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Based on observation, interview, and record review, the hospital failed to protect Patient 3's patient's right to physical safety when an anesthesia machine was placed on bypass during her operative procedure, depriving her of oxygen, which had the potential for great bodily harm or death to Patient 3.

Findings:

During an interview with the Surgical Services Manager (SSM) on 11/14/11 at 1:50 PM, the SSM stated the anesthesia machine used during Patient 3's operative procedure was checked for the possibility it malfunctioned but was found to be working appropriately by Biomedical Technician (BT) A. He stated after an investigation was completed, he believed Anesthesiologist 1 had mistakenly put the anesthesia machine on bypass during Patient 3's operative procedure.

During a concurrent observation of the anesthesia machine and interview with BT A on 11/14/11 at 2:22 PM, he stated he had checked the anesthesia machine and found it to be in working order. While demonstrating the stand-by procedure, BT A stated in order for the anesthesia machine to be put on stand-by, Anesthesiologist 1 would have pressed a button and then turned a knob to stand-by. He stated, "It's a two-step process to make sure it's not done by accident." He stated the machine showed it was on by-pass for about 5 minutes during the time of Patient 3's operative procedure.

The clinical record for Patient 3 was reviewed on 11/15/11 at 11:30 AM. The operative report dated 9/23/11, read "The patient (Patient 3) had sinus bradycardia (a slow heart beat)...Came off the cardiopulmonary bypass (An apparatus through which the blood is temporarily diverted, especially during heart surgery, to oxygenate it and pump it throughout the body). I (Doctor 1) quickly realized that the lungs were not being fully expanded. One lung was totally done (down) and the other one was being expanded, was now almost halfway expanded. So, anesthesiologist was quickly alerted and (Anesthesiologist 1) manipulated the machine as well as hand bagged (expanding the lungs with oxygen using a mask with a bag attached) the patient in order to bring back the pink color.....and the heart rhythm became normal again."

Based on interview and record review, the hospital failed to follow their restraint policy and procedure for two out of thirteen sampled patients (1 and 2) when the restraint physicians's orders did not include a valid order and/or the time the verbal telephone order was received from the physician, which had the potential to violate their patient's rights.

Findings:

The clinical record for Patient 1 was reviewed on 11/15/11 at 3:25 PM. The record indicated Patient 1 was restrained with soft restraints (a piece of equipment or device that restricts a patient's ability to move) to both his wrists from 10/6/11 through 10/15/11. The hospital's document titled "Restraint Physicians's Order Sheet" (RPOS) for the above dates indicated Patient 1 was to be restrained for a 24 hour period. None of the ten RPOS documents reviewed indicated the time the verbal orders for the initiation of the restraints and the continued use of the restraints were obtained from the physician which made it difficult to determine if Patient 1 was restrained for longer than 24 hours before another order was received. The RPOS dated 10/7/11 indicated the physician did not order restraints nor was a verbal order obtained from the doctor by the nurse. The hospital's document titled "24 Hour Restraint Medical/Surgical Flowsheet" dated 10/7/11 indicated Patient 1 was restrained on that date.

The clinical record for Patient 2 was reviewed on 11/15/11 at 3:40 PM. The record indicated Patient 2 was restrained with a soft restraint to his left wrist for the days of 8/17/11 and 8/18/11. The two RPOS documents did not indicate the time the initial order was obtained from the physician for the restraint or the time the order was renewed by the physician to determine if it was within the 24 hour time limit.

During a concurrent clinical record review for Patient 1 and 2 and interview with the Vice-President of Clinical Services on 11/15/11 at 4:45 PM, she verified the RPOS documents did not include the time the verbal restraint orders were obtained from the physicians by the nurses.

The hospital policy and procedure titled 'Restraint of Patients" revised 12/17/09, read "In an emergency situation if the physician is not available to issue an order, restraint use may be initiated by the registered nurse based on the assessment of the patient. The nurse will notify the physician of the initiation and obtain a verbal order within 12 hours of the initiation of the restraint. Maximum length of order will not exceed 24 HOURS. Orders for restraints must be renewed every 24 HOURs and if the patient continues to meet the clinical justification."

Based on interview and record review, the hospital failed to ensure physicians authenticated verbal telephone orders within 48 hours for two out of thirteen sampled patients (1 and 2) which had the potential to adversely affect patient safety.

Findings:

During a concurrent clinical record review for Patient 1 and interview with the Health Information Director (HIMD) on 11/15/11 at 3:25 PM, ten restraint physician's order sheets dated between 10/6/11 and 10/15/11 were reviewed. Nine of the ten restraint physician's order sheets reviewed were verbal telephone orders and had not been authenticated by the physicians within the required 48 hour time frame. The authenticating dates ranged from 22 to 30 days after the orders were written. This was verified by the HIMD.

During a concurrent clinical record review for Patient 2 and interview with the HIMD on 11/15/11 at 3:40 PM, two restraint physician's order sheets dated 8/17/11 and 8/18/11 were reviewed. Both order sheets were verbal telephone orders and were not authenticated by the physician within the 48 hour time frame. These orders were authenticated on 8/30/11 and 8/25/11 respectfully. This was verified by the HIMD. The HIMD stated all verbal telephone orders should be authenticated within 48 hours.

The hospital's rules and regulations titled "rules and regulations of the Medical Staff" dated 3/24/2000, read "Verbal Orders: All orders for drugs and biologicals must be in writing and signed by the ordering practitioner or another practitioner(s) responsible for the care of the patient within forty-eight (48) hours. . ." Federal regulation requires all verbal telephone orders to be authenticated within 48 hours.

Based on observation, interview, and record review, the hospital failed to remove expired medications from patient care areas, which had the potential for adverse patient outcomes.

Findings:

During an observation of the anesthesia medication carts in operating rooms one and three with the Surgical Service Manager (SSM) on 11/14/11 at 1:50 PM, the following expired medications were found:

Lidocaine 1 % with Epinephrine (a medication used to numb the skin), four vials with expiration date of 10/1/11
Procainamide (a medication used to treat abnormal heart rhythms), eight vials with expiration date of 9/1/11
Amiodarone (a medication used to treat abnormal heart rhythms), three vials with expiration date of 9/1/11

At this time the expiration dates for the above medications were verified with the SSM.

During an interview with the Pharmacy Manager on 11/14/11 at 2:40 PM, he stated he was unaware there were expired medications in the anesthesia medication carts. He stated when the medications were expired, the pharmacy technicians or the pharmacists should be removing them from the carts during the monthly checks for expired medications.

The hospital policy and procedure titled "Automated dispensing Machines-Inspection and Inventory" dated 12/17/09 and presented by the Pharmacy Manager as the policy followed for all medications regardless of the location of the medications, read "Automated dispensing machines on each patient care unit will be inspected monthly by the Department of Pharmacy services. This includes verifying the inventory of stocked medications, checking expiration dates. . ."