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305 S STATE ST POST OFFICE BOX 4450

ABERDEEN, SD 57401

PATIENT RIGHTS: NOTICE OF RIGHTS

Tag No.: A0117

Based on record review and interview, the provider failed to inform four randomly sampled outpatients ( 28, 32, 40, and 41) in four of four outpatient locations (outpatient therapy, hospital outpatient services department, pain clinic, and same day surgery) of their Patient Rights. Findings include:

1. Interview with the director of quality/patient services on 1/28/10 at 10:20 a.m. revealed at the outpatient therapy services location off campus the patients registered and signed consents. She confirmed the patients had not received Patient Rights information.



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2. Record review on the outpatient services department in the hospital revealed two patients had not been given information regarding Patient Rights as follows:
*Patient 40 had been admitted initially on 1/22/10 for an outpatient procedure for administration of an antibiotic and then two times a day thereafter.
*Patient 41 had been admitted initially on 1/15/10 for an outpatient procedure for a dressing change and then three times a week thereafter.

Interview on 1/28/10 at 9:30 a.m. with staff nurses confirmed the patients had not been given information regarding patient rights. It had been given to the patients at the time of registration at the business area. Further interview at that time with a registration staff person revealed they had not been giving out that information, because it was a responsibility of the nurses.

A policy regarding the distribution of the Patient Bill of Rights was requested by the survey team, however they were informed there was not a policy regarding that matter.




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3. Interview on 1/27/10 at 2:00 p.m. with the manager of the pain clinic revealed when patients were registered at the pain clinic they were provided with a brochure describing their rights related to pain management. The manager stated patients were not provided the same brochure on other Patient Rights that was presented to hospital inpatients.




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4. Review of patient 28's medical record revealed he was admitted on 1/27/10 and discharged on that same day. There was no documentation in the patient's medical record that indicated patient's rights information had been provided to him.

Interview on 1/27/10 at 11:55 a.m. with the same day surgery (SDS) nurse manager and a staff member from registration confirmed patient's rights information was not provided to patients that were discharged on the same day of their surgical procedure.

Random interview on 1/27/10 at 1:00 p.m. with a SDS patient revealed her surgical procedure had been completed earlier that morning. The patient revealed she was due to be discharged home accompanied by her husband later that day. Continued interview with that patient revealed she had not been provided information on patient's rights.





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5. Review of patient 32's medical record revealed he was admitted on 1/27/10 and discharged on that same day. There was no documentation in the patient's medical record that indicated patient's rights information had been provided to his family.

Interview on 1/27/10 at 12:05 a.m. with the same SDS nurse manager confirmed patient's rights information was not provided to patients that were discharged on the same day of their surgical procedure.

PATIENT RIGHTS: INFORMED CONSENT

Tag No.: A0131

Based on record review and interview, the provider failed to ensure the Admission Consent form was completed for one of two sampled pediatric patients (37) and one of four sampled medical patients (16) reviewed. Findings include:

1. Review of patient 16's medical record revealed an admission date of 1/23/10 to the medical floor. Further review revealed an Admission Consent form in the chart, however it had not been completed.

Interview on 1/28/10 at 9:00 a.m. with the medical unit manager confirmed the Admission Consent form had not been completed. It should have been completed at the time of admission.



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2. Review of patient 37's medical record revealed an admission date of 1/25/10 to the pediatric floor. Further review revealed an Admission Consent form in the chart that had not been completed.

Interview on 1/27/10 at 2:20 p.m. with a pediatric nurse confirmed the Admission Consent form was blank. It should have been signed before treatment.

3. Review of the provider's undated Admission of a Patient policy revealed the procedure to admit a patient. That policy included obtain a signature of the patient and a witness on the admission consent form if one was not obtained in the Emergency Department or Patient Registration.

PATIENT RIGHTS: CONFIDENTIALITY OF RECORDS

Tag No.: A0147

Based on observation and interview, the provider failed to ensure the patients' medical records and/or personal information was protected from unauthorized access for:
*Three of three intensive care unit (ICU) patients (26, 42, and one unidentified patient).
*Twelve of twelve patients (26, 27, 42, and nine unidentified patients) with cardiac monitoring.
Findings include:

1. Observation and record review on 1/26/10 from 2:45 p.m. to 3:15 p.m. revealed printed paper information was located face up on a clipboard outside one unidentified patient room and patients 26 and 42's room. No staff members were present by the patient information. The information included:
*The patient's name and age.
*Diagnosis.
*Code status.
*Family contact information with names and phone numbers listed.
*Date of surgery.
*Current medical interventions specific to each patient.
*Summary of the physician orders.

2. On 1/26/10 at 2:58 p.m. this surveyor with the director of nursing present was able to access a computer located in the hallway of the ICU. No other staff members were present. This was accomplished by double clicking on a desktop icon with the mouse. Identified was patient information on the computer for patients 26, 27, and 42 who were current ICU patients as well as three other patients currently in the ICU. This surveyor was also able to access six other hospitalized patients with identifiable names, room numbers, and current cardiac monitoring rhythms.

Interview with the director of nursing at that time revealed it was not known how this surveyor was able to access the above patient information, however it should not have occurred.

During a second attempt to access a second computer located in the hallway of the ICU on 1/26/10 at 3:30 p.m. with the ICU director present revealed this surveyor was able to view the same above patient information. No other staff members were present. Interview with the ICU director revealed:
*The individual who had accessed the computer previously had not closed out the window, therefore allowing this surveyor to access the computer information.
*When an employee was done on the computer that specific screen display was to be closed.
*The computers were located in the hallway with visitor access.
*The patient information had not been protected.

Review of the provider's undated Patient Rights pamphlet provided at the time of the patient's admission revealed all communication and medical records related to care must be kept confidential.

No Description Available

Tag No.: A0290

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Based on record review, interview, and policy review, the provider failed to ensure the operating room (OR) quality assessment program improvement (QAPI) developed action plans, implemented the action plans, and reevaluated those plans for problem resolution for two of two identified problem areas (normothermia and antibiotic administration). Findings include:

1. Review of the OR's perioperative services performance improvement data collection tool revealed three indicators had been selected for monitoring. Review of the data documented revealed two of the three indicators did not meet the OR documented 2009 goals. Those two indicators were:
*Normothermia - "The initial temperature on admission to the post-anesthesia care unit (PACU) will be greater than 96.8 percent (%)." The established goal was 100%. In October 2009 the outcome data indicated 98% of the patients had met that goal. Two percent of the surgical patients did not meet the 100% goal for having a temperature above 98.6 degrees Farenheit.
*Administration of prophylactic presurgical antibiotics - One of the two indicators listed did not meet the established goal of 100%:
-"Hysterectomy antibiotic administration less than 60 minutes of incision."
-September 2009 the outcome data indicated 90% of the patients had been administered their antibiotic less than 60 minutes before the surgical incision was made. Ten percent of the surgical patients did not meet the established goal.
-October 2009 the outcome data indicted 94% of the patients had been administered their antibiotic less than 60 minutes before the surgical incision was made. Six percent of the surgical patients did not meet the established goal.

Interview on 1/27/10 at 10:35 a.m. with the OR manager revealed:
*He was aware the indicators for September 2009 and October 2009 did not meet the 100% goal.
*When a patient's temperature was below normal and a patient antibiotic was not given prior to surgery he was informed of those events.
*He did not have an action plan to prevent the reoccurrence or ensure compliance with established goals.
*There was no documented data on the collection tool for November 2009 and December 2009.
*In November 2009 and December 2009 if a patient temperature was below goal or a patient did not receive their antibiotic he would have been notified about the event.
*He monitored by reviewing each months data.
*The provider submitted performance monitoring data to a contract company. The contract agency provided the hospital with statistical data on the problem areas that were monitored.
*The data reviewed by the surveyors at the time of the survey had been received last week from the provider's contract company and was several months old.
*No statistical data had been received for November 2009 and December 2009 from the contract agency.

Interview on 1/28/10 at 9:00 a.m. with the chief nursing officer revealed:
*The OR had not meet their established goals for maintaining patient temperature and administration of prophylactic presurgical antibiotic administration.
*Departments were required to submit an action plan if two consecutive months passed, and the established goal had not been met.
*An action plan should have been submitted by the surgical department for September 2009 and October 2009. Two consecutive months had passed, and the goal for providing antibiotics less than 60 minutes before the surgical procedure had not been meet.
*The OR manager had been notified the established goals were not met and had not submitted an action plan for improvement.
*The OR department had the ability to obtain unverified real time quality improvement data from the provider's computer network.
*It was the expectation departments submit an action, implement that action plan, and reevaluate the plan to ensure it was effective, and monitor for compliance.

Review of the provider's Performance Improvement Plan dated 11/5/09 revealed:
*The purpose of the plan was to ensure the organization monitored, analyzed, and improved performance.
*Department managers collected and reported data for quality indicators. They used quality and improvement tools including Failure Mode Effect Analysis and Root Cause Analysis to achieve performance improvement.

MEDICAL RECORD SERVICES

Tag No.: A0450

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Based on record review, interview, and policy review, the provider failed to ensure all sampled medical record entries from different patient service areas were authenticated with dates and/or times. A sample of 172 medical record entries revealed 62 instances where either the date and/or time of the entry was not recorded. Findings include:

1. Review of 113 written physicians' orders during review of medical records on all patient care areas revealed 4 were not dated, and 21 were not timed.

2. Review of 38 physicians' progress notes during review of medical records on all patient care areas revealed 15 were not timed.

3. Review of 21 miscellaneous forms regarding physician contact with the patient during review of medical records on all patient care areas revealed 3 were not dated and 19 were not timed.

Interview with eight department managers at random times during the review of medical records revealed all were aware all entries should have been dated, and two were not aware all entries should have been timed.

Review of the provider's March 2009 documentation on medical record policy revealed each progress note entry in the patient's medical record should have been dated, timed, and signed. The policy did not include a requirement for all entries to be dated and timed.

PHARMACY ADMINISTRATION

Tag No.: A0491

Based on observation and interview, the provider failed to ensure
*The manufacturer's specifications and facility policy were was followed for warming of intravenous (IV) solutions in one of four areas (anesthesia work room) where solutions were warmed.
*Morphine for intrathecal use stored at the pain management center was monitored to detect diversion.
Findings include:

1. Observation on 1/27/10 at 9:00 a.m. of the anesthesia workroom revealed a warming cabinet containing warmed IV solutions.

Interview at the above time with the anesthesia workroom technician revealed the staff rotated the solutions in the warming cabinet so those first placed in the cabinet would be the first used. The technician stated most often solutions were never in the warming cabinet for more than three or four days. The technician also stated warmed solutions would be removed from the cabinet in anticipation of their use for a surgical case. The technician stated if the solutions were not used they would be placed back in the cabinet.

Review of a letter dated 11/3/09 from the manufacturer of the IV solutions revealed:
*Solutions could be warmed for a period no longer than 14 days.
*After 14 days the solutions should have been removed from the warming cabinet and used up to their normal expiration date. Those solutions should not have been warmed again.
*Once a product was removed from the warming cabinet and allowed to cool it should not have been place back into the warmer.
*The manufacturer had not tested the effect of a warm-cool-warm cycle on the stability of the product.

Interview with a pharmacist at the above time revealed it was the policy of the pharmacy to remove all solutions from warming cabinets every 14 days. Following removal the solutions would have been marked to ensure they were not returned to the warming cabinet. The pharmacist stated this procedure was not followed for the anesthesia workroom warmer because it was under control of the anesthesia department.

2. Observation on 1/27/10 at 2:00 p.m. of a locked cabinet at the pain control center revealed a 50 mililiter syringe of morphine for intrathecal use.

Interview with a registered nurse (RN) at the above time revealed the morphine was received as a prescription for an individual patient from an outside supplier. The RN stated the pain control center had a receipt for when the morphine was received but did not maintain a controlled drug administration record for the item. When asked, the RN stated without the use of the controlled drug administration record there was no way to monitor the morphine to ensure there was no diversion.

Review of the provider's pharmacy security policy (F-2) for the pain control center revealed:
*When morphine was sent from the pharmacy to the pain control center a nurse was to sign the controlled drug administration record receipt.
*There were no directions for the use of a controlled drug administration record when the pain control center received morphine as a prescription for an individual patient from an outside supplier.

SECURE STORAGE

Tag No.: A0502

Based on observation and interview, the provider failed to ensure all drugs and biologicals were stored in a manner to prevent unmonitored access by unauthorized individuals in 7 of 19 patient care areas reviewed for drug storage. Findings include:

1. Review of the provider's pharmacy security policy revised March 2009 revealed storage of floor stock drugs would be in a secured area or locked cabinet. Drugs dispensed for specific patients should have been stored in a locked drawer in the nurse server, a medication room, a medication cabinet, or in a designated medication refrigerator. The policy did not include definitions of a secured area or of authorized personnel.

2. Interview on 1/28/10 at 9:30 a.m. with the vice president for patient care services revealed it was generally thought entry to nursing stations and areas where medications were stored was limited to nurses and other authorized personnel. Unlocked refrigerators for storing medications were located in nursing stations or areas where the public generally would not be present. The vice president stated there were no policies that outlined who would be authorized personnel to be present in areas where medications were stored in unlocked cabinets when nursing staff were not present.


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3. Observation on 1/27/10 at 9:00 a.m. of the outpatient services area revealed an unlocked refrigerator at the nurses station that contained non-controlled medications. Further observation revealed there was a lock on the refrigerator, however it was disengaged.

Observation on 1/28/10 at 9:30 a.m. revealed there were people who were not employed at the hospital that were walking in the hallway of the above area.

Interview on 1/27/10 at 9:30 a.m. with the staff nurse confirmed the refrigerator was left unlocked during the day at the time they were serving patients. She further confirmed the refrigerator was locked at night when they left. However she stated when the staff were in a treatment room working with a patient there was not always a staff person at the desk area.

4. Observation on 1/27/10 at 2:00 p.m. of the pediatric nurses station revealed an unlocked refrigerator that contained non-controlled medications. Further observation revealed a cupboard was not locked in that same area that contained biological solutions. Observation of the same area revealed an antibiotic medication laying on top of the counter in a non-secured area.

5. Observation of the treatment room in the pediatric area revealed staff entered the room by accessing a code into a punch pad. Further observation revealed biological solutions were stored on open shelves in that room. The room also contained the crash cart that had medications in it. The cart's drawers were locked with plastic break ties.

Interview at that time with a staff nurse confirmed a supply technician would enter the room and restock supplies when needed. Also housekeeping staff would enter the treatment area and was not acompanied by nursing staff. Further interview confirmed there was not a nurse with the technician when the room was being restocked. The nurse confirmed there was not always a staff person at the nurses station, and the door to that area was not locked.

6. Observation of the mental health nurses station on 1/26/10 at 2:45 p.m. revealed medications and biological solutions were stored in unlocked cupboards above the counter. Further observation revealed two entrances to that room, one with a punch pad to unlock with a code and another entrance from a dining room area used by patients and non-nursing personnel.

Interview at that time with a staff nurse confirmed the medications were not in a locked cupboard. That room was accessed by personnel other than nursing staff at many different times during the day and night.


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7. Observation on 1/27/10 at 4:15 p.m. revealed the anesthesia workroom door was propped open. There were no anesthesia staff present in the workroom. Interview at the time of the above observation with the operating room (OR) manager revealed the anesthesia workroom door was opened during the day and was not staffed 100 percent of the time. The anesthesia workroom door could have been locked when unattended. The door had a key punch locking mechanism that staff could have entered a code for entry. Continued observation in the anesthesia workroom revealed numerous medication in an unlocked medication refrigerator and in an unlocked drawer:
*Unlocked medication refrigerator:
-Numerous vials of Rocuronium, succinylcholine, and Atracurium.
-Several vials of insulin, Nimbex, Diltiazem; and Tylenol suppositories.
*Unlocked medication drawer: numerous vials of Propofol.

Interview on 1/27/10 at the time of the above observation with the technician responsible for ordering anesthesia medications revealed:
*The names of medications were listed on the outside of the medication refrigerator and medication drawer.
*There was no inventory list or an accounting of how much of each medication was on-hand. Medication orders depended on what items were low at the time.
*After checking the medication refrigerator, medication drawer, and other carts a medication order was submitted. Propofol was ordered 50 vials at a time.

Review of the provider's Anesthesia Medication Security Policy revised November 2009 revealed:
*"All anesthesia department medications must be secured in the anesthetic workroom or a locked anesthesia cart if they are to be unattended."
*Entry to the anesthesia workroom is by use of a coded lock."


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8. Observation on 1/27/10 at 8:30 a.m. of operating room six revealed:
*The operating room was unattended.
*On top of the anesthesia cart were filled syringes labelled Sufentanil, Versed, Zemuron, Diprivan, and Succinylcholine.
*The anesthesia cart was unlocked and had multiple non-controlled medications in it.

Interview on 1/27/10 at 8:35 a.m. with the director of perioperative services revealed:
*Leaving medications unsecured was against the provider's policy.
*Nurse anesthetists were to secure their carts and medications at all times when they were not present in the operating room.

Observation on 1/27/10 at 9:30 a.m. of operating room four revealed:
*The operating room was being prepared for a procedure, and the room was attended by a circulating nurse and a surgical technician.
*The anesthesia cart was unlocked, and the nurse anesthetist was not in the operating room.
*The anesthesia cart contained both controlled and non-controlled medications.

Interview on 1/27/09 at 9:35 a.m. with the circulating nurse revealed:
*She was not in charge of the medications in the anesthesia cart.
*The nurse anesthetist was the only person responsible for the medications on the anesthesia cart.
*The nurse anesthetist was out of the operating room at that time.

Interview on 1/27/10 at 9:45 a.m. with the nurse anesthetist revealed she:
*Thought she had secured the anesthesia cart prior to leaving the operating room.
*Agreed the anesthesia cart was currently unlocked, and controlled and non-controlled medications were in the cart.



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9. Observation in the rehabilitation unit on 1/26/10 at 3:10 p.m. revealed an unlocked medication refrigerator in a room behind the nurse's station. Interview with the nurse manager of the rehabilitation unit at that time revealed the medications in that refrigerator would have been accessible to all staff in the area. She stated the medications in that refrigerator would have been accessible to unauthorized persons since a nurse would not have been at the nurse's station at all times.

CONTROLLED DRUGS KEPT LOCKED

Tag No.: A0503

Based on observation, interview, and policy review, the provider failed to keep Sufentanil locked within a secure area for two of two randomly observed operating rooms. Finding include:

1. Observation on 1/27/10 at 8:30 a.m. of operating room six revealed:
*The operating room was unattended.
*On top of the anesthesia cart were filled syringes labelled Sufentanil, Versed, Zemuron, Diprivan, and Succinylcholine.
*The anesthesia cart was unlocked and had multiple non-controlled medications in it.

Interview on 1/27/10 at 8:35 a.m. with the director of perioperative services revealed:
*He agreed Sufentanil was a powerful schedule II narcotic.
*He agreed that medication should have been secured or in the possession of the nurse anesthetist at all times.
*Leaving medications unsecured was against the provider's policy.
*Nurse anesthetists are to secure their carts and medications at all times when they were not present in the operating room.

2. Observation on 1/27/10 at 9:30 a.m. of operating room four revealed:
*The operating room was being prepared for a procedure, and the room was attended by a circulating nurse and a surgical technician.
*The anesthesia cart was unlocked, and the nurse anesthetist was not in the operating room.
*In the anesthesia cart was a filled syringe labeled Sufentanil. Multiple other non-controlled medications were also in that cart.

Interview on 1/27/09 at 9:35 a.m. with the circulating nurse revealed:
*She was not in charge of the medications in the anesthesia cart.
*The nurse anesthetist was the only person responsible for the medications on the anesthesia cart.
*The nurse anesthetist was out of the operating room at that time.

Interview on 1/27/10 at 9:45 a.m. with the nurse anesthetist revealed she:
*Thought she had secured the anesthesia cart prior to leaving the operating room.
*Agreed the anesthesia cart was currently unlocked and Sufentanil was in the cart.

3. Review of the provider's policy anesthetic medication security revised November 2009 revealed "All anesthesia department medications must be secured in the anesthetic workroom or a locked anesthesia cart if they are to be unattended."

FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE

Tag No.: A0724

Based on observation, interview, and policy review, the provider failed to implement acceptable standards of practice for three of seven observed warming cabinets (one in the intensive care unit, outpatient clean utility 1-E-84, and 3rd floor south clean supply room 3-S-41) used to warm blankets for patient use. Findings include:

1. Observation of the warming cabinet in the utility room located on the intensive care unit revealed:
*Blankets were stored inside.
*The temperature was set at 159 degrees Fahrenheit (F).
*The temperature gauge read 159 degrees F.

2. Observations on 1/26-27/2010 of the warming cabinets at the following locations revealed:
*The outpatient clean utility (frame 1-E-84) warming cabinet was set at 150 degrees F, and blankets were stored inside.
*The 3rd floor south clean supply (frame 3-S-41) warming cabinet was set at 160 degrees F, and blankets were stored inside.

Review of the information and documentation on the Daily Temperature Calendar located on the door of the warming cabinet revealed:
*From January 1-26/2010 the temperature of the warming cabinet ranged from 159 to 161 degrees F.
*The temperature for the warming cabinet was not to exceed 130 degrees F.
*Notification to plant operations was to be done immediately, if the there were two consecutive readings above or below the recommended range.

Interview on 1/26/2010 at 2:45 p.m. with the director of nursing and a registered nurse revealed:
*It was not known how long the temperature had been set at 159 degrees F.
*The warming cabinet temperatures had been in the 159 to 161 degree F for a long period of time.
*The Daily Temperature Calendar indicated the warming cabinet was not to exceed 130 degrees F.
*The plant operations manager had not been notified the warming cabinet temperature readings were above 130 degrees F.

Interview on 1/28/10 at 10:30 a.m. with the plant operations director revealed:
*The warming cabinets were not on a preventive maintenance program.
*He had not been notified the temperature for the warming cabinet was above 130 degrees F.
*The temperature information was available on the Daily Temperature Calendar for the staff to use, however the information had not been used.

Review of the provider's Warmed Solutions-Blankets policy dated 11/2009 revealed for the blanket warmer:
*The temperature was to be set at 130 degrees F.
*The temperature was not to exceed the 130 degrees F.
*The daily temperature would be monitored.


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OPERATING ROOM POLICIES

Tag No.: A0951

Based on observation, interview, and policy review, the provider failed to ensure numerous scissors and clamps were sterilized in an open position to ensure all surfaces were exposed during the sterilization process for one of two instrument supply rooms. Findings include:

1. Observation on 1/27/10 at 8:45 a.m. revealed several bins that contained numerous scissors and several tissue clamps. The ends of the scissors and tissue clamps were closed.

Interview on 1/27/10 at the time of the above observation confirmed the scissors and jaws on the clamps were closed.

Interview and review of the provider's Proper Packing of Articles for Sterilization on 1/28/10 at 10:37 a.m. with the operating room manager confirmed:
*The policy revealed the box locks of instruments should have been left unclamped during the sterilization process.
*Staff were aware instruments with box locks were sterilized unclamped.
*Staff had been educated to sterilize instruments with box locks in an open position.