HospitalInspections.org

I. Based on observation, staff interviews and policy review the Critical Access Hospital (CAH) pharmacy staff failed to secure medication in 1 of 1 Diabetes Education supply area and 3 of 3 anesthesia carts. Diabetes Education staff reported approximately 15 active patients at this time. The Surgery Manager stated approximately 62 surgeries performed per month.

Failure to secure medications could result in unauthorized access, usage, and distribution of medications.

Findings include:

1. During initial tour of the Diabetes Education supply area, on 6/27/11 at 3:30 PM, Staff M, Quality Assurance, opened the unlocked door to the unsupervised room. An unlocked refrigerator under the counter contained the following insulin:
2 pens of Victoza
11 vials of Lantus insulin 110u/ml
5 vials of Humalog mix 75/25
9 prefilled Kwik Humalog pens
3 pens of Byetta exenatide injectable 250mcg/ml
2 pens of Levenir Flex pen
20 pens of Lantus Solo Star

During an interview on 6/27/11 at 4:00 PM, Staff M confirmed the unlocked door and stated since insulin was in the refrigerator, the staff needed to lock either the refrigerator or the Diabetes Education room door. Staff M stated the Diabetes Educator shared the room and kept the insulin in the fridge for patients' education.

During an interview on 6/27/11 at 4:45 PM, Staff F, Pharmacist, stated the lock to the refrigerator in the Diabetes Education supply area did not always connect and lock the fridge. Staff F thought the staff placed a requisition for a new lock to the administrative staff. Staff F stated, "I know the fridge should have been locked if it holds insulin".

During an interview on 6/28/11 at 9:00 AM, Staff N, Diabetes Educator stated they used the Diabetes Education area to instruct patients managing their disease and used the sample insulin for education and patient use. According to Staff N, they log the insulin samples upon receipt and store the insulin in the refrigerator, which is usually locked, but acknowledged she "must have forgot" to lock the refrigerator.


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2. During an observation on 6/28/11 at 9:20 AM with Staff B, the Clinical Manager, revealed 3 locked cabinets in the Family Practice Clinic that contained the following sample medications available for patient use:

a. 18 tablets (tabs) Arthrotec 75 milligrams (mg) and 18 tabs of Arthrotec 50 mg.
b. 30 tabs Vimovo 500/20 mg.
c. 12 tabs Avelox 400 mg.
d. 168 tabs Singulair 4 mg, 140 tabs Singulair 10 mg, and 16 packets of Singulair granules 4 mg.
e. 1 Nasonex 50 micrograms (mcg) inhaler.
f. 2 Ventolin 90 mcg inhalers.
g. 2 Dulera 100/5 mcg inhalers.
h. 4 Asamanex 220 mcg inhalers, 6 Asamanex 110 mcg.
i. 2 Perforomist 20mcg/2 milliliters (ml) inhalers.
j. 15 Clarinex 5 mg tabs.
k. 1 Advair 45/21 mcg inhaler and 1 Advair 118/21 mcg inhaler.
l. 1 Symbicort 08/4.5 mcg inhaler.
m. 14 tabs Onglyza 5 mg.
n. 12 tabs Kombiglyze 2.5/100 mg, and 7 tabs Kombiglyze 5/500 mg.
o. 56 tabs Janumet 50/500 mg and 58 tabs Janumet 100 mg.
p. 112 tabs Actoplus 15/850 mg.
q. 12 Namenda starter kits.
r. 12 boxes Seroquel 50 mg, 5 bottles of Seroquel 150 mg.
s. 12 boxes Lexapro 10 mg.
t. 6 bottles Straterra 18 mg.
u. 3 boxes Symbyax 3/325 mg.
v. 6 boxes Twynsta 80/5 mg.
w. 4 bottles Divan 160 mg.
x. 5 bottles Enablex 15 mg.
y. 8 boxes Savella 25 mg and 16 boxes Savella 50 mg.
z. 32 tabs Amitiza 24 mcg, and 128 tabs Amitiza 8 mcg.
aa. 75 packets Citracal tabs.
bb. 70 tabs Crestor 10 mg.
cc. 40 tabs Lipitor 10 mg, 28 tabs Lipitor 20 mg, 28 tabs Lipitor 40 mg, and 28 tabs Lipitor 80 mg.
dd. 28 tabs Vytorin 10/40 mg.
ee. 12 tabs Simcor 500/20 mg.
ff. 48 tabs Tricor 45 mg.
gg. 77 tabs Zetia 10 mg.
hh. 6 tabs Actonel 35 mg.
ii. 6 tabs Atelvia 35 mg.
jj. 28 tabs Uloric 40 mg.
kk. 102 tabs Lysteda 650 mg.
ll. 84 tabs Loestrin 1mg/20 mcg.
mm. 4 boxes Pradaxa 150 mg.
nn. 4 boxes Plavix 75 mg.
oo. 6 boxes Aggrenox 25/200 mg.
pp. 39 boxes Bystolic 5 mg, 9 boxes Bystolic 10 mg, and 6 boxes Bystolic 20 mg.
qq. 2 bottles Hydrochlorothiazide (HCTZ) 160/12.5 mg, 4 bottles HCTZ 320/25 mg, and 4 bottles HCTZ 16/12.5 mg.
rr. 4 bottles Diovan 320 mg.
ss. 3 bottles Atacand 32 mg.
tt. 6 boxes Avapro 150 mg and 6 boxes Avapro 300 mg.

Review of the "Sample Medication Registration Log" and "Sample Medication Log Dispensed" showed staff had not reconciled the amount of medication the clinic had. The documentation failed to show pharmacy oversight of the sample medications.

During an interview on 6/28/11 at 9:20 AM, Staff B stated the Orange City Clinic does not reconcile the amount of medications currently in the clinic and pharmacy does not have oversight of the medications located in the clinic.

During an interview on 6/28/11 at 3:45 PM, Staff F, Pharmacist, stated the sales representatives bring the samples in for the different clinics, the pharmacy staff does not have anything to do with these medications. Staff F stated the clinic receives the medications and keeps their own medication log for their samples.


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Observation on 6/27/11 at 10:33 AM, during the tour of the surgery department, with Staff E, Surgery Manager, revealed 3 of 3 unlocked anesthesia carts, each anesthesia cart contained 1 drug tray. Pharmacy assembled the drug trays with breakaway locks to secure the Plexiglass lids. The drug trays contained various medications used for the following conditions:

Neuromuscular blocking agents Sedation
Bronchodilators Antibiotics
Local anesthetic and general anesthetic agents
Steroids Antihistamines
Respiratory stimulates Antiemetic
Muscle Relaxants Antiarrhythmics
Hypo and hypertensive agents Diuretics
Anticoagulants Vasodilators
Analgesics

Observation in Operating Room (OR) #1 revealed the tray of the anesthesia cart failed to have the Plexiglass lid secured in place. The unsecured tray contained the above medication. Additional observation revealed an open vial of rocuronium - used for rapid sedation, omnipaque - a contrast medium, and bupivacaine - used for local anesthesia) on top of the anesthesia cart.

During an interview on 6/27/11 at 11:35 AM, Staff E, Surgery Manager, stated the housekeeping staff cleaned the area unsupervised after hours. Staff E verified anesthesia staff left the key to the unlocked anesthesia carts in the lock of each cart.

During an interview on 6/27/11 at 11:35 AM, Staff D, Certified Registered Nurse Anesthetist, stated the anesthesia staff had not used the anesthesia cart in OR #1 on 6/27/11, and was unsure when the staff last used the drug tray. Staff D verified the unsecure drugs on top of the cart, and the anesthesia staff left the keys in the lock of the anesthesia carts for their convenience.

During an interview on 6/29/11 at 9:30 AM, Staff F, Pharmacist confirmed that anesthesia staff failed to follow the policy for securing anesthesia medications.

II. Based on observation, review of policies/procedures, documentation and staff interviews the Critical Access Hospital (CAH) pharmacy staff failed to develop and maintain a system to track and account for the receipt and distribution of sample drugs subject to oversight by the pharmacy. Problem identified in the Diabetes Education supply room and the Orange City clinical area.
Diabetes Educator stated there are approximately 15 active patients at this time. The Clinic manager stated the specialty clinic, the family practice clinic and the surgical care clinic evaluate and treat approximately 300 patients a day.

Failure of pharmacy staff to provide oversight of sample medications could potentially result in theft of medication by unauthorized persons and/or patients receiving outdated/unusable medications.

Findings include:

1. During initial tour of the Diabetes Education supply area, on 6/27/11 at 3:30 PM, Staff M, Quality Assurance, opened the unlocked door to the unsupervised room. An unlocked refrigerator under the counter contained the following insulin:
2 pens of Victoza
11 vials of Lantus insulin 110u/ml
5 vials of Humalog mix 75/25
9 prefilled Kwik Humalog pens
3 pens of Byetta exenatide injectable 250mcg/ml
2 pens of Levenir Flex pen
20 pens of Lantus Solo Star

Review of policy, "Sample Medication" review date 8/14/08 revealed in part, "...Medication samples may be permitted in facility-based clinics, when authorized by the Director of Pharmacy or representative of medical staff... Medication samples shall be controlled by the pharmacy. The Director of Pharmacy or designee shall inspect medication samples. Sample medications whose integrity and stability are suspect shall be destroyed...the pharmacy's routine inspections shall include a check for unauthorized and unusable (e.g., expired) medication samples..."

During an interview on 6/27/11 at 4:45 PM, Staff F, Pharmacist, stated the pharmacy staff does not review the sample insulin in the Diabetes Education area. Staff F stated the sales representatives bring the insulin to Staff N, Diabetes Educator, for their use. Staff F stated the Pharmacy staff does not have anything to do with the sample medications.

During an interview on 6/28/11 at 9:00 AM, Staff N, Diabetes Educator stated the staff log in the samples of insulin from the sales representatives. Staff N stated the staff used the insulin for education and for patient use. Staff N stated the pharmacy staff does not oversee the samples or the insulin log.

Based on observation, policy review, document review and staff interviews, the Critical Access Hospital (CAH) dietary staff failed to follow infection control policies and procedures when delivering of patient meal trays and sanitizing the meal tray delivery carts. The CAH Dietary Manager reported the dietary staff provided approximately 40 patient meals daily.

Failure to follow infection control policies and procedures could potentially result in transmission of infection and communicable diseases to the CAH patients.

Findings include:

1. Observation during patient meal tray delivery on 6/28/11 from 11:36 a.m. to 12:15 p.m., showed Staff J, AM dietary assistant, delivered 4 meal trays to inpatients and 3 meals to chemotherapy patients. Observation showed Staff J handled bedside tray tables, a call light, a water pitcher and a walker in the rooms, before placing meal trays in front of the patients. Staff J removed plastic wrap from beverages and salads in each room. Staff J failed to use hand sanitizer or wash hands when he/she left each patient room.

During an interview on 6/28/11 at 12:15 p.m., Staff J reported training included the use of hand sanitizer or washing hands if he/she touched a patient or handled money, before delivering patient meal trays.

Observation during patient meal tray delivery on 6/29/11 from 8:09 a.m. to 8:15 a.m. showed Staff I, AM dietary assistant, delivered two inpatient meal trays. Observation showed Staff I reposition a bedside tray table, a walker and oxygen tubing on the floor, before she placed the first meal tray in front of the patient. Staff I failed to use hand sanitizer or wash hands when leaving the room or entering the next room. Staff I removed plastic wrap from beverages and fruit, upon delivery of the second meal tray.

During an interview on 6/29/11 at 8:15 a.m., Staff I reported the only time he/she used hand sanitizer or washed her hands with patient meal tray delivery, included if she touched a patient or handled money.

During an interview on 6/29/11 at 8:50 a.m., Staff M, Director of Quality/Infection Control, reported involvement in education with all facility staff on infection control practices, which included hand hygiene. He/she relayed staff were trained to use hand sanitizer or wash hands upon departure from a patient room. He/she confirmed this included patient meal tray delivery by dietary staff.

During an interview on 6/29/11 at 9:00 a.m., Staff K, Dietary Manager, reported dietary staff were trained on proper hand washing during department orientation upon hire and at dietary staff inservices. He/she relayed staff were instructed to use hand sanitizer or wash hands if they handle money or touch the patient in the course of meal tray delivery. Staff K confirmed he/she had not trained dietary staff to wash hands or use hand sanitizer if items in the patient's room are touched .

During an interview on 6/29/11 at 10:40 a.m., Staff L, Consultant Dietitian, reported involvement in staff education and training of dietary staff at in-service meetings. She reported dietary staff were trained to wash hands or use hand sanitizer with patient meal tray delivery, if they touch the patient, handle money and upon return to the kitchen. Staff L confirmed dietary staff were a trained to wash hands or use hand sanitizer if they touched patient's items.

During an interview on 6/29/11 at 12:45 p.m., Staff M reported all CAH staff were required to complete an on-line training course annually, titled "Infection Prevention", which included good hand hygiene. Staff M was concerned that staff failed to sanitize their hands after touching patient items in accordance with facility policy/procedures and training. Staff M reported he/she completed an in-service with dietary staff yearly and contents included education on hand hygiene.

Review of the on-line training course titled "Infection Prevention" page number eight revealed in part "...Clean hands with patients: ...After contact with patient surroundings". Page number twenty revealed in part "Use an Antiseptic for Hand Hygiene: ...after contact with inanimate objects in the patient's vicinity".

2. On 6/28/11 at 11:42 a.m., Staff J entered the soiled utility room on the inpatient floor. Staff J removed a meal tray delivery cart from the room and transported it to the dish room in the kitchen. Staff J removed meal trays from the previous meal, then obtained a cloth from a bucket of sanitizing solution and wiped off the outside top of the cart. Staff J failed to sanitize the inside of the tray cart.

During an interview at 11:45 a.m., Staff J reported he/she always wiped off the top of the cart when returning to the dish room, only wiped down the rest of the cart if there were spills.

4. On 6/29/11 at 8:15 a.m., Staff I entered the soiled utility room on the inpatient floor. Staff I removed a meal tray delivery cart from the room and transported it to the dish room in the kitchen. Staff I removed the meal trays from the previous meal. Staff I obtained a cloth from a bucket of sanitizing solution and wiped off the outside top of the cart and the outside edges of the cart door.

During an interview on 6/29/11 at 8:25 a.m., Staff I reported he/she wiped off the top of the cart and around the outside edge of the cart door when returned to the dish room. She relayed the inside wiped down only if there were spills.

During an interview on 6/29/11 at 9:00 a.m., Staff K, reported dietary staff are trained to sanitize the outside top and handle of the meal tray delivery cart, when returned to the dish room. He/she further reported dietary staff were trained to sanitize the entire cart, inside and out, at the end of the day.

Review of policy number D-304 titled "Cleaning Tray Carts", dated 11/1/2010, revealed the following information in part. "...Carts must be wiped clean after each meal. Using mild facility approved germicidal solution and a sponge, wipe the inside and outside of each cart, rinse and allow to air dry.

Review of policy number IC 2.14 titled "Infection Control in Dietary Nutritional Food Services", dated 6/20/01, revealed the following information in part. "...Unitray carts are sanitized with a quaternary ammonium detergent-disinfectant inside and outside after each meal".

Based on observation, document review, and staff interviews, the Critical Access Hospital (CAH) administrative staff failed ensure all department staff protect all confidential patient information from unauthorized access in 1 of 1 Cardiac Rehabilitation rooms, 1 of 1 Health Information office and 1 of 1 Radiology departments. The CAH identified a census of 7 patients.

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

Findings include:

1. Observation on 6/28/11 at 3:10 PM with Staff C, Director of Radiology, revealed an open file cabinet with approximately 30 patient radiology films by the main x-ray work area. Another observation showed approximately 5,000 radiology films stored in the medical record storage room behind the Family Practice Clinic.

During an interview on 6/28/11 at 3:10 PM, Staff C said housekeeping staff clean the radiology department unsupervised after radiology staff leaveeft for the night. Staff C verified the quantity of radiology films in the radiology department and medical record storage room.


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2. Observations on 6/27/11 at 3:36 PM, during a tour of the Cardiac Rehabilitation room, with Staff M, Director of Quality, revealed the door to the Cardiac Rehabilitation room was unlocked. Observation inside the Cardiac Rehabilitation room revealed an unloked 2-drawer file that contained apporoximate 50 patient medical records.

Review of the policy titled "Confidentiality dated 5/20/11, revealed in part, "...An objective of the Health Information Department is to protect the confidentiality of primary and secondary health records ... The CAH administrative staff failed to address the security of medical records in the Cardiac Rehabilitation room ..."

During an interview on 6/28/11 at 9:15 AM, Staff N, Cardiac Rehabilitation nurse, verified the unlocked 2-drawer file contained patient medical records. Staff N stated she failed to lock the drawers at the end of the day.

3. Observations on 6/28/11 at 9:15 AM, during the tour of the Health Information office, with Staff H, Director of Health Information, revealed approximately 2000 patient medical records on open shelving units. Staff H stated that housekeeping cleaned the area unsupervised after business hours and would have access to patient files while cleaning.

Review of the policy titled " Confidentiality " dated 5/20/11, stated in part, " ...An objective of the Health Information Department is to protect the confidentiality of primary and secondary health records ... "

Based on document review, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure 2 of 3 Radiologists (A, B) selected for review, received external peer review. The CAH administrative staff reported of the 3 Radiologists on the medical staff, Radiologist A reviewed 874 procedures and Radiologist B reviewed 274 procedures.

Failure to insure all medical staff members received external peer review could potentially expose patients to inappropriate medical care.

Findings include:

1. Review of credential files on 36/29/11 at 10:30 AM revealed the following:

a. Radiologist A's credential file lacked documented evidence of an external peer.

b. Radiologist B's credential file lacked documented evidence of an external peer.

2. Review of the Addendum to the CAH Rural Health Network Agreement dated 4/11/2008, stated in part, "...Central Verification Office (CVO) will provide primary source verification of credentials for those making application as health care provider. The hospital CVO verification will include application reviews, professional peer references (including appropriateness and treatment) and credentials..."

3. During an interview on 6/29/11 at 10:30 AM, Staff M, Director of Quality, confirmed the CAH administration failed to ensure an external peer review for the Radiologists. Staff M stated, the Radiologists complete an internal peer review on each other.