B-220683, NOV 22, 1985, OFFICE OF GENERAL COUNSEL

B-220683: Nov 22, 1985

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SINCE THIS IS A MATTER OF RESPONSIBILITY AND THEREFORE THE REQUIRED AUTHORIZATION NEED ONLY BE OBTAINED PRIOR TO THE SCHEDULED START OF PERFORMANCE. WE HAVE NO RECORD OF ADAC'S HAVING FILED A PROTEST WITH OUR OFFICE. ADAC QUESTIONED WHETHER THE RADIATION THERAPY PLANNING SYSTEM THAT COMPUTERIZED MEDICAL SYSTEMS PROPOSED TO SUPPLY TO THE AIR FORCE WAS PROPERLY REGISTERED WITH THE FOOD AND DRUG ADMINISTRATION (FDA). THE CONTRACTING OFFICER CONTACTED AN FDA OFFICIAL ABOUT THE MATTER AND WAS TOLD THAT IF THE PRODUCT HAD BEEN IN USE BEFORE MAY 1976 (WHEN THE REGISTRATION REQUIREMENTS WENT INTO EFFECT). IT WAS "GRANDFATHERED" IN AND DID NOT HAVE TO GO THROUGH THE REGISTRATION PROCESS. THE PRESIDENT TOLD HER THAT IT DID NOT AND THAT HE WAS REASONABLY CERTAIN THAT NO SUCH APPROVAL WOULD BE NEEDED.

B-220683, NOV 22, 1985, OFFICE OF GENERAL COUNSEL

CONTRACTORS - RESPONSIBILITY - DETERMINATION - DEFINITIVE RESPONSIBILITY CRITERIA - COMPLIANCE DIGEST: AS A MATTER OF INFORMATION TO A MEMBER OF CONGRESS WHOSE CONSTITUENT'S PROTEST WOULD BE UNTIMELY UNDER THE BID PROTEST REGULATIONS, GAO CONCLUDES THAT THE AIR FORCE ACTED PROPERLY IN MAKING AWARD TO A FIRM WHOSE PRODUCT HAS NOT RECEIVED FDA APPROVAL, SINCE THIS IS A MATTER OF RESPONSIBILITY AND THEREFORE THE REQUIRED AUTHORIZATION NEED ONLY BE OBTAINED PRIOR TO THE SCHEDULED START OF PERFORMANCE.

THE HONORABLE JIM SASSER:

UNITED STATES SENATE

WE REFER TO YOUR LETTER OF OCTOBER 2, 1985, CONCERNING A PROTEST FILED BY ADAC LABORATORIES OF BRENTWOOD, TENNESSEE, WITH TRAVIS AIR FORCE BASE, CALIFORNIA, REGARDING A CONTRACT AWARDED TO COMPUTERIZED MEDICAL SYSTEMS, INC. UNDER INVITATION FOR BIDS (IFB) NO. F04626-85 B0055.

AS YOU KNOW, OUR OFFICE CONSIDERS PROTESTS SUCH AS ADAC'S UNDER OUR BID PROTEST REGULATIONS, 4 C.F.R. PART 21 (1985). HOWEVER, WE HAVE NO RECORD OF ADAC'S HAVING FILED A PROTEST WITH OUR OFFICE. THE AIR FORCE INFORMS US THAT ADAC DID FILE A PROTEST WITH THE CONTRACTING OFFICER ON AUGUST 26, 1985. IN THIS AGENCY-LEVEL PROTEST, ADAC QUESTIONED WHETHER THE RADIATION THERAPY PLANNING SYSTEM THAT COMPUTERIZED MEDICAL SYSTEMS PROPOSED TO SUPPLY TO THE AIR FORCE WAS PROPERLY REGISTERED WITH THE FOOD AND DRUG ADMINISTRATION (FDA), AS REQUIRED BY SECTION 510(K) OF THE PURE FOOD, DRUG, AND COSMETIC ACT, 21 U.S.C. 360(K) (1982).

ACCORDING TO THE PROTEST FILE FORWARDED TO US BY THE AIR FORCE, THE CONTRACTING OFFICER CONTACTED AN FDA OFFICIAL ABOUT THE MATTER AND WAS TOLD THAT IF THE PRODUCT HAD BEEN IN USE BEFORE MAY 1976 (WHEN THE REGISTRATION REQUIREMENTS WENT INTO EFFECT), IT WAS "GRANDFATHERED" IN AND DID NOT HAVE TO GO THROUGH THE REGISTRATION PROCESS; HOWEVER, THE FDA STATED, IF THE PRODUCT HAD BEEN ALTERED IN OTHER THAN AESTHETIC APPEARANCE AFTER MAY 1976, FDA APPROVAL PROBABLY WOULD BE REQUIRED.

AFTER LEARNING THIS, THE CONTRACTING OFFICER STATES THAT SHE CONTACTED THE PRESIDENT OF COMPUTERIZED MEDICAL SYSTEMS TO DETERMINE WHETHER THE PROPOSED SYSTEM HAD THE FDA APPROVAL. THE PRESIDENT TOLD HER THAT IT DID NOT AND THAT HE WAS REASONABLY CERTAIN THAT NO SUCH APPROVAL WOULD BE NEEDED. HE STATED, HOWEVER, THAT HE COULD NOT BE SURE UNTIL HE RECEIVED AN FDA FORM HE HAD REQUESTED THAT WOULD TELL HIM WHETHER CHANGES MADE IN THE SYSTEM SINCE ITS ORIGINAL MANUFACTURE MADE IT NECESSARY TO FILE FOR FDA APPROVAL. THE CONTRACTING OFFICER ALSO STATES THAT SHE LEARNED THAT THE SYSTEM WAS IN USE IN A NUMBER OF GOVERNMENT FACILITIES AROUND THE COUNTRY AND THAT NO PRIOR FDA APPROVAL HAD BEEN REQUIRED FOR THOSE PROCUREMENTS.

APPARENTLY THE AIR FORCE CONCLUDED THAT THE SYSTEM DID IN FACT REQUIRE FDA APPROVAL, SINCE THE RECORD INDICATES THAT COMPUTERIZED MEDICAL SYSTEMS HAS FILED THE NECESSARY PAPER WORK WITH THE FDA AND THE AIR FORCE INFORMS US THAT IT WILL NOT ALLOW THE FIRM TO BEGIN CONTRACT PERFORMANCE UNTIL THE PROPOSED SYSTEM IS APPROVED. IF THE FDA SHOULD NOT APPROVE THE SYSTEM, THE AIR FORCE STATES THAT IT WILL TERMINATE THE COMPUTERIZED MEDICAL SYSTEMS CONTRACT AND RESOLICIT THE REQUIREMENT.

THE AIR FORCE PROTEST FILE INDICATES THAT ON SEPTEMBER 6, 1985, THE CONTRACTING OFFICER EXPLAINED THIS TO ADAC'S GENERAL MANAGER, WHO ORALLY WITHDREW THE PROTEST. THIS ORAL WITHDRAWAL WAS LATER CONFIRMED IN A LETTER DATED SEPTEMBER 26, 1985. ON SEPTEMBER 16 (10 DAYS BEFORE IT CONFIRMED ITS ORAL WITHDRAWAL IN WRITING), HOWEVER, ADAC WROTE YOU COMPLAINING ABOUT THE AIR FORCE'S DECISION AND ASKING YOU TO INVESTIGATE THE MATTER FURTHER.

UNDER OUR REGULATIONS, ADAC SHOULD HAVE FILED A PROTEST WITH OUR OFFICE NOT LATER THAN 10 WORKING DAYS AFTER IT LEARNED OF THE AIR FORCE'S POSITION (IN OTHER WORDS, NOT LATER THAN SEPTEMBER 20). AT THIS POINT, HOWEVER, ANY PROTEST FILED BY ADAC WOULD BE UNTIMELY. SEE 4 C.F.R. SEC. 21.2(A)(3).

NEVERTHELESS, FROM THE INFORMATION AVAILABLE TO US, IT APPEARS THAT THE AIR FORCE IS ACTING PROPERLY. WHERE, AS HERE, A SOLICITATION DOES NOT SPECIFICALLY REQUIRE SECTION 510(K) APPROVAL AT THE TIME OF AWARD, THE CONTRACTING AGENCY MAY MAKE AN AWARD TO A COMPANY THAT LACKS THIS NECESSARY AUTHORIZATION, PROVIDED THE AWARDEE REASONABLY CAN BE EXPECTED TO OBTAIN APPROVAL BEFORE PERFORMANCE BEGINS. THIS INVOLVES THE CONTRACTOR'S RESPONSIBILITY-- IN THIS CASE, ITS ABILITY TO OBTAIN 510(K) APPROVAL BEFORE PERFORMANCE OF THE CONTRACT. OUR OFFICE DOES NOT REVIEW AFFIRMATIVE DETERMINATIONS OF RESPONSIBILITY UNLESS THERE IS A SHOWING OF POSSIBLE FRAUD OR THE SOLICITATION CONTAINS DEFINITIVE RESPONSIBILITY REQUIREMENTS THAT ALLEGEDLY HAVE NOT BEEN MET. SEE IMPACT INSTRUMENTATION, INC., B-217291, FEB. 26, 1985, 85-1 CPD PARA. 240. ADAC'S PROTEST DOES NOT FALL WITHIN EITHER EXCEPTION.

THEREFORE, UNDER THE FACTS PRESENTED, WE CANNOT SAY THAT THE AIR FORCE'S DECISION TO AWARD THE CONTRACT AND DELAY THE START OF PERFORMANCE UNTIL COMPUTERIZED MEDICAL SYSTEMS RECEIVED FDA APPROVAL IS LEGALLY OBJECTIONABLE.

I HOPE THIS INFORMATION WILL BE HELPFUL TO YOU.