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Based on observation and staff interview CAH staff failed to remove outdated supplies in the radiology and obstetrical departments. The radiology manager reported approximately 10 abdominal and pelvic Computerized Tomography (CT) procedures. The director of education services identified 4 admissions with noted latex allergies in the past year.

Failure to remove outdated supplies could potentially expose patients to supplies that were no longer sterile and/or less effective.

Findings include:

1. Observations during a tour of the obstetrical labor and delivery department on 3/21/11 at 12:32 PM revealed the following outdated supplies available for patient use:

a. Eight of 12 Latex free French self-catheters expired 6/2009.
b. Ten of 12 Latex free French self-catheters expired 12/2007.
c. Nine of 12 Latex free French self-catheters expired 6/2010.

During an interview on 3/21/2011 at 12:45 PM, Staff R reported that nursing staff checked for outdated supplies in the obstetrical department monthly. However, they did not track or document the monthly checks. According to Staff R, the nursing staff should have removed the expired supplies and sent them to the purchasing department.

2. Observations during a tour of the radiology department on 3/22/11 at 11:40 AM, revealed the following outdated supplies in the CT control room available for patient use:

a. Three of 3, 450 milliliters (ml) Berry Smoothie, barium sulfate suspension, expired 7/2009
b. One of 1, 450 ml Berry Smoothie, barium sulfate suspension, expired 5/2009
c. One of 1, 450 ml Berry Smoothie, barium sulfate suspension, expired 1/2010
d. Five of 5, 450 milliliters (ml) Berry Smoothie, barium sulfate suspension, expired 8/2009

During an interview, at the time of the observation, the radiology department director stated radiology staff checks for outdated supplies monthly and document the date on a form titled "checklist for outdated supplies. " The radiology department director reported radiology staff last checked the supplies for outdates on 3/8/11.

During an interview on 3/22/11 at 11:50 AM, Staff S, radiology technician (RT) acknowledged completing the check for expired supplies on 3/8/11. Staff S failed to check the expiration dates on the supplies in the CT control room on 3/8/11.

During an interview on 3/23/11 at 7:45 AM, the Chief Financial Officer (CFO) said the hospital did not have a "formal" policy for monitoring the expiration dates of the supplies. According to the CFO, all staff was responsible for periodically checking the stock supplies and removing any outdated items.

Based on Critical Access Hospital (CAH) medication error reports reviewed , policy review and staff interview, the nursing staff failed to notify the physician when medication errors occurred for 12 of 20 Patients, (Patients #1, #2, #3, #4, #5, #6, #7, #8, #9, #10, #11 and #12). The CAH had a current census of 11 patients.

Failure to report medication errors to the physician could potentially cause harm to patients if they received the wrong medication, medication at the wrong time or by the wrong route.

Findings include:

Review of the CAH policy titled Medication Mis-administration, board approved 5/2009, revealed in part... "All medication administration errors are to be reported to the physician. This report may be made the next time the physician makes rounds unless the nurse feels the error could cause harm to the patient. In these cases the report will be made immediately."

Document review showed the nurses documented medication errors on a form titled " Medication Event Reports. " Review of the Medication Event Reports revealed the following information.

1. The Medication Events report for Patient #1 dated 3/2/10 at 2:20 AM revealed Patient #1 received an insulin drip in normal saline solution, but should have received the insulin drip in D5 and 1/2 normal saline (5% sugar and .45% salt water) solution. Nursing staff evaluated the patient's blood sugar at 3:30 AM, results 74, and found the medication error. Nursing staff failed to contact the physician an error occurred.

2. The Medication Events report dated 3/3/10, no time, revealed Patient #2 received Maalox (antacid) instead of Milk of Magnesia (laxative). The nursing staff failed to administer the correct medication to the patient. The nursing staff failed to notify the physician an error occurred.

3. The Medication Events report dated 3/3/10 at 6:45 PM revealed Patient #3 did not receive Carafate (antacid) as ordered by the physician. Nursing staff failed to give one dose as ordered. Nursing staff failed to notify the physician an error occurred.

4. The Medication Events report dated 3/3/10 at 12:01 AM revealed Patient #4 did not receive sliding scale insulin 2 units as ordered by the physician. Nursing staff failed to notify the physician an error occurred.

5. The Medication Events report dated 3/18/10 at 6:00 AM revealed Patient #5 received the wrong dosage of Dilantin (seizure medication). The patient received 100 mg (milligrams) instead of 200 mg of Dilantin as ordered, for 1 dose. Nursing staff failed to notify the physician an error occurred.

6. The Medication Events report dated 5/7/10, not timed, revealed Patient #6 did not receive Arixtra (anticoagulant) medication after surgery as ordered by the physician. Nursing staff failed to notify the physician an error occurred.

7. The Medication Events report dated 6/22/10 at 8:00 AM revealed Patient #7 did not receive intravenous Rocephin (antibiotic) as ordered by the physician. Nursing staff failed to notify the physician an error occurred.

8. The Medication Events report dated 7/3/10, not timed, revealed Patient #8 did not receive Toradol (anti-inflammatory) as ordered by the physician. Nursing staff failed to give 1 dose of the medication as ordered. Nursing staff failed to notify the physician an error occurred.

9. The Medication Events report dated 7/7/10 at 6:00 AM revealed Patient #9 received Levaquin (antibiotic) at 6:00 AM instead of 7:00 PM as ordered by the physician. Nursing staff failed to notify the physician an error occurred.

10. The Medication Events report dated 7/21/10 at 9:20 PM revealed Patient #10 received Rocephin (antibiotic) instead of Ancef (antibiotic) as ordered by the physician. Nursing staff failed to notify the physician an error occurred.

11. The Medication Events report dated 7/21/10 at 7:53 PM revealed Patient #11 received Depakote Extended Release (seizure medication) instead of regular Depakote. Nursing staff failed to notify the physician an error occurred.

12. The Medication Events report dated 9/13/10, not timed, revealed Patient #12 did not receive Enoxaparin (blood thinner used to prevent clots) after surgery as ordered by the physician. Nursing staff failed to notify the physician an error occurred.

During an interview on 3/23/11 at 8:45 AM, Staff A, Quality Assurance/ Infection Control Nurse agreed that nursing staff were not notifying the physicians when medication errors occurred, in accordance with the medication Mis-administration policy. According to Staff A, nursing staff were instructed during orientation, how to correctly fill out medication error reports and to notify the physician with all medication errors that occur.

Based on document review, observations and staff interviews the Critical Access Hospital (CAH) Dietician failed to ensure Staff H, I, J, K, L, M, N, O, Q, and T, wore hairnets that completely cover their hair while working in the kitchen. The Dietician reported approximately 112 to 120 meals served per day.

Failure to cover hair completely when working in the kitchen could potentially result in hair dropping into the patient ' s food.

Findings included:

1. Review of the policy, "Infection Control", revised November, 2010 stated in part, "in accordance with the 2009 Food Code...All food service employees follow the dress and grooming code: hair...covered with hair net (not just the ponytail)..."

Review of the policy, "Orientation and on the job training", revised November 2010 stated in part, "...new employees are oriented...dress code is discussed..."
Review of the " FDA (Food and Drug Administration) 2009 Food Code" stated in part, "...Food Contamination Prevention...employees shall wear hair restraints such as...hair coverings or nets...designed and worn to effectively keep their hair from contacting exposed food...clean utensils..."

2. Observation on 3/22/11 at 10:30 AM revealed Staff Q, a housekeeper in the kitchen without wearing a hairnet. Staff Q emptied the wastebasket in the food prep area of the kitchen. During an interview, at the time of the observation, Staff Q reported that she emptied all of the wastebaskets in the kitchen. Staff Q said she did not have a hairnet because the dietitian told her she did not need one.

Observation on 3/22/11 at 10:40 AM revealed Staff T, Mobile Meal Coordinator, walking in the food prep area of the kitchen. Staff R's hairnet did not cover the bangs that hung down Staff R's forehead.

Observation on 3/22/11 at 10:50 AM revealed the Dietician in the food prep area of the kitchen. The Dietician's hairnet did not cover the bangs that hung down the Dietician's forehead.

Observation on 3/22/11 at 10:50 AM revealed Staff H, dietary staff, in the food prep area of the kitchen. Staff H's hairnet did not cover the bangs that hung down Staff H's forehead.

Observation on 3/22/11 at 10:50 AM revealed Staff I, dietary staff, in the food prep area of the kitchen. Staff I's hairnet did not cover the bangs that hung down Staff I's forehead.

Observation on 3/22/11 at 10:50 AM revealed Staff J, dietary staff, in the food prep area of the kitchen. Staff J's hairnet did not cover hair on the side of Staff J's head.

Observation on 3/22/11 at 10:50 AM revealed Staff K, dietary staff, in the food prep area of the kitchen. Staff K's hairnet did not cover hair on the side of Staff K's head.

Observation on 3/22/11 at 10:50 AM revealed Staff L, dietary staff, in the food prep area of the kitchen. Staff L's hairnet did not cover the bangs that hung down Staff L's forehead.

Observation on 3/22/11 at 10:50 AM revealed Staff M, dietary staff, in the food prep area of the kitchen. Staff M's hairnet covered only the ponytail on the back of Staff M's head.

Observation on 3/22/11 at 10:50 AM revealed Staff N, dietary staff, in the food prep area of the kitchen. Staff N's hairnet did not cover the bangs that hung down Staff N's forehead.

Observation on 3/22/11 at 10:50 AM revealed Staff O, dietary staff, in the food prep area of the kitchen. Staff O's hairnet did not cover the bangs that hung down Staff O's forehead.

3. During an interview on 3/22/11 at 10:50, the Dietician acknowledged that staff in the food prep area did not cover their hair completely. The Dietician did not believe the hairnets had to cover all the hair and thought hairnets were supposed to cover the hair, but did not think they had to cover all the hair. The Dietician did not think the Food Code said all of the hair had to be covered.

During an interview on 3/22/11 at 2:30 PM, the Dietician reviewed the CAH policy and 2009 Food Code. The Dietician stated all the dietary staff read the policy during orientation and should have been aware of the policy.

Based on review of documents, medical records, and staff interviews, the Critical Access Hospital (CAH) administration failed to ensure the Physician signed the Physician Certification and Recertification form for 4 of 5 Swing Bed inpatients (SWB), Patients #13, 14, 15, and 16
The CAH administrator reported a census of 4 SWB inpatients for the fiscal year 7/1/10 thru 2/28/11.

Failure to certify or recertify each Patient's need for Swing Bed placement could potentially result in a denial of Medicare/Medicaid Benefits for the patient ' s hospitalization.

Findings included:

1. Review of the Physician Certification and Recertification form revealed in part, "Admission Certification on or before day 5...Recertification of continued SNF inpatient care. On or before the 14th day of admission...certify that post-acute care Swing Bed services are required on an inpatient basis because of the residents need on a daily basis for skilled nursing or rehabilitation services..." The Physician Certification and Recertification form revealed an area for "Physician's Signature and date (the date may only be recorded by the physician)."

Review of the Rules and Regulations of the Medical Staff revealed in part, "...The attending physician shall see that the medical record is complete..."

Review of policy and procedure titled, "Chart Assembly" revealed in part, "...A complete medical record is maintained on all Patients...SNF (Skill Nursing Facility) chart...Physician Certification..."

2. Review of Patient #13's medical record On 3/21/11 at 11:45 AM, showed the physician admitted Patient #13 to SWB on 3/7/11. Patient #13's medical record had a Physician Certification and Recertification form that showed an admission certification date of 3/7/11 and a recertification due date of 3/20/11. The Physician failed to sign or date the form.

Review of Patient #14's medical record on 3/21/11 at 11:45 AM, a showed the physician admitted Patient #14 to SWB on 3/7/11. Patient #14's medical record had a Physician Certification and Recertification form that showed an admission certification date of 3/7/11 and a recertification due date of 3/20/11. The Physician failed to sign or dated the recertification form Certification for the recertification that was due on 3/20/11.

Review of Patient #15's medical record on 3/22/11 at 9:30 AM, showed the physician admitted Patient #15 to SWB on 3/19/11. Patient #15's medical record had an undated/unsigned Physician Certification and Recertification form.

review of Patient #16's medical record on 3/24/11 at 9:00 AM, showed the physician admitted Patient #16 to SWB on 3/19/11. Patient #16's medical record had an undated/unsigned Physician Certification and Recertification form.

3. During an interview on 3/22/11 at 11:50 AM, Staff P, Registered Nurse (RN) stated there are times when the Physician does not see the SWB patient for a week and may not make the deadline to sign the Physician Certification and Recertification form. According to Staff P, it was the Utilization Review Nurse's responsibility to ensure the Physician filled out the Physician Certification and Recertification forms correctly and timely.

During an interview on 3/22/11 at 12:05 PM, Staff Q, RN Utilization Review Nurse, acknowledged placing reminders for the Physician to sign the Physician Certification and Recertification form. Staff Q further acknowledged the Physician Certification and Recertification forms lacked Physician signatures and dates in a timely manner.

During an interview on 3/24/11 at 8:30 AM, Staff C, RN Manager of Medical Surgical unit, acknowledged the physicians failed to sign or date the Physician Certification and Recertification forms for Patients #13, 14, 15, and 16. According to Staff C, the forms were the Physicians responsibility and Staff C was not sure why the physicians had not signed and dated them.

Based on observation, review of documents, medical record and staff interviews, the Critical Access Hospital (CAH) administration failed to ensure the patient and/or the patient's representatives signed a video surveillance consent form for Patient #13. The CAH staff reported a monthly average of 2-3 Swing Bed Patients video surveillance.

Failure to let patients know that staff uses video surveillance to monitor some patients, tell them where they may go for privacy, could potentially result in patient's being videotaped against their wishes.

Findings included:

1. An observation on 3/21/11 at 11:30 at the medical/surgical unit revealed a video screen at the nursing station monitoring Patient #13 in room 121. Staff E, Registered Nurse (RN), stated staff moved Patient #13 to room 121 to monitor for safety.

An observation on 3/22/11 at 10:30 at the medical/surgical unit revealed the surveillance monitor continued to monitor Patient #13 in room 121.

2. A review of the policy "Medical Records" renewal date January, 2009 stated in part, "...The medical record contain information...describes the patient's progress and response to...services...properly executed informed consent forms for procedures...specified by the medical staff...to require written patient consent..."

3. Review of Patient #13's medical record on 3/21/11 at 11:45 AM, revealed no evidence of a consent form for video surveillance. Patient #13's medical record lacked documented evidence the staff provided the patient and/or family information, explanations, consequences or options needed in order to consent to the video surveillance.

4. During an interview on 3/21/11 at 4:20 PM, Staff E, RN and daughter of Patient #13 stated the staff did not provide the family or the patient video surveillance consent form to sign. Staff E was not aware of a surveillance form for patient and/or family to sign.

During an interview on 3/2/11 at 4:00 PM, Staff C, RN Manager of Medical/Surgical unit, stated the staff used the video surveillance for patient safety. Staff C acknowledged Patient #13's medical record lacked a consent form for the video surveillance and stated, "We have never had a consent form for this."

Based on document review, observations, and staff interviews, the Critical Access Hospital (CAH) staff failed to secure all confidential patient information from unauthorized access in various departments of the CAH, including but not limited to the following areas of the CAH.

Radiology: The radiology staff identified a monthly average of 90 inpatients and 1,500 outpatients.

Medical Surgical unit: The CAH administrative staff identified a daily average of 12.3.

Medical/Surgical Manager's office: The room remained unlocked due to student nurses and housekeeping used the office.

Special Care Unit (SCU): The SCU identified a daily average of 2 patients.

Physical Therapy (PT): The PT staff identified a daily average of 4-5 inpatients and 30 out patients.

Occupational Therapy (OT): The OT staff identified a daily average of 4 inpatients and 10 out patients.

Cardiac Rehab: The Cardiac Rehab staff identified a daily average of 3 Phase II patients and 20-25 Phase III patients.

Failure to secure medical records against unauthorized access could result in identity theft and/or unauthorized disclosure of personal medical information.

Findings included:

1. Review of hospital policy titled "Shredding" approval date 1/20/11 revealed in part, " ...Do not leave records that are to be shredded unattended...all medical record information is confidential and available to authorized persons...blue baskets are emptied every night into the shredding bins located in the department...the large shredding bins are locked at all times when not in use by staff in the department ..."

2. Tours of Radiology, Medical Surgical unit, Physical Therapy, Occupational Therapy, and the Cardiac Rehabilitation departments revealed the following unsecured medical records.

a. Observation in the Radiology Department on 3/22/11 at 11:15 AM revealed 3 open baskets. One open basked located in the receptionist office and the radiologist's office. The baskets contained patient information including but not limited to names, date of birth, medical record number, diagnosis and the radiological procedure performed. The radiology director stated, "The baskets are emptied weekly into the locked shred bins."

During an interview on 3/22/11 at 11:25 AM, the Radiology Director stated housekeeping cleaned the radiology department including all office areas and could access the patient information contained in the open baskets and did not have a need to know patient's medical information.

b. Observation on the Medical Surgical Unit 3/21/11 at 4:00 PM, revealed 5 open baskets located under the nursing station. The baskets contained patient information as noted above. Staff E, Registered Nurse (RN), stated the unit secretary empties the baskets at the end of their shift into the large bin in the break room. Staff E opened the unlocked door to the break room and revealed a large tan bin with an unsecured lid. Patient medical and personal information papers filled the bin approximately 3/4 from the top.

During an interview on 3/21/11 at 4:30 PM, Staff E, RN stated staff from various departments, that should not have access to confidential patient information, used the break room. Staff E acknowledged the unsecured tan bin held patient medical and personal information and was accessible to anyone in the break room.

c. Observation on the Medical Surgical Unit 3/22/11 at 9:20 AM revealed 2 computer terminals in the hallway. Each computer terminal contained an open basket with papers that had patient's confidential medical and personal information.

During an interview on 3/22/11 at 9:20 AM, Staff C, RN Manager of Medical/Surgical unit, acknowledged families and/or patients walked the hallway and would have access to patient medical and personal information.

d. Observation in the Nurse Managers office on 3/22/11 at 9:30 AM revealed an open basket by the desk. The basket contained papers with patient's personal and medical information.

During an interview on 3/22/11 at 9:20 AM, Staff C acknowledged the office door remained unlocked at all times and the open basket contained papers with patient's medical and personal information. Staff C stated student nurses and housekeeping accessed the room for various reasons and would have access to the patient ' s medical and personal information in the basket. Staff C acknowledged housekeeping staff did not have a need to know patient's personal and medical information.

e. Observation on the Special Care Unit 3/22/11 at 9:35 AM revealed 2 open baskets under the nurse's desk. The baskets contained papers with patient ' s personal and medical information.

During an interview on 3/22/11 at 9:35 AM, Staff G, RN on the Special Care unit, acknowledged the papers in the open baskets contained patient personal and medical information. Staff G stated staff emptied the baskets into the large bin in the room behind the nursing station however, the large bin did not have a lid and never did. Staff G acknowledged housekeeping staff cleaned the room unsupervised and housekeeping did not have a need to know patient's personal and medical information.

f. Observation at the PT receptionist's desk 3/22/11 at 8:15 AM revealed 1 open basket under the receptionist's desk. The basket contained papers with patient personal and medical information.

During an interview on 3/22/11 at 8:15 AM, the PT Receptionist acknowledged the papers in the open basket contained patient personal and medical information. The PT Receptionist acknowledged housekeeping staff cleaned the room unsupervised and housekeeping did not have a need to know patient's personal and medical information.

g. Observation on OT Unit 3/22/11 at 8:45 AM, revealed an open basket under the OT desk. The basket contained papers with patient personal and medical information.

During an interview on 3/22/11 at 8:45 AM, the Occupational Therapist acknowledged the papers in the open basket contained patient personal and medical information. The Occupational Therapist acknowledged housekeeping staff cleaned the room unsupervised and housekeeping did not have a need to know patient's personal and medical information.

h. Observation on the Cardiac Rehabilitation Unit 3/22/11 at 9:45 AM, revealed an open basket under the Cardiac Rehabilitation desk. The basket contained papers with patient personal and medical information.

During an interview on 3/22/11 at 10:00 AM, Staff D, Assistant Administrator of Clinical Services stated, "All departments have the open basket for disposal of patient personal and medical information papers." Staff D acknowledged the baskets were unsecured and stated, "We will work on this issue."


20126

Based on record review and staff interview, the Critical Access Hospital (CAH) staff failed to complete external peer review on the Nebraska Iowa Radiology Consultants (NIRC), (Practitioners A, B, C, D, E, F, G) and the Virtual Radiology Consultants (VRC), (Practitioners H, I, J, K, L, M, N, O, P, Q, R, S, T). The administrative staff reported a census of 90 inpatients per month and 1500 outpatients per month using various radiological procedures.

Failure to complete external peer review could potentially expose patients to undiagnosed, mis-diagnosed, and/or inappropriate medical care.

Findings include:

1. Review of Medical Staff Bylaws on 3/23/11, with a revision date of February 2010, stated in part..."1.12 Peer Review means the process of evaluating care rendered generally or to individual patients in the hospital and the process of evaluating the credentials, fitness, or performance of individual practitioners, and therefore includes, without limitation, risk management activities of the Medical Staff, professional review activity involving practitioners, the credentialing, application, appointment, and reappointment process, the hearing and appeals process, the utilization review and quality assurance functions cared on with in the Medical Staff committee or hospital structure, and all functions treated as peer review under Iowa law and all functions treated as professional review activity or otherwise eligible for immunity under HCQIA (Health Care Quality Improvement Act) and under state law....Information. In reviewing applications for reappointment and renewal of privileges, the Medical Staff and Board will not be limited to review of information supplied within or in support of the application, but may review and consider any other records and information deemed relevant to their review. Without limitation, this may include review of such items as: (2) Utilization review, quality assurance, and other peer review records and reports."

Review of the Critical Access Hospital Network Agreement on 3/23/11, dated August 1, 2005, stated in part..."The Network hospital will assist the CAH upon request from time to time, in identifying and arranging for qualified physicians and other practitioners to consult with the CAH on peer review matters, including but not limited to the establishment of standards and protocols, the provision of peer review and advice with respect to individual patient records, and service and peer review committees or hearing panels.

2. During an interview on 3/23/11 at 11:00 AM, Staff A, Quality Assurance Director, verified that CAH staff had not completed external peer review for 13 of 13 VRC and 7 of 7 NIRC practitioners. According to Staff A, they had a contract ready to begin the process of external peer review for radiologist, but they had not started the process yet.

During an interview on 3/23/11 at 11:18 AM, Staff B, Director of Radiology, reported they were not completing external peer review for the VRC and the NIRC practitioners. Seven of 7 NIRC practitioners and 13 of 13 VRC practitioners read radiological films in the department.