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B-165631, JUN 29, 1972

B-165631 Jun 29, 1972
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GAO WILL ACCEPT THE TECHNICAL DETERMINATIONS OF THE PROCURING AGENCIES UNLESS SUCH DECISIONS ARE SHOWN TO BE ARBITRARY OR CAPRICIOUS. H. EMERSON COMPANY: REFERENCE IS MADE TO YOUR LETTER OF MARCH 1. THAT CLINICAL TESTS WERE ALSO MADE AT VARIOUS STAGES WITH PROTOTYPES OF THE DEVICE ON HUMAN PATIENTS. 000 HOUR CONTINUOUS DUTY TEST AT ABERDEEN PROVING GROUNDS WHICH WAS STATED TO SIMULATE MANY YEARS OF NORMAL USE. IN VIEW OF SUCH DATA AND THE WELL-ESTABLISHED POSITION OF OUR OFFICE TO ACCEPT THE TECHNICAL DETERMINATIONS OF THE PROCURING AGENCIES UNLESS SUCH DECISIONS ARE SHOWN TO BE ARBITRARY. YOU NOW STATE THAT THE PROCUREMENT IS DESIGNED TO BENEFIT AN ENGINEER EMPLOYED BY MERDL WHO POSSESSES A PATENT ON THE RESUSCITATOR.

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B-165631, JUN 29, 1972

BID PROTEST - TECHNICAL EVALUATIONS - DETERMINATION BY AGENCY DECISION DENYING A REQUEST BY J. H. EMERSON COMPANY FOR RECONSIDERATION OF DECISION B-165631, JUNE 25 AND NOVEMBER 24, 1970, WHICH DENIED ITS PROTEST UNDER RFP NO. DSA 120-70-R-1216, ISSUED BY THE DEFENSE PERSONNEL SUPPORT CENTER, FOR THE PROCUREMENT OF 422 FIELD RESUSCITATORS. GAO WILL ACCEPT THE TECHNICAL DETERMINATIONS OF THE PROCURING AGENCIES UNLESS SUCH DECISIONS ARE SHOWN TO BE ARBITRARY OR CAPRICIOUS. THE RECORD IN THIS CASE DOES NOT SUPPORT PROTESTANT'S CONTENTIONS REGARDING THE SUITABILITY OF THE EQUIPMENT AND, THEREFORE, THE REQUEST FOR RECONSIDERATION MUST BE DENIED.

TO J. H. EMERSON COMPANY:

REFERENCE IS MADE TO YOUR LETTER OF MARCH 1, 1971, AND SUBSEQUENT CORRESPONDENCE REQUESTING RECONSIDERATION OF OUR DECISION B-165631, JUNE 25 AND NOVEMBER 24, 1970, WHICH DENIED YOUR PROTEST UNDER RFP NO. DSA 120- 70-R-1216, ISSUED BY THE DEFENSE PERSONNEL SUPPORT CENTER, DEFENSE SUPPLY AGENCY (DSA), FOR THE PROCUREMENT OF 422 FIELD RESUSCITATORS, 110 VOLT, 60 CYCLE, AC, OR 24 VOLT, DC, STOCK NUMBER 6515-926-9157.

THE PRINCIPAL ELEMENT OF YOUR PROTEST INVOLVED THE PROPOSITION THAT THE DEVICES HAD NOT BEEN SUFFICIENTLY TESTED TO JUSTIFY THE PROPOSED USES OF THE RESUSCITATORS.

IN RESPONSE TO YOUR ALLEGATION DSA FURNISHED US WITH A COMPREHENSIVE REPORT FROM THE MEDICAL EQUIPMENT RESEARCH AND DEVELOPMENT LABORATORY (MERDL), DEPARTMENT OF THE ARMY, WHICH STATED THAT THE RESUSCITATORS HAD BEEN GIVEN EXTENSIVE LABORATORY AND CLINICAL TESTS AT SEVERAL CIVILIAN AND MILITARY INSTALLATIONS DURING THE DEVELOPMENT OF THE UNITS; THAT CLINICAL TESTS WERE ALSO MADE AT VARIOUS STAGES WITH PROTOTYPES OF THE DEVICE ON HUMAN PATIENTS; THAT THE BASIC DURABILITY AND SUITABILITY OF THE DEVICE HAD BEEN DEMONSTRATED IN A 1,000 HOUR CONTINUOUS DUTY TEST AT ABERDEEN PROVING GROUNDS WHICH WAS STATED TO SIMULATE MANY YEARS OF NORMAL USE; AND THAT THE UNIT ELIMINATED THE NEED FOR USING A PROPRIETARY RESUSCITATOR VALVE.

IN VIEW OF SUCH DATA AND THE WELL-ESTABLISHED POSITION OF OUR OFFICE TO ACCEPT THE TECHNICAL DETERMINATIONS OF THE PROCURING AGENCIES UNLESS SUCH DECISIONS ARE SHOWN TO BE ARBITRARY, WE COULD NOT CONCLUDE THAT AN ADEQUATE BASIS HAD BEEN ESTABLISHED WHICH WOULD JUSTIFY OUR INTERFERENCE WITH DSA'S PROPOSED PROCUREMENT OF THE RESUSCITATORS. IN VIEW THEREOF, DSA PROCEEDED WITH THE PROCUREMENT AND MADE AN AWARD UNDER THE SUBJECT RFP TO GLOBE SAFETY PRODUCTS, INC; ON JANUARY 28, 1971.

YOU NOW STATE THAT THE PROCUREMENT IS DESIGNED TO BENEFIT AN ENGINEER EMPLOYED BY MERDL WHO POSSESSES A PATENT ON THE RESUSCITATOR; THAT THE USE OF YOUR RESUSCITATOR VALVE DOES NOT RESTRICT COMPETITION IN RESUSCITATOR PROCUREMENTS; THAT THE DEVICE AS SPECIFIED WILL NOT OPERATE ON TANKED OXYGEN; AND THAT THE MERDL REPORT, NOTED ABOVE, CONTAINED MISSTATEMENTS. YOU ALSO STATE AGAIN THAT THE DEVICES HAVE NOT BEEN SUFFICIENTLY TESTED TO JUSTIFY PURCHASING THE SUBJECT REQUIREMENT.

IN REPORTS DATED APRIL 5 AND APRIL 26, 1971, COPIES OF WHICH HAVE BEEN FURNISHED TO YOUR CONCERN, DSA HAS FURNISHED THIS OFFICE WITH RESPONSES TO YOUR ALLEGATIONS.

WITH RESPECT TO YOUR STATEMENT THAT A MERDL ENGINEER WILL FINANCIALLY BENEFIT FROM THE PATENT WHICH HE HAS ON THE RESUSCITATOR, MERDL STATES THAT THE GOVERNMENT HAS BEEN GRANTED AN IRREVOCABLE, WORLD-WIDE, NONEXCLUSIVE, ROYALTY FREE LICENSE TO THE DEVICE, AND THAT THERE CAN BE NO FINANCIAL BENEFIT TO ANY INDIVIDUAL AS A RESULT OF GOVERNMENT PROCUREMENT. WE CANNOT DISPUTE SUCH POSITION ON THE BASIS OF THE PRESENT RECORD.

CONCERNING YOUR STATEMENTS THAT THE EMERSON RESUSCITATOR VALVES ARE NOT RESTRICTIVE IN PROCUREMENT AND THAT THE SPECIFIED RESUSCITATOR DOES NOT OPERATE ON TANKED OXYGEN MERDL HAS REPLIED AS FOLLOWS:

"EVERY COMMERCIAL RESUSCITATOR VALVE MARKETED IS RESTRICTIVE IN PROCUREMENT AND REPAIR PARTS TO A SINGLE SOURCE. ONLY IF A SPECIFICATION IS PREPARED ON A PERFORMANCE BASIS, IS IT POSSIBLE TO OBTAIN COMPETITIVE BIDS. HOWEVER, END ITEMS OFFERED ARE DIFFERENT FROM EACH OTHER IN CONSTRUCTION AND REPAIR PARTS. BY CONTRAST THE MERDL UNIT EMPLOYS OFF-THE -SHELF COMPONENTS MANUFACTURED BY FIRMS NOT IN THE BUSINESS OF MAKING RESUSCITATORS. THEY HAVE DISTRIBUTORS THROUGHOUT THE COUNTRY AND PUBLISH CATALOGS, WITH PRICE LISTS. THE END ITEM MANUFACTURED BY ANY SOURCE WOULD BE COMPLETELY INTERCHANGEABLE WITH A SIMILAR ITEM PRODUCED BY ANOTHER MANUFACTURER. IN MOST CASES, OFF-THE SHELF COMPONENTS CAPABLE OF BEING USED ARE AVAILABLE FROM SEVERAL SOURCES. ALTHOUGH THE BILL OF MATERIALS ACCOMPANYING THE DETAIL DRAWINGS GIVES ONE SOURCE FOR EACH ITEM, THE SPECIFICATION PROVIDES FOR OTHER SOURCES. THE MANY STRAIGHT SPECIFICATION BIDS RECEIVED DURING REQUESTS FOR QUOTATIONS FOR THE RESUSCITATOR, ATTESTS TO ITS NON RESTRICTIVE STATUS.

"THE MERDL RESUSCITATOR IS A GAS DRIVEN DEVICE, CAPABLE OF BEING DRIVEN EQUALLY WELL FROM THE INTEGRAL ELECTRIC AIR COMPRESSOR, FROM EXTERNAL MANIFOLD LINES, OR FROM EXTERNAL TANKED GAS. IT WAS THE PROFESSIONAL DESIRE THAT THE BASIC SOURCE OF POWER BE 110 VOLT 60 CYCLE AC OR 24 VOLT D.C. VEHICULAR POWER. HOWEVER, IT WAS RECOGNIZED THAT ON OCCASIONS IT MAY BE DESIRABLE TO HAVE THE UNIT OPERATED FROM TANKED GAS (PARTICULARLY IN THOSE CASES WHERE ELECTRICITY IS NOT AVAILABLE, OR IN AN EXPLOSIVE ATMOSPHERE WHERE AN ELECTRIC MOTOR DRIVEN COMPRESSOR IS CONSIDERED A HAZARD, OR WHERE THE COMPRESSOR NOISE IS OBJECTIONABLE). SINCE MEDICAL UNITS HAVING TANKED OXYGEN ALSO HAVE REGULATORS, SUCH AS FSN 6680-935- 4242, REGULATOR, PRESSURE, MEDICAL GAS ADMINISTRATION, LIGHTWEIGHT, OXYGEN WITH FLOWMETER, AND IT IS SIMPLE TO SUBSTITUTE QUICK CONNECT FITTINGS, FURNISHED WITH EACH MERDL RESUSCITATOR, FOR THE FLOWMETER, IT IS NOT CONSIDERED NECESSARY TO INCLUDE A REGULATOR WITH EACH RESUSCITATOR UNIT. THUS, AS FURNISHED, A MEDICAL UNIT HAVING OXYGEN, WOULD HAVE NO DIFFICULTY IN USING FITTINGS SUPPLIED WITH THE RESUSCITATOR TO CONVERT AN OXYGEN REGULATOR FOR CONVENIENT AND IMMEDIATE USE."

FROM OUR REVIEW OF THE SEVERAL REPORTS SUBMITTED TO THIS OFFICE WE PERCEIVE NO BASIS FOR DISAGREEING WITH MERDL'S POSITION IN THESE MATTERS.

YOU ALSO STATE THAT THE MERDL REPORT OMITTED CERTAIN UNFAVORABLE COMMENTS CONCERNING THE RESULTS OF TESTING THE UNIT WITH AN ORONASAL MASK WHICH WERE SUBMITTED BY DR. JAMES O. ELAM AND DR. ELWYN S. BROWN.

FROM OUR REVIEW OF THE DOCTORS' REPORT, WE AGREE WITH YOUR ASSERTION. HOWEVER THESE DOCTORS ALSO STATED IN THE SUMMARY SECTION OF THE REPORT THAT THE RESUSCITATOR, WHEN COUPLED TO THE PATIENT BY ORONASAL MASK, PRODUCED ADEQUATE VENTILATION IN UNCONSCIOUS ADULTS PROVIDED: (1) THE MASK FIT WAS SNUG; (2) THE PATIENT'S HEAD WAS HYPEREXTENDED AND/OR HIS MANDIBLE WAS DISPLACED FORWARD; AND (3) THE PATIENT HAD A NORMAL COMPLIANCE AND RESISTANCE. FURTHERMORE, BY CHECK MARKS ON A QUESTIONNAIRE ATTACHED TO THE REPORT THE DOCTORS INDICATED THAT THE RESUSCITATOR WAS "SUITABLE FOR THE INTENDED PURPOSE OF SAFELY AND EFFECTIVELY VENTILATING CASUALTIES ENCOUNTERED UNDER FIELD MEDICAL MEDICATIONS"; THAT NONMEDICAL PERSONNEL COULD BE TRAINED TO "EFFECTIVELY USE THIS EQUIPMENT AS AN EMERGENCY MEANS TO RESUSCITATE THE APENIC INDIVIDUAL OR TO MAINTAIN VENTILATION IN THE RESPIRATORY CRIPPLE"; AND THAT THE MERDL PROTOTYPE CYCLING UNIT SHOULD BE "TYPE CLASSIFIED AS STANDARD AS A PIECE OF FIELD RESUSCITATION EQUIPMENT EITHER ALONE OR AS A COMPONENT PART OF A FIELD RESUSCITATION OUTFIT." VIEW OF THESE REPRESENTATIONS, WE CANNOT CONCLUDE THAT MERDL'S FAILURE TO REPORT ALL COMMENTS IN THE REPORT MISREPRESENTED THE CONCLUSIONS OF THIS STUDY AS INDICATED ON THE QUESTIONNAIRE.

WITH RESPECT TO THE QUESTION OF THE ADEQUACY OF TESTING EMPLOYED IN DEVELOPING THE RESUSCITATOR, OUR OFFICE MADE A REVIEW OF THE COMPLAINTS RAISED BY YOUR CONCERN AND OTHER MEDICAL PROFESSIONALS. A SUMMARY OF THE RESULTS OF THAT REVIEW IS ENCLOSED. AS INDICATED THEREIN, ALL OF THE REPORTS OF THE TESTING ACTIVITIES WHICH WERE AVAILABLE AT THE TIME OF THE SUBJECT AWARD CONCLUDED THAT THE RESUSCITATOR WAS ADEQUATE TO RESUSCITATE CHEMICAL WARFARE CASUALTIES AND THAT NON-MEDICAL PERSONNEL COULD BE TRAINED TO EFFECTIVELY USE THE ITEM. ACCORDINGLY, WE CANNOT CONCLUDE THAT THE AWARD TO GLOBE WAS IMPROPER OR THAT IT SHOULD NOW BE CANCELLED AS YOU CONTEND.

HOWEVER, IN VIEW OF THE RESERVATIONS EXPRESSED BY SEVERAL MEDICAL PROFESSIONALS, INCLUDING THE CHAIRMAN OF THE AMERICAN SOCIETY OF ANESTHESIOLOGISTS COMMITTEE ON MECHANICAL EQUIPMENT, WHO EVALUATED CURRENT TESTING DATA ON THE UNIT AT OUR REQUEST, WE ARE ADVISING THE SECRETARY OF DEFENSE THAT IT IS OUR OPINION THAT THE ARMY SHOULD NOT BUY ADDITIONAL RESUSCITATORS UNTIL MORE ASSURANCE IS OBTAINED AS TO THE USEFULNESS OF THE EQUIPMENT.

FOR THE REASONS SET FORTH ABOVE, OUR DECISION OF JUNE 25, 1970, INSOFAR AS IT DENIED YOUR REQUEST FOR THIS OFFICE TO CANCEL THE SUBJECT REQUIREMENT, IS AFFIRMED.

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