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Based on observation, interview and policy review, the facility failed to monitor, restock, and remove outdated emergency supplies from patient care areas and to ensure that laryngoscope equipment (used to insert breathing tubes) was properly disinfected and functioning for five [Emergency Department (ED), Medical Surgical Unit, Surgical Unit, Outpatient Unit and the Cardio-Pulmonary (heart and lung) Rehabilitation Unit] of six units. These deficient practices failed to ensure emergency equipment and supplies were immediately available and failed to ensure a safe and sanitary environment for patients. The facility census was 13.

Findings included:

1. Record review of the 2013 Recommended Practices for Sterilization by the American Association of periOperative Nurses (AORN) showed semicritical devices:
- Come in contact with mucous membranes (such as the lining of the mouth and throat);
- Require high level disinfection, and
- Include laryngoscope blades.

Record review of the 2013 Recommendations for Selection and Use of Packaging Systems for Sterilization by AORN showed packaging ensures the integrity of the sterilized contents until opened for use.

2. Record review of the facility's policy titled, "Guideline Regarding Emergency Crash Cart," (cart that contains emergency medications and supplies) reviewed date 06/13, showed this direction for staff:
- The purpose of the policy is to ensure the adequate supply and readiness of drugs and supplies in a life threatening situation.
- Each month, it is the responsibility of the staff to check all the equipment for any outdates.
- If there are any expired items, remove them so they may be replaced.

3. Observation on 02/10/14 at approximately 2:45 PM, in the Emergency Department showed supplies contained in the adult crash cart in ED 4 included two packages of Betadine swabs expired 06/12 and 01/12 and 4 laryngoscope blades, not packaged and stored in a box with laryngoscope handles. Observation of the Pediatric crash cart in ED 4 showed:
- Neonatal Speci Cath Kit (used to obtain a urine specimen using a small tube placed in the bladder), expired 04/12;
- Pediatric intubation set (Disposable set of supplies used to obtain an airway by placing a tube down the throat) 20/24 (type of measurement), expired 02/12;
- Pediatric intubation set 18/22, expired 01/12;
- Three intubation modules (kit containing supplies for Oxygen delivery and placing a small tube in the lungs) expired 03/13;
- Duo tube (feeding tube placed in the upper small intestine and used to provide nutrition to patients who cannot obtain nutrition by mouth) expired 08/13; and
-Eight laryngoscope blades not sterile.

Observation on 02/10/14 at approximately 2:45 PM of the crash cart supplies in ED 1 showed:
-Nasopharyngeal Airway expired 01/14;
-Endotracheal tube stylet expired 12/13; and
-Four laryngoscope blades not sterile.

Observation on 02/10/14 at approximately 2:45 PM of sterile supplies in ED 2 showed four 20 gauge venocaths expired 05/13.
4. During an interview on 02/10/14 at approximately 2:45 PM, Staff J, Registered Nurse (RN), ED Manager stated that:
- The Emergency Room Technicians (ERT) are responsible for checking rooms for supplies against the inventory list, placing needed supplies on an order and putting supplies away;
- The pharmacy technician was responsible to check the crash cart medications for expirations, removing outdated medication and restocking;
- ED nursing staff was responsible to check for expired supplies and to restock the crash cart supplies.

5. Observation on 02/10/14 at approximately 2:45 PM in the ED showed there were no tracheotomy trays (instrument set used to obtain an emergency airway when a patient's airway is compromised due to obstruction) in ED 1, ED 2, or ED 4. After more than an hour (2:45 PM to 3:54 PM) of searching for a tracheotomy tray the ED staff was unable to locate one.

6. Record review of the ED Supply Inventory Lists showed there should be four sterile tracheotomy trays immediately available in the ED, two in ED 1 and two in ED 4.

7. During an interview on 02/10/14 at 4:00 PM Staff J, ED Nurse Manager, stated that two Tracheotomy trays were kept in the storage cabinets in ED 1 and ED 4, and back up supplies were kept in the supply room. Staff J was unable to locate a tracheotomy tray in the supply store room.

8. Record review of the facility policy titled, "Outdated Supplies," dated 09/10, showed direction for facility staff to perform:
- The Medical Surgical unit will be checked monthly for outdated supplies.
- The results of this check will be logged on the Ward Clerk duty sheet by the Medical Surgical employee assigned to the task.
- If outdated supplies are found, this will be reported to the Medical Surgical Nurse Manager and then returned to purchasing.

9. Observation concurrent with interview on 02/11/14 at 9:20 AM showed six, 24 gauge (type of measurement), intravenous (IV) catheters (small tubes placed to allow fluids to go into the vein of the body) with expired date of 12/12. Staff K, Charge Nurse, stated that the charge nurses check for outdates and night shift checked the stock the majority of the time. She felt the expired supplies were there because the staff failed to check for expired supplies.

10. During an interview on 02/11/14 at approximately 9:30 AM, Staff E, Medical Surgical Manager, stated that the night shift staff was responsible for checking for expired supplies once a month.

11. Record review of the Nightshift Ward Clerk Duties form showed night shift staff checked the supplies in the cabinet where the IV catheters were stored and failed to remove the outdated IV catheters during the night shift on 02/10/14 .

12. Observation in the Cardio-Pulmonary (heart and lung) Rehabilitation Unit showed monitor patches (patch that sticks to a patient's chest for monitoring heart rhythm) with an expiration date of 12/12.

13. During an interview on 02/12/14 at approximately 2:00 PM, Staff RR, Director of the Cardio-Pulmonary Rehabilitation Unit, stated that she forgot to check the expiration date on the monitor patches.

14. During an interview on 02/12/14 at 3:02 PM, Staff B, Chief Nursing Officer (CNO), stated that she expected staff to check for expired supplies and pull them out of the patient care area if expired.

15. Observation on 02/11/14 at approximately 8:30 AM showed the crash cart on the medical unit contained:
- Two IV start kits with an expiration date of 09/13;
- Two trays with various sizes of laryngoscope blades open to air; and
- Two battery-powered laryngoscope handles that failed to power the blade's light bulb.

16. During an interview on 02/11/14 at approximately 8:30 AM, Staff E, Medical Surgical Unit Manager, stated that staff should maintain the crash cart by ensuring that:
- There are no expired supplies;
- Laryngoscope blades are in sterilized packages; and
- Laryngoscope handles function properly.

17. Observation on 02/11/14 at approximately 9:15 AM of a surgical procedure under local anesthesia showed there were three laryngoscope blades and a stylet lying open on top of the anesthesia Pyxis (an electronic medication and supply dispensing machine) prepared for intubation of the next general anesthesia patient.

18. Observation on 02/11/14 at approximately 10:20 AM of the emergency crash cart located in the Outpatient Department showed eight laryngoscope blades not sterile.

19. During an interview on 02/11/14 at approximately 10:00 AM, Staff BB, Director of Surgical Services and Sterile Processing stated that:
- She was responsible for Sterile Processing and for sterilization of reusable sterile instrumentation for the facility.
- She used AORN as a reference for writing policies and procedures related to Surgical Services and Sterile Processing.
- She was not aware that laryngoscope blades need to be sterile packaged and that laryngoscope blades and tubes opened in preparation for a case should be disposed of or re-sterilized prior to the next case.











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29117

Based on observation, interview, and policy review, the facility failed to ensure all patient use equipment was inspected periodically to assure it is properly calibrated and functioning properly. This deficient practice has the potential to be harmful to patients if the equipment malfunctions. The facility census was 13.

Findings included:

1. Record review of the facility's policy "Environment of Care Policy" revised on 04/01/12, showed the following direction:
Upon receipt of new equipment, Biomedical Services will evaluate equipment for inclusion in the Medical Equipment Management Plan. Once included in the Plan, Biomedical Services will determine appropriate maintenance strategies and intervals of inspection for included items.

2. Observation on 02/12/14 during an afternoon tour of the off-site outpatient physical therapy unit showed the following:
- One Therapeutic Ultrasound Center unit (which provides controlled electrical stimulation to the patients muscles) with a PM (Preventive Maintenance) sticker attached showing the unit was due for inspection in May of 2013.
-Two treadmills (used by patients for exercise by walking at a controlled pace) with PM stickers attached showing no inspection had been performed on either unit.
- One Hydrocolletor (a water filled heating device that heats hot packs to be applied to a patients muscles. The water temperatures should be adjusted to reach a maximum of 160 degrees Fahrenheit) with a PM sticker attached showing the unit was due for inspection in August of 2013.
- Two Metron Neuromuscular Stimulators (units which also provide controlled electrical stimulation to a patients muscles) with no PM sticker attached to either machine to show when each unit was last inspected.

3. During a telephone interview on 02/26/14 at 11:00 AM, Staff EE, Facilities Manager, stated that an evaluation of the Preventive Maintenance services provided by an outside contractor is conducted by the facility Safety Committee on an annual basis. The last evaluation took place on April 1, 2013.

Based on observation, interview, and policy review, the facility failed to ensure that staff followed infection control procedures for one patient (#5) of one patient receiving tracheostomy (artificial opening in the neck for breathing) care, two patients (#1 and #2) of four patients receiving medications, and two staff (T and U) of three staff observed in the Dietary Department. These deficient practices had the potential to increase the risk of infection and cross contamination and placed all patients and personnel at risk for hospital acquired infections (HAI) and contracting communicable diseases. The facility census was 13.

Findings included:

1. Record review of the facility policy titled, "Suctioning," reviewed date 09/27/11, showed this direction for respiratory therapy personnel:
- Obtain sterile suction catheter (long tube for suctioning mucous secretions);
- Put sterile glove on right or left hand as required to maintain its sterility;
- Catch sterile catheter with gloved hand; and
- Insert catheter gently into airway (tracheostomy).

2. Observation on 02/11/14 at approximately 3:00 PM showed Staff O, Respiratory Therapist, in Patient #5's room to perform tracheostomy suctioning:
- She put on non-sterile disposable gloves on both hands and opened a sterile suction catheter kit.
- She failed to use the sterile glove in the kit.
- Using her right hand with non-sterile glove, she touched the bare catheter, inserted it into the patient's tracheostomy, and removed the catheter as she suctioned mucous secretions. She repeated the procedure and discarded the catheter.

3. During an interview on 02/11/14 at approximately 3:15 PM, Staff O stated that:
- She should have used a sterile glove on her right hand when she handled the sterile suction catheter.
- She got confused and thought the non-sterile disposable gloves were sterile because they were purple-colored and she has used sterile gloves that were purple-colored in the past.
- She did not know there was a sterile glove in the suction catheter kit.

4. During an interview on 02/12/14 at approximately 10:45 AM, Staff NN, Director of Quality and Infection Control, stated that Staff O should have used a sterile glove to touch the suction catheter when she suctioned Patient #5's tracheostomy.

5. Record review of the facility's policy titled, "Hand Washing," reviewed on 09/11, showed direction for facility staff to perform hand hygiene (wash hands with soap and water or use hand sanitizer) after direct contact with a patient's intact skin (as in taking a pulse, blood pressure, or lifting a patient) and after removing gloves.

6. Observation on 02/10/12 at 3:15 PM showed Staff I, Registered Nurse (RN), obtained a blood pressure from Patient #2 and failed to perform hand hygiene before she used the computer key pad.

7. During an interview on 02/10/14 at 3:30 PM, Staff I stated that she should have performed hand hygiene after taking the patient's blood pressure.

8. Observation on 02/11/14 at 9:00 AM showed Staff P, RN, touching Patient #1's arm to find a vein for an intravenous (IV) catheter (small tube that is placed to allow fluids to go into the vein of the body) insertion. Then she failed to perform hand hygiene prior to putting on gloves.

9. During an interview on 02/11/14 at 9:14 AM, Staff P stated that she should have completed hand hygiene prior to putting on gloves. She stated she failed to perform hand hygiene because she forgot.

10. During an interview on 02/12/14 at 3:02 PM, Staff B, Chief Nursing Officer (CNO), stated that she expected all staff to perform hand hygiene after touching a patient and before putting on gloves and after removing gloves.

11. Observation on 02/11/14 at 11:40 AM showed Staff T, Dietary Aide, with gloves on and washing dishes. Staff T removed his gloves and failed to perform hand hygiene before he put on another pair of gloves and picked up a colander of meat.

12. During an interview on 02/11/14 at 11:52 AM, Staff T stated that he should have washed his hands after he removed his gloves.

13. Observation on 02/11/14 at 11:45 AM showed Staff U, Dietary aide, with gloves on as she prepared bread. Staff U removed the gloves and failed to perform hand hygiene.

14. During an interview on 02/11/14 at 11:50 AM, Staff U stated that she should have performed hand hygiene before putting on gloves and after removing the gloves.

15. During an interview on 02/11/14 at 11:55 AM Staff N, Director of Dietary, stated that all staff should perform hand hygiene before putting on gloves and after removing gloves.







29117

Based on observation, interview, record review, and policy review, facility staff failed to ensure:
- The dishwasher final rinse cycle was consistently at the proper temperature of 180 degrees Fahrenheit (F, a scale for temperature).
- The Dietary Manager monitored nutritional supplement (a drink added to the diet, usually to increase calories and/or protein to increase weight) intake for four patients (#3, #4, #6 and #9) of four patients with nutritional supplements ordered.
- The Dietary Department implemented existing policies and procedures for safe storage of nutritional supplements for one type of nutritional supplement in Medical Surgical Unit.
These deficient practices had the potential to cause harm to patients by providing inadequate nutritional care and unsafe, unsanitary food service. The facility census was 13.

Findings included:

1. Record review of the facility's undated policy titled, "Regular Washing," showed direction for facility staff to run the dishwasher machine and check the final rinse for proper temperature of 180 degrees F.

Record review of the facility's policy titled, "Regular Warewashing," revised on 03/26/02, showed direction for facility staff to check to see that the proper water temperature was maintained. The final rinse should be a minimum of 180 degrees F.

2. Record review of the final rinse cycle document form showed the dishwasher rinse cycle temperatures for the month of February 2014 were less than 180 degrees F for seven out of 11 days after breakfast and two out of 10 days after the evening meal.

3. During an interview on 02/11/14 at 11:25 AM, Staff R, Dietary Aide, stated that she wrote the temperature down for the final rinse cycle of the dishwasher but did not know what the temperature was supposed to be.

4. During an interview on 02/11/14 at 1:30 PM, Staff N, Director of Dietary, stated that the staff received no education and there was no policy that instructed staff what to do if the dishwasher rinse cycle was below 180 degrees F. Staff N was unaware of the final rinse cycles that were below 180 degrees F.

During an interview on 02/12/14 at 11:45 AM, Staff N stated that the quality assessment was to record the temperature of the final rinse, but if the temperature was below 180 degrees F it was not reported to Staff N.

5. During an interview on 02/12/14 at 3:02 PM, Staff B, Chief Nursing Officer (CNO), stated that she supervised the Director of Dietary and expected the dietary staff to be instructed on the correct temperature of the dishwasher rinse cycle and know when to report if the temperature was out of range.

6. Record review of the facility's policy titled, "Nourishments: Supplement Feedings," dated 01/01/14, showed direction for the Food Services Supervisor to monitor the patient's acceptance and tolerance of the supplement, making adjustments as necessary according to tolerance.

7. Record review of Patient #6's medical record showed a physician order dated 02/09/14 for supplement two times a day and showed staff failed to document any supplement intake.

8. During an interview on 02/11/14 at 11:00 AM, Staff E, Medical Surgical Manager, stated "You are not going to be able to see that supplements are being given."

9. During an interview on 02/11/14 at 11:05 AM, Staff L, Licensed Practical Nurse (LPN), stated that she was not able to find documentation of supplement intake on the patient medical record.

10. Record review of Patient #4's medical record showed a physician order dated 02/04/14 for a supplement twice a day and showed staff failed to document any supplement intake.

11. Record review of Patient #3's medical record showed a physician order dated 02/11/14 for a supplement between meals (9:00 AM, 2:00 PM and 7:00 PM) and showed staff failed to document supplement intake for 9:00 AM.

12. Record review of Patient #9's medical record showed a physician order dated 02/11/14 for a supplement between meals and showed staff failed to document supplement intake for 9:00 AM.

13. Record review of the facility's policy titled, "Kitchenette," revised on 0/01/14, directed Dietary staff to restock kitchenettes weekly and dispose of any outdated items.

14. Observation on 01/11/14 at 11:30 AM in the kitchenette (area used to stock supplements for patients) on the Medical Surgical Unit showed two boxes of supplement powder packages with an expiration date of 07/09/13.

15. During an interview on 02/11/14 at 1:45 PM, Staff N, Director of Dietary, stated that:
- It was her responsibility to assess patients for protein and intake needs.
- Nursing staff is responsible for charting supplement intake.
- She thought it was a computer "glitch" that the supplement intakes were not documented.
- She confirmed that it was the Dietary Department's responsibility to check supplements and to remove outdated items.






15697

Based on interview and record review, the facility failed to include six of 14 contracted patient services in its Quality Assurance (QA) activities. This failure increased the potential for patients to receive substandard care. The facility census was 13.

Findings included:

1. Record review of a list of contracted patient services provided by Staff A, Administrator, showed 14 contracted patient services.

2. Record review of the facility's 2013 QA reports showed no quality measures for six contracted services:
- Three contracts for interpreters;
- One contract for linen services;
- One contract for lithotripsy services; and
- One contract for Licensed Professional Counselor.

3. During an interview on 02/12/14 at approximately 3:00 PM, Staff A stated that not all contracted services were included in QA activities and she did not know this was a regulatory requirement.

Based on observation, interview, and policy review the facility failed to follow their policy by not asking the patient their name prior to administration of medication for four patients (#1, #2, #3, and #12) of eight patients observed during medication administration. This failure increased the potential for medication errors to occur for all patients receiving medication. The facility census was 13.

Findings included:

1. Record review of the facility's policy titled, "Medication Administration," revised on 09/13, showed direction for facility staff to verify the patient's name with the patient before administering medication.

2. Observation on 02/10/14 at 3:15 PM showed Staff I, Registered Nurse (RN), asked Patient #2 his date of birth and allergies but failed to ask the patient to verify his name.

3. Observation on 02/10/14 at 3:20 PM showed Staff I asked Patient #3 her date of birth and allergies but failed to ask the patient to verify her name.

4. During an interview on 02/10/14 at 3:30 PM, Staff I stated that she failed to verify each patient's name because she knew them.

5. Observation on 02/11/14 at 8:25 AM showed Staff P, RN, asked Patient #12 her date of birth and allergies, but failed to ask the patient to verify her name.

6. Observation on 02/11/14 at 8:35 AM showed Staff P asked Patient #1 his date of birth and allergies but failed to ask the patient to verify his name.

7. During an interview on 02/11/14 at 5:30 PM, Staff P stated that she should have verified each patient's name but failed to do so because she knew them from previous hospital stays.

8. During an interview on 02/12/14 at 9:30 AM, Staff E, Medical Surgical Manager, stated that she expected each of the nurses to ask the patient their name prior to medication administration.

9. During an interview on 02/12/14 at 3:02 PM, Staff B, Chief Nursing Officer (CNO), stated that she expected the nurses to ask the patients their name prior to medication administration.

Based on record review and policy review, the facility failed to ensure that physician orders for treatment were present in the medical record and that medical records were properly authenticated per policy (signed, dated and timed) for six (#16, #18, #21, #22, #23, #24 ) of six patient records reviewed. The facility census was 13.

Findings included:

1. Record review of the facility's "Board of Trustees By-Laws", dated 03/07, showed the medical records required for all patients admitted to the hospital shall include physician's orders.

2. Record review of the facility's undated "Rules and Regulations of the Medical Staff" showed:
- The attending physician of the patient admitted to the hospital shall be held responsible for the preparation of a completed medical record for the hospital file.
- Patient records will not be considered complete until the required forms are filled out, signed, dated, and timed by the responsible doctor.
- The attending surgeon shall sign, date, and time the anesthesia record upon completion of an operation.
- The attending surgeon shall complete, sign, date and time the surgery report upon completion of an operation.
- All orders shall be in writing and include authentication, date, and time of entry.
- Patients may be discharged only with the order of the doctor.
- Medical records are to be completed on a timely basis. The medical record must be completed in its entirety within thirty days of discharge.

3. Record review of Patient #16's medical record dated 01/22/14 showed the Post Anesthesia Care (PAC) and discharge orders were signed and dated but not timed and the pre and post anesthesia evaluation and anesthesia record by the Certified Registered Nurse Anesthetist (CRNA) were signed by the surgeon but not dated or timed.

4. Record review of Patient #18's medical record dated 01/22/14 showed the post operative recovery and discharge orders were written and signed at 8:00 AM, prior to surgery start at 8:26 AM.

5. Record review of Patient #21's medical record dated 01/09/14 showed the pre and post anesthesia evaluation and anesthesia record by the CRNA were signed by the surgeon but not dated or timed and the surgical report was signed but not timed.

6. Record review of Patient #22's medical record dated 11/26/13 showed he presented to surgery for a flexible cystoscopy (look into the urinary bladder using a flexible tube with light and video camera) under local anesthesia. Patient #22 was prepped for surgery and consent signed with no physician orders on the record. The consent for operation was signed and dated but not timed.

Further review of Patient #22's medical record showed he returned to surgery on 11/26/13 for a flexible cystoscopy with stent (a thin tube inserted into the ureter, which is a tube that carries urine from the kidneys to the bladder to prevent or treat obstruction of the urine flow from the kidney) removal under general anesthesia. Patient #22 was administered a scopolamine patch for nausea without a physician written order. The pre and post anesthesia record for Patient #22 were signed by the surgeon but were not dated or timed.

7. Record review of Patient #23's medical record dated 11/13/13 showed:
- Holding area standing orders were not signed by the surgeon.
- The pre and post anesthesia evaluation and anesthesia record by the CRNA were signed by the surgeon but not dated or timed.
- The Operative Note did not include the type of anesthesia;
- The Extracorporeal Shock Wave Lithotripsy (ESWL, uses shock waves to break a kidney stone into small pieces that can more easily pass thru the body) Operative Note was signed by the surgeon but did not include a full date or time.
- The PACU standing orders were not signed, dated, or timed as acknowledged by a nurse.

8. Record review of Patient #24's medical record dated 01/10/14 showed the operative note was not signed, dated or timed and the pre and post anesthesia evaluation and anesthesia record by the CRNA were signed by the surgeon but not dated or timed.

Based on observation, interview, policy review,and record review, the facility failed to ensure Surgical Services were performed in a safe manner in accordance with applicable Federal regulations and guidelines governing surgical services as well as standards and recommendations promoted by the Association of periOperative Registered Nurses (AORN) and the Association for the Advancement of Medical Instrumentation (AAMI) by:
- Failing to ensure policies and defined scope of services were in place for surgical services;
- Failing to ensure current standards of practice for patient safety in Surgical Services including: Safety Practices for the Prevention of Wrong-Patient, Wrong Site, and Wrong Procedure and for Malignant Hyperthermia protocols and preparedness;
- Failing to ensure completion of a History and Physical (H&P) prior to surgery for five (#16, #22, #25, #24, #26) of 10 patient's medical records reviewed;
- Failing to ensure policies and procedures were in place for sterilization and disinfection procedures; and
-Failing to ensure aseptic surveillance and practice.
These deficient practices failed to ensure a sanitary environment and put the safety of all patients receiving surgical care at risk.
The severity and cumulative effect of these deficient practices resulted in the facility's overall non-compliance with the requirements found at CFR 485.639 Condition of Participation: Surgical Services. The facility performs an average of 70 surgical cases per month and 840 annually. The facility census was 13.

Findings included:

1. Record review of the 2013 AORN "Quality and Performance Improvement Standard II: Delineate the scope of patient care activities or services" showed the scope of patient care activities or services describes who is served, what services are provided, who provides the services, physical sites and times that services are provided.

2. Record review of the 2013 AORN Position Statement "Preventing Wrong-Patient, Wrong-Site, and Wrong-Procedure Events" showed:
- Multidisciplinary teams that include perioperative RNs, surgeons, anesthesia care providers, risk managers, and other health care professionals should collaboratively develop procedures and protocols to prevent wrong-patient, wrong-site, wrong-procedure events.
- Multidisciplinary team members should implement and monitor standardized processes for the prevention of wrong-patient, wrong-site, wrong-procedure events.
- Policies for individual health care organizations should clearly delineate the role and responsibility of the physician and other team members in marking and verifying the correct surgical site.
- Surgical team members should complete a preoperative checklist that includes, but is not limited to, preprocedure verification, site marking, and time-out procedures.

3. During an interview and concurrent record review of policies and procedures on 02/11/14 at approximately 2:35 PM, Staff BB, Manager of Surgical Services, Outpatient Services and Sterile Processing, stated that the facility did not have the following written Surgical policies and procedures:
- Scope of surgical services including hours of operation, capabilities and cases performed;
- Identification of infected and non-infected cases;
- Safety Practices including: Prevention of Wrong-Patient, Wrong Site, and Wrong Procedure Surgeries, Use of two patient identifiers, and Monitoring of patients with conscious sedation; and
- House keeping requirements/procedures including terminal cleaning and damp dusting of the operating rooms.

4. Review of 2013 AORN "Malignant Hyperthermia Guide?line" (MH, a rare life-threatening condition that is usually triggered by exposure to certain drugs used for general anesthesia. In susceptible individuals, these drugs can induce a drastic and uncontrolled increase in skeletal muscle rigidity, which overwhelms the body's capacity to supply oxygen, remove carbon dioxide and eventually lead to circulatory collapse and death if not treated quickly) showed:
- Nurses should be prepared to monitor the patient and treat a MH crisis if they are working in any type of facility or department where MH trig?gering agents are used (OR-operating room, labor and delivery, interventional radiology, emergency department).
- Perioperative nurses and other health care provid?ers should stay up-to-date with new research and treatment recommendations.
- AORN Malignant Hyperthermia Guideline, Table 5, showed the suggested content for a (MH) Cart was consistent with the recommendation of the Malignant Hyperthermia Association of the United States (MHAUS).

5. Review of the MHAUS "Recommendation for MH" showed:
- Therapy should be aimed at prompt treatment of hyperkalemia (condition in which the concentration of the electrolyte potassium in the blood is elevated), administration of Dantrolene (a muscle relaxant, it's the only specific and effective treatment for MH), hyperventilation (rapid or deep breathing beyond the normal rate), and cooling to target core temperature 38?C.
- The recommended Malignant Hyperthermia cart content includes drugs, general equipment, monitoring equipment, nursing supplies, and laboratory testing supplies.
- Thirty-six (36) vials of Dantrolene will allow for initial stabilization and treatment while more vials are being acquired to continue treatment, as needed.

6. During an interview on 02/11/14 at approximately 8:45 AM, Staff BB, Manager of Surgical Services, Outpatient Services and Sterile Processing, stated that they did not have an organized supply of MH supplies or a MH cart for the Operating Room (OR). Staff BB stated that they maintained a stock of Dantrolene in the OR but she did not know how many vials.

7. During an interview on 02/11/14 at approximately 1:00 PM, Staff FF, Certified Registered Nurse Anesthetist (CRNA) stated that Dantrolene was kept in the OR but he was not aware of how much. Staff FF stated that a back-up supply was kept in the pharmacy. Staff FF did not know if surgery staff had performed a MH crisis drill. During an interview on 02/12/14 at approximately 2:25 PM, Staff FF stated that the OR stock of Dantrolene was six vials.

8. During an interview on 02/11/14 at approximately 1:30 PM, Staff W, Director of Pharmacy, stated that he had no Dantrolene in the pharmacy.

9. Record review of the facility's "Board of Trustees By-Laws", dated 03/07, showed no anesthesia shall be administered or operation begun until the patient has had approved pre-surgical work-up and a history and physical examination to determine the anesthetic and surgical risks. In addition, the patient's chart, which accompanies them to the operating room, shall contain past history, presenting complaint, and pre-operative diagnosis.

10. Record review of the facility's undated "Medical Staff Rules and Regulations" showed no patient shall be operated upon where there is not a complete history and physical examination recorded in the chart. When the history and physical examination are not recorded before the time stated for operation, the operation shall be canceled, unless the attending surgeon states in writing that such a delay would constitute a hazard to the patient.

11. Observation and concurrent record review of Patient #26 on 02/11/14 at 9:15 AM showed the patient was in the OR undergoing a surgical procedure with local anesthetic (local insensitivity to pain). Patient #26's medical record did not contain a H&P examination.

12. During an interview on 02/11/14 at approximately 9:15 AM, Staff CC, Registered Nurse (RN), stated that a H&P was not required for patients receiving local anesthetic in the OR.

13. During an interview on 02/11/14 at approximately 9:30 AM, Staff BB, Manager of Surgical Services, Outpatient Services and Sterile Processing, stated that a H&P was not required for surgical patients receiving local anesthetic.

14. During an interview on 02/11/14 at 11:20 AM, Staff HH, Director of Health Information Management (HIM), stated that all surgery patients were required to have a H&P. Staff HH stated that surgery was supposed to be canceled if there was no H&P for the patient.

15. During an interview on 02/12/14 at approximately 2:30 PM, Staff KK, Chief of Staff, stated that:
- A H&P had to be done for all patients.
- Endoscopies had a short H&P form that was used.
- A H&P two to three weeks old had to be updated.
- The H&P included a physical exam and problem at hand.

16. Record review of discharged patients medical records showed the following:
- Patient #16 had a surgical procedure performed on 01/28/14 with no H&P;
- Patient #22 had a surgical procedure performed on 11/26/13 with no H&P;
- Patient #24 had a surgical procedure performed on 01/10/14 with no H&P; and
- Patient #25 had a surgical procedure performed on 01/17/14 with no H&P.

17. Record review of the 2013 AORN "Recommended Practices for Traffic Patterns in the Perioperative Practice Setting" showed:
- Clearly defined and enforced traffic control practices protect personnel, patient, supplies and equipment from potential sources of cross contamination.
- Surgical supplies prepared for surgical procedures outside the surgical suite (e.g.. In central processing) should be transported to the surgical suite to maintain cleanliness and sterility and to prevent physical damage.
- Use of correct procedures for transporting items preserves the qualities of the sterile and clean environment.
- Separation of clean and sterile supplies and equipment from soiled materials by space, time and traffic patterns decreases the risk of infection.

18. Record review of the 2010 AAMI "Comprehensive guide to steam sterilization and sterility assurance in health care facilities" showed:
- Clean or sterile items being transported in uncontrolled environments should be in a covered or enclosed cart with a solid bottom shelf.
- If items are placed inside plastic or paper bags or boxes for transport, they should be arranged within the containers so as to prevent them from being crushed or otherwise damage or contaminated.
- Written policies and procedures should be developed for the use of specific transport of equipment, appropriate handling practices, and acceptable environmental conditions for the transport of sterile packages.

19. During concurrent observation and interview on 02/11/14 at approximately 9:30 AM, Staff BB, Manager of Surgical Services, Outpatient Services and Sterile Processing, stated that:
- There was not a direct connection between the OR and Sterile Processing.
- Following decontamination of surgical instruments, they were transported through a surgical corridor containing sterile supplies in cabinets and equipment used in the OR including C-Arms (medical imaging device that is based on X-ray technology with a C-shaped arm used to connect the X-ray source and X-ray detector to one another).
- The corridor led to a public hallway off the facility lobby where instruments were transported to the Sterile Processing department for sterilization.
- Sterile instruments and supplies were transported by the reverse flow from Sterile Processing into a public hallway off the facility lobby, through the OR corridor and put away in closed cupboards in the corridor or surgical suite.
-Surgical instruments and sterile supplies were transported through public hallways without being covered.
-The facility did not have a policy for transport of sterile supplies outside the OR.

20. Review of Missouri State Statutes 19 CSR 30.20.008(6) showed written procedures shall specify how items stored in central services can be obtained when central services is considered closed.

21. Review of Missouri State Statutes 19 CSR 30.20.008(7) showed reprocessed packaged item(s) shall be identified as to content, show evidence of sterilization and be labeled indicating the sterilizer used and the load/cycle number. A policy on shelf life of a package sterile item shall be established in accordance with acceptable standards of sterilization and dependent on the quality of the packaging material, storage conditions and the amount of handling.

22. Record review of the 2013 AORN" Recommended Practices for Sterilization" showed access to sterile supply areas should be limited to personnel who are trained in handling sterile supplies. Policies and procedures should be developed and implemented for processes including documentation of sterilization processes, environmental conditions, load contents and load numbers; and transport and distribution of sterile items.

23. Record review of the 2010 AAMI "Comprehensive guide to steam sterilization and sterility assurance in health care facilities" showed:
- There should be written policies and procedures for how shelf life is determined and how it is indicated on the product.
- Each item or package intended for use as a sterile product should be labeled with a lot control identifier.
- The lot control identifier should designate the sterilizer identification number or code, the date of sterilization, and the cycle number (cycle run of the sterilizer).

24. During concurrent observation and interview on 02/11/14 at approximately 9:30 AM, Staff BB, Manager of Surgical Services, Outpatient Services and Sterile Processing, stated that:
- She used AORN as a reference for Surgical Services policies including Sterile Processing.
- She was not familiar with AAMI standards for sterilization.
- The facility did not have a policy for who could retrieve sterile supplies from Sterile Processing or Surgery after hours.
- The facility did not have a policy regarding shelf life of reprocessed sterile items.
- Reprocessed packaged items were not identified by load/cycle number.

Based on observation, interview, record review and policy review, the facility failed to ensure credentialing of five (Staff FF, Staff SS, Staff TT, Staff UU and Staff VV) of five anesthesia providers according to policies and procedures approved by the facility medical staff and governing board. These deficient practices failed to ensure care was provided by qualified medical staff and failed to ensure a safe environment for all patients presenting to the facility for surgical care. The facility performs approximately 70 surgical cases per month and 840 cases annually. The facility census was 13.

Findings included:

1. Review of the facility's policies titled "Board of Trustees By-Laws", dated 03/07, showed:
- Applications for active, consulting, and courtesy staff and nurse practitioner (NP) staff appointment and reappointment shall be in writing and shall signify agreement of the applicant to conform with the bylaws;
- Each application shall be accompanied by evidence of education, training, professional qualifications, license, and standards of performance;
- This process will include an inquiry of the National Practitioner Data Bank.

2. Record view of the credentialing file for Staff FF, Certified Registered Nurse Anesthetist (CRNA), showed no evidence of National Practitioner Data Bank inquiry or evaluation of clinical practice for re-credentialing, including peer review.

3. Record review of the credentialing file for Staff SS, CRNA, showed no evidence of verification of original education transcript or National Practitioner Data Bank inquiry.

4. Record review of the credentialing file for Staff TT, CRNA, showed no evidence of verification of original education transcript, National Practitioner Data Bank inquiry or evaluation of clinical practice for re-credentialing, including peer review.

5. Record review of the credentialing file for Staff UU, CRNA, showed no evidence of original education transcript, National Practitioner Data Bank inquiry or evaluation of clinical practice for re-credentialing, including peer review.

6. Record review of the credentialing file for Staff VV, CRNA, showed no evidence of original education transcript, National Practitioner Data Bank inquiry or evaluation of clinical practice for re-credentialing, including peer review.

7. Record review of the CRNA billed services for 2013 showed:
- Staff FF, CRNA, provided anesthesia services for 476 patients;
- Staff SS, CRNA, provided anesthesia services for 26 patients;
- Staff TT, CRNA, provided anesthesia services for 15 patients;
- Staff UU, CRNA, provided anesthesia services for 3 patients; and
- Staff VV, CRNA, provided anesthesia services for 13 patients.

8. During an interview on 02/12/14 at approximately 2:45 PM, Staff C, Manager of Medical Staff Services, stated that the policy for credentialing Nurse Practitioners was outlined in the Medical Staff By-Laws but she did not have guidance for credentialing CRNAs. Staff C stated that she did not check the Practitioner Data Bank for CRNAs.

Based on interview and record review, the facility failed to include the volume of outpatient surgical procedures in its 2013 Annual Evaluation. This failure resulted in these procedures being omitted from the Physician Chart Review, which increased the potential for surgical patients to receive substandard care. The facility census was 13.

Findings included:

1. During an interview on 02/11/14 at approximately 8:45 AM, Staff BB, Director of Surgical Services, Outpatient Services and Sterile Processing, stated that the average surgical case volume was 70 cases per month and that 75% of those cases were scope procedures performed in the Outpatient area. Staff BB stated that the scope of surgeries performed at the facility was primarily:
- Orthopedic (surgery of the body's bones, muscles, cartilage and tendons, ligaments and joints);
- Urological (surgery of the male and female urinary tract and male reproductive organs);
- Podiatry (surgical treatment of disorders of the foot, ankle and lower extremity);
- Gynecological (GYN, dealing with the female reproductive organs) cases; and
- Endoscopy (examining the inside of a person's body using an endoscope, which is a medical device consisting of a long, thin, flexible or rigid tube which has a light and a video camera. Images of the inside of the patient's body can be seen on a screen or video recorded.)

2. Record review of the Volume of Services section of the facility's 2013 Annual Evaluation showed:
- A written statement that "surgery volume was nonexistent."
- The only surgical categories were general and cataract surgeries that had zero volume.
- No volume for outpatient surgical procedures was included

3. During an interview on 02/11/14 at approximately 4:00 PM, Staff A, Administrator, stated that outpatient surgical procedures were not included in the 2013 Annual Evaluation but should be.

4. Record review of the Physician Chart Review as part of the facility's 2013 Annual Evaluation showed items for operative and other invasive procedures, including History & Physical documented prior to procedure. These items contained review entries for June, August, and September.

5. During a telephone interview on 02/19/14 at 9:30 AM, Staff HH, Medical Records Manager, stated that she is responsible for performing the Physician Chart Reviews for the facility's Annual Evaluation. She stated that the operative and other invasive procedures items reviewed in June, August, and September 2013 were on inpatient medical records and no reviews were done on outpatient surgical procedures.

Based on interview, the facility failed to provide a mechanism for review and evaluation of the quality and scope of anesthesia services. This failed practice had the potential to place patients at risk for care in an unsafe environment. The facility census was 13.

Findings included:

1. During an interview on 02/11/14 at approximately 8:45 AM, Staff BB, Manager of Surgical Services, Outpatient Services and Sterile Processing, stated that she was not aware of any quality indicators that were being monitored for anesthesia services.

2. During an interview on 02/11/14 at approximately 1:00 PM, Staff FF, Certified Registered Nurse Anesthetist (CRNA) stated that Anesthesia Services did not have a formal Quality Assurance Performance Improvement (QAPI, a process that identifies a problem, selects and implements solutions, then monitors to ensure the problem is resolved) plan or designated indicators. Staff FF stated that complications or events outside the expected outcome would be recorded as a narrative note on the anesthesia record.

Based on interview and record review, the facility failed to evaluate the quality and appropriateness of the treatment furnished by the Certified Registered Nurse Anesthetist (CRNA) for five (#FF, #SS, #TT, #UU, #VV) of five CRNAs. This failed practice had the potential to place patients at risk for care in an unsafe environment. The facility census was 13.

Findings included:

1. Record review of CRNA's credentialing files on 02/12/14 showed there was no quality evaluation of clinical practice for five (#FF, #SS, #TT, #UU, #VV) of five CRNA files reviewed.

2. During an interview on 02/12/14 at approximately 3:00 PM, Staff C, Manager of Medical Staff Services, stated that the facility did not require quality evaluation of clinical practice for credentialing or re-credentialing of CRNAs.

3. Record review showed Anesthesia Services were provided for 628 patients during 2013.

Based on interview and record review, the facility failed to ensure that quality indicators were analyzed and corrective plans implemented for three [Emergency Department (ED), Infection Control (IC), Operating Room (OR)] of 10 patient care departments reporting quality measures. This failure increased the potential for all patients to receive substandard care. The facility census was 13.

Findings included:

1. Record review of the 2013 Quality Assurance (QA) Plan showed the performance improvement model used by the facility was Plan, Do, Check, Act, an ongoing process that requires analysis of indicator results to identify areas for improvement and to implement corrective actions.

2. Record review of the 2013 Quality/Performance Improvement reports showed these indicators not meeting targets:
- ED door to doctor wait times;
- IC hand hygiene compliance; and
- OR patient procedure wait time less than an hour.

3. Record review of 2013 Quality Committee meeting minutes showed no reports from the ED, IC, and OR managers with analysis of the indicators needing improvement and corrective actions to improve them.

4. During an interview on 02/12/14 at approximately 3:30 PM, Staff NN, Director of Quality and Infection Control, stated that facility departments are to submit reports with indicator results analysis and any corrective actions to her for reporting to the Quality Committee. She stated she does not receive these reports from the ED and OR managers and has not reported on these for IC. She also stated that these quality improvement functions are necessary to maintain compliance with the QA Plan.