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Based on observation, review of facility policy and procedure, and staff interview, the Critical Access Hospital (CAH) failed to follow professional standards of care relating to infection control practices observed during patient care on 2 of 2 days of observation (December 10-11, 2014). Failure to follow established infection control practices may allow transmission of organisms and pathogens from patients to staff, to other patients, or to visitors, and from one environment to another.

Findings include:

Review of the policy "Standard Precautions" occurred on 12/11/14. This policy, revised March 2003, stated, ". . . 1. Hand washing: Routine hand washing with a plain soap is essential with patient contact whether or not gloves are worn. It may be necessary to wash hands between tasks and procedures on the same patient to prevent cross-contamination of different body sites . . . HAND WASHING IS AN EXTREMELY IMPORTANT MEASURE IN PREVENTING THE TRANSMISSION OF INFECTION . . . Gloves should be changed after each patient contact and between care of different body sites on the same patient. Remove gloves promptly after use and before touching non-contaminated surfaces. Wash hands after glove removal. GLOVES ARE NOT A SUBSTITUTE FOR HANDWASHING . . . 5. Patient Care Equipment: Handle all used equipment in a manner that prevents skin and mucous membrane exposure, contamination of clothing, transfer of micro-organisms to other patients and the environment. . . ."

Review of Patient #2's medical record occurred on December 10-11, 2014 and identified the facility placed the patient on contact precautions for the presence of vancomycin-resistant enterococci (VRE) (an infection caused by bacteria normally present in human intestines) in the patient's bowels.

On 12/10/14 at 4:48 p.m., observation showed two certified nursing assistants (CNAs) (#3 and #4) assisted Patient #2 with personal cares and transferred her to her wheelchair. During the observation, a CNA (#4) completed perineal cares, changed the patient's incontinence product, and transferred the patient into her wheelchair using a full-body mechanical lift. The CNA (#4) failed to perform hand hygiene after completing perineal cares and prior to transferring the patient.

On 12/11/14 at 8:00 a.m., observation showed two CNAs (#5 and #6) assisted Patient #2 with morning cares. Both CNAs (#5 and #6) rinsed out the patient's colostomy bag and cleansed around the stoma. After colostomy cares, both CNAs (#5 and #6) changed their gloves, completed perineal cares, and changed the patient's incontinence product. The CNAs (#5 and #6) changed their gloves, finished washing the rest of the patient's body, applied lotion, dressed the patient, and transferred her to her wheelchair using a full-body mechanical lift. One CNA (#5) brushed Patient #2's hair and poured her a cup of mouthwash for oral cares. Both CNAs (#5 and #6) failed to perform hand hygiene after cleansing the patient's colostomy bag and stoma and after completing perineal cares.

During an interview on the morning of 12/11/14, an administrative nurse (#1) stated staff should wash their hands after removing their gloves and after completing perineal cares.

SIDE RAIL USE:

1. Based on observation, record review, professional literature review, and staff interview, the Critical Access Hospital (CAH) failed to evaluate the safe use of side rails, failed to assess each patient individually prior to utilizing side rails, failed to consider side rails as a potential entrapment hazard, and failed to provide education to the patient and responsible party regarding the hazards of side rail use for 2 of 2 active patients (Patient #1 and #2) observed with elevated side rails. Failure to assess and evaluate the use of side rails, to consider side rails as a potential entrapment hazard, and to educate patients and responsible parties regarding the hazards of using side rails placed patients at risk of entrapment or injury.

Findings include:

The Hospital Bed Safety Workgroup (HBSW) publication titled, "Clinical Guidance for the Assessment and Implementation of Bed Rails in Hospitals, Long Term Care Facilities, and Home Care Settings, dated April 2003, stated, ". . . bed rails may pose increased risk to patient safety. . . . evidence indicates that half-rails pose a risk of entrapment . . . as well as falls that occur when patients climb over the rails or footboards when the rails are in use. . . . CMS [Centers for Medicare and Medicaid Services] issued guidance in June 2000 . . . One section of the guidance states, 'It is important to note that side rails present an inherent safety risk, particularly when the patient is elderly or disoriented. Even when a side rail is not intentionally used as a restraint, patients may become trapped between the mattress or bed frame and the side rail. Disoriented patients may view a raised side rail as a barrier to climb over, may slide between raised, segmented side rails, or may scoot to the end of the bed to get around a raised side rail. When attempting to exit the bed . . . the patient is at risk for entrapment, entanglement, or falling from a greater height posed by the raised side rail, with a possibility for sustaining greater injury or death than if he/she had fallen from the height of a lowered bed without raised siderails. . . . The population at risk for entrapment are patients who are frail or elderly or those who have conditions such as agitation, delirium, confusion, pain . . . 1. Regardless of the purpose for which bed rails are being used or considered, a decision to utilize . . . those in current use should occur within the framework of an individual patient assessment. . . . 3. Use of bed rails should be based on patients' assessed medical needs and should be documented clearly . . . The patient's chart should include a risk-benefit assessment that identifies why other care interventions are not appropriate or not effective if they were previously attempted . . . The care plan should include educating the patient about possible bed rail danger to enable the patient to make an informed decision . . . If a bed rail has been determined to be necessary, steps should be taken to reduce the known risks associated with its use. . . . Assessment of risk should be part of the individual patient's assessment, and steps to address the risk should be incorporated into the patient's care plan. . . ."

The HBSW publication titled, "A Guide to Bed Safety - Bed Rails in Hospitals, Nursing Homes and Home Health Care: The Facts", revised April 2010, stated, ". . . Potential risks of bed rails may include: Strangling, suffocating, bodily injury or death when patients or part of their body are caught between rails or between the bed rails and mattress. More serious injuries from falls when patients climb over rails. Skin bruising, cuts, and scrapes. Inducing agitated behavior when bed rails are used as a restraint. . . . Preventing patients, who are able to get out of bed, from performing routine activities . . . Most patients can be in bed safely without bed rails. Consider the following: Use beds that can be raised and lowered close to the floor . . . Keep the bed in the lowest position with wheels locked. When the patient is at risk of falling out of bed, place mats next to the bed . . . Monitor patients frequently. Anticipate the reasons patients get out of bed . . . meet these needs . . . When bed rails are used, perform an on-going assessment of the patient's physical and mental status; closely monitor high-risk patients. . . . Reassess the need for using bed rails on a frequent, regular basis."

- Observation of Patient #1, while he rested in bed on the morning of 12/11/14, identified two elevated one-quarter upper rails on the bed.

Review of Patient #1's active swing bed record occurred on December 10-11, 2014 and diagnoses included dementia and chronic obstructive pulmonary disease. The current care plan identified the patient required extensive assistance with activities of daily living and transfers/ambulation and was at risk for falls.

- Observation of Patient #2, while she rested in bed on the afternoon of 12/10/14 and the morning of 12/11/14, identified two elevated one-quarter upper rails on the bed.

Review of Patient #2's active swing bed record occurred on December 10-11, 2014 and diagnoses included a stroke with right-sided weakness. The current care plan identified the patient required extensive to total assistance with activities of daily living and transfers.

Patient #1 and #2's records lacked an individualized assessment of risk and safety for the use of side rails and lacked evidence of patient or responsible party education regarding the hazards of side rail use.

During an interview on 12/11/14 at 7:50 a.m., a nurse (#2) stated patients used the elevated side rails for positioning and confirmed nursing staff do not assess for risk factors or safe use of side rails. The staff member (#2) also confirmed staff do not educate patients or families on the risks of using side rails.


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AS NEEDED MEDICATIONS:

2. Based on record review, professional reference review, and staff interview, the Critical Access Hospital (CAH) failed to assess and document the effectiveness of medications given to patients on an as needed (prn) basis in a timely manner for 3 of 3 active swing bed patients (Patient #1, #2, and #3) and 1 closed inpatient (Patient #4) record reviewed. Failure to appropriately evaluate the patients' response to prn medications limited the nursing staff's ability to assess whether the medication achieved the desired effect or if the patients experienced any side effects or adverse reactions from the medication.

Findings include:

Berman and Snyder, "Kozier & Erb's Fundamentals of Nursing: Concepts, Process, and Practice," 9th ed., Pearson Education, Inc., New Jersey, page 870, states, ". . . Administering Oral Medications . . . Evaluation . . . Return to the client when the medication is expected to take effect (usually 30 minutes) to evaluate the effects of the medication on the client. . . ."

- Review of Patient #2's medical record occurred on December 10-11, 2014 and diagnoses included a stroke with right-sided weakness. Physician orders included Tramadol (used to treat pain) 50 milligrams (mg) by mouth every eight hours prn and acetaminophen (used to treat mild pain or fever) 500 mg by mouth every six hours prn.

Patient #2's online medication administration record (OMAR) showed the following administration and reassessment times for the prn medications:
*Tramadol:
12/03/14 at 4:55 p.m. - reassessed at 8:07 p.m. (over three hours later)
*Acetaminophen:
11/30/14 at 7:15 p.m. - reassessed at 9:00 p.m. (almost two hours later)
12/01/14 at 6:30 p.m. - reassessed at 8:30 p.m. (two hours later)
12/05/14 at 3:05 p.m. - reassessed at 8:01 p.m. (over five hours later)

- Review of Patient #1's medical record occurred on December 10-11, 2014 and identified diagnoses including dementia without behavior disturbance and rheumatoid arthritis. Physician's orders included Tramadol 50 mg by mouth as needed for pain and lorazepam (used to treat anxiety) 1 mg by mouth as need for persistent agitation and insomnia.

Patient #1's OMAR showed the following administration and reassessment times for the prn medications:
*Tramadol:
11/30/14 at 5:39 a.m. - reassessed at 7:29 a.m. (almost two hours later)
12/01/14 at 11:57 p.m. - reassessed on 12/02/14 at 7:26 a.m. (over seven hours later)
12/09/14 at 5:42 a.m. - reassessed at 7:35 a.m. (almost two hours later)
12/09/14 at 4:45 p.m. - reassessed at 6:54 p.m. (over two hours later)
12/09/14 at 11:14 p.m. - reassessed at 11:32 p.m. (18 minutes after administration)
*lorazepam:
12/02/14 at 2:15 a.m. - reassessed at 7:26 a.m. (over five hours later)
12/06/14 at 4:00 a.m. - reassessed at 9:00 a.m. (five hours later)
12/11/14 at 2:09 a.m. - reassessed at 5:25 a.m. (over three hours later)

- Review of Patient #3's medical record occurred on December 10-11, 2014 and identified a diagnosis of left hip fracture. Physician's orders included acetaminophen with codeine 30 mg (used to treat pain) by mouth two times a day as needed for pain.

Patient #3's OMAR showed the following administration and reassessment times for the prn medication:
*acetaminophen with codeine 30 mg:
11/29/14 at 2:51 a.m. - reassessed at 5:06 a.m. (over two hours later)
11/30/14 at 3:40 a.m. - reassessed at 5:45 a.m. (two hours later)
12/01/14 at 4:20 a.m. - reassessed at 5:55 a.m. (over an hour later)
12/02/14 at 5:27 a.m. - reassessed at 7:26 a.m. (two hours later)
12/07/14 at 4:02 a.m. - reassessed at 6:25 a.m. (over two hours later)

- Review of Patient #4's closed medical record occurred on 12/10/14 and identified diagnoses of degenerative joint disease. Physician orders included acetaminophen 500 mg by mouth every four hours prn and acetaminophen with codeine (used to treat pain) 30 mg by mouth every six hours prn.

Patient #4's OMAR showed the following administration and reassessment times for the prn medications:
*Acetaminophen:
11/27/14 at 11:53 p.m. - reassessed on 11/28/14 at 2:42 a.m. (almost three hours later)
11/29/14 at 2:42 a.m. - reassessed at 5:06 a.m. (almost two and a half hours later)
*Acetaminophen with Codeine
11/29/14 at 5:22 p.m. - reassessed at 8:39 p.m. (over three hours later)

During an interview on 12/10/14 at 3:00 p.m., a nurse (#7) stated staff should reassess the effectiveness of prn medications one hour after administering oral medications.

Based on record review, and staff interview, the Critical Access Hospital (CAH) failed to ensure a complete and accurate medical record for 1 of 1 active swing bed patient (Patient #1) who sustained an injury during a fall. Failure to ensure a complete and accurate record inhibits staff's ability to provide care based on the patient's current status and needs.

Findings include:

Review of Patient #1's medical record occurred on December 10-11, 2014. Nurses' Notes, dated 11/27/14 at 8:31 a.m., stated,"RN [registered nurse] requested to come to shower room per aide regarding patient. Aide states she was undressing patient for a bath when she was taking his shirt off and noticed pus and serous fluid leaking around. She states it was like a pimple had burst. Left elbow has a 1 cm [centimeter] open area where the drainage was coming from. Tenderness/purple discoloration noted. Pustule was then checked and with a sterile q-tip. Looking at the wound from a clock perspective there was a tunning [sic] at 12, 3, 6, and 9. Tunneling noted to be 2.5 cm all around. Wound culture obtained. Will notify on-call physician regarding wound." The record lacked information regarding the origin of the left elbow injury/wound.

A physician's progress note, dated 11/28/14, stated, "He reportedly had a fall. He injured his left elbow. Over the past day or so it was noted to be draining and swollen . . . Left elbow injury with acute olecranon [elbow] bursitis [inflammation]/effusion [fluid accumulation]/infection." The record showed the physician ordered an antibiotic and dressing changes to the area.

A care conference note, dated 12/02/14 at 1:00 p.m., stated, ". . . He had a fall that resulted in a injury to his elbowe [sic] . . ." The note failed to address the date of the fall or other details related to the fall.

During an interview on 12/11/14 at 8:15 a.m., an administrative nurse (#1) stated Patient #1's left elbow wound started with a skin tear. She stated the patient did not fall, but had a "near miss" which occurred "near Thanksgiving." The nurse (#1) provided an "Unusual Occurrence" report, dated 12/01/14 (four days after staff identified the wound), regarding a "near miss" when the resident "stumbled against the wall." The report identified the time of the fall as 7:15 p.m. on 12/01/14. The nurse provided no information regarding falls/near misses prior to 11/27/14, when staff first identified the elbow injury.

Based on review of the North Dakota Department of Health, Division of Health Facilities provider files, review of Quality Assurance (QA) and Infection Control meeting minutes, and staff interview, the Critical Access Hospital (CAH) failed to ensure all departments established thresholds of acceptability and reported to the QA Committee as scheduled for 13 of 13 months reviewed (October 2013-November 2014). Failure to ensure reporting and establishment of threshold limits the CAH's ability to identify risk factors affecting patient care and implement corrective action if necessary.

Findings include:

Reviewed during the recertification survey completed on 10/22/14, the CAH's "Quality Assurance Plan," approved 01/23/03, stated,
"Purpose
The purpose of the Quality Assurance program of St. Luke's Hospital is to ensure the delivery of optimal patient care . . .
Objectives
A. To establish an ongoing, comprehensive, and objective mechanism to monitor and evaluate the quality and appropriateness of patient care through routine data collection and analysis. . . .
Authority and Responsibility
Governing Board: The Governing Board of St. Luke's Hospital shall reaffirm its delegation of responsibility for the quality of medical care to the Medical Staff. . . .
Quality Assurance Requirements . . .
B. The quality and appropriateness of patient care in the following services shall be monitored and evaluated on an ongoing basis. Each department will report at least annually . . . 6. Pharmacy Services . . .
Duties of the Quality Assurance Committee . . .
D. To promote and assist where needed, in developing standards of care (criteria) . . ."

During the recertification survey completed on 10/22/14, the April 2014 QA meeting minutes and department monitors lacked evidence pharmacy submitted a QA report during the timeframe October 2013 - September 2014.

During the recertification survey completed on 10/22/14, the October 2013 - September 2014 QA monitors lacked evidence the following departments established thresholds of acceptability: operating room, dietary, swing bed activities, physical therapy, rural health clinics, administration (credentialing), maintenance, emergency department, discharge planning, housekeeping, laboratory, and radiology.

Review of the Infection Control Committee meeting minutes, dated 12/03/14, occurred on 12/10/14 and failed to identify the on-going concerns with handwashing and glove use. Refer to C278.

Review of the QA meeting minutes, dated 12/03/14, occurred on 12/10/14 and failed to identify the above departments established thresholds of acceptability and failed to identify a report from the pharmacy. The minutes also failed to identify the on-going concerns related to side rail use and related to documentation of the patient's response to as needed medications. Refer to C294.

During interview on 12/11/14 at 8:15 a.m., an administrative nursing staff member (#1) responsible for QA confirmed the above listed departments had not yet established thresholds of acceptability for their QA monitoring.