B-165631, JUN. 25, 1970

B-165631, JUN. 25, 1970

CONTRACTS--SPECIFICATIONS--ADMINISTRATIVE DETERMINATION CONCLUSIVENESS- TECHNICAL EVALUATIONS CONCERNING SPECIFICATION SETTING FORTH TECHNICAL REQUIREMENTS UNDER REQUEST FOR PROPOSALS FOR FIELD RESUSCITATORS WHERE UNITS HAD BEEN SUBJECTED TO LENGTHY CLINICAL, ENGINEERING, SERVICE AND MAINTENANCE TESTING AND EVALUATION PRIOR TO ADOPTION BY MILITARY, SPECIFICATION MAY NOT BE NEGATED OR DICTATED OVER AGENCY OBJECTIONS BY PROSPECTIVE SUPPLIER SINCE DETERMINATIONS OF ACTUAL GOVERNMENT NEEDS AND DRAFTING SPECIFICATIONS THEREFOR ARE RESPONSIBILITY OF AGENCY INVOLVED AND, WHERE DECISIONS REQUIRE EXPERT JUDGMENT OF TECHNICAL OR SCIENTIFIC PERSONNEL, GAO WILL NOT QUESTION AGENCY'S CONCLUSIONS, ABSENT CLEAR SHOWING OF FRAUD, ABUSE OF AUTHORITY OR ARBITRARY ACTION, NOT SHOWN HEREIN.

TO J. H. EMERSON COMPANY:

REFERENCE IS MADE TO YOUR LETTER DATED FEBRUARY 23, 1970, TO THE DEFENSE PERSONNEL SUPPORT CENTER, DEFENSE SUPPLY AGENCY, IN WHICH YOU PROTESTED AGAINST A PROPOSED PROCUREMENT OF 422 FIELD RESUSCITATORS, 110 VOLT, 60 CYCLE, AC, OR 24 VOLT, DC, STOCK NUMBER 6515-926-9157 UNDER REQUEST FOR PROPOSALS (RFP) NO. DSA120-70-R-1216, ISSUED BY THE CENTER ON JANUARY 28, 1970. THE TECHNICAL REQUIREMENTS FOR THE FIELD RESUSCITATORS WERE SET FORTH IN MILITARY SPECIFICATION, MIL-R-36563A, DATED OCTOBER 3, 1969, AS AMENDED, WHICH STATED THAT THE SPECIFICATION WAS MANDATORY FOR USE BY ALL DEPARTMENTS AND AGENCIES OF THE DEPARTMENT OF DEFENSE. PARAGRAPH 1.1 OF THE SPECIFICATION DESCRIBED THE USES OF THE DEVICE AS FOLLOWS:

"1.1 THIS SPECIFICATION COVERS ONE TYPE OF MECHANICAL, INTERMITTENT, POSITIVE AUTOMATIC RESUSCITATOR, SUITABLE FOR VENTILATION OF CHEMICAL WARFARE CASUALTIES AS WELL AS FOR GENERAL MEDICAL RESUSCITATION, AND FOR FIELD USE IN EITHER A CONTAMINATED OR UNCONTAMINATED ATMOSPHERE."

YOU STATE THAT THE GROUNDS OF YOUR PROTEST ARE THE SAME AS THOSE YOU SET FORTH IN A COMPLAINT CONCERNING THE CENTER'S ATTEMPT TO PURCHASE THE SAME RESUSCITATOR IN 1968. THE EARLIER PROCUREMENT ACTION WAS CANCELLED WHEN THE DEPARTMENT OF THE ARMY INFORMED THE CENTER THAT ITS REQUIREMENTS WERE BEING WITHDRAWN FOR EVALUATION BY THE PROFESSIONAL STAFF OF THE SURGEON GENERAL'S OFFICE.

THE PRINCIPAL AND MATERIAL ELEMENTS OF YOUR PROTEST CENTER AROUND THE PROPOSITION THAT THE DEVICE HAS NOT BEEN SUFFICIENTLY TESTED TO JUSTIFY THE PROPOSED USES OF THE RESUSCITATOR ON EITHER A CLINICAL OR A MECHANICAL BASIS. IN THIS REGARD YOU MAINTAIN THAT THE DEVICE HAS NOT BEEN TESTED IN ANY RESCUE SITUATION ON HUMAN PATIENTS; THAT NO CLINICAL EVALUATION OF THE DEVICE HAS BEEN PUBLISHED IN ANY MEDICAL JOURNAL; AND THAT THERE IS NO RECORD OF EXPERIENCE TO SHOW THAT THE RESUSCITATOR IS CONVENIENT OR RELIABLE.

IN RESPONSE TO THESE ALLEGATIONS, THE MEDICAL EQUIPMENT RESEARCH AND DEVELOPMENT LABORATORY OF THE DEPARTMENT OF THE ARMY SUBMITTED THE FOLLOWING STATEMENT:

" *** 2. THIS LABORATORY COMPLIES WITH THE ARMY REGULATIONS THAT OUTLINE THE PROCEDURES FOR ALL RESEARCH AND DEVELOPMENT PROJECTS. ARMY REGULATION NO. 70-10 COVERS THE OBJECTIVES, RESPONSIBILITIES AND POLICY GUIDANCE FOR TESTING CONDUCTED DURING DEVELOPMENT AND EARLY PRODUCTION OF MATERIEL. NORMALLY, AN ENGINEER DESIGN TEST (EDT), AN ENGINEERING TEST (ET), AND A SERVICE TEST (ST) ARE CONDUCTED DURING THE DEVELOPMENT PHASE. IN THE DEVELOPMENT OF SUBJECT RESUSCITATOR, ALL OF THE ABOVE TESTS WERE EMPLOYED, AS DESCRIBED IN THE FOLLOWING PARAGRAPHS.

"3. THE ENGINEER DESIGN TEST (EDT) IS A TEST PROGRAM CONDUCTED BY OR UNDER THE CONTROL OF THE DESIGN AGENCY FOR THE PURPOSE OF COLLECTING DESIGN DATA, CONFIRM PRELIMINARY CONCEPTS AND CALCULATIONS, AND TO DETERMINE THE COMPATIBILITY OF COMPONENTS. THE EDT PROGRAM CONSISTED OF (1) ENGINEERING TESTS AT MERDL, (2) LABORATORY TESTS ACCOMPLISHED BY MEDICAL PERSONNEL, AND (3) CLINICAL TESTS ACCOMPLISHED BY MEDICAL PERSONNEL, PRIMARILY ANESTHESIOLOGISTS, AT NINE MEDICAL CENTERS. THE ENGINEERING TESTS AT MERDL WERE CONDUCTED AS NECESSARY THROUGHOUT THE ENGINEERING DEVELOPMENT PHASE TO VERIFY CHOICE OF MATERIEL, DESIGN, ETC. THE LABORATORY TESTS WERE CONDUCTED PRIMARILY AT THE MEDICAL LABORATORY OF THE ARMY CHEMICAL CENTER, EDGEWOOD ARSENAL AND AT THE DEPARTMENT OF ANESTHESIOLOGY, JOHNS HOPKINS UNIVERSITY DURING 1960 1961. PRINCIPAL MEDICAL INVESTIGATORS WERE DR. ROBERT F. HUSTEAD AND DR. JOHN A. CLEMENTS. BOTH EXPERIMENTAL ANIMALS AND ANALOG LOADS WERE EMPLOYED. THE RESUSCITATORS WERE OPERATED WITH IMPEDANCE LOADS SIMULATING ALL POSSIBLE CONDITIONS FOUND IN CASUALTIES REQUIRING RESUSCITATION. BY MEANS OF RECORDERS AND TRANSDUCERS, INSTANTANEOUS WAVE TRACES OF FLOW, LUNG PRESSURE, MASK PRESSURE, AND RESUSCITATOR BELLOWS PRESSURE VERSUS TIME WERE MEASURED AND RECORDED. AFTER INITIAL RESULTS WERE EVALUATED AND THE RESUSCITATORS CONSIDERED SUITABLE FOR THE TREATMENT OF CHEMICAL WARFARE CASUALTIES, AS WELL AS FOR GENERAL MEDICAL RESUSCITATION, DR. HUSTEAD EMPLOYED THE RESUSCITATORS AT JOHNS HOPKINS HOSPITAL IN BOTH THE RECOVERY AND OPERATING ROOM SUCCESSFULLY ON BOTH MALE AND FEMALE ADULT PATIENTS. DR. DONALD BENSON, IN CHARGE OF ANESTHESIOLOGY AT JOHNS HOPKINS WAS CONSULTED BY DR. HUSTEAD TO VERIFY HIS FINDINGS. CLINICAL TESTS WERE ACCOMPLISHED DURING 1962 AT THE FOLLOWING INSTALLATIONS:

A. DEPARTMENT OF ANESTHESIOLOGY

USAF HOSPITAL LACKLAND

LACKLAND AIR FORCE BASE, TEXAS

B. DEPARTMENT OF ANESTHESIOLOGY

USAF HOSPITAL ANDREWS

ANDREWS AIR FORCE BASE, WASHINGTON, D. C.

C. CAPTAIN T. C. DEAS, M.C; USN

U.S. NAVAL HOSPITAL

PHILADELPHIA, PENNSYLVANIA

D. CAPTAIN J. G. KURFEES, M.C; USN

U. S. NAVAL HOSPITAL

NATIONAL NAVAL MEDICAL CENTER

BETHESDA, MARYLAND

E. MEDICAL DIRECTORATE

USA CHEMICAL RESEARCH & DEVELOPMENT

LABORATORY

ARMY CHEMICAL CENTER

EDGEWOOD, MARYLAND

F. COLONEL HARVEY C. SLOCUM, M.C.

CHIEF, ANESTHESIA & OPERATIVE SERVICE

WALTER REED ARMY MEDICAL CENTER

WASHINGTON, D. C.

G. DR. JAMES O. ELAM

ROSWELL PARK MEMORIAL INSTITUTE

BUFFALO, NEW YORK

H. DR. ROBERT D. DRIPPS

DEPARTMENT OF ANESTHESIA

UNIVERSITY OF PENNSYLVANIA

PHILADELPHIA, PENNSYLVANIA

I. DR. ROBERT HUSTEAD

DEPARTMENT OF ANESTHESIA

UNIVERSITY OF KANSAS SCHOOL OF MEDICINE KANSAS CITY, KANSAS

A LENGTHY TEST QUESTIONNAIRE, COPY INCLOSED, WAS FORWARDED TO EACH ACTIVITY FOR COMPLETION. COMPLETED QUESTIONNAIRES WERE RECEIVED FROM EACH ACTIVITY AS WELL AS ONE AT A LATER DATE FROM THE U. S. ARMY 64TH FIELD HOSPITAL HOLDING MANEUVERS IN ALASKA DURING EXERCISE 'TIMBER LINE' IN 1963. BASED ON THE CLINICAL TESTS CONDUCTED BY THE ABOVE ACTIVITIES, A MASTER SUMMARY OF THE REPORTS WERE PREPARED AND DISTRIBUTED TO ALL PARTICIPANTS IN THE TEST AS WELL AS ALL OTHER INDIVIDUALS INVOLVED IN THE PROGRAM.

"4. THE ENGINEERING TEST (ET) IS A TEST PROGRAM CONDUCTED BY OR UNDER THE SUPERVISION OF A SEPARATE TEST AGENCY, NOT A PART OF THE DEVELOPING INSTALLATION, FOR THE PURPOSE OF MEASURING THE INTEGRITY OF THE ITEM FROM A STRUCTURAL, ELECTRICAL, PHYSICAL AND CHEMICAL POINT OF VIEW. TESTS ARE CONDUCTED UNDER CONTROLLED CONDITIONS UTILIZING ENVIRONMENTAL CHAMBERS, PHYSICAL MEASUREMENT TECHNIQUES, CONTROLLED LABORATORY SHOP AND FIELD TRIALS. THE ET PROGRAM CONSISTED OF (1) ENGINEERING TESTS CONDUCTED BY THE U. S. ARMY TEST AND EVALUATION COMMAND AT ABERDEEN PROVING GROUND, MARYLAND FROM DECEMBER 1965 THROUGH APRIL 1966, AND (2) OBTAINING OF INSTANTANEOUS FLOW AND PRESSURE TRACES AT THE MEDICAL RESEARCH LABORATORY, EXPERIMENTAL MEDICINE DEPARTMENT, ARMY CHEMICAL CENTER, EDGEWOOD, MARYLAND DURING JANUARY 1966. THE TESTS AT THE ABERDEEN PROVING GROUND CONSISTED OF (A) ROUGH HANDLING TEST, (B) PRECIPITATION TEST, (C) ALTITUDE TEST, (D) HUMIDITY TEST, (E) HIGH TEMPERATURE STORAGE TEST, (F) LOW TEMPERATURE STORAGE TEST, (G) RADIO INTERFERENCE TEST, (H) TEMPERATURE RANGE OPERATING TEST, AND (I) A LIFE TEST DURING WHICH THE UNIT WAS REQUIRED TO OPERATE CONTINUOUSLY FOR 1,000 HOURS WITHOUT FAILURE. THE TESTS AT THE ARMY CHEMICAL CENTER WERE FOR THE PURPOSE OF OBTAINING INFORMATION (IN TERMS OF FLOW AND PRESSURE TRACES) FOR A DESIGNATED SERIES OF RESISTANCE AND COMPLIANCE LOADS UNDER VARIOUS DESIGNATED TEMPERATURE CONDITIONS VARYING FROM 0 DEGREES TO 130 DEGREES F AND VARYING AC AND DC VOLTAGE INPUTS. THESE TRACES WERE LATER EVALUATED BY COLONEL JOHN A. JENICEK, M.C; PROFESSIONAL CONSULTANT TO THE ARMY SURGEON GENERAL, ANESTHESIOLOGY, WHO ON 22 MARCH 1966 STATED: 'THE DATA SUBMITTED ARE ACCEPTABLE CRITERIA FOR ADOPTION OF THE RESUSCITATOR FOR THE PURPOSE INTENDED. THE PERFORMANCE TRACES UNDER VARIOUS LOAD AND TEMPERATURE CONDITIONS ARE VERY SATISFACTORY -- . IN MY OPINION THE RESUSCITATOR HAS MET DESIGN, CLINICAL AND TEST CRITERIA DEFINED FOR IT, AND IS ACCEPTABLE FOR STANDARDIZATION.'

"5. THE SERVICE TEST (ST) IS A TEST CONDUCTED UNDER SIMULATED OR ACTUAL FIELD CONDITIONS WHERE THE OBJECTIVE IS TO DETERMINE TO WHAT DEGREE THE ITEM PERFORMS THE INTENDED MISSION. THE TEST IS CONDUCTED USING SOLDIERS REPRESENTATIVE OF THOSE WHO WILL OPERATE AND MAINTAIN THE EQUIPMENT IN THE FIELD. THE SERVICE TEST PROVIDES THE BASIS FOR RECOMMENDATIONS ON TYPE CLASSIFICATION. THE ST PROGRAM CONSISTED OF (1) SERVICE TESTS CONDUCTED BY THE U. S. ARMY MEDICAL SERVICE TEST AND EVALUATION ACTIVITY, BROOKE ARMY MEDICAL CENTER, FORT SAM HOUSTON, TEXAS DURING 1966, AND (2) A MAINTENANCE EVALUATION AT THE AMEDS MATERIEL MAINTENANCE BRANCH, FITZSIMONS GENERAL HOSPITAL FROM APRIL TO JULY 1966. TESTS AT THE SERVICE TEST AND EVALUATION ACTIVITY WERE CONDUCTED UNDER ACTUAL AND/OR SIMULATED CONDITIONS EMPLOYING MEDICAL PERSONNEL, ACTUAL PATIENTS, EXPERIMENTAL ANIMALS (GOATS) AND TRAINING DEVICES. THE UNITS WERE TESTED IN BOTH NON- CONTAMINATED AND CONTAMINATED ATMOSPHERES AND WERE OPERATED IN MILITARY VEHICLES AND HELICOPTERS. THE FINAL REPORT REQUESTED MINOR MODIFICATIONS (WHICH WERE ACCOMPLISHED) AND CONCLUDED: 'IT IS LOGISTICALLY ACCEPTABLE, BEING RUGGED, COMPACT, EASILY MAINTAINED, AND HAVING A GREATER FLEXIBILITY THAN SIMILAR STANDARD ITEMS.' THE MAINTENANCE EVALUATION WAS FOR THE PURPOSE OF DETERMINING EASE OF MAINTENANCE, MAINTENANCE MANPOWER REQUIREMENTS, POTENTIAL SAFETY HAZARDS, AND THE USE OF STANDARD PARTS AND COMPONENTS. THE FINDINGS WERE THAT ... 'THE RESUSCITATOR IS WELL DESIGNED AND WILL SERVE ITS INTENDED PURPOSE.'

"6. THE LETTER FROM J. H. EMERSON COMPANY IS IN ERROR IN STATING THAT THE UNIT CAN ONLY BE OPERATED ELECTRICALLY. UNITS ARE CAPABLE OF BEING OPERATED FROM TANKED OR MANIFOLD GAS SUPPLIES. THE ELECTRIC COMPRESSOR FURNISHED WITH EACH UNIT IS A SPECIFIC MILITARY REQUIREMENT SO THAT UNITS CAN BE OPERATED FROM MILITARY VEHICULAR D. C. SUPPLIES AS WELL AS A. C. SUPPLIES IN EMERGENCY ROOMS. TANKED OXYGEN CAN BE USED AND, IF ALL POWER SOURCES ARE NOT AVAILABLE, THEN THE UNIT CAN BE MANUALLY-POWERED EMPLOYING THE RESUSCITATOR CASUALTY CIRCUIT COMPONENTS. INCIDENTALLY, WHEN OPERATED FROM AN OXYGEN CYLINDER, THE UNIT WILL OPERATE FROM 2 TO 4 TIMES LONGER THAN COMPARABLE COMMERCIAL UNITS FROM A GIVEN AMOUNT OF OXYGEN. THE PROTOTYPE UNIT SHOWN TO THE REPRESENTATIVES OF INDUSTRY AT THE PRE- PROPOSAL CONFERENCE HELD ON 11 SEPTEMBER 1968 AT DPSC IN PHILADELPHIA, WAS A UNIT WHICH HAD BEEN SUBJECTED TO ENGINEERING TESTS, CONSISTING OF EXTREMES OF TEMPERATURE AND HUMIDITY, ELECTRICAL OVERLOAD, ETC. AND WAS NOT CONSIDERED A NEW UNIT. IT WAS SHOWN FOR 'STYLE AND DESIGN' PURPOSES ONLY AND WOULD REQUIRE MINOR MAINTENANCE AND REPAIRS BEFORE BEING CONSIDERED FUNCTIONAL AND SUITABLE FOR ISSUE AND USE. THE BASIC DURABILITY OF THE DEVICE AND SUITABILITY OF THE COMPRESSOR HAS BEEN DEMONSTRATED IN THE 1,000 HOUR CONTINOUS DUTY TEST CONDUCTED AT ABERDEEN AND VERIFIED AT MERDL. CONTINUOUS OPERATION FOR MORE THAN A 41 DAY PERIOD IS EQUIVALENT TO MANY YEARS OF NORMAL USE.

"7. IT IS THUS SEEN THAT THE UNITS HAVE BEEN SUBJECTED TO LENGTHY CLINICAL, ENGINEERING, SERVICE AND MAINTENANCE TESTING AND EVALUATION PRIOR TO ADOPTION BY THE MILITARY SERVICES."

THE DEFENSE SUPPLY AGENCY HAS ALSO FURNISHED THIS OFFICE WITH THE REPORT OF THE ARMY SURGEON GENERAL'S OFFICE CONCERNING ITS REEVALUATION OF THE DEVICE. THE REPORT STATES THAT THE RESUSCITATOR WAS REEVALUATED BY THE SURGEON GENERAL'S PROFESSIONAL STAFF, INCLUDING THE ANESTHESIOLOGIST, AND IT WAS CONCLUDED THAT THE ITEM WAS SUITABLE IN ALL RESPECTS FOR THE MEDICAL PURPOSES INTENDED. THE REEVALUATION ENCOMPASSED A REVIEW OF ALL AVAILABLE TEST DATA AND AN EXAMINATION OF THE QUESTIONS WHICH HAD BEEN RAISED CONCERNING THE QUALIFICATIONS OF THE THE ITEM. IN THIS REGARD, THE CENTER HAS REPORTED THAT IT HAS NOT RECEIVED ANY UNSATISFACTORY REPORTS ON THE PROTOTYPES OF THE RESUSCITATORS WHICH ARE IN USE TODAY AT VARIOUS FIELD ACTIVITIES, INCLUDING VIETNAM.

YOU FURTHER ALLEGE THAT A REPRESENTATIVE OF THE CENTER FALSELY INFORMED YOU THAT CERTAIN CIVILIAN DOCTORS WERE AWARE OF THE PLAN TO PURCHASE THE ITEM, AND WERE IN AGREEMENT THAT IT WAS A SATISFACTORY UNIT. YOU STATE THAT YOU CONTACTED FIVE OF THESE DOCTORS AND THAT THE REPRESENTATIVE'S ALLEGATION THAT THEY SUPPORTED THE PROCUREMENT WAS WITHOUT FOUNDATION. THE CENTER MAINTAINS THAT YOU WERE NOT ADVISED THAT THESE DOCTORS ENDORSED THE ITEM OR WERE EVEN AWARE OF ITS PROPOSED PURCHASE, BUT MERELY THAT THE DOCTORS HAD CONDUCTED CLINICAL TESTS OF THE RESUSCITATOR OR WERE CONSULTED IN THE EVALUATION OF THE DEVICE SEVERAL YEARS PRIOR THERETO. IRRESPECTIVE OF WHICH VERSION MAY MORE ACCURATELY PORTRAY THE STATEMENTS OF THE GOVERNMENT'S REPRESENTATIVE, IT SEEMS CLEAR THAT THE ACCEPTABILITY OF THE RESUSCITATOR WAS DETERMINED ON THE BASIS OF THE TEST DATA AND REPORTS ACTUALLY OF RECORD, AND WHICH WERE SUBMITTED BY THE PERSONNEL OR ACTIVITIES HAVING PRIMARY RESPONSIBILITY FOR THE MATERIAL OR CONCLUSIONS CONTAINED THEREIN. PROTESTS SUCH AS THIS, QUESTIONING DETERMINATIONS OF GOVERNMENT AGENCIES AS TO THE REQUIREMENTS OR ADEQUACY OF ITEMS BEING PROCURED, HAVE BEEN PRESENTED TO THIS OFFICE ON MANY OCCASIONS BY MANUFACTURERS AND CONTRACTORS. IT HAS BEEN OUR CONSISTENT POSITION IN A LONG LINE OF DECISIONS INVOLVING SIMILAR DISAGREEMENTS BETWEEN PROCUREMENT OFFICIALS AND INTERESTED PARTIES THAT DETERMINATIONS AS TO THE ACTUAL NEEDS OF THE GOVERNMENT, AND THE DRAFTING OF SPECIFICATIONS TO DESCRIBE AND SECURE THOSE NEEDS, ARE THE RESPONSIBILITY OF THE AGENCIES INVOLVED AND SUCH SPECIFICATIONS MAY NOT BE EITHER NEGATED OR DICTATED OVER AGENCY OBJECTIONS BY MANUFACTURERS OR PROSPECTIVE SUPPLIERS. FURTHER, WHERE THE DECISIONS IN SUCH MATTERS REQUIRE THE EXPERT JUDGMENT OF TECHNICAL OR SCIENTIFIC PERSONNEL WE WILL NOT QUESTION THE CONCLUSIONS OF THE AGENCIES UNLESS THERE IS A CLEAR SHOWING OF FRAUD OR ABUSE OF AUTHORITY OR ARBITRARY ACTION, NONE OF WHICH, WE BELIEVE, ARE EVIDENCED HERE IN VIEW OF THE EXTENSIVE ADMINISTRATIVE TESTING AND EVALUATION OF THE ITEM AS REFLECTED BY THE RECORD.

ACCORDINGLY, WE CANNOT CONCLUDE THAT PROCUREMENTS UTILIZING THE SUBJECT SPECIFICATION, WHICH IS MANDATORY FOR USE BY DEFENSE AGENCIES ONLY IN THOSE CASES WHERE IT HAS BEEN DETERMINED THAT THERE IS A NEED FOR RESUSCITATORS OF THE TYPE DESCRIBED THEREIN, ARE IMPROPER.

FOR THE REASONS SET FORTH ABOVE, YOUR PROTEST IS DENIED.