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Based on the manner and degree of deficiencies cited, the facility failed to be in compliance with the Condition of Participation of Quality Assessment and Performance Improvement. The facility failed to ensure its Quality Assessment and Performance Improvement Program focused on indicators related to improved health outcomes in each hospital department and service provided. Cross Reference to the following standard: A0275 - QAPI Quality of Care for the facility's failure and potential for negative outcome.

Based on staff interview, medical record review, internal documents, and facility correspondence, the facility failed to maintain an active and ongoing process to ensure cohesive oversight and monitoring of the effectiveness and safety of service and quality of care. Specifically, several patient deaths occurred on or after admission to the PPS Rehab Unit (Rehabilitation Patient Care Unit) and nursing as well as physician care was questioned, however, although actions were taken to improve care provided on the unit, no comprehensive and active oversight of such actions was evidenced. This failure created the potential for negative patient outcomes.

The findings were:

Review of nineteen PPS Rehab (RPCU) medical records, spanning from January 2010 to May 2011, was conducted on 5/17/11. Nine patient deaths were identified to have occurred either on the unit or shortly after a transfer from the unit to a higher level of care. An interview conducted with the Director of Medical Staff Services revealed that four additional deaths occurred on the unit during that time span.

An interview with the Chief Medical Officer was conducted on 5/19/11 at approximately 11:30 a.m. When asked about the patients' deaths, s/he revealed the deaths were "looked at." When asked if the results of the findings were shared with the physicians on RPCU, the CMO stated that he spoke with one of the physicians but not the second. The CMO was not able to provide documentation of the issues addressed with the physician and dates done so. The CMO did discuss the change in medical direction on the unit and new processes to occur going forward, for example, s/he stated "I know I am supposed to be notified if there are any MET (Medical Emergency Team) calls...and I have not had any calls..." However, a recent MET call had been documented in the SAFER SAM (the facility's electronic variance reporting system) reports provided to the surveyors.

An interview was conducted with the Director of RPCU on 5/18/11 at approximately 1:40 p.m. He stated, "There were questions in 2010 about nurse competency from our physicians, as well as about the nurse ratio. We had someone (a clinical educator from the ICU) come follow our nurses and they said they were competent...and found appropriate."

Two additional patient cases were discussed with the Director of Regulatory Affairs and the Director of Patient Safety due to internal reviews which occurred. One review was generated because of several reasons, one of which was that the "staff was upset," according to the Director of Regulatory Affairs on 5/18/11 at approximately 1:30 p.m. The review identified nursing and physician care concerns. The second review was conducted due to nursing and physician care concerns and process changes were implemented after the review, such a a prompter method of ordering Arterial Blood Gases and the hospital's new "Ticket to Ride" process.

An interview with the RPCU's Clinical Director was conducted on 5/18/11 at approximately 10:00 a.m. When asked about the high patient acuity level and process and ability to transfer patients to a higher level of care, s/he stated, "It is a physician to physician transfer requiring an order, as it is an entirely different facility." In regards to admissions, s/he stated, "We said we've got to get some control of this." S/he stated that they formulated a team and that the Pre-Admission Liaison may now "ask other floors if they can wait a weekend until the patient is more stable." With the team, s/he stated that if the physicians are not discharging a patient and concerns are identified, that the unit's Director, the unit's Rehab Director, and him/herself (Clinical Director) "will go in and talk to the physician." S/he stated that the new Medical Director was agreeable with this team process. When asked about staffing, s/he stated that they have been talking about decreasing the patient to nurse ratio ever since s/he began working there. S/he stated that a presentation and study were taken to "leadership" to increase the number of CNAs. S/he stated that last summer the unit changed the process so the charge nurse "does not take as many patients." S/he also stated that s/he (Clinical Director) is always available for assistance, attends morning report, and is "on-call all the time." When asked further about the new pre-admission process s/he stated that "admissions have improved and tightened up." In addition, s/he stated, "The unit hired an additional nurse approximately two years ago who works Monday through Friday, 12:00 p.m. to 8:00 p.m., to admit and discharge patients and help with IV (intravenous) starts."

Further interview with the main Director of RPCU on 5/18/11 at approximately 2:00 p.m. confirmed that many recent improvements had occurred in the RPCU after concerns were identified within the unit, such as the nurse to patient ratio and patient acuity level. When asked about the change in management structure, the Director stated, "I had one manager for 90 bodies...now I have [a therapy manager] as the RPCU manager over only therapy (40 bodies), [a nurse manager] over clinical, and [a second therapy manager] does acute care only." Further changes were reviewed with the Director. S/he stated that the Medical Director change was enacted 3/11 (and via documentation review was evidenced to have been finalized on 4/22/11), the new leadership changes were enacted 8/10, a new pre-admission policy and team process was finalized 11/10, and that currently there was a new Inpatient Pre- Admission Liaison role open for hire, which was approved two months prior. When asked further about implementing more CNAs and/or techs on the floor, s/he stated that it was presented to the former CNO and now that nursing competency has been "validated we are still considering" it, but no actions had been taken to move it forward.

In an interview with the Director of RPCU on 5/18/11 at approximately 1:00 p.m., quality assurance was addressed. When asked about ongoing audits done within the unit, s/he stated that audits are now done quarterly. S/he stated CMS audits are conducted by the liaisons to ensure patients are admitted appropriately, peer audits are conducted by therapy staff, peer audits are conducted by nursing staff, and that "compliance" also conducts audits. S/he stated that information is compiled and informally presented as staff meetings. When asked what occurs if patients are not meeting their required three hours of daily skilled therapy, s/he stated, "If not meeting the three hours of therapy for three days, they don't belong on the unit. If they don't hit it for a day or two, the MD must document..." S/he stated that the physicians are informed when patients are not meeting their rehab criteria time.

After further review of the survey findings, the Director of Regulatory Affairs was telephoned on 5/23/11 and asked what specific quality monitoring was being done in regards to the issues identified by the facility and their staff and the changes made thereafter. An email was received on 5/31/11 which stated, in pertinent part, that clinical competency was assessed on nursing staff by "shadowing" and one on one interviews in the months of November and December of 2010. The email stated that the facility's SAFER SAM method of variance reporting is reviewed daily by the RPCU Clinical Manager, Nursing Director, Service Line Director, Medical Director of Rehab Services, and Patient Safety Officer. It also stated "An alert is also sent to the Chief Medical Officer," and that such review would determine if further review would be needed. The email stated that all admissions are "reviewed by the unit's leadership team" and that issues would be addressed with the physician on daily "Lightning Rounds (brief team meeting to review patients)." It stated, "In addition, patients are evaluated on a weekly basis for compliance with continued stay criteria..." The email confirmed two dates wherein the CMO met with different physicians to discuss concerns which occurred on the RPCU. In response to the specific question "What quality monitoring is being done at MHS in regards to RPCU?" the emailed stated the following:

"- Unit level quality indicators are collected and reported to unit leadership including but not limited to the Director of Rehabilitation Services, Director of Critical Care, VP of Professional Services, and Chief Nursing Officer.
- MET calls and Code Blue events are reported through the electronic variance reporting tool and are reviewed by RPCU leadership and the Patient Safety Officer.
- MSH MET calls and Code Blue data are collected and reported by the Critical Care Clinical Specialist quarterly. Data is also included in unit level Performance Improvement reports.
- The Professional Services quality measures, which include the RPCU, are reported monthly through the System Quality and Patient Safety Committee which has Board representation. A summary of this data is available to the Board Quality Committee.
- All serious Safety Events, including RPCU's, are reported monthly to the System Quality and Patient Safety Committee and to the Board Quality Committee."

In summary, several issues were identified with patient care on the RPCU, such as patient acuity levels during admissions as well as current patient acuity levels, staffing ratios, and nursing and physician provided care. Several positive changes within the unit were implemented, however there was a clear lack of monitoring, oversight, and support by the system-wide QAPI Program specifically to the Rehabilitation Patient Care Unit in which to assess and ensure the safety and service of quality care in a problem identified area. Although the unit itself and the facility's Quality Department were doing routine audits, there was no specific monitoring implemented in regards to the issues identified by facility staff/physicians as well as by surveyors and also no further integration of such monitoring into the facility's Quality Assessment and Performance Improvement Program. Specifically, admissions to the facility were only reviewed by the facility's "leadership team," current patient acuity levels were only monitored by the RPCU's new management team, no evidence existed that nursing staffing ratios had been recently addressed by those other than directors of the RPCU, nursing care had not been assessed since December of 2010, and, although a change in medical direction recently occurred within the unit, physician care and practice was not under any continual active assessment and instead monitoring was dependent on safety alerts and events.

Based on medical record review, facility policies/procedures, staff and physician interviews, and review of the Medical Staff Bylaws/Rules and Regulations, the facility failed to ensure the Medical Staff was accountable to the governing body for the quality of medical care provided to the patients. Specifically, the Rehabilitation Care Unit (PPS Rehab Unit) failed to follow its policy in regards to discharge criteria in three of nineteen PPS Rehab sample medical records. This failure created the potential for a negative patient outcome.

The findings were:

Review of medical records was conducted on 5/17/11 and revealed the following:

Sample patient medical record #2 was a patient admitted on 1/4/10 and discharged on 1/28/10. The discharge summary revealed that the patient was an adult female who had a diagnosis of end-stage liver disease. The patient was admitted to the PPS Rehab unit after a long course in the acute care hospital. The patient was "originally getting stronger in her rehabilitation..." however the patient became septic and increasingly ill. The DC Summary stated, "...While these discussions were ongoing with the family, she and the family were encouraged to consider hospice...Intensified discussion ensued with the family, and they decided to give her comfort care. She passed away peacefully..." Further medical record review revealed the patient was very complex and received the following care during her admission on the Rehab unit: hemodialysis, blood transfusions, blood cultures (on several different occasions), chest x-rays, telemetry monitoring, intravenous fluid boluses for low blood pressure, abdominal ultrasounds, a CT scan, subcutaneous Vitamin K and Insulin injections. In addition, the patient last received Occupational Therapy on 1/22 and last received Physical Therapy on 1/21, therefore the patient was on the unit for six days without the administration of skilled therapy. In summary, the patient required a high level of care and was not able to meet the rehabilitation criteria time.

Sample patient medical record #8 was a patient admitted on 10/25/10 and discharged on 11/11/10. The discharge summary revealed the patient was admitted following an open reduction and internal fixation (surgery) of his right hip fracture. The patient had a very complicated past medical history as well as several complications upon presentation to the Emergency Room, including rib fractures, a pleural effusion, as well as multiple thoracic and lumbar compression fractures. The DC Summary continued, in pertinent part: "The patient had nice healing of incision during his time on rehab. Unfortunately, medically the patient was not doing well..." The DC Summary detailed the patient's complications while on the PPS Rehab unit, including fluid overload, questionable pneumonitis, bleeding, supraventricular tachycardia, and finally a bradycardic/junctional rhythm combined with respiratory distress. "The patient was transferred emergently to the ICU to the critical care team following intubation to ensure adequate oxygenation..." The patient had several consults while on the unit, including pulmonary, gastrointestinal, and cardiology. Review of the therapy notes revealed that the patient had last met his three hour rehabilitation time minimum on 11/5, approximately six days prior to his transfer (from 11/5 to 11/11 the patient received only six hours and 23 minutes of skilled rehab). In summary, the patient was medically complex and did not meet the rehabilitation criteria time.

Sample patient medical record #11 was a patient admitted on 3/31/11 and discharged on 4/14/11. The discharge summary revealed that while in the acute care hospital, the patient was febrile and meningitis was suspected however the patient also was positive for streptococcus pneumoniae. The DC Summary stated, "The patient was making nice progress; however, he was still requiring moderate assist to go from sit to stand and ambulate 25 feet..." Upon admission to the PPS Rehab unit, the patient was somnolent, still receiving antibiotics and required changes in such due to continued fevers. The DC Summary stated: "The patient improved nicely and on April 13, 2011, had a very active and productive day. He was performing activities of daily living (ADLs) and eating without difficulty and conversing. Patient has even obtained a book to read from the volunteer cart and gone through a large portion on 4/13/11..." However, the Speech Therapist's note from 4/13 stated the following, in pertinent part: "Pt. was uncooperative and non-compliant during his therapy session. He demonstrates decreased motivation during all therapy task." The DC Summary stated that the patient declined the morning of 4/14. Nursing documentation from 4/14/11 at 2:05 a.m. revealed the patient opened his eyes spontaneously, was confused, and obeyed simple commands rendering a Glasgow comma scale (GSC) of 14, however nursing documentation supported that the patient declined as the morning progressed. At 11:13 a.m., the patient's GSC was 3, the patient's motor response was flaccid, and he had no verbal or eye response. At 2:00 p.m., a physician's note stated "pt. less alert- quite somnolent today - very active & alert yesterday..." Per internal facility documents, the MET (Medical Emergency Team) was called at 2:45 p.m. due to seizures and the physician's order to transfer the patient was written at approximately 2:50 p.m., over six hours after the patient had notable decline in status. The last day the patient met the full three hours of rehabilitation was on 4/8, approximately six days prior to his transfer out (his total hours of skilled rehab from 4/8 to 4/14 was seven hours and 50 minutes). In summary, the patient was not meeting his rehab minimum limit, had significant neurological issues with an unclear diagnosis, and had a decline in status noted by nursing staff over several hours prior to his transfer off the unit.

A joint interview with the PPS Rehab Unit's two physicians was conducted on 3/17/11 at approximately 3:30 p.m. When one of the physicians was asked about appropriateness to be on the PPS Rehab unit, s/he stated, "The best we've been able to direct: we want patients on our unit that can really participate and help...[If they are] borderline, [we] look at the case: is that really something holding him from participating...then where will he go, if it is something medical?" When asked how physicians determine that patients should be transferred to a higher level of care, s/he stated, "[It] is done in conjunction with people that follow us. We have continue stay criteria...Insurance does play a roll sometimes, if not participating. But if not acutely ill, [we] want [them] to go back to the hospital or SNF..." When asked again about how patients are determined inappropriate to be on the unit any longer, s/he stated, "It is a judgement call...In the back of my head...had 72 hour threshold. If we can't fix it, [we] transfer. If someone needs one to one nursing care, we will transfer..." When asked further about patients not able to participate in therapy, s/he stated, "If we think there is enough of an issue that we can get them back on track, we look at that." When asked about the high care needs a particular patient exhibited (sample medical record #2) and why the patient was not participating in skilled rehab for days and yet not transferred off the unit, the physician stated, "I guess the question is where [would the patient be transferred to]. I'm not going to get a SNF to take them...We were in those discussions with hospice...It doesn't help her/him at all to go sit on the medical floor..." Both physicians confirmed that they are weekly updated on patients who are not meeting their rehab criteria times.

An interview with the PPS Rehab Unit's Director was conducted on 5/16/11 at approximately 12:30 p.m. The Director confirmed that patients must meet three hours of skilled rehab five times per week or fifteen hours over a seven day window in order to be on the unit. When asked what occurs if the patients are not able to continue this therapy after admission, s/he stated, "It is addressed in staffing, but ultimately the decision is the physician's." Several patient cases were brought to the attention of the Director and in multiple situations s/he stated, "...again it would be the decision of the doc." The Director stated that patients are assessed as to if they have the ability to learn, thus making them a continued candidate for skilled rehab. When asked about discharges and transfers out of the unit, the Director stated, "We can bring it up in UR (Utilization Review)...but always a physician call." When asked if there was anything to determine patient medical acuteness besides the physician, s/he stated, "No, it is the MD. Nursing and therapy are an extension of the Doc..." When asked if the MET team is an option to get patients transferred out, s/he stated, "The MET team is the rip cord...We should discuss it with the MD and in Lighting Rounds (which occur daily) first." The Director stated that many recent improvements had occurred in the unit, such as a new Medical Director, a change in management leadership to a more cohesive and team process, a tightened admission policy, and a new role for an inpatient pre-admission liaison. However, no changes were identified or evidenced as to expedition of patients to a higher or lower level of care when skilled rehab time criteria were not met.

An interview with the PPS Rehab Unit's Clinical Director was conducted on 5/18/11 at approximately 10:00 a.m. When asked how patients are transferred out of the unit, s/he stated it is a physician to physician transfer requiring an order, as it is an entirely different facility [from the main hospital].

When the PPS Rehab Unit's Director was asked if a policy existed on criteria that must be met for a patient to stay on the unit, the policy titled "Medical Necessity," dated with an effective date of 6/2010, was provided. It was reviewed on 5/18 and stated the following, in pertinent part: "4. Patient will be discharged from RPCU and re-admitted to medical/ ICU for: -Medical emergencies (Code, MI, PE, fractures requiring surgery, etc) -Inpatient surgical procedures. -Medical decline preventing patient's participation in therapy beyond a 72 'medical hold." However, an additional policy titled "Admission, Continued Stay, and Discharge Criteria for Rehab Patient Care Unit (RPCU)" with an effective date of 6/10 was also reviewed. It stated the following, in pertinent part: "Discharge Criteria...The patient is discharged when one or more of the following criteria are met:...The patient experiences a major medical problem or intervention that precludes benefit from a continuos rehabilitation program...The patient has not met the 3 hour criteria for 3 consecutive days without a medical hold documented in the chart by the physician or the patient has not met the 3 hour criteria for greater than 3 days with a medical hold..."

The facility's Medical, Dental, and Podiatric Staff Rules and Regulations, last updated March 23, 2011, was reviewed on 5/18/11. It stated the following, in pertinent part:
"ARTICLE II: GENERAL HOSPITAL RULES
SECTION 1. Admission and Discharge of Patients...
I. Patients shall be discharged only upon an order of the Attending Staff Member or the Staff Member on call for the Attending Staff Member..."