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Based on review of hospital Medical Staff Rules and Regulations, policy/procedure, medical record and staff interview, it was determined the hospital failed to require a physician order restraints for the management of violent or self-destructive behavior to include the type of restraint, the reason for the restraint and the duration of the restraint, as required by hospital policy/procedure, for 1 of 1 patient, (patient # 13).

Findings include:

Medical Staff Rules and Regulations revealed: "...special treatment orders, such as use of restraints will be documented to include type of restraint, justification and time limits...."

Hospital policy titled "Restraints" revealed: "...The restraint order must include description of the behavior requiring restraints, the type of restraint used, reason for restraint and start time...."

Physician order for patient # 13 revealed: "...order date/time 4/14/14 2:20 PM release date/time None, Start Date/Time 4/14/14 2:05 PM, End Date/Time 4/14/14 2:05 PM, frequency STAT signed by Physician # 14....." The next order for restraint occurred on 4/15/14 at 0543 hours.

Medical record nursing flowsheet revealed: "...4/14/14 at 1336 hours Start Nylon lockable R (right) wrist, L (left) wrist, R ankle, L ankle...."

The Director of the Emergency Department confirmed in an interview on 4/22/14 that the initial behavioral restraint order was STAT and did not include the type and duration for the behavioral restraint or the reason for restraint as required.

The Director of the ICU confirmed in an interview that, patient # 13 was restrained upon arrival to the
ICU 4/14/14 at 1719 hours, and did not have an order for restraints until 4/15/14 0543 hours.

Based on review of Medical Staff Rules and Regulations, hospital policy/procedure, medical records and staff interviews, it was determined that the hospital failed to require that the physician renew the order for restraint for the management of violent or self-destructive behavior for 1 of 1 patient (patient # 12).
Findings include:

Medical Staff Rules and Regulations revealed: "...when a patient is placed in restraints for behavioral reasons, new orders are required every (4) four hours for adults...."

Hospital policy titled "Restraints" revealed: "...The restraint order must include description of the behavior requiring restraints, the type of restraint used, reason for restraint and start time...if the patient remains in restraints, new orders are required at four (4) hours for adults...the physician is not required to perform another face-to-face assessment after the initial assessment...when the order is about to expire, the RN should call the physician to report the results of their most recent assessment and request the order be renewed for another time period...."

Medical record physician progress note revealed: "... 4/15/14 at 0652 hours: per nursing staff and the charge nurse, the patient has been verbally abusive with multiple staff members. The patient will be put in 4 point restraints to protect the staff ...."

Medical record physician orders revealed: "...restraints behavioral adult (age 18+)...start date/time 4/15/14 0658 hours...end date/time 4/15/14 1057 hours...danger to others...the MD (medical doctor) must conduct a face to face assessment within 1 hour of initiation of restraint order and every 8 hours thereafter... order signed by Physician # 9...."

Medical record of flowsheet data revealed: "... 4/15/14 at 0656 hours, start nylon lockable R (right) Wrist, L(left) Wrist, R ankle, L ankle...4/15/14 1329 hours pt (patient) restraints removed...."

The Director of the Emergency Department confirmed in an interview conducted on 4/22/14 that there was no documentation of a physician renewal order for behavioral restraints between 1057 hours and 1329 hours. Additionally, the RN did not document patient behavior prior to removal of restraints.

Based on review Medical Staff Rules and Regulations, hospital policy/procedure, medical record and staff interviews, it was determined the hospital failed to require the physician renew a safety restraint for the management of non-violent patient behavior for 1 of 1 patients ( patient # 11).

Findings include:

Medical Staff Rules and Regulations revealed: "...Special treatment orders, such as use of restraints, will be documented to include type of restraint, justification and time limits...not to exceed 24 hours. Subsequent restraint orders must be written by the physician every day of continuation of the restraint...."

Hospital policy title "Restraints" revealed: "...Application of restraints requires a physician or licensed independent practitioner (LIP) written or verbal order prior to initiation of a restraint...

Medical record of nursing flowsheet for patient # 11 revealed: "...4/19/14 at 2000 hours soft restraint R (right) wrist, soft wrist restraint L (left) wrist... continued through 4/21/14 to 2000 hours...continued 4/22/14 at 0800 hours...discontinue 4/22/14 at 0815 hours...."

Medical record of physician orders revealed: "...4/19/14 at 1144 PM to 4/20/14 at 11:43 PM, soft restraint bilateral wrist continuous X 1 day...4/21/14 at 2:21 PM to 4/22/14 2:20 PM, soft restraint bilateral wrist continuous X 1 day...."

The Director of ICU confirmed in an interview on 4/23/14 that, the RN documented the patient in soft bilateral wrist restraints 3 hours and 44 minutes before obtaining a physician or LIP order for restraints, the patient remained in restraints without an order from 4/20/14 at 11:44 PM to 4/21/14 at 2:20 PM, (15 hours), the documentation of restraints on the nursing flowsheet from 4/21/14 from 2200 hour to 4/22/14 0400 hours did not record continued or discontinued status of restraints, and on 4/22/14 at 0800 the nursing flowsheet recorded soft restraints bilateral wrists without a physician order.

Based on review of the hospital policy/procedure, medical record, credential files and interviews, it was determined that the hospital failed to require that physicians authorized to order restraints have documentation of a working knowledge of hospital restraint policy for 3 of 3 physicians.

Findings include:

Hospital policy titled "Restraints" revealed: "...Physicians and Licensed Independent Practitioners (LIP) will be informed of hospital policy for restraint and seclusion...."

Medical record for patient # 12 identified Physician # 9 ordered behavioral restraints and Physician # 1 provided medical care during the time the patient was placed in behavioral restraints.

Medical record for patient # 13 identified, Physician # 14 provided behavioral restraint orders.

Physician #'s 1, 9 and 14 credential files did not contain documentation of knowledge of the hospital restraint policy.

The Medical Director and the Director of Quality confirmed the credential files for physician #'s 1, 9 and 14, did not contain documentation of a working knowledge of hospital restraint policy.

Based on hospital policy/procedure, medical records, and staff interviews, it was determined the hospital failed to require the RN follow the hospital behavioral restraint policy for frequent observations and restraint release for patient # 12.

Findings include:

Hospital policy titled "Restraints" revealed: "...Frequent observations of the patient and attention to basic needs are required due to the patient's restricted movement and inability to attend to certain needs while in restraints. At a minimum, a patient in restraints for behavioral reasons must be monitored every hour for circulatory impairment; behavior/mental status; comfort; need for food, fluids, and toileting; skin condition; the need to continue or terminated restraints based on the patients' behavior...patient in restraints should be released at least every two hours...."

In the medical record, the Emergency Department flowsheet for patient # 12 identified the patient was placed in bilateral wrist and ankle nylon lockable restraints 4/15/14 at 0656 hours, by RN # 29. On 4/15/14 at 13:59 hours, RN # 12 documented in the Emergency Department (ED) notes the patient restraints were removed. The behavioral/violent restraints flowsheet did not contain hourly observations or restraint release after the initial application of the restraints. Vital signs were recorded 4/15/14 at 0332 with only a blood pressure of 119/66. The next set of vital signs were recorded 4/14/14 at 2130 with blood pressure, pulse, respirations, temperature and oxygen saturation.

The Director of the Emergency Department confirmed in an interview on 4/22/14 that patient # 12 did not have documentation of monitoring as required by the hospital policy/procedure.

Based on review of hospital policy/procedure, nursing assignment sheets, medical records and interviews, it was determined that the hospital failed to require that a registered nurse evaluate patients' response to nursing intervention as evidenced by:

1. failing to require that the RN document the effects of intravenous (IV) sedation as required by physician order and hospital policy for 1 of 1 patient who received IV Diprivan (Pt # 11); and

2. failing to require that the RN document assessment of patients' pain after administration of IV pain medication as required by hospital policy/procedure for 2 of 4 patients who received IV pain medication (Pts # 36 and 42).

Findings include:

1. Hospital policy title "Diprivan" revealed: "...Diprivan is a short acting intravenous sedative hypnotic agent utilized for intensive care unit (ICU) sedation and control of stress response in intubated mechanically ventilated adult patients...assess sedation every two (2) hours using modified Ramsey Sedation Scale or RASS...perform assessment of respiratory parameters and neurological function every 12 hours and prn by completion of the following:...decrease infusion rate in 5-10 micrograms(mcg)/kilograms (kg)/minute (min) increments at 10-15 minute intervals until light level of sedation achieved (Ramsey 2)...after completing the evaluation of the level of sedation, titrate to the ordered level of sedation per Ramsey Sedation Scale or RASS by increasing the infusion rate in 5-10 mcg/kg/min intervals...."

Medical record physician order on 4/19/14 revealed: "...Diprivan (IV sedation) ...titrate to achieve a Ramsey Scale score of between 3 and 4 OR a RASS score of 0 to -3. Hold for Sedation Vacation every 12 hours...."

Medical record nursing flow sheet revealed: "...4/19/14 Dose (mcg/kg/min) propofol (Diprivan) started at 0654 hours...2000 hours Ramsey score 2...4/20/14 at 0700 hours Ramsey score 4...0800 hours Ramsey score 4...1000 hours Ramsey score 4...1200 hours Ramsey score 4...1600 hours Ramsey score 4...4/22/14 at 0700 hours stopped...1108 hours restarted...1115 hours Ramsey 3...1145 hours Ramsey 3...1200 hours Ramsey 3...1300 hours Ramsey 3...1500 hours Ramsey 4...."

The Director of ICU confirmed in an interview conducted on 4/24/ 14 that the RN did not follow the physician order for documenting and/or titrating propofol (Diprivan) using a Ramsey score or a Rass score, nor the Sedation Vacation was not followed as ordered by the physician or per hospital policy.

2. Review of hospital policy/procedure titled Pain Management Protocol, Appendix G: Pain Management Documentation Guidelines revealed: "...b. Medicate as indicated by patient score and according to physician order based on the assessment...c. Reassess pain score after intervention. Minimally pain should be reassessed within 30 minutes for IV medication...."

Review of Pt # 36's medical record revealed:

On 4/21/14 at 0945, a physician ordered Hydromorphone (Dilaudid) injection 1-4 mg IV every 2 hours PRN for severe pain.

On 4/21/14 at 1608, an RN documented administration of 4 mg Dilaudid IV to Pt # 36. The medical record did not contain documentation of Pt # 36's pain after administration of the medication. An RN administered 4 mg of Dilaudid at 1855. The medical record did not contain documentation of Pt # 36's pain assessment prior to administration or after administration of the medication.

Review of Pt # 42's medical record revealed:

On 4/20/14 at 1039, a physician ordered Fentanyl (Sublimaze) injection 25 mcg IV every 6 hours PRN for severe pain.

An RN documented administration of 25 mcg IV on 4/20/14 at 1118 and 2127 and on 4/21/14 at 0409 and 1835. The RN did not document assessment of Pt # 42's pain after administration of the medication.

On 4/17/14 at 1638, a physician ordered Morphine injection 2-4 mg IV every 4 hours PRN for severe pain.

An RN documented administration of 4 mg Morphine IV to Pt # 42 on 4/17/14 at 1705 and 2300; on 4/18/14 at 0345, 0740, 1143, 1559 and 1959; and on 4/19 at 0648. The RN did not document assessment of Pt # 42's pain prior to or after administration of the Morphine on 4/17/14 and 4/18/14.

On 4/15/14 at 2300, a physician ordered Morphine injection 2-4 mg IV every 3 hours PRN moderate to severe pain.

An RN documented administration of 4 mg Morphine IV on 4/16/14 at 2000 and did not document assessment of Pt # 42's pain after administration of the Morphine.

On 4/24/14, RN # 49, the Director of 6 E Unit, confirmed that nursing did not document Pt # 42's pain assessment as required by hospital policy/procedure.

Based on review of hospital policies and procedures, hospital documents, medical records, and staff interviews, it was determined that the hospital failed to require that an RN administer medication according to physician orders as evidenced by:

1. failing to administer intravenous (IV) infusion of Diprivan as ordered by physician for 1 of 1 patient ( Pt. # 11);

2. failing to document the presence of pain with administration of PRN (as needed) IV pain medication, as required by hospital policy for 1 of 4 patients who received PRN IV pain medication (Pt # 42); and

3. failing to administer scheduled pain medication as ordered by physician for 1 of 2 patients who received scheduled IV pain medication (Pt # 42.

Findings include:

1. Review of hospital policy titled "Diprivan" revealed: "...Obtain/verify physician order to initiate Diprivan IV infusion...Maintain or initiate additional IV access , as ordered...."

Medical record review of physician orders revealed: "... start 4/19/14 0700 propofol (Diprivan) infusion...start at five (5) micrograms (mcg)/kilograms (kg)/minute (min) IV. Titrate five (5) mcg/kg/min every five (5) minutes...."

Medical record nursing flow sheet revealed: "... 4/19/14, propofol drip (mcg/kg/min) 0654 hours, rate 20...0745 hours, rate...0 ...0830 hours, rate 10...0930 hours, rate 20...1553 hours, rate 20...1830 hours, rate 10...1900 hours, rate 20...."

The Director of ICU confirmed in an interview on 4/24/14 that the propofol (Diprivan) infusion physician orders were not followed according to starting rate and titration doses.

2. Review of hospital policy titled General Nursing: Medication Administration revealed: "...PRN orders are only administered if the symptom or indication is present...."

Review of Pt # 42's medical record revealed:

On 4/15/14 at 2250, a physician ordered Hydromorphone (Dilaudid) injection 0.5-1 mg IV every 3 hours PRN for severe pain.

On 4/16/14 at 0418, an RN documented administration of 1 mg Dilaudid IV to Pt # 42. The medical record did not contain documentation of Pt # 42's pain prior to administration of the medication.

On 4/17/14 at 1638, a physician ordered Morphine injection 2-4 mg IV every 4 hours PRN for severe pain.

An RN documented administration of 4 mg Morphine IV to Pt # 42 on 4/17/14 at 1705 and 2300 and on 4/18/14 at 0345, 0740, 1143, 1559 and 1959 . The medical record did not contain documentation of Pt # 42's pain prior to administration of the Morphine on 4/17/14 and 4/18/14.

On 4/24/14, RN # 49, the Director of 6 E Unit, confirmed that nursing did not document Pt # 42's pain prior to administering IV medication for pain as required by physician order and hospital policy/procedure.

3. Review of hospital policy titled General Nursing; Medication Administration revealed: "...Medications are administered...upon the receipt of a complete order from a member of the medical staff or (LIP) Licensed Independent Practitioner...."

Review of Pt # 42's medical record revealed:

On 4/15/14 at 2300, a physician ordered Oxycodone ER (Extended Release) 10 mg PO (by mouth), 2 times per day.

An RN documented administration of 10 mg Oxycodone ER PO to Pt # 42, on 4/16/14, at 0408, 0924 and 2053.

On 4/24/14, RN # 49 confirmed that nursing did not administer the Oxycodone ER as ordered by the physician.

Based on review of the Association of Perioperative Registered Nurses' (AORN) recommendations, MetriCide OPA manufacturer's recommendations, hospital documents, direct observations and interviews, it was determined the Administrator failed to implement nationally recognized standards of practice for sterilizing and disinfecting of instruments and equipment as evidenced by:

1. Failure to require nationally accepted standards of practice for the implementation of immediate use sterilization in the hospital and Outpatient Surgery Center (OSC) surgical suits; and

2. Failure to follow manufacturer's recommendations for high level disinfection in the Outpatient Medical Imaging; Ultra Sound (US) Departments.

Findings include:

1. AORN Perioperative Standards and Recommended Practices For Inpatient and Ambulatory Settings 2014 Edition; Recommendation VII.a.2. pg. 582 requires: "...Immediate use steam sterilization should not be used as a substitute for sufficient instrument inventory...."

Hospital policy titled " Sterilization-Instruments, Equipment, Unwrapped" Policy #7031-21.418 requires: "...Flash sterilization is only utilized when no other alternative is available ...not adequate time to follow any other method prior to time of surgical procedure...."

Review of the OSC's Autoclave Log revealed the following information: date, sterilizer #, time, load #, patient sticker, load contents, implants yes/no, reason for flash, and indicator. The bottom of the OSC log revealed the explanation stating the reason for immediate use sterilization. "A) Dr. Instruments; B) Vendor Instruments; C) Hole in wrapper; D) Implants not sterilized; E) Instruments needed for TF (to follow) case; F) Contaminated during case; G) Usually kept sterile/not sterile; H) Decontaminate explants/Dr Instruments; I) Unsterile item."

Review of OSC log from Sterilizer #3, dated 03/18/14 revealed: Physician #11's instruments were sterilized to be used for four (4) "to follow" cases.

Review of OSC log from Sterilizer #3, dated 03/25/14 revealed: Physician #11's instruments were sterilized to be used for two (2) "to follow" cases.

Review of OSC log from Sterilizer #3, dated 04/01/14 revealed: Physician #11's instruments were sterilized to be used for three (3) "to follow" cases.

Review of OSC log from Sterilizer #3, dated 04/08/14 revealed: Physician #11's instruments were sterilized to be used for four (4) "to follow" cases.

Review of OSC log from Sterilizer #3, dated 04/22/14 revealed: Physician #11's instruments were sterilized to be used for four (4) "to follow" cases.

Employee #52 confirmed during an interview conducted 04/24/14 that Physician #11 routinely schedules surgeries on Tuesday. He has one set of instruments that are needed for each of his hand cases. The instruments are sterilized several times throughout the day using the immediate use sterilization parameters.

Review of the "Autoclave Sterilization Log" revealed a total of 61 loads that were run in the autoclaves located in the main operating room between 04/01/14 through 04/21/14. Of the 61 loads, 28 loads were run because the instruments were needed for "to follow" cases.

The Senior Director of Peri-op confirmed during an interview conducted 04/24/13 that the facility uses the nationally recognized AORN guidelines. The Director confirmed the hospital continues to sterilize instruments using the immediate use guidelines and are adding instrumentation when possible.

2. There was no policy available for surveyor review on storage and labeling of MetriCide OPA. The Director of Radiology confirmed there was no policy for the labeling and storage of MetriCide OPA.

Observation on tour on 04/24/14 found in ultrasound room 2, a one liter white bottle containing solution in the sink.

Employee #51 confirmed that the bottle contained MetriCide OPA, was not labeled, and was stored in the only sink in the room.

The Director of Radiology confirmed the above findings.

MetriCide OPA Plus high level disinfectant for semi critical devices recommendations requires: "...The user should be adequately trained...handling of liquid chemical germicides...Always use Test strips to monitor the concentration...before each use...Manual Processing...at a minimum of 20 C (68 F)...minimum of 12 minutes...to destroy all pathogenic microorganisms...."

Review of hospital document titled "Practice Guideline For Metricide OPA Plus in Ultrasound" used at the Outpatient Medical Imaging-Tatum revealed: "...Clean the endocavity probes by soaking them for a minimum of 12 minutes in a Metricide OPA Plus solution after each use...Excessive soaking...longer than an hour...and/or not rinsing three times...may cause staining, irritation...."

Review of the Solution Testing Log Sheet located at the Outpatient Medical Imaging-Tatum; Ultrasound (US) Department revealed no documentation of the solution concentration prior to each patient use, no documentation of the temperature of the disinfectant and no documentation of the immersion time of the vaginal probe.

The Radiology Supervisor (Employee #4) and the US Technician (Employee #5) confirmed during an interview conducted 04/23/14 that the solution concentration is only tested daily, not prior to each patient use and temperature of the solution and soak times are not recorded on the Solution Testing Log Sheet per manufacturer's recommendations.

Based on review of hospital policies/procedures, medical records and interviews, it was determined that the facility failed to require that the discharge planning evaluation include an evaluation of the patient's return to the pre-hospital environment for 1 of 1 patient who was admitted to the hospital from the behavioral health program of an assisted living facility (Pt # 37).

Findings include:

Review of hospital policy/procedure titled Quality Management: Discharge Planning from Inpatient Setting revealed: "...(name of hospital) supports the patient and their right to choose after care providers, while recognizing that some insurance plans may require patient referral to a specific after care provider. The patient/patient representative shall be involved in the selection of the after care provider and their choice shall be documented on a Patient Choice letter that shall be signed and retained in the patient's medical record...For those patients needing post-discharge care, the patient/patient representative is provided with choices of aftercare providers...."

Review of Pt # 37's medical record revealed:

MSW # 22 documented on 4/16/2014, at 1014 AM: "Pt admitted with Dehydration, Renal failure, UTI (Urinary Tract Infection) and Fall, Contusion of right knee. Pt has history for Schizophrenia...Pt lives at (name of assisted living facility)...Spoke with...RN...Pt uses O2 as needed. Pt uses a wheelchair to park and walk to the diner...Pt has (name of third party payor)...."

RN # 23, a Case Manager, documented on 4/21/2014, at 4:00 PM: "Met with pt this afternoon...pt doesn't know where to go. All she knows is she does not want to return to (name of assisted living facility)...She does not want choices. Have sent a request...for help in placing pt...."

RN # 23 documented on 4/22/14, at 10:05 AM: "Pt will be returning to (name of assisted living facility). This is a psych facility which pt has been at and does well there. There will be no changes made...."

MSW # 22 documented on 4/22/2014, at 3:11 PM: "Pt is returning to (name of assisted living facility) via stretcher van...set up transportation...."

Nursing documented on 4/22/14 at 1905: "Transport here with stretcher to take pt...DC (Discharge packet including...instructions and rxs (prescriptions) with transport staff...."

Electronic Medical Record document titled After Visit Summary: "...Hospital Problems...Acute encephalopathy, C. difficile colitis...renal failure...Sepsis...Ureteral calculi...Your Medication List...sodium chloride 0.9%...SOLN 100 mL with cefepime 2 G SOLR 2g...Inject 2 g into the vein every 12 (twelve hours for 11 days...DISCHARGE MISC ORDERS...Home Health IV Antibiotic Therapy...Home Health Physical Therapy Eval and Treat...."

Pt # 37's medical record did not contain documentation of arrangements for Home Health.

MSW #23 confirmed, during interview conducted on 4/23/14, that patients who are admitted to the hospital from a psychiatric facility are returned to the facility when they are ready for discharge. S/he confirmed that Case Management/Social Work usually does not let the patient make decisions regarding placement after discharge. S/he also confirmed that Pt # 37 signed the Conditions of Admission form as consent for treatment at the time of admission to the hospital and that the medical record did not contain documentation that the patient had a medical power of attorney or other surrogate decision maker. MSW # 23 contacted (name of assisted living facility) to inquire whether Pt # 37 was a voluntary patient at the facility. She received information that the patient was voluntary and had signed herself into the facility.

RNP # 13 confirmed, during interview conducted on 4/23/14, that Pt # 37's medical record did not contain documentation that the patient lacked decision-making capacity.

The Director of Clinical Resource Management confirmed during interview conducted on 4/24/14 that the hospital does not have a policy whereby patients who are admitted from a psychiatric facility must return there after discharge. She confirmed that if a patient does not want to return to their pre-hospital placement, that the hospital has a responsibility to determine the reason and determine if the patient needs to be placed elsewhere after discharge. The Director of Clinical Resource Management contacted Pt # 37's third party payor after the patient's discharge. She confirmed that Pt # 37 has a Case Manager through her third party payor who will investigate the patient's fall at the assisted living facility and determine if the patient wants to continue to reside there. She confirmed that her discharge planning should have included further evaluation of the environment from which she had entered the hospital. She also confirmed that MSW # 23 had determined that the medical unit at the assisted living facility could arrange for the patient's intravenous medication and physical therapy. She also confirmed that the medical record did not contain documentation of these arrangements prior to the patient's discharge.