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ST CHARLES MADRAS 470 NE A STREET MADRAS, OR 97741 Dec. 11, 2015
VIOLATION: PATIENT CARE POLICIES Tag No: C0271
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview, documentation reviewed in the medical record of a patient who presented to the ED with a complaint of sexual abuse (Patient 2), documentation of personnel records for 3 of 3 contract radiology techs reviewed (Employees 1, 2 and 3), and review of CAH policies, procedures and other documentation, it was determined that the CAH failed to ensure its policies and procedures were clear, fully developed and implemented as follows:
* CAH policies and procedures were not fully developed and implemented to ensure a timely and thorough investigation was conducted and documented for an allegation of sexual abuse for Patient 2.
* CAH policies and procedures were not implemented to ensure Patient 2, who submitted a complaint related to sexual abuse, was provided a written response.
* CAH policies and procedures were not clear, fully developed and implemented to ensure criminal background checks and other background checks were conducted on CAH employees, including contract employees.

Findings included:

1. The medical record of Patient 1 was reviewed. The record reflected the patient was admitted on [DATE] at 1406 for outpatient radiology services. The record contained a MRI report for the patient dated 10/09/2015. The report reflected the patient had a brain MRI and the indication for the procedure was "Facial weakness." The record reflected the patient was discharged on [DATE] and the "Discharge Status" was recorded "Routine Discharge." The record contained a "MRI Patient Screening Form-Part A" that was signed but not dated or timed by the patient. The "Reason for Exam/Clinical Symptoms:" section on the form was not completed and was blank. The "Technologist Comments" section was followed by an illegible entry. The "Technologist's Signature:" section was followed by Employee 1's signature and was dated "10/9/15" but was not timed. There was no information in the record related to the time the patient was discharged from the outpatient department and no information reflecting how the patient tolerated the MRI procedure.

During an interview with the Radiology Manager on 12/10/2015 at 1350, he/she stated Employee 1, a contract MRI tech, was the individual who performed Patient 1's MRI on 10/09/2015.

2. The ED record of Patient 2, who was the same patient (Patient 1) who had an MRI on 10/09/2015 in finding #1 above, was reviewed. The record reflected the patient (MDS) dated [DATE] at 1547 with a chief complaint of "[SANE] Exam."

The physician notes dated 10/09/2015 at 1703 reflected "...[patient] presents with possible sexual assault from an MRI technician...When [patient] arrived for [his/her] MRI, [patient] was placed on the table and told by the MRI tech that there was something wrong with [patient's] kidneys and [he/she] needed to manually evaluate [patient] with [his/her] finger. [Patient] stated [he/she] aggressively put [his/her] finger into [patient's] vagina and vaginally raped [patient]. [Patient] continuously refers to actions as happening to 'us'. [Patient] left the MRI room and then reported that the MRI tech 'raped us'. [Patient] states the technician showed [patient] [his/her] genitalia but did not use [his/her] penis for the assault. [Patient] denies other injury...[Patient] also endorses seeing a little [boy/girl] leaving the trailer and looking rattled and saying 'it hurts' while leaving...Patient initially told nursing that [he/she] did not want police involved. However, given concern for a minor being involved in the situation, I informed [patient] that I was obligated to report to the police."

The RN notes recorded at 1734 reflected "...[Patient] reports involvement of child as previously reported. [Police department] called." The record reflected the patient was transferred to another hospital for a SANE examination on 10/09/2015 at 2015.

A packet of documents was provided by the Risk Manager concerning Patient 2's 10/09/2015 allegation of sexual abuse. The Risk Manager stated the packet was the CAH's investigation of the allegation. The packet was reviewed and contained the following:
* A document titled "Event Summary with All Tasks." The summary reflected it was completed by quality and other CAH management individuals. It reflected "...Occurred on [DATE] 2:47PM in Radiology (Diagnostic) - Madras...Reported...on 10/13/2015 at 14:27...Description: Patient alleges [he/she] was raped by the MRI tech..." The summary contained no documentation of an investigation.
* A one page document titled "Human Resources Summary" that indicated it was prepared by the Director of Ancillary & Support Services. It reflected "Date: October 9, 2015...Facts: Patient alleges [he/she] was raped in the MRI...The MRI was performed by [Employee 1]..." The summary reflected interviews were conducted with 2 CAH individuals. However, there was no documentation to reflect when the interviews or the summary were conducted.
* Email communications between CAH quality and other CAH management individuals dated 10/13/2015, 10/14/2015 and 11/05/2015. The emails were primarily related to notification of various agencies and individuals of the patient's allegation and actions that still needed to be taken. For example, an email dated 10/13/2015 at 1436 from a CAH quality individual reflected "Actions we still need to take...Identify and interview all caregivers that would have seen and/or spoken with the complainant before and after the alleged event...Create a time line or chronology of the above interactions...Review policies/procedures for what we might do differently to reduce/eliminate this type of event/allegation in the future...Stay in the loop with the police investigation." However, during an interview on 12/11/2015 at 1400 the Risk Manager stated the CAH had no timeline or chronology of the incident, review of policies and procedures or other documentation or investigation related to Patient 2's allegation of sexual abuse.

The policy and procedure titled "Serious Adverse Events-Sentinel Events_Reportable Events and Root Cause Analysis (RCA)" with an effective date of 01/02/2015 was reviewed. The "Policy Statement/Purpose" section of the policy reflected "...in the event of any serious adverse event, sentinel event or reportable event occurring...a thorough and credible investigation will be taken to discover the systems and processes underlying the apparent cause of the event, and to identify the system and/or process changes that will reduce the likelihood of a similar event occurring in the future." The "Definitions" section of the policy reflected "...A sentinel event is any occurrence that meets any of the following criteria...Rape...Such events are called 'sentinel' because they signal the need for immediate investigation and response...In indeterminate cases, the event will be presumed reviewable and the prescribed procedures and time frames will apply without delays..." The policy reflected "...rape is defined as unconsented sexual contact involving a patient and another patient, staff member, or other perpetrator while being treated on the premises of the hospital. It includes oral, vaginal, or anal penetration or fondling of the patient's sex organ(s) by another individual's hand, sex organ, or object. One or more of the following must be present to determine reviewability under this work instruction...Any staff-witnessed sexual contact as described above...Sufficient clinical evidence obtained by the hospital to support allegations of unconsented sexual contact...Admission by the perpetrator that sexual contact...occurred on the premises." The "Instructions" section of the policy reflected "In the event that a patient incident occurs that is thought to lead to a serious physical or psychological injury, major permanent loss of function or death or risk thereof the...Caregiver identifying incident will...Notify the following immediately...on-duty charge RN for the affected department...the House Supervisor...the Director and/or Manager...Complete appropriate report online within the Event Management System (EMS), including all available pertinent information relating to the event...DO NOT remove equipment and other items involved in the event from the patient or the room...House Supervisor or Director/Manager will...Verbally notify the SCHS Risk Manager (sic) Clinical Risk Manager immediately. The Risk Manager will evaluate the need to respond to the hospital to immediately begin an investigation, and the need to sequester equipment...Verbally notify the Chief Nursing Officer (CNO) immediately, but no later than 24 hours after the event...Verbally notify the Duty Administrator immediately, but no later than 24 hours after the event...As directed by Risk Manager, double bag disposables and label with patient name and medical record number. Take to SCHS Risk Manager...If requested by Risk Manager, assist the caregiver involved in the event with a written chronological sequence of the event happenings...Duty Administrator will...Verbally notify SCHS CEO immediately or as soon as possible...Verbally notify the hospital CEO immediately or as soon as possible...SCHS-Clinical Risk Management will...Ensure there is not an ongoing potential safety problem...Determine the need to sequester items...Assess need for immediate discussion /response to the patient...Convene an ad hoc group for decision-making as appropriate...Facilitate investigation of the event, including determining the timeline, sequence of events, involved caregivers and physicians...Prepare a credible root cause analysis (RCA) and action plan within 45 calendar days of the event or of becoming aware of the event...Prepare an action plan...Track action plan to resolution...VP of Quality or VP Legal/Risk, or designee will...Convene the leadership group to develop immediate investigation plan and action plan...CEO will...Report event/incident to the System President/CEO and to the SCHS Board of Trustees as directed...Root Cause Analysis (RCA)...A root cause analysis will be facilitated by the SCHS Clinical Risk Management team or designee..."

An interview was conducted with the Risk Manager on 12/11/2015 at 1500. The Risk Manager stated that the allegation of sexual abuse reported by Patient 2 should have been managed as a sentinel event in accordance with the policy and procedure above. The Risk Manager reviewed the policy and procedure and acknowledged it was not fully developed as it did not clearly address all allegations of "rape" such as circumstances whereby the allegation was not staff-witnessed and/or there was no clinical evidence or admission by the perpetrator. During the interview the Risk Manager acknowledged that many of the steps in the CAH's policy and procedure were not documented and carried out as they should have been including but not limited to the following: Ensuring equipment and other patient items were not removed from the patient's care environment, immediate notification of the Risk Manger in order to evaluate the need to respond and begin an investigation/sequester equipment, verbally notify the CNO immediately but no later than 24 hours after the event, facilitate an investigation including determining a timeline, develop an immediate investigation and action plan, and prepare a thorough and credible RCA and action plan. In addition, the Risk Manager stated the hospital had no investigation or other documentation related to Patient 2's reported "concern for a minor being involved in the situation" that was reflected in the patient's 10/09/2015 ED record above.

3. The policy and procedure titled "Patient (Patient Representative) Complaint-Grievance Resolution Process" with an effective date of 04/01/2015 was reviewed. The "Definitions" section reflected "...Grievance...A verbal complaint not promptly resolved by the caregiver(s) present, or a written complaint from a patient/representative regarding care or services provided by SCHS, including alleged neglect or abuse." The "Instructions" section reflected "For the resolution of all SCHS patient/patient representative grievances...Receiver of the complaint...document the unresolved grievance in the Complaint section of the Event Management System (EMS)...Manager or Designee...Investigates the documented grievance within seven days of receiving the EMS Management Investigation Task...Documents the investigation outcome in the EMS Management Investigation report...Responds to the patient/patient representative in writing within seven days of receiving the EMS Management Investigation Task...If the grievance is not yet resolved, respond to the complainant using the form template letter...The written response must minimally include...An explanation of the ongoing process involved to resolve the grievance...Anticipated date of next written response from the hospital."

During an interview on 12/10/2015 at 1325 the Risk Manager acknowledged the CAH did not investigate and provide a written response to Patient 2 in relation to his/her reported allegation of sexual abuse in accordance with the CAH's grievance policy and procedure.

4. During an interview with the CEO on 12/10/2015 at 1220, he/she stated the CAH had a contract with "Alliance" for the provision of patient MRI services. The CEO stated the contract included a mobile MRI unit and MRI techs who provided MRI procedures at the CAH.

A "MRI Master Services Agreement" was reviewed. It was signed but not dated by the CAH CFO and signed and dated by an individual of "Alliance Healthcare Services, Inc. d/b/a Alliance Imaging" on 07/26/2011. The agreement required that the services to be provided included "...Alliance shall provide a MRI system [the "Unit"]...Alliances shall provide the services of technical personnel to operate the Unit...Alliance will provide to Client in writing upon request...A letter from Alliance's Vice President of Human Resources or designee attesting that criminal background checks have been performed for each of Alliance technical personnel who provide services on the Unit and that such personnel meet requirements to be employed by Alliance. Alliance shall not be obligated to provide any background check report...for any of Alliance's technical personnel...not disclose (directly or indirectly, in whole or in part) the Confidential Personnel Information to any third-party except with the prior written consent of Alliance or when and if properly disclosed in connection with...federal and state compliance surveys, audits, reviews and record requests..."

Personnel records for Employee 2 were reviewed. The records reflected the employee was an MRI tech and was a contract employee. An undated document titled "Third Party Access Request Form" was reviewed and reflected "Date Contractor will start work: 10/15/15" and "Date Contractor will stop work...12/31/15". The records contained no criminal background check. The records contained OIG and SAM background check reports and reflected they were both completed on 10/19/2015 which was after the 10/15/2015 start date. Both the OIG and SAM reports had a handwritten line written through the entire report and there was no documentation to identify the individual who wrote over the reports, the date the reports were written over, and the reason the reports were written over. This was confirmed during an interview with the Director of Ancillary & Support Services on 12/11/2015 at 0930. The Director of Ancillary & Support Services acknowledged the results of the reports were unclear.

Personnel records for Employee 1 were reviewed. The records reflected the employee was a MRI tech and was a contract employee. A document titled "Non-SCHS Personnel Access Request" reflected the employee's start date was 07/01/2011 and reflected the employee's contract term was for 5 years and expired on [DATE]. An undated document titled "Third Party Access Request Form" was also reviewed and reflected "Date contractor will start work: Already started" and "Date contractor will stop work: (1 year maximum)...10/02/16." There was no other documentation to reflect the employee's contract start and end date. The records included a criminal background and other background checks with "Order Date: 11/19/2009" and a last "Complete" date of 11/24/2009, 20 months prior to the employee's recorded start date. The background records included unclear information related to offenses and violations and there was no other information in the records to describe the offenses and violations. The records also contained OIG and EPLS background check reports that reflected they were completed on 08/05/2011 and 08/10/2011 respectively, which was after the employee's 07/01/2011 start date. These findings were confirmed during an interview with the Human Resources Operations and Information Manager on 12/11/2015 at 1200.

Personnel records for Employee 3 were reviewed. The records reflected the employee was an MRI tech and was a contract employee. A "SC Medical Staff Services Practitioner Identification Notification & Information Management Systems Access Form" reflected "Estimated Start Date: 10/03/2014." The area on the form that reflected "Start Date:" and "End Date:" were not completed and were blank. There was no information on the form reflecting the employee's start date and contract end date. The records contained OIG and SAM background check reports and reflected they were both completed on 11/25/2015 which was more than a year after the employee's "estimated start date."

During an interview with the Director of Ancillary & Support Services on 12/11/2015 at 1055, he/she provided a 4 page document titled "TRAK-1" report summary. He/she stated the document was a criminal background check for Employee 3. Page 1 of the summary reflected only "Report Summary: SSN Trak Complete 9/18/2014...FACIS Level 3 Complete 9/18/2014...Broadway Verify Clear 9/18/2014..." and contained no details or additional information. Pages 2 and 3 of the report appeared overexposed and were illegible. Page 4 of the report reflected only "SSN Trak" information. The record contained another criminal background check that reflected it was completed on 11/18/2015 which was more than a year after the employee's "estimated start date" of 10/03/2014.

A policy and procedure titled "Employment" with an effective date 06/26/2014 was reviewed and reflected "...Employment of all caregivers shall be coordinated through the Human Resources Recruiting Department. Under no circumstances will a Director/Manager/Supervisor offer, hire or employ caregivers who have not been properly processed by the recruiting department...All job offers are contingent upon successful completion of the pre-employment eligibility requirements..." The policy contained no information reflecting the stated process that a national criminal background check, OIG and SAM be conducted on all employees prior to employment. This was confirmed during an interview with the Director of Ancillary & Support Services on 12/10/2015 at 1510.

An undated document provided titled "Code of Ethics and Standards of Conduct" Ref # 970. Ver. 1, was reviewed and reflected "SCHS will exercise due care not to delegate substantial discretionary authority to individuals whom the organization knew, or should have known through exercise of due diligence, had a propensity to engage in illegal activities. This will be accomplished by conducting background checks on new hires..." The document contained no specific information related to what type of background checks were to be conducted, when the background checks were to be conducted with respect to when the employee started work, and included no information specific to contract employees. This was confirmed during an interview with the Director of Ancillary & Support Services on 12/11/2015 at 1045.

A document titled "Instructions for Third Party Onboarding (Software and Badge Access) dated "2014" was provided by the Human Resources Operations and Information Manager. During an interview with the Human Resources Operations and Information Manager on 12/11/2015 at 1145, he/she stated the document was the CAH's process for conducting OIG and SAM background checks on contract staff. It was reviewed and contained no information identifying who the author of the document was. The document was primarily related to granting "badge and software access" to "third party vendors" and reflected "...HR runs web based background checks...[OIG] Officer of Inspector General (Medicare check)...[SAM] System for Awards Management (Lien check)...HR scans documentation into [computer]...into appropriate year..." The document was unclear related to when the OIG and SAM background checks were to be completed in relation to when the individual started work, and contained no information related to criminal background checks.

During an interview on 12/11/2015 beginning at approximately 0900 the Director of Ancillary & Support Services stated the CAH was responsible to ensure a national criminal background check, SAM (or EPLS) and OIG was conducted on all CAH employees, including contract employees, prior to the individual beginning work. He/she stated that for contract employees, the hospital relied on the contractor to conduct the criminal background checks and stated the hospital had no process for verifying they were done before the individual started work. During the interview, the Director of Ancillary & Support Services acknowledged the CAH lacked clear policies and procedures reflecting the type of background checks that were to be conducted for CAH employees, when the background checks should be performed, including background checks for contract employees.














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