Report 2013-120 All Recommendation Responses

Report 2013-120: Sterilization of Female Inmates: Some Inmates Were Sterilized Unlawfully, and Safeguards Designed to Limit Occurrences of the Procedure Failed (Release Date: June 2014)

Recommendation #1 To: Correctional Health Care Services, California

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.

60-Day Agency Response

Proposed Action Plan:

Referrals are to be made to the California Department of Public Health and the Medical Board of California as requested by the California State Auditor.

Status/Comments:

Initial referral letters were sent to the California Department of Public Health (CDPH) and the Medical Board of California (MBC) on June 18, 2014. The supporting documents for the referral were sent to CDPH and MBC on July 2 and 3, 2014 respectively. Both CDPH and MBC have confirmed the receipt of the supporting documents.

California State Auditor's Assessment of 60-Day Status: Fully Implemented

Recommendation #2 To: Correctional Health Care Services, California

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 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.

1-Year Agency Response

The Utilization Management (UM) program conducted a webinar training for all schedulers on September 8, 2014 and September 15, 2014, titled "Sterilization of Female Inmates" and covered Gynecological Procedure Checklist / Sterilization Procedures.

In December 2014, a representative of the Receiver's Office of Legal Affairs presented webinar training to medical staff with the primary goal to ensure adherence to the informed consent requirements of Title 22, Sections 70707.1 through 70707.7. Attendees included statewide clinical staff and California Correctional Health Care Services' (CCHCS) headquarter staff. The training emphasized the requirements for obtaining informed consent for sterilization procedures and the correct documentation required to support how and when the informed consent process took place. CCHCS intends to provide periodic training.

To ensure that consent is obtained and is proper, the UM program, which oversees and monitors the delivery of network health care services for all institutions have implemented procedures and processes to monitor and track every referral that has potential for sterilization. Upon approval of the procedure, the institution clinical staff has been advised of protocol that requires the operating surgeon complete the Gynecologic Procedures Checklist and send to UM. UM then issues an approval letter to the institution. UM maintains a spreadsheet to monitor adherence to informed consent requirements. (See Attachment #1)

California State Auditor's Assessment of 1-Year Status: Fully Implemented

6-Month Agency Response

A representative of the Receiver's Office of Legal Affairs presented a webinar related to the subject of informed consent and informed consent for sterilization procedures. Attendees included clinical staff from California Institution for Women and the Central California Women's Facility. (See Attachments #1)

California State Auditor's Assessment of 6-Month Status: Partially Implemented

The Receiver's Office did not substantiate its claim of full implementation. The Receiver's Office provided a one-time training which does not fully implement the recommendation. Although providing training about Title 22 is likely beneficial to prison medical staff, the recommendation calls for the Receiver's Office to establish a process to better monitor adherence to informed consent requirements which includes training. Moreover, despite the Receiver's Office directing prison medical staff to ensure that community hospital staff obtain consent for sterilization, prison medical staff are still required to ensure that consent is obtained and is proper. In our opinion, it is reasonable for prison staff to require and receive periodic training to ensure they perform their role effectively,

60-Day Agency Response

Proposed Action Plan:

Provide additional training to prison medical staff regarding Title 22 requirements for obtaining informed consent.

Status/Comments:

A PowerPoint presentation for training has been drafted and is currently under review on the subject of informed consent.

California State Auditor's Assessment of 60-Day Status: Partially Implemented

Recommendation #3 To: Correctional Health Care Services, California

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 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.

6-Month Agency Response

The Medical Services, Utilization Management Program (UM) developed a checklist and training tool as well as issued a memorandum to all medical staff dated September 12, 2014, to ensure medical sterilization procedures are scheduled at least 30 days after and no more than 180 days of consent. Additionally, the UM conducted webinar training for all schedulers on September 8th and 15th titled "Sterilization of Female Inmates" and covered Gynecological Procedure Checklist/Sterilization Procedures. (See Attachments #2, #3 and #4)

California State Auditor's Assessment of 6-Month Status: Fully Implemented

60-Day Agency Response

Proposed Action Plan:

Develop checklist/procedures and training for the institution schedulers.

Status/Comments:

The Gynecological Procedure Checklist/Sterilization Procedures are being developed and will be disseminated to the institution schedulers. The schedulers will complete the checklist before scheduling sterilization procedures. Training will begin October 2014.

California State Auditor's Assessment of 60-Day Status: Partially Implemented

Recommendation #4 To: Correctional Health Care Services, California

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 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.

6-Month Agency Response

Utilization Management (UM), as part of its committee approval process is conducting prospective reviews to assure proper consent is obtained for all cases where sterilization may occur.

A monthly audit is conducted to assure that all claims with applicable CPT codes are flagged by CCHCS' Third Party Administrator and sent to UM for retrospective review. This review of claims is to verify that approved procedures were performed after at least 30 days and no greater than 180 days from the date the informed consent was signed, consent was signed by operating surgeon/provider and the proper reviews and approvals were given. (See Attachment #5)

*It should be noted that since July 2014 the above review process has been ongoing.

California State Auditor's Assessment of 6-Month Status: Fully Implemented

60-Day Agency Response

Proposed Action Plan:

Identify and flag Current Procedural Terminology codes that are for services that may directly or indirectly result in sterilization.

Status/Comments:

The Healthcare Invoice, Data and Provider Services Branch has flagged cases from paid claims with all Current Procedural Terminology (CPT) codes that are for services that may directly or indirectly result in sterilization. These cases are then referred to the Utilization Management for review.

California State Auditor's Assessment of 60-Day Status: Partially Implemented

This recommendation is focused on the Receiver's Office periodically ensuring that all informed consent requirements are satisfied. However, the Receiver's Office did not provide evidence demonstrating what its Utilization Management review consists of and that the review addresses the required elements of informed consent.

Recommendation #5 To: Correctional Health Care Services, California

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 working with Corrections to establish a process whereby inmates can have witnesses of their choice when consenting to sterilization, as required by Title 22, or working to revise such requirements so that there is an appropriate balance between the need for secure custody and the inmate's ability to have a witness of her choice.

Annual Follow-Up Agency Response From November 2019

CSA's position is that it is the Receiver's Office responsibility to ensure that informed consent requirements are followed, even though CCHCS does not perform the sterilization procedures. Part of the informed consent process requires that a patient must be given an opportunity to have a witness of choice. CSA stated in their report that a lack of physician signatures on informed consent forms and waiting period violations were compounded because inmates had little or no opportunity to have a witness of their choice present when they signed the sterilization consent form while in prison. It is CCHCS' position that specific provision of Title 22 do not apply to prison employees because Title 22 applies to general acute care hospitals. Specialty services, such as sterilization procedures, are performed by outside surgeons and informed consent is obtained consistent with that surgeon's hospital processes. Although it is not feasible for inmates to have a witness of choice in a correctional setting due to safety and security concerns, CCHCS has implemented a reauthorization process through its electronic health records system that requires headquarters approval for procedures that could result in fertility loss. This process, in part, helps ensure that informed consent forms have required signatures, waiting period requirements are met, and the procedure is clinically necessary. This preauthorization process helps address, in part, CSA's concerns (see Recommendation 11). CCHCS Status "Resolved" as of 10/31/19.

California State Auditor's Assessment of Annual Follow-Up Status: Will Not Implement

Title 22 is very clear in stating that an individual has given informed consent to sterilization "only if" certain requirements are met. One of these requirements is being permitted to have a witness of the patient's choice present when consent is obtained. Having the patient's choice of a witness present serves as a safeguard to help ensure that the patient understands the procedure and truly desires to be permanently sterilized. A witness also helps protect the State from allegations that the inmate was coerced into her decision to be sterilized. Since 2014 the Receiver's Office has expressed that it will not implement this recommendation. However, it has offered no information to suggest that it has arranged for female inmates to have a witness of their choice either in the correctional facility or at the hospital, depending on where consent is obtained. The Receiver's Office has also not specified that it is working to revise the Title 22 requirements for witnesses in a correctional setting. Further, the Receiver's Office's response that it has changed its internal administrative process does not ensure inmates can have witnesses of their choice when consenting to sterilization, as required by Title 22. Accordingly, we stand by our recommendation and conclude that the Receiver's Office will not implement it.

Annual Follow-Up Agency Response From November 2018

The response remains "will not implement."

California State Auditor's Assessment of Annual Follow-Up Status: Will Not Implement

Title 22 is very clear in stating that an individual has given informed consent to sterilization "only if" certain requirements are met. One of these requirements is being permitted to have a witness of the patient's choice present when consent is obtained. Having the patient's choice of a witness present serves as a safeguard to help ensure that the patient understands the procedure and truly desires to be permanently sterilized. A witness also helps protect the State from allegations that the inmate was coerced into her decision to be sterilized. The Receiver's Office offered no information to suggest that it was working to revise the Title 22 requirements for witnesses in a correctional setting. We stand by our recommendations. The Receiver's Office response that it cannot comply with existing law, without noting its next steps, is not a complete response to our recommendation.

1-Year Agency Response

The California Department of Corrections and Rehabilitation and California Correctional Health Care Services have concluded that compliance within a correctional setting is not feasible.

California State Auditor's Assessment of 1-Year Status: Will Not Implement

Title 22 is very clear in stating that an individual has given informed consent to sterilization "only if" certain requirements are met. One of these requirements is being permitted to have a witness of the patient's choice present when consent is obtained. Having the patient's choice of a witness present serves as a safeguard to help ensure that the patient understands the procedure and truly desires to be permanently sterilized. A witness also helps protect the State from allegations that the inmate was coerced into her decision to be sterilized. The Receiver's Office offered no information to suggest that it was working to revise the Title 22 requirements for witnesses in a correctional setting. We stand by our recommendations. The Receiver's Office response that it cannot comply with existing law, without noting its next steps, is not a complete response to our recommendation.

6-Month Agency Response

CDCR and CCHCS will continue to explore the extent to which partial compliance may be feasible and under what circumstances.

California State Auditor's Assessment of 6-Month Status: Will Not Implement

Under Title 22, the provision of a witness is required for lawful consent for procedures where the purpose of sterilization is to render the patient incapable of reproduction.

60-Day Agency Response

Proposed Action Plan:

Discussion regarding this recommendation with CDCR is ongoing.

Status/Comments:

A meeting with CDCR was held on July 22, 2014 to discuss with establishment of the process. CDCR and CCHCS have discussed the interplay of the statutory requirements and the difficulties in full compliance in a correctional setting. We will continue to explore the extent to which partial compliance may be feasible and under what circumstances.

California State Auditor's Assessment of 60-Day Status: Pending

Recommendation #6 To: Correctional Health Care Services, California

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 inmates consent.

6-Month Agency Response

On September 12, 2014, a memorandum was sent to all medical staff working in CDCR institutions directing them to defer the consent process to the community hospital. The memorandum further directs institutions to request the community hospital surgeon who will be performing the procedure personally obtain consent from the patient. (See Attachment #3)

California State Auditor's Assessment of 6-Month Status: Fully Implemented

60-Day Agency Response

Proposed Action Plan:

Develop a memorandum to instruct all medical staff to discontinue the practice of facilitating inmate's consent for sterilization and defer to the community hospital.

Status/Comments:

A memorandum is being drafted and once approved will be sent to all medical staff working in CDCR institutions to discontinue the practice of facilitating inmate's consent for sterilization and deferring the consent process to the community general acute care hospital.

California State Auditor's Assessment of 60-Day Status: Pending

Recommendation #7 To: Correctional Health Care Services, California

To improve the quality of the information prison medical staff document in inmate medical records, the Receiver's Office should train its entire 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.

1-Year Agency Response

The Utilization Management (UM) Program conducted a webinar training for all schedulers on September 8, 2014 and September 15, 2014, titled "Sterilization of Female Inmates" and covered Gynecological Procedure Checklist/Sterilization Procedures.

In December 2014, a representative of the Receiver's Office of Legal Affairs presented webinar training to medical staff with the primary goal to ensure adherence to the informed consent requirements of Title 22, Sections 70707.1 through 70707.7. Attendees included statewide clinical staff and California Correctional Health Care Services' (CCHCS) headquarter staff. The training emphasized the requirements for obtaining informed consent for sterilization procedures and provided a practical guide for correctly and comprehensively documenting consultation provided to the patient regarding any potential risk and alternatives to support how and when the informed consent process took place. CCHCS intends to provide periodic training.

California State Auditor's Assessment of 1-Year Status: Fully Implemented

6-Month Agency Response

Medical Services will develop a Continuing Medical Education activity that will address clinical documentation and informed consent. The training will be provided to all medical staff regarding comprehensive documentation about consultation provided to the inmate regarding any potential procedure and its risk and alternatives.

California State Auditor's Assessment of 6-Month Status: Pending

60-Day Agency Response

Proposed Action Plan:

Create a training for all medical staff on clinical documentation and informed consent.

Status/Comments:

Medical Services will develop a Continuing Medical Education activity that will address clinical documentation and informed consent. The training will be provided to all medical staff.

California State Auditor's Assessment of 60-Day Status: Pending

Recommendation #8 To: Correctional Health Care Services, California

To improve the quality of the information prison medical staff document in inmate medical records, the Receiver's Office should either develop or incorporate into an existing process a means by which it evaluates prison medical staffs' documentation in inmates' medical records and retrains medical staff as necessary. The Receiver's Office should develop and implement this process by June 30, 2015.

60-Day Agency Response

Proposed Action Plan:

Review current policies and procedures and make any necessary changes.

Status/Comments:

Medical Services currently has existing policies and processes to systematically evaluate medical staff for professional competency which includes clinical documentation and performance improvement plans, if necessary. [Please refer to Inmate Medical Services Policies and Procedures Volume 3, Chapter 4A - Primary Care Provider Mentoring - Proctoring Program and Clinical Performance Appraisal Process Policy; Chapter 4B - Primary Care Provider Mentoring - Proctoring Program and Clinical Performance Appraisal Process Procedure.]

California State Auditor's Assessment of 60-Day Status: Fully Implemented

Recommendation #9 To: Correctional Health Care Services, California

To ensure that inmates receive only medical services that are authorized through its utilization management process, the Receiver's Office should 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.

60-Day Agency Response

Proposed Action Plan:

Create additional InterQual custom criteria to ensure that a procedure that may result in sterilization is not scheduled without proper approval.

Status/Comments:

InterQual custom criteria were created. Notification within each criteria subset that requires secondary, Institution Utilization Management Committee and Headquarters Utilization Management Committee reviews are established.

California State Auditor's Assessment of 60-Day Status: Fully Implemented

Recommendation #10 To: Correctional Health Care Services, California

To ensure that inmates receive only medical services that are authorized through its utilization management process, the Receiver's Office should 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.

6-Month Agency Response

The Utilization Management Program conducted a webinar training for all schedulers on September 8th and 15th titled "Sterilization of Female Inmates" and covered Gynecological Procedure Checklist / Sterilization Procedures. This training included a discussion on the requirement of obtaining Headquarter Utilization Management Committee determination approval, prior to scheduling. (See Attachment #2). The training will continue to be provided on annual basis.

California State Auditor's Assessment of 6-Month Status: Fully Implemented

60-Day Agency Response

Proposed Action Plan:

Provide training no later than October 31st and annually thereafter.

Status/Comments:

Training will commence no later than October 31, 2014 and be held annually, at the time of the InterQual in-service for all established and new employees in Utilization Management and Scheduling.

California State Auditor's Assessment of 60-Day Status: Pending

Recommendation #11 To: Correctional Health Care Services, California

To ensure that inmates receive only medical services that are authorized through its utilization management process, the Receiver's Office should ensure that the computer system it procures includes functionality to electronically link medical scheduling with authorization through the utilization management process to prevent all unauthorized procedures, regardless of whether they may result in sterilization, from being scheduled.

Annual Follow-Up Agency Response From October 2019

The California Correctional Health Care Services (CCHCS) has implemented a mechanism to electronically link medical scheduling with authorization through the utilization management process to prevent all unauthorized procedures that may result in sterilization. The health care provider cannot refer a patient directly to an outside entity for procedures that would lead to loss of fertility. The electronic health record system routes requests for these types of high risk procedures through a utilization management process for secondary review and then ultimately by a CCHCS headquarters review committee.

California State Auditor's Assessment of Annual Follow-Up Status: Fully Implemented

Annual Follow-Up Agency Response From November 2018

The response remains unchanged from last year: The California Correctional Health Care Services (CCHCS) has implemented tracking mechanisms to identify patients who need procedures that may result in sterilization. In addition, a monthly review of the claims payment system has shown that each relevant case has been reviewed and approved by Utilization Management Staff. These processes have proved effective. Further, the statewide rollout of the Electronic Health Records System (EHRS) was completed in October 2017. To supplement existing safeguards, CCHCS will leverage the functionality of the EHRS to identify these patients, rather than procure a separate new system. CCHCS is pursuing a change order to be added to the existing EHRS enhancement queue and should have a solution by the end of 2019.

California State Auditor's Assessment of Annual Follow-Up Status: Pending

Annual Follow-Up Agency Response From November 2017

The California Correctional Health Care Services (CCHCS) has implemented tracking mechanisms to identify patients who need procedures that may result in sterilization. In addition, a monthly review of the claims payment system has shown that each relevant case has been reviewed and approved by Utilization Management Staff. These processes have proved effective. Further, the statewide rollout of the Electronic Health Records System (EHRS) was completed in October 2017. To supplement existing safeguards, CCHCS will leverage the functionality of the EHRS to identify these patients, rather than procure a separate new system. CCHCS is pursuing a change order to be added to the existing EHRS enhancement queue and should have a solution by the end of 2019.

California State Auditor's Assessment of Annual Follow-Up Status: Pending

Annual Follow-Up Agency Response From October 2016

The California Correctional Health Care Services (CCHCS) entered into a contract with Health Net Federal Services (HNFS) in October 2014 to procure an electronic Prior Authorization System. This system was due to be implemented no later than August 2015. After numerous attempts to deploy the system, it remained unstable and ultimately unusable. CCHCS did not reimburse HNFS for this failed application and intends to revisit procuring a system after the statewide rollout of the Electronic Health Records System (EHRS). Staff are researching a possible flag in the EHRS system to identify these cases on a real time basis. In the meantime, all non-emergent referrals for services that may result in sterilization are reviewed by the Headquarters Utilization Management Committee monthly. Additionally, provider claims and the Interqual decision support tool are reviewed to ensure no referral has bypassed the process.

California State Auditor's Assessment of Annual Follow-Up Status: Not Fully Implemented

Annual Follow-Up Agency Response From October 2015

California Correctional Health Care Services procured an electronic prior authorization system, which is on schedule to be fully implemented and operational by December 2015. This system will require that all procedures that may directly or indirectly result in sterilization be authorized by the Utilization Management executives.

California State Auditor's Assessment of Annual Follow-Up Status: Not Fully Implemented

1-Year Agency Response

California Correctional Health Care Services procured an electronic prior authorization system, which should be fully implemented and operational in December 2015, to allow staff access and link medical scheduling, in real time, with authorization through the utilization process.

California State Auditor's Assessment of 1-Year Status: Pending

6-Month Agency Response

On November 3, 2014, the contract was awarded and Utilization Management is currently working with the contractor in constructing a system that has the capacity to flag procedures requiring authorization and preventing them from being scheduled, regardless of whether the procedure results in sterilization.

California State Auditor's Assessment of 6-Month Status: Pending

60-Day Agency Response

Proposed Action Plan:

Procure an electronic prior authorization system.

Status/Comments:

California Correctional Health Care Services is in the process of procuring an electronic prior authorization system which should be fully implemented one year after the contract is awarded. This system will require that all procedures that may directly or indirectly result in sterilization be authorized by the Utilization Management executives.

California State Auditor's Assessment of 60-Day Status: Pending

All Recommendations in 2013-120

Agency responses received are posted verbatim.