Full opinion text
ORDER TRAXLER, Circuit Judge. This matter is before the court pursuant to a lawsuit filed by a physician and two medical clinics which offer first trimester abortion services in South Carolina, challenging the constitutionality of a state regulation, S.C.Code Ann. Regs. 61-12, which governs the licensure and operation of physicians’ offices and abortion clinics that perform five or more first trimester abortions per month. Plaintiffs seek a declaration that the regulation is unconstitutional and injunctive relief against state officials who would enforce it. On July 19, 1996, this court issued an order granting plaintiffs’ motion for a temporary restraining order and enjoining defendants from enforcing the challenged regulation, pending a hearing on the issuance of a preliminary injunction. Prior to such hearing, however, the parties notified the court that they had agreed to continue the injunction until a decision could be rendered on the merits. A six day non-jury trial was held before this court beginning July 13, 1998, and arguments were heard on October 9,1998. INTRODUCTION In 1973, the Supreme Court of the United States ruled that a woman’s decision to have an abortion was a fundamental right protected by the Constitution. Because the South Carolina Department of Health and Environmental Control, (“DHEC”), has promulgated a regulation governing abortions and abortion clinics, and because there is a legal challenge to its requirements, it has become the responsibility of this court to examine the regulation to determine if it can withstand a challenge to its constitutionality. An analysis of this issue begins not only with an understanding that a woman’s right to choose to undergo an abortion is a constitutionally protected one, but also with a recognition that a state has a legitimate interest in regulating abortions in order to protect maternal health and to promote fetal life. A state has a duty to protect its citizens and this court will uphold such efforts so long as a state’s laws do not tread improperly upon rights protected by the United States Constitu-^on' In this case, DHEC has promulgated a regulation in the area of abortions which it clearly had the right to do. What it did wrong was to go too far. Despite the fact that abortion clinics have been operated in a safe manner for the past twenty-three years, DHEC loaded these abortion clinics down with so many unnecessary requirements that the court has no choice but to conclude that the regulation unduly burdens a woman’s fundamental right to undergo an abortion and, therefore, violates the Due Process Clause of the Fourteenth Amendment to the Constitution. The regulation also violates the Equal Protection Clause of the Fourteenth Amendment. Simply put, this regulation would impose severe requirements on physicians and clinics performing five or more abortions per month, but not on physicians and clinics performing four abortions per month and/or other, virtually identical, procedures. At trial, there was no logical reason offered as to why these two groups should be treated so differently. As a result of the many problems with the regulation, this court is constrained to find that it is facially unconstitutional under the Fourteenth Amendment. This court has tried to sever the objectionable portions from the regulation, but the problems are so many and so diffuse that their omission would render the regulation unworkable. Consequently, this court has no alternative but to declare the regulation as a whole invalid and unenforceable. FINDINGS OF FACT A. The Parties 1. Plaintiff Greenville Women’s Clinic (“GWC”), located in Greenville, South Carolina, is a women’s health care clinic providing gynecological health services, including abortions through 14 weeks of pregnancy measured from the pregnant woman’s last menstrual period (“Imp”). Dr. Terry Buffkin and Dr. Thomas Campbell own and operate GWC, which has been in operation since 1978. Both are physicians licensed to practice medicine in South Carolina and are board certified in obstetrics and gynecology. On average, GWC performs approximately 2,746 first trimester abortions per year. 2. Plaintiff Charleston Women’s Medical Clinic, Inc. (“CWMC”), located in Charleston, South Carolina, is also a women’s health care clinic providing gynecological health services, including abortions through 12.5 weeks of pregnancy Imp. CWMC has been in operation for approximately 25 years. Ms. Lorraine Maguire, a licensed practical nurse, is the administrator of CWMC, and Dr. Richard Manning is its medical director. Dr. Manning is licensed to practice medicine in South Carolina and is board certified in obstetrics and gynecology. The CWMC, on average, performs approximately 2,408 first trimester abortions per year. 3. Plaintiff William Lynn, M.D. is a physician licensed to practice medicine in South Carolina and is board certified in obstetrics and gynecology. Dr. Lynn owns and operates two medical practices — an office in Beaufort, South Carolina (“Dr. Lynn’s Beaufort office”) and an office in Greenville, South Carolina that does business as the Palmetto State Medical Center (“PSMC”). Dr. Lynn has been regularly performing abortions since 1980. As part of his practice, Dr. Lynn provides abortions up to 13.9 weeks Imp. On average, Dr. Lynn performs 407 first trimester abortions per year in Beaufort and 536 first trimester abortions per year in Greenville. 4. Defendants are Douglas E. Bryant, in his official capacity as Commissioner of the South Carolina Department of Health and Environmental Control (“DHEC”), the Governor of the State of South Carolina, in his official capacity, and Charles M. Condon, in his official capacity as Attorney General of the State of South Carolina. B. The Challenged Regulation 5. Prior to 1995, the State of South Carolina only required licensing of physicians’ offices or other facilities in which second trimester abortions were performed. See S.C.Code Ann. §§ 44-41-20(b) and 70(b) (Law Co-op 1985). On January 3, 1995, however, the South Carolina legislature amended Chapter 41 of Title 44 as follows: (A) A facility in which any second trimester or five or more first trimester abortions are performed in a month must be licensed by [DHEC] to operate as an abortion clinic and must comply with the provisions of Article 3 [the Woman’s Right to Know Act]. (B) The department shall promulgate regulations concerning sanitation, housekeeping, maintenance, staff qualifications, emergency equipment and procedures to provide emergency care, medical records and reports, laboratory, procedure and recovery rooms, physical plant, quality assurance, infection control, and information on and access to patient follow-up care necessary to carry out the purposes of this section. 5.C.Code Ann. § 44-41-75 (Law Co-op Supp.1997) (emphasis added). The legislation is not challenged in this action. 6. Pursuant to this legislative directive, and procedures governing the promulgation of state regulations (the South Carolina Administrative Procedures Act (“APA”), S.C.Code Ann. § 1-23-10 et. seq. (Law. Co-op.1986 and Supp.1997)), DHEC officials drafted the challenged regulation, entitled “Standards for Licensing Abortion Clinics,” S.C.Code Regs. 61-12. The regulation consists of approximately twenty-seven pages of detailed requirements that an abortion clinic must comply with in order to obtain and maintain a license to perform abortions, which is to be issued annually by DHEC. An abortion clinic is defined as “[a]ny facility, other than a hospital as defined in Section 101.J, in which any second trimester or five or more first trimester abortions per month are performed.” S.C.Code Regs. 61-12, Section 101.B. Thus, it includes all abortion clinics, regardless of their ownership, as well as privately owned and operated physicians’ offices. The regulation is divided into ten “Parts,” as follows: Part I Definitions and Requirements for Licensure; Part II Administration and Management; Part III Patient Care; Part IV Medical Records and Reports; Part V Functional Safety and Maintenance; Part VI Infection Control and Sanitation; Part VII Fire Protection and Prevention; Part VIII Design and Construction; Part IX Prerequisites for Initial Li-censure; and Part X General. With the exception of Parts IX and X, each Part is in turn divided into several sections which impose detailed requirements for the clinic’s physical plant, staffing, and provision of medical care. There is no severability clause contained within the regulation. 7. Currently, South Carolina does not require licensing of physicians’ offices outside of the abortion context. Furthermore, physicians licensed to practice medicine in the state are not subject to DHEC regulation, but rather are governed by the South Carolina State Board of Medical Examiners. See S.C.Code Ann. § 40-47-5 et. seq. (Law Co-op.1986 and Supp.1997). The State Board of Medical Examiners handles the examination and licensure of physicians within the state, complaints against physicians, the suspension and revocation of licenses when appropriate, and the imposition of civil penalties and other sanctions against physicians. With the exception of standard building codes imposed by their particular locales, physicians’ offices are not subject to any mandated design and construction requirements. Thus, physicians who limit their abortion practice to less than five first trimester abortions per month are exempt from the requirements of Regulation 61-12. See S.C.Code Ann. § 44-41-75(A); S.C.Code Regs. 61-12, Section 101.B. In addition, physicians who perform surgical procedures in their offices which are comparable in terms of risks and duration to first trimester abortions are not subject to the stringent requirements which Regulation 61-12 imposes upon those physicians who regularly perform abortions in their offices. 8. Plaintiffs contend that Regulation 61-12 violates the substantive due process rights of women seeking abortions in South Carolina because it was not designed to and does not further the state’s interest in maternal health, and because the costly provisions will place an undue burden upon a woman’s fundamental right to obtain an abortion. Plaintiffs also contend that Regulation 61-12 violates the Equal Protection Clause because it imposes burdensome and costly requirements upon licensed physicians who regularly perform first trimester abortions which are not imposed upon licensed physicians who perform either identical procedures in lesser numbers or comparable surgical procedures regardless of the frequency. In addition, plaintiffs contend that certain sections of the regulation are unconstitutionally vague, violate the confidentiality rights of patients undergoing the abortion procedure, and violate the Establishment Clause con-tamed within the First Amendment. C. Specific Requirements of the Challenged Regulation 9. Plaintiffs contend that the regulation as a whole is medically unnecessary and unduly burdensome to the providers of first trimester abortions in South Carolina and their patients. In addition, plaintiffs have raised individual challenges to specific sections of the regulation. The comprehensive nature of Regulation 61-12 renders a summary of its provisions a daunting task. What follows is a summary by categories created by the regulation, placing special attention on those portions upon which plaintiffs have focused this challenge. 10. Part I of the regulation sets forth general “Requirements for Licen-sure” of abortion clinics. In order to operate, the facility must undergo a pre-licensure inspection. Once the initial license is obtained, the facility must be inspected annually in order to obtain renewal of the license. In addition, the regulation provides that the facility may be subjected to unannounced DHEC inspections at any time, during which DHEC “inspectors shall have access to all properties and areas, objects, records and reports, and shall have the authority to make photocopies of those documents required in the course of inspections or investigations.” S.C.Code Regs. 61-12, Section 102.F.2. There is no requirement in the regulation that DHEC or its inspectors maintain the confidentiality of any records, including the patient’s personal medical records, although DHEC has included such confidentiality directives in regulations governing other types of health care facilities. See e.g., S.C.Code Ann. Regs. 61-91, Section 1001-D (mandating that DHEC “safeguard[ ] information in the medical records [of patients in ambulatory surgical centers] against ... use by unauthorized persons”). 11.Upon a determination by DHEC that a facility is in violation of “any statutory provision, rule or regulation relating to the operation or maintenance of such facility,’’DHEC may deny, suspend or revoke the license. S.C.Code Regs. 61-12, Section 103. In addition, DHEC may assess a monetary penalty for each violation up to $5000. The amount of the penalty is based upon the specific provision at issue, which has been preassigned a designation as either a Class I, II, or III violation. In addition to the detailed requirements already set forth in the regulation, the regulation also authorizes imposition of a Class III penalty for any practice deemed to be “against the best practices as interpreted by the Department,” S.C.Code Regs. 61-12, Section 103.C., without further guidance or definition. 12. Part II of the regulation governs “Administration and Management” of the clinic. Section 201 requires the facility to develop and implement detailed written policies and procedures for operation of the facility, which must include at a minimum policies and procedures to ensure compliance with all federal, state, and local laws which govern the facility; designation of a responsible person and the establishment of methods for holding the person responsible; personnel policies and procedures, including in-service training requirements; a facility-wide quality improvement program, including statistical summaries, and a written plan of implementation; a policy and procedure for- patient rights and grievance procedures; functional safety and maintenance policies and procedures; a policy and procedure for incident reporting; and policies and procedures for obtaining informed consent from the patient. In addition, the facility’s policies and procedures must include a provision for annual review and evaluation of the facility’s other policies and procedures, as well as for its management and operation. No specific guidance is provided as to what these policies and procedures must contain. 13. Section 203 requires the facility to maintain on file all current policies and procedures concerning operation of the facility, memoranda of agreements and credentialing documentation, a copy of the regulation, annual elevator safety inspections and an annual heating, ventilation, and air conditioning inspection report. 14. Section 204 sets forth detailed personnel requirements. The facility must obtain and verify professional and personal background information on every employee and must develop and implement a written orientation program for new staff members, to include orientation on the other policies and procedures. A formal, written, inservice training program must also be planned and provided for all employees and volunteers, and records kept of attendance. The inservice training of all employees and volunteers must include four specified areas — infection control, fire protection, confidentiality and patient rights, and licensing regulations. Written job descriptions must be prepared and reviewed annually, and a personnel file containing various mandated information must be kept on all employees. Annually, each employee must have a tuberculin skin test or, if previously positive, a chest x-ray to determine whether tuberculosis is present. If tuberculosis is diagnosed, the facility must provide treatment and investigate employee contacts. Employees and volunteers are also banned from working if they have any infected wounds, boils, sores, acute respiratory infections, or any other contagious disease or illness. According to the medical evidence in this case, this would include such ordinary illnesses as a common cold. In addition, all professional and allied health professional staff members must be certified by the American Red Cross or American Heart Association as capable of performing CPR, although only one such certified person must be with patients when they undergo the abortion procedure and during the recovery period. 15.Section 205 sets forth requirements for the clinical staff, which encompasses all physicians, nurses, and allied health professionals. Abortions may only be performed by physicians licensed to practice medicine in South Carolina who are also “properly qualified by training and experience to perform pregnancy termination procedures.” S.C.Code Regs. 61-12, Section 205.-C.l. The regulation, however, provides no guidance on the additional credentials required beyond that of a medical license to meet this qualification standard. The facility must also obtain and maintain signed, written agreements with at least one physician board certified in obstetrics and gynecology who has admitting privileges at a local hospital which provides obstetrical and gynecological services. All nursing care is required to be under the supervision of a registered nurse licensed in the State of South Carolina, regardless of the presence of a physician in the facility, and the registered nurse must be “on duty to provide or supervise all nursing care” during preparation, the procedure, recovery, and discharge. S.C.Code Regs. 61-12, Section 205.D.2. Licensed practical nurses may be employed so long as they work under the supervision and direction of a registered nurse. Ultrasounds may only be conducted by physicians or ultrasound technicians who have documented evidence of completion of a training course in ultrasonography. Finally, the entire clinical staff must participate in quarterly meetings to review and analyze clinical experiences, and minutes must be kept and maintained of each meeting. 16. Sections 206 through 208 of the regulation require the facility to comply with state statutory sections pertaining to the dissemination of information to women seeking abortions and to obtaining consent to perform the procedure, each of which already contains penalty provisions for the failure to comply. Thus, these portions of the regulation do nothing more that impose a second layer of penalties (indeed, the most severe Class I penalties) for the conduct already punishable under the statutory sections incorporated within the regulation. 17. Section 209 of the regulation requires the facility to “have written policies and procedures to assure the individual patient the right to dignity, privacy, safety, and to register complaints with [DHEC].” S.C.Code Regs. 61-12, Section 209. A copy of the patient rights must be conspicuously displayed, and a copy must be signed by each patient and included in the patient’s medical record. However, no guidance is provided as to what specific information must be included in these documents. 18.Part III of the regulation sets forth requirements for “Patient Care.” Additional “patient care policies and procedures designed to ensure professional and safe care for patients” must be developed, S.C.Code Regs. 61-12, Section 301, and must include, but are not limited to, policies and procedures for admission criteria; physician and nurse responsibilities; details regarding the preoperative procedures (including history and physical, special examinations, lab procedures and consultations which will be required, and ultrasonography procedures); details regarding the actual abortion procedure (including the use of IV’s, fluids, analgesia, anesthesia, and tissue examination and disposal); details regarding post-procedure care and recovery room care, including emergency care; “[provisions for education of the patient, family and others, as appropriate in pre and post-procedure care,” S.C.Code Regs. 61-12, Section 301.F.; plans for follow-up care, including arrangements for a postoperative visit and specific instructions in the event of an emergency; procedures for the management and referral of high-risk conditions; procedures for the transfer of patients when needed; procedures for infection control and sanitation (including duties and responsibilities of an infection control committee which are, in turn, charged with the responsibility of developing and implementing specific patient care and administrative policies to investigate, control and prevent in-feetions in the facility); and procedures for the registration of fetal death or death certificates. 19. Section 303 of the regulation imposes detailed requirements concerning emergency drugs which must be kept on the premises, and specifies seven medical conditions for which drugs and equipment must be available. In addition, the regulation mandates the presence of a refrigerator with “[a] thermometer accurate to +/3 degrees Fahrenheit.” S.C.Code Regs. 61-12, Section 303.C. A specific method of preparing medications for administration is mandated, including a requirement that a sink and counter be in the area. 20. Section 304 requires laboratory services to be performed in compliance with the requirements already mandated by the Clinical Laboratory Improvement Amendments of 1988, (“CLIA”), 42 U.S.C.A. § 263a (West 1991). It further requires the physician to perform a urine pregnancy test (unless fetal heart beats or movements are identified on physical examination), a urinalysis which includes albumin and glucose examination, and a hematocrit or hemoglobin test. In addition, the physician must perform a test to determine Rh factor. If the patient is Rh positive, an additional Du variant test is required. Rh (D) immune globulin must be administered if the patient is determined to be Rh negative. Testing for chlamydia and gonorrhea is mandatory, but testing for syphilis serology and performance of a Pa-panicolaou (pap) smear must only be offered to the patient. 21. Section 305 provides additional requirements for emergency care. It requires that “[a]ll staff and/or eon-suiting physicians” have admitting privileges at one or more local hospitals that provide appropriate obstetrical/gynecological services or have in place documented arrangements approved by DHEC for the transfer of emergency cases when hospitalization becomes necessary. S.C.Code Regs. 61-12, Section 305.A. The facility must maintain equipment and services to render emergency resuscitative and life-support procedures pending transfer. And the facility must notify, in writing, the local ambulance service of the location of the facility and the nature of the medical problems which may result from abortions. 22. Section 306 mandates that the facility purchase and maintain' specific equipment and supplies, including such items as “[a] bed or recliner suitable for recovery,” oxygen, mechanical suction, resuscitative equipment, emergency medications, intravenous fluids, “[a] clock with a sweep second hand,” sterile suturing equipment and supplies, an adjustable examination light, and soiled linen and waste containers. S.C.Code Regs. 61-12, Section 306. 23. Section 307 mandates that the facility have “[ajrrangements ... for consultation or referral services in the specialties of obstetrics/gynecology, anesthesiology, surgery, psychiatry, psychology, clinical pathology and pathology, clergy, and social services, as well as any other indicated field, to be available as needed.” S.C.Code Regs. 61-12, Section 307. The regulation does not specify whether the “arrangements” must be in writing, nor does it specify the number of clergymen or types of religious counseling which must be made available. 24. Section 308, entitled “Quality Improvement,” again mandates a written plan for a quality improvement program for patient care and designation of an individual responsible for coordinating the program. Specific requirements include ongoing monitoring and evaluation of “patient care services, staffing, infection prevention and control, housekeeping, sanitation, safety, maintenance of physical plant and equipment, patient care statistics, and discharge planning services.” S.C.Code Regs. 61-12, Section 308.B. Evaluation of patient care is required to be “criteria-based, so that certain actions are taken or triggered when specific quantified, predetermined levels of outcomes or potential problems are identified,” S.C.Code Regs. 61-12, Section 308.B, but the regulation does not specify what criteria are acceptable or required. The process must incorporate a quarterly review of a minimum of five percent of the medical records per quarter, and must include a means of obtaining input from families of patients if they are “involved in the care and services provided by the facility.” S.C.Code Regs. 61-12, Section 308.E. The facility administrator must review the findings of the program and ensure corrective actions are taken. The program must also identify and establish indicators of quality care, specific to the facility, that must be monitored and evaluated. Annual review of the results is also required. 26. Part IV of the regulation sets forth requirements for “Medical Records and Reports.” Section 401 begins by setting forth detailed requirements for the preparation and maintenance of medical records, which must include, at a minimum, twenty categories of information. Of particular concern to the plaintiffs in this case, the section requires a face sheet with patient identification data, including the name of the patient’s husband in addition to the name, address and telephone number of a person to be notified in the event of an emergency. The records are required to be kept confidential by the facility (although no such requirement is imposed upon DHEC inspectors who obtain them) and must be stored for a minimum of 10 years. Section 403 requires the preparation of additional reports, including a record of every accident or incident occurring in the facility which involves patients, staff, or visitors. If it results in serious injury, the accident or incident must be self-reported to DHEC. Serious injuries “include, but are not limited to,” accidents and incidents that lead to hospitalization or death (other than of a fetus) and adverse drug reactions. S.C.Code Regs. 61-12, Section 403.B. 26. Part V of the regulation, entitled “Functional Safety and Maintenance” requires additional policies and procedures, including, but not limited to, safety rules and practices for personnel, equipment, gases, liquids, drugs, supplies, and services; provisions for investigating accidents on the premises; provisions for disseminating safety-related information to employees and users of the facility; provisions for syringe and needle handling and storage; and provisions for managing infections waste in accordance with another DHEC regulation already governing such matters. In addition, the facility must prepare and post a disaster preparedness plan for evacuation in the event of a fire or other emergency. All parts and portions of the facility are generically required to be kept “in good repair and operating condition,” and “free of hazards.” S.C.Code Regs. 61-12, Section 503.A. In addition, the section requires that “[a]ll wooden surfaces shall be sealed with a non-lead based paint, lacquer, varnish, or shellac that will allow sani-tization.” Id. A written preventive maintenance program must be developed and implemented for patient monitoring equipment and tested in accordance with manufacturer’s specifications, but not less than annually. Records of maintenance and testing must be kept. 27.Part VI of the regulation is entitled “Infection Control and Sanitation.” It sets forth specific requirements for sterilization, including daily testing of the autoclave and a log of results, as well as periodic calibration and preventative maintenance as necessary, but not less than annually. The regulation contains provisions mandating “adequate” linens and “proper laundering,” and provides that “[a] sufficient supply of cloth or disposable towels shall be available so that a fresh towel can be used after each handwash-ing.” S.C.Code Regs. 61-12, Section 603. It specifically prohibits towel-sharing. The regulation also generically requires that the facility “be kept neat, clean, and free from odors,” mandates specific requirements for cleaning methods to be used and prohibits others, and imposes requirements for refuse and waste disposal. S.C.Code Regs. 61-12, Sections 604 & 605. Section 606 requires that “[a]ll outside areas, grounds and/or adjacent buildings shall be kept free of rubbish, grass, and weeds that may serve as a fire hazard or as a haven for insects, rodents and other pests,” and that all “[ojutside stairs, walkways, ramps and porches shall be maintained free from accumulations of water, ice, snow, and other impediments.” S.C.Code Regs. 61-12, Section 606. 28. Part VII of the regulation, entitled “Fire Protection and Prevention,” provides detailed requirements for fire-fighting equipment and systems, an evacuation plan, training of employees in the evacuation plan, mandatory fire drills at least once every three months, maintenance of fire equipment, and maintenance of records proving compliance with the provisions. 29. Part VIII of the regulation sets forth detailed requirements for the “Design and Construction” of abortion facilities. There is no grandfathering provision (unlike other DHEC regulations governing medical and patient care facilities)— rather all facilities must be in full compliance within two years. The requirements are set forth in overwhelming detail, rendering a summary of them impossible. By way of example, however, the regulation governs the number and size of procedure and recovery rooms, specifies the design and equipment required in toilet rooms, regulates the direction of the “[a]ir flow” within the sterilization rooms, S.C.Code Regs. 61-12, Section 807.-F., mandates a minimum width for doors and corridors, sets forth specific requirements for heating and air conditioning (the unit must be capable of maintaining a temperature between 72 and 76 degrees), regulates the facility’s air supply and exhaust, regulates design criteria for clinic entrances, sets forth specific requirements for the “janitor’s closets,” S.C.Code Regs. 61-12, Section 807.0., and specifies the corridor glazing materials, wall finishes, wall bases, and interior finish materials that must be present. The regulation also regulates water supply and plumbing within the facilities. 30. Part IX of the regulation sets forth additional “Prerequisites for Initial Licensure” of the facility, including plan and construction approval by DHEC, and specifies the documentation required to be submitted with the facility’s initial application for licensure. 31. Finally, Part X of the regulation, entitled “General” states in its entirety that “[cjonditions arising that have not been addressed in these regulations shall be managed in accordance with the best practices as interpreted by the Department.” S.C.Code Regs. 61-12, Part X. As noted previously, a violation of such an unspecified requirement is considered a Class III violation of the regulation. 32. At the trial of the case, defendants sought to enter several “stipulations” concerning their intended interpretation of certain requirements of the regulation. First, as to Section 102.F.2., which grants DHEC inspectors the right to copy medical records without a confidentiality provision, defendants assert that DHEC “policy” would protect the confidentiality of these records, as would the provisions of S.C.Code Ann. §§ 44-7-310 and 315 (Law Co-op. Supp.1997). Second, as to Section 307 which requires the facility to make “[a]rrangements” with various specialties, defendants contend that the section does not require written “agreements” with such specialties, but only that the physician attempt to assist the patient in obtaining a referral when such services are indicated and/or requested by the patient. Third, as to Section 205(C)(2) which requires the facility to enter into a signed written agreement with at least one physician board certified in obstetrics and gynecology (if one is not on staff) and who has admitting privileges at a local hospital, defendants sought to delete the board-certification requirement. Finally, as to Section 602.C.1 which requires daily autoclave testing, defendants admit this is an error and that it should be weekly testing. Plaintiffs have not joined in these “stipulations.” Instead, they contend that defendants’ proposals are efforts to rewrite the regulation. D. Abortion Services in South Carolina 33. According to the evidence in this case, there are no abortion providers in South Carolina who perform elective abortions (those not associated with medical complications) in the second trimester of pregnancy. All of the plaintiffs in this action limit their services to abortions during the first trimester of pregnancy. 34. Plaintiffs in this case currently use the suction curettage procedure during the first trimester for elective abortions. The procedure is also utilized for spontaneous miscarriages. Although not wholly without risks, it is undisputed that a suction curettage abortion during the first trimester of pregnancy is a relatively safe and quick medical procedure performed between six and fourteen weeks Imp. It involves dilating the cervix, inserting a suction catheter into the uterus, and applying suction to remove the contents of the uterus. Although the patient is usually in the procedure room for a total of ten minutes, the procedure itself only takes approximately two to five minutes. It involves no incision and a minimum of bleeding. After the procedure, patients usually walk to the recovery area, where their pulse and blood pressure are monitored and they are checked for any abnormal bleeding. Possible complications from the suction curettage procedure are fainting from vasova-gal response, uterine perforation, excessive bleeding, infection, and retained tissue in the uterus. However, while the total complication rate for the procedure is about 1 in 100, serious complications are rare. The rate for complications requiring hospitalization is only about 1 in 2000. And the mortality rate is 1 in 100,000, which is about 25 times less risky than carrying a pregnancy to term. There is no evidence in this case that a first trimester suction curettage abortion has ever resulted in a woman’s death in this state. 35.Physicians in South Carolina, including Dr. Buffkin and Dr. Campbell, also perform medical abortions to terminate pregnancies located outside the uterus (such as in the fallopian tube) during the first six to seven weeks of pregnancy. A medical abortion is an even safer procedure than the suction curettage. It involves the performance of a routine blood test to measure the patient’s hormone levels, followed by the injection of a drug (methotrexate) into the patient’s arm. There is no recovery time after the injection, and only mild vaginal bleeding. Follow-up care consists of rechecking the patient’s hormone levels several days after the injection, and rechecks thereafter at seven day intervals. Although currently limited in use to the termination of ectopic pregnancies, methotrexate and a second drug, RU-486, are currently being used in research protocols for use in terminating intrauterine pregnancies. 36. Regulation 61-12 applies to abortion clinics performing five or more first trimester abortions and/or a single second trimester abortion per month. It is undisputed that second trimester abortions are significantly more risky to the health of women than first trimester abortions. Because the plaintiffs in this case only provide abortions during the first trimester of pregnancy, plaintiffs’ challenge to the regulation is limited to its application to providers of first trimester abortions in South Carolina. Accordingly, the court will express no opinion as to the constitutionality of Regulation 61-12 as applied to facilities which may seek to perform second trimester abortions in the future. E. The Drafting and Promulgation of Regulation 61-12 37. At the trial of this case, several DHEC employees and a DHEC consultant testified concerning the drafting and promulgation of Regulation 61-12. The testimony reveals that the regulation was not tailored to further the state’s legitimate interest in preserving and protecting the health of women seeking first trimester abortions and that the drafters took no meaningful steps to ensure that it would serve that purpose. Nor did they attempt, in any meaningful fashion, to determine the financial impact the regulation might have on the provision of first trimester abortion services in the state. 38. First, DHEC officials were not aware of any public health problem associated with facilities providing abortions in South Carolina and did not investigate whether there were any such public health problems prior to drafting the regulation. Indeed, it is undisputed that DHEC promulgated the regulation solely in response to the legislative directive contained within S.C.Code Ann. § 44^11-75. 39. After the legislation requiring li-censure of abortion clinics was passed, Mr. Alan Samuels with DHEC was charged with the responsibility for supervising the drafting and promulgation of the regulation. Although Mr. Samuels has some experience in health care administration, he has received no formal medical training or education. Upon completion of his college education, Mr. Samuels served in the United States Army for twenty-four years, where he served with the adjutant general corps and the medical services corps as a personnel officer and hospital inspec- ' tor. After leaving military service, Mr. Samuels began employment with DHEC, where his duties consisted of inspecting various types of health care facilities for compliance with existing regulations. He was eventually promoted to the position of director of the DHEC Health Licensing Division, and has now retired. 40. Although Mr. Samuels provided some input and edits during the drafting process, he did not personally draft any portions of the regulation. Rather, he delegated the primary drafting responsibility to Mr. George Moore, who was the Director of Outpatient and Home Care within the Division of Health Licensing. Mr. Samuels admitted that he knew very little about abortion procedures or the differences between first trimester and second trimester abortions when the regulation was promulgated. His testimony also reveals that he personally conducted no meaningful study or research into the differences between a first and second trimester abortion, and conducted no meaningful inquiry into what regulatory requirements were appropriate for facilities performing only first trimester abortions. 41.Like Mr. Samuels, Mr. Moore has some education and experience with hospital administration, but has received no formal medical training or education. After receiving an undergraduate degree, Mr. Moore joined the United States Army where he served twenty-five years. He spent the early part of his service in the adjutant general corps performing general administrative duties, after which time he transferred to the medical services corps where he performed administrative duties associated with health care facilities and hospitals. During his service, Mr. Moore received a masters degree in hospital administration. Upon his retirement from military service in 1988, Mr. Moore began employment with DHEC, inspecting hospitals and nursing homes for compliance with existing regulations. He was later promoted to Director of Outpatient and Home Care within the Division of Health Licensing, the position he held when Mr. Samuels asked him to assume primary responsibility for the drafting of the regulation. In preparation for drafting the regulation, however, Mr. Moore also took no meaningful steps to educate himself about first trimester abortions, how they differed from second trimester abortions, or what requirements would be appropriate for a facility which performed only first trimester abortions. 42. For assistance with Parts VII and VIII of the regulation (Fire Protection and Prevention/Design and Construction), Mr. Moore turned to Mr. William Lafferty, who was the Director of Health Facilities Construction with DHEC. Like Mr. Samuels and Mr. Moore, Mr. Lafferty has received no formal medical training or education. He testified that in drafting these portions of the regulations, he made no effort to determine whether the requirements were medically appropriate for facilities performing only first trimester abortions and that this was not his orientation. Mr. Lafferty also testified that he approached the design and construction requirements from the standpoint of new construction requirements and anticipated that existing facilities would be grandfathered. The decision to include a mandatory two-year compliance provision in that portion of the regulation was not made by Mr. Lafferty. 43. According to Mr. Moore, the preexisting South Carolina regulation governing second trimester abortions was utilized as a starting point for the new regulation, and many of the additional provisions of the new regulation were simply adopted or derived from DHEC regulations governing other types of health care facilities. They included regulations governing Ambulatory Surgical Centers, Renal Dialysis Facilities, Community Residential Care Facilities, Day Care Facilities for Adults, Outpatient Facilities for Chemically Dependent Persons, Habitation Centers for the Mentally Retarded, Residential Treatment Facilities for Children and Adolescents, Nursing Homes, and facilities providing home health care and hospice services. According to defendants, DHEC sought to standardize its regulations governing medical facilities and medical care so that the licensing requirements would have consistent wording, and to codify existing departmental practices. 44. According to the DHEC officials, this attempt to standardize its regulations and to codify existing practices included DHEC’s desire to grant its inspectors the authority to copy medical records in all medical facilities. Mr. Moore testified that departmental practice currently allows the copying of medical records during a complaint investigation and that DHEC would maintain the confidentiality of the records. However, there is no provision in Regulation 61-12 which would mandate such confidentiality and defendants have pointed to no other state laws or regulations which would, in the court’s opinion, adequately protect a patient’s confidential medical records. In addition, the court notes that the DHEC regulation governing ambulatory surgical centers contains a specific provision protecting the confidentiality of medical records. See S.C.Code Regs. 61-91, Section 1001.E (providing that records may only be removed from the premises by subpoena or court order). 45. Furthermore, defendants presented no evidence comparing the patient risks presented in other types of facilities regulated by DHEC with those presented in physicians’ offices or clinics performing first trimester abortions, with the possible exception of ambulatory surgical centers. However, the medical evidence presented reveals, and there is little dispute, that the risks and potential complications of surgical procedures typically performed in ambulatory surgical centers are significantly higher than those associated with first trimester abortions. Yet a comparison of the regulations reveals that in many ways Regulation 61-12 imposes requirements more stringent than those imposed upon ambulatory care centers. Furthermore, there is no evidence in the record as to how DHEC formulated the regulations applicable to ambulatory surgical centers, or whether they received substantial assistance from medical professionals during the drafting process. Accordingly, the mere fact that some of the requirements contained within Regulation 61-12 are similar to those contained within the ambulatory surgical center regulation is of little assistance to this court in determining whether they are appropriate requirements to impose upon a physician or clinic performing only first trimester abortions. 46.Although the DHEC officials testified that they primarily utilized existing South Carolina regulations as the basis for the challenged regulation, defendants have pointed to additional sources of information to defend the regulation. Fust, there is testimony that Mr. Moore obtained copies of abortion regulations from North Carolina and Tennessee. However, Mr. Moore did not speak with anyone in those states about the regulations or how they had affected maternal health and, in any event, the requirements of Regulation 61-12 exceed those contained in the regulations of these neighboring states. There is also testimony that Mr. Moore reviewed standards and guidelines issued by the Planned Parenthood Federation of America, Inc. (“Planned Parenthood”), the National Abortion Federation (“NAF”), and the American College of Obstetricians and Gynecologists (“ACOG”). However, with the exception of Planned Parenthood, which requires its affiliates to comply with its standards unless an exception is granted, the majority of the standards reviewed by Mr. Moore are not mandated standards of medical care. Rather, they are guidelines which must be accommodated to the needs of a particular facility and its patients through the exercise of physician judgment and discretion. Furthermore, a comparison of Regulation 61-12 with the standards and guidelines offered in support of the regulation reveals that DHEC in fact far exceeded even those guidelines. 47. According to witnesses presented by both sides of this controversy, ACOG is a well-respected, nationwide organization of obstetricians and gynecologists which serves to develop and further the standard of care in this specialty. During the drafting process, the general counsel of ACOG wrote a letter to DHEC expressing concern that the requirements of the regulation would not enhance patient well-being or safety and offering DHEC the assistance of ACOG in the drafting of an appropriate regulation. The DHEC drafters declined ACOG’s assistance. 48. After an initial draft of Regulation 61-12 was completed, Mr. Moore requested limited input and comments from two medical personnel associated with DHEC. The first, Richard Goodrich, M.D., is a licensed physician, board certified in obstetrics and gynecology, who practiced in Zanesville, Ohio until he retired. After his retirement, he moved to South Carolina and became a consultant with DHEC in the area of maternal and child health. During his medical practice, however, Dr. Goodrich performed only two abortions, both of which were due to medical complications. Furthermore, Dr. Goodrich was not asked to and did not draft any portion of Regulation 61-12. Rather, he was only asked to review discrete portions of the regulation dealing exclusively with medical events and medical testing, and he conducted no review of and provided no input on the majority of the regulatory requirements. While he is of the opinion that the portions of the regulation that he reviewed are appropriate medical standards of care, he testified that the same standards would be appropriate for physicians’ offices in which comparable obstetrical and gynecological surgical procedures are performed. Dr. Goodrich further testified that he did not recommend the regulation’s requirement of physician qualifications beyond state licen-sure, and acknowledged that he did not know how the required “training and experience” qualifications could be determined under the regulation. Dr. Goodrich also interpreted the regulation’s requirement that a registered nurse be “on duty” as requiring that a registered nurse have ultimate responsibility, and not that a registered nurse should or needs to be on the premises at all times. Dr. Goodrich further testified that, while he has no specific experience with medical abortions, it would not be his intent to cover the provision of medical abortions under the regulation. He acknowledged, however, that the regulation as drafted would in fact cover such abortions. Finally, Dr. Goodrich testified that he is aware of no existing problem with abortion providers in South Carolina and has no opinion as to how the cost and availability of abortions affect women’s health issues. 49. Mr. Moore also sought some limited input from Robert Lawyer, R.N., who was Director of Nursing for DHEC. Mr. Lawyer received his bachelor of science degree in nursing while in the United States Army, and later received a masters degree in health services management and business administration. He has some experience with providing nursing care for first and second trimester abortions performed in a military hospital. After retiring from the Army in 1989, he began working with DHEC. He is currently nurse manager with the Division of Health Licensing, where his primary duty is the inspection of various health care facilities for compliance with existing regulations. He too was only asked by Mr. Moore and Mr. Sam-uels to review and provide input concerning discrete portions of the regulation, primarily those governing nursing care. Mr. Lawyer is of the opinion that, for first trimester abortions, a registered nurse should either personally monitor the patient or supervise all patient care, unless the physician is present in the facility and available to come to the recovery room if necessary. Unlike Dr. Goodrich, however, he interprets the regulation as requiring the “on duty” registered nurse to be on the premises. In formulating his opinion, Mr. Lawyer did not conduct any research on abortion practices in South Carolina, nor did he consult with nursing professionals who specialize in abortion procedures. Mr. Lawyer testified that while he is aware that the regulation would apply to facilities performing only medical abortions, he has no knowledge of what nursing skills are required in the context of medical abortions or whether they would require a registered nurse as opposed to a licensed practical nurse. 50. With the exception of these limited consultations with medical personnel associated with DHEC, the drafters of Regulation 61-12 did not seek any input from medical professionals during the drafting process and rejected ACOG’s offer of assistance. As some support for the text of the regulation, defendants contend that the drafters conducted a “mock inspection” of Planned Parenthood’s facility in Columbia, South Carolina and determined that the facility met the great majority of the regulation’s requirements. The evidence presented, however, reveals that the drafters simply toured the facility and, during one such visit, may have spoken briefly to a Planned Parenthood physician. There is no evidence that the physician was asked to comment upon the regulatory requirements or whether they were medically indicated for first trimester abortions, nor does the evidence support a finding that DHEC received any meaningful input from Planned Parenthood physicians prior to or during the early stages of the drafting process. 51. After this initial drafting process was concluded, DHEC issued a proposed regulation and held public hearings as mandated by the APA. Some of the suggestions made during this public comment period resulted in changes to the regulation, including some suggestions made by Planned Parenthood and the plaintiffs in this case. 52. On January 23, 1996, DHEC submitted the regulation to the South Carolina Legislature for approval, as required by the APA. Because the legislature took no action on the regulation within 120 days after its submission, it became automatically effective upon publication in the State Register on June 28, 1996. 53. Plaintiffs filed this lawsuit the day before the regulation’s publication date. As noted previously, this court enjoined its implementation on July 19, 1996 via a temporary restraining order, which the parties agreed to continue pending a determination on the merits of plaintiffs’ claims. F. Testimony of Local Providers of Surgical Care 54. At the trial, Dr. Terry Buffkin, Dr. Thomas Campbell, Dr. William Lynn, and Dr. Richard Manning testified concerning the regulation at issue and its probable effect on the health of women and the availability of abortions in South Carolina. 55. Dr. Terry Buffkin is board certified in obstetrics and gynecology, licensed to practice medicine in South Carolina, a fellow in ACOG, a member of numerous state and local medical organizations, and has been granted admitting privileges at two local hospitals. He and his partner, Dr. Campbell, have been performing first trimester abortions at GWC since 1978. 56. Dr. Buffldn testified that first trimester suction curettage abortions can be safely performed in a physician’s office, clinic, ambulatory surgical center or hospital. Ambulatory surgical centers, however, are typically used for more invasive type procedures (such as tubal liga-tions and laparoscopic procedures), and hospitals would be appropriate only if the patient has other significant medical problems which might complicate the procedure (such as heart disease). Dr. Buffkin also testified that medical abortions can be safely performed for ectopic pregnancies in a physician’s office or clinic setting. 57. Dr. Buffldn testified that he is aware of no public health problem with the provision of abortion services in South Carolina and that he is aware of no physicians or others who are providing inadequate health care in regard to first trimester abortions in South Carolina. 58. Dr. Buffkin testified that GWC already complies with some, but not all, of the requirements of Regulation 61-12. For example, Dr. Buffkin testified that they do not perform all of the medical tests mandated by the regulation as a matter of course, but rather perform only those medical tests that are indicated based upon the patient’s history, risk factors, and physical examination. He testified that the ACOG guidelines are not, and should not be, mandated standards of medical care, and that they can be varied from without compromising good patient care. 59. Dr. Buffkin testified that the regulation will not improve the health care of women seeking first trimester abortions in the state. He further testified that the regulation will directly increase the cost of abortion services to patients in South Carolina because it mandates the performance of unnecessary and expensive tests. It will also increase costs by imposing detailed administrative, structural, and other requirements which, although perhaps appropriate in an ambulatory surgical center or hospital environment, are not necessary in a small clinic or physician’s office where the staff interacts daily. Dr. Buffkin also opined that the detailed requirements carry significant hidden costs in the nature of penalties and legal fees to challenge cited violations in the future. Finally, Dr. Buffkin is of the opinion that the increased cost of abortion services will result in a number of women either delaying the procedure or being unable to obtain the procedure, both of which increase the health risks to the pregnant woman. 60. Dr. Thomas Campbell is also a licensed physician in South Carolina, board certified in obstetrics and gynecology, and has been granted admitting privileges at several local hospitals. He is also of the opinion that Regulation 61-12 will increase the cost and decrease the availability of abortion services in South Carolina. Dr. Campbell testified that the detailed provisions of the regulation are unnecessary and inappropriate for a clinic performing first trimester abortions, and that they will not improve the health of women seeking abortions in South Carolina. 61. Dr. William Lynn is also licensed to practice medicine in South Carolina, is board certified in obstetrics and gynecology, and has been granted admitting privileges at a local hospital. He has been performing first trimester abortions continuously since 1980. Dr. Lynn testified that he is aware of no public health problem associated with the provision of abortions in South Carolina. It is his opinion that the regulation will greatly increase the cost of abortion services in South Carolina, may make it impossible for some physicians to continue to offer abortion services, will not enhance women’s health or increase the level of medical care in the community, and will make it more difficult for women to obtain reasonable abortion care in a safe setting. He farther opines that the regulation is inappropriate for a first trimester abortion clinic and is instead more suited to a hospital environment. Dr. Lynn testified that the regulation mandates standards of care and costs which are contrary to the current trend of moving medical care away from hospitals and into outpatient facilities and physicians’ offices to decrease costs. 62. Dr. Richard Manning is also board certified in obstetrics and gynecology, and is licensed to practice medicine in South Carolina and five other states. He currently serves as medical director of CWMC and performs first trimester abortions on a regular basis. He shares the opinion that the regulation will increase the cost of abortions and will not improve health care, and that the detailed regulations, while possibly appropriate for a large hospital, are unnecessary for a small clinic performing first trimester abortions where people work together and communicate daily. 63. In addition to the testimony of the plaintiff providers, plaintiffs presented expert testimony of a well-qualified general surgeon licensed to practice medicine in South Carolina. According to the testimony of this witness, licensed physicians currently perform a number of surgical procedures in their private offices — particularly those which do not require the use of general anesthesia — because it is significantly quicker, less expensive, and more comfortable for the patient. The surgeon’s testimony, in conjunction with the other medical evidence presented by the parties, reveals that the risks and potential complications associated with surgeries typically performed in the office setting by general surgeons are substantially similar to those associated with first trimester abortions. Significantly, the general surgeon testified that physicians’ offices in which such comparable procedures are performed, including his own, would not comply with a number of the requirements imposed by Regulation 61-12, yet would meet appropriate standards of surgical care. 64.Plaintiffs also presented the testimony of a clinical assistant professor of nursing at the University of South Carolina, who has observed and/or participated in a total of twenty-five to fifty abortions performed in the first and second trimesters of pregnancy, and who currently provides follow-up care to women who have received abortions. According to this witness, licensed practical nurses are competent to provide nursing care during the abortion and recovery period, and such nursing care is adequate to meet the needs of the patients. The witness was further of the opinion that requiring a registered nurse to supervise all nursing care in a facility performing only first trimester abortions is unnecessary if a physician is supervising care, and that it is permissible to allow a licensed practical nurse to observe the recovery of an abortion