CMS SOM App. L, Tag Q-0203

. . . must meet the requirements specified in § 482.26(b), (c)(2), and (d)(2) of this

chapter.

Interpretive Guidelines §416.49(b)(1)

The scope and complexity of radiological services provided within the ASC, either

directly or under arrangement, as an integral part of the ASC’s surgical services must be

specified in writing and approved by the governing body. The ASC must also ensure that

the provision of radiological services in the ASC complies with the hospital radiologic

services requirements at § 482.26(b), (c)(2), and (d)(2), regardless of whether the service

is provided directly by the ASC or under arrangement.

The interpretive guidelines for § 482.26(b), (c)(2), and (d)(2) in Appendix A, Survey

Protocol, Regulations and Interpretive Guidelines for Hospitals of the State Operations

Manual, provide the following guidance in determining compliance:

§482.26(b) Standard: Safety for Patients and Personnel

The radiologic services, particularly ionizing radiology procedures, must be free from

hazards for patients and personnel.

Interpretive Guidelines §482.26(b)

The hospital must adopt and implement policies and procedures that provide safety for

patients and personnel.

Survey Procedures §482.26(b)

Observe locations where radiological services are provided. Are they safe for patients

and personnel? Are any hazards to patients or personnel observed?

§482.26(b)(1) Proper safety precautions must be maintained against radiation

hazards. This includes adequate shielding for patients, personnel, and facilities, as

well as appropriate storage, use and disposal of radioactive materials.

Interpretive Guidelines §482.26(b)(1)

The hospital policies must contain safety standards for at least:

• Adequate shielding for patients, personnel and facilities;

• Labeling of radioactive materials, waste, and hazardous areas;

• Transportation of radioactive materials between locations within the

hospital;

• Security of radioactive materials, including determining who may have

access to radioactive materials and controlling access to radioactive

materials;

• Testing of equipment for radiation hazards;

• Maintenance of personal radiation monitoring devices;

• Proper storage of radiation monitoring badges when not in use;

• Storage of radio nuclides and radio pharmaceuticals as well as radioactive

waste; and

• Disposal of radio nuclides, unused radio pharmaceuticals, and radioactive

waste.

• Methods of identifying pregnant patients.

The hospital must implement and ensure compliance with its established safety standards.

Survey Procedures §482.26(b)(1)

• Verify that patient shielding (aprons, etc.) are properly maintained and

routinely inspected by the hospital.

• Verify that hazardous materials are stored properly in a safe manner.

• Observe areas where testing is done for violations in safety precautions.

§482.26(b)(2) Periodic inspection of equipment must be made and hazards identified

must be properly corrected.

Interpretive Guidelines §482.26(b)(2)

The hospital must have policies and procedures in place to ensure that periodic

inspections of radiology equipment are conducted, current and that problems identified

are corrected in a timely manner. The hospital must ensure that equipment is inspected in

accordance with manufacturer’s instructions, Federal and State laws, regulations, and

guidelines, and hospital policy. The hospital must have a system in place, qualified

employees or contracts, to correct hazards. The hospital must be able to demonstrate

current inspection and proper correction of all hazards.

Survey Procedures §482.26(b)(2)

• Review the inspection records (logs) to verify that periodic inspections are

conducted in accordance with manufacturer’s instructions, Federal and

State laws, regulations, and guidelines and hospital policy.

• Determine that any problems identified are properly corrected in a timely

manner.

§482.26(b)(3) Radiation workers must be checked periodically, by the use of

exposure meters or badge tests, for amount of radiation exposure.

Interpretive Guidelines §482.26(b)(3)

The requirement that “radiation workers must be checked periodically, by use of

exposure meters or badge tests, for amount of radiation exposure” would include

radiological services personnel, as well as, other hospital employees who may be

regularly exposed to radiation due to working near radiation sources. This could include

personnel such as certain nursing and maintenance staff.

Survey Procedures §482.26(b)(3)

• Verify that the hospital requires periodic checks on all radiology personnel

and any other hospital staff exposed to radiation and that the personnel are

knowledgeable about radiation exposure for month, year, and

cumulative/entire working life.

• Observe that appropriate staff have a radiation-detecting device and that

they appropriately wear their radiation detecting device.

• Review records to verify that periodic tests of radiology personnel by

exposure meters or test badges are performed.

§482.26(b)(4) Radiologic services must be provided only on the order of

practitioners with clinical privileges or, consistent with State law, of other

practitioners authorized by the medical staff and the governing body to order the

services.

Survey Procedures §482.26(b)(4)

Review medical records to determine that radiological services are provided only on the

orders of practitioners with clinical privileges and to practitioners outside the hospital

who have been authorized by the medical staff and the governing body to order

radiological services, consistent with State law.

§482.26(c)(2) Only personnel designated as qualified by the medical staff may use

the radiologic equipment and administer procedures.

Interpretive Guidelines §482.26(c)(2)

There should be written policies, developed and approved by the medical staff, consistent

with State law, to designate which personnel are qualified to use the radiological

equipment and administer procedures.

Survey Procedures §482.26(c)(2)

Determine which staff are using differing pieces of radiological equipment and/or

administering patient procedures. Review their personnel folders to determine they meet

the qualifications established by the medical staff for the tasks they perform.

§482.26(d)(2) The hospital must maintain the following for at least 5 years:

(i) Copies of reports and printouts

(ii) Films, scans, and other image records, as appropriate.

Interpretive Guidelines §482.26(d)(2)

Patient radiology records are a type of patient medical record. The hospital must

maintain radiology records in compliance with the medical records CoP and this CoP.

Medical records, including radiology records, must be maintained for 5 years.

Survey Procedures §482.26(d)(2)

• Verify that the hospital maintains records for at least 5 years.

• Verify that radiology records are maintained in the manner required by the

Medical Records….” [CfC].

Survey Procedures: §416.49(b)(1)

• If the ASC provides radiologic services as an integral part of surgical

procedures, does it comply with the requirements of §482.26(b), (c)(2),

and (d)(2) in its provision of those services, using the hospital radiologic

services interpretive guidelines cited above?

• Interview the individual designated responsible for assuring compliance

with this CfC and review related documentation to assess how these

responsibilities have been implemented in the ASC. For example, is there

evidence that this individual monitors and/or oversees the monitoring of

compliance with all of the requirements in §482.26(b), (c)(2), and (d)(2)?

What steps are available to this individual to remedy the situation if there

is evidence of noncompliance with any of the requirements?