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1405 NW CHURCH STREET

LEON, IA 50144

No Description Available

Tag No.: C0276

I. Based on observation, policy/procedure review, and staff interview, the CAH (Critical Access Hospital) staff failed to ensure outdated epinephrine was not available for patient use in the radiographic room and CT (Computed Tomography) room for use in the event of an emergency. The CAH staff reported the radiology department served an average census of 107 outpatients and 5 inpatients a month.

Failure to remove outdated medications in patient care areas could potentially result in staff administering outdated and/or ineffective medications to patients in the event of an emergency.

Findings include:

1. Observations during the tour of radiology on 2/15/11 at 8:20 AM, with Staff E, the Radiology Service Director, revealed the following.

a. The radiographic room contained a red tackle box in an unlocked cupboard. The red tackle box contained two vials of epinephrine 1 mg (milligram) with an expiration dates of 10/10/10.

b. The CT room contained a red tackle box in an unlocked cupboard. The red tackle box contained two vials of epinephrine 1 mg with an expiration date of 8/01/09.

2. During an interview on 2/15/11 at 8:20 AM, Staff E confirmed the epinephrine vials, contained in the 2 red tackle boxes, were expired. Staff E said pharmacy was responsible for checking for outdated medications in the 2 red tackle boxes.

During an interview on 2/15/11 at 11:45 AM, Staff I, a pharmacy tech, said each department checks for its own outdated medications.

During an interview on 2/16/11 at 2:05 PM, Staff B, the Director of Nurses, said pharmacy is responsible for checking for outdated medications.

3. Review of the CAH policy titled "Unusable Drugs or Devices/Discontinued Drugs", reviewed 6/96, revealed in part," ...outdated or otherwise unusable drugs or devices shall be identified and their distribution prevented...The Director of Pharmacy or the qualified designee shall inspect the pharmacy and all areas where medications are dispensed, administered or stored at least every 3 months. Items scheduled to expire during the following month shall be removed."

II. Based on observation, policy/procedure review, and staff interview, the CAH staff failed to secure contrast medium in the radiographic room and CT room. The CAH staff reported the radiology department served an average census of 107 outpatients and 5 inpatients a month.

Failure to secure contrast medium could result in access to the contrast medium by unauthorized access.

Findings include:

1. Observation on 2/15/11 at 8:25 AM, revealed the following amounts of unsecured contrast medium in the radiology department. The radiographic room contained 9 - 50 ml (milliliters) bottles of Omnipaque 300, 20 - 900 ml bottles of Readi-Cat 2, and 3 300 ml bottles of Cystografin. The CT room contained 2 - 50 ml bottles of Omnipaque 300 and 30 - 100 ml bottles of Omnipaque 300.

2. During an interview on 2/15/11 at 8:25 AM, Staff E said, the doors to the radiographic room and CT room were unlocked and the cupboards containing the contrast medium bottles were unlocked. Housekeeping staff clean during off hours and are not supervised in these areas.

3. Review of the policy titled, " Medication Security/Access to Pharmacy", reviewed 3/05 revealed in part, "...to define the lockup and authorize the accessibility of drugs...Medication security departments such as Surgery, ER, X-ray, CAT Scan, OB is in locked closets, cabinets or drawers. Responsibility of security resets with the service director of that area."

PATIENT CARE POLICIES

Tag No.: C0278

Based on staff interview and policy/procedure review, the Critical Access Hospital (CAH) staff failed to ensure that employees followed manufacturers' instructions for the use of a hospital approved disinfection product, Triple Neutral Disinfectant, used for cleaning patient care equipment in the Outpatient Services areas and the Emergency Room. The CAH staff reported treating an average of 250 to 300 patients a month in outpatient services and an average of 200 patients a month in the emergency room.

Failure to use disinfection products as directed by the manufacturer potentially puts patients at risk for exposure to infections and blood borne pathogens.

Findings include:

1. Review of the product insert for Triple Neutral Disinfectant, rev 6/2007, revealed Triple Neutral Disinfectant is effective against virus, infectious substances, and other pathogens when used as directed. According to the product insert, to disinfect a surface apply Triple Disinfectant solution with a cloth, mop, sponge or course spray. Let solution remain on surface for a minimum of 10 minutes. Rinse or allow to air dry.

2. During an interview on 2/14/11 at 10:05 AM, Staff C, Registered Nurse (RN) said equipment and surfaces are disinfected with Triple Disinfectant between all patients seen in ER. Staff spray the equipment and surfaces with Triple Disinfectant and let it stay wet for 2 to 3 minutes, then wipe them down with a cloth.

During an interview on 2/14/11 at 3:10 PM, Staff B, Director of Nursing, reported the Emergency Room (ER) staff assess 200 patients a month. The CAH had not identified cases of infections acquired during ER visits.

During an interview on 2/15/11 at 8:10 AM, Staff A, Outpatient Clinic Coordinator, reported all surfaces in the clinic are cleansed between patients with Triple Disinfectant. Staff spray the equipment and surfaces, let them stay wet for 3 minutes, then wipe the equipment and surfaces with a cloth. Staff A stated the Outpatient Clinic had no identified patient infections.

During an interview on 2/15/11 at 3:15 PM,Staff D, Infection Control Supervisor, said the CAH changed to using the Triple Disinfectant about 2 years ago. A memorandum was sent to all staff directing the correct use of the product.

3. Review of the CAH Outpatient Services and ER policy and procedure titled Cleaning Exam Rooms, issued 8/20/05, revealed in part, "... to spray exam tables, bedside or over bed tables, Mayo stands, pillow covers, counters and other services with a fine mist and allow full 3 minutes contact time before wiping surfaces dry with a soft dry cloth." The policy failed to follow the manufactures guidelines for using the product.

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No Description Available

Tag No.: C0308

Based on observation, document review, and staff interviews, the Critical Access Hospital (CAH) administrative staff failed to ensure that a system was in place that assured the CAH staff secured all patient records to prevent access by unauthorized persons in the radiology department and in an 800 square foot trailer. The CAH administration staff reported a census of 7 patients with a daily average of 5 patients and an average monthly average of 107 outpatients.

Failure to secure medical records to prevent unauthorized access could result in inappropriate release of medical information and/or identity theft.

Findings include:

1. Review of the "Secure Filing of Medical Records" policy, revised 12/2008 revealed, in part, "..to maintain records in a secure manner...it is the policy of the [CAH] that the medical records are maintained in a secured and confidential manner...restricted to authorized personnel... Medical records stored within the hospital shall be kept in secure areas at all times... Medical records will not be left unattended in areas accessible to unauthorized individuals."

2. Observation on 2/14/11 at 4:30 PM, revealed an open room within the unlocked Ultra Sound room, identified by the Staff B, Director of Nursing, as a x-ray reading room used by the physicians. The x-ray reading room contained a 2 row shelf with 7 slots on each shelf and each slot held 1-3 large envelopes labeled with patient identifying information.

Observation on 2/14/11 at 4:30 PM, revealed Staff F, Housekeeping manager, in the x-ray reading room unsupervised. Staff F stated the housekeeping staff clean several areas in the evening. Staff F reported he/she was unaware housekeeping staff needed supervision to clean the x-ray reading room. Staff B acknowledged the labels on the envelopes contained patient identifying information. Staff B instructed Staff F to lock up the area and clean only when the radiology staff were available for supervision.

During an interview on 2/15/11 at 8:15 AM, Staff E, Director of Radiology, acknowledged the labeled medical records stored in the x-ray reading room, held patient identifying information. Staff E stated staff kept the Ultra Sound room unlocked and the door to the x-ray reading room lacked a locking mechanism. Staff E, acknowledged the housekeeping staff had access to these areas while unsupervised.

3. Observation on the initial environmental tour on 2/15/11 at 1:00 PM, with Staff G, Director of Engineering and Staff H, Medical Record Director, revealed a 800 square foot trailer, located on the CAH grounds, containing the medical records of deceased and minor patients, ER and surgery logs dating 2005-2010. Staff G and Staff H verified all maintenance personnel have keys to the storage area.

QUALITY ASSURANCE

Tag No.: C0340

Based on review of policies/procedures, document review, and staff interview, the Critical Access Hospital (CAH) staff failed to ensure an appropriate entity evaluated the quality and appropriateness of the diagnosis and treatment furnished by doctors of the CAH. Concern noted for 15 of 15 consulting Radiologist physicians (Practitioners A, B, C, D, E, F, G, H, I, J, K, L, M, N and O). The CAH staff reported the radiology department served an average census of 107 outpatients and 5 inpatients a month.

Failure to ensure an external entity evaluated the quality and appropriateness of the diagnosis and treatment furnished by doctors at the CAH could potentially result in medical staff members misdiagnosing patients and/or providing inappropriate or substandard patient care.

Findings included:

1. Review of Physician credential files revealed the CAH staff failed to include Practitioners A, B, C, D, E, F, G, H, I, J, K, L, M, N and O in the external peer review process. The purpose of an external peer review is the evaluation of the quality and appropriateness of the diagnosis and treatment furnished by all physicians at the CAH.

2. Review of the undated CAH policy/procedure titled "Quality Improvement (QI) Medical Staff" revealed the following in part, "...CAH Medical Staff is accountable to the Board of Trustees for...Assuring the quality of care is being evaluated through the peer review process...."

3. Review of the CAH Network agreement dated 8/2/10 showed it stated in part, "...Medical record review as part of the quality and medical necessity of medical care at Hospital.... Such review may be performed by direct inspection by member or another designated employee of or physician affiliated with Medical Center, by analysis of Hospital's internal chart audits or by examination of external peer review reports..."

4. During an interview on 2/16/11 at 9:00 AM, the Director of Quality Assurance (QA) reported the network hospital staff completed an external peer review for the physicians on staff but the consulting radiologist group conducted their own peer review within their group and sent their results to the CAH. The Director of QA stated, "We know this is an issue and are working on it." The Director of QA provided e-mails with the network hospital, dated 1/17/11 and 2/15/11, addressing the issue of the lack of external peer reviews for the consulting radiologist group with the network hospital.