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I. Based on observation, policy/procedure review, and staff interview the Critical Access Hospital (CAH) administration failed to ensure the security of anesthesia medications located in the Surgery Department. The Operating Room staff reported a case load of approximately 40 surgical cases per month.

Failure to secure anesthesia medications has the potential place patients at risk of receiving medications tampered with by unauthorized personnel.

Findings include:

1. An observation in the anti room between Operating Rooms #1 and #2, on 2/17/10 at 2:10 PM, revealed a small, unlocked refrigerator containing anesthesia medications and other medications ready for administration to surgery patients.

2. During an interview on 2/17/10 at 2:15 PM the Head Nurse of Surgery, acknowledged that staff did not lock the medication refrigerator when the surgery department is closed and housekeeping staff had access to the contents of the refrigerator after hours.

3. Observation in Operating Rooms #1 and #2, on 2/17/10 at 2:20 PM, revealed a locked cabinet near the head of the surgical bed. When asked, the Head Nurse of Surgery revealed the cabinet contained all medications used by anesthesia personnel during surgery. The cabinet contained anesthesia medications, narcotic analgesic medications, and intravenous fluids. Staff kept the key for the anesthesia medication cabinet in the top drawer of an unlocked anesthesia cart. The anesthesia medication cabinet and anesthesia cart were less than 3 feet apart.

4.During an interview on 2/17/10 at 2:25 PM, the Head Nurse of Surgery, confirmed the OR staff kept the keys to the anesthesia medication cabinets in the unlocked anesthesia cart less than 3 feet away from the medication cabinet. The Head Nurse of Surgery also confirmed housekeeping has access to the operating rooms and the contents of the anesthesia medication cabinets after the surgery department is closed.

5. Review of the Anesthesia Policies/Procedures and Surgery Policies/Procedures revealed no evidence of a policy that addressed the security of anesthesia medication in the OR rooms or anti-room.


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II. Based on review of the Critical Access Hospital (CAH) documents, observations, and staff interviews the CAH failed to ensure the safe storage and handling drugs in the Pharmacy. The CAH stated a census of 7 in-patients.

Failure to ensure the safety of medications could and did result in the loss of scheduled IV medication.

Findings included:

1. A review of the CAH's Policy,
a. "Pharmacist Job Description" effective date 4/08 stated: Job Duties: 1. Know and adheres to all laws and regulations pertaining to patient health, safety and medical information.
b. "Narcotics or Other Controlled Drugs" reviewed 2/08 stated: Policy: Maintain accountability of controlled substances as to meet state and Federal Regulations and prevent inappropriate use. Purchasing personnel are to contact either pharmacy or nursing personnel to have them unlock the pharmacy door and allow them to place the drug order in the pharmacy.

c. "Potential Error/Event Reporting System (PEERS)" report dated 12/29/09 noted on 11/3/09 an actual count was done on the Lorazepam injection. On 12/21/09 an actual count was done on the Lorazepam injections in the pharmacy. We were noted to be short 10 doses. The pharmacist checked the 100 wing count and refills, Emergency room count and refills and outdated meds. Intervention placed: lock box for the Lorazepam injection vials in refrigerator.

d. Manufacture's insert of Lorazepam Injection noted: Lorazepam an anti-anxiety medication intended for Intramuscular or intravenous routes of administration. Drug Abuse and Dependence: Lorazepam is a controlled substance in Schedule IV. Lorazepam injection has a potential for abuse and may lead to dependence.

e. "Security", dated 3/04 note the policy is to ensure appropriate control over drugs and chemicals in the pharmacy. Access to Pharmacy when pharmacist absent: 2 keys are available to non-pharmacist personnel: one key held by the hospital Director of Nursing and one held by the charge nurse and passed at each shift change.

In an interview on 2/17/10 at 4:20 PM, the Director of Nursing (DON) stated this policy needed to be updated to reflect who now has access to keys. The DON provided a list of staff who have access to Pharmacy when working as house supervisor (ER) or charge nurse. This list of 12 staff members consisted of Registered nurses, Paramedics and Purchase Personnel.

2. Observation during the initial pharmacy tour on 2/16/10 at 2:00 PM noted a locked plastic box in the refrigerator containing two boxes of injectable Lorazepam 2 mg/1 ml vials. A numbered red plastic lock secured the Lorazepam in the plastic box. The Pharmacist stated that during a routine inventory check 10 vials of injectable Lorazepam were noted to be missing. The hospital investigation lacked a resolution to where the vials of injectable Lorazepam had gone. The Pharmacist stated the investigation continues at this time. On 2/18/10 the Pharmacist provided a facsimile (fax) addressed to the Iowa Board of Pharmacy reporting the missing injectable Lorazepam.

3. During an interviews on 2/17/10:
a. 8:20 AM, the DON noted an investigation continued on the missing Lorazepam. At this time all Lorazepam given to patients had been accounted for. The DON indicated the Pharmacist wanted to continue to investigate to see if the missing medication showed up.

b. 12:15 PM, the Pharmacist stated the 10 vials of Lorazepam 2 mg/1ml was not a "significant loss" of this medication. The Pharmacist indicated the box could have possibly gone on the ambulance during a transfer of a patient and just hadn't been recorded yet. The Pharmacist indicated when he called the Iowa Board of Pharmacy he was instructed to refer to his compliance officer on policy of reporting the incident to Iowa Board of Pharmacy. The Pharmacist stated the Hospital Compliance Officer felt this incident didn't need to be reported as is was not a "significant loss" of medication. The Pharmacist stated to finish off the investigation, he would report the incident. The Pharmacist provided a copy of the incident reported to the Iowa Board of Pharmacy.

c. 12:50 PM, the DON provided a copy of the pharmacy log for 10/27/09 through 1/7/10. The DON stated the log indicates personnel who accessed the pharmacy may not be on the list of approved staff. The DON noted at times the person in charge of the key to Pharmacy would give the key to another person to access pharmacy for medications needed. The DON indicated she was not comfortable with this practice and had relayed this information to the supervisors.

d. 2:30 PM, Surgery supervisor stated she had a key to the pharmacy. The Surgery Supervisor indicated when she was busy she would give the key to another nurse for access into Pharmacy to retrieve medications needed. "I've worked with most of these nurses and feel comfortable with giving them the key. We have done it this way for the 20+ years I've worked here." The Surgery Supervisor noted she wasn't aware of any policy of who could or could not have a key to the Pharmacy.

4. During a tour of purchasing/delivery area on 2/18/10 at 10:00 AM, Staff A, purchasing personnel, explained the process when medications are delivered to the storage room. Medications are delivered in bins with a purchasing slip. Staff A compares the purchasing slip with the medications delivered. Each medication received has a "bar code" type sticky paper to attach to the medication bottle for billing.

Staff A retrieves the pharmacy key from the Pyxis system in the ER, this requires Staff A's password and fingerprint to record who removed the key. Two keys noted on the key ring retrieved, one for the pharmacy door and one for the file drawer to lock up any narcotics that may be in the supply of medication delivered.

Staff A stated the key to the file drawer for narcotics was on the key ring in the Pyxis in ER and the Supervisor of the day would also have a key to the file drawer in pharmacy.

5. Review of the Pharmacy Log showed that staff documented each time they entered the pharmacy and any medications they removed from the pharmacy. Review of the Pharmacy Log from 10/27/09 through 1/7/10 showed unauthorized staff accessed the pharmacy 30 times.

6. During an interview on 2/18/10 at 10:30 AM, the DON stated the supervisor carries a key for Pharmacy and for the file to lock up narcotics until the Pharmacist arrives. The DON also stated that the Purchasing personnel alerted the supervisor when narcotics were delivered and the supervisor locked the narcotics in the file drawer. The DON stated she was unaware the ER Pyxis system held a key to both the Pharmacy and the file drawer for locking up narcotics. The DON stated, "I'm not comfortable with this process, we will have to review our Pharmacy access process".

Based on observation, record review, and staff interview, the CAH (Critical Access Hospital) staff failed to maintain a clean and sanitary kitchen environment. The CAH had a census of 7 patients.

Failure to maintain a clean and sanitary kitchen environment could potentially result in a food borne illness outbreak.

Observations on 2/16/10 at 2:06 PM, during the initial tour of the dietary department, revealed the following:
a. Two Norlake freezers with dried on food debris and food crumbs on the floor of the freezers.
b.Observation of the inside surface of the stainless steel hood over the oven showed a greasy build-up of black-brown lint

Review of the Dietary policies/procedures last reviewed, 2/24/09 stated in part ..." A daily and weekly cleaning schedule is posted and is to be followed. Weekly sanitation check is to be made in department ... " Review of the weekly cleaning logs verified that dietary staff cleaned the freezers and the oven hood weekly.

During an interview on 02/16/10 at 2:06 PM, the Director of Nutrition Services verified the above findings.

Based on policy/procedure review and staff interview the hospital failed to provide radiation-detecting devices for all operating room nurses, surgeons, and anesthesiologists while performing procedures involving a C-Arm fluoroscope. The hospital identified an average of 2 to 3 fluoroscope procedures per week where staff utilized the C-Arm.

Failure to provide staff with radiation-detecting devices could potentially allow a staff member to receive unrecognized large quantities of radiation, and result in health hazards such as cancer or death.

Findings include:

1. Review of hospital policy titled Radiation Safety revealed the hospital failed to implement policies and procedures that address surgical and operating room (OR) personnel exposure to ionizing radiation during fluoroscopy procedures.

2. Review of Radiology Department policy titled Employee Safety (Revision date 3/04) revealed:

Section: Radiation Safety, # B. Wear film badges while on duty; then leave them in an area protected from heat, moisture, chemical, and radiation exposure.

3. During an interview, on 2/17/10 at 1:30 PM, the Head Nurse of Surgery reported fluoroscopy procedures are done in the hospital's operating room. During fluoroscopy procedures the x-ray technician is in "charge" of the machine and OR staff/physicians are present in the room. All staff and physicians in the operating room wear lead shielding but they do not wear dosimeters. When asked if the OR personnel received training or education specific to fluoroscopy, the Head Nurse of Surgery stated "No".

Based on observation, document review, and staff interview, the CAH administration failed to secure patient medical records in the Radiology Department and the Physical Therapy Department against unauthorized access.

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

Findings include:

1. Tour of the Radiology Department on 2/16/10 at 1:15 PM, reveled an open room, identified by the Director of Radiology as a file room. Located in the room were several rows of floor to ceiling shelving units that contained unsecured radiology files. The files contained radiology films labeled with patient identifying information.

2. During an interview on 2/16/10 at 1:20 PM, the Director of Radiology acknowledged the radiology films stored in the file room were labeled with patient identifying information and the file room was unlocked at all times. The Director of Radiology also acknowledged that housekeeping had access to the file room when staff was not present.

3. Tour of the Physical Therapy Department on 2/16/10 at 2:30 PM, reveled an open two-drawer file cabinet, located at the receptionists desk that contained open medical records of current patients seen in the Physical Therapy Department. Additionally, an unlocked cabinet behind the receptionist ' s desk contained medical records of past Physical Therapy patients.

4. During an interview on 2/16/10 at 2:35 PM, the Director of Physical Therapy acknowledged the medical records were unsecured and accessible to unauthorized personnel.

5. Review of Health Information policies and procedures titled Access to Medical Records, reviewed/revised 4/2007, revealed, in part: "All patient care information shall be regarded as confidential and be available only to authorized users".

Based on policy review, medical record review, and staff interview the Critical Access Hospital (CAH) administration failed to ensure a qualified practitioner evaluated each patient for proper anesthesia recovery prior to discharge for 5 of 6 patient closed records reviewed (Patient's #11, #12, #13, #14, and #15). Surgery department staff reported approximately 20 outpatient surgical procedures are performed per month.

Failure to provide a proper anesthesia recovery assessment by a qualified practitioner could potentially harm patients if complications, related to the use of anesthesia, occur after surgery and the patient has returned home.

Findings include:

1. Review of Palo Alto Community Health System Anesthesia Policy titled: "Patient Care Policies", reviewed/revised 3/04, revealed:
a. Procedure: C: Post-Anesthesia Record: 4. The patient will be released from the Post Anesthesia Care Unit (PACU) on order from the operating practitioner and/or when established PACU discharge criteria have been met ....
b. The policy lacks a requirement for a qualified practitioner to assess the patient prior to discharge.

2. Review of the medical records for Patient's #11, #12, #13, #14, and #15, revealed a qualified practitioner failed to document a post anesthesia assessment in each patients' medical record prior to the patients being discharged to home.

3. During an interview, on 2/17/10 at 1:15 PM, the Head Nurse of Surgery reported that a qualified practitioner completes the post anesthesia assessment after surgery when the patient transfers to the Registered Nurse in the PACU. The qualified practitioner completes the assessment at that time and would not complete any further assessment prior to the patient discharge. The Registered Nurse who discharges the patient assesses the patient prior to discharge. The Head Nurse of Surgery agreed that the CAH policy lacked a requirement for the qualified practitioner to assess each patient and document the assessment prior to the patient ' s discharge.