Full opinion text
ORDER AND MEMORANDUM RAINEY, District Judge. Pending before the Court is the motion for preliminary injunction (Dkt.#4) filed by the plaintiffs. Women’s Medical Center of N.W. Houston; Denton Health Services for Women; Austin Women’s Health Center. P.A.; Robert P. Kaminsky, M.D. and M.D., P.A.; Lamar Robinson, M.D. and M.D., P.A.; Fred W. Hansen M.D. and M.D., P.A.; L.L. Tad Davis, M.D.; and Mary E. Smith, M.D. and M.D., P.A. The plaintiff physicians brought this action “on behalf of themselves and the patients they serve.” The defendants are Texas Commissioner of Health William R. Archer. Ill, and Texas Attorney General John Cornyn. After reviewing the parties’ submitted evidence and briefing, considering the testimony and exhibits received at a preliminary injunction hearing on December 13 and 14, 1999, reviewing the entire record, and analyzing the applicable law, the Court finds that the plaintiffs have met their burden of showing that they are entitled to a preliminary injunction with regard to their equal protection claims and their vagueness claims. Therefore, for the reasons set out in this order, the plaintiffs’ motion for preliminary injunction (Dkt.# 4) is GRANTED with regard to the claims that the 1999 amendments violate the plaintiffs’ equal protection rights; is GRANTED with regard to the three provisions found to be unconstitutionally vague; but is DENIED with regard to the claims that the 1999 amendments violate the plaintiffs’ patients’ due process rights. I. Introduction The plaintiffs filed this lawsuit under 42 U.S.C. § 1983 to challenge the constitutionality of the 1999 amendments to Texas’ abortion licensing statute and regulations. The regulatory scheme requires that all facilities at which any abortions are performed become licensed and comply with detailed administrative, operating and personnel provisions. Prior to the 1999 amendments that are being challenged in this lawsuit, physicians’ offices were exempt from the licensing requirement unless the physician’s office was “used primarily for the purpose of performing abortions.” See Tex. Health & Safety Code § 245.004(2). (Vernon 1992). “Primarily,” for purposes of the statute, has been interpreted by the regulations to mean “51 % or more of the patients actually treated within the previous calendar year.” 25 TAC § 139.2(21)(B) (1998). The 1999 amendments will significantly narrow the exemption for physicians’ offices, by requiring physicians’ offices in which 300 or more abortions are performed in any twelve-month period to comply with the licensing scheme. See House Bill 2085, Sixty-Seventh Legislature, 1999 Regular Session, 1999 Tex. Sess. Law Serv. Ch. 1411 (H.B.2085) (Vernon’s). The plaintiff physicians currently provide a wide range of gynecological services, including abortions, in their private offices. It is undisputed that all of the plaintiffs were exempt from licensing and regulation under the pre-1999 law because abortion constitutes less than 51 percent of their practices. It is also undisputed that all of the plaintiffs currently perform more than 300 abortions per year, and therefore must become licensed abortion facilities if they wish to continue providing their current levels of abortion services. Previously unlicensed physicians’ offices, such as those of the plaintiffs, must become licensed by January 1, 2000. The plaintiffs seek a preliminary injunction against enforcement of the 1999 amendments pending final resolution of their constitutional claims. II. The Plaintiffs’ Claims The plaintiffs claim that the 1999 amendments will subject them to onerous administrative requirements that will do nothing to advance the health and safety of their patients. For example, they point out that the regulations require an abortion provider’s non-medical office staff, including bookkeepers, receptionists, and insurance verification clerks, to be trained in infection control procedures and numerous other subjects that may be of questionable relevance to their jobs. The plaintiffs contend that the detailed administrative operating and personnel provisions depart from generally accepted medical practice and require a leyel of formal administration far beyond accepted practice for private physicians’ offices. Plaintiffs further contend that requiring written policies to be developed and maintained regarding more than 30 different subject matters, mandating that a “quality control committee” meet quarterly, or requiring that organizational charts be drawn up to show lines of authority, might be appropriate for a large clinic setting where many contract physicians work for a clinic owner who may not be a physician. But some of the requirements border on the absurd, plaintiffs assert, when applied to a private physician’s office with four staff members. Some of the plaintiff physicians claim that the costs associated with compliance will require them to increase their fees for abortions. Other plaintiffs testified that they will cease performing abortions altogether, either due to being financially unable to absorb the anticipated costs of compliance, or due to their fear of incurring civil or criminal liability through arbitrary enforcement or varying interpretations of the statute and regulations. The plaintiffs allege that enforcement of the 1999 amendments will reduce abortion availability and increase costs, which may make these services inaccessible for some Texas women due to prohibitive expense or increased travel. In addition, the plaintiffs feel that the diversion of the physician and staffs time away from patient care, and toward policy-drafting and regulatory compliance, will cause the quality of care to deteriorate. The plaintiffs claim that the 1999 amendments will place an undue burden on Texas women’s right to choose abortion and will violate their patients’ constitutional guarantees of privacy in reproductive decision making. The plaintiffs also allege that the 1999 amendments are irrational because they single out physicians who perform abortions in their offices for stringent and burdensome regulations, while physicians performing similar or more risky non-abortion outpatient procedures in their offices are not subject to similar requirements. In addition, the plaintiffs claim that it is irrational to regulate physicians who perform 300 abortions per year in a given location, while leaving unregulated physicians who perform fewer than 300 abortions. Therefore, the plaintiffs claim, the 1999 amendments violate their right to equal protection. Finally, the plaintiffs contend that certain regulatory provisions (which will be applied to them by the 1999 amendments) are unconstitutionally vague. III. The Regulations The following is a summary of some of the regulatory provisions to which the plaintiffs will be subjected on January 1, 2000, barring a preliminary injunction enjoining enforcement: Licensed abortion facilities are required to provide written notice of the Department of Health’s toll-free number to every woman “at the time the woman initially consults the facility.” 25 TAC § 139.6. Women calling the number can access information regarding licensed abortion clinics, including status of license, date of last inspection, and any fines or penalties rendered against the facility. 25 TAC § 139.6. Additionally, at the time of “initial onsite consultation,” each woman must be provided with a written statement informing her that any complaints about the facility shall be sent to the Health Department. 25 TAC § 139.50. A written plan of quality assurance implementation must be created and maintained in a licensed abortion facility, and must be reviewed and updated or revised “at least annually.” 25 TAC § 139.8 A quality assurance committee comprised of a physician “medical consultant,” a registered nurse (“RN”) or licensed vocational nurse (“LVN”) and" “at least two other members of the facility’s staff’ must be formed and must hold meetings “at least quarterly” and must, at a minimum, evaluate all services related to patient care, ensure review of complications, address issues of unprofessional conduct by any staff member, monitor infection control, address medication, address the integrity of surgical instruments, medical equipment, and patient supplies, and address “the appropriateness of diagnosis and treatment.” The QA committee must document all remedial action. 25 TAC § 139.8. “Quality” is defined subjectively in the regulations as “the degree to which care meets or exceeds the expectations set by the patient.” 25 TAC § 139.2(43). “An abortion facility shall prominently and conspicuously post the license issued under the Act for display in a public area of the facility that is readily accessible to patients, employees, and visitors.” 25 TAC § 139.21(7). Facilities must pay an initial licensing fee of $1,000, a first annual renewal fee of $1,500, then a $2,500 annual fee to maintain the license. 25 TAC § 139.22. Physicians applying for licenses must provide personal information such as their home address, Social Security number, date of birth, driver’s license number, and Texas physician license number. 25 TAC § 139.23. Applicants must also provide information on previous felony arrests or convictions, criminal misdemeanor arrests or convictions, tax liens, and judgments. A state inspector or “surveyor” may enter the premises of a licensed facility, announced or unannounced, “at reasonable times during business hours and at other times as it considers necessary to ensure compliance.” not only with the abortion facility regulations, but with any order of the health commissioner, a court order granting injunctive relief, or “other enforcement actions.” 25 TAC § 139.31. Inspection surveys are also performed annually in connection with license renewal. The surveyor is entitled to access all records, and “shall perform an on-site investigation ... to investigate a complaint received by the department.” If a surveyor finds a deficiency of any type, the facility owner must submit a written plan for correction of the deficiency within 10 days after being notified of the deficiency, and “the department shall determine if the written plan or correction is acceptable” If the correction plan is not deemed acceptable, the facility owner must submit a revised plan within 10 days. A license or license renewal may be refused if the facility fails to comply with any provision of the Act, or for numerous other reasons. 25 TAC § 139.32. Administrative penalties up to $1,000 a day may be assessed for any violation. 25 TAC § 139.33. In determining the amount of an administrative penalty, the Health Department may consider all matters “that justice may require.” Id. Operation of the facility without an appropriate license subjects the physician to criminal liability. See Tex. Health & Safety Code § 245.014; 25 TAC § 139.33. The criminal offense was previously a Class C misdemeanor, but the 1999 amendments will increase the offense to a Class A misdemeanor. See House Bill 2085, Sixty-Seventh Legislature, 1999 Regular Session, 1999 Tex. Sess. Law Serv. Ch. 1411 (H.B.2085). While the maximum penalty for a Class C misdemeanor is $400, a Class A misdemeanor is punishable by a jail sentence of up to one year and a fine of up to $4,000, or both. See Tex. Penal Code §§ 12.21; 12.23. A licensed abortion facility is required to create and maintain written policies and procedures dealing with at least 30 different subject matters. See 25 TAC § 139.41. et seq. The policies must cover the following areas: 1. administrative policies covering, “at a minimum,” A. personnel B. employee training, orientation, and evaluation, C. employee and patient record system, D. auditing system for monitoring state or federal funds, E. advertisements, F. accuracy of public education materials and activities in relation to abortion, birth control, and sexually transmitted diseases, G. patient education/information services and referral services; H. reporting requirements; I. procedures for the resolution of complaints regarding quality of care. (All complaints must be documented and investigated within 30 days). 2. Clinical policies covering, “at a minimum,” A. the provision of medical and clinical services; B. the provision of laboratory services; C. examination of fetal tissue, D. disposition of medical waste, E. emergency services, F. condition on discharge procedures, G. clinical recordings, H. reporting and filing requirements I. monitoring post-procedure infections 3. A policy to ensure compliance with the Health and Safety Code. 4. A policy to ensure compliance with fire safety codes; 5. Policies on decontamination, disinfection, and sterilization, and storage of sterile supplies. All of these written policies must be reviewed and revised as necessary, “periodically, but no less than once every two years,” and must bear the date of the last review. 25 TAC § 139 41. Section 139.42 requires a “written organizational structure” identifying the physician, administrator and clinical staff and providing “a description of the structure of an abortion facility and defines the lines of authority.” Section 139.43 requires personnel policies, including job descriptions, orientation, training, annual evaluations, continuing education, and basic life support certification. All employees must sign a statement acknowledging patient rights. Section 139,44 requires a “written orientation and training program” that requires all employees, including office staff, to understand and demonstrate competency in about 10 different areas, including patient care, sterilization and infection control, abortion techniques and possible complications of the procedure. All training needs to be documented in each employee’s file. Section 139.45 contains specific requirements for the contents of each employee’s personnel file, including test results for mycobacterium tuberculosis and hepatitis B. Section 139.46 sets out specific required job qualifications for the office administrator, education and information staff, and laboratory staff, including type of degree, and certain level and type of experience, and requires that the staff include an RN or LVN. Section 139.47 sets out the specific job duties of the office administrator. The administrator must “develop and make available to all staff and the department, a policy and procedure manual including protocols and description of the roles and responsibilities of all personnel.” 25 TAC § 139.47(a)(4). Staffing schedules, time-worked schedules, and on-call schedules must be retained for two years, and retained schedules must be stored so they can be retrieved within two hours. 25 TAC § 139.47(c). Section 139.48 sets out physical and environmental requirements, including a separate recovery room, “a written protocol for emergency evacuation for fire and other disasters tailored to the facility’s geographic location,” two functioning sinks and a functioning toilet, and the capacity to provide patients with liquids. In general, a facility must “have a safe and sanitary environment, properly constructed, equipped, and maintained to protect the health and safety of patients and staff at all times.” 25 TAC § 139.48(1)(A). The facility must develop and maintain written infection control standards which “shall include, but not be limited to HIV, hepatitis B and C, tuberculosis and streptococcus.” 25 TAC § 139 49. There also must be written policies on “educational course requirements” and “decontamination, disinfection, sterilization and storage of sterile supplies.” These written policies must include provisions regarding “the receiving, cleaning, decontaminating, disinfecting, preparing and sterilization of critical items” and “assembly, wrapping, storage, distribution, and quality control of sterile items and equipment.” Section 139.49 also requires written policies and procedures on cleaning procedure rooms, and a written policy on the “handling, processing, storing and transporting of clean and dirty laundry” Several pages of specific detailed sterilization instructions set out in the regulations are required to be included in the written policies. Each sterilizer must be monitored during operation for pressure, temperature, and time at desired temperature and pressure, and a record kept of all these items. Performance records for all sterilizers shall be maintained for at least two years. A preventative maintenance record for each sterilizer must be maintained for at least two years, and stored records must be available within two hours. 25 TAC § 139.49. The licensee shall “ensure that all patients ... are cared for in a manner and in an environment that enhances each patient’s dignity and respect in full recognition of her individuality.” and shall ensure that all patients “receive care in a manner that maintains and enhances her self-esteem and self-worth.” 25 TAC § 139.51. Section 139.53 requires that a physician, physician extender, registered nurse or licensed vocational nurse “must be in the facility whenever there is a patient in the procedure room or recovery room.” A patient may not be left unattended in the procedure or recovery room. The recovery room must be supervised by a physician, physician extender, or registered nurse. Section 139.55 provides that the daily patient roster records must be maintained for 5 years, and requires a written policy and procedures regarding the removal of records and the release of information. The facility “shall establish and maintain a clinical record for each patient ... to assure that the care and services provided to each patient is [sic] completely and accurately documented, readily, and systematically organized to facilitate the compilation and retrieval of information.” Section 139.55(c) contains detailed instructions on how to create and maintain a patient’s file, including a specific list of what information and documents must be in each file. Patient records must be retained “in their original state” and “correction fluid or tape shall not be used in the record. Corrections shall be made by striking through the error with a single line and shall include the date the' correction was made and the initials of the person making the correction.” Clinical records for adults must be maintained for 5 years; records for minors must be maintained for 5 years after the patient reaches majority. Retained patient records must be retrievable within 2 hours. The facility must create and maintain “a readily accessible written protocol for managing medical emergencies.” 25 TAC § 139.56. Physicians must have admitting privileges at a local hospital, or have “a working arrangement” with a physician who has admitting privileges. The facility “must have the necessary ' equipment and personnel for cardiopulmonary resuscitation.” 25 TAC § 139.56(b). Section 139.57 requires “written discharge instructions” including a list of specific information that must be included. Written policies are required regarding examination and referral of all patients who report complications. (Complaints and responses must be documented in the patient’s record under “a written system of documentation”). A written policy must be developed regarding the review of the record-keeping system for complications. Section 139.59 contains definitions of different levels of anesthesia, and sets out required procedures, equipment and standards for procedure rooms relating to anesthesia services. Section 139.60 -requires that the facility must be in compliance with other laws and regulations, including all state and federal laws on handling drugs, the Clinical Laboratory Improvement Amendments, the Certification of Laboratories Act, the Texas Medical Practice Act, the Physician Assistant Licensing Act, the Nursing Practice Act, the Board of Vocational Nurse Examiners rules, the Texas Pharmacy Act, the Health and Safety Code provisions on misbranded drugs, the Texas Deceptive Trade Practices-Consumer Protection Act, federal OSHA requirements, and federal regulations regarding fire prevention, emergency plans, personal protective equipment, eye protection and hand protection, fire extinguishers, food-borne pathogens, and hazardous use of chemicals. IV. Findings of Fact In 1997, more than 84,000 abortions were performed in Texas. Under current law, Texas has 31 licensed abortion facilities. The abortion statistics that all physicians are required to report annually show there are 7 physicians who currently perform more than 10 abortions per year, but fewer than 300 abortions, so they are currently exempt from abortion facility licensing and will remain exempt under the 1999 amendments. A handful of physicians, “a single-digit number,” perform fewer than 10 abortions a year. The challenged 1999 amendments will bring -within the regulation only physicians who perform more than 300 abortions a year in their private offices, but whose abortion patients constitute less than 51 percent of their total private practice patients. The evidence before the Court indicates that there are 12 physicians in Texas (approximately 20 percent of the state’s abortion providers) who meet this definition and who therefore will become subject to the abortion facility licensing and regulatory requirements as of January 1, 2000. Five of the 12 physicians affected by the challenged provisions are plaintiffs in this case. Plaintiff Dr. Fred Hansen is a board certified physician with more than 30 years of OB/GYN practice. He owns a private gynecology practice in Austin under the professional association name Fred W. Hansen. M.D., P.A. Hansen provides comprehensive gynecological care to his patients, including annual exams and pap smears, treatment of female reproductive system problems, family planning, and infertility counseling. He also performs approximately 950 to 1,050 abortions a year. His office staff consists of a medical assistant, a receptionist, an office manager, and a part-time transcriptionist. Hansen said abortion is simply one procedure among many that he provides to his patients. He does not advertise that he provides abortion; almost all of his abortion patients are referred to him by other physicians. He also receives referrals of active military personnel and dependents from many areas who cannot get an abortion for any reason at a military hospital, and many of his patients come regionally from the areas surrounding Austin. In addition to his private practice, Hansen has served for 16 years as a medical director to Reproductive Health Services, an Austin abortion facility that has been licensed under Texas law since licensing of abortion clinics was first required in 1985. Many of the abortions Hansen provides in his private practice are for what he calls “obstetrical tragedies” that occur in wanted pregnancies, such as the discovery of a profound fetal abnormality in the skull, heart, or other vital organs, or the diagnosis of a chromosomal defect. These “medically indicated” abortions typically occur past the 15th week of pregnancy, when perinatal tests reveal the problems with the pregnancy. Hansen testified that he is currently the only private physician in Austin who provides abortions beyond the 15th week of pregnancy, so if Hansen were to close his private abortion practice, couples in the Austin area who are facing the tragic choice of whether to abort a pregnancy when defects are discovered would have to go to an abortion clinic rather than a private office. This, Hansen says, would greatly reduce the emotional support and counseling such patients would receive. The private setting also offers an element of privacy lacking at a clinic, where virtually all of the patients there have come for an abortion. Currently, a woman in Hansen’s waiting room could be there for birth control pills, an annual exam, or another gynecological procedure, not just an abortion. Hansen’s office is not listed on any public registry of abortion providers, and he has been picketed rarely, only three times in the last 12 years. In contrast, he said, a clinic might see up to 35 patients a day, and clinic patients are subjected daily to confrontational anti-abortion picketers. Women seeking abortions at a clinic often must wait five to nine hours at the facility, and Hansen believes that their already fragile emotional state will deteriorate in this setting. In addition, staff turnover at clinics tends to be higher, so personnel are likely to be less experienced and sensitive to patients’ needs. Hansen testified that he, and other gynecologists, perform gynecological procedures in their offices other than abortion, Abortion does not require a different, or more stringent, type of sterilization of instruments than other gynecological procedures Hansen performs in his office, such as endometrial biopsies, cervical biopsies, dilation and curettage (“D & C”), and the removal of a fetus that has died in útero. These procedures carry risks similar to those of abortion, and it would not be unusual for a gynecologist to perform a combined 300 or more of these procedures in a year. Hansen also testified that other outpatient surgical procedures are also routinely performed in physicians’ offices, such as liposuction, which can involve more risks than abortion. Yet only abortion subjects a physician to regulation. Hansen knows of no other outpatient procedure that is regulated based on the number of procedures performed in a year. He testified that there is no medical or logical reason to distinguish between a physician who performs 300 abortions a year from one who performs 299 abortions a year, or from one who performs 300 similar gynecological procedures. In his practice, Hansen testified, he has trained all of his employees in sterilization procedures, with the assistance of the manual for the sterilizer. He does not have written infection control and sterilization policies, because he and his seasoned staff already know the procedure. He is always there when the office is open, so he is there to see that sterilization is done properly, although due to the long tenure of his staff, it is “extremely rare” that he sees a sterilization problem that needs correcting. “My infection rate is almost nonexistent,” he testified. He admitted, however, that he had not calculated or come up with any hard estimate on how long it would take him to draft infection control or sterilization policies. He does not believe he could copy them from the licensed facility where he works because they are proprietary materials. He admitted that he has not looked to see whether some of the regulations duplicate requirements in statutes to which he is already subject, such as the Clinical Laboratory Improvement Amendments, OSHA, or the Texas Medical Practices Act. If Hansen were to become licensed, he would have to immediately hire an RN or LVN, because the regulations require that an RN or LVN be on staff. He testified that because he and his staff are all fully occupied by their current workload, (and because he does not believe that any of his current staff members have the required expertise to track compliance of these detailed regulations), he estimates that he would have to add an additional person to ensure compliance. Another option would be to replace his office manager and tran-scriptionist, who have worked for him for 14 and 22 years, respectively, and replace them with the RN and a staff person who would serve as the administrator in charge of regulation compliance. However, he does not believe an RN or LVN is necessary to provide good medical care to his patients. He does not currently have formal written personnel policies for his four employees, and he has no written organizational chart showing delegation of authority. Hansen also expressed concern with the requirement that he post or provide each patient with notice of the toll-free number to the abortion licensing division where “all complaints” must be directed. “I run an integrated medical practice, and I just don’t know how my 71-year-old patients are going to react [to a document telling them] that if they’re dissatisfied that they’re to call the abortion licensing division of the Texas Department of Health. It’s a demeaning requirement to ordinary patients.” Having to provide personal identifying information with the license application bothers him, because of recent incidents around the country where abortion practitioners were killed. He fears being more vulnerable to violent activists who might target him for harassment or violence. Hansen estimates that if he were to become licensed and comply with the regulations, he would incur about $60,000 in additional costs annually for the two new staff members. Since he does about 1,000 abortions a year, the extra staff expense alone would equal a cost of $60 per procedure, although he testified that he would not necessarily raise the price to his patients. In general, Hansen agreed that the requirement that freestanding abortion clinics be licensed and regulated by the state has done some good in deterring “individuals who would establish corner clinics, mul-tistate clinics, and be interested only in it for a remunerative basis.” When non-physicians own abortion clinics, Hansen said, he sees the possibility that quality medical care may be sacrificed to the “bottom line.” He acknowledged that if a private physician is doing 2,000 abortions a year, then “a more formal process might be perhaps advantageous.” But he does not believe that becoming licensed at his own private office would improve patient care. Hansen testified that he will stop providing abortions in his private office rather than seek to be licensed, because he believes patient care would suffer while he and his staff spend time on burdensome administrative tasks, and because he does not want to be subjected to possible fines and criminal penalties. He will continue to serve as medical director to Reproductive Health Services and will continue to perform abortions at that facility. Plaintiff Dr. Mary Smith operates a private gynecology practice in Denton, Texas, under the professional corporation name Mary E. Smith, M.D., P.A., She does business as “Denton Health Services for Women.” (“DHS”), which she opened 22 years ago. At DHS she provides her patients with gynecological examinations, early pregnancy tests, sonograms, emergency contraception, family planning services, and testing and treatment for sexually transmitted diseases. She provides abortion services two mornings a week at DHS. Smith testified that she does much of the practice management herself. She has one full-time employee, a counselor who also answers the phone, and she employs a part-time receptionist, and an RN and an LVN who alternate coming in on days when she does surgery. She currently provides about 350 to 400 abortions a year at DHS. She testified that she feels comfortable with keeping the number of abortions she provides at around 400, because at that level she can remember each patient’s name and personally supervise their care. “That’s enough for me to keep in' my head and know at home when they call me,” she testified. Smith also performs abortions two and a half days a week at the Fairmont Center, a licensed abortion clinic in Dallas. The Fairmont clinic is about 45 minutes to 90 minutes away from DHS by car, and she is not aware of any public transportation available between Dallas and Denton. She performs about 2,000 abortions a year at the Fairmont clinic. Occasionally she treats patients from Denton at the Dallas clinic. She testified that her experience with health department surveyors at the Fairmont clinic has been negative. However, she admitted that the regulations have the potential to improve health care in some physicians’ offices, whether they perform abortion or other surgical procedures. Smith testified that she is the only Texas abortion provider north of Dallas, Many of her patients are from Denton, a university town, but some come from throughout Denton County and north of Denton all the way to Oklahoma. Some patients drive in from other cities to come to her because they prefer a female doctor. “To my knowledge, I am the only female physician providing abortions in Texas,” Smith testified. Many of her Denton patients have difficulty paying for an abortion and often have to delay the procedure in order to come up with the money. A lot of the patients arrive by taxi or trolley and have no transportation back home, so Smith or her staff have to drive “quite a few” of their patients home after the procedure. Smith and her nurses are responsible for sterilization of instruments, and Smith supervises the sterilization to be sure it is done properly. The counselor and receptionist do not have any training in sterilization. She testified that if she were to become licensed, she would have to purchase a new autoclave to meet the requirements of 25 TAC § 139.49, which requires sterilizers to be “monitored during operation” and requires recording and keeping records on the pressure, temperature, and time maintained at desired temperature and pressure. Because her “ancient” autoclave does not electronically record this data, she would either have to buy a new one or have someone sit in the room with the autoclave during the time when it is running to record all the required information. She would have to purchase an oral suction machine apparatus, which is required under 25 TAC § 139.59(f)(4) in facilities which use light sedation. She currently does not have any of the required written policies required by the regulations, and she sees no need to, for example, draft a written “advertising” policy regarding her one listing in the phone book, or to draft a written policy regarding the accuracy of public health information that she herself provides to her patients. She has no written complaint policy, but she personally deals with any complaints that come in. She has no written policy regarding the monitoring of post-procedure infections, but her patients can and do call her directly with any concerns about infection. “It’s worked for me for 22 years,” she testified. “I’m having a hard time understanding why I need to change.” She believes that none of the regulations ■would improve patient care in her practice, because she would be distracted by having to meet all the requirements, which would take time and attention away from patient care. The required quality control committee composed of at least four staff members could not be assembled without requiring one or more of her part-time employees to take off from their other job to come in, because her four staff members are very rarely in the office at the same time. It would be very difficult to schedule such meetings during regular working time, because she and her staff already are fully occupied on the days the office is open and providing abortions. Smith does not plan to become licensed. She testified that her practice in Denton is already struggling financially, and has only been continued due to her feelings of loyalty and commitment to the community of Denton. However, the increase in expenses due to the licensing fees, purchase of required equipment, and compliance with the regulations would make it financially impossible to continue. She would have to either hire someone to draft all the required policies, or find the time to draft them herself, because no one else on her staff would be capable of doing it. She has talked to the person who drafted the policies for the Fairmont Center in Dallas, and found out that drafting those policies took three months. She doesn’t believe that the Fairmont policies could be used as a model for policies for DHS, because the procedures at a clinic of 20 employees are necessarily different from a private practice with four employees. Section 139.53 requires the recovery room to be supervised by a physician, physician extender or RN, and Smith testified that she needs her nurse to assist her with surgery, so she probably would have to hire another nurse to supervise the recovery room. She admitted, however, that she has not put pencil to paper to calculate exactly what all the costs of compliance would be. Because 80 percent of her income is from providing abortions both at DHS and at the Fairmont Center in Dallas, ceasing to provide abortions in Denton would mean that she would have to shut down her entire private practice in Denton. As a result, her patients in Denton would lose the personalized care she has been able to give them, and some may be prohibited from obtaining abortions due to lack of money and transportation. “Some of them will make it to Dallas,” she testified. “The ones who can’t will go on and have babies.” Plaintiff Dr. Tad Davis is a board certified OB/GYN who conducts a private gynecology practice in Austin, Texas under the professional name Austin Women’s Health Center, P.A. (“AWHC”). Davis has approximately 15 part-time and full-time employees, including three front-desk employees who do insurance verification, receptionist work and other clerical tasks, two certified counselors, four medical assistants, three LVN’s, a bookkeeper, a personnel director and another physician. AWHC provides comprehensive gynecological care, including routine examinations, family planning, and diagnosis and treatment of diseases affecting the reproductive system, he also provides abortions up to 15 and a half weeks of pregnancy. His patients come regionally from the area surrounding Austin, including areas southwest to San Antonio, northeast to Waco, south to Interstate 10, and northwest to Killeen and Copperas Cove and up into the Texas panhandle, including Lubbock, Midland, and Odessa. He estimates that about 25 percent of his patients fall below the federal poverty level. Davis testified that his patients benefit greatly by the private atmosphere of a practice that provides a wide range of other medical care besides abortion, and by having the accountability of one physician who is responsible for the entire practice. “Unfortunately in clinics sometimes there is the cattle herd mentality where a number of patients are brought in, sent through procedures, and tender love and care is not given to them as much as in the private office,” Davis testified. Davis testified that having to comply with the regulations will jeopardize confidentiality, increase costs, and cause a great deal of dissatisfaction among his staff. He estimated that the additional costs of compliance will require him to raise his abortion fees by $25 to $50 per procedure. That estimate does not include the one-time cost of a consultant he intends to hire to come in and draft his policies and help him come into compliance. “The regs are very difficult in the fact that they’re open to interpretation,” Davis testified. “They’re very difficult in the fact that it requires pounds and pounds and pages and pages of paperwork, and things that physicians’ offices are just not attuned to, so one has to have a consultant in order to proceed, if they’re going to get licensing.” He testified that his consultant estimates that it will take three weeks, at $1,000 a day, to get all of the required policies written. In addition, the consultant estimated that he would have to close the office down for one week to train all of his employees. The cost of paying the consultant for three weeks, and the cost of closing down the office for a week to train his employees, would mean $50,000 to $60,000 in start-up costs, he testified. He admitted on cross-examination, however, that he has not attempted to locate a less expensive consultant, and he admitted that he did not provide his consultant with a copy of all the regulations to. review before coming up with her cost estimate; he merely read some of the regulations to her over the phone. He also did not tell the consultant that the pre-licensing procedure includes a visit from a health department surveyor for the purpose of explaining and interpreting the regulations and helping the office become compliant. He testified, however, that he does not believe the health department will be of much help to him in interpreting the regulations, based on a phone call he made to the health department seeking to understand certain parts of the regulations. He states that the person he spoke to did not answer his specific questions, but merely read the regulation to him. He admitted, however, that he does not know who he spoke to and whether that person was an experienced surveyor. Davis admitted that he has not compared the various written manuals he currently has in his office with the regulations to see whether he already has on hand some of the required written policies. He testified that he would not have to add any more employees to comply with the regulations. Davis does not believe that any medical benefit would be gained by having to train his front office employees — whose sole duties are to verify insurance, perform receptionist duties, and schedule appointments — in areas such as infection control and sterilization. He believes his practices are already effective to prevent infections. “Our complication rate has been one of the lowest in the world,” he testified. In addition, he estimates that training the front desk employees and the bookkeeper, who do not have any medical education, will take longer than training a medical assistant or other person who has health care background or credentials. In addition some of his employees are part-time, so it may be difficult to schedule a time for them all to come in to be trained. Currently, AWHC charges $850 to $550 for an abortion. Davis testified that all of the costs of compliance will be passed on to his abortion patients, many of whom “barely can come up with the funds now, and this will put them over the edge where they will not be able to have abortions.” This increase of $25 to $50 (or more, depending on the period over which the start-up costs are recovered) per procedure will be on top of other expenses many of the abortion patients are already having to pay, such as medications, and the cost of travel and overnight accommodations for those patients who travel for long distances to come to his office. He testified that these estimates contemplate passing the increased costs along only to his abortion patients, not to his practice as a whole, and he admitted that he has not determined how long of a period he would use to defray the start-up costs. Davis also performs other gynecological procedures in his office that carry risks similar or identical to abortion, such as D & Cs, endometrial biopsies, hysteroscopies,' and conization. He testified that a D & C is virtually the same procedure as an abortion, and a conization, in which a portion of the cervix is surgically excised for the diagnosis and treatment of pre-cancerous tissue, is more complicated and involves more risks than abortion. Yet only abortions will subject him to regulation. In addition, he testified that almost all physicians do some sort of invasive procedures in their offices, some of which carry a higher risk to the patient than abortion. He testified that tummy-tucks, facelifts, liposuction, endoscopy, and laparoscopy are commonly performed in physicians offices, but do not subject physicians to regulation. Laparoscopy, for example — which has been approved by a reputable medical organization as being appropriately performed in a physician’s office — carries a risk 10 times higher than that of abortion. Davis sees no medical reason to regulate these other office surgical procedures differently from abortion. He also sees no reason to regulate a physician who performs 300 abortions a year in his office, but leave unregulated a physician who performs 299 abortions. On the contrary, in his experience a physician who does a greater number of procedures tends to be more competent than an occasional practitioner. He testified that the amount of time a doctor has to spend with each patient is not necessarily related simply to the number of abortions the doctor performs; rather, it depends on a number of factors, including the length of office hours, the availability of other medical support staff, and the number of total patients seen or non-abortion procedures performed. Davis has for about 10 years participated in the review and discipline process of the Texas Board of Medical Examiners, and he testified that the TBME has done an excellent job for at least the last 10 or 12 years in monitoring physicians and disciplining physicians who provide substandard medical care. In addition, he testified that under the “captain of the ship” doctrine, the TBME holds the physician personally responsible for any substandard care provided by his staff. He testified that the possibility of a complaint to the TBME or a malpractice lawsuit causes him to be vigilant in maintaining the proper standard of care for his patients. He admitted, however, that the TBME does not promulgate regulations or regularly inspect physicians’ offices, but reacts only to complaints about a physician from patients, hospitals or other practitioners. Davis testified that an abortion is one of the most traumatic events in a woman’s life, and although his office tries to provide comfort, counseling, and “TLC” to maintain the patient’s self esteem and self-worth, he’s not' sure that it is possible for an abortion to “enhance” a patient’s self worth, as required by 25 TAC § 139.49. In fact, Davis believes that the time that will be required to reach and maintain compliance with the regulations will actually decrease the time he and his staff have available to provide personalized care, which could make the experience worse for many of his patients. Davis plans to seek to become licensed, but he has doubts about how long he will continue providing abortions, or whether in the future he will try to limit his abortions to fewer than 300 a year. Plaintiff Dr. Robert Kaminsky is a Houston gynecologist who owns a private practice under the professional corporation Robert P. Kaminsky, M.D., P.A., doing business as Women’s Medical Center of Northwest Houston. Kaminsky has one other physician who works with him at the Women’s Medical Center, and he also employs a nurse practitioner, a part-time licensed vocational nurse (“LVN”), three full-time medical assistants, two receptionists, two office employees who deal with insurance verification, an accountant-bookkeeper, and an administrator. The office provides comprehensive gynecological care, including diagnosis and treatment of menstrual disorders and sexual dysfunction, contraceptive planning, infertility evaluation, gynecological surgery and abortions. Kaminsky estimates that he personally performed 700 to 750 abortions during the last year, which is half of the abortions done in his office. He testified that he spends about half of his time doing abortions, and about two-thirds of his income in 1998 came from abortions. In his medical opinion, abortion is no more complicated and entails no greater risk than many gynecological surgeries that he routinely performs in his office. Kaminsky also performs pap smears, IUD insertions, D & C’s, and cervical and en-dometrial biopsies. Endometrial biopsy, a procedure to sample and remove a tissue specimen from the inside of the uterus, is virtually identical to a first-trimester abortion in technique and technical difficulty, as well as in the instruments and medication used. He testified that he has developed infection and sterilization procedures that have proven extremely effective for all the surgical procedures he performs, although they may not meet all the particulars of the regulatory scheme. He uses the same sterilization procedures for abortions as for other procedures, and he testified that there is nothing about the abortion procedure itself that would require a different protocol. “There is no basis for the state to single out abortion procedures and dictate the sterilization and infection procedures,” Kaminsky states. “Nor can I understand, from a medical perspective, why a distinction is made between physicians performing less than 300 abortions and those performing more than 300 in a twelve-month period.” He testified that a medical assistant who has worked for him for 10 years instructs other medical assistants on how to sterilize instruments He has no written sterilization policy other than manuals for the equipment. He has no written infection control policy, and states that his office has not had a problem with infection. He does have a personnel policy, a checklist of items to cover in the orientation of new medical assistants, and some other instructional documents. Kaminsky does not have a formal quality assurance program, but he monitors the provision of medical services on an ongoing basis, dealing with problems as they arise and during staff meetings if necessary. “This system, while informal, has proven efficient and effective,” he states. “The quality assurance provisions in the regulatory scheme may be appropriate for an ambulatory surgery center setting because different physicians use the facility and patients will most often receive follow-up care in the private office of their referring physician. In my private office practice, where I am ultimately responsible for all of the medical care, I do not believe that this type of quality assurance program is necessary to ensure patient health and safety. Compliance, would, however, require additional staff time.” Kaminsky estimates that he spent approximately 45 minutes reviewing the challenged regulations, but that he has not asked his staff to review them, and he has not considered whether the regulations would require any physical changes to his facility. He admitted that he has not done a general cost estimate on how much it would cost him to comply with the regulations. He believes most of the additional costs will come from the additional staff time needed to develop the required written policies and to document compliance. He believes that having to comply with the regulations will likely result in an increase in abortion fees, which will force women to pay more for the procedure or go elsewhere. Plaintiff Dr. Lamar Robinson provides a wide range of obstetrics and gynecology services, as well as other general practice medical care, in his private office in Dallas. He performs abortions at his private office, and he also performs abortions at a licensed abortion facility, the Aaron’s Women’s Health Center in Dallas, for four half-days a week. Robinson testified that 2,211 abortions were performed at his private office during 1998, and he estimates that the 1999 total would be similar. He estimates that 40 or 50 percent of his income comes from abortions. He has 14 employees at his private office, and he has two other physicians who help him on a part-time basis. His employees include an office administrator, an office manager, a lab manager, a business manager, nurse practitioners, nurse staff, a registered nurse, several medical assistants, a designated cashier, and one designated receptionist. Robinson has submitted a preliminary application and has paid an initial licensing fee to become licensed under the Abortion Facility Reporting and Licensing Act, and has participated in an initial telephone survey with the health department. He and his staff have compiled a list of anticipated costs associated with becoming licensed. He estimates that he will have additional payroll expenses for additional staff hours spent writing policies, generating new forms, and revising old forms. Robinson testified that he currently has written infection control procedures, written personnel policies and training materials. He anticipates having to make changes in his sterilization area, and expects to incur ongoing additional costs of about $5 a patient to meet the requirement that new suction tubing be used for every procedure. Robinson currently charges $250 for a first-trimester abortion in his private office. Overall, Robinson expects to incur costs associated with becoming licensed that will total as high as $100 per patient. Robinson objected to the requirement that the abortion facility license' be “prominently displayed for everybody who comes in the door.” See 25 TAC § 139.21(7) (“An abortion facility shall prominently and conspicuously post the license issued under the Act for display in a public area of the facility that is readily accessible to patients, employees and visitors.”). Robinson expects his practice to suffer due to the posting requirement, because the posted abortion license is likely to offend his obstetrical patients and male patients, some of whom oppose abortion. Robinson sees no medical reason to single out abortion for this type of regulation. He states that he also performs diagnostic hysteroscopy and D & C procedures in his office, and that these procedures involve virtually the same instrumentation, sedation, techniques, duration, and risks as a first-trimester abortion. Yet only the abortions will subject him to regulation. The burdens of the regulatory scheme, according to Robinson, come from requiring an office which has operated informally, as most private offices do, to follow requirements more appropriate for a facility like an ambulatory surgery center. “I do not think these written policies are necessary to improve or ensure patient safety,” Robinson testified. “Compliance with the ’ provisions of the regulations would be driven by the threat of civil and administrative penalties and a loss of license rather than a perception that they will enhance the well-being of my patients.” The defendants introduced the deposition testimony of Dr. Janet Lawson, a board certified OB/GYN who is currently employed by the Texas Department of Health as the medical consultant for women’s health. Lawson was formerly in private practice, and she has performed abortions in the past. Lawson testified that she participated in a committee in 1997 to revise the abortion facility regulations. The revisions that she helped draft became effective on August 13, 1998, and were applicable at that time to abortion clinics and physicians’ offices used primarily for the purpose of performing abortions. Lawson was not involved in drafting the 1999 amendments that are being challenged in the instant case, so she did not participate in choosing the number 300 as a cut-off for the physicians’ office exemption. During the 1997 committee process to draft the 1998 revisions to the abortion regulations, Lawson was a consultant to the sterilization committee and a member of the quality of care subcommittee. The overall ad hoc committee included physicians, nurses, pro-life activists, pro-choice activists, health department personnel, a director of a licensed abortion facility, and a physician specializing in epidemiology and infectious diseases. Lawson helped draft the part of the regulation requiring a quality control committee because “having quality assurance in any practice is important.” She testified that when she was in private practice, she had policies in place to deal with patient care, triage, the handling of complaints, and other areas. Lawson said that one of the 1997 committee’s goals was to avoid decreasing access to abortion or unnecessarily increase costs to abortion facilities. She does not specifically recall talking about the cost implications for individual physicians’ offices. The patients’ rights section was drafted to make sure each woman was taken care of in a dignified way respectful of her individuality, “much as you would in the practice of medicine as a physician anyway.” As a physician, she does not consider the patients’ rights language to be vague. Lawson testified that a woman’s right to quality care and right to regulatory protection are the same whether she is going in for an abortion or for any other procedure. She is of the opinion that Texas should have regulations similar to the abortion facility regulations in place for other medical procedures as well, regulations that take into account the actual risks for each individual procedure. She testified that she has performed D & C procedures, and that, depending on why the D & C is being done, a D & C might present more or less risk than an abortion. She was not involved in choosing the 300-abortion cutoff for the 1999 amendments, so she doesn’t know how or why that number was chosen, but she does believe that, “[a]s you increase the number of abortions, or procedures that are done of any type,” the physician tends to have less time to attend to issues like sterilization, counseling, and triage, and more of those duties are left to the physician’s staff. Therefore, Lawson reasoned, it makes sense to require that the staff receive specific training to be able to handle problems or complications when the physician is not immediately available. “As the distance between the physician and the patient gets wider, it’s harder for the physician to take care of [the patients’] needs, unless there’s some specific policies, guidelines, processes, that are in place.” The defendants also presented the testimony of Dr. Kate Hendricks, a physician specializing in infectious diseases and epidemiology who currently is employed by the health department. Epidemiology is the study of how disease is distributed in a population, how disease spreads, and how that spreading can be prevented. Hendricks was involved in the 1997 committee that drafted the 1998 revisions to the abortion regulations. However, she testified that she was not involved at all in the passage of the 1999 amendments, and was not consulted regarding the narrowing of the physicians’ office exemption to include all offices where 300 or more abortions are performed in a year. During the 1997 revisions to the regulations, Hendricks was specifically involved in the subcommittee on sterilization regulations. She helped to select other resources the regulation drafters used, such as documents from the “hospital infection control” section of the Centers for Disease Control and Prevention. She remembers that the applicability of the regulations to physicians’ offices was discussed “some,” but not extensively. Because the regulations at that time only applied to physicians’ offices used primarily for abortions, the drafters had in mind only those “51 percent or more” physicians’ offices, she said. Hendricks testified that regardless of where a woman goes to have a procedure done, whether in an operating room, at a clinic, or in a physician’s office, she should have the same protection from infections. Hendricks testified that infection control standards and sterilization are important in the abortion context because the procedure invades the uterus, which is normally a sterile body cavity. She said that staff training is important in these areas, because some of the dangers of contamination are not obvious; for example, a staff member might accidentally cross-contaminate sterilized instruments if he or she has not been taught how to handle them properly. She also testified, however, the sterilization and infection control requirements that she helped to draft are equally applicable to all invasive surgical procedures performed in a physician’s office. She states that the American College of Obstetrics and Gynecologists (“ACOG”) would agree that such requirements are equally appropriate for abortion and all gynecological surgery. During the 1997 committee discussions, the members did not discuss how much time it would take for physicians’ offices to draft all of the required policies, but Lawson pointed out that there exist