speech pathologists, and

(1) Is eligible for a certificate of clinical competence in speech pathology granted by the American Speech and Hearing Association under its requirements in effect on January 17, 1974; or

(2) Meets the educational requirements for certification, and is in the process of accumulating the supervised clinical experience required for certification.

(1) Supervision. Authoritative procedural guidance by a qualified person for the accomplishment of a function or activity within such person's sphere of competence, with initial direction and periodic inspection of the actual act of accomplishing the function or activity. Unless otherwise stated in this part 405, such qualified person must be on the premises if the person performing the function or activity does not meet assistant-level qualifications specified in this section.

(m) Vocational specialist. A person who has a baccalaureate degree and:

(1) Two years experience in vocational counseling in a rehabilitation setting such as a sheltered workshop, State employment service agency, etc.;

or

(2) At least 18 semester hours in vocational rehabilitation, educational or vocational guidance, psychology, social