Full opinion text
MEMORANDUM OPINION HUVELLE, District Judge. Plaintiffs are Beverly Health and Rehabilitation Services, Inc., which owns and operates 300 nursing homes nationwide, and its subsidiary Beverly Enterprises— Florida, Inc., the licensee in the State of Florida for Beverly Health and Rehabilitation — Spring Hill (“Spring Hill”). Prior to June 2, 1998, Spring Hill had contracts with the Health Care Financing Administration (“HCFA”), a subagency of the Department of Health and Human Services (“HHS”), and the State of Florida, to provide nursing home services to beneficiaries of the federal Medicare program and the Florida Medicaid program, pursuant to sections 1819 and 1919 of the Social Security Act, 42 U.S.C. §§ 1395Í-3,1396r. On June 2, 1998, the Secretary of HHS terminated Spring Hill’s contract to participate in the Medicare and Medicaid programs. This termination decision was upheld by an Administrative Law Judge, and thereafter affirmed by the Appellate Panel, Departmental Appeals Board, HHS. Plaintiffs have now sued Tommy Thompson, in his official capacity as the Secretary of HHS, and Thomas A. Scully, in his official capacity as Administrator of CMS. Plaintiffs’ challenge to the Spring Hill termination extends far beyond the particular decision in this case. Plaintiffs seek the invalidation of the federal nursing home enforcement regulations and the standard survey protocol used by state and federal surveyors to monitor compliance with substantive statutory and regulatory requirements for nursing home participation in the Medicare and Medicaid programs. Plaintiffs also challenge the ter-miration decision as being arbitrary and capricious. In addition to opposing these arguments, defendants argue that plaintiffs lack standing to assert injury from a survey protocol that allegedly has not been validated, and that the question of whether the Secretary has validated the survey protocol is not reviewable but has been committed to agency discretion. In addressing the myriad of issues raised by the parties, the Court will begin its analysis in Section I by tracing the relevant legislative and regulatory history, as well as HHS’ development of the Long-Term Care (“LTC”) Survey Protocol that is at the center of this litigation. Thereafter, the Court will address the legal arguments raised by the parties by answering the following questions: Section II: Do Plaintiffs Have Standing to Challenge the Survey Protocol? Section III: Does Defendants’ Use of the Survey Protocol Violate the Statute, the APA, or the Fifth Amendment? Section IV: Can the Survey Protocol Be Used as An Enforcement Tool If It Was Not Promulgated Through Notice and Comment Rulemaking Proceedings? Section V: Are Defendants’ Enforcement Regulations Invalid Because of a Failure to Respond to Comments Regarding the Invalidity of the Survey Protocol or to Disclose the Abt Study? Section VI: Was the Termination Decision Arbitrary and Capricious, Not in Accordance with Law, or In Violation of Plaintiffs’ Rights to Due Process and Equal Protection under the Law? As explained more fully below, the Court will not reverse defendants’ decision to terminate Spring Hill, enjoin the agency’s use of the protocol, or invalidate the agency’s enforcement regulations. Therefore, plaintiffs’ motion for summary judgment will be denied, and summary judgment is entered in favor of defendants. I. BACKGROUND: THE HISTORY OF NURSING HOME LEGISLATION AND REGULATION A. Pre-OBRA ’87 History Congress has maintained a longstanding, continuing concern with the well being of America’s elderly population, and today the nursing home industry is heavily regulated and monitored by the government through HHS and its subagency HCFA. The government began its attempts to regulate nursing homes in 1935 with the passage of the Social Security Act. (R.R. at 253, Institute of Medicine, Improving the Quality of Care in Nursing Homes (1986).) The creation of Medicare and Medicaid in 1965 changed the landscape regarding regulation of nursing homes, as federal funding and agency oversight of nursing homes expanded. (See id. at 256.) Ultimately, a major overhaul, of the nursing home regulatory system occurred in 1987 with the passage of the Omnibus Budget Reconciliation Act of 1987 (“OBRA ’87”), H.R.Rep. No. 100-391(1), at 452 (1987), reprinted in 1987 U.S.C.C.A.N. 2313-1, 2313-272. It is this Act and the regulations promulgated thereunder, as well as the survey protocol used to monitor compliance with the regulations, that is at issue here. However, before the Court can address these legislative and regulatory developments, it is necessary to digress momentarily to discuss the protracted litigation in Smith v. Bowen that took place beginning in the 1970s and lasted through the 1990s. In 1975, Medicaid recipients filed a class action lawsuit seeking to require the agency to meet its statutory duty to provide residents of nursing homes with adequate care. See Estate of Smith v. O’Halloran, 557 F.Supp. 289 (D.Colo.1983), rev’d sub. nom., Estate of Smith v. Heckler, 747 F.2d 583 (10th Cir.1984). In 1984, the Tenth Circuit reversed the district court’s decision and held that the agency had failed to meets its statutory duty of examining whether facilities were providing adequate care. See Estate of Smith, 747 F.2d at 589-90. The Tenth Circuit concluded: The Secretary of Health and Human Services ha[d] a duty to establish a system to adequately inform herself as to whether the facilities receiving federal money are satisfying the requirements of the Act. These requirements include providing high quality patient care. This duty to be adequately informed is not only a duty to be informed at the time a facility is originally certified, but is a duty of continued supervision. Nothing in the Medicaid Act indicates that Congress intended the physical facilities to be the end product. Rather, the purpose of the Act is to provide medical assistance and rehabilitative services. 42 U.S.C. § 1396. The Act repeatedly focuses on the care to be provided, with facilities being only part of that care. Id. at 589. The Tenth Circuit issued an order requiring the Secretary “to promulgate regulations which will enable her to be informed as to whether the nursing facilities receiving federal Medicaid funds are actually providing high quality medical care.” Id. at 591. As to implementation of the remedy, the Court, however, recognized that it was not a “super agency” and could not control “the specifics of how the Secretary satisfie[d] the duty.” Id. Thereafter, on remand in 1985, the district court ordered the Secretary of HHS to “develop and publish a notice of proposed rule making, consistent with the requirements of the APA, regarding a new survey system which will enable the Secretary to perform the duty prescribed by the Tenth Circuit Court of Appeals.” Estate of Smith v. Heckler, 622 F.Supp. 403, 411 (D.Colo.1985). In March 1987, the court required the Secretary to publish a Notice of Proposed Rule Making (“NPRM”) that included the guidelines and forms of the survey protocol. Estate of Smith v. Bowen, 656 F.Supp. 1093 (D.Colo.1987). In response, the Secretary published an NPRM on July 1, 1987. See 52 Fed.Reg. 24752 (July 1, 1987). In December 1987, upon plaintiffs’ motion for contempt, alleging that the NPRM was defective because it contained only substantive standards of care, the court concluded that, the agency was technically in contempt of court and must “promulgate regulations to effectuate the congressional purpose.... Under the Act, the states are responsible for establishing health standards and for determining whether institutions meet and continue to satisfy the requirements for participation in the Medicaid program.” Estate of Smith v. Bowen, 675 F.Supp. 586, 589 (D.Colo.1987). The court stated: To exercise the discretion granted by Congress, the Secretary must remain informed, on a continuing basis, whether facilities receiving federal money are meeting the requirements of the Act. To become and remain informed, the Secretary must establish uniform standards for facility -performance and a uniform methodology for evaluating that performance to ensure the delivery of high quality health care. Thus, the regulations required for these purposes must be prescriptive and legislative. Id. at 589 (emphasis added). As the Smith litigation was proceeding, the legal landscape was shifting throughout the 1980s. Congress and HCFA increased their focus on remedying the serious deficiencies in the nursing home regulatory system. In 1983, HCFA contracted with the Institute of Medicine to conduct a study on nursing home care in America and how it could be improved. HCFA was concerned that nursing homes were not providing a sufficient level of care and that the enforcement system was too lax. As a result, IOM published its report in 1986, entitled Improving the Quality of Care in Nursing Homes (“IOM Report”), which concluded that “[t]here is broad consensus that government regulation of nursing homes, as it now functions, is not satisfactory, because it allows too many marginal or substandard nursing homes to continue in operation.” (R.R. at 17.) The IOM Report noted that too many government certified nursing homes provided “very inadequate — sometimes shockingly deficient — care.” (Id.) It also indicated that many studies of nursing home care, which were conducted in the 1970s and 1980s, identified “both grossly inadequate care and abuse of residents.” (Id. at 18.) The IOM Report reached the following conclusions: (1) quality of care and quality of life in many nursing homes are not satisfactory; (2) more effective government regulation can substantially improve quality in nursing homes and a stronger federal role is necessary; (3) specific improvements are needed in the regulatory system; (4) there are opportunities to improve quality of care independent of changes in Medicaid payment policies or bed supply; (5) regulation is necessary but not sufficient for high-quality care; (6) a system to obtain standardized data on residents is essential; and (7) the regulatory system should be dynamic and evolutionary in outlook. (Id. at 36-39.) With respect to the regulatory system, the IOM Report recommended that the requirements imposed on nursing homes to participate in the Medicare and Medicaid programs be strengthened. IOM concluded that the three central requirements needed to provide sufficient nursing home care were: “(1) a competently conducted, comprehensive assessment of each resident; (2) development of a treatment plan that integrates the contributions of all relevant nursing home staff, based on the assessment findings; and (3) properly coordinated, competent, and conscientious execution of all aspects of the treatment plan.” (Id. at 63.) Among its recommendations for improving the regulatory system, IOM proposed a two-stage survey process with a standard and an extended survey taking place after a preliminary assessment. (Id. at 129-30.) B. OBRA’87 On December 22, 1987, Congress passed OBRA ’87, Pub.L. No. 100-203, which imposed strict new requirements on nursing homes and enacted measures to improve the enforcement process. In an effort to improve the quality of care that Medicare and Medicaid recipients were receiving in such facilities, Congress adopted many of the recommendations of the IOM Report and revised the conditions it required for facilities to participate in the Medicare and Medicaid programs, the survey, and certification process used to oversee participating facilities, and the sanctions that were to be imposed on noncompliant facilities. In enacting OBRA ’87, “the central purpose ... [wa]s to improve the quality of care for Medicaid-eligible nursing-home residents, and either to bring substandard facilities into compliance with Medicaid quality of care requirements or to exclude them from the program.” H.R.Rep. No. 100-391(1) at 452, reprinted in 1987 U.S.C.C.A.N. at 2313-272. In OBRA ’87, Congress established over 100 conditions for facilities to receive Medicare and Medicaid funds. To monitor compliance with these conditions, nursing homes have to enter into provider agreements that permitted unannounced annual standard surveys under 42 U.S.C. §§ 1395i — 3(g) and 1396r(g). Pursuant to contracts with state agencies, state surveyors have to conduct yearly surveys to determine whether nursing homes are meeting their statutory requirements. See id. §§ 1395aa, 1395i-3(g), 1396r(g). Surveyors must use a “case-mix stratified sample of residents,” and conduct “a survey of the quality of care furnished” by the facility as measured by various quality of life and of care indicators, an evaluation of resident assessments, and a review of the facility’s compliance with residents’ rights. Id. §§ 1395i — 3(g)(2)(A)(ii), 1396r(g)(2)(A)(ii). If surveyors conclude that a nursing home provides “substandard quality of care,” then an extended survey is done immediately. See id. §§ 1395i-3(g)(2)(B), 1396r(g)(2)(B). Under OBRA ’87, state “surveyors” must conduct these surveys using a “survey protocol” that has been “developed, tested, and validated.” 42 U.S.C. §§ 1395i — 3 (g) (2) (C), 1396r(g)(2)(C). The survey protocol consists of the forms, procedures, and guidelines that state surveyors use in assessing compliance by nursing homes with their statutory obligations. The survey is to be conducted by a “multidisciplinary team of professionals,” which must include a registered professional nurse. Id. §§ 1395i-3(g)(2)(E), 1396r(g)(2)(E). The Secretary must provide for “the comprehensive training of State and Federal surveyors in the conduct of standard and extended surveys.” Id. With respect to the requirements of the survey protocol, OBRA ’87 specifies that: Standard and extended surveys shall be conducted— (i) based upon a protocol which Secretary has developed, tested, and validated by not later than January 1, 1990, and (ii) by individuals, of a survey team, who meet such minimum qualifications as the Secretary establishes by not later than such date. The failure of the Secretary to develop, test, or validate such protocols or to establish such minimum qualifications shall not relieve any State of its responsibility (or the Secretary of the Secretary’s responsibility) to conduct surveys under this subsection. Id. §§ 1395i-3(g)(2)(C)(i), 1396r(g)(2)(C)(i). OBRA ’87 also specifies that: “Each State shall implement programs to measure and reduce inconsistency in the application of survey results among surveyors.” Id. §§ 1395i — 3(g)(2)(D), 1396r(g)(2)(D). C. Post-OBRA ’87 Agency Action Given OBRA ’87’s sweeping substantive changes to the regulatory framework governing nursing homes, defendants were required to publish substantive rules regarding participation and enforcement requirements. The rules containing participation requirements, which are located at 42 C.F.R. §§ 483.1^183.75, became fully effective on October 1, 1990. See 54 Fed. Reg. 5316; see also 56 Fed.Reg. 48826 (Sept. 26, 1991) (containing rules effective April 1, 1992, which contained changes following comment period). They were much more outcome-oriented than the pre-OBRA ’87 regulations, and they changed the focus to how services are provided to residents and the actual or potential effect on residents rather than on a facility’s capacity to provide services. See 56 Fed. Reg. at 48826. The new regulations contained a host of new substantive provisions enacted pursuant to OBRA ’87 and its emphasis on quality of life concerns. For example, the regulations require facilities to respect dignity, privacy, and the right of self-determination and to provide for medically-related social services. See 42 C.F.R. § 483.15. In short, the post-OBRA ’87 regulatory scheme was far more comprehensive in scope than its predecessor. After passage of OBRA ’87, but before its effective date on October 1, 1990, HCFA sought relief from the 1987 court orders in Smith requiring promulgation of survey forms, guidelines, and procedures through notice and comment proceedings. The agency argued that congressional action had mooted any need for formal rule-making. On February 18, 1988, the district court denied the agency’s Motion To Vacate Judgment and Order In Light Of New Legislation. Smith v. Bowen, 1988 WL 235574, at *1 (D.Colo. Feb.18, 1988). Since the court appreciated that there would be a substantial period of time before the pertinent OBRA ’87 amendments would be effective, it concluded that there was no reason to allow the agency to delay implementation any longer. Id. In response, on June 17, 1988, the Secretary published regulations that contained the forms, procedures, and guidelines in use at the time. See 53 Fed.Reg. 22,850 (June 17, 1988) (codified at 42 C.F.R. Part 488, Subpart C). Pursuant to OBRA ’87, the agency promulgated its participation regulations through notice and comment rulemaking proceedings. These regulations became effective as of OBRA ’87’s effective date— October 1, 1990. Given the fundamental changes to the system brought about by OBRA ’87, the agency again sought relief from the district court with respect to its prior orders. In response, the court found on September 27, 1990, that it was “necessary to permit the Secretary to implement the survey forms, procedures, and interpretive guidelines ... without requiring notice and comment rulemaking pursuant to the Administrative Procedures Act....” in order to “facilitate the implementation of the nursing home reforms of OBRA ’87 without final resolution of the issues before the Court.” (Pis.’ Mem.Ex. 33, Smith v. Sullivan, Order at 2 (Sept. 27, 1990).) Based on this finding, the court held that “[effective October 1, 1990, the Secretary shall be permitted on an interim basis to require the use of the new survey forms, procedures, and interpretive guidelines....” (Id.) The court also held that the survey and certification forms and guidelines located at 42 C.F.R. Part 488, Subpart C “shall be suspended but not repealed pending further orders of this Court regarding the appropriateness of the relief sought by the Defendant’s Motion.” (Id.) Since this order in 1990, the court has not again taken up this issue, and the protocol that was passed without notice and comment, has now been in effect since October 1,1990. Consistent with the court’s order, the agency has used this new survey protocol based on the duly promulgated participation regulations and the requirements of OBRA ’87, and it has required that it be used by all surveyors to investigate nursing homes. Thereafter, it released revised procedures to the survey protocol in the April 1992 State Operations Manual (“SOM”). (See A.R. at 14349.) The agency also subsequently released two revised versions of the survey protocol, Appendix P to the SOM, released in 1995 (see Pis.’ Mem.Ex. 21), and Appendices P and PP to the SOM, released in 1999. (See Defs.’ Mem.Exs. 6 and 7.) Section 2712 of the SOM, “Use of the Survey Protocol in the Survey Process,” notes that: Survey protocols are established to provide you with guidance in conducting surveys to assess the compliance of providers and suppliers participating in the Medicare and Medicare programs with certain regulatory requirements.... [Their purpose] is to provide instructions, check lists, and other tools for use both in preparation for the survey and when you are on-site performing the survey. (Pis.’ Mem.Ex. 21 at 2-137.) The SOM further indicates that: Survey protocols identify relevant areas and issues to be surveyed as specified in each regulation, and, in some cases, the methods to be used to survey those areas and issues. These protocols promote consistency in the survey process. They also assure that a facility’s compliance with the regulations is reviewed in a thorough, efficient, and consistent manner. (Id.) Part I of the survey protocol — “Survey Procedures for Long Term Care Facilities”- — outlines the survey tasks: Task 1: Offsite Survey Preparation (see id. at P-5-P-7); Task 2: Entrance Conference/Onsite Preparatory Activities (see id. at P-7 - P-10); Task 3: Initial Tour (see id. at P-10 - P-13); Task 4: Sample Selection (see id. at P-13 - P-19); Task 5: Information Gathering (General Observations of the Facility; Kitchen/Food Service Observation, Resident Review, Quality of Life Assessment, Medication Pass, and Quality Assessment and Assurance Review) (see id. at P-20 - P-41); Task 6: Information Analysis for Deficiency Determination (see id. at P-41 - P-46); and Task 7: Exit Conference. (See id. at P-46 - P-48.) Part I describes the steps that surveyors must take when performing each task. Appendix P also contains instructions for conducting extended and partial extended surveys. (See id. at P-46.) It also instructs surveyors on writing the statement of deficiencies, noting that the statement should: • Specifically reflect the content of each requirement that is not met; • Clearly identify how/why the requirement is/was not met; • Identify the extent of the deficient practice, including systemic practices, where appropriate; • Identify the source(s) of evidence (e.g., interview, observation, or record review); and • Identify the impact or potential impact of the facility’s noncompliance on the resident, and how it prevents the resident from reaching his/her highest practicable physical, mental, or psychosocial well-being. (Id. at P-48.) The Appendix also addresses deficiency categorizations and provides guidance on severity and scope levels (see id. at P-49), and it discusses confidentiality and respect for resident privacy. (See id. at P-54). Part II of the survey protocol, “Guidance to Surveyors-Long Term Care Facilities,” provides surveyors with multiple forms designed to provide guidance on various regulations. Each form is organized in three tabular columns. The first column identifies the tag number, the second provides the text of the regulation, and.the third contains guidelines, procedures, and probes. LEGAL ANALYSIS II. DO PLAINTIFFS HAVE STANDING TO CHALLENGE THE SURVEY PROTOCOL? Before addressing the merits of plaintiffs’ claims, the Court must first determine whether plaintiffs have standing to challenge the validity of the survey protocol. The question of standing involves both constitutional limitations on federal court jurisdiction, as well as prudential limitations on its exercise. See Bennett v. Spear, 520 U.S. 154, 117 S.Ct. 1154, 137 L.Ed.2d 281 (1997); see also Mountain States Legal Found. v. Glickman, 92 F.3d 1228, 1233 (D.C.Cir.1996). Article III constitutional standing limits judicial intervention to genuine disputes between adverse parties which are “ ‘in a form ... capable of judicial resolution,’ ” Florida Audubon Society v. Bentsen, 94 F.3d 658, 663 (D.C.Cir.1996) (quoting Flast v. Cohen, 392 U.S. 83, 101, 88 S.Ct. 1942, 20 L.Ed.2d 947 (1968)), and therefore, it “ ‘is an essential and unchanging predicate to any exercise of [federal] jurisdiction.’ ” Id. (quoting Lujan v. Defenders of Wildlife, 504 U.S. 555, 560, 112 S.Ct. 2130, 119 L.Ed.2d 351 (1992)). To meet the “irreducible constitutional minimum” requirements for Article III standing, plaintiffs bear the burden of showing that: (1) they have suffered an injury which is (a) concrete and particularized, and (b) actual or imminent, not conjectural or hypothetical; (2) there is a causal connection between the alleged injury and conduct that is fairly traceable to defendants, and not the result of the independent action of some third party not before the court; and (3) it is likely, as opposed to merely speculative, that the injury will be redressed by a favorable decision. See Lujan, 504 U.S. at 561-62, 112 S.Ct. 2130. Because the elements of standing are “not mere pleading requirements, but rather an indispensable part of the plaintiffs case, each element must be supported in the same way as any other matter on which the plaintiff bears the burden of proof, i.e., with the manner and degree of evidence required at the successive stages of the litigation.” Id. at 561, 112 S.Ct. 2130. If “plaintiffs’ standing does not adequately appear from all materials of record, the complaint must be dismissed.” Warth v. Seldin, 422 U.S. 490, 502, 95 S.Ct. 2197, 45 L.Ed.2d 343 (1975). A. Injury In Fact Plaintiffs first bear the burden of establishing an injury in fact. See Lujan, 504 U.S. at 561, 112 S.Ct. 2130. Plaintiffs must show that they suffer a “concrete and particularized” injury that is “actual or imminent.” Id. at 560, 112 S.Ct. 2130. Defendants argue that the “thrust of [plaintiffs’] evidence is that, if there is any problem with the nursing-home enforcement process, it is that it does not uncover as many violations as it could.” (Defs.’ Reply at 5.) According to defendants’ argument, plaintiffs are not injured from “un-derenforcement,” and thus, they have no standing to challenge the validity of the survey protocol. Plaintiffs respond that their injury is concrete and particularized, since they have suffered two distinct types of injuries. First, they argue that the Spring Hill facility was terminated and incurred substantial civil penalties based on an invalid instrument that has not been tested or validated as required by Congress and that produces arbitrary and inconsistent results in violation of federal law. Second, plaintiffs argue that they are injured because they will continue to be subjected to this illegal protocol in the future. (See Pis.’ Opp. at 5-11.) It is beyond dispute that plaintiffs have suffered injury and will continue to suffer injury in the future, because their 300 nursing homes nationwide will be subjected to an allegedly illegal survey at least every fifteen months, pursuant to 42 U.S.C. §§ 1395i-3(g)(2), 1396r(g)(2), and “an agency rule ... is typically reviewable without waiting for enforcement.” Chamber of Commerce v. FEC, 69 F.3d 600, 604 (D.C.Cir.1995). Moreover, plaintiffs convincingly compare this case to Abbott Laboratories v. Gardner, 387 U.S. 136, 153-54, 87 S.Ct. 1507,18 L.Ed.2d 681 (1967); Bristol-Myers Squibb Co. v. Shalala, 91 F.3d 1493 (D.C.Cir.1996); and Chamber of Commerce, 69 F.3d at 604. In all three cases, the Courts held that plaintiffs had standing to challenge rules that had a continuous or future impact on them. For instance, in Abbott Laboratories, the Supreme Court granted standing to drug companies challenging the Food and Drug Administration’s regulation, since “the regulation [wa]s directed at [drug companies] in particular; it require[d] them to make significant changes in their everyday business practices; [and] if they fail[ed] to observe the Commissioner’s rule they [we]re quite clearly exposed to the imposition of strong sanctions.” 387 U.S. at 154, 87 S.Ct. 1507. See also Bristol-Myers Squibb Co., 91 F.3d at 1498 (challenged regulations create “threat of recurring harms”); Chamber of Commerce, 69 F.3d at 604. Here, there can be no dispute that the survey protocol is directed at nursing homes, it substantially impacts plaintiffs’ everyday practices, and they were exposed to sanctions, including termination and fines, after use of the survey. Moreover, defendants mischaracterize plaintiffs’ claims by trying to suggest that they are only complaining about the protocol’s failure to identify more violations. Rather, plaintiffs are challenging the agency’s failure to use a tested and validated survey protocol and the resultant sanctions that flow from application of this allegedly illegal enforcement tool. (Pis.’ Opp. at 10-11.) Thus, plaintiffs have met their burden of establishing that they have suffered an injury in fact. B. Causation Plaintiffs’ alleged injury is also “fairly traceable” to defendants. Lujan, 504 U.S. at 560, 112 S.Ct. 2130 (requiring causal connection between alleged injury and conduct “fairly traceable” to defendant). “A court may act only to redress injury that fairly can be traced to the challenged action of the defendant, and not injury ‘that results from the independent action of some third party not before the court.’ ” Northwest Airlines, Inc. v. FAA, 795 F.2d 195, 203-04 (D.C.Cir.1986) (citation omitted); see also Mideast Systems and China Civil Construction Saipan Joint Venture, Inc. v. Model, 792 F.2d 1172, 1177 (D.C.Cir.1986) (“The presence of an independent variable between either the harm and the relief or the harm and the conduct makes causation sufficiently tenuous that standing should be denied.”). Here, plaintiffs allege that defendants’ actions are arbitrary and capricious. Plaintiffs challenge “the validity of the regulations and the process used by the Secretary to survey nursing facilities because the standards applied are too vague and surveyors are given too much discretion, because the Secretary has failed to test and validate the procedure as directed by Congress, and because a study commissioned by HCFA to evaluate the survey process demonstrated that the process is unreliable and inconsistent.” (Comply 24(b).) Furthermore, it is defendants who require their surveyors to use the survey protocol alleged to be invalid, and the use of the survey protocol can result in sanctions. See 42 U.S.C. §§ 1395i-3(g)(2)(C), 1396r(g)(2)(C). C. Redressability Plaintiffs have shown that there is a “substantial likelihood” that their injuries would be redressed by a favorable decision on the merits. “[Plaintiffs] need not show to a certainty that a favorable decision will redress [their] injury. A mere likelihood wiH do.” Nat’l Wildlife Fed. v. Hodel, 839 F.2d 694, 705 (D.C.Cir.1988). In their Complaint, plaintiffs have requested several remedies, including: (1) that defendants’ decision to terminate plaintiffs from the Medicare and Medicaid programs be vacated and given no legal effect; (2) that defendants be required to design a valid survey process conforming to statutory requirements; (3) that defendants be required to refrain from using invalid survey forms; (4) that 42 C.F.R., Part 488, Subpart C be properly amended or repealed; and (5) that defendants refrain from employing nursing home law enforcement regulations. While it may be true, as argued by defendants (Defs.’ Mem. at 32-33), that invalidation of the existing protocol would not redress the problem of underenforcement, this argument does not accurately represent plaintiffs’ claim of injury. Moreover, it is clear that if plaintiffs were to succeed in invalidating the survey protocol, their injuries would be redressed, for they would not be exposed to an allegedly invalid protocol. D.Prudential Standing and Statutory Authority to Bring Suit Lastly, defendants claim that plaintiffs lack prudential standing, arguing that plaintiffs fall outside the required “zone of interests,” because Congress intended to protect nursing home residents and not the nursing homes when enacting the survey and certification provisions of OBRA ’87. (See Defs.’ Mem. at 33-34.) Defendants, however, provide no case law in support of this argument; moreover, their reply does not even address plaintiffs’ argument that they do not need to establish prudential standing, for when Congress has authorized a party to bring an action, such action “ ‘eliminates any prudential standing limitations!].]’” FEC v. Akins, 524 U.S. 11, 20, 118 S.Ct. 1777, 141 L.Ed.2d 10 (1998) (quoting Raines v. Byrd, 521 U.S. 811, 820 n. 3, 117 S.Ct. 2312, 138 L.Ed.2d 849 (1997)); see also Bennett, 520 U.S. at 163-64, 117 S.Ct. 1154 (statutory provision stating “any person may commence a civil suit” negates prudential standing requirement). To establish statutory authority to sue, plaintiffs rely upon the Supreme Court’s decision in Shalala v. Illinois Council on Long Term Care, Inc., 529 U.S. 1, 20-21, 120 S.Ct. 1084, 146 L.Ed.2d 1 (2000), which involved a strikingly similar and recent attempt by nursing homes to challenge the Secretary’s enforcement regulations. In Illinois Council, an association of nursing homes brought suit against the Secretary, alleging, inter alia, that Medicare-related regulations violated OBRA ’87. Specifically, they claimed that (1) certain terms, e.g., “substantial compliance,” were unconstitutionally vague; (2) the regulations and manual violated the statutory requirement seeking enforcement consistency, 42 U.S.C. § 1395i — 3(g)(2)(D); (3) the regulations violated due process; and (4) the manual and agency publications created legislative rules not promulgated with necessary “notice and comment” and a statement of “basis and purpose,” pursuant to 5 U.S.C. § 553. 529 U.S. at 6, 120 S.Ct. 1084. The association “complain[ed] that a host of procedural regulations unlawfully limit the extent to which the agency itself will provide the administrative review channel leading to judicial review, for example, regulations insulating from review decisions about a home’s level of noncompliance or a determination to impose one, rather than another, penalty.” Id. at 23, 120 S.Ct. 1084 (citing 42 C.F.R. §§ 431.153(b), 488.408(g)(2), 498.3(d)(10)(ii)). While the Supreme Court held that there was a lack of federal question jurisdiction so that the association was unable to make an anticipatory challenge to the validity of the Medicare regulations, it nonetheless provided guidance as to how nursing home facilities should proceed in order to obtain judicial review by directing parties to proceed through the special review channel created by the Medicare statute (see 529 U.S. at 20-22, 120 S.Ct. 1084), which is exactly what plaintiffs have done here: The [association’s members remain free, however, after following the special review route that the statutes prescribe, to contest in court the lawfulness of any regulation or statute upon which an agency determination depends. The fact that the agency might not provide a hearing for that particular contention, or may lack the power to provide one ... is beside the point, because it is the “action” arising under the Medicare Act that must be channeled through the agency.... After the action has been so channeled, the court will consider the contention when it later revieivs the action. And a court revieioing an agency determination under § 105(g) has ade- quote authority to resolve any statutory or constitutional contention that the agency does not, or cannot, decide, ... including, where necessary, the authority to develop an evidentiary record. Proceeding through the agency in this way provides the agency the opportunity to reconsider its policies, interpretations, and regulations in light of those challenges. Id. at 23-24, 120 S.Ct. 1084 (emphasis added) (citations omitted). Thus, under Illinois Council, plaintiffs have statutory authority to bring suit. III. DOES DEFENDANTS’ USE OF THE SURVEY PROTOCOL VIOLATE THE STATUTE, THE APA, OR THE FIFTH AMENDMENT? Plaintiffs argue that the decision to terminate Spring Hill from the Medicare program must be set aside. First, they argue that the agency’s determination to terminate was predicated on findings based on an invalid survey protocol, because it has never been “tested[] and validated,” as required by statute. Second, plaintiffs argue that the survey process produces arbitrary, inaccurate, and inconsistent results in violation of the Social Security Act, the Administrative Procedure Act (“APA”), and the Fifth Amendment to the Constitution. With respect to plaintiffs’ first argument, they cite to the statutory language requiring that surveys “shall be conducted ... based upon a protocol which the Secretary has developed, tested, and validated by not later than January 1, 1990.” 42 U.S.C. §§ 1395i-3(g)(2)(C), 1396r(g)(2)(C). Plaintiffs argue that this language requires that the survey protocol “produce accurate, reliable and consistent results” (Pis.’ Mem. at 10), but despite this mandate, plaintiffs claim that: Year after year, defendants are ordered to adopt a survey protocol that produces accurate and consistent assessment of care. Time and again, defendants promise to develop and utilize valid and reliable measurements of the quality of care. Yet, the survey process still continues to be found inaccurate, unreliable and inconsistent in independent studies, in defendants’ own studies, in studies performed by other government agencies and, in fact, by participants at every level in the delivery and receipt of nursing home care. The history of nursing home regulation is characterized by nothing so much as defendants’ broken promises and obdurate failure to comply with the law, whether announced by courts or imposed by Congress. (Id. at 14.) With respect to their second argument, plaintiffs claim “[t]he mandate to measure and reduce inconsistency on a going forward basis sets forth Congress’ requirement that the Secretary articulate clearly and apply uniformly the standards and principles that govern his discretionary survey and enforcement decisions.” (Id. at 47-48.) While conceding that the level of consistency and accuracy is not specified in the statute (see id. at 48), plaintiffs rely on studies, including a 2001 IOM Report (id. Ex. 14) and GAO and OIG Reports (id. Exs. 6, 9), that they claim demonstrate “substantial,” “wide” and “considerable” variation of an unacceptable, nature in the pattern of deficiency citations across states. (Id. at 52.) They argue that the survey and enforcement process is at odds with the goals of OBRA ’87, because the protocol is not a credible tool to promote quality medical care. (Id. at 63) (citing Motor Vehicle Mfrs. Ass’n v. State Farm Mut. Ins. Co., 463 U.S. 29, 43, 103 S.Ct. 2856, 77 L.Ed.2d 443 (1983)). Lastly, plaintiffs and amicus AHCA argue that the protocol is so vague as to deny due process. Based on these arguments, plaintiffs claim that the inspection findings are invalid and cannot be used to impose sanctions against nursing homes generally and Spring Hill in particular. They also contend that the survey protocol is an invalid instrument that cannot be used as an enforcement tool in the future. At the outset, the' Court must reject plaintiffs’ attempt to reverse Spring Hill’s termination on the grounds that the survey is “invalid.” Contrary to plaintiffs’ argument, the • surveyors’ inspection, findings remain valid regardless of whether the survey protocol has been tested and validated, for OBRA ’87 makes clear that the lack of a validated protocol does not discharge defendants of their statutory obligation to conduct surveys: Standard and extended surveys shall be conducted: (i) based upon a protocol which Secretary has developed, tested, and validated by not later than January 1, 1990, and (ii) by individuals, of a survey team, who meet such minimum qualifications as the Secretary establishes by not later than such date. The failure of the Secretary to develop, test, or validate such protocols or to establish such minimum qualifications shall not relieve any State of its responsibility (or the Secretary of the Secretary’s responsibility) to conduct surveys under this subsection. 42 U.S.C. §§ 1395i-3(g)(2)(C), 1396r(g)(2)(C) (emphasis added). Plaintiffs quote selectively from this statutory language by focusing only on the language requiring that the survey shall be conducted based upon a “protocol which the Secretary has developed, tested, and validated by not later than January 1, 1990,” omitting the subsequent language. (See, e.g., Pls.’ Mem. at 9.) The statutory language, however, unambiguously states that the Secretary and States must conduct surveys, irrespective of whether the protocol has been validated, and as defendants, observe, this language does not limit defendants’ obligation to conduct surveys to the specific time period that elapses on January 1, 1990. Plaintiffs’ interpretation would also contravene the remedial nature of OBRA ’87 and its central purpose of “improvfing] the quality of care.” H.R.Rep. No. 100-391(1) at 452, reprinted in 1987 U.S.C.C.A.N. 2313-272. As the legislative history states: “[T]he failure of the Secretary to develop such protocols would not relieve the States or the Secretary of their responsibilities to conduct standard and extended surveys. It is the Committee’s expectation that the use of protocols will enable facilities, residents, and residents’ families and advocates to know how surveys will be conducted and how data will be analyzed to reach conclusions about the quality of care at a facility.” Id. at 468, reprinted in 1987 U.S.C.C.A.N. 2313-288. The Secretary correctly interpreted this same language in 1994 when deciding to implement 42 C.F.R. § 488.305(b), which states in relevant part, “[t]he State survey agency’s failure to follow the procedures set forth in this section will not invalidate otherwise legitimate determinations that a facility’s deficiencies exist.” See Fed.Reg. at 56,133-56,134. In responding to comments suggesting deletion of this provision and questioning whether it was sanctioned by Congress, the Secretary stated the belief that “the provision accurately reflects the intent of the Act....” and reasoned: To invalidate legitimate determinations of noncompliance and leave them unaddressed would be in opposition to the mandate of OBRA ’87 that all requirements be met and enforced, and would lead to inconsistent application of the law. Sections 1819(g)(2)(C) and 1919(g)(2)(C) of the Act reveal the intent of the Act very clearly. These sections state that standard surveys must be conducted based upon a protocol, but add that the failure of the Secretary to develop, test or validate such a protocol will not relieve any State or the Secretary of the responsibility to conduct surveys. Because the Congress intended for survey results to be binding even when surveys tvere conducted in the absence of a foivnal protocol, it is clear that the Congress vieivs the substance of suwey findings to be of greater' importance than the process used to identify them.... [Sjince the source of noncompliance will not rest on whether the survey protocol was rigorously followed, but on whether a requirement of the Act or the regulations has been violated.... [Wjhether or not a surveyor follows protocols must be subordinate in importance to whether or not a facility meets Federal participation requirements. Violations must be recognized and remedied appropriately if resident interests are to be protected and integrity is to remain in the enforcement system. Id. (emphasis added). Thus; Spring Hill cannot avoid responsibility for its deficiencies based on an allegedly invalid protocol. A. Standard of Review With respect to plaintiffs’ facial challenge to the protocol, they argue that it is fundamentally flawed, because it produces arbitrary, inaccurate, and inconsistent results. The Court must first determine if, as argued by defendants, this matter is committed to agency discretion, and if not, what is the appropriate standard of review. Defendants argue that the Secretary’s decision regarding the validation of the protocol is unreviewable, because the contested agency action has been committed to agency discretion by law. See 5 U.S.C. § 701. There is, however, a strong presumption favoring judicial review of agency actions, see, e.g., Abbott Laboratories, 387 U.S. at 140, 87 S.Ct. 1507, which can be rebutted only by showing that “ ‘(1) the statutes preclude judicial review; or (2) agency action is committed to agency discretion by law.’ ” Natural Resources Defense Council, Inc. v. SEC, 606 F.2d 1031, 1043 (D.C.Cir.1979) (quoting 5 U.S.C. § 701(a)). It is undisputed that the statute does not expressly preclude judicial review. With respect to the second inquiry, the Court concludes that there is law to apply in a meaningful manner, and thus, it may exercise at least a limited power of review. The exception to the general presumption favoring judicial review that defendants seek to invoke can apply only in “those rare instances where ‘statutes are drawn in such broad terms that in a given case there is no law to apply.’ ” Citizens to Preserve Overton Park v. Volpe, 401 U.S. 402, 410, 91 S.Ct. 814, 28 L.Ed.2d 136 (1971) (citation omitted). For instance, in Heckler v. Chaney, 470 U.S. 821, 830, 105 S.Ct. 1649, 84 L.Ed.2d 714 (1985), the Supreme Court held that an agency’s decision not to take an enforcement action was not reviewable. The instant facts, however, are distinguishable from Chaney, for they do not directly involve an agency’s decision regarding whether to undertake an enforcement action; rather, plaintiffs challenge whether defendants have met their statutory mandate to “validate” the survey protocol. Thus, the statutory requirement is sufficiently removed from the enforcement and investigation process to fall outside of the enforcement arena. In determining what standard to apply, this Circuit’s reasoning in Robbins is instructive: Even when there are no clear statutory guidelines, courts often are still able to discern from the statutory scheme a congressional intention to pursue a general goal. If the agency action is found not to be reasonably consistent with this goal, then the courts must invalidate it. The mere fact that a statute grants broad discretion to an agency does not render the agency’s decision completely nonreviewable under the “committed to agency discretion by law” exception unless the statutory scheme, taken together with other relevant materials, provides absolutely no guidance as to how that discretion is to be exercised. Robbins, 780 F.2d at 45. As noted by the Circuit Court, “courts have a clear role to play in ensuring that an agency’s practical implementation of its program is consistent with its own declared intentions and goals. Courts often have invalidated agency action because it simply did not comport with standards of rational decisionmaking given the agency’s uncontested goal.” Id. at 46 (citing Telocator Network of America v. FCC, 691 F.2d 525, 537 (D.C.Cir.1982)). Thus, unless the presumption of reviewa-bility is rebutted by an “affirmative showing that the statute’s allocation of discretion is so broad that the Courts simply have no standards to apply,” Robbins, 780 F.2d at 47, the agency’s action must be reviewable. Here, “the statutory scheme, taken together with other relevant materials, provides ... guidance as to how the discretion is to be exercised.” Id. at 46. The statutory language, 42 U.S.C. §§ 1395i-3(g)(2)(C), 1396r(g)(2)(C), mandates that surveys “shall be conducted ... based upon a protocol which Secretary has developed, tested, and validated by not later than January 1, 1990.” (emphasis added). Defendants attempt to avoid this statutory requirement by arguing that the word “shall” does not modify the word “validate” (see Defs.’ Mem. at 36), but their argument is unpersuasive. Congress’ language is plainly that “of obligation rather than discretion,” Bennett, 520 U.S. at 172, 117 S.Ct. 1154, and such mandatory language is evidence that Congress intended that the statute be subject to judicial review. See, e.g., Armstrong v. Bush, 924 F.2d 282, 293 (D.C.Cir.1991) (finding there was “law to apply” in a statute providing that agency heads “shall establish and maintain” records management programs and “shall establish safeguards against the removal or loss of records[.]”) The mandatory nature of this requirement is also made clear by the House Committee Report’s language summarizing statutory guidelines— upon which defendants rely (see Defs.’ Reply at 10) — which states that the Secretary “must establish standard [and] extended survey protocols and minimum] qualifications for surveyors.” H.R.Rep. No. 100-391(1) at 481, reprinted in 1987 U.S.C.C.A.N. at 2313-301. Thus, the presence of the word “shall” makes it mandatory for surveys to be conducted “using a tested and validated” protocol. Under the familiar “arbitrary and capricious” standard in the APA, requiring a court to review whether the agency actions are “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law,” 5 U.S.C. § 706(2)(A), the Court must determine here whether the agency’s actions in fulfilling the statutory mandate to “validate” the survey “comport with standards of rational decisionmaking” given the goals of OBRA ’87. Robbins, 780 F.2d at 45-46. In conducting such a review, it is, however, “well settled that the Secretary’s decisions interpreting the Medicare Act are entitled to ‘great deference.’ ” Sentara-Hampton General Hosp. v. Sullivan, 980 F.2d 749, 755 (D.C.Cir.1992). See also Methodist Hosp. of Sacramento v. Shalala, 38 F.3d 1225, 1229 (D.C.Cir.1994) (“The Supreme Court has made clear that courts must give heightened deference to the Secretary’s interpretation of a ‘complex and highly technical regulatory program’ such as Medicare.”) (quoting Thomas Jefferson Univ. v. Shalala, 512 U.S. 504, 114 S.Ct. 2381, 2387, 129 L.Ed.2d 405 (1994)); Schweiker v. Gray Panthers, 453 U.S. 34, 43, 101 S.Ct. 2633, 69 L.Ed.2d 460 (1981) (“The Social Security Act is among the most intricate ever drafted by Congress.”); County of Los Angeles v. Shalala, 192 F.3d 1005, 1016 (D.C.Cir.1999) (“In marking off the metes and bounds of our review under the second step of Chevron, we accord particular deference to the Secretary’s interpretation ... ‘given the tremendous complexity of the Medicare statute.’ ”) (quoting Appalachian Reg’l Healthcare, Inc. v. Shalala, 131 F.3d 1050, 1054 (D.C.Cir.1997)). B. Legal Analysis Applying this deferential standard of review to the record, the Court finds that the agency has complied with the requirements of the statute and the APA. As demonstrated below, plaintiffs’ argument for invalidation is unsound and contrary to the substantial evidence that the agency has engaged in a continual and lengthy process of rational decisionmaking, consistent with the goals of OBRA ’87, in an effort to develop, test, revise, and improve the survey protocol so as to validate it. 1. Flaws in Plaintiffs’ Argument a. There is no standard for judging accuracy and consistency If one were to accept plaintiffs’ argument, the Court would have to make decisions that Congress did not authorize it to make. It is not for the Court to determine what is the acceptable level of accuracy or consistency, for neither the statute nor its legislative history defines how much inconsistency or inaccuracy is too much. Congress appreciated the complexity and enormity of the agency’s task of developing an enforcement process to ensure that nursing homes provide an adequate level of care to the elderly — and it did not expect perfection. Instead, it demanded the agency to take its charge seriously, but it anticipated that improvements would occur gradually. Congress acknowledged that there would be a certain level of inconsistency, and that even training would not eliminate the problem, so it required that “each State and the Secretary shall implement programs to measure and reduce inconsistency in the application of survey results among surveyors.” 42 U.S.C. §§ 1395i-3(g)(2)(D), 1396r(g)(2)(D). See also H.R.Rep. No. 100-391(1), at 468 (1987), reprinted in 1987 U.S.C.C.A.N. 2313-288. Even the dictionary definition of the term “validate” that plaintiffs offer does not require perfection or establish permissible levels of consistency and accuracy. Rather, it implies an ongoing process that will result in changes and refinements. Plaintiffs concede as much: “[T]he amendments did not merely obligate defendants to test and validate the survey protocol on a one-time basis, i.e., prior to implementation. To the contrary, the statute requires on-going actions to assure accurate and consistent survey results.” (Pis.’ Mem. at ID Plaintiffs nonetheless continually complain that the survey findings and sanctions are unacceptably inconsistent (see, e.g., id. at 50), but they rely on vague generalities — “[e]very study of the survey process ... demonstrates that survey findings and enforcement sanctions continue to be unacceptably inconsistent....” (id.); “[s]urvey results ... are arbitrary and are characterized by gross inconsistency.... ” (id. at 51); “ ‘variability ... in consistency ... is problematic....’ ” (id.) (citing Pis.’ Mem.Ex. 14, IOM 2001 Report); “inconsistencies” are “ ‘substantial’, “wide’ and ‘considerable.’ ” (id. at 52); “ ‘the pattern of citations suggest that states probably vary widely....’” (Id. at 53) (quoting Pis.’ Mem.Ex. 13, 1998 Report to Congress.) Plaintiffs, however, provide no yardstick for determining an acceptable level of variation, but leave it for the Court to decide, even though this is a matter within the agency’s— and not the Court’s. — discretion and expertise. b. Plaintiffs have failed to prove that the protocol is invalid Plaintiffs have failed to present sufficient evidence that the survey protocol has not been validated, as required by statute. Although defendants acknowledge the validity of much of the data and criticisms presented by plaintiffs, they correctly argue that there is no conclusive evidence as to the cause of these problems. (See Defs.’ Mem. at 38-39.) Correlation does not necessarily mean causation, for there are many other factors that contribute to the survey results. For instance, there could be differences in the quality of care. In its 1998 Report to Congress, the agency identified the problem: Enforcement is inherently difficult to measure. Although there is considerable variation among states in degree of enforcement, as measured by rates of deficiency or substandard quality of care determination, it is difficult to separate what proportion of behavior is due to true differences in nursing home quality and what proportion is attributable to differences in surveyor behavior. (Pis.’ MenxEx. 13 at 41.) In fact, variability in results is desirable as long as it accurately reflects the differential quality of care that is being provided in different locales. Second, resident populations could differ in size or could have different characteristics that would impact the results. Additionally, surveyor performance could vary, and there could be legitimate differences in professional judgment, which by definition can lead to varying results. As to the latter, the system requires some level of professional judgment. (See Defs.’ Mem. Ex. 1 at 20) (“[Pjrofessional judgment is an essential component in identifying poor care.”) States also devote different levels of time and resources to the survey process or may have varying degrees of success in conducting unannounced surveys. (See Pis.’ Mem.Ex. 28 at 31.) Additionally, much of the critical data upon which plaintiffs rely relates to the problem of underreporting of deficiencies. (See, e.g., Pis.’ Mem.Ex. 28 at 10, 32-33, Testimony of William Scanlon; Pis.’ Opp.Ex. 2 at 5, 2001 RFP.) However, un-derreporting does not necessarily result from an invalid survey protocol, nor does it mean that the protocol is not being used to find legitimate violations. It could be due to other factors, such as lax enforcement. In sum, the evidence does not permit one to conclude that defects in the protocol are to blame for the inconsistencies and inaccuracies. c. Plaintiffs’ factual presentation regarding the survey protocol is inaccurate and incomplete Plaintiffs mischaracterize both the agency’s efforts to validate the protocol and the studies that have been undertaken to review the protocol. Plaintiffs also ignore studies that reach positive conclusions about the protocol, and they fail to acknowledge the improvements that have been made in the protocol since it was first used in the early 1990s. For instance, plaintiffs do not take into account the studies published in the 1990s, which indicate that survey results are generally reliable. For example, in 1995 and 1996, the Center for Health Systems Research and Analysis (“CHSRA”) at the University of Wisconsin concluded that independent researchers disagreed with only five percent of the deficiencies cited by the state surveyors considered. (See Defs Mem.Ex. 5 at 12.) A 1999 GAO Report examined 107 randomly selected survey reports, which spanned all ten regions, and relied on the fact that ninety-eight percent of surveys documented actual harm to residents to conclude that HCFA should increase its use of the existing survey by targeting repeat violators. (See Defs.’ Mem.Ex. 3 at 2, 5-6.) Another 1999 GAO Report concluded that appropriate regulatory action had been taken in all eight examples that amicus AHCA had submitted to Congress as examples of allegedly inaccurate citations. (See Defs.’ Ex. 4 at 2.) Plaintiffs also misrepresent defendants’ 1998 Report to Congress, focusing on its admission that “the new enforcement regulation does not appear to be working as intended[.]” (See Pis.’ Mem. at 37) (quoting Pis.’ Mem.Ex. 13 at 540.) But plaintiffs ignore the context of such a statement and the report’s general conclusions noting progress: “With respect to ... the existing system of survey and certification, evidence was produced that the OBRA ’87 reforms implemented in October 1990 resulted in improved resident outcomes. Also, there is some suggestive but inconclusive evidence that the more recent enforcement provisions resulted in improvements in resident outcomes, although many of the enforcement processes we examined aré not working as intended.” (Id. at xiii.) Plaintiffs also rely on seven other studies (four GAO Reports from July 1998, March 1999, June 1999, and November 1999 and three reports issued by OIG) and the testimony of Dr. Scanlon before the Senate’s Special Committee on Aging, but these materials merely point to the obvious fact that a complex, nationwide regulatory system that must rely on human beings for its implementation cannot be expected to be infallible. They do not prove that the protocol is invalid. Plaintiffs reliance on defendants’ Request for Proposal (“RFP”), published on July 12, 2001, to study “the effectiveness of enforcement” is misguided. (Pis’ Opp.Ex. 2.) What plaintiffs point to as troubling is defendants’ concession that ■ “[although many aspects of this system have been studied, there is little empirical evidence supporting the most fundamental assumptions of this system, including a consensus of what the system has achieved or is expected to achieve.” (Pis.’ Opp. at 35) (quoting Pis.’ Opp.Ex. 2 at 4, 10.) While this statement reflects significant agency concern with the oversight of nursing homes, the RFP nonetheless presents a far more nuanced picture than plaintiffs are willing to admit: During the last few years, there have been countless news reports, articles, and public hearings reporting the widespread occurrence of resident abuse, neglect, and problems of dehydration, malnutrition, and pressure ulcers. In response, beginning with HCFA’s July Report to Congress ..., there have been several studies and investigatory reports on various aspects of the system of survey and certification. The HCFA study found that the OBRA ’87 reforms implemented in October 1990 through July 1995 resulted in improved resident outcomes. However, many of the enforcement processes, e.g., the identification of serious problems, were not working as intended. Id. (emphasis added). Contrary to plaintiffs’ slant, the RFP represents an effort to evaluate “an evolving package of reforms,” the President’s 1998 Nursing Home Initiative (“NHI”), which was instituted in response to HCFA and GAO reports. The NHI “centers on improving nursing home inspections by placing a stronger emphasis on looking for care problems related to pressure sores, dehydration, nutrition, and the use of restraints and strengthening state and federal enforcement efforts.” (Id.) It is exactly the type of reform that Congress would have expected the agency to undertake to fulfill its statutory mandate. As noted in the RFP, in reviewing the effectiveness of the reforms, results have been mixed: “The GAO found some i