Report 2013-120 Summary - June 2014
Sterilization of Female Inmates:
Some Inmates Were Sterilized Unlawfully, and Safeguards Designed to Limit Occurrences of the Procedure Failed
Our audit of female inmate sterilizations occurring over an eight-year period revealed the following:
- 144 female inmates were sterilized through a surgery known as bilateral tubal ligation.
- 39 inmates were sterilized following deficiencies in the informed consent process.
- We saw no evidence that the inmate's physician signed the required consent form in 27 cases.
- In 18 cases, we noted potential violations of the required waiting period between when the inmate consented to the procedure and when the sterilization procedure actually took place.
- Among these 39 inmates there were six cases where we noted violations of both consent form and waiting period.
- Neither the California Department of Corrections and Rehabilitation nor the California Correctional Health Care Services ensured that the informed consent requirements were followed in 19 instances in which their employees obtained inmates' consent.
RESULTS IN BRIEF
The California Department of Corrections and Rehabilitation (Corrections) oversees the inmate population of the State's 33 adult prisons. During our eight-year audit period—which we defined as fiscal years 2005-06 through 2012-13—four of these prisons housed substantially all of the female inmates: California Institution for Women, Central California Women's Facility, Folsom Women's Facility, and Valley State Prison for Women (Valley). Valley no longer houses women since its conversion to a men's prison in January 2013. For much of our audit period, Corrections' role in providing inmates with medical care was not significant; the more substantial role was played by California Correctional Health Care Services (Receiver's Office) under the direction of a federal court-appointed receiver. A receiver took control of prison medical care in 2006 and will retain control until the court finds that Corrections can maintain a constitutionally adequate prison medical care system.
From fiscal years 2005-06 through 2012-13, 144 female inmates were sterilized by a procedure known as a bilateral tubal ligation. The last of these female inmate sterilizations occurred in 2011. Although various surgical procedures may result in a female's sterilization, bilateral tubal ligations are generally surgical procedures that are performed for the sole purpose of sterilization, and state regulations impose certain requirements that must be met before such a procedure is performed. However, the state entities responsible for providing medical care to these inmates—Corrections1 and the Receiver's Office—sometimes failed to ensure that inmates' consent for sterilization was lawfully obtained. Overall, we noted that 39 inmates2 were sterilized following deficiencies in the informed consent process. We found two types of deficiencies. First, we found no evidence that the inmate's physician—the individual who would perform the procedure in a hospital or an alternate physician—signed the consent form as required by state regulations. Second, we noted potential violations of the required waiting period between when the inmate consented to the procedure and when the sterilization surgery actually took place. Some inmates were sterilized following violations of both of these requirements. Although neither Corrections nor employees of the Receiver's Office actually performed the sterilization procedures, we concluded that they had a responsibility to ensure that the informed consent requirements were followed in those instances when their employees obtained inmates' consent, which was the case for at least 19 of the 39 inmates. Either the remaining 20 inmates signed their consent to be sterilized at a physical location other than a prison or the Receiver's Office had difficulty determining whether the individual who obtained consent was an employee.
Lawful consent is represented by key steps as defined by the California Code of Regulations, Title 22 (Title 22). For example, the physician or an alternate physician must sign the consent form just before performing the surgery, and a waiting period is required after the patient signs the consent form. The missing physicians' signatures on some of the inmates' consent forms are especially concerning because of what the physician signature certifies: that the required waiting period has been satisfied and that the patient appears mentally competent and understands the lasting effects of sterilization. The physician is the last check in the informed consent process and provides the patient with the final opportunity to change her mind.
All the bilateral tubal ligations we reviewed were performed at general acute care hospitals rather than in prison medical facilities. A lawyer for the Receiver's Office stated that the specific provisions of Title 22 do not apply to prison employees, because Title 22 applies only to general acute care hospitals. Nevertheless, because employees of the Receiver's Office played a significant role in these 19 inmates' care and in obtaining their consent to be sterilized, our legal counsel advised us that a court would likely find that the Receiver's Office had a responsibility to ensure that consent was lawfully obtained from these inmates in accordance with Title 22.
Although the consent forms we were able to review demonstrated that each female inmate signed a consent form, we have concerns about whether the female inmates undergoing bilateral tubal ligations received adequate counseling about their decision to be sterilized. Despite a Receiver's Office policy that prison medical staff must use progress notes—a term for documenting information made in an inmate's medical record—to summarize discussions with inmates, in no instance did we find a female inmate whose progress notes adequately reflected that she had been counseled about her decision to be sterilized. The lack of notes in the inmates' medical records regarding informed consent and sterilization made it impossible for us to reach a conclusion as to the quality and content of the consultations between prison medical staff and inmates. We were also unable to conclude whether inmates received educational materials, whether prison medical staff answered inmates' questions, or whether these staff provided the inmates with all of the necessary information to make such a sensitive and life-changing decision as sterilization.
The Receiver's Office also failed to ensure that the prison medical staff under its direction followed state regulations requiring specific approvals for bilateral tubal ligation procedures, including approvals by two committees made up of high-ranking prison medical staff and medical executives from the Receiver's Office. The failure to obtain the necessary approvals was systemic; all but one of the 144 bilateral tubal ligation procedures lacked the necessary approvals. Overall, our file review demonstrated that prison medical staff infrequently requested approval to sterilize inmates, and when they did, it was not always clear that these requests were approved. In many cases, prison medical staff simply requested approval for other medical procedures—such as cesarean sections at hospitals—and did not indicate that the inmate was also to be sterilized.
Since January 2010, when the Receiver's Office asserts it became aware of the sterilization procedures—following allegations by a legal advocacy group—its medical claims data show that the number of female inmates who have undergone bilateral tubal ligations and other medical procedures that result in sterilization has greatly decreased. In addition, since that time we found that the Receiver's Office has better adhered to its processes for reviewing medical services for necessity and for obtaining required approvals for medical services. Nevertheless, because the function of approving a medical procedure has been and remains separate from the process for scheduling the procedure at a general acute care hospital or other community medical facility, the opportunity still exists for inmates to receive medical services that are not authorized. Until the Receiver's Office ensures that medical scheduling is driven by authorized requests for service, it risks subjecting inmates to potentially unnecessary medical procedures and cannot demonstrate that it is in full control of the medical care inmates receive.
To ensure that the necessary education and disciplinary action can be taken, the Receiver's Office should report to the California Department of Public Health, which licenses general acute care hospitals, and the Medical Board of California, which licenses physicians, the names of all hospitals and physicians associated with inmates' bilateral tubal ligations during fiscal years 2005-06 through 2012-13 for which consent was unlawfully obtained. The Receiver's Office should make these referrals as soon as is practicable.
To ensure that it can better monitor how its medical staff and contractors adhere to the informed consent requirements of Title 22, sections 70707.1 through 70707.7, the Receiver's Office should develop a plan by August 2014 to implement a process by December 2014 that would include the following:
- Providing additional training to prison medical staff regarding Title 22 requirements for obtaining informed consent for sterilization procedures, including the applicable forms and mandatory waiting period requirements, to ensure that consent is lawfully obtained.
- Developing checklists or other tools that prison medical staff can use to ensure that medical procedures are not scheduled until after the applicable waiting periods for sterilization have been satisfied.
- Periodically reviewing, on a consistent basis, a sample of cases in which inmates received treatment resulting in sterilization at general acute care hospitals, to ensure that all informed consent requirements were satisfied.
- Until such time as the Receiver's Office implements a process for obtaining inmate consent for sterilization under Title 22 that complies with all aspects of the regulations, it should discontinue its practice of facilitating an inmate's consent for sterilization in the prison and allow the general acute care hospital to obtain an inmate's consent.
To improve the quality of the information prison medical staff document in inmate medical records, the Receiver's Office should do the following:
- Train its entire prison medical staff on its policy in the inmate medical procedures related to appropriate documentation in inmates' medical records. This training should be completed by December 31, 2014.
- Either develop or incorporate into an existing process a means by which it evaluates prison medical staffs' documentation in inmate medical records and retrains prison medical staff as necessary. The Receiver's Office should develop and implement this process by June 30, 2015.
To ensure that inmates receive only medical services that are authorized through its utilization management process, the Receiver's Office should do the following:
- Develop processes by August 31, 2014, such that a procedure that may result in sterilization is not scheduled unless the procedure is approved at the necessary level of the utilization management process.
- By October 31, 2014, train its scheduling staff to verify that the appropriate utilization management approvals are documented before they schedule a procedure that may result in sterilization.
In its response to the audit, the Receiver's Office generally agreed with the report's factual findings, but noted that it reached conclusions about its duty to ensure compliance with the sterilization and consent procedures set forth in Title 22 that differ from the report. Nevertheless, the Receiver's Office pledged to implement all of the recommendations.
1 Corrections was responsible for inmate health care between July 1, 2005, and the appointment of the first federal receiver, effective April 2006. During this time period, 15 inmates had tubal ligation procedures, and based on available and potentially incomplete medical records, documentation for at least four of these inmates demonstrated potential violations of informed consent requirements.
2 The true number of inmates for whom Corrections or the Receiver's Office did not ensure that lawful consent was obtained before sterilization may be higher. For example, one hospital destroyed seven inmate medical records in accordance with its records retention policy. Five of these seven inmates consented to the sterilization procedure while in prison, and it is unclear—based on available records—whether physicians signed the sterilization consent forms just prior to surgery.