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Based on documentation and interview, it was determined that the hospital failed to promote and protect the rights of 2 of 5 patients (P30 and P28) reviewed who had physical/chemical restraints used to manage their behaviors.

Findings include:

The hospital did not meet the Condition of Participation of Patient Rights at 42 CFR 482.13. The cumulative effect of this system failure resulted in the hospital's inability to ensure patient rights were protected and promoted.

Based on documentation and interview, the hospital failed to ensure that 1 of 5 patients (P30) received medications to manage her behaviors in accordance with Court Orders. Refer to A-0131.

Based on documentation and interview, the hospital failed to ensure residents were free from restraints not required to treat medical symptoms for 1 of 1 patient (P28) reviewed. Refer to A-0154.

Based on interview and record review, the hospital failed to ensure a patient, or representative, had the right to participate in the provision of treatment for 1 of 30 patients reviewed (P30) who required psychiatric medication use.

The findings include:

P30 was admitted to the hospital on 9/23/15, with diagnoses including chronic schizoaffective disorder and bipolar disorder.

A psychiatric progress note from 9/30/15, indicated P30 had exhibited increasing agitated behaviors that morning: "...She had come out of her room entirely naked and was screaming and yelling. She was then partially covered with a sheet. She did argue and rant at this writer. She refused redirection...She did accept guidance to the seclusion room and took 20 mg [milligrams] of Zyprexa [an antipsychotic medication] orally....I met with her about 12:15 [p.m.] in the common area. She was sitting by the phone and was yelling and again making religious statements and wanted alcohol. She threatened this writer with physical harm. Despite multiple staff interventions to verbally calm her, she just got more agitated. I indicated she would be getting Haldol IM [intramuscular]." The notes further indicated the patient received Haldol 10 mg, Benadryl 50 mg, and Ativan 2 mg intramuscularly at 12:25 p.m.

The Physician Order indicated Haldol 5 mg orally (po) twice a day (BID) had been prescribed for P30 on 10/2/15, at 1:59 p.m., due to the patient's refusal to accept treatment for "significant hypothermia." Review of the medication administration records revealed P30 received oral Haldol 5 mg on 10/2/15 at 8:21 p.m., on 10/3/15 at 8:58 a.m. and 8:49 p.m., 10/4/15 at 8:29 a.m. and 7:09 p.m., and on 10/5/15 at 8:59 a.m.

Additional review of P30's record revealed a notice from the District Court Judge, to the hospital, dated 10/5/15 which indicated: "HALDOL AND RISPERDAL REMAIN EXCLUDED AND SHALL NOT BE ADMINISTERED. Continued administration of those medications is in violation of this Court's Order. Failure to comply will result in an Order to Show Cause and a hearing as to whether this Court should find the prescribing/administering physician in contempt or violation of this Court's Order..." Subsequently, P30's record revealed a discontinuation order dated 10/5/15, at 12:20 p.m. for the use of the oral Haldol 5 mg.

During interview with the psychiatrist responsible for P30's care, on 10/22/15, at 11:15 a.m., the psychiatrist stated he had been unaware of the Haldol exclusion on the patient's Court Order for use of neuroleptic medication treatment. The psychiatrist provided a copy of a 3/19/15, Court Order which did not indicate any exclusions. However, in Court documents related to the civil commitment of P30, and the use of electroconvulsive therapy, dated 9/9/15, the District Court Judge had added, "Respondent's current neuroleptic treatment order dated March 19, 2015 is amended to exclude Haldol and Risperdal..." The psychiatrist stated he did not think the exclusion for the use of these neuroleptic medications should have been documented on this form. He stated he had not looked in the record to check for any other documentation related to exclusions since he'd reviewed the 3/19/15, Court Order. Additional documentation in P30's record included a hand documented form which had been completed 7/14/15 for "New ECT" Order. The exclusions at the end stated, "current neuroleptic treatment order amended to exclude Haldol and Risperdal."

During interview with the medical records (MR) staff-B on 10/22/15, at 1:00 p.m. she confirmed the Court Order filed 7/14/15, had been received with P30 at the time of admission and had been filed in P30's chart on 9/23/15.

Based on interview and document review, the facility failed to treat an intermittently used Posey device as a restraint, failed to obtain orders for each use, failed to monitor P28 for circulation or adverse outcomes, failed to document start and finish times, and failed to consider alternatives to restraint prior to use of the Posey device restraint for 1 of 1 patient (P28) reviewed who used a Posey restraint.
Findings include:
P28 was admitted to the facility on 10/9/15, with diagnoses which included major neurocognitive disorder, (likely due to alcoholism), dementia, diabetes, hypertension, problems with aggression, and history of falls per the Patient Treatment Plan Report.

The Physician Order dated 10/9/15, noted nursing was to use an adjustable Posey on P28 to "eliminate pt. [patient] falling from wheelchair."

The Patient Treatment Plan Report which included the Comprehensive Plan Update dated 10/15/15, indicated P28 would be free from injury from any potential falls. P28 was impulsive and could be resistive to cues. The intervention was to have nursing utilize a bed alarm and Posey positioning device for use in wheelchair to reduce the risk of P28 getting up impulsively and falling.

A Progress Note dated 10/20/15, read "Staff continue to utilize bed alarm and Posey positioning device for use in wheelchair to reduce risk of getting up impulsively and falling." P28 "continues to be cooperative in using his bed alarm and Posey positioning device in the wheelchair. He maintained it on throughout the shift."

On 10/22/15, at 12:50 p.m. registered nurse (RN)-E was interviewed and stated, according to the record P28 was at risk for falls due to confusion, unsteadiness with ambulation, and forgetfulness. RN-E verified there was no documentation in the record of an assessment for use of the Posey device, monitoring of use, or indications of when it was to be utilized or released. RN-E further stated she was not certain when the Posey was last utilized, but the care plan and explanation in the record indicated it was being used as a restraint. RN-E also confirmed an assessment should have been completed as to the least restrictive measure to be utilized and parameters set up in the treatment plan.

RN-F was interviewed on 10/22/15, at 1:25 p.m. and indicted P28 was very confused and disoriented as to time, place and situation. RN-F indicated P28 was able to follow simple directions and could possibly open the Posey device, but not on a consistent basis. RN-F further replied P28 had an unsteady gait and would impulsively stand and attempt to walk/run away from wheelchair. RN-F confirmed a Posey device was utilized in resident's wheelchair.

The Adult Mental Health Seclusion or Restraint policy dated 9/25/15, identified a restraint as "Any manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely." The policy also indicated the facility was "to evaluate the patient's immediate situation, the patient reaction to the intervention, the patient's medical and behavioral condition, and the need to continue or terminate the restraint or seclusion."

Based on interview and document review, the hospital failed to ensure a process for Quality Assessment and Performance Improvement (QAPI) activities that reflected the need for patient safety and enhanced health outcomes when providing treatment for behavioral symptoms. This had the potential to affect all patients who received services from the hospital.

Findings include:

The failure to ensure the Quality Assessment and Performance Improvement committee had a process to identify quantitative and qualitative measures in accordance with the hospital's complexity to provide a safe environment when treating individuals with behavioral symptoms resulted in the hospital's inability to determine qualitative assessment measures and implement improvement activities. Therefore, the hospital was unable to meet the Condition of Participation: Quality Assessment and Performance Improvement Program at 42 CFR 482.21. The cumulative effect of this system failure resulted in the hospital's inability to ensure an effective QAPI program.

The deficient practice had the potential to impact all patients receiving services at the hospital.

Based on interview and document review the hospital failed to ensure a Quality Assessment and Performance Improvement program that measured, analyzed and tracked aspects of performance that assess processes of care, hospital service and operations and therefore, failed to use that data to monitor the effectiveness and safety of services and quality of care for all patients including 2 of 30 patients reviewed who had medication/ restraint used to manage behavior with out appropriate orders and/or assessment:

P30, who received an antipsychotic medication identified as an exclusion to her Court Orders. Refer to A-0131

P28 was restrained without appropriate assessment and review. Refer to A-0154

Nursing care plans failed to identify all necessary interventions to meet the needs of patients. Refer to A-0396.

30951

Based on interview and document review, the facility failed to have on going effective Quality Assessment Performance Improvement (QAPI) programs for each of the hospital designated areas and for the areas that had programs were not always reporting their findings and programs to the overall QAPI program. This had the potential to affect 108 of 108 current inpatients and all future patients. In addition, the facility failed to bring forth a medication error for QAPI for 1 of 1 patient (P30) who inadvertently received Haldol and for 1 of 1 patient (P28) who was restrained.

Findings include:

On 10/21/15, at 9:00 a.m. a meeting was held with the director of quality assurance for the facility. During the meeting an overview of the facility's QAPI program was discussed. The information taken out of the meeting was that the facility did have a QAPI program which included Centers for Medicare and Medicaid (CMS) directed core measures. The CMS directed core measures were the following: initial assessments done within three days, the use of multiple antipsychotic medications and justification, care plans created, care plans to providers within five days, restraint hours, and seclusion hours. The facility's quality programs included: cardiometabolic syndrome screening which included body mass index (BMI), blood pressure (BP), and smoking; inpatient consumer surveys (ICS), reducing admissions, psych evaluations, discharge orders, discharge summaries, medication errors and adverse drug reactions.

The minutes for the QAPI meetings were reviewed for the following dates: 10/23/14, 1/22/15, 3/26/15, 5/28/15, 7/23/15, and 10/6/15. Areas that were not included in the overall facility quality programs were contracted services which included laboratory and radiology, kitchen, maintenance, rehabilitation services, safety, and medical records.

The QA director was interviewed on 10/21/15, at 2:00 p.m. and confirmed she called the director of dietary once a year to discuss any issues in dietary. The QA director then confirmed dietary did not have any QAPI programs with established goals. In addition, the QA director confirmed maintenance did not have any QAPI programs and there was no reports of maintenance issues brought forward to the QAPI hospital wide program.

The computer programmer for the facility was interviewed on 10/21/15, at 2:55 p.m. and revealed the facility's computer had many reports that could be pulled up with data. For instance, a safety report can be run with a multitude of items such as small parts or screws loose/shower hooks. The small parts and/or screws had been known to be swallowed by current patients. Self-injurious behavior (SIB) reports can also be run and reviewed for frequency by a patient. The computer program confirmed staff can run reports on just about anything and used for quality improvement.

The facility's QA director was again interviewed on 10/22/15, at 10:30 a.m. and indicated the facility had two projects that they had been working on which were reducing restraints and seclusion and second provisional discharge and risk assessment timeliness.

On 10/22/15, at 3:00 p.m. a meeting was held with the director of psychology (DOP). The DOP confirmed rehabilitation services had been tracking attendance at activities on the weekends since 8/11. The rehabilitation department tracked patient attendance at four activities which included: community resource room, computer usage, library usage, and the fitness center. The data collected was used within the rehabilitation department and had not been shared with the hospital wide QAPI program. The DOP indicated the information had not been requested by the hospital QAPI program and there was not representation from the rehabilitation department on the QAPI committee.

During interview on 10/22/15, at 3:30 p.m. the director of the pharmacy was asked to provide documentation of a QAPI program for the pharmacy department of the facility. The director of pharmacy replied that there was no QAPI program for the pharmacy department.

On 10/23/15, at 9:30 a.m. the senior process improvement and the director of regional affairs at the cooperate level were interviewed by phone. Both of these individuals confirmed the Anoka facility did have a QA program using the CMS core measures. In addition, it was confirmed the facility did not have QAPI programs for each area in the facility. They revealed "a few months ago they did not have tools" to collect the data and had been working on the tools since they have been having many surveys. They were going to e-mail the tools, lab, they were proposing for quality after the phone interview. They had a lab process completed which had not been put into effect at the time of the phone interview. The next phase would be to identity each area for quality improvement which had not been done. In addition, they were not aware that some departments (rehab, kitchen, maintenance) had not been reporting data to the facility's QAPI program. They acknowledged the QA policy dated 1/1/15, was the most current policy. These employees further confirmed the facility did not have an effective ongoing QA program at the time of survey. The facility provided the QA outline for lab services after phone interview. Lab QA had not been put into place at time of survey.

Performance Evaluations were done for the contracted radiology and laboratory services both done on 5/26/15. The documentation indicated there were no concerns with these vendors for either. The facility's QA director was interviewed on 10/23/15, at 2:00 p.m. and confirmed there were no QAPI programs with goals for either of these contracted services. The contract for the laboratory services was due to end on 10/31/15, and was being renegotiated with the current vendor. The contract for radiology had been extended from 6/30/15 to 6/30/18.

P28 was admitted to the facility on 10/9/15, with diagnoses which included major neurocognitive disorder, (likely due to alcoholism), dementia, diabetes, hypertension, problems with aggression, and history of falls per the Patient Treatment Plan Report.

The Physician Order dated 10/9/15, noted nursing was to use an adjustable Posey on P28 to "eliminate pt. [patient] falling from wheelchair."

The Patient Treatment Plan Report which included the Comprehensive Plan Update dated 10/15/15, indicated P28 would be free from injury from any potential falls. P28 was impulsive and could be resistive to cues. The intervention was to have nursing utilize a bed alarm and Posey positioning device for use in wheelchair to reduce the risk of P28 getting up impulsively and falling.

A Progress Note dated 10/20/15, read "Staff continue to utilize bed alarm and Posey positioning device for use in wheelchair to reduce risk of getting up impulsively and falling." P28 "continues to be cooperative in using his bed alarm and Posey positioning device in the wheelchair. He maintained it on throughout the shift."

During interview on 10/22/15, at 10:47 a.m. the assistant director of nursing was asked to provide documentation of a QAPI program for the nursing department of the facility. She stated that she was not aware of any QAPI program project in the nursing department. She verified being unaware of any QAPI for P28 related to restraint.

On 10/22/15, at 12:50 p.m. registered nurse (RN)-E was interviewed and stated, according to the record P28 was at risk for falls due to confusion, unsteadiness with ambulation, and forgetfulness. RN-E verified there was no documentation in the record of an assessment for use of the Posey device, monitoring of use, or indications of when it was to be utilized or released. RN-E further stated she was not certain when the Posey was last utilized, but the care plan and explanation in the record indicated it was being used as a restraint. RN-E also confirmed an assessment should have been completed as to the least restrictive measure to be utilized and parameters set up in the treatment plan.

P30 was admitted to the hospital on 9/23/15, with diagnoses including chronic schizoaffective disorder and bipolar disorder. P30 received Haldol in which there was no order for the Haldol. The medication error was not brought to the attention of the facility's QA director for QAPI.

A psychiatric progress note from 9/30/15, indicated P30 had exhibited increasing agitated behaviors that morning: "...She had come out of her room entirely naked and was screaming and yelling. She was then partially covered with a sheet. She did argue and rant at this writer. She refused redirection...She did accept guidance to the seclusion room and took 20 mg [milligrams] of Zyprexa [an antipsychotic medication] orally....I met with her about 12:15 [p.m.] in the common area. She was sitting by the phone and was yelling and again making religious statements and wanted alcohol. She threatened this writer with physical harm. Despite multiple staff interventions to verbally calm her, she just got more agitated. I indicated she would be getting Haldol IM [intramuscular]." The notes further indicated the patient received Haldol 10 mg, Benadryl 50 mg, and Ativan 2 mg intramuscularly at 12:25 p.m.

The Physician Order indicated Haldol 5 mg po (orally) Bid (twice a day) had been prescribed for P30 on 10/2/15, at 1:59 p.m., due to the patient's refusal to accept treatment for "significant hypothermia." Review of the medication administration records revealed P30 received oral Haldol 5 mg on 10/2/15 at 8:21 p.m., on 10/3/15 at 8:58 a.m. and 8:49 p.m., 10/4/15 at 8:29 a.m. and 7:09 p.m., and on 10/5/15 at 8:59 a.m.

Additional review of P30's record revealed a notice from the District Court Judge, to the hospital, dated 10/5/15 which indicated: "HALDOL AND RISPERDAL REMAIN EXCLUDED AND SHALL NOT BE ADMINISTERED. Continued administration of those medications is in violation of this Court's Order. Failure to comply will result in an Order to Show Cause and a hearing as to whether this Court should find the prescribing/administering physician in contempt or violation of this Court's Order..." Subsequently, P30's record revealed a discontinuation order dated 10/5/15, at 12:20 p.m. for the use of the oral Haldol 5 mg.

During interview with the psychiatrist responsible for P30's care, on 10/22/15, at 11:15 a.m., the psychiatrist stated he had been unaware of the Haldol exclusion on the patient's Court Order for use of neuroleptic medication treatment. The psychiatrist provided a copy of a 3/19/15, Court Order which did not indicate any exclusions. However, in Court documents related to the civil commitment of P30, and the use of electroconvulsive therapy, dated 9/9/15, the District Court Judge had added, "Respondent's current neuroleptic treatment order dated March 19, 2015 is amended to exclude Haldol and Risperdal..." The psychiatrist stated he did not think the exclusion for the use of these neuroleptic medications should have been documented on this form. He stated he had not looked in the record to check for any other documentation related to exclusions since he'd reviewed the 3/19/15, Court Order. Additional documentation in P30's record included a hand documented form which had been completed 7/14/15, for "New ECT" Order. The exclusions at the end stated, "current neuroleptic treatment order amended to exclude Haldol and Risperdal."

During interview on 10/22/15, at 10:47 a.m. the assistant director of nursing was asked to provide documentation of a QAPI program for the nursing department of the facility. She stated that she was not aware of any QAPI program project in the nursing department. She verified being unaware of any QAPI related to the use of Haldol for P30.

The facility's policy, Direct Care and Treatment State Operated Services Quality Improvement Plan dated, 1/1/15, indicated that the Quality Improvement Plan highlighted the quality improvement framework for Direct Care and Treatment/State Operated Services. This document indicated that quality improvement was important and that "we strive to maintain and promote a culture of continuous quality improvement and to partner with the people we serve so they can acquire the tools they need to live independently in their own home that they have chosen in the community." "A culture of continuous improvement takes a methodical team based approach to measuring, evaluating, and improving services throughout the system on a priority basis. With this, quality improvement work occurs at all levels and areas of Direct Care and Treatment/State Operated Services. This includes all systems of care and management." "Successful Quality Improvement processes create feedback loops, by using data to inform practice, measure results, and proactively prevent and reduce risk. Fact-based decisions are likely to be correct decisions." "For continuous improvement of care, statistical tools and methods are needed that foster knowledge and understanding. We use a defined set of analytic tools such as run charts, cause and effect diagrams, flowcharts, Pareto charts, histograms, control charts, Failure Mode and Effect Analysis, Root Cause Analysis, Results Based Accountability, and process mapping to turn data into information." Under continuous improvement, the policy indicated processes must be continually reviewed and improved. Small incremental changes do make an impact and we can almost always find an opportunity to make things better.

The QA policy further outlined there were six sigma which were: (only five were in the policy).
"DEFINE the problem and set the goal: focused not simply on the outcomes, but on the process
MEASURE the defects or process operation. Develop a tool to collect the necessary data. Looking at existing sources that you may already be collecting to help measure the problem.
ANALYZE the data and discover the causes of the problem. Use brainstorming techniques, bar graphs, etc., to help analyze. Identify the process that needs improving (identify the root causes, both direct and indirect)
IMPROVE the process to remove causes of defects. Test solutions a small scale to see if they work. If it doesn't work, try another process.
CONTROL the process to make sure defects don't recur. Establish standard measures to maintain performance."