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I. Based on observations, staff interview, and policy/procedure review, the Critical Access Hospital (CAH) pharmacy staff failed to remove all outdated medication from the pharmacy, in accordance with CAH policy. The CAH had an average inpatient census of 4 patients per day.

Failure to remove expired medications from the Pharmacy shelves puts patients at risk of receiving less effective, ineffective, or poisonous medications potentially resulting in patients failing to improve, deterioration of their condition, longer hospital stay, and/or death.

Findings included:

1. Observation in the CAH Pharmacy on 1/4/11 at 10:10 AM, with the CAH Pharmacist, revealed the following expired medications available for patient use:
a. 1 (of 1) Ceftriaxone injection (antibiotic) 250 mg, expired on 8/2010.
b. 1 of 2 Byetta Exenatide injection (diabetes medication) pens expired on 8/2010.
c. 10 of 10 Atracurium Besilate (muscle relaxant) multi dose vials expired on 7/2010.

2. During an interview, at the time of the observation, the Pharmacist acknowledged that the medications were outdated and available for patient use. The Pharmacist further acknowledged that, they could not guarantee the efficacy of expired medications. The Pharmacist immediately removed the medications from the Pharmacy shelves.

3. During an interview, on 1/4/11 at 10:20 AM, the CAH Pharmacist reported that the Pharmacy Technician is responsible for checking the Pharmacy for outdated mediations and removing the medications from the Pharmacy shelves.

4. Review of CAH Pharmacy policy/procedure titled "Outdate, Mislabeled, or otherwise Unusable Medications: Storing and Disposing of" revised 3/18/2010, revealed the following, in part. "Policy - No outdated, mislabeled, or otherwise unusable medication shall be dispensed to patients." "Medications in the pharmacy will be removed on a quarterly basis before they outdate."

II. Based on observations, staff interview, and policy/procedure review, the Critical Access Hospital (CAH) pharmacy staff failed to remove all outdated medication from the Omnicells located in the Emergency Room (ER) and the medical/surgical inpatient unit, in accordance with CAH policy. The CAH had an average inpatient census of 4 patients and approximately 15 ER visits per day.

Failure to remove expired medications from the Pharmacy shelves puts patients at risk of receiving less effective, ineffective, or poisonous medications potentially resulting in patients failing to improve, deterioration of their condition, longer hospital stay, and/or death.

Findings included:

1. Observation of the Omnicell located in the Emergency Room (ER) medication room, on 1/4/11 at 1:30 PM, with the CAH Pharmacy Technician, revealed the following expired medication in the Omnicell available for patient use:
a. 4 of 4 Lidocaine HCl 1% injection, 5 ml syringes, expired on 9/2010.
b. 6 of 6 Infant Sodium Bicarbonate 4.2% injection, 10 ml syringes, expired on 7/2010.
c. .3 of 3 25% Dextrose injection, 250 mg per ml syringes, expired on 5/2010.

2. Observation of the Omnicell located in the medical/surgical medication room, on 1/5/11 at 7:50 AM with the CAH Pharmacy Technician, revealed the following expired medication in the Omnicell available for patient use:
a. 6 of 12 Ampicillin 1 gram vials expired on 9/2010.
b. 2 of 4 Nalbuphine 10 mg/ml 10 ml multi dose vials expired on 6/2010.

3. During an interview, at the time of the ER observation, the Pharmacy Technician acknowledged that the medications were outdated and available for patient use. The Pharmacy Technician further acknowledged that, they could not guarantee the efficacy of expired medications. The Pharmacy Technician immediately removed the medications from the Pharmacy shelves.

4. During an interview, at the time of the Medical/Surgical inpatient observation, the Pharmacy Technician acknowledged that the medications were outdated and available for patient use. The Pharmacy Technician further acknowledged that, they could not guarantee the efficacy of expired medications. The Pharmacy Technician immediately removed the medications from the Pharmacy shelves.

5. During an interview, on 1/5/11 at 8:35 AM, the Pharmacist reported that after finding the outdates in the ER Omnicell, the Pharmacist and the Pharmacy Technician went back and checked the medications against the dates of expiration entered into the system. The Pharmacist found that they had entered the correct month of expiration, but the incorrect year of expiration in the system. The Pharmacist reiterated stating, " We may have mis-entered the year of expiration."

6. Review of CAH Pharmacy policy/procedure titled "Outdate, Mislabeled, or otherwise Unusable Medications: Storing and Disposing of," revised 3/18/2010, revealed the following, in part.
" ...Policy - No outdated, mislabeled, or otherwise unusable medication shall be dispensed to patients. Medications in the pharmacy will be removed on a quarterly basis before they outdate ...."


III. Based on observation, document review, and staff interview, the Critical Access Hospital (CAH) pharmacy staff failed to ensure the anesthesia providers dated vials of paralytic medications when they removed 1 of 1 vial of succinylcholine, and 4 of 4 vials of rocuronium bromide from the refrigerator, and stored them at room temperature. The Operating Room/Emergency Room (OR/ER) nurse manager stated the surgical services staff performed an average of 12 surgical procedures involving anesthesia per month.

Failure to date the vial when anesthesia providers remove succinylcholine and rocuronium bromide vials from the refrigerator to room temperature could potentially result in patients receiving excessive doses of anesthesia medications, and potentially result in side effects such as prolonged recovery from the medication, or even death.

Findings include:

1. Observations, during a tour of the operating room, revealed 1 of 1 anesthesia medication cart located in the operating room. The anesthesia medication cart contained 1 of 1 multi-dose vial of succinylcholine 200 mg/10 mL, which lacked a date when anesthesia staff had removed the medication from the refrigerator. The anesthesia medication cart also contained 4 of 4 multi-dose vials of rocuronium bromide 10 mg/mL, which lacked a date when anesthesia staff had removed the medication from the refrigerator. The anesthesia staff stored the vials at room temperature.

2. During an interview, at the time of the tour, the OR/ER manager confirmed the vials of succinylcholine and rocuronium bromide lacked documentation of when anesthesia staff removed the medications from the refrigerator.

3. Review of the manufacturer's instructions for succinylcholine, not dated, revealed in part, "Store in refrigerator... The multi-dose vials are stable for up to 14 days at room temperature without significant loss of potency."

4. Review of the manufacturer's instructions for rocuronium bromide, issued 11/08, revealed in part, "Rocuronium bromide ... should be stored in a refrigerator... Upon removal from refrigeration to room temperature storage conditions ... use rocuronium bromide ... within 60 days."

5. During an interview on 1/3/11 at 2:45 PM, the Pharmacist stated the anesthesia providers did not date when they removed the succinylcholine and rocuronium bromide from the refrigerator. If the medications lacked potency, the anesthesia providers administered additional medication to the patient, until the anesthesia providers achieved the desired level of paralysis.

Based on observation, document review, and staff interview, the Critical Access Hospital (CAH) Surgical Services administrative staff failed to ensure surgical staff tested the disinfecting solution in 1 of 1 Automated Endoscope Reprocessors before each use, and the disinfecting solution in 2 of 2 disinfecting buckets. Surgical Services administrative staff identified an average of approximately 40 endoscopy procedures per month.

Failure to test the disinfecting solutions prior to each use could potentially result in the disinfecting solution lacking sufficient strength of the active ingredient to kill all microorganisms, resulting in the spread of infectious microorganisms between patients.

Findings include:

1. Observations, during a tour of the sterile processing area, on 1/3/11 at 1:10 PM revealed 2 of 2 large basins contained Cidex OPA Solution. Additional observations during the tour revealed 1 of 1 automated endoscope reprocessor that contained Cidex OPA Solution.

2. Review of the Cidex OPA Solution Test Log, revealed surgical services staff only tested the Cidex OPA Solution once per day.

3. During an interview, at the time of the tour, the OR/ER nurse manager stated surgical services staff only tested the Cidex OPA Solution, in both the disinfecting buckets and Automated Endoscope Reprocessor, at the beginning of the day, and did not test the Cidex OPA solution prior to each time staff used the Cidex OPA Solution to disinfect equipment.

4. Review of the manufacturer's directions for Cidex OPA Solution, copyright 2006, revealed in part, "The [active ingredient] concentration of Cidex OPA Solution during its use-life must be verified by the Cidex OPA Solution Test Strips prior to each use..."
5. During a further interview, at the time of the tour, the OR/ER nurse manager acknowledged the surgical services staff did not follow the manufacturer's recommendations to test the Cidex OPA Solution prior to each time staff used the solution to disinfect equipment. Surgical services staff had interpreted the directions to instruct staff to test the solution once a day. However, "after reading the directions, it makes sense to test the solution prior to each time staff use the solution to disinfect equipment."

Based on observation, staff interview, and document review, the Critical Access Hospital's (CAH) administrative staff failed to develop a policy requiring all staff exposed to radiation in the operating room to wear a dosimetry badge in the operating room, and provide dosimetry badges to all staff in the operating room during surgical procedures utilizing 1 of 1 C-Arm fluoroscopes. The CAH staff performed an average of 4 surgical procedures utilizing the C-Arm fluoroscope per month, with 3 staff members present in the room during the procedures that utilized the C-Arm fluoroscope.

Failure to provide dosimetry badges for all staff could potentially result in repeated staff exposure to unsafe levels to unintentional, and unknown amounts of x-rays, which could cause cancer or death.

Findings include:

1. Observations during a tour of the Surgery Department on 1/3/11 at 1:10 PM revealed 1 of 1 C-Arm Fluoroscope.

2. During an interview at the time of the tour, the Operating Room/Emergency Room (OR/ER) nurse manager stated that during use of the C-Arm Fluoroscope, all surgical services staff leave the room, except for the surgeon, anesthesia provider, and radiation technologist. The surgeons and anesthesia providers had chosen to not wear dosimetry badges.

3. Review of the policy, "Radiation Safety", effective 12/31/02, revealed the policy lacked a requirement for all staff present in the operating room during the use of a C-Arm Fluoroscope to wear dosimetry badges.

4. Review of the document "Film Badge Usage", dated 8/3/09, provided by the Radiology Manager, revealed CAH administrative staff asked surgeons and anesthesia providers if they wanted to wear dosimetry badges. The surgeons and anesthesia providers "decided they did not want to have to wear the [dosimetry] badges."

5. During a further interview at the time of the tour, the OR/ER manager acknowledged the surgeon and anesthesia provider could have received an undetected exposure to radiation, since the surgeon and anesthesia provider did not wear dosimetry badges.

Based on review of documents and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure all physicians authenticated, dated and or timed, all orders for 3 of 5 inpatient medical records (Patient #6, 7, and 8), 5 of 5 closed inpatient medical records (Patient #1, 2, 3, 4, and 5), 7 of 10 closed inpatient physical therapy orders (Patient #25, 26, 27, 29, 30, and #32), 8 of 10 closed inpatient speech therapy orders (Patient # 9, 10, 11, 12, 13, 14, 15, and 20), and 7 of 7 closed inpatient occupational therapy orders (Patient #17, 19, 20, 21, 23, and 24). The CAH administrative staff identified an average daily inpatient census of approximately 4 patients, an average monthly inpatient physical therapy census of 32 patients, an average monthly inpatient occupational therapy census of 10 patients, and an average monthly inpatient speech therapy census of 10 patients.

Failure to authenticate, date and or time record entries potentially could cause harm to patients by delay in treatments, actions or assessments provided.

Findings included:

1. Review of Medical Staff Bylaws dated January 2009 showed the Bylaws lacked a requirement for authentication, dating and timing of physician orders.

2. Review of CAH policy titled "Verbal, Written or Telephone Medication and Treatment Orders" dated, 11-8-10 revealed in part ":...prescriber must sign the order the next time the prescribing Practioner provides care to the patient, assess the patient, or documents information in the patient's medical record."

3. Review of Patient #6's medical record showed:
a. 1 of 1 speech therapy orders lacked the date and time the physician wrote the order.
b. 1 of 1 physical and occupational therapy orders lacked the date and time the physician wrote the order.
c. 3 of 3 verbal orders lacked authentication/counter signature.
d. 1 of 1 admission/physician orders lacked the time the physician wrote the order.

4. Review of Patient #7's medical record showed:
a. 1 of 1 physical and occupational therapy orders lacked the time the physician wrote the order.
b. 1 of 1 admission orders lacked the time the physician wrote the order.
c. 1 of 2 orders lacked the time the physician wrote the order.

5. Review of Patient #8's medical record showed 1 of 1 pre and post colonoscopy orders lacked the time the physician wrote the order.

6. Review of Patient #1's medical record showed 1 of 1 verbal orders lacked authentication/counter signature, the date and time of the physician's verbal order.

7. Review of Patient #2's medical record showed 2 of 2 verbal orders lacked authentication/counter signature, the date and time of the physician's verbal order.

8. Review of Patient #3's medical record showed:
a. 1 of 1 admission orders lacked the time the physician wrote the order.
b. 1 of 1 verbal orders lacked authentication/counter signature, the date and time of the physician's verbal order.

9. Review of Patient #4's medical record showed:
a. 2 of 2 verbal orders lacked authentication/counter signature, the date and time of the physician's verbal order.
b. 1 of 1 physician's order for occupational therapy lacked the time the physician wrote the order.
c. 1 of 1 physician's admission order sheet lacked the time the physician wrote the orders.

10. Review of Patient #5's medical records showed 1 of 1 verbal orders lacked authentication/counter signature, the date and time of the physician's verbal order.

11. Review of closed physical therapy medical records showed the medical providers failed to authenticate, date and or time 1 of 1 physical therapy treatment orders in 7 of 10 medical records (Patients #25, 26, 27, 29, 30, 31, and 32).

12. Review of Patient #9's medical record showed.
a. 1 of 1 verbal orders lacked authentication/counter signature, the date and time of the physician's verbal order.
b. 1 of 1 physicians orders for speech therapy services lacked the time the physician wrote the order.

13. Review of Patient #10's medical record showed 3 of 3 verbal orders lacked authentication/counter signature, the date and time of the physician's verbal order for speech therapy.

14. Review of Patient #11's medical record showed 4 of 4 speech therapy entries lacked the date and time when the physician authorized evaluations/therapy recommendations.

15. Review of Patient #12's medical record showed:
a. 2 of 2 verbal orders lacked authentication/counter signature, the date and time of the physician's verbal order.
b. 2 of 2 speech therapy entries lacked the date and time when the physician authorized evaluations/therapy recommendations and 1 of 1 lacked physician signature.

16. Review of Patient #13's medical record showed:
a. 1 of 1 physicians order for speech therapy lacked the time the physician wrote the order.
b. 1 of 1 physician's admission order sheet lacked the time the physician wrote the orders.

17. Review of Patient #14's medical record showed:
a. 3 of 3 verbal orders lacked authentication/counter signature, the date and time of the physician's verbal order.
b. 2 of 2 speech therapy entries lacked the date and time when the physician authorized evaluations/therapy recommendations.
c. 1 of 1 speech therapy dysphagia evaluation and treatment plan lacked the date the physician reviewed the plan.
d. 1 of 1 physician's admission order sheet including but not limited to occupation therapy evaluation and treatment orders lacked the time the physician wrote the orders.

18. Review of Patient #15's medical record showed:
a. 1 of 1 speech therapy dysphagia evaluation and treatment plan lacked the date the physician reviewed the plan.
b. 3 of 3 verbal orders lacked authentication/counter signature, the date and time of the physician's verbal order.
c. 1 of 1 physician order for speech therapy services lacked the time the physician wrote the order.

19. Review of Patient #20's medical record showed:
a. 1 of 1 lacked authentication/counter signature, the date and time of the physician's verbal order.
b. 1 of 1 speech therapy entries lacked the date and time when the physician authorized evaluations/therapy recommendations.
c. 1 of 1 physician's admission order sheet lacked the time the physician wrote the orders.

20. Review of Patient #17's medical record showed 1 of 1 physician's admission order sheet including but not limited to occupation therapy evaluation and treatment orders lacked the time the physician wrote the orders.

21. Review of Patient #19's medical record showed 1 of 1 occupation therapy treatment plan lacked the date the physician reviewed the plan.

22. Review of Patient #21's medical record showed 1 of 1 physician's admission order sheet including but not limited to occupation therapy evaluation and treatment orders lacked the time the physician wrote the orders.

23. Review of Patient #22's medical record showed 1 of 1 physician's admission order sheet including but not limited to occupation therapy evaluation and treatment orders lacked the time the physician wrote the orders.

24. Review of Patient #23's medical record showed 1 of 1 physician's admission order sheet including but not limited to occupation therapy evaluation and treatment orders lacked the time the physician wrote the orders.

25. Review of Patient #24's medical record showed 1 of 1 physician's admission order sheet including but not limited to occupation therapy evaluation and treatment orders lacked the time the physician wrote the orders.

26. During an interview, and review of the sampled medical records, on 1/5/2011 at 1:20 PM, the Chief Nursing Officer (CNO) confirmed the findings. The CNO reported that the they had not required the physicians to authenticate, date and time medical record entries.

Based on observation, document review, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to secure all medical records in 1 of 1 basement storage area, and 1 of 1 Health Information Management (HIM) department storage area, against unauthorized access. The CAH Health Information Manager identified approximately 43,000 medical records stored in the CAH.

Failure to secure medical records against unauthorized access could potentially result in unauthorized disclosure of patient information, including name, date of birth, or social security number.

Findings include:

1. Review of the policy, "Release of Information Policy", reviewed 3/24/10, revealed in part, "All information in the patient medical records shall be kept confidential and secure."

2. Observations during a tour of the basement storage area on 1/4/11 at 1:30 PM revealed:

a. 4 shelving units approximately 6 feet tall, with 5 shelves per unit, filled with radiology medical records, which contained patient names, date of birth, and all radiology procedures performed on the patient.

b. 2 shelves approximately 4 feet wide, filled with radiology medical records, which contained patient names, date of birth, and all radiology procedures performed on the patient.

3. During an interview at the time of the tour, the Plant Services Supervisor stated volunteers from the auxiliary gift shop went into the basement storage area without CAH staff present, and acknowledged the volunteers could access patient medical records, without a need to know the information in the medical records.

4. Observations during the tour of the basement storage area on 1/4/11 at 1:30 PM also revealed a locked storage cage that contained:

a. 10 large boxes filled with medical records, and the medical records contained the patient's name, date of birth, and personal medical information.

b. 19 large boxes filled with medical records from deceased patients, and the medical records contained the patient's name, date of birth, and personal medical information.

c. 2 large boxes filled with medical records from patients who had stress tests performed at the CAH. The medical records contained the patient's name, date of birth, and personal medical information.

d. 1 large box filled with diabetic education medical records. The medical records contained the patient's name, date of birth, and personal medical information.

e. a 9 drawer filing cabinet labeled "Master Index Cards." Each card included the patient's name, date of birth, date of service, and medical diagnosis.

f. 10 boxes of personnel records, containing name, date of birth, and social security number.

g. 8 boxes of CAH accounting records.

5. During an interview at the time of the tour, the Plant Services Supervisor stated CAH accounting and human resources staff, who did not have a need to know patient medical information, could access the patient medical records in the locked storage cage.

6. Observations during a tour of the Health Information Management department on 1/4/11 at 3:00 PM, revealed approximately 43, 000 active medical records stored on movable storage shelves. The department also contained microfilm medical records for all patients from 1990-2003. The medical records contained the patient's name, date of birth, and personal medical information.

7. During an interview on 1/4/11 at 3:00 PM, the HIM Department Manager stated environmental services staff cleaned the department, including the record storage area, before HIM staff arrived in the morning. The HIM Department Manager acknowledged that environmental services staff could access patient medical records, and the environmental services staff did not have a need to know the patient's medical information.