HospitalInspections.org

Based on record review, review of medical staff bylaws/rules and regulations, and staff interview, the Critical Access Hospital (CAH) failed to establish and implement medical staff policies/procedures governing provision of services to acutely mentally ill/suicidal patients and provision for examination by a qualified practitioner of all patients presenting to the emergency room for 2 of 2 sampled patients (Patients #8 and #13) with suicidal attempt/ideation and 3 of 4 patients (Patients #19, #21, and #22) admitted for observation.

Findings include:

- Reviewed on 06/01/10, Patient #13's emergency room record, dated 11/30/09, showed the patient presented via ambulance to the emergency room at 11:05 p.m. The admission note by the licensed nurse stated, ". . . Pt [patient] took 60 mg [milligrams] phenazepam, a shot of 50 proof alcohol, 2 [whiskey mixed drinks] and 750 ml [milliliters] of [name of wine]. Pt came into the ER [emergency room] with hand cuffs on. Pt has suicidal ideation. . . . Pt states 'I tried to do this one other time. I didn't succeed so I said next time I am going to use pills.'"

The record indicated Patient #13 remained in the emergency room until admission to the critical access hospital (CAH) at 12:30 a.m. The record lacked evidence of suicide precautionary/preventative measures implemented while the patient remained in the ER.

The record lacked evidence a physician/mid-level practitioner examined Patient #13 in the emergency room and based upon the examination, prescribed necessary treatment and/or transfer to an appropriate facility for services/care. The record included a dictated note from the physician dated 12/14/09 (two weeks later) and provided a reiteration of the admission note by the licensed nurse. The physician provided no assessment to validate the CAH's ability to meet/respond to Patient #13's suicidal ideation and acute mental health problems/concerns.

Following a request for the acute care admission record for Patient #13 on the afternoon of 06/01/10, an administrative nursing staff member (#2) and medical record staff member (#8) indicated the facility no longer had Patient #13's acute care record for the admission on 12/01/09 (Refer to C308).

During the above referenced interview and again on the morning of 06/02/10, a nursing staff member (#2) stated the physician admitted Patient #13 to an observation bed in the CAH at 11:05 p.m. on 11/30/09, where the patient remained until 1:15 a.m. on 12/01/09. The staff member stated the nursing staff contacted the physician and informed him they [nursing staff] "did not have any suicide prevention/precautionary policies and they were not equipped to care for [Patient #13]. The physician responded, 'Oh, it's ok. He just needs to sleep it off.'" The staff member described Patient #13 as "out of control" and "in the operating room looking for something to kill himself with." After further discussion between nursing staff and the physician, the staff member (#2) indicated the physician consented to transfer Patient #13 to an inpatient psychiatric unit.

- Reviewed on 06/02/10, Patient #8's acute stay medical record showed a physician admitted the patient on 06/22/09 with a diagnosis of "profound depression with suicidal ideation." Admission orders did not include orders for suicide precaution/preventative protocols.

Reviewed June 1-3, 2010, the medical staff bylaws, approved 10/27/03, and the rules and regulations, approved 08/25/08, showed no approved medical staff policies and procedures governing the facility's provision of care for patients with suicidal ideation and/or acute/severe mental illness.

During an interview with an administrative nursing staff member (#2) on the morning of 06/02/10, the staff member indicated the facility did not have established policies/procedures regarding the provision of care for patients who present to the emergency room and/or the CAH admits to the facility with suicidal ideation and/or severe/acute mental illness.

- Reviewed on June 2-3, 2010, the records for Patients #19, #21, and #22 showed the patients presented to the emergency room prior to the CAH admitting the patients to a "holding bed." The emergency room records for each patient lacked evidence of an examination by the physician/practitioner to determine the patients' needs for admission to a holding bed for further monitoring/observation. Refer to C211.

Based on record review and staff interview, the Critical Access Hospital (CAH) failed to establish and implement specific criteria for admission to an observation/holding bed for 3 of 4 patients (Patients #19, #21, and #22) reviewed.

Findings include:

Center for Medicare/Medicaid Services (CMS), State Operations Manuel (SOM) Appendix W - Survey Protocol, Regulation and Interpretive Guidelines for Critical Access Hospitals and Swing-Beds in CAHS, effective 04/04/08, stated, ". . . Observation care is a well-defined set of specific, clinically appropriate services that include ongoing short-term treatment, assessment, and reassessment, that are provided before a decision can be made regarding whether a patient will require further treatment as an inpatient, or may be safely discharged. Observation status is commonly assigned to patients with unexpectedly prolonged recovery after outpatient surgery, and to patients who present to the emergency department and who then require a significant period of treatment or monitoring before a clinical decision is made concerning their next placement. The CAH should ensure that once there is sufficient information to render this clinical decision, the patient should be expeditiously admitted, appropriately transferred, or discharged.
A patient may be in an observation status even though the CAH furnishes the patient overnight accommodation, food, and nursing care.
Observation services are NOT appropriate:
o As a substitute for an inpatient admission;
o For continuous monitoring;
o For medically stable patients who need diagnostic testing or outpatient procedures (e.g., blood transfusion, chemotherapy, dialysis) that are routinely provided in an outpatient setting;
o For patients awaiting nursing home placement;
o To be used as a convenience to the patient, his or her family, the CAH, or the CAH's staff;
o For routine prep or recovery prior to or following diagnostic or surgical services; or
o As a routine 'stop' between the emergency department and an inpatient admission.
Observation services BEGIN and END with an order by a physician or other qualified licensed practitioner of the CAH.
o The order for observation services must be written prior to initiation of the service, as documented by a dated and timed order in the patient's medical record. The order may not be backdated. Orders should be clear for the level of care intended, such as 'admit to inpatient' or 'admit for observation.'
o Observation services end when the physician or other qualified licensed practitioner orders an inpatient admission, a transfer to another health care facility, or discharge. The inpatient stay begins on the date and time of the new order.
o Standing orders for observation services are not acceptable, since it is not necessary to employ observation services for every patient in a given category, e.g., every emergency department patient, in order to reach a clinical decision about the appropriate next step in the patient's care. . . ."

- Reviewed on June 2-3, 2010, the records for Patients #19, #21, and #22, showed the patients presented to the emergency room prior to the CAH admitting the patients directly to a "holding bed." The following emergency room records for each patient lacked evidence of an examination by the physician/practitioner to determine the patient's need for admission to a holding bed for further monitoring/observation:
*Patient #19's record showed the patient presented to the emergency room on 03/19/09, and the physician admitted the patient to a "holding bed," with no evidence the physician examined the patient in the emergency room or established a need for further monitoring/evaluation. Patient #19 remained in a holding bed until 03/21/09, when the physician admitted the patient to an acute bed. The physician discharged Patient #19 from the CAH on 03/22/09.
*Patient #21's record showed the patient presented to the emergency room on 05/25/09, and the physician admitted the patient to a holding bed with no evidence the physician examined the patient in the emergency room and determined the specific need for further monitoring/observation prior to determining a diagnoses or need for further care. The record showed the physician admitted Patient #21 to acute care on 05/27/09 and to a swing-bed on 05/31/09.
*Patient #22's record showed the patient presented to the emergency room on 09/16/09 and included no evidence the physician examined and determined a specific need for further monitoring/observation before admitting the patient directly to a "holding bed." Patient #22 remained in a holding bed until 09/19/09, when the physician admitted the patient to an acute care bed. The physician discharged Patient #22 on 09/23/09.

Following a request on the afternoon of 06/03/10 for the facility's policy for admission to a holding bed, an administrative nursing staff member (#2) responded, "We don't have any criteria or policies for admission to a holding bed. We're working on it."

Based on policy review, observation, and staff interview, the Critical Access Hospital (CAH) failed to ensure the safety of patients, staff, and the public by not securely storing 1 of 7 oxygen K-tanks (in the oxygen storage room). Failure to secure oxygen tanks places any person in the vicinity at risk for injury should the tank become damaged.

Findings include:

Review of the policy titled "Compressed Gas Cylinders" occurred on 06/03/10 at 1:50 p.m. This policy, dated 06/20/01, stated, "Tanks . . . must be chained or secured in such a way that they cannot tip or fall over . . ."

During the environmental tour on 06/03/10 at 1:45 p.m., observation identified one oxygen K-tank stored unsecured on the floor in the oxygen storage room.

During interview on 06/03/10 at 1:45 p.m., two maintenance staff members (#4 and #5) confirmed the CAH staff failed to store the oxygen in a secure manner.

Based on review of bylaws, credentialing files, and staff interview, the governing body of the Critical Access Hospital (CAH) failed to ensure credentialing of providers followed the CAH's bylaws for 1 of 6 providers' (Provider #1) files reviewed. By failing to approve privileges according to the CAH's bylaws, the governing body did not ensure the provider possessed the necessary qualifications for medical staff membership.

Findings include:

Review of "Medical Staff By-Laws Linton Hospital" occurred the afternoon of 06/01/10. These bylaws, dated 10/27/03, stated, ". . . Article III Membership . . .
Section 3. Terms of Appointment
1. Initial appointment shall be provisioned for six (6) months. . . .
Section 4. Procedure of Appointment
1. Application for membership on the Medical Staff shall be presented in writing, and shall include qualifications, National Practitioners Databank Query, two references that state professional competence, professional liability, ethical character, and whether privileges have been revoked, suspended or not renewed, and request of privileges of the applicant and shall also signify his/her agreement to abide by the By-laws, Rules and Regulations of the Medical Staff. . . ."

Review of Provider #1's credentialing file occurred the afternoon of 06/03/10. Provider #1's file failed to include evidence the provider submitted qualifications or two references for the CAH to review and evaluate prior to approving the appointment of Provider #1. The CAH did not check the National Practitioners Databank Query prior to approving the appointment of Provider #1. The CAH approved an initial appointment for Provider #1 for two years instead of a six month provisional initial appointment.

During an interview on 06/03/10 at 3:30 p.m., an administrative staff member (#1) confirmed the CAH did not follow the medical staff bylaws for credentialing Provider #1.

Based on observation, review of facility policy, and staff interview, the Critical Access Hospital (CAH) failed to ensure the removal of outdated medications from 1 of 1 nurse medication room and 1 of 1 off-site clinic; and failed to secure medications in accordance with accepted professional principles in 1 of 2 Emergency rooms (Emergency Room #2), 2 of 3 Radiology rooms (Computerized Tomography [CT] Exam Room and general Radiology Exam Room) and 1 of 1 off-site clinic.

Findings include:

Review of the facility policy titled "Medication Administration" occurred on 06/03/10. This policy, dated June 2008, stated, ". . . Out Dated Medication: The nurse giving medications is responsible for checking for outdates. . . ."

- Observation of the nurse's medication room, on 06/01/10 at 3:40 p.m., showed the following expired medications:
*Cozaar - expired July 2009 (4 tablets)
*Vytorin - expired November 2009 (4 tablets)
*Zyprexa 10 milligrams (mg) - expired August 2009
*Zyprexa 5 mg - expired August 2009
*Actoplus Met 15 mg/850 mg - expired January 2009
*Actoplus Met 15 mg/500 mg - expired December 2008
*Lexapro - expired April 2009
*Azor - 5 mg/20 mg - expired August 2009
*Azor - 5 mg/40 mg - expired September 2009

- Observation of the surgical department on 06/02/10 at 10:15 a.m.
showed the medication Dantrium on the anesthesia cart with an expiration date of March 2010.

- Observation of medication storage at the CAH's off-site clinic, on 06/03/10 at 9:45 a.m. showed the following expired medications:
*Caduet 10 mg/140 mg - expired May 2009 (4 boxes)
*Caduet 5 mg/40 mg - expired July 2009 (4 boxes)
*Caduet 10 mg/20 mg - expired June 2009 (4 boxes)
*Caduet 10 mg/10 mg - expired August 2009 (4 boxes)
*Caduet 5 mg/10 mg - expired December 2009 (3 boxes)

- Observation of Emergency Room #2, on 06/02/10 at 4:45 p.m. showed the following unsecured medications:
*Cabinet #3 (unlocked) - Marcaine 0.5%, Lidocaine 1%, Epinephrine 1:100,000, and Activated Charcoal.
*Cabinet #4 (unlocked) - Eye and ear medications (drops and ointments).

- Observation of the Radiology Department, on 06/02/10 at 1:45 p.m. showed the following unsecured medications:
*Epinephrine 1 milligram/milliliter (mg/ml) and Diphenhydramine 50 mg/ml on a tray in an unlocked cabinet in the general radiology exam room.
*Epinephrine 1 mg/ml and Diphenhydramine 50 mg/ml on a tray on the counter in the CT exam room.

During interview on 06/03/10 at 3:45 p.m., an administrative radiology staff member (#6) confirmed staff did not lock medication storage areas.

- Observation of the CAH's off-site clinic on 06/03/10 at 9:45 a.m. showed the following unsecured medications:
*Bicillin (antibiotic), Pneumococcal vaccine, and Diptheria/Pertussis/Tetanus vaccine - stored in an unlocked medication refrigerator, located in the patient waiting area.
*Lidocaine 1%, Marcaine 0.5%, Ceftriaxone, Kenalog, Solumedrol, Promethazine, Ketorolac, Furosemide, Zantac, Zofran, Maalox, Viscous Lidocaine, Epinephrine, and Benadryl - stored in an unlocked cupboard in an open nurse's station located in the hallway.

During interview at 10:00 a.m. on 06/03/10, a nursing staff member (#10) confirmed staff do not lock the medication refrigerator or the medication cupboard at the nurse's station. The staff member (#10) stated cleaning staff are in the facility when clinic staff are not present. Failure to lock medications allows persons without legal access to have unmonitored access to drugs and biologicals.

Based on observation, record review, patient interview, policy review, and staff interview, the Critical Access Hospital (CAH) failed to ensure staff implemented infection control and prevention measures for 1 of 1 patient requiring contact precautions (Patient #3).

Findings include:

Review of the facility policy titled "Contact Precautions" occurred on 06/03/10. This policy, dated May 2005, stated, "In addition to Standard Precautions, use Contact Precautions, or the equivalent, for specified patients known or suspected to be infected or colonized with epidemiologically important microorganisms that can be transmitted by direct contact with the patient (hand or skin-to-skin that occurs when performing patient-care activities that require touching the patient's dry skin) or indirect contact (touching) with environmental surfaces or patient-care items in the patient's environment. . . . 2. Gloves and Handwashing: in addition to wearing gloves as outlined under standard precautions, wear gloves (clean, nonsterile gloves are adequate) when entering the room. During the course of providing care for a patient, change gloves after having contact with infective material that may contain high concentrations of microorganisms . . . Remove gloves before leaving the patient's room and wash hands immediately with an antimicrobial agent or waterless antiseptic agent. After glove removal and handwashing, ensure that hands do not touch potentially contaminated environmental surfaces or items in the patient's room to avoid transfer of microorganisms to other patient environments. . . . 3. Gown: . . . wear a gown (a clean, nonsterile gown is adequate) when entering the room if you anticipate that your clothing will have substantial contact with the patient, environmental surfaces, or items in the patient's room, or if the patient is incontinent or has diarrhea . . . Remove the gown before leaving the patient's environment. After gown removal, ensure that clothing does not contain potentially contaminated environmental surfaces to avoid transfer of microorganisms to other patients or environments. . . ."

Review of the facility policy titled "Handwashing" occurred on 06/03/10. This policy, dated June 2008, stated, "Purpose: Proper hand washing is the single most important way to prevent and reduce infections. . . . CONTACT PRECAUTIONS require that you wash your hands after removing gloves, but before leaving the patient's room. You must wear gloves whenever you enter the room of a patient requiring contact precautions. . . . *Alcohol based antiseptic hand wash is an acceptable substitute for hand washing if hands are not visibly soiled. . . ."

Review of Patient #3's medical record, on June 1-3, 2010, identified an admission date of 05/30/10 with diagnoses of hematochezia (passage of stool containing blood) and diarrhea. A stool culture report received on 06/01/10 identified the presence of Clostridium difficile.
The Centers for Disease Control identifies Clostridium difficile as a bacterium that causes diarrhea. People can become infected if they touch items or surfaces contaminated with feces and then touch their mouth or mucous membranes. Healthcare workers can spread the bacteria to other patients or contaminate surfaces through hand contact.
Observation at 1:55 p.m. on 06/01/10 showed a nursing staff member (#9) entered Patient #3's room with an IV (intravenous) fluid bag. The nurse checked Patient #3's IV pump and fluids and identified the IV bag she brought in was for the patient in the next room. During this observation, the nurse had hand contact with the patient's IV pump and pole which the patient contacted during self-transfer to and from the bathroom. The nurse exited Patient #3's room with the IV bag and entered the next patient room. The nurse did not wear gloves, wash her hands, or use antiseptic hand wash when entering and exiting Patient #3's room or when entering the next patient room. Observation showed no isolation sign or isolation cart outside of Patient #3's room.

During interview, at 2:25 p.m. on 06/01/10, Patient #3 stated she had not observed the nurses washing their hands or using antiseptic hand wash when in her room. Patient #3 stated, "That nurse who came in here with the IV bag left without washing her hands and I bet she went into that room next door."

Review of Patient #3's Kardex identified "Stool Contact Isolation." Observations throughout the day on 06/01/10 showed no isolation sign or isolation cart outside of Patient #3's room.

Observation at 8:00 a.m. on 06/02/10, showed an isolation cart outside of Patient #3's room and a contact isolation sign on the door. Patient #3 stated, "Now everyone is supposed to wear a gown and gloves when they come in my room."

During interview the afternoon of 06/02/10, an administrative nurse (#2) confirmed staff should have followed contact isolation precautions for Patient #3 on 06/01/10 when the stool culture result came back positive for Clostridium difficile.

Based on observation, record review, review of incident/accident reports, review of facility policies, and staff interview, the facility failed to assess and monitor the need/use of restraints, failed to assess causative factors and risks associated with falls and/or behavior associated with the use of restraints, and failed to assess and implement plans for providing toileting assistance for 3 of 3 sampled patients (Patients #16, #19, and #23) placed in geri-chairs or in beds with raised side rails; failed to assess 5 of 5 current inpatients (Patients #1, #2, #3, #4, and #5) for fall risk and side rail use; and failed to make available for patient use beds with conforming side-rail spacing requirements during 3 of 3 days of survey (June 1-3, 2010).

Findings include:

Review of the policy titled "Restraint/Seclusion" occurred on 06/03/10. This policy, undated, stated, "Policy: . . . Restraints shall be used only where alternative methods are not sufficient to protect patients or others from injury and are not a substitute for less restrictive forms of protective restraint. All patients will have an assessment performed to determine the safety and protective needs of the patient prior to the application of restraints or medical protective device. . . . Physical Restraint is defined: Any manual method or physical or mechanical device, material or equipment attached or adjacent to the patient's body that he or she cannot easily remove, that restricts freedom of movement or normal access to one's body. A Drug Used as a Restraint is defined: a medication used to control behavior or to restrict the patient's freedom of movement and is not a standard treatment for the patient's medical or psychiatric condition.
The use of restraint must be: Selected only when other less restrictive measures have been found to be ineffective to protect the patient or other from harm. In accordance with the order of a physician or other licensed independent practitioner. . . The order must: . . . In accordance with a written modification to the patient's plan of care. . . . The condition of the restrained patient must be continually assessed, monitored, and reevaluated. . . ."

- Reviewed on 06/02/10, Patient #16's medical record showed the facility admitted the resident on 10/28/09 with a diagnosis of pneumonia. Nurses' notes included the following:
* 10/29/09 - 9 a.m., "Restless - Noisy- Hollering 'Get me out of here' (geri-chair); . . . 11 a.m. Restless and noisy increased; brought out to nurses station hall and given snack and juice . . . but no relief or calming affect. . . . 11:30 a.m. Ativan [an anti-anxiety medication] PRN [as needed] given. Pt [patient] continues to sit in geri-chair . . ."

Patient #16's nurses' notes showed the facility continued to place Patient #16 in a geri-chair until discharge on 11/01/09. The record lacked evidence of a physician order for the geri-chair, assessment and reassessment of the need for the geri-chair, and assessment of the safety risks associated with use of the geri-chair, including the patient's increased anxiety and restlessness associated with its' use.

- Reviewed on 06/02/10, Patient #19's medical record showed the facility admitted the patient on 03/19/09 for severe neck pain. The nurses' notes stated,
* 03/20/09 - 3 p.m., ". . . Is arousing more, dozes off and on. Bed check is on. Side-rails up x4. . . . 4:30 p.m. Pt restless. Assisted CNA [certified nurse assistant] to transfer pt to geri-chair. . . . 6:30 p.m. Pt out to nurses desk after found 1/2 way out of geri-chair. . . . "
* 03/21/09 - 10:45 a.m., "Patient attempts to climb out of geri-chair. Has legs over the side with the table top in place. He is assisted to straighten out and stand. He is given assistance to void per urinal before but did not void. Was incontinent . . . 11:00 a.m. Patient rests comfortably in chair with tabletop in place. . . . 11:30 a.m. Pt sitting in geri-chair, irritable at times."
* 03/22/09 - 3 a.m., "Pt attempting to get out of chair . . . 9:35 a.m. Patient found on floor beside geri-chair with tray table attached. Staff were alerted by his calling out. . . . small scratch to left back and quarter size abrasion to left hip . . . Chair placed at nurses station with staff member staying present at station at all times."

Patient #19's record lacked assessment of the safety risks associated with use of the geri-chair, including the patient's increased anxiety and restlessness associated with the inability to get out of the chair per self.

Review of the "General Event Report" regarding Patient #19's fall from the geri-chair lacked assessment or investigation of the factors contributing to the fall and that staff revised the patient's plan of care to prevent further falls and/or injury. The "General Event Report" stated, "Causes - unsure." Neither the nurses notes nor the General Event Report showed evidence of assessment of the patient's unmet needs, including the need for toileting.

Patient #19's admission nursing assessment on 03/19/09 identified the patient as "continent" prior to admission. The nurses' notes following admission showed the patient experienced urinary incontinence. The record lacked evidence of an assessment of Patient #19's toileting needs and an established plan to assist the patient in maintaining previous levels of bowel and bladder continence.

- Reviewed on 06/03/10, Patient #23's medical record showed the facility admitted the patient to a swing-bed on 04/10/09 with diagnosis of "aftercare for healing traumatic fracture of hip." Nurses' notes stated,
* 04/10/09 - 8:30 p.m., "PT attempting to crawl out of bed. . . . 1:30 a.m. Pt at end of bed. Incontinent at this time . . ." Nurses shift assessment showed Patient #23 had side-rails raised at the top half of the bed during this time.
* 04/10/09 - 12 noon, ". . . In geri-chair. . . . 2 p.m. - In geri-chair. 2:45 p.m. -Incontinent of stool. Pt cleaned up. Back in geri-chair. 4 p.m. - In geri-chair - restless."
* 04/10/09 - 8 p.m., "Pt sitting in geri-chair at this time. 8:45 p.m. - Pt changed from incontinent pad. . . ."
* 04/11/09 - 2 a.m., "Pt incontinent. . . . 12 noon - In geri-chair. 2 p.m. - Remains in geri-chair. 6 p.m. - In geri-chair . . . 8:10 p.m. - Pt in geriatric chair at this time. . . . 9:35 p.m. - Pt removed pullup [disposable brief] and urinated on bed and floor."
*04/12/09 - 4 p.m. "Pt voided in bed, bed changed. . . . 12 noon . . . In geri-chair. 2 p.m. . . . Pt was in geri-chair. . . .4 p.m. - In geri-chair . . . 6 p.m. . . . In geri-chair. 8:20 p.m. - In geri-chair. . . . 9:30 p.m. - Pt in geriatric chair."

Patient #23's nurses' notes continued to show the patient placed in a geri-chair from 04/12/09 to 04/15/09. Nurses' notes on 04/15/09 stated, "1800 [6 p.m.] . . . States he does not like the tray on geri-chair - will remove when finished eating." The medical record did not show evidence of the tray being removed from Patient #23's geri-chair. A "General Event Report," dated 04/15/09 at 7 p.m. (one hour later), stated, "Heard call and loud noise from pt room - found pt on floor in front of geri-chair. . . . Causes: Unsure."

Patient #23's record lacked evidence of an assessment of the safety risks associated with use of the geri-chair and the use of side-rails and lacked evidence of an assessment of the patient's needs regarding assistance with toileting. The General Event Report referenced above lacked evidence of assessment or investigation of the causative factors contributing to Patient #23's fall from the geri-chair and that staff revised the plan of care to prevent further falls and/or injury.

During an interview on the afternoon of 06/03/10, an administrative nursing staff member (#2) indicated the facility had not implemented a process for assessment and care planning the use/need for restraints and did not have a policy for the assessment and care planning for management of bowel/bladder incontinence.


19410


- 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 . . ." The FDA's recommendation of the spacing between the inside surface of the rail and the mattress compressed by the weight of the patient's head be small enough to prevent head entrapment when taking into account the mattress compressibility, any lateral shift of the mattress or rail, and degree of play from loosened rails. The IEC and the FDA recommend a dimension limit of less than 120 millimeters (4 and 3/4 inches) for the following: 1) within the rail; 2) under the rail, between rail supports or next to a single rail support; and 3) between the rail and mattress.

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. . . .

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. . . ."

Observation of the beds utilized on the nursing unit occurred on June 1-3, 2010. The beds varied in make and style with all of the beds having either four half rails (two half rails on each side) or two half rails (one half rail on each side). Of the 20 beds observed in rooms 14-26, ten of the beds had spaces between the rails which measured greater than 4 and 3/4 inches.

Random observations throughout the survey showed Patients #1, #2, #3, #4, and #5 in beds with the upper 1/2 side rails elevated.

Review of the medical records for Patients #1, #2, #3, #4, and #5 occurred on all days of survey. The records lacked documentation staff assessed each patient for the utilization of side rails. The CAH staff failed to consider the side rails as a potential entrapment and safety hazard. Review of the "Fall Risk Assessment" on the admission patient assessment form identified staff did not assess these patients for risk of falls. During interview the afternoon of 06/03/10, an administrative nurse (#2) confirmed staff should assess each patient and complete the Fall Risk Assessment on admission.

Based on record review, policy review, and staff interview, the Critical Access Hospital (CAH) failed to develop, revise as necessary, and implement the plan of care for 3 of 3 discharged patients (Patients #16, #19, and #23) placed in restraints and experiencing falls, anxiety, and incontinence, and 1 of 5 current patient (Patient #3) requiring infection control interventions.

Findings include:

Review of the policy titled "Usage of the Patient Care Plan" occurred on 06/03/10. This policy, dated April 2008, stated, "Procedure: Within eight hours of admission, all patients shall have a plan of care started . . . The Plan of Care shall be individualized based on the diagnosis and patient assessment. The Plan of Care shall address the learning needs of the patient and family. After initiation of the Plan of Care by nursing those disciplines consulting in the care shall contribute to the plan as appropriate to the patient's assessed needs. The transfer of patients between levels of nursing care shall require a revision in the Plan of Care as appropriate to that level of care. The Plan of Care shall be updated daily, with revisions reflecting the assessment of the needs of the patient. All staff using the Plan of Care are responsible for interdisciplinary collaboration to establish goals and appropriate interventions as well as ongoing evaluations and revisions."

- Reviewed on 06/02/10, Patient #16's medical record showed the facility admitted the resident 10/28/09 with a diagnosis of pneumonia. Nurses' notes included the following:
* 10/29/09 - 9 a.m., "Restless - Noisy- Hollering 'Get me out of here' (geri-chair); . . . 11 a.m. Restless and noisy increased; brought out to nurses station hall and given snack and juice . . . but no relief or calming affect. . . . 11:30 a.m. Ativan [an anti-anxiety medication] PRN [as needed] given. Pt [patient] continues to sit in geri-chair . . . "

Resident #16's nurses' notes showed the facility continued to place Patient #16 in a geri-chair until discharge on 11/01/09. Patient #16's plan of care lacked an identified need for the use of the geri-chair, including approaches and interventions for monitoring the need and continued use and the patient's response to the restraint. Patient #16's plan of care lacked identification of the patient's anxiety and planned interventions to minimize the anxiety other than the use of an anti-anxiety medication.

- Reviewed on 06/02/10, Patient #19's medical record showed the facility admitted the patient on 03/19/09 for severe neck pain. Nurses' notes stated,
* 03/20/09 - 3 p.m., ". . . Is arousing more, dozes off and on. Bed check is on. Side-rails up x4. . . . 4:30 p.m. Pt restless. Assisted CNA [certified nurse assistant] to transfer pt to geri-chair. . . . 6:30 p.m. Pt out to nurses desk after found 1/2 way out of geri-chair. . . . "
* 03/21/09 - 10:45 a.m., "Patient attempts to climb out of geri-chair. Has legs over the side with the table top in place. He is assisted to straighten out and stand. He is given assistance to void per urinal before but did not void. Was incontinent . . . 11:00 a.m. Patient rests comfortably in chair with tabletop in place. . . . 11:30 a.m. Pt sitting in geri-chair, irritable at times."
* 03/22/09 - 3 a.m., "Pt attempting to get out of chair . . . 9:35 a.m. Patient found on floor beside geri-chair with tray table attached. Staff were alerted by his calling out. . . . small scratch to left back and quarter size abrasion to left hip . . . Chair placed at nurses station with staff member staying present at station at all times."

Patient #19's plan of care lacked any reference to the need for use of the geri-chair and the side rails, the use of less restrictive interventions or approaches, and interventions to address the safety risks associated with the use of the restraints.

Review of the "General Event Report" regarding Patient #19's fall from the geri-chair lacked assessment or investigation of the factors contributing to the fall and revisions to the patient's plan of care to prevent further falls and/or injury. The "General Event Report" stated, "Causes - unsure." Patient #19's plan of care showed no revision to prevent further falls and/or injury.

Patient #19's admission nursing assessment on 03/19/09 identified the patient as "continent" prior to admission. The nurses' notes following admission showed the patient experienced urinary incontinence. Patient #19's plan of care did not address the patient's incontinence and included no planned interventions to assist the patient in maintaining prior levels of bowel and bladder continence.

- Reviewed on 06/03/10, Patient #23's medical record showed the facility admitted the patient to a swing-bed on 04/10/09, with diagnosis of "aftercare for healing traumatic fracture of hip." Nurses' notes stated,
* 04/10/09 - 8:30 p.m., "PT attempting to crawl out of bed. . . . 1:30 a.m. Pt at end of bed. Incontinent at this time.." Nurses' shift assessment showed raised side-rails at the top half of the bed during this time.
* 04/10/09 - 12 noon, ". . . In geri-chair. . . . 2 p.m. - In geri-chair. 2:45 p.m. -Incontinent of stool. Pt cleaned up. Back in geri-chair. 4 p.m. - In geri-chair - restless."
* 04/10/09 - 8 p.m., "Pt sitting in geri-chair at this time. 8:45 p.m. - Pt changed from incontinent pad. . . ."
* 04/11/09 - 2 a.m., "Pt incontinent. . . . 12 noon - In geri-chair. 2 p.m. - Remains in geri-chair. 6 p.m. - In geri-chair . . . 8:10 p.m. - Pt in geriatric chair at this time. . . . 9:35 p.m. - Pt removed pullup [disposable brief] and urinated on bed and floor."
*04/12/09 - 4 p.m. "Pt voided in bed, bed changed. . . . 12 noon . . . In geri-chair. 2 p.m. . . . Pt was in geri-chair. . . .4 p.m. - In geri-chair . . . 6 p.m. . . . In geri-chair. 8:20 p.m. - In geri-chair. . . . 9:30 p.m. - Pt in geriatric chair."

Patient #23's nurses' notes showed the staff continued to place the patient in a geri-chair from 04/12/09 to 04/15/09. Nurses' notes on 04/15/09 stated, "1800 [6 p.m.] . . . States he does not like the tray on geri-chair - will remove when finished eating." The medical record did not show evidence staff removed the tray from Patient #23's geri-chair. A "General Event Report," dated 04/15/09 at 7 p.m. (one hour later), stated, "Heard call and loud noise from pt room - found pt on floor in front of geri-chair. . . . Causes: Unsure."

Patient #23's plan of care failed to address the use of the geri-chair and side rails, the risks associated with the use of the restraints, and provision for use of less restrictive approaches or interventions. The plan of care failed to address Patient #23's toileting and incontinence needs and failed to include planned approaches or interventions to assist the patient with maintaining his highest level of bowel and bladder continence/control.

The General Event Report referenced above lacked evidence of assessment/investigation of the causative factors contributing to Patient #23's fall from the geri-chair, and changes to the plan of care occurred to prevent further falls and/or injury.

During an interview on the afternoon of 06/03/10, an administrative nursing staff member (#2), the staff member indicated the facility had not implemented a process for assessment and care planning for the use of restraints and did not have a policy for the assessment and care planning of bowel and bladder incontinence.


19410

Reviewed on June 1-3, 2010, Patient #3's medical record identified an admission date of 05/30/10 with diagnoses of hematochezia (passage of stool containing blood) and diarrhea. A stool culture result received on 06/01/10 reported Clostridium difficile (a bacterium that causes diarrhea).

Reviewed the afternoon of 06/02/10, Patient #3's care plan did not identify the patient's infection and isolation status nor evidence of patient education regarding hand washing and isolation precautions.

Based on observation, record review, review of medical staff bylaws and rules and regulations, and staff interview, the Critical Access Hospital (CAH) failed to ensure timely completion of history and physical examinations for admitted and surgical patients (Refer to C302); failed to obtain consent for treatment for patients admitted or treated in the ER (Refer to C304); failed to ensure the timely documentation of patient daily progress notes (Refer to C306); failed to ensure timing, dating, and authentication of medical record entries (Refer to C307); and failed to safeguard medical records (Refer to C308). The cumulative effect of these systemic problems resulted in the CAH's inability to ensure medical records provided continuance of quality health care to the CAH's patients.

Based on record review and review of medical staff bylaws and rules and regulations, the Critical Access Hospital (CAH) failed to ensure admitted patients received a complete history and physical examination within 24 hours of admission for 3 of 8 patients (Patients #6, #7, and #19) reviewed and failed to ensure the completion of a current history and physical prior to surgery for 4 of 6 surgical patients (Patients #24, #25, #28, and #29) reviewed. Failure to complete the admission H&P in a timely manner does not provide opportunity for identification of all health related risk factors and implementation of appropriate care. Failure to complete a current H&P or update the previous H&P with a current physical examination placed the patients at risk for avoidable complications or poor surgery outcomes.

Findings include:

Review of medical staff bylaws and rules and regulations occurred on June 01-03, 2010. The rules and regulations, approved 08/25/08, stated, "C. Medical Records. . . . 2. A complete admission history and physical (H&P) examination shall be recorded within 24 hours of admission. . . ." The bylaws, approved 10/27/03, and rules and regulations did not address the acceptable time-frame for history and physical examinations completed prior to admission or surgery, the need for an interval note, the degree of patient examination to constitute an update of a previously completed history and physical, and the consequences of not having completed an H&P prior to scheduled surgery.

Reviewed on June 01-03, 2010, the records of patients admitted to the CAH showed the following:
- The CAH admitted Patient #6 on 04/04/09. The practitioner did not complete the admission H&P until 04/10/09.
- The CAH admitted Patient #7 on 06/22/09. The practitioner did not complete the admission H&P until 11/16/09.
- The CAH admitted Patient #19 on 03/19/09. The practitioner did not complete the admission H&P until 04/15/09.

Reviewed on June 01-03, 2010, the records of patients admitted for surgical procedures showed the following:
- The CAH admitted Patient #24 for a surgical procedure under general anesthesia on 03/31/10. The record included an H&P completed 03/18/10, with no evidence of an interval exam to ensure the H&P remained current or documentation of the patient's status prior to surgery.
- The CAH admitted Patient #25 for a surgical procedure under general anesthesia on 05/05/10. The record included an H&P completed 04/19/10, with no evidence of an interval exam to ensure the H&P remained current or documentation of the patient's status prior to surgery.
- The CAH admitted Patient #28 for a surgical procedure under conscious sedation on 05/21/10. The record included an H&P completed 05/12/10, with no evidence of an interval exam to ensure the H&P remained current or documentation of the patient's status prior to surgery.
- The CAH admitted Patient #29 for a surgical procedure under general anesthesia on 09/24/09. The record included an H&P completed 09/01/09, with no evidence of an interval exam to ensure the H&P remained current or documentation of the patient's status prior to surgery.

Based on record review and review of medical staff rules and regulations, the Critical Access Hospital (CAH) failed to obtain a general consent for treatment at the time of admission for 3 of 8 admitted patients (Patients #7, #16, and #22) reviewed and 4 of 14 emergency room patients (Patients #10, #13, #16 and #22) reviewed.

Findings include:

Review of medical staff rules and regulations occurred on June 01-03, 2010. The rules and regulations, approved 08/25/08, stated, "D. General Conduct of Care. 1. A general consent form, signed by or on behalf of every patient admitted to hospital, must be obtained at the time of admission."

Reviewed June 1-3, 2010, the medical records for Patients #7, #10, #13, #16,and #22 showed the following:
* The CAH admitted Patient #7 on 06/22/09. The record lacked a signed consent for treatment by or on behalf of the patient.
* Patient #10 presented to the emergency room on 01/16/10. The record showed Patient #10 as unable to sign the consent for treatment. The CAH did not obtain or attempt to obtain consent from the patient's spouse.
* Patient #13 presented to the emergency room on 11/30/09 accompanied by his parents. The record lacked consent for treatment by or on behalf of the patient.
* Patient #16 presented to the emergency room on 10/28/09, and the CAH admitted the patient. The record lacked consent for treatment by the patient. The record identified the patient had a designated responsible person for decision making. The record lacked evidence the CAH obtained consent for treatment on behalf of Patient #16.
* Patient #22 presented to the emergency room on 09/18/09, and the CAH admitted the patient. The record lacked a consent for treatment by or on behalf of the patient.

Based on record review, and review of medical staff rules and regulations, the Critical Access Hospital (CAH) failed to ensure practitioners entered and/or dictated patient progress notes consistent with established facility policy for 3 of 8 discharged patients (Patients #20, #21, and #22) reviewed. Failure to enter timely progress notes into the medical record prevents access to pertinent information regarding the patient's current status and/or progress towards improvement to staff involved in the patient's care.

Findings include:

Review of medical staff rules and regulations occurred June 01-03, 2010. The rules and regulations, approved 08/25/08, stated, "C. Medical Records. . . . 3. Progress notes shall be written at least daily on acutely ill patients and those where there is difficulty in diagnosis or management of clinical problems."

Reviewed on 06/03/10, the records for Patient #20, #21, and #22 showed the following:
* The CAH admitted Patient #20 to acute care on 06/04/09. The physician did not dictate progress notes for 06/05/09 and 06/06/09 until 06/14/09.
* The CAH admitted Patient #21 to acute care on 05/27/09. The physician dictated a progress note for 05/29/09 on 07/11/09 and a progress note for 05/30/09 on 06/14/09.
* The CAH admitted Patient #22 to acute care on 09/18/09. The physician dictated progress notes for 09/21/09 and 09/22/09 on 11/12/09.

Based on record review, review of medical staff rules and regulations, and staff interview, the Critical Access Hospital (CAH) failed to ensure accurate dating, timing, and authentication of entries into the medical record for 5 of 5 current records (Patient #1, #2, #3, #4, and #5) reviewed and 24 of 24 closed records (Patients #6 through #29) reviewed.

Findings include:

Review of the medical staff rules and regulations occurred on June 01-03, 2010. The rules and regulations, approved 08/25/08, stated: "C. Medical Records. . . . 5. All clinical entries in the patient's medical record shall be accurately dated, time indicated and authenticated."

A review of the medical records for Patients #1 through #29 occurred June 1-3, 2010. The majority of entries by practitioners into the records of these patients lacked date and time of the entry.

During an interview on the afternoon of 06/02/10, an administrative staff member (#1) stated, "I know they are not dating and timing their entries."

Based on observation and staff interview, the Critical Access Hospital (CAH) failed to develop and implement an effective system to safeguard medical records against loss, destruction, or unauthorized use for 2 of 24 randomly requested records for review (Patient #13 and #14) and 3 of 3 medical record storage areas (off-site clinic, medical records department, and basement of the attached clinic).

Findings include:

Following submission of a list of records for review to the medical record department on the afternoon of 06/01/10, an administrative medical record staff member (#8) and a nursing administrative staff member (#2) stated, "The records for Patient #13 and #14 are missing from the facility. They have been missing for several months."

Review of the emergency room log showed Patient #13 presented to the emergency room on 11/30/09 with suicidal ideation. The practitioner admitted Patient #13 to the critical access hospital (CAH). According to the medical record staff member (#8) the facility no longer had the medical record for Patient #13's inpatient stay.

The emergency room log showed Patient #14 presented to the emergency room on 12/05/09 with a diagnosis of "spontaneous abortion." The log showed Patient #14 received treatment in the emergency room prior to transfer to another hospital. The medical record staff member (#8) indicated the facility no longer had Patient #14's emergency room record for 12/05/09.

During a tour of medical record storage areas on the morning of 06/03/10 at the off-site clinic and two areas for the CAH on the afternoon of 06/03/10, observation showed the following:
- At the off-site clinic location, the clinic stored records of expired patients in a cardboard box in an unlocked general storage room off the patient waiting area. The clinic stored records requiring completion by the practitioner in a basket on the counter at the front desk reception area.
- The CAH kept the key for the medical record department and active medical record storage area under a table next to the locked door. A medical record management staff member indicated "pretty much everyone knows where the key is."
- Observation showed in excess of fifty boxes and 10-12 four drawer files of inactive CAH medical records stored in a locked room in the basement of the attached clinic. Observation found the key hanging on the wall next to the door.

Based on record review, policy review, and staff interview, the Critical Access Hospital (CAH) failed to perform a review of a representative sample of both active and closed clinical records as part of the annual program evaluation for 1 of 1 year reviewed (2009). Failure to review clinical records as part of the annual program evaluation limits the CAH's ability to assess the need for change.

Findings include:

Reviewed on June 1-3, 2010, the 2009 program evaluation, included in the 2009 governing board and medical staff minutes, lacked evidence the CAH reviewed a representative sample of both active and closed clinical records as part of the annual program evaluation.

Review of the policy titled "Linton Hospital Annual Program Evaluation" occurred on 06/03/10. This policy, undated, stated, "The Administrator will coordinate the annual program evaluation of the overall quality assurance and policy development. The annual evaluation at a minimum will include: . . . 4. An audit of a representative sample of both active and closed clinical records . . ."

During an interview on 06/03/10 at 3:20 p.m., an administrative staff member (#1) confirmed the CAH did not review a representative sample of both active and closed clinical records as part of the annual program evaluation in 2009.

Based on review of medical staff bylaws, quality assurance (QA) plan, facility policy, QA reports, risk management/safety reports, meeting minutes, and staff interview, the Critical Access Hospital (CAH) failed to ensure the QA program evaluated all patient care services and other services affecting CAH patient health and safety for 16 of 16 months reviewed (January 2009 - April 2010). The CAH has the potential of failing to identify risk factors affecting patient care and failing to implement corrective action if necessary by not ensuring all departments providing patient care participate in QA monitoring, report to the QA Committee, perform quality of care monitoring, and initiate corrective action.

Findings include:

Review of the "Medical Staff By-Laws Linton Hospital" occurred the afternoon of 06/01/10. These bylaws, dated 10/27/03, stated,
". . . Article VII Officers and Committees . . .
Section 2. Committees and Responsibilities . . .
6. Quality Assurance Committee: The Linton Hospital quality improvement plan shall be facility wide; to include all departments whose activities directly influence patient care. . . . Minutes will be recorded and attached to the QA report summary . . ."

Review of the policy titled "Linton Hospital Quality Assurance Plan" occurred on 06/03/10. This policy, dated 02/15/05, stated,
". . . III. Objectives: 1. To provide an ongoing system of monitoring and evaluation of the effectiveness and safety of patient care provided at Linton Hospital, including but not limited to measurable improvement in indicators that will identify and reduce medical errors and improve health outcomes. 2. To identify problems or important concerns regarding the quality of care provided to patients. 3. To provide for a system of follow-up and implementation of actions designed to measure, analyze, and track quality indicators, including adverse patient events, and other aspects performance that assess processes of care, hospital services, and operations. 4. To provide documentation that will substantiate action taken on problems and resolution of results incurred from those actions, using data from quality indicator projects, patient care, and other relevant sources. . . .
IV. Scope: The Linton Hospital Quality Assurance Plan shall be facility wide, to include all departments whose activities directly influence patient care. . . .
V. . . . Documentation: 1. The findings and analysis of monitoring activities and the action taken to correct problems and improve patient care are documented, reported as appropriate, and integrated with the overall hospital's quality assurance program. . . .
VIII. Departments: The following departments will perform Quality Assurance activities: . . . Maintenance, Medical Records, . . . Physical Therapy . . ."

Review of the policy titled "Professional & General Liability Occurrence Report Policy" occurred on 06/03/10. This policy, dated February 2004, stated, ". . . Occurrence Report Review: . . . The Risk Manager will review incident reports (by occurrence category) at Risk Management meetings to determine whether there are any trends that represent potential problems and then positively addressing those problems. . . ."

- Upon request on 06/02/10, CAH staff members did not provide evidence the QA Committee reviewed the quarterly department reports or discussed the results.

- Reviewed on 06/03/10, the 2009 Quality Assurance Quarterly Reports lacked evidence the maintenance department reported to the QA Committee.

- Reviewed on 06/03/10, the 2009 Quality Assurance Quarterly Reports lacked evidence the medical records and physical therapy departments evaluated the quality of patient care as part of the monitoring activities reported to the QA Committee.

- Review of Medical Staff Meeting Minutes occurred on 06/02/10. The CAH staff submitted 2009 monthly monitoring reports at Medical Staff Meetings from May 2009 through January 2010. During an interview at 3:30 p.m. on 06/02/2010, an administrative nursing staff member (#2) stated the expected threshold of acceptability for QA monitors is 90% compliance. The reports included the following:
"Medical Records Compliance 2009" monthly monitoring -
*H&P (History and Physical) dictated:
10 of 12 months had 25%-82% compliance
*Discharge summary dictated w/in (within) 30 days of discharge:
6 of 12 months had 20%-88% compliance
*Daily progress notes present:
3 of 12 months had 80%-89% compliance
*Blank spaces (in dictation) accounted for:
11 of 12 months had 0%-89% compliance
*Doctor orders timed:
9 of 12 months had 60%-86% compliance
"Code Level Audit Compliance By Physician 2009" monthly monitoring for Providers #2, #3, #4, #5, and #6 -
*Pre-printed form used:
11 of 12 months had 0%-83% compliance
*Code Level documented:
12 of 12 months had 0%-88% compliance
*Physician signature:
12 of 12 months had 0%-88% compliance
*Date of discussion (with patient or family):
12 of 12 months had 0%-89% compliance
The Medical Staff Meeting minutes and QA Committee Quarterly Reports lacked evidence the medical staff or QA Committee discussed the monitoring reports or recommended corrective action.

- Reviewed on June 2-3, 2010, the Risk Management/Safety reports lacked evidence the CAH staff analyzed or performed corrective action for the following: eight falls reported in April 2010, one fall reported in November 2009, one fall reported in July 2009, and two falls reported in June 2009.

- Reviewed on June 2-3, 2010, the Risk Management/Safety reports from August and September 2009 included discussion of failure of an emergency generator during a power outage in July 2009. The committee initiated corrective action to perform weekly generator checks to ensure proper functioning of the generator. Review of the 2010 weekly generator checklist indicated staff performed the checks on 01/03/10, 02/07/10, 02/14/10, 03/07/10, 03/28/10, 05/23/10, and 05/30/10. The Risk Management/Safety Committee and the QA Committee reports lacked evidence of monitoring to ensure staff performed the weekly generator checks. During an interview at 2:30 p.m. on 06/03/10, an administrative nursing staff member (#2) stated the emergency generator failed again on 05/21/10.

During an interview at 3:30 p.m. on 06/02/2010, an administrative nursing staff member (#2) confirmed the following: the QA Committee did not record minutes or attendance from the quarterly meetings; the QA Committee did not review or recommend corrective action regarding the monthly Medical Records Compliance and Code Level Audit Compliance By Physician reports submitted to the Medical Staff; and confirmed the Risk Management/Safety Committee did not always analyze reported occurrences to determine root causes and whether trends occurred.

During an interview at 11:10 a.m. on 06/03/2010, an administrative staff member (#1) confirmed the Medical Staff Meeting meetings lacked documentation of discussion or corrective action regarding the monthly Medical Records Compliance and Code Level Audit Compliance By Physician reports submitted to the Medical Staff.

During an interview at 2:05 p.m. on 06/03/2010, an administrative nursing staff member (#2) confirmed the maintenance department had not submitted reports to the QA Committee and medical records and physical therapy did not report quality of care monitoring in 2009.

During an interview at 2:30 p.m. on 06/03/10, an administrative nursing staff member (#2) confirmed neither the QA Committee or Risk Management/Safety Committee had monitored the performance of the weekly generator checks.

Based on review of Pharmacy and Therapeutics Committee meeting minutes, review of Risk Management/Safety reports, and staff interview, the Critical Access Hospital (CAH) failed to ensure analysis of medication errors for the existence of patterns and trends causative factors/reasons and corrective action plans during 12 of 12 months (March 2009 - March 2010) reviewed.

Findings include:

- Review of the Risk Management/Safety reports occurred on June 2-3, 2010. These reports lacked evidence the CAH staff analyzed or performed corrective action for one medication error (transcription) reported in January 2010, one medication error (wrong dose given) reported in October 2009, two medication errors (heparin not adjusted and transcription) reported in July 2009, and two medication errors (transcription) reported in June 2009.

Review of the quarterly Pharmacy and Therapeutics Committee Meeting minutes from March 2009 to March 2010 occurred on 06/02/10. (The December 2009 quarterly meeting was not held due to the pharmacist not being available to attend). The meeting minutes dated March 2009, June 2009, September 2009, and March 2010 lacked evidence of investigative actions to determine causative factors of the medication errors, analysis of patterns/trends, and corrective actions taken.

During interview on the afternoon of 06/02/10, an administrative pharmacy staff member (#12) confirmed the committee does not analyze medication errors for patterns/trends.

Based on review of bylaws, policy, peer review records, and staff interview, the Critical Access Hospital (CAH) failed to have a provider with the same qualifications/privileges review the quality and appropriateness of the diagnosis and treatment furnished by 1 of 1 physician who performed surgical procedures at the CAH in 2009 (Physician #1). By failing to perform peer review, the CAH cannot ensure the physician performing surgical procedures provided quality and appropriate care to the CAH's patients.

Findings include:

Review of the "Medical Staff By-Laws Linton Hospital" occurred June 1-3, 2010. These bylaws, dated 10/27/03, stated,
". . . Article VII Officers and Committees . . .
Section 2. Committees and Responsibilities . . .
8. Peer Review Committee
The Peer Review Committee will be multidisciplinary and will include representation from the Medical Staff. The role of the Peer Review Committee will be to determine the nature of the issue and develop a plan for improvement which focuses on education and process development. . . . Peer review findings will be reported quarterly to the QA [Quality Assurance] Coordinator who will summarize findings to the Medical Staff. . . ."

Review of the policy titled "Linton Hospital Peer Review" occurred the afternoon of 06/02/10. This policy, revised August 2009, stated, ". . . 3. Peer Review is a part of the overall quality and utilization review process and enhances all other policies, procedures, and bylaws which address quality of care concerns. . . . 4. . . . Peer Review should: a. Be performed by a provider from the same discipline with the same type of practice. . . . b. This process should assess the quality of care rendered, guided by provider established/approved guidelines . . . 5. The Peer Review Committee will be multidisciplinary . . ."
This policy did not require the performance of peer review for each member of the medical staff providing care to the CAH's patients.

Reviewed at 5:00 p.m. on 06/02/10, the 2009 peer review records lacked evidence a provider with the same qualifications/privileges reviewed the quality and appropriateness of the diagnosis and treatment furnished by one physician (#1) who performed surgical procedures at the CAH in 2009.

During interview at 10:25 a.m. on 06/03/10, a staff member (#3) confirmed a provider with the same qualifications/privileges did not review the quality and appropriateness of the diagnosis and treatment furnished by one physician who performed surgical procedures at the CAH in 2009.

Based on record review, policy review, and staff interview, the Critical Access Hospital (CAH) failed to ensure swing-bed patients remained free of restraints for 1 of 1 discharged swing-bed patient (Patient #23) reviewed. Placement of Patient #23 in a geri-chair with a tray table attached compromised the patient's safety, placed the patient at risk for functional decline, and resulted in the patient experiencing an avoidable fall.

Findings include:

Review of the policy titled "Restraint/Seclusion" occurred 06/03/10. The undated policy stated, "Policy: . . . Restraints shall be used only where alternative methods are not sufficient to protect patients or others from injury and are not a substitute for less restrictive forms of protective restraint. All patients will have an assessment performed to determine the safety and protective needs of the patient prior to the application of restraints or medical protective device. . . . Physical Restraint is defined: Any manual method or physical or mechanical device, material or equipment attached or adjacent to the patient's body that he or she cannot easily remove, that restricts freedom of movement or normal access to one's body. A Drug Used as a Restraint is defined: a medication used to control behavior or to restrict the patient's freedom of movement and is not a standard treatment for the patient's medical or psychiatric condition.
The use of restraint must be: Selected only when other less restrictive measures have been found to be ineffective to protect the patient or other from harm. In accordance with the order of a physician or other licensed independent practitioner . . . The order must: . . . In accordance with a written modification to the patient's plan of care. . . . The condition of the restrained patient must be continually assessed, monitored, and reevaluated. . . ."

- Reviewed on 06/03/10, Patient #23's medical record showed the CAH admitted the patient to a swing-bed on 04/10/09 with diagnosis of "aftercare for healing traumatic fracture of hip." Nurses' notes stated the following:
* 04/10/09 - 8:30 p.m., "PT attempting to crawl out of bed. . . . 1:30 a.m. Pt at end of bed. Incontinent at this time . . ." Nurses' shift assessment showed side-rails raised at the top half of the bed during this time.
* 04/10/09 - 12 noon, ". . . In geri-chair. . . . 2 p.m. - In geri-chair. 2:45 p.m. -Incontinent of stool. Pt cleaned up. Back in geri-chair. 4 p.m. - In geri-chair - restless."
* 04/10/09 - 8 p.m., "Pt sitting in geri-chair at this time. 8:45 p.m. - Pt changed from incontinent pad. . . ."
* 04/11/09 - 2 a.m., "Pt incontinent. . . . 12 noon - In geri-chair. 2 p.m. - Remains in geri-chair. 6 p.m. - In geri-chair . . . 8:10 p.m. - Pt in geriatric chair at this time. . . . 9:35 p.m. - Pt removed pullup [disposable brief] and urinated on bed and floor."
*04/12/09 - 4 p.m. "Pt voided in bed, bed changed. . . . 12 noon . . . In geri-chair. 2 p.m. . . . Pt was in geri-chair. . . . 4 p.m. - In geri-chair . . . 6 p.m. . . . In geri-chair. 8:20 p.m. - In geri-chair. . . . 9:30 p.m. - Pt in geriatric chair."

Patient #23's nurses' notes showed continued placement of the patient in a geri-chair from 04/12/09 to 04/15/09. Nurses' notes on 04/15/09 stated, "1800 [6 p.m.] . . . States he does not like the tray on geri-chair - will remove when finished eating." The medical record did not show evidence the staff removed the tray from Patient #23's geri-chair. A "General Event Report," dated 04/15/09 at 7 p.m. (one hour later), stated, "Heard call and loud noise from pt room - found pt on floor in front of geri-chair. . . . Causes: Unsure."

Patient #23's record lacked assessment of the safety risks associated with use of the geri-chair and the use of side-rails. The General Event Report referenced above lacked evidence of investigation of the causative factors contributing to Patient #23's fall from the geri-chair and that staff revised the plan of care to prevent further falls or injury.

During an interview on the afternoon of 06/03/10, an administrative nursing staff member (#2) indicated the facility had not implemented a process for assessment and care planning for the use of restraints.

Based on review of personnel files and staff interview, the Critical Access Hospital (CAH) failed to determine prior to employment, certified nurses aides did not have a finding entered into the State nurse aide registry concerning abuse, neglect, mistreatment of residents or misappropriation of their property for 1 of 1 certified nurse aide (#11) personnel file reviewed.

Findings include:

Review of the personnel file of a certified nurse aide (#11) hired by the facility on 03/29/10 occurred on the afternoon of 06/03/10. The file lacked evidence the facility contacted the State nurse aide registry and determined the individual did not have a finding of prior resident abuse.

During an interview on the afternoon of 06/03/10, an administrative nursing staff member (#2) stated, "We did not check the registry. We have not been doing that."