HospitalInspections.org

Based on observations, record review, and staff interview, it was determined that the hospital's Governing Body (GB) failed to demonstrate that it was responsible for the effective management of the hospital to ensure the patients received appropriate care, treatment, and services. The findings of noncompliance are referenced in 42 CFR §482.21 Condition of Participation: Quality Assessment and Performance Improvement (QAPI) Program and 42 CFR §482.13 Condition of Participation: Patient Rights. The GB failed to ensure that the QAPI programs were effective and hospital-wide and that the patient rights requirements were met. As a result of these failures, the Condition of Participation of Governing Body was determined to be out of compliance.

On 7/24/14 at 9:23 AM, in an interview with the Administrator, he revealed that he is involved in the QAPI program, working with the Performance Improvement/Risk Manager (PIRM) daily. He stated that he sometimes attends the QAPI meetings but relies on the PIRM to do the QAPI. Additionally, he indicated there is a hospital executive staff meeting every Monday which includes QAPI. The Administrator commented that they are short staffed, under funded, and work in crisis mode. When the root cause analyses (RCA) related to fetal demises and maternal deaths was mentioned by the surveyor, the Administrator was aware of the occurrences and said that they were improving the process, focusing on the outcomes and fixing the problems.

On 7/21/14 at 10:42 AM, observation and staff interview with the Inpatient Department Nursing Supervisor (IPD) revealed the lack of an infant security system for the OB area. The babies were noted to room-in with the mothers on an open unit. The IPD said that the security system was needed and was on order.

During the interview with the Administrator on 7/24/14, he acknowledged that the hospital needed an infant security system, stated how much it cost, and said that it was ordered. Although the need for this system to protect infants from being removed from the hospital illegally was known to the Administrative staff, no temporary security measures had been implemented until the system was purchased and installed.

See the following for details:

A0263 - 42 CFR §482.21 Condition of Participation: Quality Assessment and Performance Improvement (QAPI) Program - The Hospital failed to ensure that the QAPI program was fully functioning and effective with quality reviews and programs for all areas of the Hospital. Departments were not doing and had not done QAPI for extended amounts of time.

A0115 - 42 CFR §482.13 Condition of Participation: Patient Rights - The Hospital failed to ensure that patient rights requirements were met in relation to the use of restraints, obtaining consents, lack of training of staff in relation to the use of restraints, and ensuring privacy during the provision of care.

Based on record review and staff interview, it was determined that the hospital failed to have an overall institutional plan that provided for capital expenditures for at least a 3-year period. The findings included:

On 7/24/14 at 1:50 PM, in an interview with the Administrator, he indicated that the hospital did not have a three year plan for capital expenditures. He revealed that the Billings Area Office was responsible for the budget development. The Administrator verified that the hospital had a current operating budget and they were working on the FY 2015 budget requests.

On 7/24/14, the Finance staff member provided a copy of the FY 2014 budget and draft of a partial FY 2015 operating cost spread sheet. The staff member verified that they do not do their budget plan for three years because that is determined by the Area Office.

Based on observation, record review, and staff interview, it was determined that the hospital failed to protect patient rights in the areas of privacy, informed consent, restraint use, staff restraint training, and death reporting when restraints were used.

The findings included:

A 131 - 42 CFR §482.13(b)(2) Patient Rights; Informed Consent. The hospital failed to obtain patient consent for treatment as required by the Medical Staff.

A 143 - 42 CFR §482.13(c)(1) Patient Rights: Personnel Privacy. The hospital failed to provide privacy during patient care.

A 169 - 42 CFR §482.13(e)(5) Patient Rights: Restraint or Seclusion. The hospital failed to ensure that restraint order was not written as a PRN (as needed) order.

A 169 - 42 CFR §482.13(e)(6) Patient Rights: Restraint or Seclusion. The hospital failed to obtain an order for the use of restraints.

A 171 - 42 CFR §482.13(e)(8) Patient Rights: Restraint or Seclusion. The hospital failed to re-evaluate patients within the required time frame.

A 174 - 42 CFR §482.13(e)(9) Patient Rights: Restraint or Seclusion. The hospital failed to remove restraint when the patient behavior indicated the restraints were no longer required.

A 194 - 42 CFR §482.13(f) Patient Rights: Restraint or Seclusion. The hospital failed to provide training on the safe application of restraints.

A 213 - 42 CFR §482.13(g)(1) & (3)(i) Patient Rights: Restraint or Seclusion Death Reporting. The hospital failed to report to CMS a patient death after restraint use as required.

Based on interview and record review the hospital failed to ensure all patients, or their representatives, were given the opportunity to consent for treatment on admission into the hospital for 14 sampled and 17 un-sampled patients (sampled patients 1-14 and un-sampled patients 15-31). Failure to obtain consent for treatment was inconsistent with the Medical Staff Rules and Regulations.

The findings included:

During the week of 7/21/14 to 7/24/14 the electronic and paper medical records for the sampled and un-sampled patients were reviewed. Neither the electronic nor the paper medical records contained a consent form obtained on admission by or on behalf of every patient admitted into the hospital.

During an interview on 7/23/14 at 3:30 PM, the medical records supervisor stated that implied consent was assumed for all individuals that presented to the facility.

On 7/23/14 the Rules and Regulations of the Medical Staff of the United States Public Health Service, Indian Health Service Hospital in Browning were reviewed. Under General Medical Care it states under subparagraph 4.2 which addresses access to care " A general consent form signed by or on behalf of every patient admitted to the hospital must be obtained at the time of admission. The admitting personnel should notify the attending practitioner whenever such consent has not been obtained. "

Based on observation, the hospital did not ensure that the patient had the right to privacy during the provision of care.

The findings included:

During the environmental tour at about 10:35 AM on 7/24/14, a biomed staff looking for a key to open the equipment storage room in the inpatient unit found a licensed nurse inside a patient's room. The nurse, who stated that she had the key, was observed changing a patient's hospital gown. Because the door to the room was wide open, the male patient, who was standing at the bedside and had his backside exposed, could be seen by anyone from the public hallway for one of 14 sampled patients.

After the licensed nurse handed the key over to the biomed staff member who had then entered the room, the nurse thereafter informed him to "please close the door" as he was walking out.

Based on record review of the Emergency Department's (ED) Restraint Log, medical record, and restraint policy and staff interview, it was determined that the hospital failed to have a verbal order signed for restraints on a ten (10) year old patient (#22). The findings included:

1. On 7/23/14 at 10:43 AM, review of the ED Restraint Log with the ER Nurse Supervisor revealed that patient #22, a ten (10) year old male, was listed as having been in the ED on 3/6/14 starting at 10:30 PM. The patient was combative and was placed in four point (both arms and legs), soft wrist restraints per a verbal order. The ER Nursing Supervisor verified that the only type of restraints used in the ED were wrist restraints. She showed the surveyor the supply of wrist restraints. (Note: Wrist restraints are not designed for use on the legs.)

Review of the patient's electronic health record (EHR) with the ER Nurse Supervisor evidenced that the order to use restraints was not in the EHR. The nurse verified that the verbal order for the use of restraints had not been signed by the physician.

2. Review of the hospital's Patient Restraint Use Policy, which was not signed or dated, revealed:

BLACKFEET SERVICE UNIT STATION POLICY NO. 01-09-050

Patient Restraint Use Policy

"I. PURPOSE:
The purpose of this policy is to guide the safe, appropriate, and clinically justified use of
restraints in accordance with applicable Federal and State regulations, to ensure patient
safety, rights, dignity and well-being.

ll. APPLICABILITY:
The patient protections contained in this policy apply to all hospital patients when the use of restraint becomes necessary regardless of patient location. The reason for restraint use is not driven by the treatment setting of the patient nor is it determined by the patient's diagnosis

These requirements are specific to the patient behavior that the restraint intervention is being used to address and applies to the following two reasons for use:

· Nonviolent, non-self destructive behavior (any individual not acting out or behaving dangerously or destructively who has symptoms of confusion, disorientation, or unsteady gait, continues to get out of bed, or dislodge tubes and/or lines even after less restrictive methods have been tried.


· Violent, self-destructive behavior (any individual who exhibits aggressive, combative, or violent behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others....

b. Violent or Self-Destructive Behavior

· In emergency application situations, an RN may initiate the emergency application of restraint.

o In these situations, the order must be obtained during the emergency application or immediately (within a few minutes) after the restraint has been applied.
· Written order for restraint includes:

o Date and time restraint order written;
o Reason for use (indicate need for restraint use);
o Time Frame for Use:
· Every 4 hours for patients 18 years of age or older;
· Every 2 hours for patients age 9 to 17 years of age;
· Every 1 hour for children under 9 years of age.
o Type of restraint to be used;
o Monitoring frequency;
o Assess for early release."

Based on record review of the Emergency Department's (ED) Restraint Log, medical record, and restraint policy and staff interview, it was determined that the hospital failed to ensure that the restraint order for patient (#23) was not written as a PRN (as needed) order. The findings included:

On 7/23/14 at 10:43 AM, review of the ED Restraint Log with the ER Nurse Supervisor revealed that patient #23 arrived in the ED on 5/16/14 at 11:05 AM with a complaint of "took some medications at school". The patient was noted to be unresponsive and was given Narcan. The patient became combative and was placed in four point (both arms and legs), soft wrist restraints. (Note: Wrist restraints are not designed for use on the legs.)

Review of the patient's electronic health record (EHR) with the ER Nurse Supervisor evidenced that an order was written at 12:07 PM. The physician wrote the order for "restrain pt, soft restraint PRN". The written restraint order did not contain all the pertinent information as required by regulation and hospital policy.

Review of the hospital's Patient Restraint Use Policy, which was not signed or dated, revealed:

BLACKFEET SERVICE UNIT STATION POLICY NO. 01-09-050

Patient Restraint Use Policy
"...
5. Orders: The use of restraint must be in accordance with the order of a physician or other licensed independent practitioner who is responsible for the care of the patient. Orders for the use of restraint must never be written as a standing order or on an as needed basis (prn)..."

Written order for restraint includes:
o Date and time restraint order written;
o Reason for use (indicate need for restraint use);
o Time Frame for Use:
· Every 4 hours for patients 18 years of age or older;
· Every 2 hours for patients age 9 to 17 years of age;
· Every 1 hour for children under 9 years of age.
o Type of restraint to be used;
o Monitoring frequency;
o Assess for early release."

Based on record review of the Emergency Department's (ED) Restraint Log, medical record, and restraint policy and staff interview, it was determined that the hospital failed to have a 14 year old patient (#23) and a 10 year old patient (#22) re-evaluated within two hours after the application of restraints. The findings included:

1. On 7/23/14 at 10:43 AM, review of the ED Restraint Log with the ER Nurse Supervisor revealed that patient #23 arrived in the ED on 5/16/14 at 11:05 AM with a complaint of "took some medications at school". The patient was noted to be unresponsive and was given Narcan. The patient became combative and was placed in four point (both arms and legs), soft wrist restraints. (Note: Wrist restraints are not designed for use on the legs.)

Review of the patient's electronic health record (EHR) with the ER Nurse Supervisor evidenced the following:

At 11:10 AM the physician performed the Medical Screening Exam (MSE).

At 11:45 AM the patient was placed in four point restraints after becoming combative.

At 12:07 PM the physician wrote the order for the restraints ("restrain pt, soft restraint PRN").

At 12:15 PM, 12:30 PM, 1:00 PM, 1:15 PM, 1:30 PM, and 1:45 PM the patient was checked. The ER Nurse Supervisor stated that the nurse stayed in the room with the patient.

At 2:00 PM, 2:15 PM, and 2:30 PM, the restraints were noted to be checked and the patient was sleeping with the nurse in the room.

At 2:35 PM the restraints were removed.

The ER Nurse Supervisor verified that the hospital/staff had been reprimanded for leaving the patient in restraints once the patient was sleeping. She indicated that the staff would be receiving training around the restraint issues.

Additionally, there was no evidence to show that the patient was re-assessed timely for the continuing use of restraints by a member of the medical staff.

2. On 7/23/14 at 10:43 AM, review of the ED Restraint Log with the ER Nurse Supervisor revealed that patient #22, a ten (10) year old male, was listed as having been in the ED on 5/18/14 starting at 12:52 AM. The patient was combative and arrived in four point restraints.

Review of the patient's electronic health record (EHR) evidenced that the order to use restraints was written on a "Restraint Order/Flow Sheet - Violent/Self Destructive Behavior" form. This was signed at 12:52 AM. The order was put into the EHR at 1:03 AM. The order was noted to be discontinued at 3:55 AM.

Review of the nursing notes evidenced that the restraints were removed at 1:58 AM (one hour and six minutes after the original order). At 2:06 AM, the nursing notes indicated that the behavioral health (BH) was here to assess patient.

Although the restraints were removed in less than two hours, the order was not discontinued. The potential remained for the use of the restraint for more than two hours and/or the re-application without an assessment.

3. Review of the hospital's Patient Restraint Use Policy, which was not signed or dated, revealed:

BLACKFEET SERVICE UNIT STATION POLICY NO. 01-09-050

Patient Restraint Use Policy
"...
b. Violent or Self-Destructive Behavior

· In emergency application situations, an RN may initiate the emergency application of restraint.

o In these situations, the order must be obtained during the emergency application or immediately (within a few minutes) after the restraint has been applied.

· Written order for restraint includes:

o Date and time restraint order written;
o Reason for use (indicate need for restraint use);
o Time Frame for Use:
· Every 4 hours for patients 18 years of age or older;
· Every 2 hours for patients age 9 to 17 years of age;
· Every 1 hour for children under 9 years of age.
o Type of restraint to be used;
o Monitoring frequency;
o Assess for early release.

· Face-to-Face Evaluation: Patient must be seen face-to-face by a physician or other LIP within 1 hour of application of restraint for
. violent, self-destructive behavior to evaluate:

o The patient's immediate situation;
o The patient's reaction to the intervention;
o The patient's medical and behavioral condition
· Assessment to determine if other factors (i.e. drugs, hypoxia, electrolyte imbalance) are contributing to patients behavior; and
0 The need to continue or terminate the restraint.

· Renewal of order: At the end of the age defined timeframe, if continued use of restraint is still required, an RN may contact the physician, report the results of his/her most recent assessment and request that the original order be renewed.

o The original order may be renewed within the age defined time limit for up to a total of 24 hours.

o After the original order expires (24 hours) a physician must see and assess the patient before issuing another order...."

Based on record review of the Emergency Department's Restraint Log, medical record, and restraint policy and staff interview, it was determined that the hospital failed to remove the restraints from a 14 year old patient when she no longer needed the restraints. The findings included:

On 7/23/14 at 10:43 AM, review of the ED Restraint Log with the ER Nurse Supervisor revealed that patient #23 arrived in the ED on 5/16/14 at 11:05 AM with a complaint of "took some medications at school". The patient was noted to be unresponsive and was given Narcan. The patient became combative and was placed in four point, soft wrist restraints at 11:45 AM.

At 2:00 PM, 2:15 PM, and 2:30 PM, the restraints were noted to be checked and the patient was sleeping with the nurse in the room.

At 2:35 PM the restraints were removed.

The ER Nurse Supervisor verified that the hospital/staff had been reprimanded for leaving the patient in restraints once the patient was sleeping. She indicated that the staff would be receiving training around the restraint issues.

Review of the hospital's Patient Restraint Use Policy, which was not signed or dated, revealed:

BLACKFEET SERVICE UNIT STATION POLICY NO. 01-09-050

Patient Restraint Use Policy

"...b. Violent or Self-Destructive Behavior

· In emergency application situations, an RN may initiate 1:he emergency application of restraint.

o In these situations, the order must be obtained during the emergency application or immediately (within a few minutes) after the restraint has been applied.

· Written order for restraint includes:

o Date and time restraint order written;
o Reason for use (indicate need for restraint use);
o Time Frame for Use:
· Every 4 hours for patients 18 years of age or older;
· Every 2 hours for patients age 9 to 17 years of age;
· Every 1 hour for children under 9 years of age.
o Type of restraint to be used;
o Monitoring frequency;
o Assess for early release.

· Face-to-Face Evaluation: Patient must be seen face-to-face by a physician or other LIP within 1 hour of application of restraint for
. violent, self-destructive behavior to evaluate:

o The patient's immediate situation;
o The patient's reaction to the intervention;
o The patient's medical and behavioral condition
· Assessment to determine if other factors (i.e. drugs, hypoxia, electrolyte imbalance) are contributing to patients behavior; and
0 The need to continue or terminate the restraint.

· Renewal of order: At the end of the age defined timeframe, if continued use of restraint is still required, an RN may contact the physician, report the results of his/her most recent assessment and request that the original order be renewed.

o The original order may be renewed within the age defined time limit for up to a total of 24 hours.

o After the original order expires (24 hours) a physician must see and assess the patient before issuing another order...."

Based on staff interview and policy review, the hospital failed to ensure implementation of the staff training and education program for restraints.
The findings included:
1. On 7/23/14 at 10:43 AM, review of the ED Restraint Log with the ER Nurse Supervisor revealed that three patients (#22, #23, and #24) had been admitted with restraints in place or applied for combative behaviors.

2. Review of patient #23's EHR record with the ER Nurse Supervisor evidenced that on 5/16/14 at 2:00 PM, 2:15 PM, and 2:30 PM, the patient was sleeping with four point (both arms and legs) restraints on and with the nurse in the room. At 2:35 PM the restraints were removed.

The ER Nurse Supervisor verified that the ED staff had been reprimanded for leaving the patient in restraints once the patient was sleeping. She indicated that the staff would be receiving training around the restraint issues once the training could be scheduled.
3. During an interview on 7/23/14 at 11:30 AM, the acting director of nursing stated that there had been no restraining training since 2010 or 2011.
4. The hospital policy titled, Patient Restraint Use Policy (policy # 01-09-050) and dated 8/23/11 was reviewed on 7/23/14. A specific training interval was not defined by the policy.
Section B. 4 stated "Training interval for designated staff include:
a. Prior to participating in the application of restraints, or monitoring, assessment, or care of patients in restraints;
b. As part of the new employee orientation; and
c. Subsequently on a periodic basis as a result of skills and knowledge assessments, new equipment, or QAPI data that indicates a need for targeted training or more frequently or revised training."
5. Evidence of current training records for nursing staff was not provided.
6. During the survey exit meeting on 7/24/14 at 4:30 PM, the staff training records were requested again. Restraint training records were not provided.

Based on record review of the Emergency Department's Restraint Log, medical record, and restraint policy and staff interview, it was determined that the hospital failed to report the death of a patient (#24) who was restrained. The findings included:

Review of patient #24's ED EHR (electronic health record) with the ER Nurse Supervisor revealed that the patient was admitted on 3/3/14 at 5:46 PM with diagnoses of gunshot wound to the abdomen and hemorrhagic shock. The patient was noted to be in four point restraints at 5:49 PM as the "Patient presented to ED combative, flailing both upper and lower extremities." The patient was taken to the operating room and expired at 6:48 PM.

Review of the CMS Death Reporting Log in the Denver Regional Office confirmed that this patient was not reported as required for the death of a patient in restraints (other than two point soft restraints).

Review of the hospital's Patient Restraint Use Policy, which was not signed or dated, revealed:

BLACKFEET SERVICE UNIT STATION POLICY NO. 01-09-050

Patient Restraint Use Policy

"... C. DEATH REPORTING REQUIREMENTS:

1. Staff must immediately notify their supervisor or the Director of Nursing and report deaths associated with the use of restraints. This includes:

a. While a patient is in restraints; or

b. Within 24 hours after the patient has been removed from restraints; or

c. Within 1 week after use of restraints where it is reasonable to assume that the use of restraint contributed directly or indirectly to the patient's death (i.e. death related to chest compression, restriction of breathing. or asphyxiation).

2. Hospital. must report any death to CMS by telephone no later than the close of business the next business day following knowledge of the patient's death. The date and time CMS was notified must be documented in the patient's medical record."

Based on interview and record review, the hospital failed to establish a hospital wide, data driven quality assessment and performance improvement (QAPI) program.

The findings included:

During an interview on 7/24/14, the performance improvement/risk management coordinator(PIRM) stated that she was the only staff working in QAPI. She was responsible for QAPI, risk management, peer review for the chronic pain clinic, blood utilization chart reviews, the emergency room log reviews, and restraint and mortality monitoring. If there are complaints or a tort, she must focus on those activities first. If the various departments do no submit quarterly reports, she has no supervisory authority and reports to the CEO.

The position description for the performance improvement/risk management coordinator was reviewed. The major duties were defined as 44% for QAPI activities, 28% for risk management, and 28% for in-service education, professional/technical consultation to all para-professionals, and professional staff, and participation assigned committees.

A 273 - 42 CFR §482.21(a),b(1), B(2)(i),B(3) Data Collection and Analysis - The hospital failed to ensure that all hospital departments submitted QAPI reports to enable analysis, tracking and measurement of care services and operations.

A 286 - 42 CFR §482.21(a), c(2), e(3) Patient Safety - The hospital failed to ensure that patient adverse events were timely measured, analyzed, and tracked to improve patient outcomes.

A297 - 42 CFR §482.21(d) QAPI Performance Improvement Projects - The hospital failed to conduct, and document QAPI performance improvement projects that reflected the scope of hospital services.

Based on record review and interview, the hospital did not ensure that its QAPI (quality assessment and performance improvement) program measured, analyzed, and tracked quality indicators and other aspects of performance that assessed processes of care, hospital services, and operations.

The findings included:

1. Review of the hospital's performance improvement (PI) program tracking form which outlined data submitted revealed that not all the departments were reporting data within the timeframe so that hospital-wide analysis, tracking, and measurement of processes of care, services, and operations could be conducted timely.

a. During an interview on 7/24/14, the hospital's performance improvement/risk management coordinator (PIRM) stated that data from the departments were to be submitted on a quarterly basis.

b. During a interview on 7/24/14 at 2:55 PM, the medical records supervisor confirmed that the first quarter QAPI for Medical Records was not submitted to the risk manager.

c. During an interview on 7/23/14 at 2:55 PM, the mental health supervisor confirmed that the staff member who was submitting the quarterly QAPI reports was no longer at the hospital and the quarterly QAPI reports were not submitted to the risk manager since the staff member left.

d. Review of the tracking form for 2014 revealed that of 24 departments listed from which data was to be reported, only seven (7) did for the first quarter of 2014 (January - March), a submission rate of only 29%. No data was reported by several departments including biomedical, contract health, housekeeping, infection control, information technology, maintenance, medical records, physical therapy, radiology, and mental health. In addition, of the seven (7) departments, two submitted incomplete data. For the department of nursing services which had eight divisions, three had not submitted data including diabetes, the medical/surgical unit, and the outpatient clinics.

For the second quarter of 2014 (April - June), only laboratory had reported data when the tracking form was reviewed on 7/24/14.

e. In the same interview on 7/24/14, PIRM stated that timely submission of QAPI data was a challenge including 2013; and that while she eventually received data from all the departments, evaluation of the hospital-wide QAPI program (for 2013) was delayed and, on 7/24/14 during the survey, had not been completed. The 2013 tracking form revealed that the evaluation was due on 2/01/14.

2. Review of department-specific QAPI documents during the survey revealed the lack of evidence documenting QAPI activities including data gathering methodologies, the establishments of benchmarks or target goals, analysis, and determining whether performance improvement had occurred.

For example:

a. During a tour of the women's clinic, a licensed staff member explained that QAPI activities (in the clinic) included an analysis of "no-shows" to address the problem of patients not showing up for their appointments. While the staff added that this was a problem, there was no documentation about information gathering activities, benchmarks, and data analysis. When asked what the "no-show" rate was, the staff stated that it was "high" adding that she did not know the percentage rate. When asked for other QAPI activities, the staff presented a "recent study" by a member of the medical staff entitled "Blackfeet Community Hospital IUDE Review Analysis" outlining substance exposure and other factors affecting pregnancy and maternal and neonatal health.

b. During a tour of the north outpatient clinic on 7/23/14, a licensed staff stated that documentation of the clinic's QAPI activities was kept by the nurse supervisor. When the documents were requested, the supervisor stated that she would be giving the information after lunch on 7/23/14. None however was submitted.

c. On 7/24/14 at 9:56 AM, in an interview with the Director of the Rehabilitation Department, he said that they did physical therapy, including treatment of wounds. The Director revealed that the Department did not have any current QAPI projects. He stated that he was not sure what they could evaluate.

3. During an interview on 7/24/14 at 8:30 AM, PIRM confirmed there was no QAPI for contracted services.

During an interview on 7/22/14 at 4:00 PM, the laboratory supervisor stated that a "demo" test was sent monthly to Lab Corp (the contract laboratory). The pathologist reviews the results. A report does not go to QAPI. There is a 5 year contract for laboratory services with no specific criterions for QAPI.

Based on record review and staff interview, it was determined that the hospital failed to measure, analyze, and track adverse patient events in a timely manner in order to improve patient outcomes. The findings included:

On 7/23/14 at 8:53 AM, in an interview with the hospital's Performance Improvement/Risk Management Coordinator (PIRM), she discussed five root cause analyses (RCA) that she had done. All five patients expired either in the hospital or after being transferred to another hospital. She revealed that two of the five significant events were brought to her attention through legal actions, not by the hospital staff identifying problem issues which should be reviewed at the time of the occurrences. The reviews were not done timely which delayed the implementation of performance improvement plans.

The PIRM talked about another incident which occurred on 5/27/14 close to midnight. She indicated that she made a timeline for this. Three patients were brought into the Emergency Department (ED) after being involved in a high speed motor vehicle accident (MVA) without seatbelts. The patients had high blood alcohol levels. All of the patients had significant traumatic injuries with radiology studies done. The x-rays were not ordered "stat" so the (teleradiology) radiologist did not review them until later in the morning. All three were admitted to the hospital. Two were transferred out after the radiologist read the x-rays. The third patient was transferred two days later after her pulse rate reached 142. The PIRM verified that the patients had not received appropriate, timely treatment for their injuries, especially based on the high trauma they had experienced. These three patients were not reviewed through the hospital's RCA process. Since the x-rays were not read due to an error in ordering and the patient's care and treatment was inadequate for the level of trauma they sustained, it was not clear why the cases had not been reviewed as RCAs.

The PIRM was asked about patient #15 who presented to the ED on 5/30/14 in labor. The PIRM said that she was aware of the patient who had a delivery at 27 weeks with a fetal demise. She described the patient's labor, how Piper forceps were used, and the trauma to the infant. The PIRM said that she had not done a RCA, but the case was supposed to be reviewed at the medical staff next Wednesday (July 30, 2014). It was not clear why there was a delay in medical staff review of this case or why the case had not been reviewed as an RCA.

Based on record review and interview, the hospital did not ensure that as part of QAPI, the hospital must conduct performance improvement projects, document the reasons for conducting the projects and the measurable progress achieved on the projects.

The findings included:

1. During a tour of the north outpatient clinic on 7/23/14 at about 9:00 AM, a licensed staff stated in an interview that a performance improvement project being conducted was reconciliation of the patient workload of a medical provider. The staff explained that the project involved sorting and updating the workload to determine which patients were active, expired, or had moved on and lost to follow-up. When asked if the project had resulted in any measurable progress, the staff was unable to present any data but added that she was still working on the reconciliation if she had time. When documentation was requested outlining the reasons for the project, the timetable, and measurable the progress to be achieved, none was presented. In the same interview, the staff stated that the project was "informal."

2. Review of an example of a performance improvement project in the eye clinic on 7/22/14 at about 8:45 AM revealed a "Diabetes Follow-Up PI Worksheet" which was completed over a quarter-period. The worksheet contained a listing of randomly selected patients who have had a dilated fundus examination within the last 18 months. While data gathered for the second quarter of 2014 revealed that 88% of patients on the list have had the examination, no documentation was available as to reasons for the project being conducted, the goals to be reached, and measurable progress achieved so far. During an interview, an optometry staff stated that the clinic was just gathering and reporting the data to the QAPI coordinator.

3. In the pediatric clinic, a licensed staff interviewed on 7/24/14 at 9:00 AM during the tour explained that performance improvement projects (in the clinic) included employee PMAPs and staff training. When asked if there were patient care, hospital service-specific performance improvement projects, the staff stated that she could not think of any.



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4. During an interview on 7/24/14, the performance improvement/risk management coordinator confirmed that the hospital did not have a defined performance improvement project.

Based on observation, interview, record review and policy review, the hospital failed to assure that the hospital policy was followed for one medication administration observed.

The findings included:

On 7/23/14 at 11:00 AM, the registered nurse (RN) was observed preparing to administrator Famotidine 20 mg IV to patient (#10). The surveyor stopped the nurse just prior to administration, the IV bag was hung on the administration pole and the nurse was ready to insert the cannula. The medication was labeled for patient (#5). At that time, the nurse agreed that the medication was not labeled for patient (#10).

The hospital policy titled "Preparation and Administration of Drugs" was received on 7/23/14 at 11:55 AM. The policy was not numbered, signed or dated.

On page 9, the policy stated "The accepted standards of practice require the following be confirmed prior to administration of each medication: The patients' identity..... The patient's identification must be confirmed to be in agreement with the medication administration recorded and medication labeling prior to medication administration to ensure that the medication is being given to the correct patient."

During an interview on 7/24/14 at 2:15 PM, the Inpatient Department Nurse Supervisor confirmed that this was a medication error in the category of "near miss".

Based on record review and staff interview, it was determined that the hospital failed to ensure that medical record entries were complete for 8 of 31 patients (#15 and #25 through #31). Additionally, based on record review of the "Delivery Room Register" Obstetrics (OB) Log (extension of the Emergency Department log) and staff interview, it was determined that the documentation on the OB log was incomplete, inaccurate, and/or did not follow documentation standards for medical records to ensure that information about four patients (#15, #25, #26, and #27) was communicated and documented accurately. The medical record patient orders were not complete for 3 of 3 patient tissue biopsies reviewed and one of one urine dipstick result and order.

The findings included:

1. Record Review

Closed record review for patient #15 revealed that the patient presented to the Emergency Department (ED) on 5/30/14 at 2:01 AM with a chief complaint of "ob in labor". The patient was noted to be "28 weeks?".

Review of the patient's Inpatient Nurse Admission note timed at 2:10 PM included:

"Diagnosis of preterm labor with a history of pre-term labor on last pregnancy.
Pain was rated at 10 out of 10.
No fetal heart tones.
Contractions every 2 - 3 (minutes), lasting 30 - 60 seconds, strong.
Dilated 10.
Effaced 100%.
Presentation breech.
Membranes intact.

Admission Note: SVE (sterile vaginal exam) done completely diated (sic)
with bulging bag. ER doctor notified, _____(OB doctor's name), ____(Pediatrician's name) notified all are on their way in. Attempted to start IV X 5. Blood drawn & sent to lab."

Labor & Delivery Summary:

Chronology:
Estimated Date of Confinement: 8/28/14
Admission: 5/30/14 @0210
Membranes Ruptured: 5/30/14 @0235
Onset of Labor: 5/30/14 @0130
Complete Dilatation: 5/30/14 @0215
Delivery of Infant: 5/30/14 @0420
Delivery of Placenta: 5/30/14 (no time was noted).

Delivery Events:
Membranes Rupture: Intact
Method of Delivery: Vaginal, Forceps
Position of patient for delivery: (blank)
Prep Type: Betadine
Presentation: Breech

Delivery Medication Anesthesia: Spinal
IV fluids: Spinal
IV medications: (blank)

Delivered by: Physician

Infant data: Male, Still born

Date/time: 5/30/14 @0330
Data: To OR via the bed.

Date/time: 5/30/14 @0440
Data: Traumatic delivery of Fetus in OR at 0420."

a. Review of the patient's Intraoperative Care Plan appeared to be a standardized form with nursing diagnosis, potential for stated problem, outcome, and nursing interventions. Several of these plans were not appropriate for the patient. For example:

i. The patient did not have a surgical incision. The potential was for infection relation to surgical wound. The interventions included use sterile drapes, supplies, instruments; proper 10 min surgical scrub by all team members; proper gowning and gloving; constant surveillance of surgical field for breaks in technique and quick correction if they occur; Betadine scrub and solution preparation for 10 min.

ii. The potential for blood loss related to extensive surgical resection was not appropriate for a patient who did not have surgery.

b. The OB physician's documentation, dated 5/30/14, related to this patient and the patient's delivery included:

i. 7:00 PM - history and physical with a plan "routine postpartum care after delivery of fetal head in the OR with Piper forceps (note was written about 14 1/2 hours after the delivery).

ii. 9:11 PM - description of what had occurred leading up to and during the delivery (note was written about 17 hours after the delivery).

c. Review of the patient's Postoperative Care Plan appeared to be a standardized form with nursing diagnosis, potential for stated problem, outcome, and nursing interventions. Several of these plans were not appropriate for the patient. For example:

i. The potential for physiological injury related to respiratory insufficiency secondary to general anesthesia. The outcome was that the patient would not have respiratory insufficiency. The nursing interventions included maintain airway (ET, oral/nasal); maintain oxygenation (mask or T tube) or as ordered by CRNA. The patient had a spinal, not general anesthesia.

ii. The potential was for anxiety/disorganization related to anesthesia. The outcome was that the patient would return to consciousness. The nursing interventions included assess level of consciousness upon admission, assess level of consciousness and orientation every 15 minutes. The patient had a spinal, not general anesthesia.

iii. The potential related to knowledge deficit regarding post-op care. The outcome will be that the patient is knowledgeable regarding post-op care as evidenced by verbalization of instructions regarding post-op care. The patient had a spinal, not general anesthesia.

d. The patient was discharged to home on the same day as the delivery.

The electronic health record (EHR) for this patient was incomplete, inaccurate and documentation was not completed timely.

2. OB Log

The Delivery Room Register (OB log) information was incomplete. The following were examples:

a. On 5/26/14 patient #25 - no time of admission, no EBL (estimated blood loss) with a C-section.

b. On 5/30/14 patient #15 - no time for rupture of membranes, no EBL.

c. No date (June) patient #26 - no date or time of admission, no age, no rupture of membrane information, no time for placenta delivery, no infant information (except APGAR).

d. No date (June) patient #27 - line drawn through the patient's name and hospital number with no initials, rest of information was not completed.

3. Tissues

a. The tissue biopsy order dated 7/7/14 at 2:09 PM for patient #28 did not identify the type of tissue collected.

b. The tissue biopsy order dated 7/15/14 at 3:10 PM for patient #29 did not identify the type of tissue collected.

c. The tissue biopsy order dated 6/30/14 at 10:00 AM for patient #30 did not identify the type of tissue collected.

d. The tissue biopsy order dated 7/15/14 at 1:48 PM for patient #30 identified one tissue type and two separate tissue biopsies were sent for examination.

During an interview on 7/22/14 at 11:40 AM, the acting laboratory supervisor confirmed that the tissue biopsy orders did not identify the tissue type. The reference laboratory requisitions identified the tissue type. The laboratory department kept copies of the original reference laboratory requisitions. The originals were not scanned into the electronic health record and were discarded after two years.

During an interview on 7/22/14 at 4:00 PM, the laboratory supervisor confirmed that tissue was used in the EHR. The EHR system did not accept the type of tissue as an entry into the medical record.

4. Urine order

On 7/03/14 at 2:34 PM patient #31 presented at the Heart Butte Clinic (HBC), an outpatient clinic of the hospital, with a complaint of urinary tract infection symptoms. The urinalysis test result on the laboratory test strip showed results for different parameters. The EHR had the urinalysis result for blood detected in the urine. Additionally, the EHR did not document an order for urinalysis (UA).

During an interview on 7/24/14 at 10:45 AM, a HBC staff member confirmed that the EHR did not document an urinalysis order or urinalysis result for patient #31.

During an interview on 7/24/14 at 1:10 PM, the Medical Records Supervisor confirmed that the EHR did not document an urinalysis order or urinalysis result for patient #31.

Based on observation and interview and record review, the hospital failed to ensure outdated, mislabeled or otherwise unusable drugs and biologicals were not available for patient use. Using expired or outdated medications could lead to potential concerns related to the medication's sterility, stability, and potency.

The findings included:

1. On 7/21/14 at 10:15 AM, the perioperative and operative areas were inspected in the presence of the operating room manager. The temperature of the blanket warmer in the ante-room between operating room 1 and operating room 2 was noted to be 110 degrees Fahrenheit (F). The warmer was observed to contain multiple blankets and several intravenous (IV) and irrigations solutions. A one liter bag of intravenous 0.9% normal saline solution was observed in the warmer; the outer wrapping of the solution had no date and the manager could not determine when the solution was placed in the warmer. During a concurrent interview she indicated all solutions should be labeled with the date when they were placed in the warmer. She also stated the solutions were only good for 14 days from the date placed in the warmer. On further interview it was revealed that the facility policy on multi-dose medications is to label the vial with the date first opened and the initials of the individual opening the medication; the vial is to be considered good for 30 days from the date in which it was opened.

2. Other expired or unlabeled medications identified and acknowledged by the manager of the surgical department included:

-One 500-ml bag of intravenous Mannitol 20%, expired June 2014;

-One opened multidose 20-ml vial of Xylocaine 1% which was not labeled with the date opened or initials of the person who opened the vial;

-One sealed 50-ml vial of Lidocaine 1% with epinephrine 1:100,000, expired 06/06/2014; and

-Three 100-ml intravenous bags of 0.9% normal saline solution, expired May 2014.

3. The Hospria manufacturer's recommendations regarding intravenous and irrigation solutions noted: "Solutions for injection and irrigation in PVC and CR3 plastic flexible containers, in their overwraps, may be warmed at a temperature not to exceed 40 degrees Celsius (104 degrees F) unless specified otherwise on the product label), and for a period no longer than two weeks (14 days)." The temperature of the blanket warmer was noted on 7/21/2014 to be 110 degrees F.



04748

4. An observation was made in the Emergency Department (ED) on 7/23/14 at 11:15 AM, in the presence of the ER Nurse Supervisor. The bags of intravenous solutions in the warmer were taken out by the ER Nurse Supervisor. One bag of Mannitol 20% 500 cc was dated to have been put in the warmer on 7/7/14. The ER Nurse Supervisor verified that the solution should have been removed in two weeks or on 7/21/14.

Based on interview and record review the hospital failed to ensure consistency on policies and procedures regarding drugs and biologicals and automatic stop orders. Failure to have consistency in automatic stop orders could lead to overdosing and/or antibiotic resistance.

The findings included:

1. On 7/23/14 10:00 AM, during an interview with the Director of Pharmacy (DOP) it was determined that the hospital policy regarding automatic stop orders for antibiotics and narcotics were 30 days and 72 hours respectively.

On that same date the hospital policy titled Automatic Stop Orders was reviewed. The policy stated that "All medication orders of unspecified length of treatment are subject to automatic discontinuation .... Established automatic stop times are as follows, unless the chart order indicates the exact number of doses or specifies the length of time such therapy shall be administered:
-Narcotics-72 hours;
-Toradol-5 days only;
-All other medications-30 days."

2. On 7/24/14 the Rules and Regulations of Medical Staff of the United States Public Health Service, Indian Health Service Hospital at Browning were reviewed and shared with the DOP. Article IV addresses General Medical Care and under subparagraph 4.5 noted, "Automatic stop orders will be established per policy. Stop orders shall include:
-Antibiotics longer than 7 days;
-Narcotics in excess of longer than 3 days (72 hours);"

The DOP acknowledged the inconsistencies in current practice, facility policy, and in the rules and regulations of the medical staff.

Based on staff interview and policy review, the hospital failed to have a policy describing the requirements for macroscopic only examination or both microscopic and macroscopic tissue examination.
The findings included:
During a tour of the laboratory on 7/21/14 at 11:20 AM, the policy for the requirements for tissue examination was requested. The acting laboratory supervisor provided the policy titled "Policy for Pathology Tracking Process "(no policy number). The policy was approved by the governing body on 2/26/14.
The policy addressed the tracking of pathology specimens not the requirements for macroscopic only or both microscopic and macroscopic examination. In the same interview, the acting laboratory supervisor stated that the reference laboratory decided whether to perform a macroscopic or both a microscopic and macroscopic examination on tissue specimens sent for testing.
During an interview on 7/22/14 at 4:00 PM, the laboratory supervisor confirmed that the laboratory did not have a policy for tissue examination requirements.

Based on staff interview and policy review, the hospital failed to establish a policy (look back policy) for when the hospital is notified that blood or blood components the hospital received have increased risk of transmitting hepatitis C virus (HCV) or human immunodeficiency virus (HIV).

The findings included:

During a tour of the hospital laboratory on 7/21/14 at 11:20 AM, the look-back policy was requested. At that time, the acting laboratory supervisor stated the hospital would follow directions from American Red Cross Blood Services (the outside blood collecting establishment). The look-back policy is in the American Red Cross Blood Services manual.

On 7/22/14 at 9:10 AM, the hospital performance improvement/risk management coordinator provided the American Red Cross Blood Services manual. The surveyor reviewed the American Red Cross Blood Services manual and a look-back policy was not found.

On 7/22/14 at 11:50 AM a letter dated March 31, 1999 from the American Red Cross Blood Services was provided as the hospital look-back policy. The letter did not address the hospital actions, documentation, and notification requirements if the hospital was notified that blood or blood components the hospital received have an increased risk of transmitting HCV or HIV.

During an interview on 7/22/14 at 4:00 PM, the laboratory supervisor confirmed that the laboratory did not have a look-back policy.

26031

Based on observation and interview, the hospital did not ensure that the hospital environment was maintained in a manner so that the safety and well-being of patients were assured.

Findings include:

1. During the initial hospital tour on 7/21/14 at about 10:45 AM, the following were observed:

a. Several ceiling tiles above the hallway leading to the inpatient unit were observed with dark colored stains.

b. In the same tour, the fluorescent bulb from the fixture on the wall where the hand washing sink was located in room 247 did not light when the wall switch was turned on.

c. In room 249, an intravenous(IV) pole was used for the patient administrations of intravenous medication. On the IV pole was a dried blood streak about 3 inches long. In an interview, the patient stated that the blood was not hers and that it had been there when the pole was brought to her room upon admission on 7/20/14.

2. During the tour of the eye clinic on 7/22/14, two ceiling tiles above the metal file cabinet in the reception area of the clinic were observed with light brown stains.

3. During a tour of the south clinic on 7/24/14 at about 8:45 AM, the following were observed:

a. A ceiling panel above the door in exam room 15 inside the pediatric clinic was removed from the frame and not replaced exposing wiring and part of plumbing. A clinic unlicensed staff member interviewed stated that someone had been working in the room the previous day. This staff did not know if the work had been completed.

b. Inside exam room 9, torn wall covering was observed adjacent to the door.

4. On 7/22/14 at 10:45 AM, during the tour of the radiology department two holes were noted on the wall next to the patient stretcher in the room where ultrasound round diagnostics were performed. The wall paper covering was torn and peeling away from the wall and measured approximately 3 feet in height by 6 inches in width. The hole where the wall covering was peeling measured approximately 5 inches in length by 1.5 inches in width. The second hole in the wall measured approximately 3 inches in length by 1.5 inches in width.

The department manager acknowledged that if the wall with the holes were inadvertently contaminated by patient secretions the staff would not be able to completely sanitized the wall.

Based on observation and interview, the hospital did not have proper procedures for the storage of trash.

The findings included:

During the building tour on 7/24/14 at about 10:45 AM, the dumpster in which hospital trash was disposed of prior to being compacted was observed wide open. This left several plastic bags of trash exposed and making them accessible to pest, rodents, and stray animals including dogs. When a hospital maintenance staff tried to close the cover, the locking mechanism would not stay in place. In an interview, the maintenance staff stated that the compactor unit belonged to the tribe that picked up garbage for the hospital.

Based on observation and interview the hospital failed to ensure that facility supplies and equipment were maintained to ensure an acceptable level of safety and quality. The use of old supplies could potentially alter the outcome of test results or could impact the number of attempted therapeutic interventions since the integrity of the supplies is not guaranteed once the supplies are expired.

The findings included:

1. On 7/21/14 at 10:15 AM, the surgical department was toured with a Registered Nurse (RN). There were two operating rooms (OR) in the department. While inspecting the ORs and the malignant hyperthermia cart, several sterile supplies were noted to be expired. The RN confirmed that the expired supplies consisted of:
- Thirty inflatable disposable anesthetic face masks, size 1, that expired on 5/2014;
- Eighteen endotracheal tubes, sizes 4 and 8, that had expired between 2012 to 2013; and
- One Arrow Trauma Kit that expired 12/2012.



13533

2. During the initial tour of the inpatient unit on 7/21/14, the following were observed:

a. One package identified as a Bard urethral catheterization tray was observed inside a drawer of the cabinet where the hand washing sink was located in room 246. The tray which was noted to have an expiration of March 2014 was stored with other patient care items.

b. In another drawer of the same cabinet, five packets labeled GE silver mactrode resting ECG electrodes were noted to have an expiration of April 2013. In one other drawer, two packets were also observed with an expiration date of May 2014. These items were kept together with other non-expired ECG packets.

c. Inside the supply room of the inpatient unit where intravenous solutions were stored, six Add-Vantage bags each containing five 100-ml of normal saline solution for injection were noted to have an expiration date of 7/01/14. These were kept together with non-expired saline bags.

d. Inside the crash cart designated for the inpatient unit, the following were observed in the cart past their expiration dates:

i. two (of 3) gripper plus non-coring safety needles with an expiration of May 2014;
ii. three green top vacutainer tubes in a paper cup with an expiration of June 2014;
iii. four purple top vacutainer tubes with an expiration of February 2014; and
iv. one 1000-cc bag of lactated ringers solution with an expiration date of 7/01/14.



04748

3. On 7/21/14 at 10:15 AM, during an initial tour of the Emergency Department (ED) with the ER Nurse Supervisor, the following was observed:

a. The ambulance bay was observed. The ER Nurse Supervisor verified that this was the area where ambulances brought patients to unload them from the ambulance. She confirmed that patients could walk into the ED through this area. Two ambulances were parked in the driveway. Each end of the drive-in area was open.

Multiple chemicals, including a gallon each of antifreeze, Exterior Cleaner, and Bleach and a large spray bottle of Super Clean, were sitting on top of a bedside stand. No staff were observed to be in the open area during the observation. An eye wash station was located close to these chemicals. A mop bucket with mops was on the other side of the eye wash station.

b. On this initial tour in the ED area, the door to a supply room (1534) was observed to be standing open. No staff were present in the area. Multiple patient care supplies were stored here, including boxes of needles and syringes. The sign on the door indicated that the door was to be closed. The ER Nurse Supervisor verified that the door should be kept closed to prevent access to the supplies.

4. On 7/21/14 at 10:45 AM, during an initial tour of the OB unit (delivery room, operating room, and rooms on the unit) with the OB Supervisor, she verified that there was no system for security of the baby. She confirmed that the hospital was working on getting one as they recognized the need to protect the babies. The newborns roomed in with their mothers on the unit.

5. On 7/21/14 at 11:18 AM. during an initial tour of the Kitchen/Dietary Department with the Dietary Manager (DM), the following observation was made. In the reach-in refrigerator, there was a tray with meat thawing on it. The DM verified that it was stew meat thawing for use on another day. The blood was observed on the tray and spilled on the bottom shelf.

6. The following observations were made in the kitchen on 7/22/14:

a. At 11:35 AM, in the presence of the DM, there was dried blood on the shelf and a large amount in the tray with the thawing stew meat. Another tray of thawing meat had been placed on top of the dried blood.

b. At 11:40 AM, the dietary staff were observed plating the noon meal. The cook was observed to pick up a piece of chicken breast with tongs. She then placed the chicken breast in her gloved hand, placed the chicken on the scale, picked up the chicken with her gloved hand and placed it on the plate. Without changing her gloves, she proceeded to plate several more plates for other patients. The DM was present during this observation. The observation was discussed with the DM and the Registered Dietician (RD). They confirmed that the cook should have changed her gloves and done handwashing.

7. On 7/23/14 at 11:15 AM an observation of the medication room in the Emergency Department (ED) was made in the presence of the ER Nurse Supervisor. Eleven Add-Vantage bags of 100-ml of normal saline solution for injection were noted to have an expiration date of 7/01/14. These were kept together with non-expired saline bags.

Based on observation, interview, and record review the hospital failed to ensure the development and implementation of a system for controlling potential infections related to the processing and storage of endoscopes. Additionally, patient care equipment was observed lying on the floor.

The findings included:

1. On 07/21/14, observations were completed of the entire Surgical Department.

2. On 7/22/14 specific interviews were conducted with the Operating Room nursing staff and the Infection Control Officer. The staff reported that endoscopies are performed in surgical suite number two and continue to detail the steps that would be taken for the processing of the endoscopes. They stated after the procedure the scope is grossly decontaminated in the room and placed in a plastic bag. The plastic bag is walked from surgical suite 2 through 2 doors and down the hall approximately 45 feet then through another 2 more doors to the manual instrument processing area. After the scope is manually processed with disinfectants it is then placed in a different plastic bag and walked back, through 4 doors, approximately 45 feet to the operative suite's anteroom. The anteroom is where the high level disinfection Medivator Reprocessing System is housed. The staff reported after the scope has been processed by the Medivator it would be ready for use by another patient or it could be stored in a plastic bin that was lined with a blue absorbent disposable pad.

3. According to the Society of Gastroenterology Nurses and Associates Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes (2012) "flexible endoscope reprocessing has been shown to have a narrow margin of safety. Any slight deviation from the recommended reprocessing protocol can lead to the survival of microorganisms and an increased risk of infection." The reprocessing of contaminated patient equipment must be done in an area designated and dedicated for this function." A recommendation regarding storage include that the endoscopes "should be stored in a manner that will protect it from contamination. Hang the endoscope in a vertical position to facilitate drying." The "storage area should be clean, well ventilated and dust free thus discouraging any microbial contamination."

4. On further interview the nursing staff and the Infection Control Officer acknowledged the potential for cross contamination related to current endoscope processing and storage practices. Tentative facility reconstruction plans to address identified concerns were also presented.



04748

5. On 7/21/14 at 3:15 PM, an observation made on the inpatient unit revealed that patient #12's catheter bag was partially lying on the floor. The bag was not covered.

6. On 7/23/14 at 10:20 AM, an observation made on the inpatient unit evidenced that patient #12's catheter bag was lying on the floor. The bag was not covered.

Based on record review and interview, the hospital did not identify at an early stage of hospitalization two patients (#7 and #8) who were likely to suffer adverse consequences if there was no adequate discharge planning upon discharge.

The findings included:

1. Patient #8 was admitted to the hospital as an "observation patient" on 7/16/14, and as an inpatient on 7/18/14 with several diagnoses including neuropathic pain, chronic interstitial lung disease, and seizure disorder.

Review of the electronic health record (EHR) revealed a nursing admission assessment dated 7/16/14 which described the patient's functional status and complaints of weakness and shortness of breath. The discharge planning data field however was noted to be blank.

Review of the Discharge Planning policy and procedure (reviewed 2/2013) noted that the initial assessment/evaluation for discharge planning needs is conducted during the nursing admission assessment..."

Further record review revealed that no update to the admission assessment (dated 7/16/14) was made when the patient was admitted as an in-patient on 7/18/14. There also was no indication that the discharge planning assessment was completed to reflect whether the patient needed a discharge planning referral.

During an interview on 7/23/14, a discharge planning staff stated that Patient #8 will need discharge planning because of his medical condition and that his respiratory status indicated consideration for oxygen use at home. The discharge planner added that she will also need to coordinate with nursing staff about conducting trials to determine if the patient could qualify to receive financial assistance for the use of oxygen (at home).

A discharge planning note dated 7/23/14 documented the first discharge planning encounter with Patient #8 and revealed further follow-up by the discharge planner to determine whether the patient would need to go home on oxygen based on the physician's review of his lung function.

Review of the hospital's Discharge Planning Guidelines (revised 5/24/14) revealed that "discharge planning interventions shall be initiated at the earliest possible time in the patient's hospitalization to optimize patient/family outcomes and reduce hospitalization rates."

2. Patient #7 was admitted to the hospital on 7/18/14 with several diagnoses including diabetes mellitus, urinary tract infection, and possible pressure sore. Review of the electronic medical record revealed that the patient was alert, had slurred speech, and "extremely hard of hearing despite hearing aid." Accordingly, the patient presented to the emergency department with several complaints including feeling cold and failure to take medications. A history and physical examination by the physician dated 7/18/14 also noted urine retention and malnutrition "of some degree."

Review of the hospital's policy and procedure on Discharge Planning (reviewed 2/2013) revealed that discharge planning was a process for identifying and evaluating patient needs including activities of daily living, emotional, medications, and nutrition. The P&P also noted that need for long term care as well as for other community agencies were also services under discharge planning.

Review of the nursing admission assessment dated 7/18/14 revealed that, notwithstanding the P&P above, Patient #7's assessment noted that there were "No needs identified" for social services referral and/or discharge planning. In addition, there was no indication that ongoing assessments were conducted by nursing staff to ensure that needs were identified "in the earliest time possible" and referred to social service or discharge planning. In an interview on 7/24/14, a utilization review staff member stated that the hospital's average length of inpatient stay was 3 - 4 days.

During an interview on 7/23/14,the discharge planner stated that Patient #7 needed discharge planning and that she had met with the patient on 7/21/14 to discuss concerns as well as possible discharge options including admission to a nursing home for 24-hour care because of her physical condition and need for wound care.

Based on interview and record review, the hospital failed to ensure post-anesthesia evaluations were written in accordance with hospital policies and that reflected current standards of anesthesia care for one sampled and five closed surgical cases (sample patient #3 and un-sampled patients #19, #20, #15, #21, and #25). Failing to complete and document assessments of: respiratory and cardiovascular function; mental status; temperature; nausea & vomiting; pain; and post-operative hydration could potentially contribute to not identify post-anesthesia complications.

The findings included:

On 07/22/14 the electronic and paper medical records of five closed un-sampled surgical cases and one sampled surgical case were reviewed with a Registered Nurse (RN). Later that same date the cases were reviewed with an anesthesia provider, it was stated the post anesthesia assessment could be written on the Anesthesia Medical Record or in the progress notes. Both staff members validated the Post Anesthesia notes section in 3 of the 6 surgical cases reviewed included the following comments:

1. Sample patient 3: "98, 74, 110/75, 16, 98%B"

2. Un-sampled patient 19: "98.6, 84, 20, 125/72 and 97%; No NV."

3. Un-sampled patient 20: The note area was completely blank.

On that same date the facility policy addressing Post-Operative Anesthesia Care policy was reviewed. The policy states "A full report will be given to the PACU (Post Anesthesia Care Unit) nurse receiving the patient, and the Anesthesia provider must perform a post-operative evaluation before the patient leaves the PACU which will included (SIC) but not limited to the following:
"Patient's condition:
- Type of surgery
- Cardiovascular Function, pulse rate and blood pressure
- Temperature, Mental status, Pain control
- Nausea and vomiting
- Hydration and fluid type
- Blood loss, urinary output, fluid intake and type
- Intra-operative vital signs
- Post-operative vital signs
- Level of consciousness and any adverse event that occurred during the anesthetic course " ...
"The attending Anesthetist is responsible for post anesthesia care of all patients who have received anesthesia. This includes documentation of all post anesthesia visits."

The "Practice Guidelines for Post-anesthetic Care: An Updated Report by the American Society of Anesthesiologist Task Force on Post-anesthetic Care (February 2013)" is an update of recommendations originally published in 2002. While the American Society of Anesthesiologist (ASA) practice guidelines are not intended as standards or absolutes "They provide basic recommendations that are supported by a synthesis and analysis of the current literature, expert and practitioner opinion, open forum commentary, and clinical feasibility data." The purpose of the Guidelines are to improve post-anesthetic care outcomes. "....These Guidelines focus on the pre-operative management of patients with the goal of reducing post-operative adverse events,"..."These Guidelines apply to patients of all ages who have just received general anesthesia, regional anesthesia, or moderate or deep sedation. The Guidelines may need to be modified to meet the needs of the certain patient populations." Based on the article and recommendations the "Perioperative and post anesthetic management of the patient includes periodic assessment and monitoring of respiratory function, cardiovascular function, neuromuscular function, mental status, temperature, pain, nausea and vomiting, fluid assessment, urine output and voiding, and drainage and bleeding." On 7/22/14 the anesthesia provider acknowledged the previously cited cases did not contain an evaluation of the elements as outlined within the facility policy or as recommended by the ASA.



04748

Record review of patient #21's "Temp IHS Form-41213 pb" (surgery information) revealed no post anesthesia evaluation. This patient had a Caesarian Section with spinal anesthesia on 5/6/14. The patient received two units of packed red blood cells and two units of fresh frozen plasma.

Record review of patient #25's "Temp IHS Form-41213 pb" (surgery information) revealed no post anesthesia evaluation. This patient had a Caesarian Section with spinal anesthesia on 5/27/14.

Record review of patient #15's "Temp IHS Form-41213 pb" (surgery information) revealed no post anesthesia evaluation. This patient had a dilation and curettage (D & C) done on 5/30/14 with spinal anesthesia.

On 7/23/14, the Director of the Medical Records Department, verified that no post anesthesia assessments were found for these three patients (#21, #25, and #15). She provided the patients' surgical forms which was where she said the assessments would be found.