HospitalInspections.org

1. Based on observation and staff interview, the Critical Access Hospital (CAH) failed to ensure a safe and sanitary environment for patients, staff, and the public regarding the lack of an anti-siphon backflow valve on the water access for the x-ray film processor and the lack of hot water at the designated patient rest room hand sink in 1 of 2 sampled off-site locations (Maddock Clinic). Failure to ensure the installation of anti-siphon backflow valves created the potential for siphoning contaminated water into the potable (drinking) water system in the event of loss of water pressure causing widespread contamination of the facility and community water system. Failure to provide hot water at the hand sink limited the ability of patients, and staff using this rest room to ensure proper hand hygiene.

Findings include:

Observation on 02/02/11 at 9:50 a.m. of the CAH's off-site location at the Maddock Clinic identified the following:
*Radiology Room - an x-ray film processor connected by a hose to a water faucet lacked an anti-siphon backflow valve.
*Patient Rest Room - rest room designated for patient use lacked hot or warm running water.

During interview at approximately 9:50 a.m. on 02/02/11, a nursing management staff member (#1) reported the CAH merged with the clinic operations in August 2010, approximately five months before the survey. This staff member reported the building owner had installed "boosters" in two examination rooms and the staff rest room to increase the availability of hot water to these rooms some time before the merger. The owner did not install a "booster" in the patient rest room. This staff member (#1) and a management staff member (#2) present during the tour confirmed the x-ray film processor lacked an anti-siphon backflow valve and agreed the patient rest room should have hot running water at the sink.



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2. Based on observation, staff interview, and review of hospital construction standards, the Critical Access Hospital (CAH) failed to ensure functioning call lights in 2 of 3 emergency/treatment rooms (Room 1 and 2). Non-functioning and inaccessible call lights posed a safety hazard to patients and staff, if during the course of care/treatment, patients or staff were unable to summon assistance.

Findings include:

The 1992-93 Guidelines for Construction and Equipment of Hospital and Medical Facilities has outlined the standards regarding a nurses calling system. ". . . In patient areas, each patient room shall be served by at least one calling station for two-way voice communication. Each bed shall be provided with a call device. Calls shall activate a visible signal in the corridor at the patient's door, in the clean workroom, in the soiled workroom, and at the nursing station of the nursing unit . . . The emergency call system shall be designed so that a signal activated at a patient's calling station will initiate a visible and audible signal distinct from the regular nurse calling system. The signal shall activate an enumerator panel at the nurses station, a visible signal in the corridor at the patient's door and at other areas defined by the functional program. Provisions for emergency calls will also be needed in outpatient and treatment areas where patients may be subject to incapacitation."

- Observation of the emergency room (ER) on 02/01/11 at 9:45 a.m. showed the availability of three rooms to treat patients (one large room designated as the "main" ER room and 2 smaller side rooms designated as exam rooms 1 and 2). Observation of exam rooms 1 and 2 showed a call light panel present on the wall. Upon activation of the call button on the panel, no audible sound emitted or visible signal illuminated from the panel.

During interview on 02/01/11 at approximately 9:45 a.m., an ER nurse manager (#10) stated the facility used exam rooms 1 and 2 to treat patients who present to the ER with minor injuries/illnesses (sore throats, sprains, broken bones, etc.), keeping the main ER available for major or more serious injuries/trauma.

During interview on 02/02/11 at 11:20 a.m., an administrative nurse (#9) stated exam rooms 1 and 2 contained a "bell" patients "ring" to summon staff assistance. This staff member confirmed staff could not hear the "bell" at the nurses station.

Based on observation, policy and procedure review, professional reference review, and staff interview, the Critical Access Hospital (CAH) failed to ensure proper labeling of drugs and biologicals available for patient use in 2 of 2 anesthesia carts (located in the main and minor operating rooms) in the Surgery Department and failed to remove outdated drugs and biologicals in 1 of 1 medication refrigerator in the Emergency Department. Failure to ensure proper labeling of drugs and biologicals and removal of outdated drugs and biologicals had potential for the availability of outdated, mislabeled, or unusable medications for patient use.

Findings include:

"APIC [Association for Professionals in Infection Control and Epidemiology] Position Paper: Safe Injection, Infusion and Medical Vial Practices in Healthcare," APIC online article, dated July 30, 2009, stated, ". . . Vials . . . Dispose of opened multi-dose medication vials 28 days after opening, unless specified otherwise by the manufacturer, or sooner if sterility is questioned or compromised. . . . Date opened multidose vials to reflect date opened and/or date of expiration. . . ."

Review of the CAH's policy and procedure "Parenteral Drugs" occurred on 02/01/11. This policy dated 04/09, stated, ". . . PROCEDURE: GENERAL GUIDELINES FOR PARENTERALS:
. . . All multi-dose vials are considered suitable for use up to 28 days after initial entry into the vial, unless otherwise noted in manufacturer's package insert. This assumes that good aseptic technique is used and that the rubber stoppers are not excessively punctured. All multi-dose vials must be dated at the point of initial entry and discarded after 28 days past the initial entry. This procedure is in accordance with updated USP [United States Pharmacopeia] 797 [General Chapter 797] Guidelines . . . Insulin vials are usable for 28 days after initial entry. This assumes that good aseptic technique is used and that the rubber stoppers are not excessively punctured. Upon initial entry all insulin vials must be dated with either the anticipated expiration date of one month or the date of initial entry. This must be clearly delineated . . . If dating is required on a vial, the date of initial entry will be noted, as well as the initials of the person who first used the vial. Alternatively, a 'DISCARD AFTER' label may be affixed to the vial with the appropriate expiration date and initials of the person preparing the label. Clear labeling of vials with an expiration date is vital. Date of initial entry and/or expiration dating must be clearly labeled. . . ."

- Observation of the Emergency Department on 02/01/11 at 9:45 a.m., with an emergency room (ER) nurse manager (#10), showed one opened multi-dose vial of Regular insulin in the ER medication refrigerator dated 12/17/10 (46 days after initial entry) available for patient use.

- Observation of the Surgical Department on 02/01/11 at 2:30 p.m., with an operating room (OR) nurse (#8), showed two operating rooms each containing a locked anesthesia cart with medications. Observation of the anesthesia cart located in the "main" OR suite showed the following opened, punctured, and undated vials of medication available for patient use: Robinul (used before surgery to decrease stomach acid production), Neostigmine (used to reverse the effects of certain muscle relaxants), and Ketorolac (used to relieve moderately severe pain). Observation of the anesthesia cart located in the "minor" OR suite showed two opened, punctured, and undated vials of Flumazenil (used to reverse the effects of certain sedatives) available for patient use.

During interview on 02/01/11 at approximately 2:30 p.m., an OR nurse (#8) stated she could not confirm when staff opened the above vials of medication for patient use.

During interview on 02/02/11 at 10:00 a.m., a pharmacy staff member (#11) stated he revised the CAH's policy pertaining to labeling of multi-dose vials eight months prior (in June 2010) to be consistent with USP 797 Guidelines. This pharmacy staff member confirmed he expected staff to label all multi-dose vials upon opening or to affix a label to the vial identifying the expiration date.

Based on observation, record review, policy and procedure review, review of a professional reference, and staff interview, the Critical Access Hospital (CAH) failed to assess each patient individually prior to utilizing side rails and failed to evaluate the safe use of side rails for 2 of 4 records (Patient #4 and #6) of active patients reviewed. Failure to assess and evaluate the use of side rails has the potential to restrict a patient's movement and place patients at risk for injury.

Findings include:

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, have 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. 1. The bars with the bed rails should be closely spaced to prevent a patient's head from passing through the openings and becoming entrapped. 2. The mattress to bed rail interface should prevent an individual from falling between the mattress and bed rails and possibly smothering. . . ."

Review of the policy "Protective Device" occurred on 02/03/11. This policy, revised in 2009, stated, ". . . POLICY: 1. Initial and ongoing assessment of patients' need for protective procedures is conducted by nursing staff. 2. Nursing staff will always implement least restrict [sic] measures . . . 6. The reason for the treatment must be clearly stated in the nurses notes and the patient care plan. . . ." Also included in this policy is a section pertaining to "Bedside Rails" which stated, ". . . 1. Inspect rails and secure properly. 2. Not considered a restraint if used to prevent falling out of bed . . . 4. Always raise rails when when leaving the patient. 5. Instruct the patient on how to lower the side rails or get out of bed between front and back rails if possibly [sic]. . . ."

Observation of the beds utilized on the nursing unit occurred on January 31-February 2, 2011. The hospital beds available for current patient use had four identical half rails, two on each side, attached to the beds. Measurement of a half side rail located in Room 102, identified a 5 to 7 inch open space within the side rails.

- Observation, on 01/31/11 at 1:50 p.m. and 02/01/11 at 7:58 a.m., identified two elevated upper half rails raised on Patient #4's bed. Review of Patient #4's active swing bed chart occurred on January 31-February 2, 2011 and identified the CAH admitted the patient on 01/30/11. Patient #4's "Kardex" identified the patient at risk for falls. A comprehensive care plan, dated 02/01/11, identified a problem of "Risk of Injury. At risk of injury as a result of environmental conditions interacting with the individual's adaptive and defensive resources" and approaches including "Side rails x[times] 2." A nursing progress notes, dated 01/30/11, identified the patient's speech as "garbled and difficult to understand," the patient exhibited visual hallucinations, and hospital staff unable to reorientate the patient. A nursing progress note, dated 01/31/11, identified Patient #4 as disoriented to person, place, and time, and displaying incomprehensible, garbled speech. Nursing progress notes, dated February 1-2, 2011, identified Patient #4 continued to be confused and disorientated. The record lacked an individualized assessment of risk and safety for the utilizations of side rails. The CAH staff failed to consider the side rails as a potential entrapment and safety hazard.

- A random observation, on 01/31/11 at 2:00 p.m., identified two elevated upper half rails raised on Patient #6's bed. Review of Patient #6's active swing bed chart occurred on February 1-2, 2011 and identified the CAH admitted the patient on 01/28/11. Patient #6's "Kardex" identified the patient at risk for falls. The record lacked an individualized assessment of risk and safety for the utilizations of side rails. The CAH staff failed to consider the side rails as a potential entrapment and safety hazard.

During interview on 02/02/11 at 11:00 a.m., two administrative nurse managers (#5 and #9) stated nursing staff elevate the two upper half side rails per patient/family request for positioning and access to bed controls/call lights and staff use the side rails to prevent patients from falling out of bed. These two nurse managers confirmed nursing staff does not perform or document an assessment for the utilization of side rails or document monitoring of side rail use. An administrative nurse (#9) stated the CAH failed to consider the side rails attached to the beds a safety risk and potential hazard for entrapment.

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1. Based on policy review, record review, and staff interview, the Critical Access Hospital (CAH) failed to ensure the evaluation of quality of care provided to the CAH's patients for 1 of 1 record (Patient #8) reviewed of a surgical case with complications in 2010 and 1 of 1 record (Patient #34) reviewed of a patient leaving against medical advice (AMA) in 2010. Failure to evaluate surgical cases with complications and patients leaving AMA places the CAH at risk of not identifying possible inappropriate care provided to the CAH's patients.

Findings include:

Review of the policy titled "2010 [name of facility] Continuous Quality Improvement Plan [CQI]" occurred February 1-2, 2011. This policy, approved 01/04/10, stated,
". . . II. Program Objectives . . .
A. To continuously improve the patient care at [name of facility] to provide optimal quality delivery in a cost-efficient and safe manner.
B. To assure that health care practices and professional performances are regularly, validly and reliably evaluated, on an ongoing basis. . . .
IV. Scope of the Program . . .
A. Activities reported to the CQI Committee: Medical Staff Functions
1. Quality and Appropriateness of patient care by Medical Staff
a. Surgical Case Review . . .
c. Critical Care Review - includes ICU and ER. . . ."

Review of the policy titled "Peer Review" occurred on February 1-2, 2011. This policy, revised 03/13/08, stated, "Purpose: To provide for mechanism for review of Medical Records to assure quality documentation and care. . . . Policy: Case/Records subject to Focused Peer Review will include: . . .
4. Medical instability of the patient at the time of discharge to home: . . . f. AMA discharge . . .
8. Trauma suffered in the hospital . . . c. Serious anesthesia complication . . ."

Review of the policy titled "Critical Care Committee" occurred the afternoon of 02/02/11. This policy, revised 2010, stated,
"Policy: The ICU and the ER has been incorporated into the Critical Care Committee. This committee reports to the CQI Committee.
. . .
Objectives of the Critical Care review: . . . . n. Review all AMA discharges from the ER or ICU.
. . ."

Review of the policy titled "Refusal or Request of Treatment/Admission" occurred the morning of 02/03/11. This policy, revised 2004, stated, "Policy: . . . 5. An Incident report should be completed on all patients/residents leaving against medical advice. . . ."

- Reviewed on January 31-February 1, 2011, the CAH's OR (Operating Room) logbook showed an entry on 04/23/10 for Patient #8 for a colonoscopy with complications listed as "PVC's" (premature ventricular contractions - extra, abnormal heartbeats). Review of Patient #8's medical record for a colonoscopy on 04/23/10 occurred on February 1-2, 2011. A history and physical, dated 04/13/10, stated, ". . . Physical Examination: . . . Cardiac: Regular rate and rhythm, no murmur or rub. . . ." An operative report, dated 04/23/10, stated, ". . . Indications: . . . After IV (intravenous) sedation was administered she developed an irregular heart rate. An EKG (electrocardiogram) was obtained . . . She was felt to have premature ventricular contractions. . . ."

Reviewed on February 2-3, 2011, the Surgical Committee Reports, CQI meeting minutes, anesthesia department's CQI report of anesthesia complications, and Peer Review records for 2010 lacked evidence the CAH evaluated this case for quality and appropriateness of treatment.

During interview on 02/02/11, an administrative health information staff member (#4) confirmed the CAH did not review Patient #8's medical record for a colonoscopy on 04/23/10 as part of the peer review process.

During interview on 02/02/11, a surgical nursing staff member (#8) confirmed surgical staff had listed a complication of PVC's in the OR logbook for Patient #8's colonoscopy on 04/23/10 and stated she was not aware of record review by the surgical staff for Patient #8's colonoscopy.

- Reviewed 01/31/11, the CAH's ER (Emergency Room) logbook showed an entry on 04/17/10 for Patient #34 listed as not seen, AMA. Review of Patient #8's ER medical record for 04/17/10 occurred on 02/02/11. A form titled "Release of Responsibility for Discharge," dated 04/17/10 and timed 11:45 (unspecified as a.m. or p.m.), stated, "This is to certify that I [signature of patient], a patient/resident in the facility of the [name of facility], am leaving the facility against the advice of the attending physician and of the facility administration. . . ."

Reviewed on February 1-2, 2011, the 2010 CQI meeting minutes lacked evidence the CAH evaluated this AMA case. Reviewed on February 2, 2011, the Critical Care Committee Meeting report for April, May, and June 2010 lacked evidence the CAH evaluated this AMA case. Reviewed on January 31-February 2, 2011, the 2010 incident reports did not include a report for this AMA case.

During interview on the afternoon of 02/02/11, a nursing staff member (#3) stated nursing staff failed to complete an incident report for Patient #34 who left the emergency room against medical advice, and therefore, the facility's CQI Committee did not review this record.


2. Based on policy review, record review, and staff interview, the Critical Access Hospital (CAH) failed to ensure the evaluation of quality of care provided by all patient care services affecting CAH patient health and safety for 12 of 12 months reviewed (January - December 2010). By not monitoring quality of care provided by all patient care services, the CAH has the potential of failing to identify risk factors affecting patient care and failing to implement corrective action if necessary.

Findings include:

Review of the policy titled "2010 [name of facility] Continuous Quality Improvement Plan" occurred February 1-2, 2011. This policy, approved 01/04/10, stated, ". . . M. Monitoring and Evaluations: 1. Each department will monitor and improve quality of care . . ."

Reviewed February 1-2, 2010, the monthly Continuous Quality Improvement (CQI) Committee meeting minutes from January-December 2010 lacked evidence the following departments reported evaluations of the quality of patient care to the facility wide CQI Committee: physical therapy, occupational therapy, and housekeeping.

During interview on 02/02/11 at 9:40 a.m., a nursing staff member (#6) confirmed physical therapy, occupational therapy, and housekeeping departments provided care to the CAH's patients and did not report evaluations of quality of care provided to patients to the CQI Committee from January-December 2010.

Based on policy review, record review, and staff interview, the Critical Access Hospital (CAH) failed to have a physician with the same qualifications/privileges review the quality and appropriateness of the diagnosis and treatment furnished for 7 of 13 peer review records reviewed (Physicians #1, #2, #3, #4, #5, #6, and #7) of physicians who provided treatment to the CAH's patients in 2010. By failing to perform peer review, the CAH cannot ensure the physicians provided quality and appropriate care to the CAH's patients.

Findings include:

Review of the policy titled "Peer Review" occurred the afternoon of 02/02/11. This policy, revised 03/13/09, stated,
". . . B. Secondary Review
a. Secondary review may be completed by a committee/team of individuals which is to include a physician of that specialty. . . ."
This policy did not require performance of peer review for all physicians who treat patients at the CAH.

Reviewed at 3:00 p.m. on 02/02/11, the 2010 peer review records lacked evidence a physician with the same qualifications/privileges reviewed the quality and appropriateness of the diagnosis and treatment furnished by seven physicians (Physicians #1, #2, #3, #4, #5, #6, and #7) who provided treatment to the CAH's patients in 2010.

During interview at approximately 3:10 p.m. on 02/02/11, a health information staff member (#3) confirmed a physician with the same qualifications/privileges did not review the quality and appropriateness of the diagnosis and treatment furnished by seven physicians who provided treatment to the CAH's patients in 2010.