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Based on staff interview and review of medical records and Medical Staff Bylaws, credentials files, meeting minutes, quality documents, IC documents, and hospital policies, it was determined the hospital's governing body failed to ensure it assumed responsibility for the conduct of the hospital. The governing body failed to provide leadership and oversight of the hospital's programs and systems. This resulted in a lack of appropriate systems, a lack of relevant policies and procedures, and a lack of direction to staff. Findings include:

1. Four "Hospital Governing Board Meeting" minutes were documented in the year preceding the start of survey on 8/09/11. These dates were 7/26/11, 4/23/11, 1/25/11, and 10/21/10. The minutes included:

a. The 7/26/11 meeting minutes documented discussion of privileges for a physician assistant whose credentials file had been damaged. This meeting also discussed credentialing for a physician who occasionally covered for the psychiatrist medical director.

b. The 4/23/11 meeting minutes documented discussion of the mission statement and involuntary hold contracts.

c. The 10/21/10 meeting minutes documented a new DNS started working at the hospital. The Board discussed the coordination of social workers and the review of staffing needs. The Board discussed a physician "taking medical duties for both parts of the operation."

None of the "Hospital Governing Board Meeting" minutes discussed care provided at the hospital, systems of care provided at the hospital, accountability of the Medical Staff, specific departments of the hospital, quality improvement programs, infection control programs, care provided by contract services, or updating hospital policies.

The Administrator was interviewed on 8/12/11 beginning at 4:30 PM. He stated there was no record of the governing body monitoring care at the hospital or discussing care systems and services.

The governing body did not oversee care provided at the hospital.

2. The governing body failed to ensure members of the Medical Staff were appointed by the Governing Body. Refer to A46 as it relates to the lack of formal appointments to the Medical Staff.

3. The governing body failed to ensure the Medical Staff was accountable to the governing body for the quality of care provided to patients. Refer to A49 as it relates to the lack of oversight of the Medical Staff by the governing body.

4. The governing body failed to ensure the CEO was responsible for managing the hospital. Refer to A57 as it relates to the lack of oversight of the CEO by the governing body.

5. The governing body failed to assume responsibility for contracted laboratory services. Refer to A83 as it relates to the lack of oversight of laboratory services.

6. The governing body failed to ensure policies and procedures for the appraisal and initial treatment of emergencies had been developed and implemented. Refer to A93 as it relates to the lack of services for the diagnosis and treatment of medical emergencies at the hospital.

7. The governing body failed to ensure patient rights were protected and promoted. Refer to A115 as it relates to the lack of systems in place to protect patient rights.

8. The governing body failed to ensure an effective, ongoing, hospital-wide, data-driven QAPI program had been developed, implemented and maintained. Refer to A263 as it relates to the lack of systems in place to measure the quality of care provided by the hospital.

9. The governing body failed to ensure the Medical Staff was organized and was responsible for the quality of medical care provided to patients by the hospital. Refer to A338 as it relates to the lack of oversight of the Medical Staff.

10. The governing body failed to ensure the nursing services were well-organized and effectively met the health care needs of patients. Refer to A385 as it relates to the lack of nursing care provided to patients.

11. The governing body failed to ensure laboratory services met the needs of patients. Refer to A576 as it relates to the lack of laboratory services provided by the hospital.

12. The governing body failed to ensure a sanitary environment was provided and also failed to ensure an active program for the prevention, of infections was maintained. Refer to A747 as it relates to the lack of an organized IC program.

The cumulative effect of these systemic omissions resulted in a lack of leadership for hospital staff.

Based on staff interview and review of medical records and hospital policies, it was determined the hospital failed to ensure patient rights were protected and promoted. This resulted in the lack of systems to inform patients of their rights and the lack of systems to involve patients in the protection of their rights. Findings include:

1. Refer to A117 as it relates to the hospital's failure to ensure patients were informed of all of their rights in advance of providing services.

2. Refer to A118 as it relates to the hospital's failure to ensure a system had been developed and implemented for the prompt resolution of patient grievances.

3. Refer to A143 as it relates to the hospital's failure to ensure personal privacy was provided for patients.

4. Refer to A144 as it relates to the hospital's failure to ensure care was provided in a safe setting.

5. Refer to A148 as it relates to the hospital's failure to ensure patients had the right to access information contained in their clinical records.

The cumulative effect of these systemic problems resulted in the the inability of the hospital to promote and protect the rights of patients.

Based on staff interview and review of hospital policies, quality documents, and governing body meeting minutes, it was determined the hospital failed to ensure an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program had been developed, implemented and maintained. This resulted in the hospital's inability to assess its systems and processes of care. Findings include:

1. The hospital failed to ensure the QAPI program included quality indicators and that those indicators showed measurable improvement over time. Refer to A265 as it relates to the lack of a defined QAPI program at the hospital.

2. The hospital failed to ensure the QAPI program measured, analyzed, and tracked quality indicators, including adverse patient events. Refer to A267 as it relates to the lack of development and analysis of quality indicators.

3. The hospital failed to ensure quality indicator data was incorporated into its QAPI program. Refer to A274 as it relates to the lack of quality indicator data.

4. The hospital failed to ensure the frequency and detail of data collection for its QAPI program was specified by the hospital's governing body. Refer to A277 as it relates to the lack of direction from the governing body.

5. The hospital failed to ensure priorities for its QAPI activities had been defined. Refer to A285 as it relates to the lack of definition for QAPI activities.

6. The hospital failed to ensure performance improvement projects were conducted as part of its QAPI program. Refer to A297 as it relates to the lack of performance improvement projects.

7. The hospital failed to ensure the governing body assumed responsibility to define, implement, and maintain its QAPI program. Refer to A310 as it relates to the lack of the governing body's involvement in the quality improvement program.

The cumulative effect of these negative systemic practices seriously impeded the ability of the hospital to assess its systems and processes of care.

Based on staff interview and review of Medical Staff Bylaws and meeting minutes, it was determined the hospital failed to ensure the Medical Staff was organized and was responsible for the quality of medical care provided to patients by the hospital. This resulted in a lack of direction to members of the Medical Staff and the inability of the Medical Staff to fulfill its duties. Findings include:

1. The hospital failed to ensure members of the Medical Staff were appointed by the governing body. Refer to A339 as it relates to the lack of a system to appoint members to the Medical Staff.

2. The hospital failed to ensure the Medical Staff conducted appraisals of its members . Refer to A340 as it relates to the absence of Medical Staff appraisals.

3. The hospital failed to ensure the Medical Staff examined the credentials of candidates for medical staff membership and made recommendations to the governing body on the appointment of those candidates. Refer to A341 as it relates to the lack of participation by the Medical Staff in the appointment process.

4. The hospital failed to ensure the Medical Staff was well organized and accountable to the governing body. Refer to A347 as it relates to the lack of organization and accountability.

The cumulative effect of these negative systemic practices resulted in the inability of the Medical Staff to assure its members were qualified and to perform their duties and prevented them from obtaining feedback on the quality of medical care provided to patients.

Based on staff interview, review of patients' clinical records, policies and procedures, and observations, it was determined the hospital failed to ensure nursing services were organized to effectively meet the health care needs of psychiatriac patients who had additional medical conditions and needed specialized monitoring of their ongoing health status needs. The findings include:

1. Refer to A395 as it relates to the failure of the facility to ensure a registered nurse provided each patient with initial and on going evaluation of his/her health care needs and supervised the delivery of nursing services.

2. Refer to A396 as it relates to the failure of the facility to ensure nursing staff developed and kept current, a care plan for each patient.

3. Refer to A405 as it relates to the failure of the hospital to administer medications as ordered by the physician, and document verification of insulin dosage with a second licensed nurse before administration for diabetic patients.

The cumulative effect of these negative systemic facility practices had the potential to place the health and safety of patients with underlying medical needs at risk.

Based on observation, staff interview, and review of medical records and laboratory policies and contracts, it was determined the hospital failed to ensure laboratory services met the needs of 3 of 20 patients (#1, #7, and #13), whose records were reviewed. The inadequate laboratory services had the potential to affect all hospital patients. This resulted in delayed testing and in the need for patients to have blood re-drawn unnecessarily. Findings include:

1. The hospital had a contract with a Boise, Idaho laboratory to provide laboratory services. The contract between the hospital and the laboratory, dated 2/02/09, stated the laboratory would provide supplies for specimen collection and transportation and would be responsible for the cost of transporting specimens. The contract did not specify who would transport specimens or how they would be transported to the laboratory.

Hospital policies did not define a procedure for the collection and transportation of specimens.

The DNS was interviewed on 8/10/11 at 12:30 PM. She stated the contract and policies did not describe specimen collection and transportation services. This led to confusion and delays in processing blood specimens as follows:

In the DNS office, on 8/09/11 at 3:35 PM, a centrifuge used for the separation of blood specimens was observed on the counter. In the centrifuge were three yellow top unlabled test tubes and one red top test tube. (The yellow top tubes did not appear to contain blood specimens). The red top test tube contained a specimen with a label indicating it was from Patient #1, and was drawn at 6:00 AM. On the counter in front of the centrifuge were two plastic zip-lock bags. Each bag contained a purple top test tube of blood, one was labled for Patient #1 and contained a requisition for a CBC, LFT, and VPA level. The other bag was labled for Patient #13 and contained a requisition for a Free T4, TSH, RPR, and B-12.

During an interview on 8/09/11 at 3:40 PM, the DNS stated the courier for the laboratory would come to the facility on a daily basis before noon, and she was surprised to see the specimens on the counter at that time. The DNS removed the specimens, stating they were expired, and the labs would be re-drawn from the patients the next morning.

The lack of clear processes for handling laboratory specimens led to delays.

3. Patient #7's medical record documented a 50 year old male who was admitted to the hospital on 5/14/11 and was discharged on 5/23/11. His diagnoses included bipolar disorder and psychosis. He was seen in the ED at an acute care hospital on 5/14/11 prior to being transferred to Safe Haven Hospital. The laboratory report from the acute care hospital stated his serum potassium level was low at 2.6. The report stated the normal potassium level was 3.6-5.2. An "ADMISSION HISTORY AND PHYSICAL," dated 5/15/11, stated the plan was to check his potassium level on 5/16/11 after he had taken potassium supplements. A order for potassium testing was written at that time. The note stated "The patient will need to be observed for evidence of neruologic changes, complaints of rhythmic disturbance." A potassium level was not completed until 5/18/11, when it measured 3.4. No reason for the delay in the laboratory testing was present in the medical record.

The DNS reviewed Patient #7's medical record on 8/10/11 at 12:30 PM. She stated the potassium level should have been completed on 5/16/11. She stated she did not know why the testing was delayed.

The hospital failed to test Patient #7's potassium level as ordered.

4. The DNS was interviewed on 8/10/11 at 12:30 PM. She stated blood specimens were drawn by nurses prior to breakfast and were stored until a courier picked them up at noon for transport to the laboratory (approximately 238 miles away). She stated procedures which described how nurses were to care for the specimens had not been developed.

The hospital did not develop procedures to direct staff in the collection and handling of laboratory specimens.

5. The hospital failed to ensure an accurate written description of laboratory services was available to staff. Refer to A584 as it relates to conflicting information regarding the hospital's on site laboratory capabilities.

The cumulative effect of these systemic problems resulted in the inability of the hospital to ensure laboratory testing was completed in a timely manner.

Based on observation, staff interview, and review of hospital policies, IC logs, and meeting minutes, it was determined the hospital failed to ensure a sanitary environment was provided. In addition, the hospital failed to ensure an active program for the prevention, control, and investigation of infections and communicable diseases was maintained. This resulted in a lack of direction to staff regarding infection control practices and increased the risk of infections for all patients. Findings include:

1. The hospital did not maintain a sanitary environment. Examples include:

a. Surveyors observed the DNS' office on on 8/09/11 at 3:35 PM. the office contained the DNS' desk and another desk used by the psychiatrist for conferences with patients and their families. A centrifuge and a fax machine sat on a counter which was approximately 5 feet long. In the centrifuge were three yellow top un-labeled test tubes and one red top test tube. (The yellow top tubes did not appear to contain blood specimens). The red top test tube contained a blood specimen. On the counter in front of the centrifuge were two plastic zip-lock bags with red, indicating they contained a biohazard product. Each bag contained a purple top test tube of blood. The end of the counter contained a sink. The sink's faucet did not work. The laboratory area was not separated from the rest of the office. This increased the exposure of patients and staff to bloodborne pathogens.

During an interview on 8/09/11 at 3:40 PM, the DNS, who was also the IC Officer, stated blood was spun in the centrifuge and specimens were kept in the area for pickup by a courier for transport to the laboratory. She stated the courier would come to the facility on a daily basis before noon. The DNS removed the specimens, stating they were expired. The DNS stated the sink was unusable and said the office had no area to wash hands.

The hospital did not isolate areas where blood was handled and stored from staff and patients. In addition, the hospital did not provide hand washing facilities for staff who handled blood.

b. On 8/11/11 at 3:45 PM, during a tour of the medication preparation area, the medication cart was inspected. The medication cart had a folded towel on the top, with a large plastic bucket on top of the towel. The plastic bucket contained straws, spoons, and small plastic medication administration cups. Resting on the back of the towel, behind the patient medication supplies, was an electric shaver. The shaver was connected to a cord, which was plugged in at the wall outlet directly behind the medication cart. The shaver was examined, and particles of hair and skin debris dropped onto the towel.

In an interview on 8/11/11 at 3:50 PM, the Charge Nurse stated the shaver belonged to Patient #10, and she stated he had used it that morning. The Charge Nurse stated she did not know if the facility had a policy regarding storage and cleaning of patient hygiene supplies.

c. On 8/11/11 at 4:00 PM, the second drawer of the medication cart contained two 10 ml vials of Sterile Water. The vials had been opened, were partially full, and undated. "Single Use Only," and "Preservative Free" was printed on the vials.

In an interview on 8/11/11 at 4:00 PM, the Charge nurse stated the sterile water was used to reconstitute IM medications, and it was a practice to store partially full vials in the medication care to be used again.

2. The hospital did not maintain an active program for the prevention, control, and investigation of infections and communicable diseases. Examples include:

The IC Officer was interviewed on 8/10/11 at 4:00 PM. IC Committee meeting minutes were requested from 8/01/10 through 8/10/11. The IC Officer stated the IC Committee had the same participants as the Unit Leadership Team and IC minutes were included as part of the Unit Leadership Team minutes.

Unit Leadership Team minutes were dated 12/31/10, 1/28/11, 3/25/11, 4/22/11, 5/06/11, and 8/05/11. None of the Unit Leadership Team minutes contained documentation of any discussion related to IC.

No documentation was present that the IC Committee had examined or approved current infection control practices at the hospital. No documentation was present that the IC Committee had examined or approved hand hygiene procedures, laboratory procedures, surveillance procedures, isolation procedures, employee health policies, housekeeping procedures and chemicals, and procedures for dealing with multi-drug resistant organisms. No documentation was present that the IC Committee had examined the hospital environment for potential IC threats.

Also, no documentation was present that the IC Committee had discussed the hospital's ability to accept and treat patients with various infections. According to the Infection Control Log, 4 patients with MRSA infections had been treated at the hospital since May 2011. No documentation was present that the IC Committee had examined the hospital's ability to care for these patients or the risks it presented to other patients and staff.

In an interview on 8/25/11 at 9:50 AM, the IC Officer stated IC issues had been discussed at Unit Leadership Team meetings but confirmed there was no record of this or other IC Committee activities. She also stated the IC Committee had not taken any formal actions affecting the care of patients at the hospital.

3. The hospital failed to ensure the IC Officer developed and implemented policies governing control of infections and communicable diseases. Refer to A748 as it relates to the lack of involvement by the IC Officer in the maintenance of policies.

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure patients and staff would be protected from infections organisms.

Based on staff interview and review of medical records and Medical Staff Bylaws and credentials files, it was determined the hospital failed to ensure 5 of 5 members of the Medical Staff (Physicians A-C and Physician Assistants D and E) were appointed by the Governing Body. This resulted in the inability of the Governing Body to ensure medical staff personnel were qualified to perform their duties. Findings include:

Medical Staff Bylaws, dated 1/15/08, stated initial appointments to the Medical Staff were provisional for a period of 6 months and reappointments were for a period of 2 years. This had not been followed.

Three physicians and 2 physician assistants practiced at the hospital. A review of credentials files beginning at 11:30 AM on 8/10/11 revealed:

a. Physician A had not been reappointed to the Medical Staff since 2004.

b. Physician B had not been appointed to the Medical Staff.

c. Physician C had been granted temporary clinical privileges on 11/10/09. These had expired on 5/10/10. He had not been reappointed to the Medical Staff.

d. "HOSPITAL GOVERNING BOARD MINUTES," dated 7/26/11, stated Physician Assistant D was "given temporary privileges due to water damage of her original packet." However, Unit Leadership Team minutes, dated 1/28/11, stated Physician Assistant D was practicing at the hospital at that time. No documentation was present to show that she had been appointed to the Medical Staff prior to being granted temporary privileges on 7/26/11.

The Administrator, interviewed on 8/10/11 at 3:30 PM, confirmed the above practitioners had not been appointed or reappointed to the Medical Staff.

e. On 8/12/11 at 4:30 PM, the Administrator stated Physician Assistant E also practiced at the hospital. The Administrator stated he had not been appointed to the medical staff.

The hospital had not appointed or reappointed members of the Medical Staff.

Based on staff interview and review of meeting minutes, it was determined the governing body failed to ensure the Medical Staff was accountable to the governing body for the quality of care provided to patients. This resulted in the inability of the governing body to ensure the Medical Staff carried out its duties. Findings include:

1. Two physicians, a psychiatrist and a family practice physician, had signed "Medical Director Service Agreements," dated 4/01/11. Both contracts were identical and stated they agreed "to provide medical director services..." The contracts also stated the duties the Medical Directors would fulfill included "assist in defining the scope and characteristics of patient services provided by the facility...assist in development and implementation of Facility policies and procedures...ensure quality control through participation in the Facility QA Committee, oversight of the peer review process, and participation in medical review studies...assume responsibility for overall management and delivery of patient care services."

No documentation was present the physicians participated in any of the duties listed above.

The Administrator, interviewed on 8/12/11 at 4:30 PM, confirmed the presence of the 2 "Medical Director Service Agreements." He also stated there was no documentation either of the physicians had performed the duties listed in the contracts. He stated the hospital had not defined the level of medical care patients could require and still be accepted for treatment at the hospital. He confirmed no policies had been developed and implemented in the past year. He stated no peer review process or medical review studies had been completed in the past year.

The governing body failed to define the hospital's Medical Staff hierarchy and failed to enforce its contract with the Medical Directors.

2. No Medical Staff meetings were documented in the year prior to 8/09/11. Instead, Unit Leadership Team meetings were documented on 12/31/10, 1/28/11, 3/25/11, 4/22/11, 5/06/11, and 8/5/11. These meetings were attended by the psychiatrist Medical Director, the DNS, the Director of Social Services, and the Director of Therapeutic Activities. No actual Medical Staff meetings were documented. No meetings between Physician A and Physician C and other members of the Medical Staff were documented. No meetings were documented in which medical staff issues were discussed.

The psychiatrist Medical Director, interviewed on 8/11/11 at 12:05 PM, confirmed no Medical Staff meetings had been held in the past year.

3. Four "Hospital Governing Board Meeting" minutes were documented in the year preceding the start of survey on 8/09/11. These dates were 7/26/11, 4/23/11, 1/25/11, and 10/21/10. The meeting minutes listed Physician A as the Medical Director on the sign in sheets for the meetings but his attendance was only documented at the 7/26/11 meeting. Physician B, who was also contracted to be the Medical Director was not listed on the meeting minutes. None of the meeting minutes mentioned oversight of the Medical Staff.

The Administrator, interviewed on 8/12/11 at 4:30 PM, confirmed no "Hospital Governing Board Meeting" minutes mentioned oversight of the Medical staff.

The hospital did not have systems in place to oversee or monitor the quality of medical care provided to patients.

Based on staff interview and review of medical records, policies, and meeting minutes, it was determined the hospital failed to ensure the CEO was responsible for managing the hospital. This resulted in a lack of policy development and a lack of development and implementation of hospital systems and processes. Findings include:

1. The CEO failed to ensure members of the Medical Staff were appointed and had been granted privileges prior to allowing them to practice at the hospital. Refer to A46 as it relates to physicians and physician assistants practicing without formal approval by the governing body.

2. The CEO failed to ensure adequate facilities and oversight were provided for contract laboratory services. Refer to A576 as it relates to the lack of space for laboratory equipment and the lack of defined laboratory services available to patients.

3. The CEO failed to ensure policies and procedures had been developed to provide a system to treat medical emergencies in the hospital. Refer to A93 as it relates to the lack of direction to staff regarding the treatment of patients with medical emergencies.

4. The CEO failed to ensure a system had been developed to inform patients of their rights. Refer to A115 as it relates to the lack of a system to promote patient rights.

5. The CEO failed to ensure a system had been developed to monitor the quality of care provided to patients. Refer to A263 as it relates to the lack of a QAPI program.

6. The CEO failed to ensure a system had been developed to evaluate the performance of the Medical Staff. Refer to A340 as it relates to the lack of a system to appraise members of the Medical Staff.

7. The CEO failed to ensure a comprehensive system had been developed to prevent and monitor infections at the hospital. Refer to A747 as it relates to the lack of an organized infection control program.

The lack of oversight by the CEO resulted in the inability of the hospital to provide safe and effective care to patients.

Based on staff interview and review of laboratory policies and contracts, it was determined the hospital's governing body failed to assume responsibility for contracted laboratory services. This resulted in a lack of monitoring of laboratory services and delays in laboratory testing. Findings include:

1. The hospital had a contract with a laboratory located in Boise, Idaho. The contract between the hospital and the laboratory, dated 2/02/09, stated the laboratory would provide supplies for specimen collection and transportation and would be responsible for the cost of transporting specimens. The contract did not specify who would transport specimens or how they would be transported to the laboratory.

The Administrator was interviewed on 8/22/11 at 2:30 PM. He stated, to his knowledge, the hospital had not evaluated the adequacy of services provided by the laboratory contractor or monitored the services it provided.

The governing body did not evaluate the contract laboratory's services.

2. During the hospital's exit interview, beginning at 10:45 AM on 8/19/11, the President of the hospital's parent organization and a member of the governing body, stated he was not aware laboratory specimens were being transported to Boise, Idaho, for testing. He stated he thought specimens were tested locally in the Pocatello area.

3. Refer to A576, the Condition of Participation for Laboratory Services, as it relates to the failure of the hospital to ensure laboratory tests were not delayed and to ensure patients' laboratory needs were met.

The governing body did not assume responsibility for oversight of laboratory services.

Based on staff interview and review of medical records, Medical Staff Bylaws, and hospital policies, it was determined the hospital failed to ensure policies and procedures for the appraisal and initial treatment of emergencies had been developed and implemented. This affected the care of 1 of 1 patient (#9) with a possible emergency medical condition and had the potential to impact the care of all patients at the hospital who experience medical emergencies. The lack of clear systems interfered with the hospital's ability to provide effective emergency treatment. Findings include:

1. Patient #9 was an 84 year old male, admitted on 7/29/11, with diagnoses of psychosis, dementia, Type 2 diabetes, hypertension, and coronary artery disease. He was currently a patient at the hospital as on 8/16/11.

Patient #9's "HISTORY AND PHYSICAL," dated 7/29/11, dictated by Physician C, the family practice physician, described a history of dementia and confusion, as well as a recent history of refusal to take medications. A "NURSE'S NOTES" on 8/02/11 at 6:00 PM documented Patient #9's blood glucose was down to 64, although on the MAR his blood glucose result for 6:00 PM was documented as 55. The "Behavior Flow Sheet" stated Patient #9 refused dinner. The "NURSE'S NOTES" stated Patient #9 also refused orange juice and graham crackers. An entry in the "NURSE'S NOTES" on 8/02/11 at 8:00 PM documented Patient #9 was in his room with his daughter, and refused to eat or drink. His blood glucose at this time was documented as 34 and the nurse notified Physician C. The note documented the physician ordered Patient #9 was to be tranferred to the ED of an acute care hospital. However, a physician order to transport Patient #9 to the ED was not documented.

The nurse documented in her 8:00 PM note that she called 911. However, when the Paramedics arrived, Patient #9 refused to be taken to the ED. The 8:00 PM note by the nurse documented the paramedics and Patient #9's daughter left. Patient #9 was noted to drink orange juice and eat some fruit. There was no documentation of a blood glucose test until 8/03/11 at 1:30 AM, which had increased to 240. A physician or other practitioner did not examine Patient #9 prior to the nurse calling 911.

In an interview on 8/12/11 at 12:25 PM, the DNS reviewed Patient #9's record and confirmed the above events.

Patient #9 was not evaluated by a practitioner prior to calling 911.

2. The hospital did not have its own ED. Page 44 of the hospital's "Medical Staff Rules and Regulations," dated 1/15/08, stated the hospital was a "Level IV Emergency Care Center" indicating the hospital had limited capacity to treat medical emergencies. The Rules and Regulations did not state under which circumstances a physician would examine hospital patients prior to calling 911. Also, the Rules and Regulations, on Page 42, stated a physician or allied health professional would be on-call for the hospital but did not state they would actually come to the hospital to examine patients with potential emergency needs. The Rules and Regulations did not specify how practitioners would be responsible for evaluating and treating patients with emergency medical conditions.

Medical Staff Rules and Regulations did not define how patients would be evaluated by members of the medical staff in potential emergency situations.

Additionally, the policy "Emergencies Physician Care," dated 1/31/2004, stated "An Emergency Department physician will evaluate patients who require an emergency evaluation and treatment." The policy stated patients would be immediately transported to an Emergency Department. The policy did not address physicians coming to the hospital to assess potential emergency situations. The policy did not address initial treatment of patients with medical emergencies, the appropriateness of referrals to other facilities, or transportation to other facilities. No other policies addressed emergency care.

The DNS was interviewed on 8/11/11 beginning at 2:00 PM. She stated the policy for emergency care only pertained to sending patients to the ED at a nearby hospital. She stated the hospital did not have policies and procedures for evaluating and treating emergency patients at the hospital.

Hospital policies did not provide sufficient direction to staff to treat potential medical emergencies in a timely manner.

Based on record review, review of facility policies, and staff interview, it was determined the hospital failed to ensure patients were informed of all of their rights in advance of providing services. This impacted 20 of 20 patients (#1 - #21) whose records were reviewed and had the potential to impact all patients receiving services at the hospital. This resulted in patients not being informed of their rights as a patient. Findings include:

1. The hospital's "Patient Rights" policy, dated 1/31/04, stated "Each patient's family or legal representative will be given a copy of the Patient's Rights form and have it explained in detail by a Social Service designee. The patient family member or legal representative will sign the Consent to Treat form indicating they have received a copy of the Patient Rights." The facility did not ensure patients or their representatives had received a copy of their right before receiving services as follows:

a. Patient #2 was a 21 year old male, admitted on 8/8/11. A notation in the "SOCIAL WORK PROGRESS NOTES" by a Social Worker, dated 8/08/11, untimed, stated Patient #2's guardian would be in on 8/09/11 to sign admit papers. Patient #2's record was reviewed at 4:30 PM on 8/09/11, the admission consents and other forms were not in the record.

In an interview on 8/12/11 at 2:00 PM, the DNS stated the information regarding patient rights would be provided at the time the admission consent packet was completed.

b. Patient #3 was a 42 year old male, admitted on 8/02/11. His medical record was reviewed on 8/09/11 at 4:00 PM, and did not contain evidence that Patient #3 or his representative had received a copy of patient rights.

In an interview on 8/09/11 at 4:30 PM, the Social Worker stated Patient #3 was on a legal hold, and it was not the practice of the facility to provide patients with rights information when they were on a legal hold.

c. Patient #16 was a 29 year old male, admitted on 5/13/11. Patient #16's medical record was reviewed. The consent for admission and statement of patient rights were signed 5/14/11 by Patient #16's court appointed guardian.

d. Patient #19 was an 83 year old female, admitted on 8/15/11. Patient #19's record was reviewed. The consent for admission and statement of patient rights were signed 8/16/11 by Patient #19's daughter and witnessed by the Social Worker.

e. Patient #11 was 55 year old female admitted on 8/04/11. Patient #11's record was reviewed. The admission consents and other forms were not in her record as of 8/10/11.

In an interview on 8/12/11 at 12:30 PM, the DNS stated the nursing staff had been instructed to complete the admission consents and other authorization forms during the actual admission process. She stated most of her nursing staff continued to defer the task to the Social Workers.

Patients or their legal representatives were not informed of the patient rights in advance of receiving care.

2. Patients #1 - #20 did not receive information regarding all of their rights. This impacted all patients who were admitted to the hospital.

The admission packet for patients contained a form, unlabeled, with the facility letterhead address, and phone numbers. The form contained two sections, the second section of the form, "Rights and Authorization," contained the statement "I have received a copy and understand my rights as a patient of Safe Haven Hospital." A copy of the "PATIENT RIGHTS" form was reviewed. The form did not contain the following rights:

* The patient has the right to participate in the development and implementation of his or her plan of care.
* The patient has the right to personal privacy.
* The patient has the right to be free from restraint or seclusion, of any form, imposed as a means of coercion, discipline, convenience, or retaliation by staff.
* The patient has the right to access information contained in his or her clinical records.

In an interview on 8/12/11 at 12:30 PM, the DNS reviewed the facility admission consent and "PATIENT RIGHTS" form and stated the patient admission packet was complete, with the patient rights as presented.

The hospital failed to inform patients of all of their rights before care was provided.

Based on staff interview and review of medical records and facility policies, it was determined the hospital failed to ensure a grievance process to had been developed. The hospital also failed to inform 20 of 20 patients (#1 - #21), whose records were reviewed, of whom to contact to file a grievance and how the grievance process worked.

1. Hospital policies did not include a policy describing a patient grievance process including filing grievances, investigating them, and providing a response to complainants.

The DNS, interviewed on 8/11/11 beginning at 10:45 AM, stated a grievance policy and procedure had not been developed.

2. Medical records for 20 patients (#1 - #21) did not contain documentation they had received notice of their rights, including the right to file grievances.

The DNS, interviewed on 8/11/11 beginning at 1045 AM, stated patients had not been notified of their right to file grievances.

The hospital had not developed and implemented a system to accept grievances from patients, investigate them, and provide a response to complainants.

Based on observations, record review, and staff interview, it was determined the hospital failed to ensure personal privacy was provided for 13 of 13 current patients (#1, #2, #3, #4, #5, #9, #10, #11, #12, #13, #19, #20, and #21), whose records were reviewed. This resulted in patient names being posted in public view and a patient's family being contacted against his wishes and without consent of his legal representative. Findings include:

1. In a tour of the hospital on 8/09/11 at 1:00 PM, and again on 8/19/11 at 11 AM, on the wall by the door of each occupied patient room the patient's last name (#1, #2, #3, #4, #5, #9, #10, #11, #12, #13, #19, #20, and #21) was written on a label.

During an interview with the CEO and Administrator on 8/19/11 at 12:30, the CEO stated the posting of last names was a practice throughout all of his facilities and that was the only way patients could find their rooms.

Patients were denied personal privacy with the posting of their last names for hospital visitors and patients to see.

2. Patient #3 was a 42 year old male admitted to the hospital on 8/02/11. Patient #3 had a legal representative appointed by the court. His record included an "ACTIVITIES EVALUATION" form dated 8/04/11, completed by the Recreation Therapist. The form documented Patient #3 did not want contact with his family and did not like to include his family. Documentation by the Social Worker on the "SOCIAL SERVICE PROGRESS NOTES," on 8/05/11, untimed, stated she was able to contact Patient #3's mother and obtain information. An additional Social Worker entry on 8/06/11, untimed, noted she had contacted Patient #3's mother for background information and the social history was completed.

In an interview on 8/12/11 at 1:35 PM, the DNS reviewed Patient #3's record and confirmed there was no documentation of Patient #3 or his representative's approval to contact his mother.

The facility did not ensure patient privacy was maintained.

Based on staff interview and review of medical records and hospital policies, it was determined the hospital failed to ensure patients with known allergies received care in a safe setting for 7 of 15 patients (#3, #4, #7, #9, #10, #12, and #13), with known allergies, whose records were reviewed. This had the potential to affect all patients with allergies and resulted in the potential for patients to receive medications or food to which they were allergic. It was also determined the hospital failed to ensure procedures were in place to treat 1 of 1 current diabetic patient (#9) whose blood glucose levels were dangerously low and who resisted treatment. These failures placed patients in immediate jeopardy of serious harm, impairment, or death. Findings include:

1. PATIENTS WITH ALLERGIES:

a. Patient #3 was a 42 year old male, admitted on 8/02/11 with a diagnosis of Schizophrenia. He was currently a patient as of 8/12/11. His record contained multiple incidences of documentation of Patient #3's allergies as follows:

The "Face Sheet," dated 8/02/11 listed Patient #3's allergies as hydrochlorothiazide, iodine, and horse serum proteins. The "PHYSICIAN'S ORDERS," dated 8/02/11, under "DRUG ALLERGIES," listed "NKDA" (no known drug allergies)

The "Safe Haven Hospital Admission Orders and Medication Reconciliation Form," dated 8/02/11, at 3:02 PM, under the section "Allergies and Reactions," listed "NKDA." The form was initiated by the admitting RN, and signed by the Psychiatrist on 8/03/11 at 11:05 AM.

A "HISTORY AND PHYSICAL," dictated by the family practice physician on 8/03/11, untimed, listed Patient #3's allergies as "NKDA."

The "Psychiatric Evaluation," dated 8/03/11, at 1:15 PM, completed by the Psychiatrist, included Patient #3's allergies of hydrochlorothiazide, iodine, and horse serum proteins.

The "24 HOUR NURSING CARE PLAN," dated 8/02/11 at 6:05 PM, by the admitting RN, under allergies, listed "IV Contrast."

The MAR for the month of August 2011 under "ALLERGIES," remained empty.

In an interview on 8/12/11 at 1:35 PM, the DNS reviewed Patient #3's record and verified the allergy information had not been transcribed or communicated to the pharmacy department. She stated the charge nurses were to perform a 12 hour and 24 hour chart check, which would involve reviewing the orders and the MAR for allergy information as well as for medication reconciliation.

Drug allergy information was not communicated to the pharmacy for inclusion on the MAR.

b. Patient #12 was an 89 year old female, admitted on 8/09/11 with diagnoses of Psychosis and Dementia. She was currently a patient as of 8/12/11. The "Initial RN Assessment of New Patient," dated 8/09/11 at 5:30 PM, by the admitting nurse, listed allergies as "Sulfa, Food-Bleu Cheese Dressing (hives- extremely severe reaction)."

In an interview on 8/11/11, the Dietary Manager stated she did not know Patient #12 had an allergy to Bleu Cheese. She stated she was notified of patient allergies by a communication notice that was hand delivered by the ward clerk. The Dietary Manager pulled out a notebook that included current hospital patients. She was able to show other patients with communication notices which included diet orders and food allergies. The Dietary Manager printed off a meal ticket for Patient #12 which would be included on her meal tray. The meal ticket listed Patient #12, as being on a Regular Diet and did not include allergies.

In an interview on 8/12/11 at 12:00 noon, the DNS stated allergy information should be included on a Communication Form, which was initiated by the RN who transcribed the admission orders. She stated the communication form would go to dietary and pharmacy.

Pertinent food allergy information did not get relayed to the Dietary Department.

c. Patient #10 was a 77 year old male, admitted on 8/09/11 with a diagnosis of Bipolar Disorder. He was currently a patient as of 8/12/11. The "Safe Haven Hospital Admission Orders and Medication Reconciliation Form," dated 8/10/11 at 6:53 AM, under the section "Allergies and Reactions," listed Aspirin and Sulfa. The form was initiated by the admitting RN, and signed by the psychiatrist on 8/10/11, untimed. The MAR for the month of August 2011 under "ALLERGIES," listed "NKDA."

In an interview on 8/11/11 at 3:30 PM, the Pharmacist described the process of obtaining patient allergy information for their records. She stated a copy of the "Safe Haven Hospital Admission Orders and Medication Reconciliation Form," as well as all copies of the "PHYSICIAN'S ORDERS" is sent to the Pharmacist. She stated she would then enter the allergy information on to the MAR.

In an interview on 8/12/11, at 1:35 PM, the DNS reviewed Patient #10's record and confirmed the MAR listed "NKDA." She was unable to explain why the MAR had not been updated to include Aspirin and Sulfa.

Drug allergy information was not communicated to the pharmacy for inclusion on the MAR.

d. Patient #13 was a 57 year old female admitted on 8/08/11 with a diagnoses of Schizoaffective and Bipolar Disorder. She was currently a patient as of 8/12/11. The record contained multiple incidences of documentation of Patient #13's allergies as follows:

The "Safe Haven Hospital Admission Orders and Medication Reconciliation Form," dated 8/09/11, at 5:33 PM, under the section "Allergies and Reactions," listed "NKDA." The form was initiated by the admitting RN, and signed by the Psychiatrist on 8/10/11, untimed.

The "Psychiatric Evaluation," dated 8/09/11, at 9:55 AM, completed by the psychiatrist, included Patient #13's allergies of Risperdal, Zyprexa, Seroquel, Geodon, and Haldol.

A "HISTORY AND PHYSICAL," dictated by the medical physician on 8/09/11, untimed, listed Patient #13's allergies as Geodon, Motrin, Reglan, Toradol, and Trileptal.

The MAR for the month of August 2011 under "ALLERGIES," remained empty.

In an interview on 8/12/11 at 12:15 PM, the DNS reviewed Patient #13's record and confirmed the MAR listed "NKDA." She was unable to explain why the MAR had not been updated to include Risperdal, Zyprexa, Seroquel, Geodon, and Haldol..

Drug allergy information was not communicated to the pharmacy for inclusion on the MAR.

2. EVALUATION AND TREATMENT OF DIABETIC PATIENTS WITH POTENTIAL MEDICAL EMERGENCIES:

a. Patient #9 was an 84 year old male, admitted on 7/29/11 with diagnoses of psychosis, dementia, Type 2 diabetes, hypertension, and coronary artery disease.

Patient #9's "HISTORY AND PHYSICAL," dated 7/29/11, dictated by the family practice physician, described a history of dementia and confusion, as well as a recent history of refusal to take medications. His admission labs included a Hemoglobin A1-c, with a result of 13.1 (normal less than 6). Orders for Patient #9 included Accucheck blood glucose monitoring before meals and at bedtime. Patient #9 had orders for insulin to be administered each morning at 8:00 AM.

-"NURSE'S NOTES" on 8/02/11 at 8:00 AM, reported Patient #9 was ambulating in the hallway with his walker and staff were present. The note stated Patient #9 was smiling and pleasant. His Accucheck was reported to be 231. The American Diabetes Association describes normal blood glucose levels as 70-100. The "Behavior Flow Sheet" included a report on how much Patient #9 ate at his mealtime. The breakfast was reported to have been 75% consumed.

-"NURSE'S NOTES" at 12:00 PM stated Patient #9 was in his room self-isolating, with a flat affect. His Accucheck was reported to be 238. The "Behavior Flow Sheet" stated Patient #9 refused lunch.

-A "NURSE'S NOTES" entry at 6:00 PM documented Patient #9's blood glucose was down to 64, although on the MAR it was documented as 55. The "Behavior Flow Sheet" stated Patient #9 refused dinner. The "NURSE'S NOTES" stated Patient #9 also refused orange juice and graham crackers.

-At 7:00 PM, a telephone order was written, and included insulin order changes. The morning dose of Levemir 24 units was discontinued, and Patient #9 was to begin on Humalin 7 units after meals if the meal was eaten. Patient #9 was to also begin on sliding scale insulin of Humalog, four times daily with the doses dependant upon the blood glucose results before meals and at bedtime.

-An entry in the "NURSE'S NOTES" at 8:00 PM, which spanned an undetermined amount of time, documented Patient #9 was in his room with his daughter and refused to eat or drink. His blood glucose result at that time was documented as 34, and the Physician was notified. The note documented Patient #9 was to be transported to the ED. The nurse further documented she called 911. Patient #9 was noted to refuse to be taken to the ED when the Paramedics arrived. The 8:00 PM nurse's entry documented the paramedics and his daughter left and Patient #9 was noted to drink orange juice and eat some fruit.

- Patient #9's blood sugar was not reassessed until 1:30 AM on 8/03/11, and was 240. Patient #9 did not get insulin at that time.

In an interview on 8/12/11 at 12:25 PM, the DNS reviewed Patient #9's record and stated his daughter was his guardian, and she was aware of his refusal to eat. The DNS stated Patient #9's daughter was unwilling to give an override and stated she did not want to take away all of Patient #9's control. The DNS confirmed there was no modification to Patient #9's plan of care that included his refusal to eat or take medications.

The policy "Refusal of Medications & Treatments," dated 1/31/04, stated patients or their "responsible party" would be informed "of the health and safety consequences of such refusal..." of medications or treatments or services. The policy did not state how the refusal of potentially lifesaving treatment would be addressed.

The Director of Nursing Services was interviewed on 8/11/11 beginning at 2:00 PM. She confirmed the lack of a policy addressing how the hospital would ensure patients with potentially emergent conditions would be assessed at the hospital.

Additionally, the policy "Emergencies Physician Care," dated 1/31/2004, stated "An Emergency Department physician will evaluate patients who require an emergency evaluation and treatment." The policy stated patients would be immediately transported to an Emergency Department. The hospital did not have an Emergency Department so it was understood the patient would be transferred to another hospital for emergency care. The policy did not state how the hospital would provide emergency evaluation and treatment in the case of a patient who could not be transferred to another hospital. Also, the policy did not address physicians coming to the hospital to assess emergency situations.

Hospital policies did not provide sufficient direction to staff to treat potential medical emergencies that could reasonably be anticipated based on the patient population.

Note: A plan to abate the immediate threat to patient health and safety was submitted by the hospital on 8/17/11. The plan stated a system had been developed to identify all allergens for each patient and stated each current patient's medical record had been updated. In addition, the plan stated a system had been developed to identify and treat medical emergencies. The plan stated nursing and dietary staff had received or would receive training on the new systems prior to working with patients.

An on-site revisit was conducted at the hospital on 8/18/11 and 8/19/11. It was determined the hospital had removed the immediate danger to patients from the above examples.

3. Further examples of deficient practice that prevented patients from receiving care in a safe setting but did not immediately threaten the health and safety of patients include:

a. Patient #4's medical record documented a 30 year old female who was hospitalized on 7/28/11 and was currently a patient as of 8/10/11. Her diagnoses included Bipolar Disorder. Her "Psychiatric Evaluation," dated 7/28/11, stated she was actively suicidal. A tour of Patient #4's room was conducted with her Psychiatric Technician at 4:20 PM on 8/09/11. A CPAP machine was observed on Patient #4's night stand. The power cord and tubing were attached. The cord and tubing could be used by patients to harm themselves. Patient #4 had a room mate who was lying on her bed. Also, the room was accessible to any patient on the unit. When asked about the CPAP machine, the Psychiatric Technician stated she was not aware of a hospital policy regarding the care and safety of CPAP machines.

The DNS was interviewed on 8/09/11 at 4:30 PM. She stated the hospital occasionally treated patients with CPAP machines. She confirmed their was no policy regarding the care and safety of CPAP machines. She removed the CPAP at the time and stated Patient #4 would only be allowed to use it at night with supervision. Patient #4 was discharged on 8/10/11.

In addition, a tour of the Day Room, a large common area where patients met, was conducted with the DNS on 8/11/11 at 8:35 AM. A snack cart was observed in the room which contained crackers, cups, etc. The cart also contained plastic knives for use with the food. Although not observed at the time, the DNS stated the cart usually contained plastic forks which were also available to patients. She stated the hospital had not taken steps to prevent patients from using the plastic utensils to harm themselves or others. She removed the utensils from the snack cart and stated their use would be supervised.

The hospital did not adopt procedures to protect patients from hazards associated with CPAP machines and plastic utensils which were accessible to patients without staff supervision.

b. Patient #7's medical record documented a 50 year old male with diagnoses of bipolar disorder and psychosis. He was admitted on 5/15/11 and discharged on 5/23/11. "NURSE'S NOTES," dated 5/14/11 at 8:30 PM, stated Patient #7 was admitted to the hospital. The note was largely illegible but it did not appear to describe specific behaviors.

The next "NURSE'S NOTES" were dated 5/15/11 at 8:00 AM. The note stated Patient #7 dropped to his knees in the hallway and started praying into his bible. Other notes dated 5/15/11 included a "NURSE'S NOTES" at 10:00 AM that stated Patient #7 was attempting to touch other patients with his bible and shout "Demons be gone in the name of the Lord." "NURSE'S NOTES" at 12:00 noon and 2:00 PM stated Patient #7 continued to wander and chant and shout. The "NURSE'S NOTES" at 4:00 PM stated Patient #7 assaulted a staff member and was medicated and placed on 1 to 1 staffing. "NURSE'S NOTES" at 5:45 PM stated Patient #7 spit water on other patients. "NURSE'S NOTES" at 7:00 PM stated Patient #7 threw water on a patient and shouted. The notes stated staff attempted to redirect him with varying success. "NURSE'S NOTES" did not describe attempts to control Patient #7's behavior or to keep other patients safe, except for redirection.

Patient #7's "NURSE'S NOTES" beginning at 8:00 PM on 5/15/11 and ending at 7:00 AM on 5/16/11 were largely illegible and it was difficult to tell what happened during that time. "NURSE'S NOTES" beginning at 8:00 AM on 5/16/11 described Patient #7 as being calmer and he did not appear to be a threat to other patients or staff.

The DNS was interviewed on 8/12/11 beginning at 9:15 AM. She confirmed the record did not indicate steps had been taken to isolate Patient #7 from other patients in order to protect all of the patients.

The hospital failed to ensure patients were cared for in a safe environment.

Based on staff interview and review of medical records and hospital policies, it was determined the hospital failed to ensure 20 of 20 current patients (#1 - #21), whose records were reviewed, had been informed of their right to review information in their medical records. This prevented patient access to their medical records. Findings include:

Medical records for 20 patients (#1 - #21) did not contain documentation they had received notice of their rights, including the right to access information in their medical record.

Hospital policies did not include a system for patients to access their medical records or a system to notify patients of their right to do so.

The DNS, interviewed on 8/11/11 beginning at 10:45 AM, stated patients were not given information on how to access their medical records. She also stated a policy and procedure for patients to access their medical records had not been developed.

The hospital did not develop and implement a system for patients to access their medical records.

Based on staff interview and review of QAPI policies, it was determined the hospital failed to ensure performance improvement projects were conducted as part of its quality assessment and performance improvement program. This resulted in a lack of feedback to the hospital about its services. Findings include:

"Quality Assurance Program" policies, "Reviewed/Revised" on 11/05/10, did not direct the hospital to conduct performance improvement projects.

The Quality Assessment Coordinator, interviewed on 8/11/11 beginning at 9:00 AM, stated the hospital had not developed or implemented any PI projects in the past year.

The hospital had not conducted performance improvement projects.

Based on staff interview and review of Medical Staff bylaws and credentials files, it was determined the hospital failed to ensure 5 of 5 members of the Medical Staff (Physicians A-C and Physician Assistants D and E) were appointed by the governing body. This resulted in the inability of Medial Staff members to ensure they were qualified to perform their duties. Findings include:

Medical Staff Bylaws, dated 1/15/08, stated initial appointments to the Medical Staff were provisional for a period of 6 months and reappointments were for a period of 2 years. This had not been followed. Three physicians and 2 physician assistants practiced at the hospital. A review of credentials files beginning at 11:30 AM on 8/10/11 revealed:

a. Physician A had not been reappointed to the Medical Staff since 2004.

b. Physician B had not been appointed to the Medical Staff.

c. Physician C had been granted temporary clinical privileges on 11/10/09. These had expired on 5/10/10. He had not been reappointed to the Medical Staff.

d. "HOSPITAL GOVERNING BOARD MINUTES," dated 7/26/11, stated Physician Assistant D was "given temporary privileges due to water damage of her original packet." However, Unit Leadership Team minutes, dated 1/28/11, stated Physician Assistant D was practicing at the hospital at that time. No documentation was present to show that she had been appointed to the Medical Staff prior to being granted temporary privileges on 7/26/11.

The Administrator, interviewed on 8/10/11 at 3:30 PM, confirmed the above practitioners had not been appointed to the Medical Staff.

e. On 8/12/11 at 4:30 PM, the Administrator stated Physician Assistant E also practiced at the hospital. The Administrator stated he had not been appointed to the medical staff.

Members of the Medical Staff had not been appointed by the governing body.

Based on staff interview and review of Medical Staff bylaws and credentials files, it was determined the hospital failed to ensure the Medical Staff conducted appraisals of 5 of 5 of its members (Physicians A-C and Physician Assistants D and E). This resulted in the inability of Medial Staff members to ensure they were qualified to perform their duties. Findings include:

Medical Staff Bylaws, dated 1/15/08, stated before appointing members to the Medical Staff, the Credentials Committee would "...examine whether the application is complete, as well as, examine the evidence of the character, professional competence, qualifications and ethical standing of the applicant. The Credentials Committee shall determine...whether he has established and meets all of the necessary qualifications for the category of staff appointment and clinical privileges requested by him." The bylaws stated the reappointment process included a review by the Medical Staff "...of the results of quality assessment and improvement on the applicant's continuing medical activities." Applicants were to be evaluated for demonstrated professional competence, participation in staff affairs, compliance with Medical Staff Bylaws, rules and regulations, data from utilization reviews, Clinical Pertinence Reviews, and Medical Staff monitoring.

Credentials files of the Physicians A, B and C and Physician Assistants D and E, who attended patients at the hospital, did not include documentation of appraisal by the medical staff.

The Administrator, interviewed on 8/10/11 at 3:30 PM. He stated the hospital did not have a Credentials Committee. He confirmed an appraisal of members by the Medical Staff was not documented for any of the 5 practitioners.

The Medical Staff had not conducted appraisals of its members.

Based on staff interview and review credentials files and Medical Staff Bylaws, it was determined the hospital failed to ensure the Medical Staff examined the credentials of 5 of 5 candidates (Physicians A, B and C and Physician Assistants D and E) for medical staff membership and made recommendations to the governing body on the appointment of those candidates. This resulted in the inability of Medial Staff members to share input with the governing body regarding candidates. Findings include:

Credentials files of 4 practitioners (Physician A, Physician B, Physician Assistant D, and Physician Assistant E) who attended patients at the hospital did not include documentation of Medical Staff recommendations to the governing body on their appointment to the Medical Staff.

Physician C's file contained a recommendation by the Medical Staff, dated 11/10/09, for granting temporary privileges. Medical Staff Bylaws, dated 1/15/08, stated initial appointments to the Medical Staff were provisional for a period of 6 months. Physician C's hospital privileges expired 5/10/10. Documentation was not present that the Medical Staff had recommended an extension of Physician C's privileges.

The Administrator, interviewed on 8/10/11 at 3:30 PM. He stated the hospital did not have a Credentials Committee. He confirmed an appraisal of members by the Medical Staff was not documented for the 5 current practitioners.

The Medical Staff had not made recommendations to the governing body on the appointment of its members.

Based on staff interview and review of Medical Staff Bylaws and credentials files, it was determined the hospital failed to ensure the Medical Staff was well organized and accountable to the governing body. This resulted in the inability of the Medical Staff to fulfill its duties. Findings include:

1. The Medical Staff was not well organized. Examples include:

a. Medical Staff Bylaws referred to a Medical Director by stating he/she would help appoint a Medical Executive Committee and supervise Medical Staff appointees. The Bylaws did not include a definitive list of the Medical Director's
duties.

The Administrator, interviewed on 8/10/11 at 3:30 PM, stated the hospital did not have a job description for the Medical Director.

b. The hospital did not have a single person responsible for Medical Staff activities and oversight of the Medical Staff. Physician A, a psychiatrist, had a contract with the hospital titled "Medical Director Services Agreement," dated 4/1/11. Physician C, a family practice physician, had a contract with the hospital titled "Medical Director Services Agreement," also dated 4/1/11. Each contract stated the physician would "...provide medical director services..." and would "...assume responsibility for overall management and delivery of patient care services." No single person was designated as being in charge of the Medical Staff of the hospital.

The Administrator, interviewed on 8/10/11 at 3:30 PM, stated Physician A was the Medical Director but he acknowledged both physicians had contracts naming them as Medical Director.

c. No Medical Staff meeting was documented from 8/01/10 through 8/09/11. Instead, Unit Leadership Team minutes were documented on 12/31/10, 1/28/11, 3/25/11, 4/22/11, 5/06/11, 8/05/11. These meetings were attended by the psychiatrist Medical Director, the Administrator, the DNS, the Social Worker, and the Activities Director. Medical Staff issues were not addressed in these meeting minutes.

The Administrator, interviewed on 8/10/11 at 3:30 PM, confirmed no Medical Staff meetings were documented in the past year.

The Medical Staff was not organized in a manner that allowed it to conduct business.

2. The Medical Staff was not accountable to the governing body.

No documentation was present that the governing body communicated with the Medical Staff between 8/01/10 and 8/09/11. Medical Staff Bylaws, dated 1/15/08, stated the responsibilities of the Medical Staff included participating in the credentialing procedure, continuous monitoring of patient care practice, and evaluation of the quality of patient care. None of these activities were documented in the past year.

The Administrator, interviewed on 8/10/11 at 3:30 PM, confirmed no communication between the Medical Staff and the governing body was documented. He also stated no documentation was present that the Medical Staff had performed its duties.

No evidence was found that the Medical Staff was accountable to the governing body.

Based on review of clinical records and hospital policies, observations, and staff interviews, it was determined the hospital failed to ensure an RN supervised and evaluated the nursing care for 4 of 13 current patients (#9, #10,#12, and #16) whose records were reviewed. The failure of a RN to evaluate the care of patients had the potential for medication errors and deterioration in patients' medical conditions without interventions to occur. Findings include:

1. Admission assessments were performed by an LPN as follows:

a. Patient #16 was a 29 year old male admitted 5/13/11 at 11:15 PM, by an LPN. The admission assessment documented Patient #16 was a paraplegic with a diagnosis of chronic paranoid schizophrenia, who had recently undergone skin grafting to his sacral pressure ulcers. Patient #16 had a PICC for IV antibiotics, a supra pubic catheter, and a drain in his surgical site.

b. Patient #9 was an 84 year old male with a diagnosis of dementia, admitted 7/29/11 at 7:30 PM, by an LPN. Patient #9's medical history included hypertension and insulin dependent diabetes.

In an interview on 8/12/11 at 12:25 PM, the DNS reviewed the records and confirmed an LPN had performed the admission assessments for both patients. The DNS reviewed the form, "Initial RN Assessment of New Patient," and stated she was not aware the form indicated RN's must perform the admission assessments. The DNS stated ther facility did not have a policy regarding admission assessments.

A RN did not perform each admission assessment.

2. Incorrect medication management as a result of LPN receipt and/or transcription of physician orders occurred as follows:

a. Patient #9 was an 84 year old male with a diagnosis of dementia, admitted 7/29/11. Patient #9's record was reviewed, and a form, "PHYSICIAN'S ORDERS," documented the receipt of telephone orders by an LPN. The orders were written on 8/02/11 at 7:00 PM, and noted 8/02/11 at 12:50 AM by the same LPN. The telephone orders did not indicate review by an RN. The orders read: "Humalin 7 units after each meal only if meal was eaten," and "Humalog per sliding scale 4X (times) daily with Accuchecks," and included the sliding scale routine. The accucheck routine on the MAR indicated they were to be done before each meal and at bedtime.

On 8/10/11 at 12:00 PM, the medication nurse, an LPN, was observed to perform the before meal Accucheck test on Patient #9. Upon return to the medication room, the MAR was reviewed with the LPN. According to the MAR, the sliding scale indicated Patient #9 was to receive 8 units of Humalog insulin. When questioned if Patient #9 would receive an injection both before and after his meal, the LPN stated she would not administer the insulin until after he ate, and then she planned to combine the two doses and administer a total of 15 units as one injection. The LPN was questioned about the two different insulins ordered, (Humalin and Humalog). She stated they were both supposed to be Humalog and stated "it was written by mistake," indicating the Humalin insulin.

In an interview on 8/10/11 at 2:30 PM, the Pharmacist stated Humalog and Humalin insulins were different. She stated the insulin orders were confusing, and should have been clarified before the administration of the medications.

In an interview on 8/12/11 at 12:25 PM, the DNS reviewed the record and confirmed the telephone orders taken and transcribed by the LPN. The DNS stated it was an unusual order, as the Humalog and Humalin were two different forms of insulin. She stated the order should have been reviewed with an RN and clarified before transcription to the MAR.

b. The facility used patient admission orders that were a standard set of printed orders with boxes to be marked by the physician after review. The physician was to mark the box next to the item indicating the test or order was to be done. If the box was left unmarked, it indicated the order or the test was not to be done. In the following examples, the box next to "Tuberculosis Test" was unmarked, indicating the physician did not want the test to be administered. However, the MAR of each patient documented a TB test was administered:

i. Patient #10 was a 77 year old male, admitted 8/09/11. His MAR documented he received a TB test on 8/10/11, untimed.

ii. Patient #12 was an 81 year old female, admitted 8/09/11. Her MAR documented she received a TB test on 8/10/11, untimed.

In an interview on 8/12/11 at 12:00 PM, the DNS reviewed the records and verified the TB tests had been administered without a physician's order.

Medication orders were transcribed without review by an RN, resulting in medication errors.

Based on observation, medical record review, and staff interview it was determined the facility failed to ensure thorough nursing care plans were developed, evaluated, and revised for 9 of 20 patients (#1, #2, #4, #7, #9, #10, #12, #14 and #15) whose records were reviewed. Lack of a complete care plan had the potential to result in unaddressed patient care needs and interfere with coordination of patient care among staff members. Findings include:

A form, titled "24 HOUR NURSING CARE PLAN," contained completion instructions which included: "....must include a minimum of 3 problems...Must include the date, nursing diagnosis, interventions, desired outcome). The instructions as well as the title of the form did not indicate ongoing assessments and/or revisions would be made to the nursing care plans according to an evaluation of the patients' needs. Comprehensive care plans were not developed as follows:

1. Patient #9 was an 81 year old male, admitted to the facility on 7/29/11. The "Initial RN Assessment of New Patient," dated 8/09/11 at 7:30 PM, documented Patient #9's reason for admission was related to dementia, psychosis, insulin dependent diabetes, medication noncompliance, high blood pressure, and he required the use of a cane as a result of a CVA. Patient #9's "24 HOUR NURSING CARE PLAN," dated 7/29/11 at 7:30 PM, included one Nursing Diagnosis, of "High risk for violence," with four interventions. The care plan did not include a desired outcome or an evaluation of the nursing diagnosis after 24 hours. The care plan did not address Patient #9's dementia, diabetes, high blood pressure, medication noncompliance, or mobility deficits related to his stroke requiring the use of a cane.

In an interview on 8/12/11 at 12:25 PM, the DNS stated the "24 HOUR NURSING CARE PLAN" for Patient #9 was incomplete and did not address his multiple problems. The DNS stated the facility nursing care plans were not adequate and needed to be redesigned.

The facility did not ensure a NCP was developed according to the needs of the patient.

2. Patient #10 was a 77 year old male, admitted to the facility on 8/09/11. The "Initial RN Assessment of New Patient," dated 8/09/11 at 6:30 PM, documented Patient #10's reason for admission was primarily related to attention seeking behavior problems. The assessment also included a past medical history of insulin dependent diabetes. Patient #10's "24 HOUR NURSING CARE PLAN," dated 8/09/11 at 6:30 PM, included three Nursing Diagnosis; risk for anxiety, risk for sleep deprivation, and risk for behavior problems. Within 24 hours of admission, the MAR indicated Patient #10 was refusing medication. The nursing care plan did not address his diabetes and was not updated to include his medication noncompliance.

In an interview on 8/12/11 at 1:25 PM, the DNS reviewed Patient #10's nursing care plan and confirmed diabetes was not addressed. The DNS stated the nursing care plans were not adequate for the needs of the patients at the facility.

The NCP was not updated and revised as patient needs changed.

3. Patient #12 was an 81 year old female, admitted to the facility on 8/09/11. The "Initial RN Assessment of New Patient," dated 8/09/11 at 7:30 PM, documented Patient #12's reason for admission was dementia, with audio and visual hallucinations, and had walked away from her residence. The nursing assessment was not fully completed due to documentation of patient confusion. Patient #12's "24 HOUR NURSING CARE PLAN," dated 8/09/11 at 5:30 PM, included three Nursing Diagnosis; risk for anxiety, risk for sleep deprivation, and risk for elopement. The nursing care plan did not address her confusion.

In an interview on 8/12/11 at 12:00, the DNS reviewed Patient #12's nursing care plan and confirmed her dementia had not been addressed. She stated the nursing care plans were not used appropriately in the facility.

The NCP did not reflect the needs of the patient.

4. Patient #2 was a 21 year old male, admitted to the facility on 8/08/11. The "Initial RN Assessment of New Patient," dated 8/08/11 at 3:20 AM, documented Patient #2's reason for admission was related to suicidal ideation as well as auditory hallucinations. In addition, the assessment documented Patient #2 had a history of asthma and recent heavy alcohol use. The admission orders included medication to assist with alcohol withdrawl symptoms. Patient #2's "24 HOUR NURSING CARE PLAN," dated 8/0/11, untimed, included two Nursing Diagnosis; high risk for injury (self directed) and altered thought process related to auditory hallucinations. The nursing care plan did not address his needs related to alcohol withdrawl or asthma.

In an interview on 8/12/11 at 2:00 PM, the DNS reviewed Patient #2's NCP and confirmed his asthma and alcohol withdrawl had not been addressed. She stated the nursing care plans were not used appropriately in the facility.

The facility did not maintain nursing care plans that reflected the patients' unique needs as determined by ongoing assessment and interventions as well as an evaluation of patients' response to the interventions.



00023

5. Patient #15's medical record documented a 61 year old female who was admitted to the hospital on 5/19/11 and was discharged on 5/27/11. Diagnoses included bipolar disorder, depression, and emphysema. A "NURSE'S NOTE" at 4:40 PM on 5/19/11 stated she was admitted from a nearby skilled nursing facility. The note stated one of the reasons for admission included "...running w/c into doors, cart, walls, no safety awareness." Other "NURSE'S NOTES," dated 5/23/11 at 4:00 PM, stated the patient was "gathering/hoarding [with] items strewn about." Another "NURSE'S NOTE" at 6:00 PM on 5/23/11, stated the results of a culture of leg wounds was positive for MRSA. Another "NURSE'S NOTE" at 7:15 PM on 5/24/11, stated Patient #15 complained of chest pain and "heavy pressure." This was relieved after administering nitroglycerine. Patient #15's psychiatric evaluation, dated 5/20/11 at 11:06 AM, stated she was also admitted to the hospital because of smoking with her oxygen on. The "24 HOUR NURSING CARE PLAN," dated 5/19/11, listed the potential for aggression, potential for falls, and potential for elevated blood sugars as problems. The plan for aggression included offering medications, orient to facility, and encourage to verbalize needs. The NCP did not address her diabetes, wheelchair safety, and smoking with her oxygen on. Also, the NCP was not updated to address hoarding behaviors, MRSA, or chest pain.

The DNS was interviewed, beginning at 9:15 PM on 8/12/11. She reviewed Patient #15's medical record. She stated Patient #15 had taken numerous items from other patients and from the hospital. Also, she stated just prior to admission, Patient #15 had run her wheelchair into a resident at the SNF and knocked the person over. She confirmed the NCP did not address these and other issues.

Nursing staff did not develop a completed NCP for Patient #15.

6. Patient #4's medical record documented a 30 year old female who was hospitalized on 7/28/11 and was currently a patient as of 8/10/11. Her diagnoses included bipolar disorder. Her "Psychiatric Evaluation," dated 7/28/11, stated she was actively suicidal.

A tour of Patient #4's room was conducted with her Psychiatric Technician at 4:20 PM on 8/09/11. A CPAP machine was observed on Patient #4's night stand. The power cord and tubing were attached.

The "24 HOUR NURSING CARE PLAN," dated 7/28/11, listed risk for sleep deprivation related to hospitalization, risk for anxiety, and risk for suicide as problems. The NCP did not address the care of the CPAP machine or how to keep Patient #4 from harming herself with the cord or tubing.

The DNS was interviewed, beginning at 9:15 PM on 8/12/11. She reviewed Patient #4's medical record. She confirmed the NCP did not address the CPAP machine.

Nursing staff did not develop a completed NCP for Patient #4.

7. Patient #1's medical record documented an 84 year old male who was hospitalized on 7/28/11 and was currently a patient as of 8/12/11. His diagnoses included dementia and hypertension.

The "HISTORY AND PHYSICAL," dated 7/28/11, stated Patient #1 had been admitted from a residential care facility where he had been having "...resident to resident altercations. He pushed one resident to the floor and attempted to hit several others, but was detained by staff."

The "24 HOUR NURSING CARE PLAN," dated 7/28/11, listed aggression toward others as a problem with "Nursing Interventions" including reorient to facility and staff, assess patients needs often, and administer medications per doctors orders. Patient #1's NCP did not provide direction to staff as to how to prevent him from physically interacting with other patients to prevent altercations and prevent injury to the patient and others.

The DNS was interviewed, beginning at 9:15 PM on 8/12/11. She reviewed Patient #1's medical record. She confirmed the NCP did not address preventing physical contact with other patients.

Nursing staff did not develop a completed NCP for Patient #1.

8. Patient #7's medical record documented a 50 year old male with diagnoses of bipolar disorder and psychosis. He was admitted on 5/15/11 and discharged on 5/23/11.

"NURSE'S NOTES," dated 5/14/11 at 8:30 PM, stated Patient #7 was admitted to the hospital. The note was largely illegible but it did not appear to describe specific behaviors. The next "NURSE'S NOTES" were dated 5/15/11 at 8:00 AM. The note stated Patient #7 dropped to his knees in the hallway and started praying into his bible. Other notes dated 5/15/11 included a "NURSE'S NOTES" at 10:00 AM that stated Patient #7 was attempting to touch other patients with his bible and shout "Demons be gone in the name of the Lord." "NURSE'S NOTES" at 12:00 noon and 2:00 PM stated Patient #7 continued to wander and chant and shout. The "NURSE'S NOTES" at 4:00 PM stated Patient #7 assaulted a staff member and was medicated and placed on 1 to 1 staffing. "NURSE'S NOTES" at 5:45 PM stated Patient #7 spit water on other patients. "NURSE'S NOTES" at 7:00 PM stated Patient #7 threw water on a patient and shouted. The notes stated staff attempted to redirect him with varying success. "NURSE'S NOTES" did not describe attempts to control Patient #7's behavior or to keep other patients safe, except for redirection.

Patient #7's NCP did not provide direction to staff as to how to prevent him from physically harming other patients.

The DNS was interviewed on 8/12/11 beginning at 9:15 AM. She confirmed Patient #7's record did not indicate steps had been taken to prevent him from physically harming other patients.

Nursing staff did not develop a completed NCP for Patient #7.

9. Patient #14's medical record documented an 81 year old female who was hospitalized on 6/29/11 and was discharged on 7/05/11. Her diagnoses included mood disorders and dementia. A "SKIN ASSESSMENT," dated 6/29/11, stated she had compression wraps on her legs due to MRSA infected wounds. The "24 HOUR NURSING CARE PLAN," dated 6/29/11, stated she had potential for "...skin issues due to low mobility." The NCP directed staff to encourage her to move every 2 hours, perform personal cares as needed, and encourage different activities." The NCP did not address the care of her wounds or MRSA infection.

The DNS was interviewed, beginning at 9:15 PM on 8/12/11. She reviewed Patient #14's medical record. She confirmed the NCP did not address the wounds or MRSA.

During an interview on 8/12/11 at 1:30 PM, the DNS declined to continue to review the nursing care plans for the 11 remaining patients, #3, #5, #6, #11, #13, #16, #17, #18, #19, #20, and #21. She stated the nursing care plans the facility had were not being used appropriately, and needed to be redesigned. The DNS stated it was her goal to educate the nursing staff on designing a useful care plan that addressed each patient's individual needs.

The hospital did not develop complete NCPs.

Based on record review, observation, and staff interview, it was determined the facility failed to administer medications as ordered by the physician, and document verification of insulin dosage with a second licensed nurse before administration for 3 of 5 diabetic patients (#9, #10, and #19) whose records were reviewed. The failure to administer medications as ordered and with established practice standards had the potential to result in deterioration of medical condition as well as medication errors. Findings include:

1. A facility policy, "Refusal of Medications and Treatments," revised 10/20/10, stated "In the event a patient refuses medication...The physician will be notified ....The responsible party of the non-compliant patient will be notified if the patient is deemed not their own responsible party....The interdisciplinary team will review and address noncompliance in the care planning process." Physicians were not notified of missed doses or patient refusal of medications as follows:

a. Patient #9 was an 84 year old insulin dependent diabetic male, admitted 7/29/11. His medical record indicated he had dementia and his daughter was the legal guardian. Review of Patient #9's MAR documented the following refusals of medications:

- 8/03/11 at 8:00 AM, Vitamin B-12

- 8/03/11 at 8:00 AM, Potassium Chloride, 10 mEq

- 8/03/11 at 8:30 AM, Humalin insulin, 7 units

- 8/03/11 at 12:30 PM, Humalin insulin, 7 units

- 8/04/11 at 6:30 PM, Humalin insulin, 7 units

- 8/05/11 at 8:00 AM, Potassium Chloride, 10 mEq

- 8/05/11 at 8:00 AM, Dorzolamide/Timolol eye drops

- 8/05/11 at 8:00 PM, Dorzolamide/Timolol eye drops

- 8/05/11 at 8:30 AM, Humalin insulin, 7 units

- 8/05/11 at 12:30 PM, Humalin insulin, 7 units

- 8/06/11 at 8:30 AM, Humalin insulin, 7 units

- 8/06/11 at 12:30 PM, Humalin insulin, 7 units

- 8/06/11 at 8:00 PM, Dorzolamide/Timolol eye drops

- 8/07/11 at 8:00 AM, Potassium Chloride, 10 mEq

- 8/07/11 at 8:00 AM, Dorzolamide/Timolol eye drops

- 8/07/11 at 8:30 AM, Humalin insulin, 7 units

- 8/08/11 at 6:30 PM, Humalin insulin, 7 units

- 8/08/11 at 8:00 PM, Humalin insulin, 7 units

- 8/08/11 at 8:00 PM, Dorzolamide/Timolol eye drops

- 8/09/11 at 8:00 AM, Potassium Chloride, 10 mEq

- 8/09/11 at 1:00 PM, Humalog insulin, 7 units

- 8/09/11 at 1:00 PM, Humalog insulin, 6 units

- 8/10/11 at 9:00 AM, Humalog insulin, 7 units

- 8/10/11 at 9:00 AM, Humalog insulin, 2 units

- 8/10/11 at 6:00 PM, Humalog insulin, 8 units

- 8/10/11 at 8:00 PM, Humalog insulin, 6 units

- 8/10/11 at 9:00 PM, Cogentin 0.5 mg

- 8/10/11 at 9:00 PM, Risperdal 1.5 mg (There were instructions on the MAR to administer Zyprexa 5 mg IM if patient #9 refused Risperdal. Patient #9 refused Risperdal, and Zyprexia was not administered).

- 8/11/11 at 8:00 AM, Potassium Chloride, 10 mEq

The medical record did not contain entries by the nursing staff informing the physician or legal guardian of Patient #9's refusal of medications. The nursing and interdisciplinary care plans did not address Patient #9's noncompliance.

b. Patient #10 was a 77 year old insulin dependent diabetic male, admitted 8/09/11. The Psychiatric Evaluation, dated 8/10/11 at 10:25 AM, documented Patient #10's reason for admission as a worsening of mental health associated with refusal of medications. Review of Patient #10's MAR documented his refusals of medications:

- 8/10/11 at 8:30 AM, Novolog insulin, 3 units

- 8/10/11 at 12:30 PM, Novolog insulin, 1 unit

- 8/10/11 at 12:30 PM, Novolog insulin, 7 units

- 8/10/11 at 6:30 PM, Novolog insulin, 1 unit

The medical record did not contain entries by the nursing staff informing the physician of Patient #10's refusal of medications. The nursing and interdisciplinary care plans did not address Patient #10's noncompliance.

In an interview on 8/12/11 at 1:25 PM, the DNS reviewed the records of Patients #9 and #10. She confirmed the records did not document communication with the physician when medications had been refused by patients. She stated the psychiatrist would meet with the patients and their nurses every morning in rounds, and the psychiatrist would then be informed of noncompliance with therapy or medication regimens.

2. Insulin orders and doses were not verified and countersigned by a second licensed nurse before administration, and site of administration was not documented.

According to the Institute for Safe Medication Practices, 2005,
-"Insulin orders should not be carried out until the order transcription has been verified and documented for accuracy by an independent double check.
-All measured insulin doses should be confirmed by independent checks by two individuals.
-An independent double check with another caregiver should occur prior to administration that includes ordered dose, insulin type, and measured dose."

This did not occur as follows:

a. Patient #9 was an 84 year old insulin dependent diabetic male on routine doses of insulin, as well as, a sliding scale according to his blood glucose level before meals and at bedtime. Additionally, his MAR did not have spaces available for documentation of the site of administration, second nurse verification, and initials of nurse who performed the glucose test.

b. Patient #10 was a 77 year old insulin dependent diabetic male on routine doses of insulin, as well as, a sliding scale according to his blood glucose level before meals and at bedtime. His MAR did not have spaces available for documentation of the site of administration, second nurse verification, and initials of nurse who performed the glucose test.

c. Patient #19 was an 83 year old insulin dependent diabetic female on routine doses of insulin, as well as, a sliding scale according to his blood glucose level before meals and at bedtime. His MAR did not have spaces available for documentation of the site of administration, second nurse verification, and initials of nurse who performed the glucose test.

In an interview on 8/10/11 at 12:00 PM, the Medication Nurse, an LPN, stated she did not know of a facility policy related to insulin administration. She stated she was frequently unable to verify drawn up insulin with another nurse prior to administration due to the other licensed nurse being unavailable.

In an interview on 8/10/11 at 12:15 PM, the Charge Nurse, an RN, explained the documentation of insulin administration on the MAR. The blood glucose reading was documented on the MAR, although no initials were placed that would indicate who had performed the procedure. The MAR contained a sliding scale routine with doses of insulin dependent upon the patient's blood glucose test result. In that section, the dose given was noted. However, the initials of the person who gave the insulin and the site where it was given, were not documented. The Charge Nurse stated the facility did not utilize a diabetic flow sheet.

The MAR did not contain key factors of proper insulin administration which would include but not be limited to: site of insulin administration, initials of the nurse who administered the dose, initials of the nurse who verified the dose of insulin, and initials of the nurse who tested the patient's blood glucose level.

Based on staff interview and review of clinical records and hospital policies, it was determined the hospital failed to ensure patient medical records were legible, complete, dated, and timed for 11 of 20 patients (#1, #2, #3, #4, #9, #10, #11, #14, #15, #16, and #17) whose records were reviewed. This resulted in a lack of clarity as to the timeline of care, which had the potential to interfere with patient safety and quality of care. Findings include:

1. Illegible nurse entries on order sheets, nursing care plans, admission assessments, and progress notes resulted in a lack of clarity and disruption in the coordination of patient care as follows:

a. Patient #2 was a 21 year old male, admitted on 8/08/11. A "24 HOUR NURSING CARE PLAN," dated 8/08/11, was illegible.

b. Patient #9 was an 84 year old male, admitted on 7/29/11. An "Initial RN Assessment of New Patient," dated 7/29/11 at 7:30 PM was illegible, and not signed. A "24 HOUR NURSING CARE PLAN," dated 7/29/11 the was illegible. "NURSE'S NOTES," dated 8/05/11, at 8:00 PM were illegible.

c. Patient #11 was a 55 year old female, admitted 8/04/11. "NURSE'S NOTES," dated 8/06/11, at 8:00 5:00 PM and 10:00 PM and 8/0711 at 1:00 AM and 6:20 AM were illegible.

d. Patient #16 was a 29 year old male, admitted 5/13/11. "PHYSICIAN'S ORDERS," dated 5/13/11 at 11:15 PM, was illegible. "NURSE'S NOTES," dated 5/15/11 at 8:00 PM and 10:00 PM, and 5/16/11 at 8:00 AM were illegible.

During an interview on 8/12/11 beginning at 11:30, the DNS reviewed the records and confirmed the illegible record entries. She stated she also had difficulty reading the entries and stated the problem would be resolved by moving to an electronic medical record.

2. Written record entries in the medical record were not signed, dated, or timed:

a. Patient #2 was a 21 year old male, admitted on 8/08/11. "ACTIVITY PROGRESS NOTES," entries dated 8/08/11, were untimed. "SOCIAL SERVICE PROGRESS NOTES," entries dated 8/08/11, were untimed.

b. Patient #3 was a 42 year old male, admitted 8/02/11. "ACTIVITY PROGRESS NOTES," entries dated 8/04/11 and 8/08/11, were untimed. "SOCIAL SERVICE PROGRESS NOTES," entries dated each day from 8/03/11 to 8/09/11, were untimed. "NURSING ADMISSION ASSESSMENT," dated 8/02/11, was untimed.

c. Patient #9 was an 84 year old male, admitted on 7/29/11. "NURSE'S NOTES," with undated entries at 2:00 PM, 4:00 PM, 6:00 PM, 6:15 PM, 8:30 PM, and 10:10 PM. "SOCIAL SERVICE PROGRESS NOTES," daily entries from 7/30/11 to 8/9/11, were all untimed.

d. Patient #10 was a 77 year old male, admitted on 8/09/11. An "Initial RN Assessment of New Patient," page 2, was not dated, timed, or signed.

e. Patient #11 was a 55 year old female, admitted 8/04/11. An "Initial RN Assessment of New Patient," page 1, was not signed. A form, "Safe Haven Hospital C.N.A. Care Guide/Plan," dated 8/04/11, was not signed. "SOCIAL SERVICE PROGRESS NOTES," daily entries from 8/04/11 to 8/9/11, were all untimed.

f. Patient #16 was a 29 year old male, admitted 5/13/11. "PHYSICIAN'S ORDERS," dated 5/13/11 at 11:15 PM, was not listed as a "telephone" or "verbal" order, and not signed by the nurse taking the order. A form, "Safe Haven Hospital C.N.A. Care Guide/Plan," dated 5/13/11, was not signed. "SOCIAL SERVICE PROGRESS NOTES," daily entries from 5/14/11 to 5/17/11, were all untimed.

During an interview on 8/12/11 beginning at 11:30 AM, the DNS reviewed the medical records and confirmed the records lacked signatures, dates, and times. The DNS stated the facility did not have a policy that included medical record documentation.

3. Patient #1's medical record documented an 84 year old male who was hospitalized on 7/28/11 and was currently a patient as of 8/12/11. "NURSE'S NOTES," dated 8/05/11 at (the time was not legible) through 8/06/11 at 6:00 AM, were not legible. Also, the form "Initial RN Assessment of New Patient," dated 7/28/11 at 11:15 AM was not signed by the person who completed the form. A signature line was not present on the form.

The DNS was interviewed beginning at 9:15 AM on 8/12/11. She reviewed Patient #1's medical record and confirmed the notes were illegible. She also confirmed the "Initial RN Assessment of New Patient" form was not signed.

4. Patient #15's medical record documented a 61 year old female who was admitted to the hospital on 5/19/11 and was discharged on 5/27/11. Diagnoses included bipolar disorder, depression, and emphysema. The form "Initial RN Assessment of New Patient" documented the date and time the patient was admitted to the hospital but did not state who filled out the form or when it was written. Also, the form "NURSING ADMISSION ASSESSMENT," dated 5/19/11, was not timed.

The DNS was interviewed beginning at 9:15 AM on 8/12/11. She reviewed Patient #15's medical record and confirmed the nursing admission forms had not been authenticated, timed, and dated.

5. Patient #4's medical record documented a 30 year old female who was admitted to the hospital on 7/28/11 and was currently a patient as of 8/09/11. Diagnoses included bipolar disorder and borderline personality disorder. The form "Initial RN Assessment of New Patient" documented the date and time the patient was admitted to the hospital but did not state who filled out the form or when it was written. Also, the form "NURSING ADMISSION ASSESSMENT," dated 7/28/11, was not timed.

The DNS was interviewed beginning at 9:15 AM on 8/12/11. She reviewed Patient #4's medical record and confirmed the nursing admission forms had not been authenticated, timed, and dated.

6. Patient #14's medical record documented an 81 year old female who was hospitalized on 6/29/11 and was discharged on 7/05/11. "NURSE'S NOTES," dated 7/01/11 at 8:00 PM through 7/02/11 at 6:10 AM, were not legible. "NURSE'S NOTES," dated 7/02/11 at 8:00 PM through 7/03/11 at 6:00 AM, were not legible. "NURSE'S NOTES," dated 7/03/11 at 8:30 PM through 7/04/11 at 6:30 AM, were not legible.

The DNS was interviewed beginning at 9:15 AM on 8/12/11. She reviewed Patient #14's medical record and confirmed the notes were illegible.

7. Patient #17's medical record documented an 70 year old male who was hospitalized on 6/17/11 and was discharged on 7/01/11. "NURSE'S NOTES," dated 6/18/11 at 8:00 PM through 6/19/11 at 6:15 AM, were not legible. "NURSE'S NOTES," dated 6/19/11 at 8:00 PM through 6/20/11 at 6:30 AM, were not legible. Also, the form "Initial RN Assessment of New Patient," dated 6/17/11 at 4:15 PM was not signed by the person who completed the form. A signature line was not present on the form.

The DNS was interviewed beginning at 9:15 AM on 8/12/11. She reviewed Patient #17's medical record and confirmed the notes were illegible. She also confirmed the "Initial RN Assessment of New Patient" form was not signed.

The facility did not insure medical record documentation was complete and legible.

Based on record review and staff interview, it was determined the facility failed to ensure all orders were dated, timed, and authenticated for 6 of 20 patients (#'s 1, #5, #9, #11, #13 and #15) whose records were reviewed. The lack of a policy that gave clear direction of the process of receipt, transcription, and authentication of physician orders had the potential to result in medications being administered without a physician order, medication and treatment errors, as well as lack of clarity about the course of patient care. Findings include:

1. The facility did not have a policy regarding physician orders, including reading back verbal and telephone orders. Verbal and telephone orders were not documented by a "read back and verify" notation by the order recipient. Examples include:

a. Patient #3 was a 42 year old male, admitted on 8/02/11. A telephone order was received on 8/02/11 at 6:05 PM by the admitting nurse and the order was written as "T.O." followed by the name of the ordering practitioner.

b. Patient #5 was a 23 year old female, admitted on 8/03/11. A telephone order was received on 8/03/11 at 10:00 PM by the admitting nurse and the order was written as "T.O." followed by the name of the ordering practitioner.

c. Patient #9 was an 84 year old male, admitted on 7/29/11. Telephone orders were received on 8/02/11 at 10:50 AM, 5:00 PM, and at 7:00 PM, and the orders were written as "T.O." followed by the name of the ordering practitioner.

d. Patient #11 was a 55 year old female, admitted on 8/04/11. A verbal order was received on 8/05/11 at 3:30 PM, and the order was written as "V.O." followed by the name of the ordering practitioner. Telephone orders were received on 8/07/11 at 6:30 PM, and 9:00 PM, and on 8/08/11 at 12:15 PM. The orders were written as "T.O." followed by the name of the ordering practitioner.

e. Patient #13 was a 57 year old female, admitted on 8/08/11. A telephone order was received on 8/09/11 at 12:30 PM, and the order was written as "T.O." followed by the name of the ordering practitioner.

In an interview on 8/12/11 beginning at 11:00 AM until 2:45 PM, the DNS reviewed the records and confirmed the nursing staff had received telephone and verbal orders without documenting a "read back verify" process had occurred. She also confirmed the hospital did not have a policy that addressed reading back telephone and verbal orders.

2. The prescribing practitioners did not sign, date and time the orders at the time of authentication.

a. Patient #3 was a 42 year old male, admitted on 8/02/11. The telephone order received on 8/02/11 at 6:05 PM by the admitting nurse was not authenticated by the ordering practitioner as of 8/11/11.

b. Patient #5 was a 23 year old female, admitted on 8/03/11. The telephone order received on 8/03/11 by the admitting nurse was not authenticated by the ordering practitioner as of 8/11/11.

c. Patient #9 was an 84 year old male, admitted on 7/29/11. The telephone orders received on 8/02/11 at 10:50 AM, 5:00 PM, and at 7:00 PM, were not authenticated by the ordering practitioner as of 8/11/11.

d. Patient #11 was a 55 year old female, admitted on 8/04/11. The verbal orders received on 8/05/11 at 3:30 PM, telephone orders received on 8/07/11 at 6:30 PM, 9:00 PM, and on 8/08/11 at 12/15/11 at 12:15 PM, were not authenticated by the ordering practitioners as of 8/11/11.

e. Patient #13 was a 57 year old female, admitted on 8/08/11. The telephone order received on 8/09/11 at 12:30 PM by the admitting nurse was not authenticated by the ordering practitioner as of 8/11/11.

In an interview on 8/12/11 beginning at 11:00 AM until 2:45 PM, the DNS reviewed the records and confirmed the ordering practitioners had not authenticated the orders.

3. The admission order set in use by the facility lacked clarity as to when they were written and when the physician authenticated them, the medication reconciliation was incorporated into the order set, and the orders were not noted by a licensed nurse after authentication by the practitioner.

Patient #15's medical record documented a 61 year old female who was admitted to the hospital on 5/19/11 and was discharged on 5/27/11. Diagnoses included bipolar disorder, depression, and emphysema. A telephone order was dated 5/23/11 at 4:40 PM to administer the medications Rifampin and Flovent and to stop the medication Azmacort. The order had not been authenticated by the physician as of 8/12/11. Also, 2 pages of telephone admission orders were dated 5/19/11. However, neither page contained the time the orders were written by the nurse or the time and date the phsycian signed the orders.

The DNS was interviewed beginning at 9:15 AM on 8/12/11. She confirmed the 5/23 order had not been authenticated and the admission orders had not been timed and dated.

In an interview on 8/11/11 at 1:00 PM, the charge nurse reviewed a form, "SafeHaven Hospital Admission Order and Medication Reconciliation Form." She stated the form was completed upon each patient admission and they were on the computer in a template form that the admitting nurse would adapt for each individual patient. She explained the first page included PRN medications as well as orders for assessments such as registered dietitian, social work, and recreation therapy. She stated certain orders were automatically checked, but others on the sheet would be left blank for the physician to check, indicating they were to be done. The Charge Nurse stated the last page, or pages would be for the medication reconciliation, and each of the medications the patient was taking at the time of admission would be included on the order sheet. Next to each of those medications, were two options, "continue" or "stop." The Charge Nurse stated the physician would check the box which would indicate the patient would either be continued on that particular medication during the hospital stay, or it was to be discontinued. The Charge Nurse stated the admitting nurse would produce the admission form upon admission and the form would be signed by the physician the next time he was at the hospital, usually the next day. The Charge Nurse confirmed the forms were not noted with a licensed nurse signature, date and time after the practitioner signed it. The Charge Nurse confirmed there was a potential for medications to be administered without a physician's order if the medication was administered before the practitioner signed the form.

The process of including the medication reconciliation form with the admission form, and lack of clarity when it was authenticated by the ordering practitioner, coupled with the lack of noting the orders impacted 100% of the patients.



00023

Based on observations, staff interviews, and review of policies, it was determined the hospital failed to ensure outdated or unusable medication was not available for use. Expired medications still accessible for patient use had the potential to impact the effectiveness of the medication therapy. Findings include:

1. On 8/11/11 at 4:00 PM, the patient medication cart was inspected. The following medications were found to be unusable, either because they were outdated, open and undated, or labeled for a discharged patient:

a. Hydrogen peroxide, 32 oz container, undated as to when initially opened, expiration date 12/2010.

b. Two 10 ml vials of Sterile Water, opened, partially full, undated, "Single Use Only," "Preservative Free" noted on vials.

c. Citrucel, 16 oz, undated as to when initially opened, expiration date 4/2011.

d. Lidocaine 1% 20 ml vial, opened, partially full, undated.

E. Hemoccult developer, opened, partially full, undated as to when initially opened, expiration date 7/2011.

f. Tums, fruit flavored, labeled for a patient that had been discharged.

g. Multivitamins, 100 tabs, open, undated.

The Charge Nurse and Medication Nurse were both present during the inspection of the medication cart. Both nurses confirmed the outdated and unlabeled medications. The Charge Nurse stated the Sterile Water was used to reconstitute IM medications, and it was a practice to store partially full vials in the medication cart to be used again. The Charge Nurse stated the Hemoccult developer solution was no longer in use, because the only "Point of Care" testing was with the glucometer for blood sugars, and stool for occult blood was sent to a lab for processing. The Medication Nurse stated the Multivitamins were not used, as all medications were "unit dose," and dispensed by the pharmacy for each patient.

The facility did not ensure unusable drugs were removed from the medication cart and returned to the pharmacy.

Based on record review and staff interview, it was determined the facility failed to develop and maintain a formulary system. The failure to maintain a formulary resulted in a disruption of the delivery of patient care and medication regime for 3 of 20 current patients (#2, #19, and #20) whose records were reviewed. The delay of medication administration as a result of unavailable medication in the hospital pharmacy had the potential to result in a disruption in medical therapy and treatment. Findings include:

1. Patient #19 was an 83 year old female who was admitted on 8/15/11. On 8/15/11 Patient #19's physician ordered Pataday Ophthalmic drops to be instilled in each eye once daily. The drug was not given on 8/16/11 and 8/17/11, and a note on the back of the MAR documented the drug was not available.

In an interview on 8/19/11 at 10:30 AM, the DNS reviewed the record and confirmed the medication had not been administered. She stated the Pharmacist would bring medications in from other sources if the hospital pharmacy did not have them.

The hospital pharmacy did not supply medication for patient administration for three days.

2. Patient #20 was an 82 year old female who was admitted on 8/15/11. On 8/18/11 Patient #20's physician ordered Wellbutrin XL 150 mg orally, once daily. The MAR documented the drug was not given at 8:00 AM on 8/19/11 and there was no documentation why the medication had not been administered.

In an interview on 8/19/11 at 10:00 AM, the Charge Nurse stated initially the medication had not been given as the hospital supplied only Wellbutrin XL 300 mg. She stated the LPN who was the "Medication Nurse," had divided the hospital supplied Wellbutrin XL 300 mg tablet in half and administered the dose to Patient #20, although she had documented it was not given.

According to "Nursing 2012 Drug Handbook," Wellbutrin tablets should not be crushed or split.

The Hospital Pharmacy did not supply patient medications in a timely manner as to avoid missed doses or wrongful administration practices.

3. Patient #2 was a 21 year old male who was admitted on 8/8/11. On 8/8/11 Patient #2's physician ordered QVAR (a corticosteroid for the reduction of inflammation of the airway for use by asthmatics). The MAR documented the 8:00 AM dose was not given and the reverse side of the MAR documented the drug was unavailable.

The DNS reviewed the record and confirmed the drug was not administered.

The hospital pharmacy did not have patient asthma medication in stock for patient use when ordered by physician.

In an interview 8/11/11 at 2:30 PM, the Pharmacist stated there was no formulary system established for the hospital, as it was not needed. She stated she knew what the two physicians routinely prescribed, and if additional medications were needed, she would obtain them for the facility. The Pharmacist stated she was available on site three days a week in the afternoon.

The facility did not have a formulary system that would ensure patients would recieve medications in a timely manner.

Based on staff interview and review of laboratory policies, it was determined the hospital failed to ensure an accurate written description of laboratory services was available to staff. This led to the potential for delays in laboratory testing. Findings include:

Routing laboratory testing was provided through a Boise, Idaho laboratory which was located approximately 238 miles from the hospital. Routine fasting blood specimens were drawn at 6:00 AM and stored until a courier picked them up at approximately 12:00 noon. Hospital policies did not address the time frames and delays experienced with routine laboratory testing.

The policy "DIAGNOSTICS," revised 10/07/11, stated the hospital provided on-premises laboratory testing including stool examinations for occult blood, PT/INR, and EKGs.

The DNS, interviewed on 8/22/11 at 11:05 AM, confirmed the delays in laboratory testing and confirmed policies and procedures did not address the delays. She also stated the hospital did not do stool examinations for occult blood, PT/INR, and EKGs on site and had not done so for at least a year.

The hospital did not have accurate policies regarding laboratory services and did not have an accurate list of the laboratory services it provided.

Based on observations and staff interview, it was determined the hospital failed to ensure supplies and equipment were maintained at an acceptable level of safety and quality. The failure to maintain supplies and equipment had the potential to directly injure or expose all patients to illnesses. The findings include:

1. Bio-medical safety and quality testing of patient medical equipment was not done. Without current inspections of medical equipment, the facility would not be able to ensure safe operation as follows:

a. During a tour of the facility on 8/11/11 at 4:00 PM, in the hospital's medication cart storage room, a Datascope blood pressure monitor on a rolling stand, Optium EZ blood glucose monitor, and an Exergan temporal thermometer were noted to not have a Bio-Medical safety and quality sticker in place.

b. In the DNS office on 8/09/11 at 3:00 PM, a blood centrifuge was noted to contain an expired bio-medical safety and quality sticker, dated 1/13/09, expiration on 1/13/10.

On 8/09/11 at 4:30 PM, the Administrator stated the hospital did not have bio-medical safety and quality checks performed on the medical equipment. He stated the centrifuge, blood pressure monitor, thermometer, glucometer and other medical equipment had not been routinely cleaned or examined for calibration and safety.

The hospital failed to ensure equipment was maintained at an acceptable level of safety and quality.

2. The Crash Cart was not readily available for hospital response to patient emergency, the cart was not checked on a routine basis, and there was no hospital policy to ensure the Crash Cart was maintained to ensure supplies were available and not outdated as follows:

a. The Crash Cart was found to be located in the adjacent SNF facility, behind locked doors. The AED was stored in a wall mounted cabinet above the Crash Cart. On 8/18/11 at 4:30 PM, the Administrator was present during the cart inspection. The Administrator stated it was the SNF staff responsibility to check the cart once daily, but was unable to find a policy for Crash cart inspection or maintanance. On the top of the cart was a notebook, for the documentation of monthly Crash Cart and Suction Machine Inspections. There was no direction provided of what the inspections were to include. The monthly log contained a space for the date of the month, staff signature, and a line for comments. There was no log for the Crash Cart inspection for the month of August, 2011. The Crash Cart log for July, 2011 was not checked on 9 occasions in July, (8, 9, 10, 11, 12, 24, 25, 30, and 31). There was no evidence the AED had been routinely checked for functioning ability or preventative maintenance.

b. The Crash Cart was inspected for expired equipment. Two pairs of sterile gloves, with expiration dates of 1/2007, and two pairs of sterile gloves with expiration dates of 11/2006 were found. A 24 gauge IV catheter, with an expiration date of 6/2011 was found. An open package was on the top of the Crash Cart, containing an oral suction device and suction tubing. The Administrator was present during the cart inspection, and confirmed the expired and open supplies.

The hospital failed to ensure equipment was checked for an acceptable level of safety and quality.

Based on staff interview and review of hospital policies, it was determined the hospital failed to ensure the IC Officer developed and implemented policies governing control of infections and communicable diseases. This resulted in a lack of direction to staff regarding infection control practices and an increased risk of exposure to infections for all patients. Findings include:

The policy "Infection Control Coordinator," dated 1/31/11, stated the IC Coordinator (Officer) was responsible for developing policies, maintaining the premises in a sanitary manner, participating in the employee health program, and developing an employee IC orientation and inservice training program.

IC policies were all dated 1/31/04. The IC Officer was interviewed on 8/11/11 beginning at 9:00 AM. She stated she had been the IC officer for approximately 1 year. She said the patient population had different IC issues since the policies were written. She stated that she had reviewed the IC policies but said no substantive changes had been made to them.

The IC Officer was interviewed on 8/25/11 at 9:50 AM. She stated she had not developed or revised any IC policies. She stated "a lot" of IC policies need to be revised and do not pertain to the practices at the hospital. She also stated she did not monitor the environment for IC hazards and practices. She stated the Human Resources Manager conducted new employee orientation and she was not sure whether IC was addressed in orientation. She stated she had not developed or conducted inservices for staff regarding IC. She stated the hospital did not take employee health into account as part of its IC program. She stated that, except for the infection control log, there was no documentation of her involvement with the IC program.

Based on staff interview and review of hospital policies and quality documents, it was determined the hospital failed to ensure the QAPI program included quality indicators and that those indicators showed measurable improvement over time. This resulted in a lack of information with which the hospital could use to improve health outcomes. Findings include:

1. "Quality Assurance Program" policies all contained an effective date of 1/31/04. The ownership and principal staff of the hospital had all changed in April 2010. The policies all stated they had been "Reviewed/Revised" on 11/05/10 by the DNS.

The DNS, a member of the CQI Committee, was interviewed on 8/11/11 beginning at 9:00 AM. She confirmed the staff and ownership had changed. She stated that she had reviewed the QAPI policies but said no substantive changes had been made to them. The Quality Assessment Coordinator, present at the same interview, stated that between 2004 and 2011 the type of patients treated at the hospital had changed from a geriatric population with dementias to a younger population with diagnoses of depression, bipolar disorders, and psychoses. He confirmed the QAPI policies had not changed to reflect this new population.

QAPI policies had not been updated.

2. Minutes of 4 CQI meetings were documented between August 2010 through July 2011. These were dated 4/08/11, 5/20/11, 6/10/11, and 7/09/11. They were reviewed with the Quality Assessment Coordinator, on 8/11/11 beginning at 9:00 AM. He stated there were no minutes prior to April 2011. He stated a plan for QAPI activities had not been developed. He said he had decided to monitor items that had historically been monitored at the hospital.

The items identified for the CQI Committee included pressure ulcers, catheters, physical restraints, falls, infections, patients receiving Coumadin, open positions, staff turnover, admissions/discharges, dietary-weekly Tray Audits and Sanitation Checks, employee injuries, and outstanding MD Orders. No goals had been developed for these items. Only the number of occurrences, such as the number of falls or the number of infections for the previous month, were documented. No processes of care were currently being evaluated by the CQI Committee. No plan was in place to compare data over time in order to show improvement. The hospital had not identified high volume, high risk areas to monitor. This was confirmed by the Quality Assessment Coordinator in the same interview.

A QAPI plan, including quality indicators to be measured, had not been developed.

3. The Quality Assessment Coordinator, interviewed on 8/11/11 beginning at 9:00 AM, stated the hospital did not have a physician peer review program or other method of assessing care provided by the Medical Staff.

A plan to assess the quality of medical care had not been developed.

The hospital had not developed quality indicators to measure and improve care.

Based on staff interview and review of quality documents, it was determined the hospital failed to ensure the QAPI program measured, analyzed, and tracked quality indicators, including adverse patient events. This directly impacted 2 of 20 patients (#7 and #9), whose records were reviewed and had the potential to impact the care of all patients receiving care at the facility. This resulted in the inability of the hospital to monitor its performance and prevent adverse events. Findings include:

1. Minutes of 4 CQI meetings were documented in the past year. These were dated 4/08/11, 5/20/11, 6/10/11, and 7/09/11. The items identified for the CQI Committee included pressure ulcers, catheters, physical restraints, falls, infections, patients receiving Coumadin, open positions, staff turnover, admissions/discharges, dietary-weekly Tray Audits and Sanitation Checks, employee injuries, and outstanding MD Orders. Numbers of events or incidents were identified, such as the number of patients with pressure ulcers or the number of falls. Only the numbers were listed. No analysis of the data was done. The minutes showed the number of events for the past month and the month prior to that. The data was not tracked for more than 2 months.

The Quality Assessment Coordinator was interviewed on 8/11/11 beginning at 9:00 AM. He confirmed the items from the CQI meeting minutes were not analyzed or tracked for more than 2 months.

The CQI Committee did not analyze or track quality indicators.

2. A policy outlining the process for reporting and analyzing adverse patient events and other incidents was not included in the quality policies. Adverse patient events and other incidents were not reported to the hospital's QAPI program. Examples include:

a. Patient #9 was an 84 year old male, admitted on 7/29/11 with diagnoses of psychosis, dementia, Type 2 diabetes, hypertension, and coronary artery disease.

"NURSE'S NOTES" on 8/02/11 at 6:00 PM documented Patient #9's blood glucose was down to 64, although on the MAR it was documented as 55. The "Behavior Flow Sheet" stated Patient #9 refused dinner. The "NURSE'S NOTES" stated Patient #9 also refused measures to raise his blood sugar. An entry in the "NURSE'S NOTES" at 8:00 PM documented Patient #9's blood glucose dropped to 34, and the physician was notified. The note documented the physician asked that Patient #9 be transported to the ED. The nurse charted she called 911. Patient #9 was noted to refuse to be taken to the ED when the paramedics arrived. The paramedics left without taking Patient #9 to the ED. An incident report for this event was not documented.

The DNS was interviewed on 8/12/11 at 2:00 PM. She confirmed an incident report for the above incident had not been generated and the event had not been investigated.

b. Patient #7's medical record documented a 50 year old male who was admitted to the hospital on 5/14/11 and was discharged on 5/23/11. His diagnoses included bipolar disorder and psychosis. He was seen in the ED at an acute care hospital on 5/14/11 prior to being transferred to Safe Haven Hospital.

The laboratory report from the acute care hospital stated his serum potassium level was low at 2.6. The report stated the normal potassium level was 3.6-5.2. An "ADMISSION HISTORY AND PHYSICAL," dated 5/15/11, stated the plan was to check his potassium level on 5/16/11 after he had taken potassium supplements. A order for potassium testing was written at that time. The note stated "The patient will need to be observed for evidence of neurological changes, complaints of rhythmic disturbance." Patient #7's potassium level was not rechecked until 5/18/11, when it measured 3.4. No reason for the delay in the laboratory testing was present in the medical record. An incident report for this event was not documented.

The DNS was interviewed on 8/10/11 at 12:30 PM. She stated the potassium level should have been completed on 5/16/11. She confirmed an incident report for the above incident had not been generated and the events had not been investigated.

Based on staff interview and review of hospital policies and quality documents, it was determined the hospital failed to ensure quality indicator data was incorporated into its QAPI program. This resulted in the inability of the hospital to monitor its performance through the use of data. Findings include:

1. Hospital policies included under the heading "Quality Assurance Program," all dated 1/31/04, did not mention the collection of data or how that data would be used.

The Quality Assessment Coordinator, interviewed on 8/11/11 beginning at 9:00 AM, stated the hospital did not have a QAPI plan which included data collection and he said policies which addressed the QAPI program did not mention data collection or usage.

The hospital did not have a plan to utilize data as part of its QAPI program.

2. Minutes of 4 CQI meetings were documented between August 2010 through July 2011. These were dated 4/08/11, 5/20/11, 6/10/11, and 7/09/11. They were reviewed with the Quality Assessment Coordinator, on 8/11/11 beginning at 9:00 AM. Only the number of occurrences, such as the number of falls or the number of infections for the previous month, were documented. Otherwise, no data was documented as collected. No discussion of the data or analysis of data was documented.

The Quality Assessment Coordinator, interviewed on 8/11/11 beginning at 9:00 AM, confirmed the lack of data collection and analysis.

The CQI Committee did not utilize data.

Based on staff interview and review of hospital policies and quality documents, it was determined the hospital failed to ensure the frequency and detail of data collection for its QAPI program was specified by the hospital's governing body. This resulted in a lack of direction to staff regarding the amount and type of data that should be collected. Findings include:

Hospital policies included under the heading "Quality Assurance Program," all dated 1/31/04, did not mention the collection of data or how that data would be used.

The Quality Assessment Coordinator, interviewed on 8/11/11 beginning at 9:00 AM, stated the hospital did not have a QAPI plan which included data collection and he said policies which addressed the QAPI program did not mention data collection or usage.

Hospital policies did not specify the frequency and detail of data collection.

2. Minutes of 4 CQI meetings were documented between August 2010 through July 2011. These were dated 4/08/11, 5/20/11, 6/10/11, and 7/09/11. They were reviewed with the Quality Assessment Coordinator, on 8/11/11 beginning at 9:00 AM. Only the number of occurrences, such as the number of falls or the number of infections for the previous month, were documented. Otherwise, no data was documented as collected. No data had been collected regarding hospital processes or the provision of care.

The Quality Assessment Coordinator, interviewed on 8/11/11 beginning at 9:00 AM, confirmed the lack of data collection.

The CQI Committee did not collect data to measure hospital processes.

Based on staff interview and review of hospital policies, it was determined the hospital failed to ensure priorities for its PI activities had been defined. This resulted in a lack of direction to members of the CQI Committee. Findings include:

"Quality Assurance Program" policies, "Reviewed/Revised" on 11/05/10, did not direct the CQI Committee to develop a PI plan. The policies did not mention setting priorities that focused on high-risk, high-volume, or problem-prone areas specific to the hospital. In addition, the hospital had not developed a PI plan.

The Quality Assessment Coordinator, interviewed on 8/11/11 beginning at 9:00 AM, stated the hospital did not have a PI plan and had not set priorities for its collection of data.

The hospital had not developed priorities for its PI activities.

Based on staff interview and review of Governing Board meeting minutes, it was determined the hospital failed to ensure the governing body assumed responsibility to define, implement, and maintain its quality improvement program. This lack of direction resulted in a dysfunctional quality improvement program. Findings include:

Five "HOSPITAL GOVERNING BOARD MEETING MINUTES," dated between 7/19/10 and 7/26/11, were reivewed. None of these meeting minutes mentioned the hospital's quality improvement program.

The Quality Assessment Coordinator was also the Administrator. He was interviewed on 8/11/11 beginning at 9:00 AM. He stated he did not have any written communication from the Governing Board concerning the hospital's quality improvement program. He further stated the Governing Board had not discussed the quality improvement program since he had started working in February 2011.

The Governing Board did not assume responsibility for the hospital's quality improvement program.

Based on record review and staff interview, it was found the hospital failed to ensure the nutritional needs for diabetic patients were met for 3 of 5 diabetic patients (#9, #10, and #19), whose records were reviewed. The failure of the hospital to meet the nutritional needs of patients had the potential to result in a disruption of homeostasis and/or a delay in recovery. Findings include:

1. Diabetic Patients were not followed by a Registered Dietitian, patients were not provided nutritional diabetic snacks by dietary on a routine basis, and patients were not re-evaluated for further nutritional intervention as follows:

a. Patient #9 was an 84 year old insulin dependent diabetic male admitted on 7/29/11. "Safe Haven Hospital Admission Orders and Medication Reconciliation Form," dated 7/29/11 included orders for a Registered Dietitian assessment. As of 8/11/11, an assessment by a Registered Dietitian had not been made.

A "NUTRITIONAL INTERVIEW AND REVIEW," dated 8/01/11 and signed by the Dietary Manager, documented a patient interview with Patient #9. The form contained a statement that an immediate referral to a Registered Dietician would not be needed. A form, "Behavior Flow Sheet" documented how much of each meal was consumed, or if they were refused by the patient. A review of the "Behavior Flow Sheet" for Patient #9 from 7/30/11 to 8/9/11, documented a refusal of 11 of the 33 meals offered. The "Behavior Flow Sheet" did not contain documentation that Patient #9 was offered supplementary meals or evening snacks. The record did not indicate a further assessment of Patient #9's nutritional status had been performed.

b. Patient #10 was a 77 year old insulin dependent diabetic male admitted on 8/09/11. "Safe Haven Hospital Admission Orders and Medication Reconciliation Form," dated 8/09/11 included orders for a Registered Dietitian assessment. As of 8/11/11, an assessment by a Registered Dietitian had not been made. The "Behavior Flow Sheet" did not contain documentation that Patient #10 was offered supplementary meals or evening snacks.

In an interview on 8/11/11 at 2:00 PM, the Dietary Manager stated she reviewed each hospital patient record, and provided an initial nutritional assessment. She stated the diabetic patients' nutritional needs were managed by the nurses and she would provide snacks or supplements only when requested by the hospital staff. The Dietary Manager stated she was unaware of Patient #9's pattern of meal refusal and confirmed she had not re-evaluated his nutritional status.

Patients were not assessed by a Registered Dietitian, and nutritional needs were not re-evaluated.

2. Hospital staff offered patients foods without caution to their documented sensitivities or allergies as follows:

a. Patient #19 was an 83 year old insulin dependent diabetic female, admitted on 8/15/11. Her medical record indicated she was lactose intolerant. On 8/17/11 a "NUTRITIONAL INTERVIEW AND REVIEW " was completed by the Dietary Manager, and documented Patient #19 had lactose intolerance. Review of the progress notes document Patient #19 received milk and milk products on five occasions between 8/16/11 and 8/18/11.

In an interview on 8/18/11 at 5:10 PM, the DNS reviewed the record and confirmed documentation that Patient #19 had received milk and milk products despite the documented lactose intolerance.

The hospital did not ensure patient dietary needs were monitored and re-evaluated.