B-180959, DEC 26, 1974

B-180959, DEC 26, 1974

1. CONTENTION THAT ISSUANCE OF RFP SPECIFYING EVALUATION OF SPECIFIC SCANNER AS DIAGNOSTIC TOOL WAS PREJUDICIAL TO FIRM THAT HAD DEVELOPED ANOTHER SCANNER IS WITHOUT MERIT SINCE RFP CONTEMPLATED EVALUATION OF SCANNER BASED ON PARALLEL STUDIES BY 5 HOSPITALS USING SPECIFIED SCANNER, AND SUCH EVALUATION COULD NOT BE CONDUCTED ON PROTESTER'S SCANNER SINCE IT IS IN OPERATIONAL USE AT ONE HOSPITAL ONLY. 2. AWARDING OF CONTRACTS UNDER RFP WHICH SPECIFIES EVALUATION OF PARTICULAR SCANNER CANNOT BE CONSTRUED AS EITHER ADVERTISEMENT OR INDORSEMENT OF SCANNER TO THE EXCLUSION OF ALL OTHER SCANNERS, AND CONTENTION THAT GOVERNMENT WILL HELP FINANCE SCANNER IS ALSO WITHOUT FOUNDATION SINCE EACH HOSPITAL WAS REQUIRED TO PURCHASE ITS OWN SCANNER PRIOR TO AWARD.

NATIONAL BIOMEDICAL RESEARCH FOUNDATION:

ON OCTOBER 4, 1973, THE NATIONAL CANCER INSTITUTE (NCI), NATIONAL INSTITUTES OF HEALTH (NIH), DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE (HEW), ISSUED A RESEARCH AND DEVELOPMENT "SOURCES SOUGHT" ANNOUNCEMENT IN THE NIH GUIDE SUPPLEMENT FOR GRANTS AND CONTRACTS PUBLICATION. THE ANNOUNCEMENT STATED THAT NCI WAS "SEEKING THE CLINICAL EVALUATION OF COMPUTERIZED TRANSAXIAL TOMOGRAPHY (CIT) AS DETERMINED BY THE INSTRUMENT DEVELOPED BY THE CENTRAL RESEARCH LABORATORIES OF EMI ELECTRONICS AND INDUSTRIAL OPERATIONS, LTD., HAYES, MIDDLESEX, ENGLAND." IN ADDITION, THE ANNOUNCEMENT PROVIDED THAT "INSTITUTIONS ALREADY USING THIS EQUIPMENT (EMI SCANNER) OR COMMITTED TO OBTAIN THIS EQUIPMENT ARE ENCOURAGED TO SUBMIT PLANS FOR THE CLINICAL EVALUATION OF THIS EQUIPMENT. ***" THIS ANNOUNCEMENT WAS ALSO PUBLISHED IN THE COMMERCE BUSINESS DAILY PURSUANT TO FEDERAL PROCUREMENT REGULATIONS (FPR) 1-1.1003-3(A) ON OCTOBER 16, 1973. THE PROCUREMENT WAS NEGOTIATED PURSUANT TO THE AUTHORITY OF 41 U.S.C. 252(C)(15) AND 42 U.S.C. 283(D)(7).

RESPONSES WERE RECEIVED FROM 21 ORGANIZATIONS. ON DECEMBER 10, 1973, A COMMITTEE REVIEWED THE RESPONSES SUBMITTED AND SELECTED 8 ORGANIZATIONS TO RECEIVE THE REQUEST FOR PROPOSALS (RFP). RFP NO. NCI CB-74-37 FOR THE CLINICAL EVALUATION OF THE EMI SCANNER WAS ISSUED ON DECEMBER 14, 1973, TO THE 8 ORGANIZATIONS SELECTED AND TO 6 OTHER ORGANIZATIONS WHICH HAD REQUESTED COPIES. NINE PROPOSALS WERE RECEIVED IN RESPONSE TO THE SOLICITATION AND FIVE WERE CHOSEN FOR AWARD SINCE THE RFP ENVISIONED A COLLABORATIVE STUDY.

BY LETTER DATED MARCH 29, 1974, THE NATIONAL BIOMEDICAL RESEARCH FOUNDATION (NBRF) PROTESTED TO OUR OFFICE THE AWARD OF ANY CONTRACTS UNDER THE ABOVE-REFERENCED RFP. NBRF STATES THAT IT HAS DEVELOPED A COMPUTERIZED TRANSAXIAL TOMOGRAPHY UNIT, THE ACTA SCANNER, WHICH IS COMMERCIALLY AVAILABLE AND MANUFACTURED IN THE UNITED STATES AND HAS FOUR TIMES THE SPACIAL RESOLUTION AND CAN SCAN ANYWHERE ON THE WHOLE BODY. NBRF CONTENDS THAT THE RFP IN QUESTION DISCRIMINATES AGAINST ITS UNIT BY SPECIFYING THAT THE EMI SCANNER BE USED. FURTHERMORE, MBRF CONTENDS THAT THE EFFECT OF AWARDING "CONTRACTS FOR SUCH EVALUATION IS: (A) TO PROVIDE FREE GOVERNMENT ADVERTISING OF THE EMI SCANNER, (B) TO HELP FINANCE OR SUBSIDIZE THE PURCHASING OF THE EMI INSTRUMENT BY HOSPITALS SELECTED TO DO THE EVALUATION AND (C) TO GIVE A GOVERNMENTAL SEAL OF APPROVAL OF THE EMI SCANNER."

BY LETTER DATED JUNE 18, 1974, OUR OFFICE WAS INFORMED THAT THE DEPUTY ASSISTANT SECRETARY FOR GRANTS AND PROCUREMENT MANAGEMENT, HEW, DETERMINED THAT, IN ACCORDANCE WITH FPR-1-2.407-8(B)(4)(II), THE FIVE AWARDS SHOULD BE MADE NOTWITHSTANDING THE PROTEST.

THE FUNDAMENTAL ISSUE THAT OUR OFFICE MUST CONSIDER IS WHETHER THE ISSUANCE OF THE RFP WHICH SPECIFIED EVALUATION OF THE EMI SCANNER WAS PROPER. 42 U.S.C. 286A.(B) PROVIDES:

"IN CARRYING OUT THE NATIONAL CANCER PROGRAM, THE DIRECTOR OF THE NATIONAL CANCER INSTITUTE SHALL:

"(4) COLLECT, ANALYZE, AND DISSEMINATE ALL DATA USEFUL IN THE PREVENTION, DIAGNOSIS, AND TREATMENT OF CANCER, INCLUDING THE ESTABLISHMENT OF AN INTERNATIONAL CANCER RESEARCH DATA BANK TO COLLECT, CATALOG, STORE, AND DISSEMINATE INSOFAR AS FEASIBLE THE RESULTS OF CANCER RESEARCH UNDERTAKEN IN ANY COUNTRY FOR THE USE OF ANY PERSON INVOLVED IN CANCER RESEARCH IN ANY COUNTRY."

THE DIVISION OF CANCER BIOLOGY DIAGNOSIS (DCBD) HAS THE PRIMARY RESPONSIBILITY WITHIN THE NCI FOR THE PLANNING AND FUNDING OF RESEARCH PROGRAMS CONCERNED WITH DIAGNOSES OF HUMAN CANCERS. AS STATED BY THE DIRECTOR OF THAT DIVISION, "A NATURAL CONSEQUENCE OF SUCH RESPONSIBILITY IS A STRONG INTEREST IN DETERMINING THE POTENTIAL VALUE OF DIAGNOSTIC INSTRUMENTS CURRENTLY ON THE MARKET, INSOFAR AS THE AVAILABILITY OF EFFECTIVE METHODS OF DIAGNOSES IS AN IMPORTANT KEY TO THE ACHIEVEMENT OF OUR OVERALL GOAL; MAKING IT POSSIBLE TO DIAGNOSE HUMAN CANCERS EARLY ENOUGH TO ALLOW FOR EFFECTIVE METHODS OF THERAPY."

THE RFP STATED THAT THE PROGRAM OBJECTIVES WERE, IN PART, AS FOLLOWS:

"A. PROGRAM OBJECTIVES

"THE EMI SCANNER DEVELOPED WITHIN THE LAST THREE YEARS IN THE UNITED KINGDOM AND NOW AVAILABLE IN A LIMITED NUMBER OF INSTITUTIONS IN THE UNITED STATES IS BELIEVED TO REPRESENT A NEW MODE OF DIAGNOSIS OF INTRACRANIAL LESIONS WITHOUT THE USE OF CONTRAST MEDIA. THE PRESENT PROGRAM IS TARGETED TO EVALUATE THIS NEW INSTRUMENT AS A DIAGNOSTIC TOOL.

"THIS PARTICULAR PROJECT HAS AS ITS OBJECTIVE THE EVALUATION OF THE EMI SCANNER IN THE DIAGNOSIS OF INTRACRANIAL LESIONS."

WE HAVE BEEN INFORMED BY THE PROCURING ACTIVITY THAT THE EMI SCANNER FIRST CAME TO THE ATTENTION OF NCI AS THE RESULT OF AN ARTICLE PUBLISHED IN THE JANUARY 1, 1973, ISSUE OF THE JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION. THE DIRECTOR OF THE DIVISION OF CANCER BIOLOGY AND DIAGNOSIS SUGGESTED THE FUNDING OF A CONTRACT TO EVALUATE THE EMI SCANNER AT A MEETING OF THE INSTITUTES DIAGNOSTIC RADIOLOGY COMMITTEE ON JULY 5 AND 6, 1973. NCI FIRST BECAME AWARE OF THE ACTA SCANNER AS THE RESULT OF AN ARTICLE PUBLISHED IN THE WASHINGTON STAR NEWS ON OCTOBER 9, 1973, WHICH WAS 5 DAYS SUBSEQUENT TO THE INITIAL PUBLICATION OF THE "SOURCES SOUGHT" ANNOUNCEMENT. THIS ARTICLE STATED THAT THE ACTA SCANNER WAS SCHEDULED TO GO INTO OPERATION IN GEORGETOWN HOSPITAL IN NOVEMBER 1973. AN ARTICLE WHICH APPEARED IN THE OCTOBER 20, 1973, ISSUE OF THE NATIONAL OBSERVER, STATED THAT ONLY ONE ACTA SCANNER HAD BEEN BUILT THUS FAR BUT THAT THE PRESIDENT OF NBRF "*** SAYS HE EXPECTS THE DEVICES WILL BE MARKETED COMMERCIALLY WITHIN SIX MONTHS ***." WE HAVE BEEN INFORMED BY NBRF THAT THE ACTA SCANNER WAS BOUGHT BY GEORGETOWN HOSPITAL IN NOVEMBER 1973 AND THAT GEORGETOWN HAS BEEN USING IT ON PATIENTS SINCE FEBRUARY 1974.

THE PURPOSE OF THE RFP WAS TO PROVIDE FOR THE EVALUATION OF THE EMI SCANNER AS A DIAGNOSTIC TOOL FOR THE DETECTION OF BRAIN TUMORS. THE RESEARCH CONSISTS OF PARALLEL EVALUATIONS, CONDUCTED PURSUANT TO A PROTOCOL ESTABLISHED BY NCI, BY FIVE HOSPITALS OR HEALTH FACILITIES WHICH POSSESS EMI SCANNERS. NCI EXPECTS THAT BY UTILIZING A PARALLEL EVALUATION SYSTEM, SUFFICIENT CLINICAL DATA CAN BE GENERATED TO DEMONSTRATE THE DIAGNOSTIC VALUE OF THE INSTRUMENT.

THE RFP SPECIFIED THE USE OF THE EMI SCANNER BECAUSE IT WAS THE ONLY SCANNER IN USE AT A NUMBER OF HOSPITALS IN THE UNITED STATES. THE ACTA SCANNER COULD NOT BE CLINICALLY EVALUATED AS CONTEMPLATED BY THE RFP SINCE, AT PRESENT, IT IS IN OPERATIONAL USE AT ONLY ONE HOSPITAL, AND THUS, COULD NOT GENERATE SUFFICIENT CLINICAL DATA FOR EVALUATION. SINCE THE ACTA SCANNER, WHICH IS THE ONLY OTHER SCANNER IN EXISTENCE AT THIS TIME, COULD NOT BE CLINICALLY EVALUATED IN THE MANNER CONTEMPLATED, WE SEE NO BASIS FOR QUESTIONING THE ISSUANCE OF THE RFP LIMITING EVALUATION TO THE EMI SCANNER AND CONCLUDE THAT IT WAS A PROPER EXERCISE OF THE AUTHORITY OF THE PROCURING ACTIVITY TO DETERMINE ITS PRESENT NEEDS. SHOULD BE NOTED THAT WE HAVE BEEN INFORMED BY THE PROCURING ACTIVITY OF THE POSSIBILITY OF EVALUATING THE ACTA SCANNER AT SUCH TIME AS IT IS COMMERCIALLY AVAILABLE AND IS IN USE BY MORE THAN ONE ORGANIZATION, PARTICULARLY IN REFERENCE TO ITS STATED ABILITY TO DETECT LESIONS THROUGHOUT THE ENTIRE BODY.

WITH REGARD TO WHAT NBRF CONTENDS ARE THE EFFECTS OF THE AWARD OF CONTRACTS UNDER THE RFP, WE DO NOT BELIEVE THAT THE AWARDS OF THE CONTRACTS IN QUESTION CAN BE CONSTRUED AS EITHER AN INDORSEMENT OR ADVERTISEMENT OF THE EMI SCANNER TO THE EXCLUSION OF ALL OTHER SCANNERS. INDEED, IT APPEARS TO US THAT PRUDENT PROSPECTIVE PURCHASERS OF THE EMI SCANNER WOULD AWAIT THE RESULTS OF THE CLINICAL EVALUATION, WHICH MAY PROVE TO BE UNFAVORABLE, BEFORE FURTHER PURCHASES OF IT ARE MADE. MOREOVER, WE HAVE ASCERTAINED THAT FOUR OF THE FIVE CONTRACTORS HAD MADE COMMITMENTS TO PURCHASE EMI SCANNERS AT LEAST SIX MONTHS PRIOR TO THE ISSUANCE OF THE "SOURCES SOUGHT" ANNOUNCEMENT OF OCTOBER 4, 1973. THE FIFTH CONTRACTOR MADE ITS COMMITMENT TO PURCHASE THE EMI SCANNER ON JANUARY 8, 1974. CLEARLY, AT LEAST AS TO FOUR OF THE FIVE CONTRACTORS, THE ISSUANCE OF THE RFP DID NOT OPERATE AS AN INDORSEMENT OR ADVERTISEMENT OF THE EMI SCANNER. NOR MAY IT BE SAID THAT THE FOUR CONTRACTORS COMMITTED THEMSELVES TO PURCHASE THE SCANNER IN ANTICIPATION OF THE ISSUANCE OF THE RFP. ALTHOUGH WE MAY NOT SAY THAT SUCH WAS THE CASE WITH RESPECT TO THE FIFTH CONTRACTOR, WE MAY CONJECTURE THAT ITS COMMITMENT COULD HAVE BEEN INFLUENCED BY CONSIDERATIONS SEPARATE AND APART FROM ISSUANCE OF THE RFP.

FURTHERMORE, THERE IS NO BASIS FOR CONTENDING THAT THE GOVERNMENT WILL HELP FINANCE THE EMI SCANNER SINCE AN ORGANIZATION COULD ONLY BE CONSIDERED FOR AWARD IF IT HAD AN EMI SCANNER OR A COMMITMENT TO PURCHASE ONE, AND EACH OF THE FIVE HOSPITALS HAD, IN FACT, PURCHASED AN EMI SCANNER PRIOR TO AWARD. IN ADDITION, THE RFP CLEARLY STATES THAT "THE GOVERNMENT WILL NOT PAY FOR THE PRELIMINARY EXAMINATIONS SUCH AS NEUROLOGICAL EXAMINATIONS, LUMBAR TAP, SKULL X-RAYS AND OTHER USUAL AND STANDARD CARE PROCEDURES."

FOR THE REASONS SET FORTH ABOVE, THE PROTEST OF NBRF IS DENIED.