HospitalInspections.org

Based on interview and record review, the facility failed to protect one patient (#33) of one discharged patient reviewed by allowing a visitor to apply mechanical restraints to the patient. The facility also failed to implement process changes to prevent this from happening again.

The facility census was 127.

Findings included:

1. Record review of the facility's policy titled, "Restraint Utilization (Violent, Self Destructive)" revised 01/30/12, showed:
- Mechanical restraint is a device attached to the patient's body that he or she cannot easily remove that restricts freedom of movement or normal access to one's body.
- A physician must order mechanical restraints used to prevent imminent risk of a patient physically harming themselves, staff or others.
- Correction applications used for security purposes (e.g. handcuffs, manacles, shackles, and other chain type restraint devices) are considered law enforcement restraints and are not considered or governed by hospital restraint guidelines.

2. Record review of Patient #33's admission history and physical showed the 76-year-old male was admitted from a mental health hospital on 05/17/13 to the intensive care unit with symptoms of cerebral vascular accident (stroke) and respiratory failure. The patient was put on a ventilator and sedated.

4. Record review of the patient's discharge summary showed the patient was discharged on 05/24/13 to a nursing home for physical therapy {a possible indication that the patient was debilitated at time of discharge}.

5. Record review of the patient's clinical documentation in the medical record showed:
- The visitor {who was dressed in a uniform} told staff that the patient was very strong and had a violent history.
- The patient was debilitated and needed maximum assistance to transfer.
- There was no physician order for mechanical restraints to prevent the patient from physically harming staff or others.
- On 05/19/13 at 8:00 PM, the visitor applied handcuff (he had in his possession) to the patient's left upper extremity.
- On 05/19/13 at 11:00 PM, "the visitor applied ankle restraints to the patient's ankles per their own protocol". The charge nurse was aware that the visitor applied ankle restraints to the patient..

6. Record review of the patient's restraint flow sheet showed "law enforcement restraints" were used on the patient's left arm and both ankles from 05/19/13 to 05/22/13.

7. During an interview on 07/10/13 at 9:00 AM, Staff WW, Director of Regulatory Compliance and Risk Management, stated that:
- The nurses thought the patient was a prisoner and were frightened of him based on what the visitor told them.
- She stated that the nursing supervisor provided locking leather restraints to the visitor when he requested them.
- The visitor put the locking leather restraints on the patient.
- The nursing supervisor was not available for interview by the surveyor.

8. During an interview on 07/10/13 at 9:10 AM, Staff VV, Director of Security, stated that:
- The visitor was employed by a private security guard company contracted with the mental health hospital that transferred the patient to the facility.
- Both facility nursing and facility Security Department staff thought the visitor was law enforcement because he wore a uniform and badge.
- The patient was a big man and nursing staff needed assistance with getting him up for toileting but there was no need for him to be shackled.
- The facility Security Department had not implemented any process changes after this event in which a visitor was allowed to mechanically restrain a patient and after an investigation by facility staff.

9. During an interview on 07/10/13 at approximately 9:30 AM, Staff Q, Deputy Director of Nursing and manager of the nursing supervisors, stated that she heard about the patient being restrained by a visitor when it occurred but was not aware of the results of the facility investigation.

10. During an interview on 07/10/13 at approximately 10:00 AM, Staff AAA, Nursing Supervisor (not the one who had provided locking leather restraints to the visitor), stated that she was not aware of the event and had not received any education directing staff not to allow visitors to restraint patients.

Based on Missouri State Statute review, personnel record review and interview the facility failed to ensure individuals listed on the Employee Disqualification List (EDL, a listing of persons who had abused or neglected patients under their care) were not employed by the facility. Record review of six (Staff G, UU, FFFF, EEEE, C and D) of twelve facility staff showed the facility failed to compare the names of staff on hire and on a quarterly basis against the EDL.

The facility census was 127.

Findings included:

1. Review of the Missouri State Statute RSMO 2003 Section 660.315 directed facilities licensed under Chapter 197 (hospitals) complete not only pre-employment EDL checks but also quarterly checks of all existing staff against the quarterly updated EDL to ensure no current staff had been recently added to the EDL (The quarterly updated EDLs are available on the Missouri Department of Health and Senior Services {DHSS} web site).

Review of the facility policy titled, "Competency Assessment and Development Procedure for Contracted Clinical Staff" dated 05/29/13 showed direction for staff to confirm pre-placement qualifications and conduct necessary background checks including the DHSS EDL.

2. Review of Staff G's personnel file showed Staff G, Wound Nurse was hired in 09/09 and the facility failed to complete a pre-employment EDL check. The first quarterly check was documented on 01/05/10 four months after Staff G was on duty.

3. Review of Staff UU's personnel file showed Staff UU, Vice President of Operations was hired in 07/09 and the facility failed to complete a pre-employment EDL check. The first quarterly check was documented on 01/05/10 six months after Staff UU was on duty.

4. Review of Staff FFFF's personnel file showed Staff FFFF, Plant Operations Manager was hired in 01/10 and the facility failed to complete a pre-employment EDL check. The first quarterly check was documented on 03/05/10 two months after Staff FFFF was on duty.

5. Review of Staff EEEE's personnel file showed Staff EEEE, Scribe (job title was scribe) was hired in 01/13 and staff failed to complete the pre-employment EDL check and any quarterly checks as of 07/10/13.

6. Review of Staff C's personnel file showed Staff C, Dietary Manager was a contractor and hired in 06/09. The facility staff failed to perform or secure evidence from the contracted company of a pre-employment EDL check on hire and failed to perform quarterly EDL checks.

7. Review of Staff D's personnel file showed Staff D, Dietitian was a contractor and hired on 11/06/78. The facility staff failed to perform or secure evidence from the contracted company of any quarterly EDL checks.

8. During an interview on 07/10/13 at approximately 2:30 PM, Staff HHHH, Employee Relations, stated that:
- An unnamed contracted company (she was asked but would not/could not provide the name) was supposed to perform EDL checks from 09/01/09 through an unknown time (she was asked but would not/could not respond).
- The unnamed contracted company was "not doing them correctly".
- She felt that many of the personnel files reviewed were for staff who had been in position prior to when the EDL statute became effective; however, she did not know the effective date.
- She did not have EDL information for Staff C and Staff D who were two dietary contractors but that information was currently being faxed to the facility.

9. Review of Staff D's faxed background information obtained from the contracted dietary company dated 08/12 showed the contractor failed to check the EDL for Staff D at any time. (The information provided showed criminal background checks and educational credential checks).

10. Even though requested multiple times onsite and after exit, the facility failed to provide EDL check information regarding Staff C.

Based on observation, interview and policy review the facility failed to ensure medications were secured in a manner to avoid tampering and potential harmful use and to secure medication designated for disposal. This failure had the potential to allow unauthorized persons access to medication designated for prescription use only. This failure occurred in the Surgical area. The facility performs an average of 25 surgical cases per day.
The facility census was 127.
Findings included:
1. Record review of the facility policy titled, "Medication Administration" dated 01/2010, showed opened medications are to be disposed of in a safe non-retrievable manner and controlled substances are wasted in a non-retrievable manner.

2. Record review of the facility's policy titled, "Controlled Substance Waste Disposal" revised 02/10, showed:
-Controlled substances are disposed of appropriately in a consistent manner to maintain accountability and to prevent diversion and abuse.
-Vials, ampoules, carpujects (a syringe device for the administration of injectable fluid medication), tablets and syrups, etc: empty remaining drug and squirt into the needle box.
-Dispose of empty container in needle box.

3. Record review of the facility policy titled, "Security of Medications- Anesthesia Carts" revised 01/01/13, showed the following:
- These areas are considered secured when these areas are staffed and staff is actively providing patient care.
- When the operating room suite is not in use (i.e., after hours, weekends, holidays), scheduled drugs (schedule class II, III, IV, V) must be locked within a secured area. This may be accomplished by the following:
- Locking the entire surgical suite;
- Locking non-mobile carts containing drugs and biologicals and locking the room where the non-mobile cart is located;
- Locking mobile carts containing drugs and biologicals within a locked room;
- Otherwise locking drugs and biologicals within a secure area.
- All controlled substances must be locked within a secure area regardless of whether a patient care area is staffed or actively providing patient care.

4. During observation of the surgical suites on 07/08/13 at approximately 2:30-3:30 PM the following observations were made:
- Observation of OR #6 showed the room to be empty of staff and the sharps containers on OR 6 Anesthesia cart to hold multiple (too many to count without entering the container, TMC) labeled and partial filled syringes containing medications including Propofol {marketed as Diprivan, a short-acting, intravenously administered hypnotic/amnestic(an agent that causes amnesia) used for the induction and maintenance of general anesthesia and procedural sedation}.
-Observation of OR #3 showed the room to be empty of staff and the sharps containers on OR 3 Anesthesia cart to hold TMC labeled and partial filled syringes containing medication; including Propofol.
-Observation of OR #7 showed the room to be empty following the last case of the day. The sharps containers on OR 7 Anesthesia cart held TMC labeled and partially filled syringes of medications including Propofol.
-Observation of OR #8 showed the room to be empty following the last case of the day and the sharps containers on OR 8 Anesthesia cart to hold multiple TMC labeled and partial filled syringes containing medications including Propofol and Morphine (Schedule II drug: defined as drugs with a high potential for abuse, with use leading to sever psychological or physical dependence. These drugs are also considered dangerous.)
-Observation of OR #4 showed the room was empty when entered following the last case of the day in that suite. The Anesthesia cart was left unlocked and unattended. The top drawer when opened revealed a full array of controlled drugs for induction and maintenance of anesthesia. The sharps containers on OR 4 Anesthesia cart contained TMC labeled and partial filled syringes of miscellaneous medications including Propofol and Fentanyl (a potent, synthetic opioid analgesic with a rapid onset and short duration of action and is a Schedule II drug).
-Observation of the Cardiac Use cart in the hallway outside OR #1 showed the attached sharps containers held TMC labeled and partially filled syringes of medications including Propofol and Succinylcholine (used to induce muscle relaxation and short-termparalysis and is a Schedule II drug).

5. During an interview on 07/10/13 at 3:00 PM, Staff IIII, Director of Pharmacy, stated that all medications left in a syringe should be wasted by squirting it into the sharps container.

Based on observation, interview and record review the facility failed to ensure all medical and nursing staff knew that the diet manual was on the facility intranet where it could be accessed and used as guidance for ordering patient diets.

The facility census was 127.

Findings included:

1. Review of the facility policy titled, "Network Clinical Nutrition: Diet Manual" revised 09/11 showed direction for staff to access the facility diet manual on the intranet.

2. During an interview on 07/09/13 at 9:05 AM on the 5th floor, Staff Y, Registered Nurse (RN) stated that she did not know anything about the facility diet manual (and consequently how to access it).

3. During an interview on 07/09/13 at 9:06 AM on the 5th floor, Staff Z, RN stated that she had been employed by the facility for three years and had never seen the diet manual.

4. During an interview on 07/09/13 at 9:11 AM on the 4th floor, Staff AA, RN stated that she had been employed by the facility for fifteen years and felt the diet manual was kept in the nurse's break room in a cabinet or on a book shelf because that was where other reference manuals were maintained.

5. Observation on 07/09/13 at 9:11 AM in the 4th floor nurse's break room showed Staff AA searched three or four shelves containing loose leaf binders and textbooks and was not able to local a diet manual.

6. During an interview on 07/09/13 at 9:11 AM Staff AA stated if she needed to provide printed diet instruction to a patient she would photocopy information from a nursing textbook (not the facility diet manual, approved by the medical staff).

Based on interview and record review, the facility failed to ensure boilers received annual safety inspections by the sole state authority having jurisdiction to issue a Certificate of Inspection in accordance with The Boiler and Pressure Vessel Safety Act, (sections 650.200-650.295, RSMo), and the National Board Inspection Code published by the American National Standards Institute (ANSI/nb23).

For the purposes of maintaining safe, adequate and effective sources of heat and steam supply for patients in accordance with Federal, State and local laws, regulations and guidelines, hospitals must ensure their boilers and pressure vessels are designed and maintained to reflect the scope and complexity of the services it offers in accordance with accepted standards of practice. Power boilers must receive a certificate of external inspection annually, and internally inspected every two years; this includes any single power boiler used to generate more than 400,000 lbs/hr. Certificates of safety inspection are only issued by the state authority responsible for conducting the inspections, the Chief Inspector, (Chief boiler and pressure vessel inspector appointed by state authority). A Special Inspector (any qualified inspector commissioned by the Chief Inspector) reports to the Chief and may also inspect on behalf of the Special Inspector. Special Inspectors may be employed by one of a limited number of certified insurance companies who are authorized to inspect based on standards equivalent to or greater than the state appointed chief inspector.

This deficient practice potentially affects all staff, visitors and patients in the hospital. The facility census was 127.

Findings included:

1. Record review of facility documents on 07/10/13 showed the facility had three Power Boilers and one hot water tube boiler that had certificates of inspection from the local county's Division of Code Enforcement, all dated as valid from August 2012 through August 2013. Each certificate stated "THIS CERTIFIES THAT THE BOILER HAS BEEN INSPECTED BY THE DEPARTMENT OF PUBLIC WORKS AND MAY BE OPERATED UNTIL EXPIRATION DATE SHOWN." The documents lacked the watermark and seal of the State Division of Fire Safety, the only agency authorized by the state to inspect boilers for safety.

2. During an a telephone interview on 07/17/13 at 3:00 PM, the Deputy Chief of the Missouri Division of Fire Safety (DFS) who oversees the Boiler Inspection program stated that he checked his listings and did not see the facility listed as having paid fees to the Division or calling for an inspection. He stated that DFS is the principle certificating authority for boiler safety inspections, which include all mechanical workings, seals, valves, vents, etc. He stated that the county was not one of the few specific insurance companies are authorized to provide boiler and pressure vessel insurance in this state or an inspector who is employed by a company that maintains an inspection department whose organization and inspection procedures meet the requirements of the National Board for Owner-User Inspection Agency and are acceptable to the Chief Inspector.

3. During a telephone interview on 07/18/13 at 4:00 PM, the Office Manager, Division of Code Enforcement, stated that their inspection services are for mechanical assurance only and not a substitute for state "safety" inspection. She stated that if the facility wished, they could submit copies of their state inspection to the county Division of Code Enforcement and for a small fee the county would deem the state inspection acceptable in lieu of a county inspection. She stated that their agency is not authorized to inspect for the state and does not submit records of their inspections to the state DFS.

Based on policy review, interview, record review and review of the practice standards and guidelines for the Association of Perioperative Registered Nurses (AORN) and the Centers for Disease Control (CDC) the Infection Control Practitioner failed to develop and maintain a system for identifying, investigating and controlling infections of patients by:
-Failing to ensure consistent standards were followed for the use of multi-dose medications and lubricants; and
-Failing to ensure adequate sterilization practices were being followed for surgical patients.
These failed practices raise the risk of disease spreading contamination and inadequate sterilization practices and place all patients at risk for hospital acquired infections (HAI).

The facility performs an average of 517 surgical cases per month. The facility census was 127.

Findings included:
1. Record review of the facility's policy titled, "Medication Storage and Control" dated 10/10 showed multi dose containers, such as ointments, ophthalmic products and insulin shall be dispensed for single patient use.
2. Record review of the facility's policy #4001 titled, "Infection Control" revised 01/01/13 showed all medications opened and unused are discarded at the end of each case.
3. Record review of the facility's policy titled, "Contrast Media Products" dated 01/12 showed contrast media [primarily used to visualize vessels and changes in tissues on radiography and CT] falls within the scope of the network policy on medication administration. Multi-dose bottles of intravenous contrast may be used up to 8 hours after spiking the bottle when aseptic technique is used.
4. Observation during rounds of the surgical areas on 07/08/13 at approximately 2:30 to 3:30 PM showed:
-OR 6, the anesthesia machine drawer contained three tubes of opened and partially used lubricant.
-OR 3, the anesthesia machine drawer contained two tubes of opened and partially used lubricant.
-OR 4, the anesthesia machine drawer contained one tube of opened and partially used lubricant.
-OR 8, the anesthesia machine drawer contained one tube of opened and partially used lubricant.
-OR 7, the anesthesia machine drawer contained one tube of opened and partially used lubricant.
5. Observation on 07/10/13 at 3:30 PM of the facility pain clinic medication storage area showed an opened multi-use vial of Betamethazone (a potent steroid with anti-inflammatory and immunosuppressive properties; inhibit or prevent activity of the immune system) 30 mg/5 ml.

6. During an interview on 07/10/13 at 3:30 PM, Staff TT, Registered Nurse (RN), stated that multi-dose vials of Betamethazone and multi-dose vials of Omnipaque were used in the pain clinic for multiple patients during the day and not wasted after a single patient use.

7. During an interview on 07/10/13 at 2:15 PM, Staff OOO, Director of Infection Control, stated that the use of multi-dose tubes of lubricant was covered under the pharmacy policy for use of multi-dose vials; it should only be used for one patient and then discarded.

8. During an interview on 07/10/13 at 4:00 PM, Staff IIII, Director of Pharmacy, stated that the use of contrast (Omipaque) was covered under the same standard as multi-dose vials of medications; it should only be used for one patient and then discarded.

9. Record review of the "Perioperative Standards and Recommended Practices", 2012 Edition, AORN, showed:
-Use of flash sterilization (Immediate Use Steam Sterilization, IUSS) should be kept to a minimum. Flash sterilization should be used only in selected situations and in a controlled manner.
-Flash sterilization should not be used as a substitute for sufficient instrument inventory.
-Loaner instruments should be requested when the surgery is scheduled and delivered to the health care organization with sufficient time available before the surgical procedure to allow inspection and inventory of the instruments and to perform reprocessing in the same manner as a facility-owned instrument.
-Policies and procedures serve as operational guidelines and establish authority, responsibility and accountability within the organization.

10. Record review of the Centers for Disease Control (CDC) Infection Control Practices Advisory Committee (HICPAC) "Guideline for Disinfection and Sterilization in Healthcare Facilities", 2008, showed:
-Flash sterilization is used when there is insufficient time to sterilize an item by the preferred package method.
-Flash sterilization should not be used for reasons of convenience, as an alternative to purchasing additional instrument sets, or to save time.
-It is not recommended as a routine sterilization method because of the lack of timely biological indicators to monitor performance and the sterilization cycle parameters (i.e., time, temperature, pressure) are minimal.
11. Record review of the facility's Sterile Processing Department Network Procedure titled, "Loaner Instrumentation" dated 03/2012, showed:
-Vendor representatives will deliver required trays to Sterile Processing 24 hours or one business day prior to the scheduled surgical case.
-Instrumentation for an "add-on" surgical case (those cases posted after the schedule has closed) will be brought to Sterile Processing 4 hours prior to the anticipated case start time.
-Vendor trays will be processed in the washer and then wrapped for sterilization.

12. Record review of the facility's Surgical Services Department "Scope of Services and Key Processes" revised 05/03/13, showed the following professional standards, guidelines or protocols used to guide services:
-AORN standards
-ASPAN guidelines (American Society of PeriAnesthesia Nurses)
-SGNA guidelines (Society of Gastroenterology Nurses and Associates, Inc)
-AAMI guidelines (Association for the Advancement of Medical Instrumentation).

13. Record review of the facility's Surgical Services policy titled, "Quality Load Control Testing and Sterilization Log Record Requirements" revised 03/09 showed sterilization log requirements were for documentation of each sterilization cycle to include specific contents of the load, exposure time and temperature of cycle, employee's identification and results of the BI {biological indicator}.

14. Record review of the facility's document "Immediate Use Sterilization Patient Log" showed the need to document the following:
-Date;
-OR Suite where instrument delivered;
-Written name of item processed;
-Patient label or patient name, medical record number and surgeon name;
-Reason key letter, indicating the reason the item had to be flash sterilized;
-Initials of staff placing the item in the sterilizer and removing it;
-Sterilization results i.e. pass, fail;
-Sterilizer Cycle count number;
-Prevac cycle length;
-Cycle actions: SPD [Sterile Processing Department] notified, Biomed notified, Biological, Closed container used.

15. Record review of the "Immediate Use Sterilization Patient Log" for 06/13 showed:
-55 flash cycles logged;
-15 cycles had no entry to sterilization results: pass or fail;
-6 cycles did not specify instrumentation flashed, only vendor instruments, etc.;
-2 cycles were identified as instruments used with implants;
-11 cycles were identified as vendor instruments requiring flash sterilization due to late arrival.

16. During an interview on 07/08/13 at 2:00 PM, Staff M, Sterile Processing Supervisor stated that:
-She was not aware the documentation of instruments flashed needed to be detailed, i.e. vendor tray was adequate.
- She knew when the flash load contained implants by the documentation of a biological on the IUSS log sheet.
-She was aware the log sheet was incomplete.
-The facility had one total joint tray flashed in June due to late delivery by a vendor.
-If the staff knew a vendor tray was needed for a case they contact the vendor and tried to get the instrumentation delivered in time to run a full sterilization cycle.

Based on observation, interview, and policy review, the facility failed to follow the Universal Protocol process for non-emergent invasive procedures known as "time out" for one Patient (# 15) of six patient's observed during time out processes. A "Time out" is a standard procedure when staff stop and verbally verify critical patient information to make sure everything is as it should be immediately before conducting an invasive procedure to keep patients safe and prevent events that should never occur during a non-emergent invasive procedure or surgery, such as wrong site surgery, wrong procedure performed and/or wrong person

The failure of facility staff to consistently follow and implement the Universal Protocol-Process policy in all departments had the potential to cause harm for all patients who undergo a non-emergent invasive surgical procedure at the facility.


The facility census was 127.

Findings included:

1. Record review of the facility's policy titled, "Universal Protocol-Process for all Non-emergent invasive Procedures" dated 06/04/13, showed direction for facility staff:
-In order to reduce the probability of harm and to assure patient safety, every non-emergent invasive surgery/procedure will include a system of verification of the correct person, site/side, and procedure;
-All departments including the emergency department (ED) and all staff including the medical staff shall follow the UP process (conduct time outs);
-Procedures performed at the patient's bedside require adherence to the verification process outlined in the policy and shall include all relevant documentation that verifies the correct information related to the patient and procedure to reduce the patient risk of harm;
-Final time out is an active focused final verification process prior to an invasive procedure that occurs immediately prior to the incision and is led by the physician in collaboration with the primary nurse and (as applicable) other members of the procedural team;
-A visual checklist or slider board is to be used to verify the critical elements of the time out;
-Active communication techniques will be used by all members of the team and requires oral (verbal) confirmation of all the critical elements;
-Confirmation will include at a minimum, the following critical elements;
1. Patient identity (using 2 patient identifiers);
2. Confirmation that the correct site/side is marked.
3. An accurate, signed procedural consent form.
4. Agreement on the procedure to be performed.
5. Correct patient position;
6. Diagnostic test results (if applicable) have been reviewed.
7. Relevant images and results are properly labeled and displayed.
8. Antibiotics have been given, as appropriate.
9. Blood products are available if applicable.
10. Availability of equipment;
11. Patient allergies;
12. That everyone on the team agrees that the elements of the "time out" are correct and complete, and that it is safe to proceed.
-Active oral communication will be used by all members of the team and at anytime any member of the team has a question or concern about the accuracy of the critical elements, the procedure will be suspended.

2. Observation on 07/09/13 at 9:55 AM in room # 19 of the ED showed Staff CC, Medical Doctor (MD) perform an incision, drainage/removal of multiple rectal hemorrhoids and associated thrombus (surgical procedure to cut open and remove blood clots from enlarged blood vessels protruding from the rectum) to Patient #15. Staff observed in room #19 at the time of the procedure was Staff FF, Registered Nurse (RN), Staff DD, Scribe, and Staff GG, RN, ED Team Leader.

3. Observation on 07/09/13 at 9:55 AM in room #19 showed a visual checklist/slider board approximately 24 inches wide by 36 inches long permanently attached to the wall and visible to the patient and all team members in the room. The board had the words "All must be confirmed by 2 Team Members" written in large letters on the board. The board had multiple blank lines provided for relevant patient and procedure specific information. The board had a vertical list of the 12 critical elements (numbered 1-12) contained in the UP policy. Adjacent to each of the twelve critical elements was a movable slider that, when moved designated visually that the specific element was confirmed.

4. Observation on 07/09/13 at 9:55 AM in the ED room #19 for the time out procedure for Patient #15 showed:
-No verification of the patient's name, date of birth, surgical procedure, diagnostic testing review/availability, antibiotic administration, or procedure site verification on the visual checklist/slider board; and
-No time out or active oral (verbal) communication that verified the critical elements listed in the UP policy were initiated by Staff CC, MD; and
-No team member present (Staff FF, Staff DD, and Staff GG) at anytime during the surgical procedure verbalized a concern for the failure to initiate a time out.

5. During an interview on 07/09/13 at 10:15 AM, Staff GG, RN, ED Team Lead, stated that the expectation was that the visual checklist/slider board was to be filled out completely and all of the critical elements listed on the board were confirmed with the physician, other team members and patient when possible. She stated that the physician should have initiated a time out immediately prior to making the incision. Staff GG stated that someone should have said something to stop him.

6. During an interview on 07/09/13 at 10:25 AM, Staff FF, RN, stated that she verified the patient's name with the patient and got consent from the patient before the patient was prepared for the procedure. She didn't think she needed to verify things that were obvious like the patient's surgical site and things that didn't exist or hadn't been ordered such as x-rays or antibiotics. She stated she didn't always fill-out the board because the information was obvious.

7. During an interview on 07/10/13 at 1:20 PM, Staff CC, MD, stated that:
-He should have verbally initiated a time out but he did not.
-He simply forgot to conduct the time out.
-He believed time outs' were one of "the safest things one can do" to ensure patient safety.
-He received recent UP training that included demonstration and verification of competency.
-He stated that in the past if he forgot to initiate the time out someone on the team would speak up and stop him.
-It was the team responsibility to speak up and stop him if he did not initiate the time out.

8. During an interview on 07/10/13 at 1:10 PM, Staff DDD, Chief Medical Officer, stated that Staff CC received recent UP education and that all staff including Medical Staff were expected to follow the UP policy.

Based on policy review and interview the facility failed to ensure Anesthesia services provided for Labor and Delivery by certified registered nurse anesthetists (CRNA) were under the supervision of the operating practitioner or of an anesthesiologist who was immediately available if needed. A review of the web site of the American Association of Nurse Anesthetists (AANA) federal supervision rule/opt-out (request exemption from the physician supervision requirement) information showed Missouri has not submitted a Gubernatorial Opt-Out Letter and the Missouri State Board of Nursing confirmed Missouri is not an Opt-Out state. Pursuant to 334.104 RSMo, CRNAs must be supervised by a physician in the state of Missouri. This practice had the potential to impact the safety of all patients who received epidural analgesia on the labor and delivery unit. The facility performs 120 deliveries per month. The facility census was 127.
Findings included:
1. Record review of the American Society of Anesthesiologist guidance titled, "Statement on the Anesthesia Care Team" approved 10/18/06 and last amended on 10/21/09 showed:
Anesthesiology is the practice of medicine including, but not limited to, preoperative patient evaluation, anesthetic planning, intraoperative and postoperative care and the management of systems and personnel that support these activities. In addition, anesthesiology involves Perioperative (time period describing the duration of a patient's surgical procedure: this commonly includes ward admission, anesthesia, surgery, and recovery) consultation, the prevention and management of untoward Perioperative patient conditions, the treatment of acute and chronic pain, and the care of critically ill patients. This care is personally provided by or directed by the anesthesiologist.
In the interest of patient safety and quality of care, the American Society of Anesthesiologists believes that the involvement of an anesthesiologist in the Perioperative care of every patient is optimal. Almost all anesthesia care is either provided personally by an anesthesiologist or is provided by a nonphysician anesthesia provider directed by an anesthesiologist. The latter mode of anesthesia delivery is called the Anesthesia Care Team and involves the delegation of monitoring and appropriate tasks by the physician to nonphysician. Such delegation should be specifically defined by the anesthesiologist and should also be consistent with state law or regulations and medical staff policy.
2. Record review of the American Society of Anesthesiologists "Guidelines for Neuraxial Anesthesia {type of regional anesthesia that involves injection of anesthetic medication in the fatty tissue that surround the nerve roots as they exit the spine} (also known as an epidural) or into the cerebrospinal fluid which surrounds the spinal cord {also known as a spinal}. This numbs the patient from the abdomen to the toes and often eliminates the need for general anesthesia] in Obstetrics", approved 10/12/88, and last amended on 10/20/10 showed these guidelines apply to the use of neuraxial anesthesia and labor anesthesia or analgesia in which local anesthetics are administered to the parturient [patient about to give birth] during labor and delivery. A physician with appropriate privileges should remain readily available during the neuraxial anesthetic to manage anesthetic complications until the patient's post-anesthesia condition is satisfactory and stable.
3. Record review of the facility's Anesthesia Services policy #6001 titled, "Scope of Services" revised 01/01/13 showed:
-Anesthesia services is responsible for developing policies and procedures governing the provision of all categories of anesthesia services, including specifying the minimum qualifications for each category of practitioner who is permitted to provide anesthesia services not subject to the anesthesia administration requirement at 42 CFR 482.52(a).
-Analgesia involves the use of a medication to provide relief of pain through the block of pain receptors in the peripheral and/or central nervous system. The patient does not lose consciousness but does not perceive pain to the extent that may otherwise prevail.
-Regional Anesthesia: the delivery of anesthetic medication at a specific level of the spinal cord and/or peripheral nerves, including epidurals, spinals and other central neuraxial nerve blocks, is used when loss of consciousness is not desire but sufficient analgesia and loss of voluntary and involuntary movement is required. Given the potential for the conversion and extension of regional to general anesthesia in certain procedures, it is necessary that the administration of regional and general anesthesia be delivered or supervised by a qualified practitioner.
-Anesthesia (regional, monitored and deep sedation) shall be administered only by qualified healthcare providers: A certified registered nurse anesthetist (CRNA), under the supervision of the operating practitioner or of an anesthesiologist who is immediately available if needed.
-Immediately available means the supervising anesthesiologist is physically located within the same area as the CRNA (i.e. in the same operative suite, labor and delivery unit, procedure room), and not otherwise occupied in a way that prevents him/her from immediately conducting hands-on intervention, if needed.
-A hospital may be exempted from the requirement for physician supervision of CRNAs as described in 482.52 (a)(4), if the state in which the hospital is located submits a letter to CMS signed by the governor, following consultation with the state's Boards of Medicine and Nursing, requesting exemption from physician supervision of CRNAs.
-During labor and delivery, the provision of acute analgesia (i.e. relief of pain via epidural or spinal route) is not considered "anesthesia" and a CRNA administering these forms of anesthesia services does not require supervision by the operating practitioner or anesthesiologist.

4. Record review of the facility's policy #6004 titled, "Nurse Anesthesia Services Organization and Direction" revised 01/01/13, showed the Department of Anesthesia shall allow CRNA, who have been successfully appointed to the medical staff category of "Allied Health Profession" and are licensed in the state of Missouri, to provide anesthesia services without the supervision of a physician. The state of Missouri permits this practice pursuant to CRNA licensure and scope of practice requirements.

5. During an interview on 07/10/13 at 2:00 PM, Staff JJJJ, Chief of Anesthesiology, stated that:
-The department of Anesthesia covered staffing of 11 total locations within the hospital with 11 CRNAs and three physician providers.
-Obstetrics (OB) was staffed with CRNAs.
-Epidurals do not require physician supervision.
-An Anesthesiologist goes to OB for all C-sections.
-The facility has CRNA coverage twenty-four hours a day/ seven days per week.
-The Anesthesiologists leave the building after the last patient had recovered.
-Off hours were covered by assigned call back and the Anesthesiologist on call was responsible for coming back to the hospital for all C-sections in OB and surgeries.

Based on record review and interview the facility failed to ensure a post anesthesia assessment was completed consistent with current standards of practice. Record review for three (#34, #35, #36) of six patients showed the post anesthesia evaluation was documented within 7-11 minutes of extubation (once there was no longer a need to mechanically breath for the patient or protect the airway during anesthesia the breathing tube was removed; this was referred to as extubation) following anesthesia. This practice failed to ensure an adequate post anesthesia evaluation of the patient and placed patients receiving general anesthesia at risk for complications.

The facility performs an average of 517 surgical cases per month.
The facility census was 127.

Findings included:
1. Record review of the American Society of Anesthesiologists (ASA), "Guidelines for Patient Care in Anesthesiology", dated 10/19/2011 showed responsibility for post anesthetic care to include:
-Ensuring the patient was discharged from the post-anesthesia care unit (PACU) in accordance with policies established by the Department of Anesthesiology.
-Ensuring that the duration of surveillance in the PACU was determined by the status of the patient and the judgment of the anesthesiologist.
-Conducting a post anesthesia evaluation, assessing patients for sequelae (complication or disorder as a result) from anesthetic interventions and arranging for appropriate follow-up.

2. Record review of the facility's policy titled, "Pre and Post Anesthesia Evaluation", revised 01/01/13 showed the post anesthesia evaluation may not begin until the patient was sufficiently recovered from the acute administration of the anesthesia so as to participate in the evaluation, i.e., answer questions appropriately, perform simple tasks.

3. Record review of the facility's policy titled, "Postoperative Anesthesia Care", revised 01/01/13 showed a licensed independent practitioner will document in the medical record the discharge of the patient from the PACU, when the patient's condition was stable and the patient met the PACU discharge criteria.

4. Record review of Patient #35's peri-operative (time period describing the duration of a patient's surgical procedure; this commonly included ward admission, anesthesia, surgery and recovery) record dated 07/10/13 showed:
-The surgery performed was a Hymenectomy (medical procedure involving the removal or opening of the hymen.
-Anesthesia type: General (drug induced loss of consciousness during which patients do not respond, even to painful stimulation and the ability to independently breath may be impaired requiring assistance to breath);
-Anesthetic induction (administration of anesthesia medication) start time was 7:31 AM and the patient was extubated at 7:58 AM.
-Post anesthesia evaluation was noted at 8:05 AM:
-No apparent anesthesia complications;
-Mental status: sufficiently recovered from acute administration of anesthesia to participate in the evaluation;
-Level of consciousness: sedated;
-Patient may be released from anesthesia care.

5. Record review of Patient #36's peri-operative record, dated 07/10/13 showed:
-The surgery performed was Vaginal Hysterectomy (removal of the uterus through the vagina).
-Anesthesia type: General;
-Anesthesia induction start time was 7:44 AM and the patient was extubated at 9:04 AM.
-Post anesthesia evaluation was noted at 9:15 AM:
-No apparent anesthesia complications;
-Mental status: sufficiently recovered from acute administration of anesthesia to participate in the evaluation and neurological status has returned to preoperative level.
-Level of consciousness: awake;
-Patient may be released from anesthesia care.

6. Record review of Patient #37's peri-operative record, dated 07/10/13 showed:
-The surgery performed was Arthroplasty Total Knee, left (total joint replacement of the left knee).
-Anesthesia type: General;
-Anesthesia induction start time was 7:20 AM and the patient was extubated at 9:02 AM.
-Post anesthesia evaluation was noted at 9:11 AM:
-Mental status sufficiently recovered from acute administration of anesthesia to participate in the evaluation.
-Level of consciousness: awake;
-Post-op nausea and vomiting; none;
-Patient may be released from anesthesia care.

7. During an interview on 07/10/13 at 2:00 PM, Staff JJJJ, Anesthesiologist, stated that:
-The anesthetist transporting the patient to PACU signed off to the nurse (gives the nurse report on the patient status), then documents the post anesthesia note.
-The post anesthesia note was completed in the electronic medical record and met the documentation requirement.
-The time of documentation was adequate to meet the standard of practice for patients receiving a MAC (monitored anesthesia care for depression of consciousness during deep sedation analgesia) but not for those patients receiving General Anesthetic.
-The anesthesiologist who was covering PACU discharged the patient from PACU. This was not always documented.