Md. Code Regs. 26.12.02.05

Current through Register Vol. 51, No. 18, September 6, 2024

Section 26.12.02.05 - Inspection Procedures

A. Procedures Common To All Radiation Machine Inspections. The inspector shall:

(1) Notify the Department's Radiological Health Program immediately by telephone if a situation is discovered where a person could receive an excess radiation dose due to a radiation machine not meeting the requirements of Sections A., B., E., F., H., I., or J. of the Regulations for the Control of Ionizing Radiation (1994), which is incorporated by reference in COMAR 26.12.01.01 a and if that dose may cause an imminent and substantial endangerment to health;

(2) Record all information required by the State Certification Data Forms;

(3) Observe if the notices to workers are posted as required by Section J. of the incorporated document in COMAR 26.12.01.01 a;

(4) Observe if the warning signs and instructions of Sections D. and F. of the incorporated document in COMAR 26.12.01.01 a are posted when required;

(5) Determine the adequacy of the personnel monitoring system if a system is required by Section D.202 of the incorporated document in COMAR 26.12.01.01 a;

(6) Forward a copy of the inspection report to the Department not later than 30 calendar days after the beginning of each radiation machine inspection; and

(7) Record the nature of any machine adjustments or repairs that are carried out during the time of the inspection on the appropriate spaces provided on the Department inspection report forms.

B. Inspections Performed According to Procedures.

(1) While inspecting a radiation machine, an inspector shall use a procedure that is adequate to determine compliance with the requirement of this subtitle.

(2) An inspector may not use an inspection test procedure that has been found by the Department to be an unacceptable test procedure under §C of this regulation.

(3) The Department will periodically audit the performance of inspectors, including verification that at least one State certification was performed during the licensing period.

C. Finding of Unacceptability of Test Procedure.

(1) Upon request by the Department, an inspector shall provide a schedule of forthcoming inspections of radiation machines.

(2) An inspector shall cooperate with any agent of the Department while the agent is auditing the performance of a radiation machine inspection.

(3) Initial Finding.

(a) Based upon audit information, inspection report information or any other pertinent information known to the Department, the Department may notify an inspector that a procedure or part of a procedure used under §B is questionable and shall provide the reasons for this finding.

(b) Not later than 20 calendar days following receipt of the notification under §C(3)(a), of this regulation, the inspector shall forward to the Department a detailed, written description of the questionable inspection procedure.

(c) If an inspector does not meet the requirement of §C(3)(b), of this regulation, a finding that a procedure is questionable under §C(3)(a), of this regulation, shall become a finding of unacceptability for the purpose of §B of this regulation.

(d) Based upon the information received under §C(3)(a) and (b), of this regulation, the Department shall notify the inspector within 25 calendar days following the forwarding of the written description under §C(3)(b), of this regulation, that the questionable inspection procedure is found to be:

(i) Acceptable; or

(ii) Initially unacceptable.

(4) Final Finding.

(a) If an initially unacceptable finding is made under §C(3)(d)(ii), the inspector may request that a final finding be made under this regulation.

(b) A finding that a procedure is initially unacceptable shall become a final finding of unacceptability for the purpose of §B, of this regulation, if the inspector does not request a final finding within 14 calendar days following the inspector's receipt of notification under §C(3)(d) of this regulation.

(c) Not later than 60 calendar days following the Department's receipt of the request for a final finding under §C(4)(a), of this regulation, the inspector shall conduct a personal demonstration for the Department of the inspection procedure in question. The personal demonstration may include:

(i) A physical demonstration of the procedure using the type of radiation machine that it was designed to inspect;

(ii) A mathematical demonstration of the theory upon which the procedure is based; or

(iii) Any other method of demonstration agreed to by the Department.

(d) A demonstration arranged by the inspector under §C(4)(c) of this regulation shall be made:

(i) At a time and location convenient to the Department;

(ii) At a reasonable expense to the Department; and

(iii) According to a demonstration protocol prepared by the inspector and approved by the Department.

(e) In making its final finding, the Department will determine whether the inspector has presented sufficient additional information that will allow the Department to change the initially unacceptable finding to an acceptable finding.

(5) In making its initial or final finding, the Department will determine whether the inspector has demonstrated, to the satisfaction of the Department, that the questionable inspection procedure can produce data that is as accurate and precise as the applicable reference inspection procedure.

D. Use of Unlicensed Personnel.

(1) Other than as provided in §C(2) of this regulation, the use of unlicensed persons in the conduct of a certification inspection is not allowed.

(2) An inspector may use an unlicensed assistant or trainee during the course of an inspection if the assistant or trainee is under the personal supervision of the licensee at all times. "Personal supervision" means guidance and instruction provided to an assistant or trainee by an inspector licensed under this chapter who is present at the site, in visual contact with the assistant or trainee while the assistant or trainee is using sources of radiation, and in such proximity that immediate advice or assistance can be given.

Md. Code Regs. 26.12.02.05

Regulations .05 adopted April 30, 1987 (14:4 Md. R. 418)
Regulation .05A, B amended effective March 29, 2004 (31:6 Md. R. 510)
Regulation .05D adopted effective October 20, 1997 (24:21 Md. R. 1453)