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Based on bylaws review, policy review, record review, and staff interview, the Critical Access Hospital (CAH) failed to follow the medical staff bylaws for appointment/reappointment to medical staff for 4 of 11 providers' files reviewed (Providers #1, #2, #3, and #4) and for 35 of 35 teleradiologists (Providers #5 - #39) providing services to the CAH. By failing to approve appointments and reappointments according to the CAH's bylaws and policies, the governing body did not ensure the providers possessed the necessary qualifications for medical staff membership.

Findings include:

Review of the governing board's "Bylaws of Carrington Health Center" occurred on 01/03/12. These bylaws, effective 05/19/09, stated, ". . . Article IX. Medical Staff . . . Section 9.1 Organization, Appointment and Hearings. 9.1.1 . . . The Board of Directors shall consider recommendations of the Medical Staff and appoint to the Medical Staff the medical practitioners who meet the qualifications for membership as set forth by the Bylaws of the Medical Staff. . . . 9.1.10 the Medical Staff shall make recommendations to the Board of Directors concerning: (a) Appointments, reappointments and alterations in staff status; (b) Granting of clinical privileges . . ."

Review of the "Carrington Health Center Medical Staff Bylaws" occurred on 01/03/12. These bylaws, adopted 03/21/02, stated, ". . . Article VI - Part B: Section 1. Credentialing Function: The duties of the medical staff with respect to credentialing shall be: (a) to review the credentials of all applicants for medical staff appointment, reappointment, and clinical privileges . . . and to make a report of its finding and recommendations on the same in accordance with Articles II and III of the Policy on Appointment, Reappointment and Clinical Privileges . . ."

Review of the "Carrington Health Center Medical Staff Procedural Policy" occurred on 01/03/12. This policy, revised 11/01, stated, ". . . Article II - Part D. Section 2. Medical Staff Procedure: (a) The medical staff . . . shall determine . . . whether the applicant has established and meets all of the necessary qualifications for clinical privileges requested. . . . Section 3. Medical Staff Report: . . . (c) The medical staff shall transmit to the Board through the Chief Executive Officer . . . its recommendation . . . Section 4. Subsequent Action on the Application: (a) When the recommendation of the medical staff is favorable to the applicant, the Chief Executive Officer shall promptly forward it . . . to the Board. All recommendations to appoint must also specifically recommend the clinical privileges to be granted . . ."

Reviewed on January 4-5, 2012, the CAH's credentialing files lacked evidence the medical staff approved the specific clinical privileges for reappointment of Providers #1 and #2 and for initial appointment of Providers #3 and #4.

Reviewed on January 4-5, 2012, the CAH's credentialing files lacked evidence the medical staff recommended privileges and the governing board approved the privileges for 35 teleradiologists (Providers #5 - #39) providing services to the CAH's patients.

During interview, at approximately 9:30 a.m. on 01/05/12, an administrative staff member (#1) and an administrative assistant staff member (#4) confirmed medical staff did not approve the specific clinical privileges for Providers #1 - #4; and confirmed the CAH did not have the medical staff recommend privileges and the governing board approve the privileges for the teleradiologists providing services to the CAH.

2. Based on policy review, record review, observation, and staff interview, the Critical Access Hospital (CAH) failed to properly dispose 50 packages of expired drugs in 1 of 2 sample medication storage areas (west side) in an off-site department (attached rural health clinic). Failure to ensure the removal of outdated drugs has the potential for outdated drugs to be available for patient use.

Findings include:

Review of the rural health clinic policy titled "Drug Samples Policy & Procedure" occurred on 01/04/12. This policy, undated, stated, "Drug samples are to be handled in same manner as Carrington Health Center Pharmacy regulations. . . . Inspection - Inspection checks for expired and deteriorated sample medications . . . will be done ONCE MONTHLY with any medications removed brought to hospital pharmacy for proper destruction. The clinic director will assign clinic nursing staff annually the duties of checking outdates on a monthly basis. Pharmacy will QA [Quality Assurance] that outdates are being checked."

Review of the pharmacy policy titled "Outdates" occurred on 01/05/12. This policy, undated, stated, "Purpose: To outline when and where outdates are checked and the processes used to remove them. . . . When: Outdates are checked towards the end of every month. All outdates must be removed from stock by the first of every month or the date on the package. . . ."

Review of the 2011 rural health clinic form titled "Outdates Check Location: West Nurses Station" occurred on 01/04/12. This form indicated staff members had checked sample medications every month in 2011 including the following dates: 08/31/11, 09/30/11, 10/11/11, 11/30/11, and 12/27/11.

Observation of the west side sample medication storage area in the attached rural health clinic, at approximately 10:25 a.m. on 01/04/12, revealed the following expired drugs:

1 package - Synthroid 200 mcg (micrograms), expired 10/28/11
1 package - Synthroid 150 mcg, expired 10/27/11
1 package - Synthroid 137 mcg, expired 11/28/11
1 package - Synthroid 125 mcg, expired 10/13/11
1 package - Synthroid 112 mcg, expired 10/13/11
1 package - Synthroid 75 mcg, expired 12/24/11
3 packages - Advair HFA, expired 09/11
4 packages - Trilipix, expired 09/23/11
2 packages - Pradaxa, expired 12/11
8 packages - Tribenzor, expired 12/11
3 packages - Caduet, expired 07/11
6 packages - Caduet, expired 08/11
15 packages - Caduet, expired 11/11
3 packages - Flovent Diskus, expired 09/11

During interview at approximately 10:25 a.m. on 01/04/12, an administrative staff member (#3) confirmed the expiration dates of the above drugs in the west side sample medication storage area of the attached rural health clinic and stated staff should have removed the outdated medications.

















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1. Based on observation, policy review, and staff interview, the Critical Access Hospital (CAH) failed to ensure staff kept all medications in a locked room or container in 1 of 1 emergency department crash cart and 1 of 1 acute-care crash cart. Failure to ensure staff stores medications in locked rooms or containers allows persons without legal access to have unmonitored access to drugs and biologicals.

Findings include:

Review of facility policy "Drug Storage and Preparation Areas" occurred on 01/05/12. This policy, revised February 2010, stated, "Policy: . . . Drugs are stored under proper conditions of . . . security. Purpose: To ensure safety and security of drugs on the premises. Procedure: . . . 3. Drug storage areas shall be locked. 4. For mobile containers such as crash carts, the containers must be in a locked room, monitored location, or secured location to ensure security. . . ."

Review of the facility policy "Medication Storage, Handling, and Labeling" occurred on 01/05/12. This policy, revised February 2010, stated, "Policy: Storage and Handling: Medications and biologicals are stored safely, securely, and properly following manufacturer's recommendations . . . Purpose: To define what constitutes safe storage . . . of medications. Procedure: Storage: . . . 2. Only licensed nurses, the consultant pharmacist, and those lawfully authorized to administer medications are allowed access to medications. Medication rooms, carts, and medication supplies are locked or attended by persons with authorized access. . . ."

- Observation and review of the acute-care crash cart, located in the hallway between the nurse's station and the Same Day Center, occurred on 01/03/12 at 11:30 a.m. Observation showed two bottles of Nitroglycerin tablets, one bottle of Nitroglycerin spray, and one bottle of Aspirin on the top of the crash cart. Facility staff failed to store these medications in a locked container or room.

- Observation of the Emergency Room occurred on 01/04/12 at 4:30 p.m. Observation showed two bottles of Nitroglycerin tablets, one bottle of Nitroglycerin spray, and one bottle of Aspirin on the top of the crash cart in the trauma room of the Emergency Department. Facility staff failed to store these medications in a locked container or room.

During interview on 01/05/12 at 10:00 a.m., an administrative pharmacy staff member (#5) confirmed staff should lock and/or secure all medications.

Based on observation, policy review, record review, professional literature review, and staff interview, the Critical Access Hospital (CAH) failed to evaluate the safe use of side rails and consider side rails as a potential entrapment and safety hazard; failed to assess each patient individually prior to utilizing side rails; and failed to provide education to the patient and responsible party regarding the hazards of side rail use for 6 of 6 active sampled patients (#1, #2, #3, #4, #5, and #6) observed with side rails and 2 of 2 closed records (#11 and #13) of patients who fell or crawled out of bed. Failure to assess and evaluate the use of side rails, to consider side rails as a potential entrapment and safety hazard, and to educate patients and responsible parties regarding the hazards of using side rails placed patients at risk of entrapment or injury.

Findings include:

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

The United States Department of Health and Human Services, Food and Drug Administration (FDA), and Center for Devices and Radiological Health (CDRH) publication titled, "Guidance for Industry and FDA Staff: Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment," issued on 03/12/06, stated, ". . . FDA is recommending dimensional limits for zones 1 through 4 . . . because . . . the majority of the entrapments . . . have occurred in these zones. . . . Zone 1 is any open space within the perimeter of the rail. Openings in the rail should be small enough to prevent the head from entering. . . . FDA is recommending a measure of less than . . . 4 3/4 inches as the dimensional limit for any open space within the perimeter of a rail. Zone 2 . . . This space is the gap under the rail between a mattress . . . Preventing the head from entering under the rail would most likely prevent neck entrapment in this space. FDA recommends that this space be small enough to prevent head entrapment, less than . . . 4 3/4 inches. . . . Zone 3 . . . This area is the space between the inside surface of the rail and the mattress compressed by the weight of a patient's head. The space should be small enough to prevent head entrapment . . . FDA is recommending a dimensional limit of less than . . . 4 3/4 inches for the area between the inside surface of the rail and the compressed mattress. Zone 4 . . . This space is the gap that forms between the mattress compressed by the patient, and the lowermost portion of the rail, at the end of a rail. . . . The space poses a risk for entrapment of a patient's neck. . . . to prevent neck entrapment. . . . FDA recommends that the dimensional limit for this space . . . be less than . . . 2 3/8 inches. . . ."

The HBSW publication titled, "A Guide to Bed Safety - Bed Rails in Hospitals, Nursing Homes and Home Health Care: The Facts," revised April 2010, stated, ". . . Potential risks of bed rails may include: Strangling, suffocating, bodily injury or death when patients or part of their body are caught between rails or between the bed rails and mattress. More serious injuries from falls when patients climb over rails. Skin bruising, cuts, and scrapes. Inducing agitated behavior when bed rails are used as a restraint. . . . Preventing patients, who are able to get out of bed, from performing routine activities . . . Keep the bed in the lowest position with wheels locked. When the patient is at risk of falling out of bed, place mats next to the bed . . . Monitor patients frequently. Anticipate the reasons patients get out of bed . . . meet these needs . . . When bed rails are used, perform an on-going assessment of the patient's physical and mental status; closely monitor high-risk patients. . . . Reassess the need for using bed rails on a frequent, regular basis."

Review of facility policy "Restraints" occurred on the morning of 01/05/12. This policy, effective 11/06/08 and revised January 2012, stated, "Policy: Carrington Health Center strives to provide a high level of patient safety while respecting the patient's right to privacy, dignity, comfort and well being. The intent is to protect the patient and other from injury that may result from the patient's physical activities. . . . The Expected Outcome is: 1. To provide for patient rights to be free from physical restraints that are not medically necessary . . . 3. To provide security and optimal protection from the patient, other patients, visitors, and staff. 4. To provide optimal protection with the least amount of restricted movement. 5. To provide an environment consistent with safe and effective care . . . Definitions: Physical Restraints - any manual method or physical or mechanical device, material, or equipment attached to or adjacent to the patient's body that the individual cannot remove easily which restricts freedom of movement or normal access to one's body. . . . Equipment: . . . 6. Restraints - i.e.: leg, wrist, vest, sheet, or side rails, etc. . . . Patient/Family Education: 1. A RN [registered nurse] or Physician shall explain to the patient/family the reason for the restraint or alternatives. . . , potential adverse effects . . . Chemical Restraint: . . . 9. Bed rails are desirable for the very young, heavily medicated patients, or any other condition that may indicate it. 10. Bed rails can be applied without a physician's order or per patient request. . . . 15. Full side rails will be used at night when needed on all patients who have received a sedative, who are mentally confused, very young, who need physical assistance to get out of bed . . . 18. No restraint record needed if side rails are applied per patient request. . . ."

Observation of the beds utilized on the nursing unit occurred on January 3-5, 2012. The beds utilized by the current observation, inpatient, and swing bed patients had four half rails, two half rails on each side, attached to the beds. When raised, the spacing between the two half rails on a side was greater than 4 3/4 inches. The beds and side rails all differed in shape, size, or make. Measurements of one type of bed, located specifically in room #111, identified 7 1/2 to 9 inch open spaces within the rails. Observation showed other patient rooms on the nursing unit contained the same type of bed located in room #111 and patients occupied some of these beds.

Observations of sampled patients # 1, #2, #3, #4, #5 and #6 on January 3-4, 2012 identified two elevated upper half rails on the bed. Review of the above patients' active medical records occurred on January 3-5, 2012. The records indicated two side rails for positioning and/or patient request. The records lacked individualized assessments of risk and safety for the use of side rails and lacked evidence of patient (or responsible party) education regarding the hazards of side rail use. The CAH staff failed to consider the elevated side rails as a potential safety and entrapment hazard for these patients.

During an interview, the afternoon of 01/04/12, a nursing staff member (#6) stated patients used the elevated side rails for positioning and use of the bed controls. The nurse stated if staff elevate more than two rails, the facility considers it a restraint.


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- Review of Patient #11's closed inpatient medical record occurred on January 3-5, 2012. The patient's medical record identified the CAH admitted the patient on 08/07/11 after a fall at home. The facility staff completed a Fall Risk Assessment which stated, "High Risk: [score of] 45 or greater." The patient's assessments at 8:00 a.m. and 8:00 p.m. on 08/08/11 showed scores of "80" and "70" respectively. The patient's care plan, dated 08/07/11, stated, "Problem . . . Alteration in comfort . . . Nursing Actions . . . 14. Fall prevention." The patient's Fall Risk Care Plan, dated 08/07/11, included interventions ". . . 11. Encourage handrail/safety bar use as appropriate. . . . 16. Individualize fall safety equipment specific to patient's needs. . . ." The care plan lacked interventions regarding the use of side rails other than handrail/safety bars, lacked documentation of the number or position of the side rails, and failed to identify side rails as potential restraints.

Patient #11's Patient Care Notes, dated 08/08/11 at 2:05 a.m. (correct date is 08/09/11), stated, "Pt. [Patient] found sitting on floor beside bed. No c/o [complaints of] new pain. . . . Pt. moves upper et [and] lower extremities [without] difficulty or c/o pain [with] movement. Pt. assisted back to bed. Side rails x [times] 3 put up [to] help prevent pt. from rolling out of bed. . . ."

Patient #11's 24 Hour Record from 7:00 a.m. on 08/08/11 to 6:00 a.m. on 08/09/11, showed two side rails in place every hour from 7:00 a.m. on 08/08/11 to 1:00 a.m. and three side rails from 08/09/11 at 2:00 a.m. to 6:00 a.m. Two side rails resumed on 08/09/11 at 7:00 a.m. and continued hourly until the patient expired in the afternoon on 08/09/11.

Review of the CAH's Fall Event Report, dated 08/16/11, identified the information from the Patient Care Note, dated 08/08/11 at 2:05 a.m. This report stated, "Revisions of fall plan of care . . . Side Rails Up x 3."

Patient #11's medical record lacked an assessment, patient and family education, and care planning regarding the use of side rails as a potential restraint or entrapment hazard. Following the patient's fall out of the bed on 08/09/11, the CAH staff implemented three side rails which increased the risk of restraint and entrapment. The CAH staff failed to assess the patient or care plan for the use of three side rails and the potential for injury and entrapment.

- Review of Patient #13's closed medical record occurred on January 3-5, 2012. The CAH admitted the patient on 10/31/11. The patient's admission diagnoses included altered mental status. Patient #13's 24 Hour Record, on an hourly schedule throughout his stay, identified two side rails in place. The patient's Patient Care Notes, dated 10/31/11 at 8:00 p.m., stated, ". . . Not orientated to time or place. . . . Pt. [Patient] crawls out of bed. . . ." Throughout his stay, Patient #13's Patient Care Notes identified he was combative and crawled out of bed. On 11/05/11, the CAH transferred Patient #13 to a tertiary care facility.

Patient #13's care plan, dated 10/31/11, lacked actions regarding use of the side rails. The patient's Fall Risk Care Plan, dated 10/31/11, included interventions ". . . 11. Encourage handrail/safety bar use as appropriate. . . . 16. Individualize fall safety equipment specific to patient's needs. . . ." The care plan lacked interventions regarding the use of side rails other than handrail/safety bars or restraints.

Patient #13's crawling out of bed placed him at risk of entrapment and increased risk of injuries with falls related to the side rails. Patient #13's medical record lacked an assessment, patient and family education, and care planning regarding the use of side rails as a potential restraint or entrapment hazard.

During interview, on 01/05/12 at 2:00 p.m., an administrative nursing staff member (#2) agreed the use of three side rails for Patient #11 could be a restraint and the CAH staff should have assessed and care planned for restraints. This staff member reported the bed controls are in the side rails and the staff routinely use the top two side rails on the beds, however, one side rail may be adequate. This staff member (#2) also reported the facility measured the openings in the side rails and investigated alternatives and different beds. This staff member reported the facility had not considered the space between the top and bottom side rail as an entrapment hazard.

Based on bylaws review, policy review, register review, and staff interview, the Critical Access Hospital (CAH) failed to evaluate the quality and appropriateness of the treatment furnished in 2011 by 2 of 3 Family Nurse Practitioners (FNP) (Providers #45 and #46) and 1 of 5 Physician's Assistants (PA) (Provider #47) providing care to the CAH's patients in the emergency department; and failed to evaluate the quality and appropriateness of the treatment furnished in 2011 by 5 of 5 Certified Registered Nurse Anesthetists (CRNAs) (Providers #40 - #44) providing anesthesia care to the CAH's patients. Failure to evaluate the quality and appropriateness of the treatment furnished has the potential to affect patient outcomes involving patient care provided by the FNPs and PA and surgical procedures requiring anesthesia services provided by the CRNAs.

Findings include:

Review of the governing board's "Bylaws of Carrington Health Center" occurred on 01/03/12. These bylaws, effective 05/19/09, stated, ". . . Article IX Medical Staff . . . 9.1.9 The Medical Staff shall conduct a continuing review of the quality of the professional care rendered in the health center . . ."

Review of the "Carrington Health Center Medical Staff Bylaws" occurred on 01/03/12. These bylaws, adopted 03/21/02, stated, ". . . Article VI - Part B: Section 8. QA [Quality Assurance]/Peer Review Functions: The medical staff shall monitor and evaluate important aspects of care through the peer review process using established criteria for review. . . ."

Review of the policy titled "Medical Staff Peer Review Process" occurred on 01/05/12. This policy, effective 04/21/10, stated, "Policy: The function of the peer review process is to assist the Medical Staff in the monitoring, evaluation and improvement of the quality of care rendered by a practitioner and the clinical performance of individuals with delineated privileges. . . . Documentation Process: . . . Results of peer review . . . will be filed . . . to be used to identify any opportunities for improvement, any trends and any recommendations related to care provided. This information will be utilized during the credentialing process . . ."

Review of the CAH's Emergency Department patient register occurred on January 4-6, 2012. The register indicated Providers #45 - #47 provided services to the CAH's patients in 2011. Review of the CAH's "Register of Operations" occurred on January 4-6, 2012. The register indicated Providers #40 - #44 provided services to the CAH's patients in 2011.

Upon request on 01/05/12, the CAH failed to provide evidence a physician evaluated the quality and appropriateness of the treatment provided by Providers #45 - #47 in 2011 and a physician with experience in anesthesiology evaluated the quality and appropriateness of the treatment provided by the CRNAs (Providers #40 - #44) in 2011.

During interview at approximately 11:30 a.m. on 01/05/12, an administrative nursing staff member (#2) confirmed Providers #45 - #47 provided care to the CAH's patients in 2011, and the CAH did not have a physician evaluate the appropriateness of the diagnosis and treatment furnished by these providers. Administrative nursing staff member #1 confirmed five CRNAs (Providers #40 - #44) provided services to the CAH's patients in 2011, and the CAH did not have a physician with anesthesiology qualifications evaluate the quality and appropriateness of the treatment provided by the CRNAs.

Based on bylaws review, policy review, register review, and staff interview, the Critical Access Hospital (CAH) failed to have a physician with the same privileges/qualifications evaluate the quality and appropriateness of the treatment furnished in 2011 by 6 of 7 courtesy/consulting providers (Providers #48 - #53) at the CAH. Failure to evaluate the quality and appropriateness of the treatment furnished by the providers limits the CAH's ability to ensure the providers furnished quality and appropriate care to the CAH's patients.

Findings include:

Review of the governing board's "Bylaws of Carrington Health Center" occurred on 01/03/12. These bylaws, effective 05/19/09, stated, ". . . Article IX Medical Staff . . . 9.1.9 The Medical Staff shall conduct a continuing review of the quality of the professional care rendered in the health center . . ."

Review of the "Carrington Health Center Medical Staff Bylaws" occurred on 01/03/12. These bylaws, adopted 03/21/02, stated, ". . . Article VI - Part B: Section 8. QA [Quality Assurance]/Peer Review Functions: The medical staff shall monitor and evaluate important aspects of care through the peer review process using established criteria for review. . . ."

Review of the policy titled "Medical Staff Peer Review Process" occurred on 01/05/12. This policy, effective 04/21/10, stated, "Policy: The function of the peer review process is to assist the Medical Staff in the monitoring, evaluation and improvement of the quality of care rendered by a practitioner and the clinical performance of individuals with delineated privileges. . . . Documentation Process: . . . Results of peer review . . . will be filed . . . to be used to identify any opportunities for improvement, any trends and any recommendations related to care provided. This information will be utilized during the credentialing process . . ."

Review of the CAH's "Register of Operations" occurred on January 4-6, 2012. The register indicated Providers #48 - #53 provided services to the CAH's patients in 2011.

Upon request on 01/05/12, the CAH failed to provide evidence a physician with similar privileges evaluated the quality and appropriateness of the treatment furnished by Providers #48 - #53 in 2011.

During interview at approximately 11:30 a.m. on 01/05/12, an administrative nursing staff member (#2) confirmed Providers #48 - #53 provided care to the CAH's patients in 2011, and the CAH did not have a physician with the same privileges/qualifications evaluate the appropriateness of the diagnosis and treatment furnished by these providers.