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I. Based on observation, review of documentation, and staff interviews, the facility failed to remove expired medications from 2 of 2 emergency drug boxes in Radiology. The Radiology Department identified a daily volume of 10-20 diagnostic procedures.

Failure to remove expired medications from the emergency drug boxes could potentially result in patients receiving expired medications.

Findings include:

1. Observation on 11/26/12 at 3:20 PM, during the initial tour of the Radiology Department, with the Radiology manager revealed 2 emergency drug boxes located in Radiology room 2 and the CT (Computed Tomography) room.

The emergency drug box in Radiology room 2 contained 2 of 2 epinephrine 1:1000 ampules, used for treatment of allergic reactions, with expiration dates of 11/1/12.

The CT room emergency drug box contained:
- 4 of 4 vials of diphenhydramine HCL50 mg (milligrams), used for treatment of allergic reactions, that expired in 2/12;
- 1 of 1 naloxone HCL 0.4 mg vial, used for treatment of narcotic overdose, that expired on 8/1/12; and
- 3 of 3 epinephrine 1:1000 ampules, used for treatment of allergic reactions expired 9/1/12.

2. Review of the policy and procedure titled, Expired Medications, revised on 9/20/12, showed it stated in part ". . . Purpose: To assure that no medications are being used that are past the manufacturer's expiration date. . . Policy: Outdated and/or unusable medications shall be removed and stored away from usable stock until proper disposition can occur. . . Procedure: Routine inspections of all medication storage areas are performed on a monthly basis to the pharmacist or designees and expired and outdated medications are pulled. . .

Review of the document titled, Pharmaceutical Outdate Check, Year: 2012 showed the list used by Pharmacy staff to document the monthly checks for medication outdates lacked the emergency drug boxes in the Radiology Department.

3. During an interview on 11/26/12 at 3:20 PM, the Radiology Manager, revealed she could not remember the last time the Emergency Drug box was checked by pharmacy.

During an interview on 11/27/12 at 9:00 AM, the consulting Pharmacist, revealed Radiology was not checked for outdates and was not included on the document titled, Pharmaceutical Outdate Check. The Pharmacist revealed that the Pharmacy staff thought that the Radiology staff was checking for outdates. Radiology has now been added to the Pharmaceutical Outdate Check.


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II. Based on document review, observation, and staff interviews, the facility failed to ensure 1 of 1 Certified Registered Nurse Anesthetist C (CRNA C) documented the date she removed 2 of 2 vials of succinylcholine and 1 of 1 vial of rocuronium from refrigerated storage. CRNA C reported approximately 3 surgical procedures per month utilizing succinylcholine and rocuronium.

Succinylcholine and rocuronium required storage at refrigerated temperatures. Once the surgical services staff members removed the succinylcholine and rocuronium from refrigerated storage, the drugs expire before the printed expiration date. Failure to document the date that surgical services staff members removed the drugs from refrigerated storage could result in the staff members using drugs after the date the manufacturer warrants the efficacy of the drug.

Findings include:

1. Review of the policy DRUG EXPIRATION, effective 10/28/11, revealed, in part, Expiration Dating: All expiration dates are maximum allowable dates. Product stability, manufacturer instructions, and other Pharmacy policies and procedures may require a shorter expiration date.

Review of the policy ANESTHESIA MEDICATIONS, effective 8/15/08, revealed, in part, that rocuronium in unopened vials can remain at room temperature for 60 days after removal from refrigeration and Succinylcholine may be kept for 14 days at room temperature after removal from refrigeration without loss of potency. The policy required staff to date rocuronium and succinylcholine vials when placed in the anesthesia cupboard and discard them as indicated.

Review of the manufacturer's product insert for rocuronium (a long-acting muscle relaxing medication used during surgery), revised 7/11, revealed, in part, "Store refrigerated . . . Upon removal from refrigeration to room temperature storage conditions . . . use rocuronium . . . within 60 days."

Review of the manufacturer's product insert for succinylcholine (a short-acting muscle relaxing medication used during surgery), dated 1/11, 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."

2. Observations on 11/26/12 at 1:20 PM during a tour of the Operating Room, accompanied by the Operating Room Nurse Manager, revealed the following:

a. 2 of 2 vials of 200 mg (milligram) per 10 mL (milliliter) succinylcholine were stored at room temperature in the operating room anesthesia cabinet. Both vials lacked documentation of the date CRNA C removed the succinylcholine from refrigerated storage or the shortened expiration date (the date prior to the manufacturer's written expiration date caused by removing the drugs from refrigerated storage).

b. 1 of 1 vial of 50 mg per 5 mL rocuronium was stored at room temperature in the operating room anesthesia cabinet. The vial lacked documentation of the date CRNA C removed the rocuronium from refrigerated storage or the shortened expiration date.

3. During an interview at the time of the tour, the Operating Room Nurse Manager acknowledged the vials lacked documentation of either the date CRNA C removed the drugs from refrigerated storage or the shortened expiration date. The Operating Room Nurse Manager acknowledged she could not ensure the drugs had not passed the shortened expiration date, if CRNA C failed to document the date she removed the drugs from refrigerated storage or the shortened expiration date.

During an interview on 11/27/12 at 8:15 AM, the Consulting Pharmacist stated the pharmacy maintained the central supply of succinylcholine and rocuronium. The pharmacy staff provided CRNA C with the drugs and CRNA C stored the drugs in the Operating Room cabinet at room temperature. The pharmacy relied on CRNA C to monitor if the drugs had passed the shortened expiration date.

During an interview on 11/27/12 at 11:45 AM, CRNA C stated she removed the drugs from the pharmacy, but failed to document the date she removed the drugs from the pharmacy. CRNA C acknowledged if she did not document the date she removed the drugs from refrigerated storage, or the shortened expiration date, she could not verify if the drugs had passed their expiration date.

Based on document review, observations, and staff interviews, the facility failed to ensure 2 of 2 on-duty Registered Nurses (RN E and RN F) in the Med/Surg Unit followed the manufacturer's instructions for the use of the PDI Super Sani-Cloths to disinfect the countertop on their wheeled computer workstation. The facility administrative staff identified 2 Registered Nurses (RN E and F) working in the inpatient Med/Surg unit during the day. The facility administrative staff identified a current inpatient census of 8 patients.

Failure to follow the manufacturer's instructions on the use of the PDI Super Sani-Cloths could result in the disinfecting liquid not remaining wet on the surface long enough to kill all disease causing germs.

Findings include:

1. During an interview on 11/28/12 at 10:00 AM, the Med/Surg Nurse Manager stated the facility lacked a policy addressing the use of PDI Super Sani-Cloths to disinfect surfaces at the facility. Instead, the facility relied on the manufacturer's directions to instruct the staff members on how to use the PDI Super Sani-Cloths.

2. Review of the undated manufacturer's directions for the PDI Super Sani-Cloths revealed in part, "TO DISINFECT ... Unfold a clean wipe and thoroughly wet surface. Treated surface must remain visibly wet for a full two (2) minutes. Use additional wipe(s) if needed to assure continuous two (2) minute wet contact time. Let air dry."

3. Observations on 11/27/12 at 8:35 AM revealed RN E used a mobile computer workstation to administer medications to a patient in the inpatient room number 100. The mobile computer workstation consisted of a tower on wheels, a computer monitor on the top of the tower, and a flat countertop approximately 24" wide by 24" deep. RN E placed the patient's medications on the computer workstation's countertop. After RN E administered the medications, she left the patient's room and wiped the countertop on her mobile computer workstation with a PDI Super Sani-Cloth wipe. RN E waited approximately 20 seconds after wiping the countertop before placing her clipboard on the countertop. When RN E placed her clipboard on the computer workstation countertop, the liquid from the PDI Super Sani-Cloth was still wet.

4. During an interview on 11/27/12 at the time of the observations, RN E stated she needed to wait 2 minutes after using the PDI Super Sani-Cloth to ensure disinfection of the surface occurred. However, RN E stated the PDI Super Sani-Cloth liquid did not need to stay wet for the full 2 minutes to kill all the surface disease causing germs.

5. Observations on 11/27/12 at 9:10 AM revealed RN F used a mobile computer workstation to administer medications to the patient in the inpatient room number 115. The mobile computer workstation contained a flat countertop approximately 24" wide by 24" deep. RN F placed the patient's medications on the flat countertop. After RN F administered the medications, she left the patient's room and wiped the countertop on her mobile computer workstation with a PDI Super Sani-Cloth wipe, leaving the countertop wet with the disinfecting solution. RN F waited approximately 15 seconds after wiping the countertop before placing her clipboard on the countertop, along with another item from the patient's room. When RN F placed her clipboard and other item on the computer workstation countertop, the liquid from the PDI Super Sani-Cloth was still wet.

6. During an interview on 11/27/12 at 9:35 AM, RN F read the product label for the PDI Super Sani-Cloth, and acknowledged the manufacturer required the user to keep the surface wet with the disinfecting liquid for 2 minutes for the liquid to kill the disease causing germs on the surface of the countertop on the computer workstation. RN F acknowledged she failed to follow the manufacturer's instructions during the observations at 9:10 AM.

7. Observations on 11/27/12 at 10:35 AM revealed RN F entered the inpatient room number 115 with a computer workstation to administer medications to the patient. RN F placed the medications on the computer workstation, and administered the medications to the patient. While RN F was in the room, she exchanged a piece of equipment. RN F wiped the computer workstation countertop with a PDI Super Sani-Cloth, leaving the surface wet with the disinfecting solution. RN F waited approximately 20 seconds before placing the dirty equipment she exchanged on the still wet surface of the workstation countertop. At 10:40 AM, RN F left the patient's room, and again wiped down the countertop on the computer workstation with a PDI Super Sani-Cloth, and left the countertop wet with the disinfecting solution. RN F waited approximately 15 seconds before placing the computer mouse on the still wet countertop.

8. During an interview on 11/27/12 at 10:55 AM, the Med/Surg Nurse Manager, who observed RN F clean the countertop at 10:40 AM, acknowledged RN F did not allow the PDI Super Sani-Cloth disinfecting liquid to remain wet for 2 minutes as required by the manufacturer before placing the computer mouse on the surface.

9. During an interview on 11/27/12 at 2:20 PM, the Infection Preventionist stated the manufacturer of the PDI Super Sani-Cloths only required the disinfecting liquid to remain wet for 4 to 10 seconds, and the liquid would kill the disease causing germs on the surface. After waiting 4 to 10 seconds, the Infection Preventionist stated the staff members could place an object on the wet surface since the disinfecting liquid had killed the disease causing germs.

Based on observations, review of policies and procedures, and staff interview, the facility staff failed to ensure the security of all patient medical records against unauthorized access in 2 of 9 areas where records are stored. (Laboratory and Radiology) The facility reported approximately 25 patient laboratory blood draws per day and approximately 10 - 20 diagnostic radiology procedures per day.

Failure to protect medical records from unauthorized access could potentially result in identity theft, theft of financial/insurance information, and/or unauthorized disclosure of personal medical information.

Findings include:

1. Review of the policy titled "Medical Records Security", dated 12/01/2010, stated, in part, "Policy of Medical Record Security: Medical records shall be confidential, secure, current, authenticated, legible and complete. . . ."

2. Observations during a tour of the Laboratory on 11/26/12 at 2:30 PM, with the Laboratory Manager, revealed the following:

a. The lab phlebotomy area of the lab (area where blood is drawn for testing) had an unlocked 2-drawer file cabinet that contained approximately 300 patient laboratory orders. The unsecured patient orders contained confidential patient information. An open file folder stored on top of the desk that contained 1 patient laboratory order that was waiting to be scanned into the computer. The unsecured patient orders contained confidential patient information.

b. The lab receiving area with 2 of 2 4-drawer file cabinets that contained 2 years of patient laboratory orders - approximately 2500 patient medical records per drawer. The unsecured patient orders contained confidential patient information.

3. During an interview on 11/26/12 at 2:30 PM, the Laboratory Manager reported that the medical records observed in the phlebotomy and receiving areas of the laboratory were not locked after staff leave each evening. The Laboratory Manager stated there was not a key to lock the 2-drawer file cabinet in the phlebotomy area. The Laboratory Manager also reported there was a key to lock the 4 - drawer file cabinets but the staff did not lock the file cabinets before they left for the evening. The Laboratory Manager reported that unsupervised housekeeping staff cleaned the laboratory area each morning before the laboratory staff arrive and would have access to the unsecured medical records stored in the Laboratory area. The Laboratory Manager also acknowledged that housekeeping staff did not have a need to know the personal or medical information contained in the medical records.

4. Observations during a tour of the Radiology area on 11/26/12 at 3:20 PM, with the Radiology Manager, revealed the following in the Radiology front office area:

a. Approximately 10 - 20 patient medical records were on an open shelf for scanning by billing staff the next day. The unsecured patient orders contained confidential patient information.

b. An open paper file box, stored on top of the desk, contained approximately 90 patient radiology orders. The unsecured patient orders contained confidential patient information.

c. There were 18 patient film jackets with x-ray results stored on open shelving. The unsecured patient film jackets contained confidential patient information.

5. During an interview on 11/26/12 at 3:20 PM, the Radiology Manager reported that the medical records observed in the Radiology front office area were not locked after staff leave each evening. The Radiology Manager reported that unsupervised housekeeping staff cleaned the radiology area each morning before the radiology staff arrive and would have access to the unsecured medical records stored in the Radiology front office. The Radiology Manager also acknowledged that housekeeping staff did not have a need to know the personal or medical information contained in the medical records.