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Based on observation, review of policies and procedures, review of contract agreements, and staff interview, the Critical Access Hospital (CAH) failed to ensure the availability of an emergency water supply for non-medical emergencies, for 3 of 3 days of survey (May 23-25, 2011). Failure to develop agreements and policies and procedures to ensure the availability of an emergency water supply places patients at risk in the event of a loss of water supply.

Findings include:

Review of the following CAH policies occurred on 05/25/11:
* The policy titled "WATER SHORTAGE," revised September 2009, from the "DISASTER PLAN MANUAL" stated, "In the event that a disaster destroys or threatens the hospital's usual water supply, an emergency supply of water will be obtained from Rolla Grocery stores. An emergency supply is kept in the hospital basement."
* A dietary policy titled "Water Shortage," revised in 2003, stated, "In the event of a water shortage, the dietary department will follow the following guidelines to conserve water efficiently. . . ."

A tour of the physical plant occurred on the afternoon of 05/24/11. Observation during the tour did not identify an emergency supply of water in the hospital basement.

The CAH's policies and procedures and contract agreements failed to identify which grocery store, estimations of water needs or agreements for an emergency water supply.

During interview, on 05/24/11 at 3:45 p.m., a maintenance department staff member (#7) reported the CAH maintained no emergency water supply, however, the reverse osmosis unit provided 100 gallons of potable water. This staff member reported he was not aware of any estimation of the amount of potable and non-potable water necessary for the CAH's operations and was not aware of any agreement with an outside provider for potable or non-potable water in the event of a loss of water supply.

During interview, on 05/25/11 at 1:50 p.m., an administrative staff member (#1) confirmed the CAH had not determined an estimated amount of potable and non-potable water necessary or an available source in the event of loss of water supply.

THIS IS A REPEAT DEFICIENCY FROM THE SURVEY COMPLETED ON JANUARY 10, 2008.

Based on review of medical staff bylaws, review of credential files, review of patient registration/admission logs, and staff interview, the Critical Access Hospital (CAH) failed to reappoint members of the medical staff consistent with the approved medical staff bylaws for 4 of 9 practitioners' files reviewed (Practitioners #1, #2, #3, and #4). Failure to reappoint and approve/delineate privileges consistent with the approved bylaws does not ensure practitioners maintain the qualifications, competency, and moral and ethical character necessary to practice at the facility and does not ensure the practitioners' medical staff appointment/privileges are current and up-to-date.

Findings include:

Review of medical staff bylaws occurred May 23-24, 2011. The bylaws, approved 04/21/10, defined the "FUNCTIONS OF THE MEDICAL STAFF" to include the "Credentialing Function" as stated,
"The duties of the Medical Staff with respect to credentialing shall be:
a. to review the credentials of all applicants for Medical Staff appointment, reappointment, and clinical privileges, to make investigations of and interview such applicants as may be necessary, and to make a report of its finding and recommendations on the same in accordance with Article II of the Policy on Appointment, Reappointment and Clinical Privileges;
b. to review as questions arise, all information available regarding the behavior and clinical competence of persons currently appointed to the Medical Staff, and as a result of such review to make recommendations on the same in accordance with Article III of the Policy on Appointment, Reappointment and Clinical Privileges."

The bylaws defined general "CLINICAL PRIVILEGES" as "Medical staff appointment or reappointment shall not confer any clinical privileges or right to practice in the Hospital. Each individual who has been given an appointment to the Medical Staff of the Hospital shall be entitled to exercise only those clinical privileges specifically granted by the Board, except as stated in policies adopted by the Board. The clinical privileges recommended to the Board shall be based upon the applicant's education, training, experience, demonstrated current competence and judgment, references, utilization patterns, health status, availability of qualified medical coverage, adequate levels of professional liability insurance coverage, the Hospital's available resources and personnel, and other information deemed relevant by the Board. The applicant shall have the burden of establishing his/her qualifications for competence to exercise the clinical privileges requested."

The bylaws defined the PROCEDURE FOR REAPPOINTMENT stating, "Each current appointee who wishes to be reappointed to the Medical Staff shall be responsible for completing the reappointment application form approved by the Board. . . . Reappointment, if granted, shall be for a period of not more than two (2) years. Failure to submit an application for reappointment by that time will result in automatic expiration of the appointee's appointment and clinical privileges. . . ."

Review of individual practitioner credential files occurred on the morning of 05/25/11 and showed the following appointment/reappointment activity since 2008:

- The credential file of Practitioner #1 identified the practitioner's courtesy staff privileges expired 12/31/10. Practitioner #1 applied for reappointment on 12/04/10. The medical staff delayed approving the practitioner's reappointment until 01/05/11; and the governing board approved the practitioner's reappointment on 01/19/11.
During interview at 11:15 a.m. on 05/25/11, a supervisory staff member (#5) agreed Practitioner #1's credentialing occurred after the previous credentialing period expired.
The credential file identified the practitioner's previous appointment had expired and a lapse of 19 days occurred before reappointment by the governing body. Review of the patient registration/admission logs identified Practitioner #1 continued to see patients at the hospital during this period of time without being credentialed.

- The credential file of Practitioner #2 identified the practitioner's initial appointment expired 12/01/10. The practitioner applied for reappointment on 12/01/10. The medical staff approved the reappointment application on 01/05/11; and the governing board approved the practitioner's reappointment on 01/19/11.
During interview at 11:15 a.m. on 05/25/11, a supervisory staff member (#8) agreed Practitioner #2's credentialing occurred after the previous credentialing period expired.
The credential file identified the practitioner did not apply for reappointment until the day his initial appointment expired, and the practitioner's previous appointment had expired 50 days before reappointment by the governing body. Review of the patient registration/admission logs identified Practitioner #2 continued to see patients at the hospital during this period of time without being credentialed.

- The credential file of Practitioner #3 identified the practitioner's temporary appointment expired on 03/14/11. The medical staff approved an initial appointment on 03/02/11; and the governing board approved the initial appointment on 04/20/11.
During interview at 11:15 a.m. on 05/25/11, a supervisory staff member (#8) agreed Practitioner #3's initial credentialing occurred after the temporary credentialing period expired.
The credential file identified Practitioner #3's temporary appointment expired 37 days before initial (reappointment) by the governing body. Review of the patient registration/admission logs identified Practitioner #3 continued to see patients at the hospital during this period of time without being credentialed.

- The credential file of Practitioner #4 identified the practitioner's appointment expired 12/01/10. The Practitioner applied for reappointment on 02/01/11. The medical staff approved the reappointment on 02/09/11; and the governing board approved the reappointment on 02/23/11.
During interview at 11:15 a.m. on 05/25/11, a supervisory staff member (#8) agreed Practitioner #4's credentialing occurred after the previous credentialing period expired.
The credential file identified the practitioner applied for reappointment two months after his appointment expired; and the practitioner's previous appointment had expired 54 days before reappointment by the governing body. Review of the patient registration/admission logs identified Practitioner #4 continued to see patients at the hospital during this period of time without being credentialed.

Based on record review, review of the Medical Staff Bylaws and Medical Staff Rules and Regulations, and staff interview, the Critical Access Hospital (CAH) failed to ensure a doctor of medicine or osteopathy periodically reviewed and signed the records of all patients cared for by Allied Health Professionals (AHP) (physician assistants and nurse practitioners), for 3 of 3 closed swing bed patient records (Patients #7, #8, and #9), 3 of 3 closed observation patient records (Patients #10, #11, and #12), 2 of 3 closed acute care patient records (Patients #12 and #14), and 5 of 14 closed emergency room records (Patients #28, #30, #31, #33, and #34). Failure to periodically review and sign records of patients cared for by the AHPs limited the CAH's ability to ensure the quality and appropriateness of patient care provided by the AHPs.

Findings include:

Review of the CAH's Medical Staff Bylaws occurred on 05/23/11. This document, approved on 04/21/10, stated, "ARTICLE II, CATEGORIES OF THE MEDICAL STAFF . . . 2.5 ALLIED HEALTH PROFESSIONALS, Categories of health care professionals other than physicians, podiatrists, dentists and optometrists approved by the Board who are licensed or certified by their respective licensing or certifying agencies and who desire to provide professional services in the Hospital are eligible to practice as Allied Health Professionals. . . ."

Review of the CAH's Medical Staff Rules and Regulations occurred on 05/23/11. This document, approved on 04/22/09, stated ". . . L. ALLIED HEALTH SERVICES, L-1. A Physician shall review and sign all patient records developed by Allied Health Professionals for patients seen by such Allied Health Professionals. Such review shall comply with all applicable Federal and/or State regulations . . . Such review shall occur periodically, or as otherwise determined and specified by the Medical Staff in accordance with regulations. . . ."

Review of the following closed medical records, including status and dates of stay, occurred on May 23-25, 2011. These records lacked evidence of physician review and signature of care and services provided by AHPs, including medication and treatment orders and progress notes:
*Swing Bed-
Patient #7 - 08/31/10 to 02/02/10
Patient #8 - 01/17/11 to 03/21/11
Patient #9 - 03/18/11 to 03/25/11
*Observation-
Patient #10 - 03/23/11 to 03/24/11
Patient #11 - 01/17/11 to 01/18/11
Patient #12 - 12/14/10 to 12/15/10
*Acute Care-
Patient #12 - 12/15/10 to 12/18/10
Patient #13 - 04/19/11 to 04/22/11
Patient #14 - 02/01/11 to 02/06/11
*Emergency Department-
Patient #28 - 12/11/10
Patient #30 - 02/20/11
Patient #31 - 03/25/11
Patient #33 - 04/24/11
Patient #34 - 04/08/11 and 04/09/11

During interview, on 05/25/11 at 2:30 p.m., a medical records management staff member (#10) reported the CAH, the medical staff, and the AHPs have discussed the issue of physician review, without resolution.

Based on observation, record review, policy and procedure review, professional reference review, meeting minutes review, and staff interview, the Critical Access Hospital (CAH) failed to ensure the provision of services by failing to implement a system to identify, report, and control infections and communicable diseases for all patients and personnel of the CAH (Refer to C278); failing to assess each patient individually prior to utilizing side rails, failing to ensure restraint use in accordance with the order of a physician or other licensed independent practitioner (LIP) who is responsible for the care of the patient, and failing to provide education to the patient and the responsible party regarding the hazards of side rail use (Refer to C295); and, failing to notify the physician in a timely manner after a patient developed signs and symptoms of injury following a fall (Refer to C295). Failure to ensure the provision of services places the CAH patients at risk of receiving improper care.

Based on record review, professional literature review, policy and procedure review, infection control meeting minutes review, and staff interview, the Critical Access Hospital (CAH) failed to implement a system to identify, report, and control infections and communicable diseases for all patients and personnel of the CAH for the past year (May 2010 to May 2011). Failure to identify and address all incidents of infections among patients and personnel has the potential for infections to go unreported, spread or reoccur, affecting the health of all patients and personnel of the CAH.

Findings include:

The Centers for Medicare and Medicaid Services (CMS) has outlined the standards of practice for establishing and maintaining an active tracking program to identify, investigate, report and prevent patient and employee infections and communicable diseases. The infection control officer(s) is responsible for developing this system. CMS recommends the infection control officer maintain a log of all incidents of infection and communicable diseases for patients and staff within the CAH. This log is not only limited to nosocomial (facility acquired) infections, it must include all incidents of infection and communicable disease. The facility should identify measures for the assessment of infections in patients and staff along with measures to prevent infection. Facilities need to provide a safe environment for patients and staff. Facilities also need to provide ongoing education for patients and staff as well as methods for monitoring and evaluating asepsis (germ-free). The facility needs to implement a system for corrective action and address it for effectiveness.

Review of the policy "Infection Control Committee" occurred on 05/25/11. This policy, undated, stated, ". . . Establish and operate a system for identifying, reporting and evaluation of infections in patients and personnel. . . ."

Review of the policy "Job Description - Infection Control Nurse" occurred on 05/25/11. This policy, undated, stated, ". . . He/she will be responsible for detecting and recording hospital acquired infections on a systematic and current basis. . . ."

Review of the policy "Employee Health" occurred on 05/25/11. This policy, undated, stated, ". . . To provide and monitor employee health . . . 2. To provide staff with the means of evaluating employees that becomes [sic] ill . . . 3. To evaluate employees with suspected infectious disease. . . ."

Reviewed on 05/24/11, the infection control meeting minutes from May 2010 to May 2011, lacked evidence the CAH identified and recognized infections of all patients, including outpatients, and personnel of the CAH. Review of the infection control program on 05/24/11, revealed the CAH failed to complete and maintain a log of all incidents of infections among patients and personnel for the past year (May 2010 to May 2011). The CAH also failed to document and maintain pertinent patient information related to infections, such as an infection control report.

During an interview on 05/24/11 at 2:20 p.m., the infection control nurse (#2) stated she received information from the CAH's laboratory of patients who received cultures, and she tracked or followed the patients with positive cultures. The nurse (#2) stated the facility did not include outpatients or surgical patients and employees in infection control surveillance. When asked to clarify the process or system the CAH implemented to identify, report, and investigate infections, the infection control nurse (#2) stated she checked the CAH's patient census daily for patients with known infections determined upon admission and included those patients in the surveillance. The nurse (#2) also stated when nursing staff suspect a patient infection, nursing staff notifies the infection control nurse in the form of an infection report or in the form of an e-mail from the ward clerk. When asked for documentation of patients with known infections on admission, infection reports, or e-mails, the nurse (#2) provided the surveyor with a folder. The folder lacked documentation of patient information related to infections other than the culture reports from the laboratory.

During an interview on 05/25/11 at 8:50 a.m., a nurse (#5) stated the night nurse used to fill out a form that was sent to the infection control nurse when staff suspected a patient had an infection, but did not think staff followed this process currently. This nurse (#5) confirmed the other nurses or other shifts were not filling out the form.

During an interview on 05/25/11 at 10:30 a.m., a staff member (#6) stated as a ward clerk, she does not complete a report or send an e-mail to the infection control nurse when staff suspects a patient has an infection.

The CAH lacked a system or process for staff to document and report suspected cases of infections to the infection control nurse for further investigation, monitoring, and recommendations. The CAH failed to implement a system to track all incidents of infections and communicable diseases of patients and employees of the CAH, and failed to document and maintain an infection control log for all patients and employees.

The failure to track all possible infections among patients and personnel within the CAH limited the CAH's ability to track, control, and prevent infections.

1. Based on observation, record review, professional literature review, policy and procedure review, and staff interview, the Critical Access Hospital (CAH) failed to assess each patient individually prior to utilizing side rails, failed to ensure restraint use in accordance with the order of a physician or other licensed independent practitioner (LIP) who is responsible for the care of the patient, and failed to provide education to the patient and the responsible party regarding the hazards of side rail use, for 1 of 3 active swing bed patients (Patient #1) and 1 of 3 closed swing bed patient records (Patient #7) restrained with four elevated side rails. Failure to assess and evaluate the use of side rails; failure to ensure the use of restraints in accordance with the order of a physician or LIP; and, failure to educate patients and responsible parties regarding the hazards of using side rails placed Patients #1 and #7 at risk of injury, physical and psychological harm, and restricted their movement. These failures resulted in Patient #7 becoming entrapped between the side rail and mattress.

Findings include:

The Centers for Medicare and Medicaid Services (CMS) has outlined the standards of practice for restraint use. Federal regulations require staff to obtain an order from the physician or LIP prior to the application of restraint. The failure to obtain an order is viewed as the application of restraint without an order.

The Food and Drug Administration (FDA) Center for Devices and Radiological Health publication titled, "Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment," issued on 03/10/06, stated, ". . . FDA has received reports in which . . . patients have become entrapped in hospital beds while undergoing care and treatment in health care facilities. The term 'entrapment' describes an event in which a patient is caught, trapped or entangled in the space in or about the bed rail, mattress, or hospital bed frame. Patient entrapments may result in death and serious injuries . . . The current International Electrotechnical Commission (IEC) standard recognizes that the bed frame, deck, and rails are the major elements involved in entrapment . . ."

Safety Alert: Entrapment Hazards with Hospital Bed Side Rails, August 23, 1995, and Joint Commission on Accreditation of Healthcare Organization: Sentinel Event Alert, Issue 27, September 6, 2002, identified bed rail-related entrapment deaths and injuries can occur in the elderly population, who are often at risk due to limited mobility, psychoactive or sedative medications, confusion, sedation, restlessness, lack of muscle control, size and physical deformities. Death by asphyxiation or injuries to the resident's extremities can occur when the resident becomes caught between the mattress and the bed rail; the headboard and the bed rail; or getting his or her head/extremity stuck in the bed rail. Both split and full rails have the potential to cause fall-related injuries as well as entrapment. Additionally fall-related injuries or injuries to extremities can occur when confused/disoriented residents climb over the top of side rails or get an arm or leg entrapped.

Clinical Guidance For the Assessment and Implementation of Bed Rails In Hospitals, Long Term Care Facilities, and Home Care Settings, Hospital Bed Safety Workgroup, Food and Drug Administration, April 2003, stated, "Guiding Principles . . . 2. Decisions to use or to discontinue the use of a bed rail should be made in the context of an individualized patient assessment using an interdisciplinary team with input from the patient and family or the patient's legal guardian. . . . Policy Considerations: 1. Regardless of the purpose for which bed rails are being used or considered, a decision to utilize or remove 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 and approved by the interdisciplinary team. Bed rail effectiveness should be reviewed on a regular basis. 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 and determined not to be the treatment of choice for the patient. . . . 7. Creating a safe bed environment does not necessarily preclude the use of bed rails. However, a decision to use them should be based on a comprehensive assessment and identification of the patient's needs, which include comparing the potential for injury or death associated with use or non-use of bed rails to the benefits for an individual patient. In creating a safe bed environment, the following general principles should be applied: Avoid the automatic use of bed rails of any size or shape. . . . Re-assess the patient's needs and re-evaluate the equipment if an episode of entrapment or near-entrapment occurs, with or without serious injury. This should be done immediately because fatal 'repeat' events can occur within minutes of the first episode. Process/Procedure Considerations . . . 1. Individualized Patient Assessment: Any decision regarding bed rail use or removal from use should be made within the framework of an individual patient assessment. . . . Risk Intervention: 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. . . . Bed Rails as Restraints: When bed rails have the effect of keeping a patient from voluntarily getting out of bed, they fall under the definition of a physical restraint. If they are not necessary to treat medical symptoms, and less restrictive interventions have not been attempted and determined to be ineffective, bed rails used as restraints should be avoided. . . . Bed Rail Safety Guidelines: If it is determined that bed rails are required and that other environmental or treatment considerations may not meet the individual patient's assessed needs, or have been tried and were unsuccessful in meeting the patient's assessed needs, then close attention must be given to the design of the rails and the relationship between rails and other parts of the bed.

Review of the policy "Patient Safety Policies" occurred on 05/25/11. This policy, revised May 2006, stated, ". . . 2. Side rails may be used for safety, security and well-being of patients if addressed in their care plan. 3. Restraints may be used if ordered by doctor. . . ."

Review of the policy "Restraint/Seclusion Policy" occurred on 05/25/11. This policy, revised 01/17/07, stated, ". . . To establish a standard for use of . . . restraint for patients at PMC [Presentation Medical Center]. . . . C. The patient has the right to be free from . . . restraints of any form that are not medically necessary . . . Also included as restraints are facility practices that meet the definition of a restraint, such as: Using bed rails to keep a patient from voluntarily getting out of bed . . . Physical Restraints . . . should be used only: 1. When ordered by a provider for a specified and limited period of time to treat a medical symptom, to improve the patient's well being and/or to ensure the safety of the patient and others. . . . 3. Restraints will only be used when less restrictive interventions have been determined to be ineffective. . . . F. There must be written modification in the nursing care plan regarding restraint use. G. Restraints must be implemented in the least restrictive manner possible in accordance with safe and appropriate restraining techniques and ended at the earliest possible time. H. The condition of the restrained patient must be continually assessed, monitored and re-evaluated. . . . A. Need for Restraint . . . 1. Prior to using a restraint . . . alternative methods should be attempted . . . B. Obtain an order for a restraint . . . 2. A provider order is necessary to use a restraint . . . 3. The order must include type of restraint, specified time limit and reason for restraint. . . . 5. After the original order expires, a provider must see and assess the patient before issuing a new order. C. Notification for Need of Restraints . . . 3. For swing bed patients only, use the 'Authorization for Use of Restraints' . . . obtain informed consent for the restraint from the patient and/or responsible person. D. Application of Restraints . . . 4. Document on Restraint . . . Record . . . the type, date and time of application of restraint. . . . F. Care of the Patient in Restraint . . . 1. Observe patient at least every hour. . . . G. Discontinuation of use of restraints . . . 1. The patient should be evaluated every hour for appropriateness of the removal or reduction of restraints . . . 3. If after assessment the provider or Charge Nurse determines the patient condition has changed, a less restrictive alternative or discontinuation may be attempted. 4. Obtained revised provider order. 5. Update Care Plan. H. Documentation 1. The Restraint . . . Record . . . should be used for documentation, in addition to appropriate flow sheets, assessment forms and narrative charting. This form must be used to document: a. Date, time and type of restraint applied. b. Number of times of checks between releases. c. Releases every two hours for toileting, position change, etc. d. Total hours and reasons released. e. Number of times food and fluids offered. f. Patient's response . . . g. Date and time restraints are removed. . . . 2. The patient's symptoms necessitating restraints must be documented. 3. Description of interventions attempted and why they were ineffective prior to the application of restraints. 4. Document on the patient's care plan: a. Medical symptom that constitutes the need for restraint . . . b. Type of restraint and time of use. c. Other interventions that are to be used to prevent adverse effects. d. A plan for systematic and gradual reduction of restraint use. e. Provision for release and monitoring of restraints. . . ."

- Observation of Patient #1 on May 23-24, 2011, while the patient rested in bed, identified four elevated half rails on the bed.

Review of Patient #1's active record occurred May 23-25, 2011 and identified the CAH admitted the patient to swing bed on 08/23/09 for assistance with activities of daily living. Patient #1's medical history included osteoarthritis, chronic right hip pain, and general weakness. Record review showed the patient sustained a fall at a previous facility resulting in a fractured pelvis prior to admission to the CAH.

Review of Patient #1's nursing documentation from 07/09/10 to 05/24/11 indicated confusion, forgetfulness, moderately impaired cognition, poor decision making, cues/supervision required, total dependence in bathing, dressing, mobility, and transfers. The nursing documentation showed Patient #1 frequently tried to get up out of the bed or chair by self. The record lacked an initial or ongoing fall and/or safety risk assessment on Patient #1. Patient #1's Falls Precaution Flowsheet from 07/09/10 to 12/27/10 indicated three elevated side rails for assistance/safety, and bed/chair alarm on. Patient #1's Kardex, undated, showed three of four side rails and bed and chair alarm in the supportive/safety section.

Patient #1's Nurses Notes stated the following:
*07/12/10 at 1:40 p.m.: "Staff heard hollering for 'help' from room. Staff found patient lying on floor on left side [with] blood spurting from laceration on (L) [left] forehead. . . . Helped from floor to wheelchair [with] assist of two and taken to ER [emergency room] . . ."
*07/12/10 at 3:00 p.m.: "Pt. [patient] returned from ER, drsg [dressing] [and] ice pack to [left] side forehead . . ."
*07/12/10 at 5:00 p.m.: "Drsg to forehead . . . [changed], soaked [with] blood . . ."
*07/12/10 at 6:40 p.m.: "Heard pt calling [and] found sliding down bed attempting to get out. Still laying on bed alarm [with] upper body [no] alarm heard. Pt. repositioned in bed, tag alert also placed on pt."
*07/12/10 at 8:10 p.m.: "Daughter . . . here visiting . . . would like 3 siderails [arrow up] for pt. safety."
*07/13/10 at 2:00 a.m.: "Ice pack to Lt [left] eye-due to [arrow up] inflammation."
*07/14/10 at 9:00 a.m.: "Dressing . . . off Lt forehead. Layers saturated [with] . . . dark, dried blood. Area has some visible sutures covered [with] dried blood [and] superficial bright red blood. . . . Area is tender to touch. Purple swelling baseball size to Lt eye [and] periorbital. Opens Lt eye 1/3 way."
*07/14/10 at 2:00 p.m.: "Purple bruising noted starting Rt [right] eyelids."
*07/15/10 at 9:30 a.m.: "pt has had some confusion . . . pt [left] eye is ecchomotic [sic] around eye, side of face is swollen [and] jaw is black [and] blue, [right] eye is ecchomotic [sic] above the eye [and] in the corner of eye."

Patient #1's Physician Orders and Progress Notes, dated 07/12/10, stated patient seen in ER for laceration of scalp post fall, change head dressing in 48 hours and daily, and sutures out in 10 days. Nurse notes on Patient #1's Swing Bed Weekly Charting form, dated 07/26/10, stated, "Lt forehead laceration had sutures removed 07/22/10 . . . healing well. Bruising to Lt face is fading. Dark purple area to Lt lower jaw/neck area. Tenderness is decreasing. . . . Unable to sit up in bed straight [without] support. Max assist of 2-3 and gait belt to transfer. Has pad alarm and clip on alarm on in addition to call light nearby. Occasionally tries to put feet over side of bed to get up and has been found sitting on the footrest of her recliner [with] alarm ringing. . . ." Patient #1's History and Physical, dated 08/04/10, stated, ". . . has bouts of confusion and has a significant fall risk. . . . She requires maximum assist. . . . She had a recent fall with significant contusion/laceration to the left side of her forehead. . . ."

Patient #1's Nurses Notes stated the following:
*12/17/10 at 11:30 p.m.: "Pt's bed alarm sounding. Pt found sitting up at side of bed. States she needs to go to the BR [bathroom] but doesn't need any help. . . ."
*12/20/10 at 11:00 a.m.: "Has been confused all weekend - slept poorly last night . . ."
*12/27/10 at 5:25 a.m.: "Pt found on the floor at the end of her bed when CNA [certified nurses aide] entered room to fill water pitcher. Pt states she slid out of bed [and] tried crawling but couldn't so she scooted to the end of the bed. Pt had blanket rolled up under her head. When asked why she didn't call out for help she said she got in trouble last time for calling out. Informed pt it is okay to holler out if she needs help [and] can't reach call light. Pt had tag alarm on but has been taking clip off. Was found [times] 2 earlier tonight without clip on after nurse had put it on."
*12/27/10 at 5:55 a.m.: "Daughter . . . notified of pt's fall. She requested that all 4 side rails be placed up. Will add to care plan."
*02/03/11 at 4:00 a.m.: "Pt has been very confused since yest [yesterday] AM [morning]. . . ."
*02/03/11 at 2:00 p.m.: "Confused [and] agitated all AM . . . Made three attempts to get out of recliner. Tag alarm alerted staff. . . . Restless in bed. . . ."
*02/04/11 at 1:00 p.m.: "Pt quite confused today, saying out of sort things. . . ."

A facility incident report, dated 12/27/10, identified staff found the patient on the floor after a fall from the bed with side rails up times three. The report stated the tag alarm had been on the last time staff checked on the patient, but the patient had removed the clip the previous two times staff were in the room. The report identified the alarm did not sound and was not clipped to the patient when staff found the patient. As indicated in the report for treatment and prevention, the patient's daughter requested all four side rails raised on the patient's bed, and staff ordered a strip bed alarm for the patient's bed.

Patient #1's Falls Precaution Flowsheet, from 12/28/10 to 05/07/11, indicated four elevated side rails for assistance/safety and bed/chair alarm on. Patient #1's updated Kardex, undated, showed four of four side rails per family request for safety and bed and chair alarm in the supportive/safety section. Nurse notes on Patient #1's Swing Bed Weekly Charting form, from 12/27/10 to 01/17/11, stated daughter requested all four rails be left up on patient's bed, 4 side rails remain up when pt. is in bed per family's request, and continue with all 4 rails up per family request.

Patient #1's care plan lacked evidence staff updated the care plan following the patient's falls, confusion, side rail use, restraint use, and failed to address a plan to prevent future falls, decrease side rail and restraint use, and manage Patient #1's confusion.

Patient #1's record showed Patient #1 attempted to get out of the bed or chair on numerous occasions and acquired multiple falls in doing so. The CAH staff failed to re-assess, implement different interventions, and establish a plan to prevent future falls.

Patient #1's medical record lacked medical or behavioral need for the four elevated side rails; lacked assessment of less restrictive interventions than the elevated side rails; lacked assessment of risk and safety for use of side rails; lacked documentation of monitoring of the side rails; lacked evidence of patient or responsible party education regarding the hazards of side rail use; and, lacked a physician's order for use of four elevated side rails. The CAH staff failed to consider the side rails as a potential restraint and entrapment hazard.

During an interview on 05/24/11 at 3:30 p.m. two nurses (#3 and #4) stated nursing staff elevate the side rails for patient safety, positioning/mobility, access to bed controls/call light, and per patient/family request. The nurse (#3) indicated confusion and safety as the reason for Patient #1's elevated side rails to prevent the patient from falling out of bed. A nurse (#4) stated nursing staff does not perform a fall risk assessment on patients, but applied fall precautions or safety measures when staff recognized a patient was at high risk for falling. The two nurses (#3 and #4) stated they failed to recognize the four elevated side rails as a restraint. The nurse (#4) stated nursing staff does not perform or document an assessment for risk factors or safety for utilization of side rails.

During an interview on 05/25/11 at 1:00 p.m., an administrative nurse (#1) stated nursing staff does not perform an assessment of risk factors or safety for utilization of side rails, nor do they perform a fall risk assessment. The nurse (#1) stated staff elevate the side rails for patient safety, positioning, and access to bed controls/call light. The administrative nurse (#1) confirmed the CAH considers elevation of four side rails as a restraint and would require a physician's order, but stated the CAH failed to consider the side rails a restraint, risk for safety, and a potential hazard for entrapment for Patient #1.

- Review of the CAH's Incident and Accident Reports for the period, May 2010 through May 2011, identified Patient #7 attempted to crawl out of bed over the side rails on 12/14/10 at 4:50 a.m. The report identified the patient's arms and upper body were over the side rail and his left leg was caught between the side rail and mattress. The report identified redness to the patient's left knee which resolved. The report identified action initiated to leave the side rails down, however, Patient #7's family requested all four side rails remain up. The CAH's action was to have staff frequently monitor Patient #7.

Review of Patient #7's closed swing bed medical record occurred on May 24-25, 2011. The CAH admitted the patient on 08/31/10 and discharged the patient to a long term care facility on 02/02/11. Admission diagnoses included agitation and confusion.

Patient #7's Nurses Notes, dated 09/09/10 at 6:20 p.m., stated, "Climbing out of bed frequently. Staff is busy [with] an admit and a transfer and all the other patients. Not enough staff to provide 1 on 1 care at this time. . . ." The patient's Nurse Notes throughout the patient's swing bed stay at the CAH identified the patient's agitation, attempts to climb out of bed, attempts to ambulate independently, and frequent falls.

Patient #7's Weekly Charting, dated 09/14/10, stated, "MOBILITY . . . Constant assistance . . . Restraints, 4 side rails per family request for safety, care planned. . . ." Weekly Charting throughout the patient's swing bed stay at the CAH identified continued use of three or four side rails.

Patient #7's Care Plan, dated 09/09/10, lacked updates regarding use of side rails or restraints. The patient's Kardex included "3-4 side rails" and lacked frequency of monitoring. The patient's medical record lacked a physician's order for the restraints, lacked assessment of Patient #7 for use of the restraints, lacked assessment for least restrictive environment, and lacked evidence of education provided to the family regarding the hazards of using side rails.

Patient #7's medical record identified the CAH staff initiated and continued to use three or four side rails for the patient at the family's request. The medical record showed the CAH staff used bed and chair alarms, but lacked assessment regarding other alternatives to the side rails; lacked planned monitoring of Patient #7; and, lacked evidence of education provided to the patient's family.

These failures resulted in Patient #7 becoming entrapped, without injury, between the side rail and the mattress on 12/14/10. Continued used of the side rails placed Patient #1 and #7 at risk of further entrapment and injury.


2. Based on record review and staff interview the Critical Access Hospital (CAH) failed to provide care in accordance with the needs of 1 of 3 active swing bed patients (Patient #2) by failing to notify the patient's physician in a timely manner after the patient developed signs and symptoms of injury following a fall. This failure resulted in a 24 day delay for identification of Patient #2's right wrist fracture and placed all patients with falls at risk of not receiving appropriate care.

Findings include:

Review of Patient #2's active record occurred on May 23-25, 2011. Record review identified the CAH admitted the patient to swing bed on 08/29/09 for physical therapy and strengthening after the patient sustained a stroke resulting in left sided weakness.

Patient #2's Nurses Notes identified the following:
*12/17/09 at 7:33 p.m.: "Pt. [patient] had banging noise coming from room. Pt. found on floor, sitting on bottom. Pt. states she was sitting in chair and was reaching behind her to throw an old roll away [and] slide [sic] out of chair onto floor. Pt. lifted up per [two] assist to a standing position. Pt. states no pain. VS [vital signs] taken @ [at] bedside. . . . Redness noted to back [and] buttock. Chg [charge] RN [registered nurse] [and] MD [medical doctor] notified of fall . . ."
*12/17/09 at 9:30 p.m.: ". . . Pt c/o [complains of] pain to [left] arm from elbow to shoulder. . . ."
*12/18/09 at 9:00 a.m.: ". . . Bruising noted to posterior upper left arm and to the Rt. [right] wrist. . . ."
*12/19/09 at 12:00 a.m.: "Pt request tylenol for pain. Pt was reported to have fallen on 12/17/09. Notes of condition s/p [status post] fall not available @ this time. Pt does have swelling [and] bruising noted throughout [right] wrist. c/o pain [with] [arrow up] swelling . . . Charge nurse notified, ace bandage placed to wrist."
*12/20/09 at 1:00 a.m.: ". . . [arrow down] limitation to [right] hand observed . . . states 'my wrist feels better [with] wrap' . . ."
*01/01/10 at 9:20 a.m.: ". . . Pt. states [right] wrist still gets sore from recent fall, minimal bruising is present on palm . . ."
*01/08/10 day shift: "LPN [licensed practical nurse] reported to me that she had put ace wrap on Rt wrist/forearm due to patient c/o tenderness to area. . . ."
*01/09/10 at 12:40 p.m.: "Patient had Rt. wrist forearm xrayed . . . per MD order. Pt c/o intermittent soreness in area."
*01/09/10 at 2:00 p.m.: "Dr [doctor] . . . called to report a impacted, nondisplaced Rt radial fx [fracture] on xray. . . ."

Nurse notes on Patient #2's Swing Bed Weekly Charting form stated the following:
*12/25/09: ". . . Pt has bruising to [right] thumb and [left] upper arm, from fall out of chair last week. . . ."
*01/01/10: ". . . Pt has minimal bruising from fall on 12/17/09 to [right] palm/wrist. . . ."
*01/15/10: ". . . Helps when able though [arrow up] cautious of getting out of chair [after] fall several weeks ago resulting in fx of [right] wrist. Pt wearing wrist 'sling'/brace now to [right] wrist, states 'not much discomfort anymore . . . Has bruise to [left upper post [posterior] arm r/t [related to] fall - healing. . . ."

Patient #2's PRN [as needed] Pain Medication Flow Sheet showed the patient received Tylenol for complaints of pain in the left arm and right wrist on December 18, 19, and 22, 2009, and on 01/01/10. This flow sheet lacked a pain score rating for each medication administration, but showed Patient #2 exhibited grimacing facial expressions, tense/restless/anxious, and guarding or holding affected body area.

Patient #2's Physician Orders and Progress Notes, dated 01/09/10, stated history of fall one month ago, patient refused to admit that there was pain in the right arm and refused an xray after the incident, right forearm tender to palpation of the distal ulna with minimal swelling, no deformity, xray right forearm due to pain with palpation and movement with history of fall. Patient #2's radiology report of right forearm xray, dated 01/09/10, indicated a displaced distal radial fracture and probable ulnar styloid fracture.

Patient #2's care plan lacked evidence staff updated the care plan following the patient's fall and failed to address a plan to prevent future falls and manage Patient #2's impaired mobility and pain related to the injury which occurred from the fall.

The record lacked documentation staff recognized Patient #2's injury following the fall and followed up with Patient #2's physician in a timely manner. The staff failed to provide appropriate care to Patient #2 related to her injury, as more than three weeks passed before Patient #2's physician provided orders and treatment.

During an interview on 05/25/11 at 1:00 p.m., an administrative nurse (#1) stated she expected nursing staff to notify the patient's physician as soon as possible after staff note a change in condition or abnormal assessment. The nurse (#1) stated based on Patient #2's assessment of increased pain and swelling post fall, nursing staff should have notified and consulted Patient #2's physician right away.


16379

Based on policy review, Performance Improvement (PI) record review, and staff interview, the Critical Access Hospital (CAH) failed to ensure the quality assurance program evaluated all patient care services affecting CAH patient health and safety, including cardiac rehabilitation and side rail and restraint use, for 10 of 10 months reviewed (June 2010-March 2011). Failure to participate in quality assurance activities places patients at risk of not receiving appropriate care and services and failing to implement corrective action if necessary.

Findings include:

Review of the CAH's "CENTRAL QUALITY IMPROVEMENT/PEER REVIEW PLAN" occurred on the afternoon of 05/24/11. The policy, revised March 2010, stated,
". . .1. Goals: . . . B. Strive for continual improvement of patient care, patient safety and departmental services. . . .
3. Program Components, A. Performance Measurement: . . . Performance measures will include data on the following: . . . 2. The performance of processes that involve risks or may result in sentinel events, some of which may include: . . . restraint use . . .
B. Data Aggregation and Analysis: . . . Conclusions about current performance are based on comparison with: . . . sentinel events . . . A root cause analysis will be performed for: sentinel events . . .
C. Performance Improvement: A fundamental goal of the performance improvement function is to improve existing processes and outcomes and then to assure that the improved performance is sustained. . . ."

- Reviewed the afternoon of 05/24/11 and morning of 05/25/11, the monthly quality improvement/peer review (QI/PR) meeting summaries from June 2010-March 2011 lacked evidence the cardiac rehabilitation department reported evaluations of the quality of patient care to the facility wide QI/PR Committee.

Reviewed the morning of 05/25/11, the QI/PR Calendar, from July 21, 2010 through July 20, 2011, used to determine which departments report to the QI/PR Committee and when the departments report, failed to include the cardiac rehabilitation department.

During interview, on 05/25/11 at 1:55 p.m., a cardiac rehabilitation management staff member (#9) reported she was not aware of quality improvement activities regarding the department and had not submitted information to the QI/PR Committee.

- Review of the QI/PR meeting summaries failed to include a review of restraint use by the CAH.

Review of Patient #1's active swing bed medical record identified the CAH used three to four side rails at the family's request. The patient experienced falls from the bed with the side rails in use. The CAH failed to consider the side rails as restraints. Refer to C295

Review of Patient #7's closed swing bed medical record identified the CAH used three to four side rails at the family's request. The patient experienced falls from the bed with the side rails in use. Patient #7's leg became entrapped between the side rail and mattress on 12/14/10. The CAH failed to consider the side rails as restraints for Patient #7. Refer to C295

The CAH continued to use the side rails for Patient #1 and Patient #7 after the patient's experienced falls and Patient #7's episode of entrapment. The medical records lacked evidence of analysis or corrective action.

Failure of the QI/PR process to monitor data, perform root cause analysis, implement corrective action, including monitoring for improvement, regarding the use of side rails as restraints, placed Patient #1 and #7 and all CAH patients at risk of injury for falls and entrapment from side rail usage.

Based on policy review and staff interview, the Critical Access Hospital (CAH) failed to evaluate the quality and appropriateness of the treatment furnished by 1 of 1 nurse anesthetist (Provider #7) reviewed and providing care to the CAH's patients within the past year. Failure to evaluate the quality and appropriateness of the treatment furnished has the potential to affect patient outcomes involving surgical procedures requiring anesthesia services.

Findings include:

Review of the policy titled "MEDICAL SERVICES QUALITY IMPROVEMENT/PEER REVIEW PLAN" occurred on May 25, 2011. This policy, dated 04/08/09, stated,
"I. QUALITY IMPROVEMENT/PEER REVIEW GOALS:
A. Assure that the Medical Services QI [Quality Improvement] Plan/Peer Review Plan is effective in monitoring key indicators of care and identifying opportunities to improve patient care, staff performance, and patient safety. . . .
D. Determine appropriate action(s) to undertake in effort to improve medical care services/performance. . . .
II. SCOPE OF SERVICES: . . .
Presentation Medical Center [PMC] collaborates with [Name of entity] to improve the quality of care for patients admitted to the hospital. PMC will participate in those quality projects and peer review activity initiatives deemed appropriate for a facility of our size and scope. Presentation Medical Center will maintain an agreement with an appropriate qualified entity, (as defined in the state rural health care plan), for peer review. . . .

External peer review will be conducted as deemed appropriate. An independent medical reviewer/review organization will be selected for this function.

The screening and peer review process of medical services at PMC will entail evaluation of no less than a 10% sample of both acute and closed clinical records of patients seen for medical services at PMC.

III. RESPONSIBILITIES:
The Medical Staff is responsible for the performance of all QI/peer review activities relevant to the scope of medical services . . ."

The CAH failed to provide evidence a physician with experience in anesthesiology evaluated the quality and appropriateness of the treatment provided by the nurse anesthetist.

During interview on the afternoon of 05/25/11, a supervisory staff member (#1) confirmed the CAH did not have a physician evaluate the quality and appropriateness of the treatment provided by the staff and/or consulting nurse anesthetist in the past year and did not have an established policy and procedure to perform an evaluation of the nurse anesthetist.

Based on policy review and staff interview, the Critical Access Hospital (CAH) failed to have 6 of 6 physicians reviewed who provided treatment to the CAH's patients (Physicians #1, #2, #4, #5, #6, and #8) evaluated for the quality and appropriateness of the diagnosis and treatment furnished. Failure to evaluate the physicians, by physicians/providers with the same qualifications/privileges, has the potential to affect patient outcomes.

Findings include:

Review of the policy titled "MEDICAL SERVICES QUALITY IMPROVEMENT/PEER REVIEW PLAN" occurred on May 25, 2011. This policy, dated 04/08/09, stated,
"I. QUALITY IMPROVEMENT/PEER REVIEW GOALS:
A. Assure that the Medical Services QI [Quality Improvement] Plan/Peer Review Plan is effective in monitoring key indicators of care and identifying opportunities to improve patient care, staff performance, and patient safety. . . .
D. Determine appropriate action(s) to undertake in effort to improve medical care services/performance. . . .
II. SCOPE OF SERVICES: . . .
Presentation Medical Center [PMC] collaborates with [Name of entity] to improve the quality of care for patients admitted to the hospital. PMC will participate in those quality projects and peer review activity initiatives deemed appropriate for a facility of our size and scope. Presentation Medical Center will maintain an agreement with an appropriate qualified entity, (as defined in the state rural health care plan), for peer review. . . .

External peer review will be conducted as deemed appropriate. An independent medical reviewer/review organization will be selected for this function.

The screening and peer review process of medical services at PMC will entail evaluation of no less than a 10% sample of both acute and closed clinical records of patients seen for medical services at PMC.

III. RESPONSIBILITIES:
The Medical Staff is responsible for the performance of all QI/peer review activities relevant to the scope of medical services . . ."

During interview on the afternoon of 05/25/11, a supervisory staff member (#1) stated the CAH does not do any peer review on any of the physicians unless the CAH identifies issues.

Based on record review, review of Organ Procurement Organization (OPO) agreement, and staff interview, the Critical Access Hospital (CAH) failed to ensure notification of the OPO of all swing bed patients whose death is imminent or who have died in the CAH, including 1 of 1 closed swing bed medical record of a patient who expired (Patient #15). Failure to notify the OPO did not allow the OPO to determine the medical suitability for organ donation.

Findings include:

Review of the CAH's amended OPO agreement occurred on 05/25/11. This amendment, dated 10/03/09, stated, ". . . RECITALS . . . 2.1 Notify [OPO], in a timely manner, of all individuals whose death is imminent or who have died . . ."

Review of Patient #15's closed swing bed medical record occurred on 05/25/11. The CAH admitted the patient to swing bed on 11/22/10 and the patient expired on 11/29/10. The medical record lacked evidence the CAH staff contacted the OPO as the patient's death appeared imminent or at the time of death.

During interview, on 05/25/11 at 3:15 p.m., an administrative nursing staff member (#1) reported the CAH staff do not contact the OPO for any deaths or imminent deaths of swing bed patients.

Failure to contact the OPO for all deaths or imminent deaths, including swing bed patients, did not allow the OPO to determine the patient's medical suitability for organ donation.