DPH passes its mammography inspection with flying colors

The Department of Public Health’s Division of Hospital Administration recently passed its annual Food and Drug Administration Mammography Quality Standards Act inspection with flying colors.

Radiology manager Dan Harding said the inspection performed on June 6 showed “very favorable” results.

“It is with great pride and satisfaction that I am able to announce the successful completion [of the inspection],” he said in a memorandum last Wednesday.

He said FDA’s Suzie Kent was very impressed with the every aspect of their mammography program and facility.

Harding said Kent was extremely encouraged with the changes initiated after last year’s inspection, as well as the direction of their program in the future. He said the inspection resulted in a “No Adverse Observations” status, which represents the best possible rating.

He told Saipan Tribune yesterday that the inspection aimed to verify the hospital administration’s Mammography Program if it is using proper quality control measures, maintaining patient and physician information statistics, and others.

Harding said they try to inform the patients and physicians of every scheduled inspection as soon as possible because FDA requires that they all do the dissemination process and other work for a 30-day period.

“We’re actually doing a great job,” he said.

He said his office sends its mammogram to Guam to have them rated there, then they get them back and return all the reports and results to patients and physicians.

He said the inspection last year yielded a level 1 noncompliance issue (the most serious) and nine level 2 noncompliance issues that required corrective actions to be undertaken and written responses to the FDA defining those actions.

After almost a year of determined efforts and progressive changes, Harding said his mammography staff has turned the department around.

Harding said he is commending the hard work of lead mammographer Nolia Muellersman for the great work she did for the past year. He said Muellersman overcame difficult obstacles in rebuilding the process. He said she has been instrumental in initiating, implementing and maintaining a stringent quality control program while handling a busy imaging specialty.

He also noted the efforts of the new mammographer in the hospital, Miriam Bayle, for her enthusiasm, drive, and expertise in carrying the process forward and for initiating a through and accurate record keeping system that would prove invaluable in the future.

Harding said the summary and comprehensive results of the inspection is due three weeks from now.