Matter of: Aegis Analytical Laboratories, Inc. File: B-252511 Date: July 2, 1993

B-252511: Jul 2, 1993

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PROCUREMENT Specifications Minimum needs standards Competitive restrictions GAO review Protest challenging as unduly restrictive a solicitation provision requiring that offerors be certified by the International Olympic Committee to perform anabolic steroid testing is denied where agency does not itself have the expertise to qualify offerors and. At the time the solicitation was issued. There were no other equivalent certifying bodies for anabolic steroid testing. The laboratory at Walter Reed will ship samples to the contractor commencing approximately 30 days after award. The contractor shall complete all testing and return results to the laboratory no later than 14 days from the date the sample is received.

Matter of: Aegis Analytical Laboratories, Inc. File: B-252511 Date: July 2, 1993

PROCUREMENT Specifications Minimum needs standards Competitive restrictions GAO review Protest challenging as unduly restrictive a solicitation provision requiring that offerors be certified by the International Olympic Committee to perform anabolic steroid testing is denied where agency does not itself have the expertise to qualify offerors and, at the time the solicitation was issued, there were no other equivalent certifying bodies for anabolic steroid testing.

Attorneys

DECISION Aegis Analytical Laboratories, Inc. protests as unduly restrictive the terms of request for proposals (RFP) No. DADA15-92-R-0148, issued by the Department of the Army, Walter Reed Army Medical Center, for steroid testing services. Specifically, Aegis objects to the requirement in the RFP that the contractor be certified by the International Olympic Committee (IOC) to perform testing for anabolic steroids.

We deny the protest.

The RFP, issued February 1, 1993, contemplates the award of a requirements contract for a 6-month base period and four 1-year option periods to provide anabolic steroid testing on human urine samples for the forensic toxicology drug testing laboratory at Walter Reed Army Medical Center.[1] Under the terms of the contract, the laboratory at Walter Reed will ship samples to the contractor commencing approximately 30 days after award, and the contractor shall complete all testing and return results to the laboratory no later than 14 days from the date the sample is received. When necessary, the contractor will be required "to provide documentary evidence in the form of [litigation support packages] to be used by the [g]overnment at [c]ourt [m]artials or . . . administrative proceedings."

Offerors were informed that the anabolic steroid testing services must be performed under the IOC's forensic and scientific specifications.[2] In this regard, the RFP provided that "[t]he contractor shall be certified by the IOC to perform testing on human urine for anabolic steroids." To maintain accreditation, accredited IOC laboratories are required to participate in quarterly proficiency tests, in which the IOC will send samples to laboratories to analyze and verify the accuracy of the laboratories' findings.

Prior to the March 2 closing date for receipt of proposals, Aegis protested that the RFP unduly restricts competition by limiting potential offerors to those laboratories which have been certified by a single, private organization, the IOC. The protester states that currently only two domestic laboratories are certified by the IOC. Aegis alleges that while the IOC certification requirements themselves are not difficult for qualified laboratories to meet, laboratories must be invited by the IOC to apply, and that it has requested, but not received, an application for IOC certification. In addition, according to the protester, the application process is time-consuming and expensive.

Aegis argues that it is capable of performing the RFP work since it has processed approximately "10,000 urine samples for the detection of anabolic steroids, amassing a databank of steroid measurements which rivals any laboratory in the world." In this regard, Aegis contends that the College of American Pathologists (CAP)[3] has an athletic drug testing program for qualifying laboratories to perform anabolic steroids testing and that the CAP certification program is equivalent, if not superior, to the IOC's, and includes quarterly proficiency testing. Aegis states that it will soon be qualified by CAP. Finally, the protester argues that by accepting only IOC's certification the agency has abdicated its evaluation responsibility since, in Aegis's view, the agency has sufficient expertise to evaluate contractors' capabilities.

The Army acknowledges that the IOC certification requirement limits the number of domestic firms capable of competing[4] but contends that anabolic steroid analyses and the process of qualifying laboratories to perform the anabolic steroid testing require a high degree of technical expertise which the Army does not have. The agency states that it needs a high degree of reliability in the test results because soldiers whose samples are tested as positive for anabolic steroids will be subject to punishment under the Uniform Code of Military Justice, including confinement and dishonorable discharge. The IOC certification requirement is necessary, according to the agency, because it was, at the time of the issuance of the RFP, the only certification body with a proficiency testing program for anabolic steroid testing in the United States. The IOC's quarterly proficiency testing ensures that accredited laboratories maintain the required degree of reliability in the performance of laboratory testing as well as reporting of those results (e.g., chain of custody).

In preparing a solicitation for supplies or services, a contracting agency must specify its needs and solicit offers in a manner designed to achieve full and open competition, 10 U.S.C. Sec. 2305(a)(1)(A) (1988), and may include restrictive provisions or conditions only to the extent necessary to satisfy the agency's needs. 10 U.S.C. Sec. 2305(a)(1)(B). Where a protester alleges that a requirement is unduly restrictive, we review the record to determine whether the requirement has been justified as necessary to satisfy the agency's minimum needs. RMS Indus., B-247233; B-247234, May 1, 1992, 92-1 CPD Para. 412. The determination of the agency's minimum needs and the best method of accommodating them are primarily within the agency's discretion and, therefore, we will not question such a determination unless the record shows that it was without a reasonable basis.[5] Id.

Our Office generally has not objected to a requirement that an item conform to a set of standards adopted by a nationally recognized organization in the field or a requirement for independent laboratory certification that such standards are met. However, we have found requirements for approval by specific organizations without recognition of equivalent approvals to be unduly restrictive. Energy Sys. Maintenance, Inc., B-227357, Aug. 14, 1987, 87-2 CPD Para. 158; see also James LaMantia, B-245287, Dec. 23, 1991, 91-2 CPD Para. 574. The absence of an endorsement by a particular private organization should not automatically exclude offers that might otherwise equally meet a procuring agency's needs. Id.

Here, we find reasonable the agency's determination that its minimum needs require the use of an independent certifying organization to approve anabolic steroid testing laboratories. The record shows that the creation of human urine anabolic steroid test samples,[6] as well as the steroid testing, is complex and requires specialized expertise that many laboratories do not have. The agency states that it does not have the necessary "technical knowledge" to perform anabolic steroid testing or create the urine test samples, and the protester has not shown otherwise. Thus, while the agency is aware of the standards employed by the IOC to qualify testing laboratories, it does not itself have the means to test the qualifications of laboratories or to perform future proficiency tests during the contract term. In light of the serious consequences resulting from an inaccurate test result and the skill required to perform the testing, we find that the agency has justified as necessary its requirement for certification by an independent organization.

We also find reasonable the RFP's requirement for IOC certification. Only the IOC was accrediting laboratories when the RFP was issued.[7] While Aegis argues that CAP will soon begin accrediting laboratories to perform anabolic steroid testing, the record shows that CAP has not yet accredited any laboratories. Specifically, the record shows that CAP began exploring in 1990 the possibility of establishing a program for the accreditation of anabolic steroid testing laboratories.[8] A pilot program and program standards and requirements for accrediting laboratories were developed. Currently, a number of laboratories, including Aegis, are undergoing testing and inspection for accreditation. As of the date of this decision, however, no laboratories have been accredited, although the record indicates that a number of laboratories may receive accreditation at a planned July 15 meeting of CAP.[9] Since, as noted above, the agency cannot independently qualify laboratories and, at the time of issuance of the RFP and currently, the IOC was the only accrediting body which had certified steroid testing laboratories, we have no basis to find unreasonable the RFP's requirement for IOC certification.

Aegis, however, asserts that in light of the "imminent" accreditation of a number of firms by CAP, our Office should recommend that the Army delay the procurement. We have no basis to do so. As discussed above, the Army had a reasonable basis for requiring the IOC certification, and the failure of Aegis (and other potential offerors) to have obtained certification, either by IOC or CAP, was not attributable to any improper government action. Moreover, agencies generally need not delay a procurement in order to provide a potential offeror with an opportunity to demonstrate that it meets approval standards. See Kitco, Inc., B-232363, Dec. 5, 1988, 88-2 CPD Para. 559; 10 U.S.C. Sec. 2319(c)(5)(1988).

Since the RFP provides for the award of a contract with several option periods, we anticipate that the agency will determine whether CAP's accreditation program will also meet its minimum needs, since this will provide the agency with a basis to determine whether the exercise of the contract options is the most advantageous method of fulfilling its need, price and other factors considered, as required by regulation. See Federal Acquisition Regulation (FAR) Sec. 17.207(c),(d).

Aegis also protests that "the procurement is tainted by conflict of interest" since a representative of a particular potential offeror allegedly served as an "advisor" to the agency regarding the procurement. In this regard, the FAR generally prohibits contractors that provide "material leading directly, predictably, and without delay" to the statement of the work from providing the required system or services. See FAR Sec. 9.505-2(b); National Credit Union Adman.; Schreiner, Legge & Co.- -Recon. B-244680.2; B-244680.3, Apr. 1, 1992, 92-1 CPD Para. 329.

Here, even if we were to conclude (and there has been no showing) that the offeror provided such material, that laboratory has not submitted an offer and therefore is ineligible for the award. In our view, no useful purpose would be served by our deciding the issue of whether a particular laboratory, which did not submit an offer, may have had an organizational conflict of interest. We therefore will not consider this protest allegation.[10]

The protest is denied.

1. The RFP provides that the contract base period will expire on September 30, 1993 and that notice of the exercise of options must be provided at least 30 days before the contract expires.

2. The IOC publishes written standards for laboratory testing of drugs, including steroids, and requirements that laboratories must meet to be accredited by the IOC. Laboratory accreditation is not open to all laboratories but is dependent upon factors such as the IOC's need for continuity of services and expected volume of work.

3. CAP is a non-profit association of pathologists that, among other things, establishes laboratory testing procedures and accredits laboratories meeting its published standards.

4. While there are only two domestic laboratories that have been certified by the IOC, there are approximately 20 such laboratories worldwide.

5. The Army argues that the requirement for IOC certification is a matter of Department of Defense medical policy, which is beyond the scope of our review. We fail to see how the Army's stated basis for the RFP's IOC certification requirement--the agency's inability to itself determine the qualifications of laboratories and perform proficiency tests--is a matter of medical policy. Thus, we will consider whether the agency reasonably required the certification.

6. The creation of human urine steroid test samples, requires the addition of trace amounts of various steroid compounds to urine.

7. The protester initially alleged that the National Institute of Drug Abuse (NIDA) of the Department of Health and Human Services and the State of New York Steroid Program also accredited laboratories. The Army explained in its report that neither NIDA nor the New York Steroid Program conducts steroid qualification tests and accredits steroid testing laboratories. Since Aegis did not reply to the agency's statements, we consider this allegation to have been abandoned. See TM Sys., Inc., B-228220, Dec. 10, 1987, 87-2 CPD Para. 573.

8. A telephone conference was conducted to receive the testimony of a forensic toxicology commissioner of CAP involved in the accreditation of anabolic steroid testing laboratories. Counsel for the parties participated and written comments were received.

9. The CAP commissioner testified that Aegis may well receive accreditation at the July 15 meeting but that he could not state "with certainty" that Aegis would be.

10. Moreover, the protester itself did not submit a proposal by the closing date, and given our decision upholding the certification requirement, Aegis would be ineligible for award. Accordingly, the firm lacks the direct economic interest to be considered an interested party to challenge the eligibility of the prospective laboratory even if that laboratory had submitted an offer. See Bid Protest Regulations, 4 C.F.R. Sec. 21.0(a); 21.1(a) (1993).