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Based on the findings of noncompliance referenced in the following Conditions of Participation, it was determined 42 CFR §482.12 Condition of Participation: Governing Body, was out of compliance.

The Governing Body failed to ensure the Hospital was in compliance with all Conditions of Participation (specifically those listed below) and failed to ensure sufficient actions were taken to correct the areas of non-compliance identified on the September 18, 2014 recertification survey.

See the following for details:

A0747 - §482.42 Condition of Participation: Infection Control which was identified as Immediate Jeopardy (IJ). On September 15, 2014 at 4:45 PM, an IJ was declared regarding Infection Control (a system for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel) for "Employee Health". The Hospital was notified on September 17, 2014 at 5:00 PM that the IJ had been abated. However, non-compliance at 42 CFR §482.42 (A0747) for Infection Control remained out of compliance.

A0263 - §482.21 Condition of Participation: Quality Assessment and Performance Improvement Program (QAPI).

A1100 - §482.55 Condition of Participation: Emergency Services.

It was determined that §482.12 Condition of Participation of Governing Body was out of compliance due to these failures.

Based on record review and staff interview, it was determined that the Hospital failed to have an effective hospital-wide, data-driven Quality Assessment/Performance Improvement (QAPI) Program which identified the quality issues, implemented plans for quality improvement, evaluated the results, and modified the plans as appropriate. The quality of care issues cited for the care provided in the Emergency Department and on the inpatient unit, and Infection Control program for Employee Health confirmed that although the Hospital had a program, the program was not effective.

See the following for details:

A0747 - §482.42 Condition of Participation: Infection Control which was identified as Immediate Jeopardy (IJ). On September 15, 2014 at 4:45 PM, an IJ was declared regarding Infection Control (a system for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel) for "Employee Health". The Hospital was notified on September 17, 2014 at 5:00 PM that the IJ had been abated. However, non-compliance at 42 CFR §482.42 (A0747) for Infection Control remained out of compliance.

A0286 - Standard: QAPI Patient Safety. The Hospital failed to focus their QAPI program on high-risk, high-volume, and/or problem-prone areas.

A0309 - Standard: QAPI Responsibilities. The Governing Body, medical staff and administrative officials failed to ensure the facility had a system in place for an ongoing, defined, implemented and maintained program of quality improvement.

A1100 - §482.55 Condition of Participation: Emergency Services

A1101 - Standard: Organization and Direction. The Hospital failed to assure that the policies and procedures for the Emergency Department were current and included procedures for transfers of patients from the hospital to other facilities that could provide a higher level of care without delay.

Based on record reviews which included infection control tracking logs, infection control policies and procedures, QAPI meeting minutes, and staff interviews the facility failed to: 1) ensure an active program for the prevention, control, and investigation of infections and communicable diseases; and 2) ensure sanitary environment was maintained to avoid sources and transmission of infections by properly sanitizing dishes and utensils.

See the following for details:

A0748 - The Hospital failed to ensure the persons designated as Infection Control Officers accomplished the tasks required for the Infection Control program by implementing policies governing control of infections and communicable diseases.

A0749 - The Hospital failed to follow Infection Control policies for "Employee Health" to protect patients, staff, and visitors. This related to the Hospital's failure to ensure that all employees had initial (new employee) and annual Tuberculin Skin Testing [TST - a test using purified protein derivative (PPD)] to check if a person has been infected with Tuberculosis bacteria and lack of tracking of Hepatitis B.

This failure represented an Immediate Jeopardy (IJ). On September 15, 2014 at 4:45 PM, an IJ was declared regarding Infection Control (a system for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel).

A0756 - The Hospital failed to ensure that the hospital-wide Quality Assessment and Performance Improvement (QAPI) program and staff in-service training programs addressed problems when "Employee Health" was not being monitored or provided through the Infection Control program.

Based on record review and staff interview it was determined that the facility failed to have maintained policies for the Emergency Department (ED). This included a fully approved and out of draft form set of policies for staff, policies for an appropriate discharge from the facility, and documenting issues and appropriate follow-up, if needed, related to possible harm to an at risk person.

See the following for details:

A1101 - Organization and Direction - Facility ED policies and procedures were not out of draft form, fully approved for use and did not include specific areas that would prevent inadequate discharges from occurring and inadequate follow-up for patients and inadequate medical documentation.

Based on review of the Hospital's complaint logs and staff interviews, the Governing Body failed to ensure the effective operation of the grievance process, by ensuring prompt review and resolution of grievances.

Findings Include:

1. On September 16, 2014 the ACEO (Acting Chief Executive Officer) provided the complaint logs for review from July 7, 2014 through September 11, 2014. The sheet identified the following areas to be documented:
- Who the complaint was assigned to,
- Date CEO received initial complaint,
- Initial meeting/letter/call of acknowledgement,
- Letter of resolution, time acknowledgment,
- Dept./area, nature of complaint,
- Summary and
- Resolution.

The log listed 41 complaints by patients and or family members during this time period. There were 19 of the 41 complaints that did not have resolution or letter of resolution completed.

Examples of the grievances that had not been resolved included:

"7/22/14 OPD (out patient department) - Patient complains two separate occasions nurses (__ name) and (__name) were very unprofessional, rude and crabby.

7/21/14 ED (emergency department) - provider and nurse, Patient complained that ED Provider (__name) misdiagnosed, rude and nurse forgot about her in room for over one hour.

7/22/14 OPD - Patient reported she can not get through the appointment line, no one is answering the phones.

8/5/14 OPD - Patient complains that she can't get through nor will anyone pick up the phone lines for the appointments.

8/11/14 ED - Patient presented to OCEO (Office of Chief Executive Officer) with her complaint that the ED Provider (__name) was very rude, talked down to patient and told her to be quiet.

8/11/14 ED- "Patient complains of the long wait time in ED and no staff checked on him; had labs and waited for over 7 hours as he was also in pain."

8/12/14 ED - Patient complains she presented to the Ed on 8/10/14 at 2 PM and did not leave until 2 AM; A nurse told her to be patient, the wait will be long; patient asked how long the wait will be to be seen as it was now 6:45 PM. The nurse was rude and argumentative. At 10:30 PM Dr. (__name) finally saw patient, with the medication she had to take. She didn't leave until 2 AM.

8/13/14 OPD - "Patient called and said that at her daughter's peds visit the nurse, (__name) treated the mother very rudely, was unprofessional and made her feel very uncomfortable."

8/15/14 ED - "ED Provider, (__name) treated the patient very rudely, patient has history of anxiety and provider told her to seek professional help outside IHS."

9/5/14 OPD - "Patient could not understand the Provider, language barrier. Patient request another appointment for another Provider."

2. Interview with the ACEO on September 17, 2014 revealed he had been in his current position as ACEO for approximately six weeks and was trying to address issues being brought through the grievances. He could not speak to the prior CEO's actions to address patient complaints. The ACEO confirmed that there was a process in place and the complaint or grievance was to be assigned to an individual who was then responsible for follow up and resolution. There were some issues that needed to be worked on through the Governing Board. He was made aware of the problem with patient's Provider due to a language barrier. He reported that he had issues with that Provider due to a language barrier and that that Provider was no longer working at the facility.

3. Interview with staff on September 17, 2014 confirmed that patients and some staff had continued to complaint about some Providers due to a language barrier.

4. Review of the patient record #25 revealed issues with a language barrier which resulted in a delay in treatment and pain management.

Patient #25 was admitted to the Hospital on September 10, 2014 at 1754 (5:54 PM) with diabetic foot ulcers and pain level 8 of 10. The assessment noted right foot ulcer with bilateral lower extremity cellulitis, Dr. (_name) to do debridement, and diagnoses included; diabetes, hypertension, atrial fibrillation on pacemaker, hyperlipidemia and borderline personality disorder. The progress notes on September 11, 2014 identified the patient having a change in condition and staff trying to reach his physician. The notes included:

2030 (8:30 PM) upon doing hourly rounds, pt's wife was concerned about husbands condition. Wife stating that her husband didn't look right. Pt. flushed, but was sleeping at the time. Wife very concerned and wanted a Dr. to come in and assess her husband.

2040 (8:40 PM) Vitals completed at this time. Attempted to call Dr. (__name) at this time. Unable to contact Dr. and message was in Spanish, I was unable to understand the message.

2041 (8:41 PM) Attempted to contact Dr. (__name), unable to reach him. Called charge nurse (name RN) in ER, (name RN) was informed of the situation with pt. and his wife's concerns. (name RN) advised me to call Dr. (__name) again and if unable to reach him to call Dr. (__name) (Clinical Director).

2048 (8:48 PM) Attempted to call Dr. (__name), unable to reach him. [patient's physician]

2057 (8:57 PM) Attempted to call Dr. (__name), unable to reach him. [patient's physician]

2100 (9:00 PM) (Clinical Director) called was able to reach her, updated her on situation.

2125 (9:25 PM) Dr. (__name) presented to 2nd floor nurses station, was given report on pt. [This was another physician not the patient's admitting physician.]

2130 (9:30 PM) Dr. (__name) in with pt. at this time and at 2140 (9:40 PM) received orders to start transfer paperwork.

The patient was transferred by ambulance at 2221 (10:21 PM).

5. Interview on September 18, 2014 with the Clinical Director confirmed that there were issues with contacting patient #25's physician and was aware of the issues with language barriers.

6. Review of the Hospital's QAPI meeting notes for discussions dated June 24, 2014, July 22, 2014 and August 28, 2014 did not address action plans for unresolved grievances.

Based on review of the Hospital's complaint logs of patient grievances and staff interviews, the facility failed to provide timely written notices and provide adequate information to address grievances which is to include; response to inform the patients in writing of steps taken to investigate the grievance, the results of the grievance process and date of completion.

Findings Include:

1. On September 16, 2014 the ACEO (Acting Chief Executive Officer) provided the complaint logs for review from July 7, 2014 through September 11, 2014. The sheet identified the following areas to be documented:
- Who the complaint was assigned to,
- Date CEO received initial complaint,
- Initial meeting/letter/call of acknowledgement,
- Letter of resolution, time acknowledgment,
- Dept./area, nature of complaint,
- Summary and
- Resolution.

The log listed 41 complaints by patients and or family members during this time period. There were 19 of the 41 complaints that did not have resolution or letter of resolution completed.

2. Interview with the ACEO on September 17, 2014 revealed he had been in his current position as ACEO for approximately six weeks and was trying to address issues being brought through the grievances. He could not speak to the prior CEO's actions to address patient complaints. The ACEO confirmed that there was a process in place and the complaint or grievance was to be assigned to an individual who was then responsible for follow up and resolution. There were some issues that needed to be worked on through the Governing Board.

Based on QAPI (Quality Assessment and Performance Improvement) Plan review, meeting minutes review, medical record reviews and staff interviews the Hospital failed to utilize data as identified in the the plan to ensure timely data analysis and enact actions. ---

Findings Include:

1. Review of the policy for the "QAPI PLAN" with the effective date of 3/5/14 included:

Purpose:

"A. Ensure that the Rapid City Service Unit (RCSU) hospital has an effective, ongoing hospital wide, data driven Quality Assessment Performance Improvement (QAPI) program.

B. Ensure that safe, high quality care is provided in a safe, fiscally responsible manner.

C. Maintain compliance to accreditation standards and federal regulations.

D. Ensure that healthcare services are appropriate, effective and responsive to patient's needs."

The policy also included performance goals which included:

"1) QAPI monitor goals will be set to emphasize efforts to review high-risk, high volume and problematic areas with consideration to the incidence, prevalence and possible severity of problems while maintaining primary focus on patient health outcomes, safety and quality of care...

4) Intensive case review for identification and analysis of specific types of adverse events and circumstances particularly those that involve patient injury or that place patients at risk of harm ...
Certain types of cases designated as sentinel events and near misses should be evaluated using Root Cause Analysis ..."

2. Review of the inpatient admissions list provided by the facility showed the Hospital had 31 patient admissions during the time from April 30, 2014 until the time of survey on September 15, 2014. There were 9 of the 31 patients that were transferred to a higher level of care.

a. Review for five (5) of nine (9) inpatient records concerning transfers were completed and examples of concerns included:

- Patient #29 was transferred within approximately two hours after being admitted to the inpatient unit on August 7, 2014. The patient identified was having sepsis. Interviews with staff on September 16, 2014 identified concerns about this patient's admission. One staff reported that the patient was lethargic and unable to provided information on admission. Staff stated, "We don't have an ICU (intense care unit) and that was our concern on accepting this patient for admission."

- Patient #31 was also transferred on the same day of admission August 5, 2014 with cellulitis of the hand.

- Patient #25 was transferred two days after admission on September 12, 2014. Patient #25 was admitted to the Hospital on September 10, 2014 at 1754 (5:54 PM) with diabetic foot ulcers and pain level at 8 of 10. The assessment noted right foot ulcer with bilateral lower extremity cellulitis, Dr. (_name) to do debridement, and diagnoses included; diabetes, hypertension, atrial fibrillation on pacemaker, hyperlipidemia and borderline personality disorder. The progress notes on September 11, 2014 identified the patient having a change in condition with unrelieved pain requiring transfer to another hospital. [Pain scale of 0 to 10, with 0 representing no pain and 10 representing severe pain.]

Interview with Nurse (C) on September 17, 2014 patient #25's medical record was reviewed. She confirmed that there was no evidence that this patient received effective pain management. The patient complained of pain with escalating behaviors resulting in a transfer from the facility. (See A0395 for details)

- Patient #33 showed the patient was admitted to the facility on August 6, 2014 and discharged August 8, 2014. The review identified the patient expired on August 9, 2014 the day after discharge from the hospital. Staff confirmed an evaluation using "Root Cause Analysis" had not been done for review of this patient's care. A "Root Cause Analysis" was done after the surveyors had asked if the facility was looking at a "Root Cause Analysis" for this patient.

3. Interview with staff from the Aberdeen Area Office on September 18, 2014 reported that there needed to be changes to the governing bylaws to ensure "Root Cause Analysis" is being done timely to prevent reoccurrence of potential issues. This would also enforce the current QAPI plan.

4. Interview on September 18, 2014 at 8:30 AM with the staff responsible for the hospital's QAPI program confirmed the issues with evaluation of inpatient admissions and root cause analysis had not been identified or addressed through the QAPI program.

5. The facility failed to maintain an effective hospital-wide Infection Control Program which included an "Employee Health" program.
A0749 - The Hospital failed to follow infection control policies for Employee Health to protect patients, staff, and visitors. This related to the Hospital's failure to ensure that all employees had initial (new employee) and annual Tuberculin Skin Testing [TST - a test using purified protein derivative (PPD)] to check if a person has been infected with Tuberculosis bacteria and lack of tracking of Hepatitis B.

This failure represented an Immediate Jeopardy (IJ). On September 15, 2014 at 4:45 PM, an IJ was declared regarding Infection Control (a system for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel).

Based on review of medical staff and QAPI meeting minutes, review of the Infection Control program and staff interviews it was determined the Governing Body, medical staff and administrative officials failed to ensure the facility had a system in place for an ongoing, defined, implemented and maintained program of quality improvement. The facility census at the time of survey was one.

Findings Included:

1. On September 18, 2014 at 8:30 AM an interview with staff responsible for the hospital's QAPI program confirmed the issues with "Employee Health" had not been identified or addressed through the QAPI program.

2. On September 16, 2014 at approximately 9:00 AM, an interview with the ICC (Infection Control Coordinator) reported that after reviewing employee files last evening (September 15, 2014) the "Employee Health" portion of the Infection Control program was incomplete and had not been maintained. She does present Infection Control as part of QAPI but the issues around "Employee Health" program and lack of monitoring and follow up had not been identified through the Hospital's Infection Control program nor had the issues been address by the hospital's QAPI program.

3. Review of the medical staff and QAPI meeting minutes for the last six months from March 27, 2014 through August 28, 2014 lacked evidence of involvement in the quality assurance process to address the lack of maintaining the "Employee Health" portion of Infection Control program.

See A0756 - The Hospital failed failed to ensure that the hospital-wide Quality Assessment and Performance Improvement (QAPI) program and staff in-service training programs addressed problems when "Employee Health" was not being monitored or provided through the Infection Control program.

This demonstrated a lack of a hospital-wide quality assessment and performance improvement which address priorities for improved quality of care and patient safety.

Based on medical record review and staff interview the hospital failed to ensure a RN evaluated the care for each patient upon admission and when appropriate on an ongoing basis in accordance with accepted standards of nursing practice and hospital policy. This related to the provision of pain management for patient #25 and assessment and documentation of skin breakdown for patient #34.

Findings Included:

PAIN MANAGEMENT:
1. Patient #25 was admitted to the Hospital on September 10, 2014 at 1754 (5:54 PM) with diabetic foot ulcers and pain level of 8 of 10. The assessment noted right foot ulcer with bilateral lower extremity cellulitis, Dr. (_name) to do debridement, and diagnoses included; diabetes, hypertension, atrial fibrillation on pacemaker, hyperlipidemia and borderline personality disorder. The progress notes on September 11, 2014 identified the patient having a change in condition with unrelieved pain requiring transfer to another hospital. [Pain scale of 0 to 10, with 0 representing no pain and 10 representing severe pain.]

a. The progress notes included on September 11, 2014 included:

At 0235 (2:35 AM) the progress notes the patient called for more pain medication. The nurse had informed the patient he could not have more for one hour and that she would get him more pillows to elevate his legs.

At 0415 (4:15 AM) "Patient going to lay down and get more rest now that pain morphine is working. Pain 6/10."

At 0735 (7:35 AM) "Morphine given 8/10 pain-IVP (intravenously push) over 2 minutes ..."

At 0945 (9:45 AM) "DR. (__name) in with pt. to start debridement on R (right) foot. Pt. tolerates well. DR. (__name) to continue debridement later today as schedule allows. Pt. to have pain medication prior to foot care ..."

At 1015 (10:15 AM) "Pt. c/o nausea and vomiting ..."

At 2030 (8:30 PM) upon doing hourly rounds, pt's wife was concerned about husbands condition. Wife stating that her husband didn't look right. Pt. flushed, but was sleeping at the time. Wife very concerned and wanted a Dr. to come in and assess her husband.
[Patient record #25 revealed issues with a language barrier which resulted in a delay in treatment and pain management. (Also see 0119)]

At 2130 (9:30 PM) Dr. (__name) in with pt. at this time and at 2140 (9:40 PM) received orders to start transfer paperwork.

At 2200 (10:00 PM) upon rounding on pt., pt. was up and walking around room, very agitated. Pt's wife and daughter came in room behind me, and pt. started cussing and crying. Pt. kept stating he didn't feel good and that his LRL (left lower leg) was hurting him. He wanted pain meds. Explained to pt. that he had to wait to take his morphine again. Pt. demanded that I cut the dressing off his R (right) leg, because his leg hurt so bad. Explained to pt. I could do so as soon as I found a scissors. Pt. started to swear at me and became very hostile. Wife tried to calm down pt. to which he became more belligerent. Security was called at this time.

At 2203 (10:03 PM) dressing was removed from the pt's leg, security was in the room with to assist. Pt. apologized for behavior. Dressing was removed with Normal saline due to dressing sticking to leg. Pt's wound was draining yellow fluid. Unable to get measurements due to pt's agitation. Wound was red in color and looked like a large blister that pooped. Pt. also had a wound located on underside of foot between the big toe and 2nd toe. Pt. demanded pain medication and wanted to speak to the Dr.

At 2205 (10:05 PM) Dr. (__name) informed of Pt. wanting to speak to him as well as pt. requesting pain medication.

At 2221 (10:21 PM) Pt. off floor by ambulance gurney ..." The patient was transferred to another Hospital.

b. Review of the patient's medication administration record revealed the following times of unrelieved pain and incomplete documentation;

9/10/14 1855 (6:55 PM) Morphine 4 mg IVP reason pain 8/10 results pain 7 of 10 at 1945 (7:45 PM),
9/10/14 0317 (3:17 AM) Morphine 4 mg IVP reason pain 8/10 results pain 6 of 10 at 0400 (4:00 AM),
9/10/14 0735 (7:35 AM) Morphine 4 mg IVP reason pain 8/10 results pain 7 of 10 at 0900 (9:00 AM),
9/11/14 0735 (7:35 AM) Morphine 4 mg IVP reason pain 9/10 results pain 8 of 10 at 1300 (1:00 AM),
9/11/14 1940 (7:40 PM) Morphine 4 mg IVP reason pain (no rating scale documented) results pain "No change" 2030 (8:30 PM).

c. Interview with Nurse (C) on September 17, 2014 patient #25's medical record was reviewed. She confirmed that there was no evidence that this patient received effective pain management. The patient complained of pain with escalating behaviors resulting in a transfer from the facility.

There was no evidence that after given the PRN pain medication and rechecking the patient's pain level which was unrelieved that the physician was called in attempt to provide effective pain management.

SKIN ASSESSMENTS:
2. Patient #34 was admitted to the Hospital inpatient floor on June 11, 2014 at 1736 (5:36 PM) with acute mental changes and unable to perform ADLs (activities of daily living). The patients' diagnoses included; dementia, diabetes, hyperlipidemia, vitamin D deficiency, stress, and urinary incontinence.

a. Review of the nursing notes of June 11, 2014 at 1810 (6:10 PM) identified the patient was given a sponge bath due to strong odor of urine and feces. It included: "Buttock and vaginal area reddened with multiple small open areas. Skin tissue macerated in those areas. Barrier cream applied and Attends applied ..."

b. The physicians H&P (history and physical) on June 11, 2014 noted sacral ulceration under skin assessment.

c. The physicians' assessment/progress note on June 16, 2014 included, "1. DM (Diabetes) 2. UTI (urinary tract infection) culture pending 3. dementia and 4. Decubitus Ulceration, dressing applied."

d. Review of the medical record also noted discharge planning comment June 12, 2014 which stated, "Possible transfer to RCRH (Rapid City Regional Hospital) for wound debridement depending on wound staging and appearance." The wound was classified as "sacral coccyx pressure ulcer". The patient was transferred on June 13, 2014 at 1405 (2:05 PM) for wound care of decubitus ulcer.

e. Interview with Nurse (C) on September 17, 2014, patient #34's medical record was reviewed. She confirmed that there was no evidence this patient had an adequate skin assessment with documentation of this patient's skin breakdown. Additionally, there was no documentation of the ongoing monitoring of these wounds even when wound debridement was identified for the need to transfer this patient to another facility.

REFERENCES:
SKIN ASSESSMENTS:
Lippincott 2009, WOUND WATCH: Assessing pressure ulcers: 2009 January/February 2009, Volume 5 Number 1, Pages 20 - 23; OVER THE CENTURIES, pressure ulcers have been referred to as decubitus ulcers, bedsores, and pressure sores. The term pressure ulcer has become the preferred name of choice because it most closely describes the etiology and resultant ulcer. The National Pressure Ulcer Advisory Panel (NPUAP) revised its definition of pressure ulcers at its 2007 consensus conference to read: "localized injury to the skin and/or underlying tissue over a bony prominence, as a result of pressure, or pressure in combination with shear and/or friction."
Pressure ulcers are usually located over bony prominences, such as the sacrum, coccyx, hips, and heels, and are staged according to the extent of observable tissue damage. Pressure ulcers can occur even with the best preventive measures. Effective treatment depends on a thorough assessment of the developing wound. Meaningful ulcer assessment requires a systematic and objective approach. Clinical assessment should include:
* ulcer history, including etiology, duration, and prior treatment
* anatomic location
* stage
* size (length, width, depth in centimeters)
* sinus tracts, undermining, and tunneling
* drainage
* necrotic tissue (slough and eschar)
* granulation tissue (newly formed tissue within a healing wound)
* epithelialization (regenerated tissue within a healing wound).
Pressure ulcer borders can provide clues to healing potential. Assess skin around the ulcer for redness, warmth, induration or hardness, swelling, and signs of infection. Before you examine the ulcer, assess the patient's pain. In most cases, pressure ulcers cause some degree of pain; in some cases, pain is severe. Have the patient rate his pain on a visual analog scale of 0 to 10, with 0 representing no pain and 10 representing severe pain. Similarly, ask the patient whether the pain interferes with his ability to function normally and, if so, to what degree.

Professional Standards of Practice in Assessment of Pain:
a. Fundamentals of Nursing, The Art & Science of Nursing Care, Fourth Edition, Taylor, Lillis, LeMone, Lippincott, 2001, Chapter 40: Comfort, page 1047-1055 indicates that a comprehensive pain assessment would identify the causes of pain, how intensely the pain was experienced, when the resident experienced the pain, which pain medication was most effective in relieving the pain, and how the pain affected other needs such as agitation and adequate sleep. Factors to assess would include:
1) The characteristics of the pain (location, duration, quantity, quality, chronology, aggravating factors, and alleviating factors),
2) The resident's physiologic response to the pain (vital signs, skin color, perspiration, pupil size, nausea, muscle tension and anxiety),
3) The resident's behavior responses (posture, gross motor activities, facial features and verbal expressions), and
4) Affective responses of the resident such as anxiety or depression. Additionally, the pain assessment should include how the pain experience affects the resident's interactions with others, how it interferes with activities of daily living, meaning of pain to the resident and the resident's expectations for pain relief. A system for comprehensive pain assessments should also include a means for assessment of pain in residents who are cognitively impaired and guides to validate pain cues and recognize pain when the resident is unable to verbalize pain.

Professional Standards of Practice in PRN medication orders:
Fundamentals of Nursing, Potter and Perry, Fourth Edition, 1997: "(Chapter 35, pp. 804): "PRN ORDERS: The physician may order a drug on a PRN basis (when a client requires it). The nurse uses objective assessments, subjective assessments, and discretion in determining the client's need. When medications are administered, the nurse documents the assessment made and the time of drug administration. The nurse should make frequent evaluation of the effectiveness of the drug and record findings in the appropriate place."

Based on staff interviews and record review the facility failed to ensure the persons designated as Infection Control Officers accomplished the tasks required for the Infection Control program by implementing policies governing control of infections and communicable diseases.

Findings Include:

1. On September 16, 2014 at approximately 9:00 AM, an interview with the ICC (Infection Control Coordinator) revealed she had been responsible for the Employee Health Program but due to all of her responsibilities it had been turned over to a nurse approximately three years ago. The responsibility then changed again and was delegated to the current staff member (nurse B) who was to be doing "Employee Health". The Infection Control Coordinator (ICC) reported that after reviewing employee files last evening (September 15, 2014) the "Employee Health" portion of the Infection Control program was incomplete and had not been maintained. The Hospital staff reported they had had a patient with positive TB in the Hospital during the past year.

2. Interview on September 15, 2014 at 3:00 PM, with nurse (nurse B) responsible for "Employee Health" revealed she was in the process of doing a retrospective look at employee files to see what employees needed TB testing. She reported that she had just started the review of employee files and that the tracking was incomplete. She was asked to provide the tracking which had been completed.

3. The tracking log was reviewed on September 15, 2014 at 3:45 PM. It was entitled "Employee Health TB 2014" and included a note which stated, "10 direct care employees with HX (history) (+) positive [TB testing] and three without documented CXR (chest X-ray) and 21 direct patient employees a year or more deficient for TB skin test". The tracking logs confirmed the program for "Employee Health" was incomplete and showed which employees had incomplete information regarding their TB status.

Nurse B was then asked about the monitoring of Hepatitis B and she reported she did not have that information. She reported there were approximately 275 hospital employees and 126 were direct patient care staff. She estimated 60 of those direct patient care staff needed to have titers for Hepatitis B which had not been done. She stated, "I know the employee health information is delinquent. They are supposed to be getting me some help to get it done."

The facility failed to ensure the Infection Control Officer(s) the time to develop and implement hospital Infection Control policies.

I. Based on interviews and record review, the facility failed to follow Infection Control policies for Employee Health to protect patients, staff, and visitors. This related to the Hospital's failure to ensure that all employees had initial (new employee) and annual Tuberculin Skin Testing [TST - a test using purified protein derivative (PPD)] to check if a person has been infected with Tuberculosis bacteria and lack of tracking of Hepatitis B.

This failure represented an Immediate Jeopardy (IJ). On September 15, 2014 at 4:45 PM, an IJ was declared regarding Infection Control (a system for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel).

Findings Include:

1. On September 15, 2014 at 3:00 PM, an interview with the nurse (nurse B) responsible for "Employee Health" revealed she was in the process of doing a retrospective look at employee files to see what employees needed TB testing. She reported that she had just started the review of employee files and that the tracking was incomplete. She was asked to provide the tracking which had been completed.

2. The tracking log was reviewed on September 15, 2014 at 3:45 PM. It was entitled "Employee Health TB 2014" and included a note which stated, "10 direct care employees with HX (history) (+) positive [TB testing] and three without documented CXR (chest X-ray) and 21 direct patient employees a year or more deficient for TB skin test". The tracking logs confirmed the program for "Employee Health" was incomplete and showed which employees' had incomplete information regarding their TB status.

Nurse B was then asked about the monitoring of Hepatitis B and she reported she did not have that information. She reported there were approximately 275 hospital employees and 126 were direct patient care staff. She estimated 60 of those direct patient care staff needed to have titers for Hepatitis B which had not been done. She stated, "I know the employee health information is delinquent. They are suppose to be getting me some help to get it done."

3. On September 15, 2014 at 4:15 PM an interview was held with the DON (Direct of Nursing) and Nurse B.
The DON reported she thought that TB and Hepatitis B was part of the new employee policy and procedure but was not aware how it was currently tracked. The policy and procedure titled, "Tuberculosis Exposure Control Plan" was provided and reviewed. The DON confirmed that the current policy and procedure was not being followed.

Policy and Procedures:
4. The facility's policy and procedure titled, "Tuberculosis Exposure Control Plan dated 7/30/2004" indicated the policy was "designed to reduce or eliminate as much as possible patient, employee and visitor exposure to Tuberculosis (TB)."

The policy and procedure also included:
"C. TB Skin Testing:
1. All new employees will be given a PPD's (2 -step method). If the employee can provide documentation of negative PPD in the last year, the second PPD is waived. Employees who are involved in direct patient care will be tested annually. Employees not involved in direct patient care will only be tested upon hire and in the event of an exposure to active TB. [Table for departments requiring annual PPD's included.]

* Note: Dental office will not treat patients who have active TB until treatment has been initiated and patient is considered non-infectious.

2. Persons with no documentation of prior PPD will be given the PPD using the following 2 step method: a. PPD is done upon hire. b. Four weeks later, if the initial test is negative, a second PPD is given.

3. Persons with prior positive PPD's or active TB infection will not have skin testing done. Chest x-ray will be ordered upon hire unless there is documentation of a negative chest x-ray within a year or if the employee develops symptoms of TB after hire ..."

The P&P referenced the CDC "Guidelines for preventing the Transmission of Mycobacterium Tuberculosis in Healthcare Facilities" Dec. 30 2005 Vol. 54/NoRR-17, APIC Text 3rd Edition, 2009."

5. On September 15, 2014 at 4:45 PM, Hospital administrative staff including the Acting Chief Executive Officer, Medical Director and DON (Director of Nursing) and the nurse responsible for tracking Employee Health were notified of the IJ related to the facility's Infection Control program.
They were informed that review of employee immunization tracking record revealed numerous employees had no evidence of initial testing and/or annual Tuberculin Testing. Staff that had been identified as having a positive test and needing chest X-ray had no follow-up.
Additionally, Nurse B identified 126 facilities employees were direct patient care staff of the approximately 275 hospital employees. Nurse B reported she estimated 60 of those direct patient care staff needed to have titers for Hepatitis B which had not been done.
6. Corrective Action Plan:
The Hospital provided a CAP (Corrective Action Plan) with steps to remove the Immediate Jeopardy situation called on September 15, 2014. This plan included the following actions:
"1. Great Plains Area oversight will continue until all deficiencies are corrected for IJ.

2. Provision for immediate employee and patient safety:
Identify Direct patient care staff who do not have a current PPD status.
Identified employees were removed from direct patient care. (Timeline done September 16, 2014)

3. Identify Direct patient care staff who do not have a current PPD status: Complete chart reviews for PPD status of all employees who are identified as direct patient care staff by 9/16/2014. 25 Staff were identified.
Employee list identifies all employees as direct patient care or non-direct patient care. An attached document showed completion of testing and those staff needing CXR (chest X-ray). (Done September 16, 2014)

4. Administer a PPD to every direct patient care employee who is not current.
Employee Health log of identified staff was provided.
DPHN will administer PPD's to identified staff. (Done September 17, 2014)

5. Administer Employee TB questionnaire to those who have a history of positive PPD: Employee questionnaire completed and administered to employees. 12 employees were identified as needing to complete the TB questionnaire. (Done September 17, 2014)

6. Update Tuberculosis Exposure Control Plan to include the 2005 CDC "Guidelines for Preventing the Transmission of Mycobacterium Tuberculosis in Healthcare Facilities", December 30, 2005 Vol. 54/No RR-17. Tuberculosis Exposure Control Plan will be updated and approved.
Education will be provided to all staff.

7. Updated Employee Health Policy:
Employee Health Policy will be updated and approved. (Provided September 16, 2014)
Education will be provided to all staff.

8. Assign the Employee Health Director (Physician). The Employee Health Director duties will be assigned to Outpatient Liaison (physician). (Done on September 17, 2014)

9. Employee Health tracking of PPD status will be tracked.

10. Employee Health Hepatitis B status will be tracked:
Direct patient care staff will all be assessed for current immunization status or titers for the following: Rubella IGG, 2. Rubeloa IGG, 3. Mumps IGG, 4. Varicella IGG, 5. Hepatitis B SAB."

Review of the final plan with Tasks completed and the documentation of actions demonstrated the Hospital had taken sufficient action to abate the IJ situation. The Hospital was notified on September 17, 2014 at 5:00 PM that the IJ had been abated.

The IJ was abated; however, non-compliance at 42 CFR §482.42 (A0747) for Infection Control remained out of compliance.

7. On September 16, 2014 at approximately 9:00 AM, an interview with the ICC (Infection Control Coordinator) revealed she had been responsible for the Employee Health Program but due to all of her responsibilities it had been turned over to a nurse approximately three years ago. The responsibility then changed again and delegated to the current staff member (nurse B) who was supposed to be doing "Employee Health". The Infection Control Coordinator (ICC) reported that after reviewing employee files last evening (September 15, 2014) the "Employee Health" portion of the Infection Control program was incomplete and had not been maintained. The Hospital staff reported they had had a patient with positive TB in the Hospital during the past year.
The cumulative effect of the facility's failure to follow Infection Control policies for identifying, reporting, investigating, and controlling infections and communicable diseases and to follow the CDC's Tuberculosis guidelines placed all patients, personnel, and visitors at risk for an adverse outcome.
REFERENCES:
The Centers for Disease Control and Prevention (CDC) on their webcourse, "TB 101 for Health Care Workers" indicate that people at high risk for TB infection includes "Health care workers who serve clients who are at increased risk for TB disease." The information indicated that people who were at a higher risk for developing TB are persons who have a history of untreated or inadequately treated TB disease, persons with diabetes, chronic renal failure, leukemia, lymphoma, or cancer (head, neck, and lungs), persons who weigh less than 90% of their ideal body weight, cigarette smokers, and persons who abuses drugs and/or alcohol. All of these high risk people are commonly seen in the CAH/hospital setting.

The CDC (Division of Tuberculosis Elimination) recommended that a health care worker who is considered at "medium risk" should receive a TST baseline (at hire) then annually. The CDC further recommends that if an employee's baseline TST is positive or who has a recent conversion to a positive TST should receive a chest x-ray to rule out active TB disease. These guidelines further indicated that when testing health care workers it is important to keep testing results for future reference.

II. Based on observation, interviews and record review, the facility failed to ensure a sanitary physical environment. The facility failed to ensure proper techniques for food sanitation by not ensuring cleaning and disinfecting of dishware.

Findings Included:

1. On September 15, 2014 at 11:15 AM a tour of the kitchen was done with the CS (Cook Supervisor) and the RD (Registered Dietician). The CS reported the dish machine was a low temperature machine. He was then asked about the chemical concentration of the machine and how the dishes and utensils were effectively sanitized to destroy potential for food borne illness. The CS reported that they were using test strips to check the chemical concentration of chlorine in the machine. He then proceeded to attempt to test the chemical concentration of the dish machine, however was unsure of where to obtain the correct reading from the test strip. The RD assisted with the testing after the CS reported the reading from the strip was too low.

2. The check of the dish room log for monitoring of the dish machine listed the temperature of the dish machine. The log did not show the sanitizer being checked. There was no evidence that the facility was monitoring the sanitizer in the dish machine. The CS reported that the machine was checked by the chemical distributor monthly.

3. Interview with the RD on the afternoon of September 15, 2014 revealed the procedure for the monitoring of the dish machine was being changed. The procedure is to ensure a check of the water temperatures and chlorine content three times per day and record. She also reported the log tracking and the testing would include the instructions that the minimum chlorine must be 50 PPM (parts per million) and water 120 degrees for proper sanitization.

Based on record review and staff interview, the hospital failed to ensure implementation of a discharge plan including: arrangement of necessary post-hospital services/care, education of the patient and family about post hospital plans or arrangements for evaluation of the home situation for (patient #26).

Findings Included:

1. Review of the medical records for patient #26 revealed the patient was admitted to the hospital on September 4, 2014 with diagnoses of head lice and ulcers with sores to back of head. The medical record indicated the patient had cellulitis of her neck and was placed on IV (intravenous) antibiotics and wound precautions. The physician noted diagnosis of "Pediculus Capitis" with orders for nursing to comb out nits Bid (twice a day).

[Note: Pediculus Capitis is a head lice infestation also known as "having nits" which is a colonization of the hair with "Head louse". This typically involves the head or scalp of the human host. Head lice feed on human blood resulting in itching from lice bites.]

Further review of the medical record revealed the patient was discharged from the hospital on September 6, 2014. There was no evidence the patient's family members were counseled to prepare them for post-hospital care and referrals for follow up care with head lice.

There was a note for a referral for Case Management. The reason for referral stated, "Mother concerned about transportation at discharge. The consultation sheet stated, "Spoke with mother about transportation needs. Mother states she does have a car but it needs to be registered and she does not have gas money. CHR transportation will be on leave until September 17, 2014. Mother states she will contact her tribe. The case manager contacted CHR requesting transportation. CHR informs this case manger they will not be transporting patients from (___name of area) 09/09/14 through 09/15/16 will notify social services for assistance."

2. Interview with Nurse (C) confirmed that she did not see documentation in the medical record of a discharge plan. There was no discharge plan for this patient to address the care and follow up needed with this patient having severe head lice. There was no evidence for a referral to the other area where the patient lived for Public Health Services to address this child's and family's care needs dealing with severe head lice.

3. Review of other medical records for patient #26 showed the patient had been having ongoing problems with head lice. The records included:

a. 6/25/14 The patient seen in outpatient department. The record noted, "31 month old female with head lice. she is itching so bad that she has sores on her scalp. Diagnosis: Pediculus Capitis [head louse] with secondary infection."

b. 8/18/14 The patient was seen in the Emergency Room with chief complaint was "2 year old female c/o (complaints of) sore to back of head, father states it itches until it bleeds times 1 month". The diagnoses listed, "Impetigo, iron deficiency anemia unspecified." The medications ordered included, Cephalexin (antibiotic) and Mupirocin 2 % ointment to effected areas.

4. Review of the Hospital's policy and procedure entitled, "Discharge Planning" revealed it was not being followed. The policy included:

"III. It is the policy of the Rapid City Service Unit that all patients admitted to the Inpatient unit will have a discharge plan implemented; ensuring patients have a plan for continuity of care after discharge from the hospital ...
F. If services are needed such as Physical Therapy, Public Health Nursing Diabetes Education, etc., consults will be completed for requested for services in EHR ...
H. The CMS Discharge Planning Checklist: for patients and their care givers preparing to leave a hospital is given to all patients upon admission. The nurse will complete the inpatient discharge note in EHR. The discharge instruction note will be printed by the nurse, signed by the patient and placed in the medical record. A copy will be given to the patient ...
K. Goals of discharge planning are to ensure that the patient and family/caregivers understand the patient's current condition and needs including precautions, activity guidelines and necessary medical follow up."

Based on record review and staff interview it was determined that the facility failed to ensure that its Emergency Department policies and procedures were updated appropriately and approved, updated to allow for appropriate transfer of an individual determined to need transfer to a facility that would provide a higher level of care; and provided policy in how staff should follow-up and document on any questionable injuries to a child that may need to be reviewed by Social Services staff. These failures involved 1 (patient #50) of 41 patients reviewed.

The Findings Include:

Patient #50 was admitted to the Emergency Department (ED) of the facility on September 11, 2014 at 5:06 PM. The patient was a three year old female who had sustained a fracture to the left upper arm (distal left humerus fracture with displacement). The parents of the patient stated that the injury occurred after the patient had fallen in the bathroom. There was no indication that follow-up had been done to determine if the child's injuries were sustained by accident.

During the course of treatment for the patient it was determined by the attending physician that the patient needed to be transferred to a higher level of care. A review of the medical record at the facility and also from Rapid City Regional Hospital was completed on September 16, 2014.

The medical records show that after the patient was admitted to the ED on September 11, 2014 the patient was examined and an x-ray taken of the left arm. The radiologist's report indicated that the patient had suffered a fracture of the left arm and that no dislocation was present ("Supracondylar fracture at the distal humerus metaphysis with full thickness posterior displacement. There is no dislocation."). The report also stated, "Recommend orthopedic referral as soon as possible."

The medical records indicated that the ED physician called Rapid City Regional Hospital (RCRH) transfer center on September 11, 2014 to transfer the patient for orthopaedic management. The physician note stated, "I called the transfer center to transfer pt (patient) for Orthopaedic management. Dr. (RCRH physician) recommended pt to be inmobilized (sic) and be scheduled tomorrow as outpatient in Black Hills Orthopaedics at first hour." A "OUT-OF-HOSPITAL TRANSFER RECORD", dated September 11, 2014, had been initiated, but was not completed. The ED vital signs sheet indicated that the patient was discharged at 6:50 PM in "stable" condition, but did not indicate the disposition of the patient.

A review of the ED's "IV/Vital Signs/Medication Flowsheet" for the patient dated September 11, 2014, found nursing notes to indicate that the parents of the patient were concerned about taking the patient home. A nursing note from this sheet at 6:15 PM stated, "Parents extremely concerned about child's pain control throughout the night & having to wait to see orthopedics tomorrow. Parents advised to use their judgment concerning child's best interest. X-ray disc given to parents." The final nursing note on the flow sheet was at 7:20 PM and stated, "Parents & pt seen leaving c (with) medication from pharmacy."

A review of the ED medical record for RCRH indicated that the patient was admitted at RCRH at 7:41 PM. The record shows the patient was transferred from Sioux San Hospital for a left (supracondylar) fracture that occurred when the patient fell after standing on a sink in the bathroom while washing her hands. The RCRH "TeleTracking" sheet from the RCRH transfer center shows an entry at 7:53 PM that states, "Pt family was advised to see Ortho as an outpatient. Unknown if pt was brought in by the parent or sent by Dr. (Sioux San ED physician) @ (at) Sioux San"

In an interview with the ED physician who treated the patient was conducted on September 18, 2014 at 8:05 AM. The physician stated that when the patient was examined and a diagnosis was confirmed, the physician called the RCRH transfer center to have the patient transferred to RCRH. The physician stated that in her opinion the patient needed to be transferred to a higher level of care that Sioux San Hospital could not provide in this instance.

The ED physician stated that when talking to the Orthopaedic consultant physician at RCRH that physician stated the patient could be brought into RCRH the next morning for care once the Sioux San ED had stabilized the patient's arm. The ED physician stated that she did not challenge the Orthopaedic consultant and did not make any attempt to call the transfer center to discuss the case with a pediatric consultant. The ED physician also stated that she felt that it was in the best interest of the patient to be transferred and not sent home. When asked why the patient was allowed to leave, the ED physician stated that it was discussed with the patient that they should visit the RCRH ED if they were uncomfortable with taking the patient home.

A review of the facility's ED policies and procedures found that the policies were still in "draft" presentation. The policies were electronically signed by the Department head and by the CEO dated back to March 27, 2014. There was no indication that the authorizing Medical official had signed off on these policies.

Review of the ED policies and procedures found that there was no part of the documents that directed how an ED physician was to handle a situation where Sioux San had determined that a patient needed to be transferred to a higher level of care, but that the initial contact with the receiving facility found that the receiving facility either disagreed or felt there was no need to transfer the patient. Review of the ED policies also did not include how issues related to injuries of a person at risk should be followed up with social services to determine if a person at risk was at risk for abuse.

Based on record review and staff interviews the facility failed to ensure that the hospital-wide Quality Assessment and Performance Improvement (QAPI) program and staff in-service training programs addressed problems when "Employee Health" was not being monitored or provided through the Infection Control program.

Findings Include:

1. On September 16, 2014 at approximately 9:00 AM, an interview with the ICC (Infection Control Coordinator) revealed she had been responsible for the Employee Health Program but due to all of her responsibilities it had been turned over to a nurse approximately three years ago. It then changed again and delegated to the current staff member (nurse B) who was supposed to be doing "Employee Health". The Infection Control Coordinator (ICC) reported that after reviewing employee files last evening (September 15, 2014) the "Employee Health" portion of the Infection Control program was incomplete and had not been maintained. The ICC reported they had had a patient with positive TB in the Hospital during the past year.

Further interview with the ICC confirmed the issues with the "Employee Health" program and lack of monitoring and follow up had not been identified through the Hospital's Infection Control program nor had the issues been address by the hospital's QAPI program.

2. On September 18, 2014 at 8:30 AM an interview with the staff responsible for the hospital's QAPI program confirmed the issues with the "Employee Health" had not been identified or addressed through the QAPI program.