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Based on observation, record review, and staff interview it was determined that the facility's Governing Body failed to ensure that the facility's Outpatient Services Department was organized and operating in compliance with the Condition of Outpatient Services 42 CFR 482.54. Cross reference Tags A-1076, A-1077 and A-1079.

Based on observation, record review and staff interview it was determined that the Condition for Outpatient Services was not met as evidenced by the following findings:

The facility failed to assign one individual to be responsible for all outpatient services and maintain appropriate professional personnel to provide outpatient services. Cross reference Tag A-1077.

The facility failed to implement policies and procedures that appropriately integrated Outpatient Services with other facility departments. Cross reference Tag A-1079.

Based on observation and staff interview it was determined that the facility failed to maintain the hospital physical plant and environment to provide for the overall safety and well-being of patients. The findings include:

1. Observation of the hospital environment during a tour of the Emergency Department on 9/20/10 at 3:30 PM revealed the handicap push plates at the two doors entering/exiting the ED from the outside would not activate the doors when pushed.

a. Observation of the front entrance to the hospital revealed the handicap push plates at the two doors entering/exiting the hospital from the outside would not activate the doors when pushed.

b. Administrative Staff (D) who was present during this tour confirmed the doors did not work correctly and would not allow a handicapped patient to freely enter the ED or the hospital main entrance.
2. Observation of the ED trauma room revealed on 9/20/10 a patient in a wheelchair waiting to be seen by the provider. The gurney in this room was covered with two absorbent underpads (Chux). These pads were marked on the side by the surveyor with an ink mark. The surveyor returned the next morning on 9/21/10 and observed the same Chux on the gurney. The ED staff present at the time of this observation indicated at least two other patients had used the trauma room since the observation on 9/20/10.

Based on observation and staff interview it was determined that the facility failed to provide emegency lighting and power in the emergency department. The findings include:

1. Observation of the ED after the power outage revealed critical ED equipment and computers were not connected to plug-ins which were powered by the emergency generator as follows:

a. The computer in the office used by provider (C) for recording MSE/ED notations in the EHR.

b. The cardiac monitors in Bay 4, Bay 6 and Room 2.

c. Computers in Room 7, one computer at the nursing station and in room utilized by provider (C)

2. In an interview with a provider (C) after the power was re-established he indicated he had been on the computer entering a MSE notation. He later confirmed the notations he had made had to be re-entered due to the power failure.

3. The ED department did not have a plan, integrated into the Hospital emergency plan, to deal with power outages. There was no plan regarding how to minimize the effect of such failures on the EHR and on patent/staff safety.

Based on interviews and record review it was determined that the facility failed to implement policies and procedures that appropriately integrated Outpatient Service with other facility departments. The findings include:

1a. An interview was conducted with the Director of the facility's main Outpatient Clinic (J) on 9/21/2010 at 4:00 PM. The Director (J) stated that the Outpatient Clinic in the main hospital received patients on an appointment basis, an adult walk-in basis, and a pediatric walk-in basis.

The Director (J) was asked if all outpatient services were conducted in the Outpatient Clinic. The Director (J) stated that some patients who came into the Outpatient Clinic in the main hospital did end of up obtaining treatment in the Emergency Department (ED). She stated that some patients would sign in at the clinic and then sign in at the ED with the expectation that they might be seen in one of the two departments sooner rather than later.

Another reason the Director (J) stated that patients may be seen in the ED was because the clinic was closing and, after patients were triaged and determined not to need immediate care, the clinic gave patients the option to come back the next day to be seen in the Outpatient Clinic or to go to the ED.

The Director (J) stated that some patients, at any time of the clinic's operation, were seen in the ED because they were considered to be emergent cases, such as very high blood sugars that required treatment that included intravenous solutions. The Director (J) stated that the clinic didn't have sufficient staff to monitor these types of patients in the clinic, even though the clinic staff had the qualifications to provide such services. The Director (J) stated that the staffing for the clinic was down due to two nurses being out on extended sick leave and that there were two vacancies the department was attempting to fill.

1b. Interviews were conducted with two Outpatient Clinic nursing staff (K and L) on 9/21/2010. The two nurses (K and L) confirmed that patients were transferred to the ED to obtain treatment for situations where the provider determined that the patients needed emergent treatment.

Both nurses (K and L) confirmed that in some cases no provider evaluation was completed prior to patient transfers to the ED and that the Outpatient Clinic staff would take the patients directly to the ED. The nurses (K and L) stated that the reason for these transfers were due to the lack of staff in the outpatient clinic to monitor these types of patients. Both nurses (K and L) confirmed that the Outpatient Clinic was operating with reduced staff due to vacant positions.

1c. An interview was conducted with one provider (B) at the Outpatient Clinic on 9/21/2010. The provider (B) stated that patients were transferred to the ED based on criteria that had been a part of the Outpatient Clinics Policy and Procedures. The provider (B) stated that the Outpatient Clinic provider or staff would generally call the ED prior to the transfer, but that there may be occasions where calls may not have always been made. The provider (B) stated that the lack of sufficient licensed staff and provider staff were main reasons that patients were transferred to the ED.

2a. During the survey information from the Inpatient Services Department indicated that some patients were being seen on the inpatient floor for treatment that would normally be considered outpatient treatments.

2b. The facility Director of Nursing (DON) (I) was interviewed on 9/23/2010 at 12:15 PM. The DON (I) stated that she was not aware that patients were being seen on the inpatient floor to have outpatient treatment provided.


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3. During the entrance conference with administrative staff on 9/20/10 it was indicated the outpatient clinic hours for appointments was 8:00 AM to 4:00 PM and walk-in clinic (no appointment needed) was from 8:00 AM to 9:00 PM Monday through Friday.

4. Observation of the ED on 9/21/10 at approximately 2:50 PM revealed patient #20 was brought to the ED from the outpatient clinic. The nurse escorting the patient indicated she had just assessed the patient's BG which was 420 and had been directed by the clinic provider to bring the patient to the ED for evaluation.

a. The Outpatient notation by provider (A), a physician assistant, indicated the patient had been scheduled for an appointment but she had directed the clinic nurse to take the patient to the ED for evaluation based on the reported BG. She indicated she had not seen the patient prior to the movement of the patient to the ED.

b. In an interview with the provider (A) on 9/21/10 at 3:25 PM the surveyor requested to see the triage policy and was shown a policy on the computer that was located in a folder titled "old policies".

c. In the interview the provider (A) she indicated she did not feel this patient could be medically managed in the outpatient clinic. She indicated a patient with an elevated BG would be treated with IV fluids and/or insulin (SQ or IV). She indicated the clinic was not able to provide this care because administration of IV fluids, IV insulin and insulin SubQ would require one-to-one monitoring by a nurse. She also indicated there was no current guideline for the management of the diabetic patient in the outpatient clinic setting.

d. The outpatient note by the provider (A) did not indicate when the patient had initially signed into the clinic area. The note indicated the patient was sent to the ED "per triage policy". There was no indication the patient was symptomatic regarding the elevated BG.

e. The outpatient note by the provider (A) indicated the patient was "returned to my door by [nurse], at approximately 1530, but I had the remaining appointments to see and had patient in my office." The provider refused to see the patient and directed her to return to the walk-in clinic.

f. The patient was not seen in the the walk-in clinic until another provider saw her at approximately 1710 (5:10 PM), about an hour and 20 minutes later. This provider indicated the patient was asymptomatic and had no complaints, wishing only to have a medication refill. Her BG (291 mg/dL) was reassessed by this provider and she was discharged home.

g. This patient's wait to receive care was increased due to the lack of integration of the outpatient clinic services with the Emergency Department. Use of an outdated, obsolete policy to send an asymptomatic patient to the ED for evaluation and treatment which could have been provided in the outpatient clinic caused this patient to have an extended wait for services and delayed her return to home which entailed a two hour drive.

5. In an interview on 9/21/10 at approximately 2:40 PM with an ED staff member (Q) she indicated the outpatient clinic was to be open from 9 PM weekdays. She indicated clinic staff often closed the clinic early. Patients (non-urgent) were directed to the ED rather than the clinic staff remaining until all patients registered had been seen or making an appointment for the patient(s) on the next day.

6. Interview with ED staff at 2:40 PM on 9/21/10 revealed the following:

a. Outpatient walk-in clinic will sometimes close early if no patients were currently signed in for care. Patients who arrive after this time even if non-urgent are directed to the ED.

b. Outpatient clinic patients with high blood pressure or high blood sugars who are asymptomatic were being sent to the ED.

c. Policy regarding referral of outpatient clinic patients to the ED was obsolete but a new policy regarding high BP and BG had not been fully developed or implemented hospital wide.

7. Administrative staff indicated current policies (hospital wide) were located on the computer.

a. Review of the policies on the computer with an administrative staff member showed the policy being used by the outpatient department to send patients to the ED (dated 7/08) was outdated or obsolete (located in a file named 'old policies'). This policy listed triage levels opposite of current ED triage categories.

b. The policy titled "Triage Policy for the ER" indicated "abnormal vital signs and physical parameters that may assist with triage decision-making include ...

- Systolic asymptomatic BP >(greater than) 240 mmHG or >220 symptomatic (dizziness, headache).

- Diastolic asymptomatic BP<(less than) 50 mmHG <70 symptomatic ...

- Blood glucose level asymptomatic >400 mg/dl or symptomatic>300 mg/dl.

- Blood Glucose <50 mg/dl


8. On 9/22/2010 at 2:00 PM, the blood bank manager reported that blood transfusions did not occur in the outpatient clinic. No space was designated for transfusions. Blood is transfused in the emergency department or inpatient department. Outpatient nurses are trained and oriented for blood transfusions.















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9. On 9/22/10 at 10:45 AM in an interview with the nursing supervisor on the inpatient (ACU) acute care unit, nurse (R) confirmed the inpatient unit was also responsible for outpatient procedures. Nurse (R) reported that patients are sent from the outpatient clinic for procedures which included: dressing changes, wound vac changes, IV (intravenous) antibiotic therapy, IV iron, blood, platelets, whirlpools, and changing Foley catheters for outpatients. The inpatient unit was currently seeing two outpatients for dressing changes one three times a week and the other two times a week. Additionally the had one outpatient coming in daily for whirlpools. Nurse (R) reported that providing outpatient procedures on the ACU did require adjustments in staffing and have had issues with not enough staff.

Interview with the DON on 9/22/10 at 4:45 AM confirmed that there were two days when the hospital went on divert and stopped taking inpatient due to staffing issues. The DON also confirmed she was not aware of the extent outpatients were being taken to ACU for outpatient procedures.

Based on record review and staff interview it was determined that the facility failed to assign one individual to be responsible for all outpatient services and maintain appropriate professional personnel available to provide outpatient services. The findings include:

1a. A review of the facility's organizational structure on 9/21/10 found the facility organization to include an Outpatient Department as part of its provided services. The facility outpatient services included an outpatient clinic in the main hospital and six off-site clinics located outside of the main hospital building.

1b. An interview was conducted with the facility's Accreditation Specialist (H) for the facility on 9/21/10 at 9:00 AM. The Accreditation Specialist (H) stated that the outpatient clinic in the main hospital was managed by the Outpatient Clinic Director (J) and that the off-site clinics were each managed by separate administrators, each responsible for individual clinics and all reporting to the Chief Executive Office (CEO) (E) of the hospital.

The Accreditation Specialist (H) stated that in recent weeks the facility's Chief of Staff (P) had been given some of the outpatient services responsibility, but that this person also had oversight of other departments and staff outside of the Outpatient Clinic area. The Accreditation Specialist (H) confirmed that there was no single individual who was responsible for all of the Outpatient Services in the facility.

1c. An interview was conducted with the Director of the facility's main Outpatient Clinic (J) on 9/21/10 at 4:00 PM. The Director (J) stated that she was responsible for the main hospital clinic and was not involved in any of the outlying clinics that the facility maintained to provide outpatient services. She stated that she reported to the facility CEO.

1d. Interviews were conducted with the Wanblee Clinic Administrator (M) in Wanblee, SD and the Kyle Clinic Administrator (N) in Kyle, SD during two separate tours of the clinics on 9/23/10. Both Administrators (M and N) confirmed that they did not report to a single person responsible solely for Outpatient Services, but reported to an Administrative officer (O) or the facility CEO (E). Both confirmed that they were operated separately from the main hospital Outpatient Clinic.

2a. The facility was asked on 9/22/2010 to provide information on the normal staffing pattern for the Outpatient Clinic during the week of 9/13/2010 through 9/17/2010.

The information provided by the Accreditation Specialist (H) identified that the facility's Outpatient Clinic had four provider vacancies, two registered nurse vacancies, and two temporary vacancies for two regular registered nurses who were on extended sick leave with no know time of return.

2b. The information showed that the Outpatient Clinic's normal staffing Monday through Friday during the week of 9/13/2010 through 9/17/2010 consisted of nine registered nurses from 8:00 AM to 4:30 PM and one registered nurse from 12:30 PM to 9:00 PM. The normal staffing schedule for the clinic had a registered nurse supervisor on duty from 8:00 AM to 4:30 PM Monday through Friday. The clinic's normal staffing schedule also included a licensed practical nurse on duty from 12:30 PM to 9:00 PM Monday through Friday.

2c. The clinic was staffed with only five registered nurses at the time of the survey and the clinic was working with four less registered nurses than would normally be scheduled.

2d. The Accreditation Specialist (H) stated during an interview on 9/23/2010 at 11:30 AM that a request was made to do an "emergency hire" for the two positions that were temporarily vacant due to extended medical leave. The request was denied by the Aberdeen Area Service Office citing that until the two regular vacancies were filled, no emergency hires could be made.

2e. A review of patient records in the facility's Outpatient Clinic was completed with the facility's Accreditation Specialist (H). The review of 31 sampled charts over a period from 8/27/2010 to 9/16/201 found that 36% of those patients had to wait in excess of 30 minutes after checking into the Outpatient Clinic to be assessed by nursing staff prior to being seen by a provider. The wait times varied from 35 minutes to two hours and 24 minutes.

3a. The facility was asked on 9/22/2010 to provide information on the number of provider and nursing staff vacancies at the off campus clinics in Wanblee, SD and Kyle, SD. This information was provided by the facility's Accreditation Specialist (H) on 9/23/2010.

3b. The information provided identified that the Wanblee Clinic had two provider vacancies, with no nursing staff vacancies. These two provider vacancies had existed for the past year.

3c. The Kyle Clinic had one Clinical Director vacancy and one nursing supervisor vacancy. The information provided stated that the nursing supervisor position at the Kyle Clinic has been vacant since November of 2009 due to a temporary assignment of that nurse to a position at the facility in Pine Ridge. The position for the Clinical Director vacancy had been vacant since March of 2009.

4. On 9/21/2010 at 10:30 AM, the hospital administrator reported that the outpatient clinic reports to the director of nursing. The director of nursing talks to the hospital medical director. The outpatient clinics have their own directors. The directors report directly to me. There is not one person responsible for all outpatient services.

The 2009 hospital organizational chart showed two off campus outpaitent clinics directly reporting to the hospital administrator.

On 9/21/2010 at 2:15 PM provider (DD) reported that the hospital medical director was in charge of the hospital on campus outpatient department. The two off campus outpatient clinics are under their own directors.

Based on record review and interview, the hospital failed to measure, analyze and track quality indicators related to the quality of patient care in the Outpatient and Emegency Departments. The findings include:

1a. A random sample of walk-in clinic patient charts was completed on 9/23/2010 with the facility Accreditation Specialist (H). The review of 31 charts was made from Outpatient Clinic walk-in visits made between 8/27/2010 and 9/16/2010. This review was to determine if the facility was meeting the Outpatient Department's Policy and Procedure of assessing patients within 30 minutes of a patient signing into the Outpatient Department and how long patients had to wait to see a provider once assessed.

Of the 30 charts reviewed 19 patients (61%) were seen by licensed staff within the 30 minutes of signing into the clinic. Eleven patients (36%) were seen beyond the 30 minutes. One of the charts (3%) showed the patient had walked off before being seen by any Outpatient Clinic staff.

The charting process did not make it possible to identify the length of time from the nursing assessment to when a patient was actually seen by a provider. This was confirmed by the Accreditation Specialist at the time of the record review.

Of the patients seen beyond 30 minutes the following was found for wait times for individual patients:

Patient # 27 - 35 minutes 9/1/10
Patient # 28 - 36 minutes 9/3/10
Patient # 29 - 38 minutes 9/16/10
Patient # 30 - 52 minutes 9/9/10
Patient # 31 - 43 minutes 9/16/10
Patient # 32 - 1 hour 4 minutes 9/16/10
Patient # 33 - 1 hour 23 minutes 9/9/10
Patient # 34 - 1 hour 29 minutes 9/7/10
Patient # 35 - 1 hour 33 minutes 9/7/10
Patient # 36 - 1 hour 43 minutes 9/7/10
Patient # 37 - 2 hours 24 minutes 9/16/10

Patients seen within the 30 minute waiting time:

Patient # 38 - Walk-off 9/16/10
Patient # 39 - 24 minutes 9/16/10
Patient # 40 - 28 minutes 9/16/10
Patient # 41 - 21 minutes 9/16/10
Patient # 42 - 29 minutes 9/16/10
Patient # 43 - 13 minutes 9/16/10
Patient # 44 - 30 minutes 9/14/10
Patient # 45 - 10 minutes 9/14/10
Patient # 46 - 19 minutes 9/14/10
Patient # 47 - 26 minutes 9/16/10
Patient # 48 - 19 minutes 9/16/10
Patient # 49 - 5 minutes 9/9/10
Patient # 50 - 22 minutes 9/9/10
Patient # 51 - 30 minutes 9/9/10
Patient # 52 - 25 minutes 9/10/10
Patient # 53 - 17 minutes 9/10/10
Patient # 54 - 13 minutes 9/14/10
Patient # 55 - 8 minutes 9/1/10
Patient # 56 - 17 minutes 9/1/10
Patient # 57 - 30 minutes 9/16/10

1b. The Accreditation Specialist (H) stated during an interview on 9/23/2010 that she was not aware of any quality improvement process being implemented by the facility to determine staffing issues in the Outpatient Clinic, improve patient wait times at the clinic, or how outpatient services were integrated with other departments. This included patients that were sent to the Emergency Department or Inpatient Department that could have been treated in the Outpatient Department.

The Accreditation Specialist (H) stated that she found that the facility had considered a study on wait times by patients in the Outpatient Clinic, but that there was nothing to indicate that a study had ever been implemented.

1c. The facility did not provide any information that any of the concerns related to inadequate staffing, wait times or Outpatient Department integration with other facility departments had ever been reviewed for Quality Assurance. CROSS REFERENCE Tags A-1076, A-1077 and A-1079


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2. Although the hospital conducted various performance improvement reviews of ED documentation and EMTALA issues, many areas continued to show non-compliance. These QA activities were not effective in identifying/correcting the EMTALA issues of MSE, stabilizing treatment and appropriate transfers. The review for the third quarter of 2010 (April-June 2010) showed many areas which failed to meet the hospital's 95% goal. The PI report indicated medications were not always double signed by nurses to ensure correct medications were given, complete vital signs including weights were not recorded, pain levels were not consistently assessed and the amount of IV fluids administered was not always recorded. The PI data showed changes in ER triage level were not always noted in the patient's record.