HospitalInspections.org

Based on medical record review, review of policies and procedures, review of meeting minutes and personnel files, observations and interviews, it was determined the governing body failed to provide sufficient oversight and management to ensure compliance with all the CoPs. This resulted in the inability of the facility to ensure appropriate care and services to patients. Findings include:

1. Refer to A115 Condition of Participation, Patient Rights and related standard level deficiencies as they relate to the failure of the governing body to ensure adequate informed consents were obtained and patients received care in a safe environment.

2. Refer to A490 Condition of Participation, Pharmacy Services and related standard level deficiencies as they relate to the failure of the governing body to ensure the pharmacy controlled the supply, dispensing, and storage of all medications for the facility.

3. Refer to A747 Condition of Participation, Infection Control as it relates to the failure of the governing body to ensure a sanitary environment and promote safe practices to avoid sources and transmission of potential infection.

The cumulative effect of these systemic failures resulted in the inability of the facility to ensure care was delivered in safe and sanitary manner.

Based on observation, interviews and review of medical records, hospital policies, and employee training records, it was determined the hospital failed to protect and promote patients' rights. This resulted in the inability of the hospital to respond in systematic ways to ensure safe and effective care was provided. Findings include:

1. Refer to A131 for the hospital's failure to ensure patients, or their representatives, were allowed to make informed decisions regarding their care.

2. Refer to A144 for the hospital's failure to provide a safe environment for patient care.

3. Refer to A164 for the hospital's failure to ensure that patients who were restrained both physically and chemically, had a comprehensive assessment which included information to determine less restrictive interventions were ineffective.

4. Refer to A166 for the hospital's failure to ensure hospital staff incorporated restraint usage into each patient's plan of care.

5. Refer to A167 for the hospital's failure to ensure safe and appropriate restraint techniques were defined by hospital policy.

6. Refer to A168 for the hospital's failure to ensure patients, who were physically restrained, had a complete physician's order for the physical restraints.

7. Refer to A169 for the hospital's failure to ensure restraint orders were not written as PRN orders.

8. Refer to A178 for the hospital's failure to ensure patients, who had restraints applied for the management of violent behavior, received a face-to-face evaluation by an appropriately qualified person within 1-hour of initiation of the intervention.

9. Refer to A196 for the hospital's failure to ensure direct care staff demonstrated competency with restraint application.

10. Refer to A207 for the hospital's failure to ensure that staff that provided restraint training were qualified to teach the course.

The cumulative effect of these deficient systemic practices compromised the hospital's ability to keep patients safe, and prevented staff from utilizing restraints in a consistent manner.

Based on interview and review of medical records and policies, it was determined the hospital failed to ensure patients were allowed to make informed decisions regarding their care for 12 of 12 patients, (#1 - #6, #15 - #18, #27 and #37) whose medical records were reviewed for proper surgical consents. This resulted in a lack of informed consents prior to surgery. Findings include:

1. The hospital's "INFORMED CONSENT" policy, revised January of 2010, stated the informed consent process included identification of the physician or other practitioners who had primary responsibility for the patient's care, as well as, the identity and professional status of the individual responsible for authorizing and performing a procedure or treatment. However, the hospital failed to obtain fully informed consents as follows:

a. Patient #1 was a 51-year-old female who had an endoscopic assisted left carpal tunnel release on 3/08/10. The Consent for Anesthesia Services, that was not dated or timed, stated, "I hereby consent to the anesthesia services and authorize that it be administered by [name of anesthesia group] or their associates..." The consent did not specify who was going to provide the anesthesia or their title. The deficient consent was confirmed on 3/09/10 at 2:45 PM, with the hospital's Compliance Officer and the Director of Surgical Services.

b. Patient #2 was a 55-year-old female who had a laparoscopic cholecystectomy on 3/08/10. The Consent for Anesthesia Services, that was dated 3/08/10 at 11:00 AM, stated, "I hereby consent to the anesthesia services and authorize that it be administered by [name of anesthesia group] or their associates..." The consent did not specify who was going to provide the anesthesia or their title. Further, Patient #2's operative report stated that a second physician assisted with the surgery. The surgical consent stated the procedure would be performed by Patient #2's attending physician and "whoever he may designate as assistants." The consent did not specify who was going to be his assistant or their title. The deficient consents were confirmed on 3/09/10 at 2:35 PM, with the hospital's Compliance Officer and the Director of Surgical Services.

c. Patient #3 was a 1-year-old female who had a dental procedure on 3/08/10. The Consent for Anesthesia Services, dated 3/08/10 un-timed, stated, "I hereby consent to the anesthesia services and authorize that it be administered by [name of anesthesia group] or their associates..." The consent did not specify who was going to provide the anesthesia or their title. The deficient consent was confirmed on 3/09/10 at 2:40 PM, with the hospital's Compliance Officer and the Director of Surgical Services.

d. Patient #4 was a 77-year-old male who had a repair on his left middle finger on 3/08/10. The Consent for Anesthesia Services, dated 3/08/10 at 8:50 AM, stated, "I hereby consent to the anesthesia services and authorize that it be administered by [name of anesthesia group] or their associates..." The consent did not specify who was going to provide the anesthesia or their title. Additionally, the consent did not list the type of anesthesia to be used. The deficient consent was confirmed on 3/09/10 at 2:55 PM, with the hospital's Compliance Officer and the Director of Surgical Services.

e. Patient #5 was a 74-year-old male who had a right shoulder arthroscopy on 3/08/10. The Consent for Anesthesia Services, dated 3/08/10 and un-timed, stated, "I hereby consent to the anesthesia services and authorize that it be administered by [name of anesthesia group] or their associates..." The consent did not specify who was going to provide the anesthesia or their title. The deficient consent was confirmed on 3/09/10 at 2:52 PM, with the hospital's Compliance Officer and the Director of Surgical Services.

f. Patient #6 was a 63-year-old male who had a right knee arthroscopy on 3/08/10. The Consent for Anesthesia Services, dated 3/08/10 timed 8:10 PM, stated, "I hereby consent to the anesthesia services and authorize that it be administered by [name of anesthesia group] or their associates..." The consent did not specify who was going to provide the anesthesia or their title. Additionally, the consent did not list the type of anesthesia to be used. The deficient consent was confirmed on 3/09/10 at 2:58 PM, with the hospital's Compliance Officer and the Director of Surgical Services.

g. Patient #15 was a 74-year-old female who had a left total knee replacement on 3/09/10. The Consent for Anesthesia Services, dated 3/09/10 timed 5:38 AM, stated, "I hereby consent to the anesthesia services and authorize that it be administered by [name of anesthesia group] or their associates..." The consent did not specify who was going to provide the anesthesia or their title. The deficient consent was confirmed on 3/09/10 at 2:56 PM, with the hospital's Compliance Officer and the Director of Surgical Services.

h. Patient #16 was a 69-year-old male who had a right total knee replacement on 3/09/10. The Consent for Anesthesia Services, dated 3/09/10 and un-timed, stated, "I hereby consent to the anesthesia services and authorize that it be administered by [name of anesthesia group] or their associates..." The consent did not specify who was going to provide the anesthesia or their title. The deficient consent was confirmed on 3/09/10 at 2:38 PM, with the hospital's Compliance Officer and the Director of Surgical Services.

i. Patient #17 was a 79-year-old male who had a left shoulder arthroscopy on 3/09/10. The Consent for Anesthesia Services, dated 3/09/10 timed 5:30 AM, stated, "I hereby consent to the anesthesia services and authorize that it be administered by [name of anesthesia group] or their associates..." The consent did not specify who was going to provide the anesthesia or their title. Additionally, the consent did not list the type of anesthesia to be used. The deficient consent was confirmed on 3/09/10 at 2:26 PM, with the hospital's Compliance Officer and the Director of Surgical Services.

j. Patient #18 was a 67-year-old female who had a cystoscopy with placement of lighted stents on 3/09/10. The Consent for Anesthesia Services, dated 3/09/10 at 5:40 AM, stated, "I hereby consent to the anesthesia services and authorize that it be administered by [name of anesthesia group] or their associates..." The consent did not specify who was going to provide the anesthesia or their title. Additionally, the consent did not list the type of anesthesia to be used. Further, Patient #18's Operative Record, dated 3/09/10 stated a second physician assisted with the surgery. The surgical consent stated the procedure would be performed by Patient #18's attending physician and "whoever he may designate as assistants." The consent did not specify who was going to be his assistant or their title. The deficient consents were confirmed on 3/09/10 at 2:16 PM, with the hospital's Compliance Officer and the Director of Surgical Services.

k. Patient #27 was a 70-year-old male who had a left total knee arthroplasty on 5/15/09. The Consent for Anesthesia Services, that was not dated or timed stated, "I hereby consent to the anesthesia services and authorize that it be administered by [name of anesthesia group] or their associates..." The consent did not specify who was going to provide the anesthesia or their title. Additionally, the consent did not list the type of anesthesia to be used. The deficient consent was confirmed on 3/10/10 at 10:05 AM, with the hospital's Compliance Officer.

l. Patient #37 was a 76-year-old female who had a plastic surgery procedure on 3/08/10. The Consent for Anesthesia Services, dated 3/08/10 at 5:45 AM, stated, "I hereby consent to the anesthesia services and authorize that it be administered by [name of anesthesia group] or their associates..." The consent did not specify who was going to provide the anesthesia or their title. Additionally, the consent did not list the type of anesthesia to be used. The deficient consent was confirmed on 3/09/10 at 3:05 PM, with the hospital's Compliance Officer and the Director of Surgical Services.

When asked, on 3/09/10 at 3:55 PM, the hospital's Compliance Officer stated that patients could not give consent to a group of professionals, but rather an individual.

The facility failed to ensure patients were given comprehensive information necessary to make a fully informed decision regarding surgical care.

Based on observations, medical record review, review of hospital policies and staff interview, it was determined the hospital failed to ensure a safe environment for patient care. This directly impacted 8 of 38 patients, (#18, #21, #27, #28 - #31 and #38) whose records were reviewed and/or whose care was observed, and had the potential to impact all patients treated at the facility. This failure had the potential to expose patients to infections and/or suffer injures. Findings include:

1. The hospital's Surgical Department was toured on 3/08/10 from 1:43 PM to 3:45 PM. During the tour it was noted Warmer #4 contained a 1 liter bottle of sterile water and a 1 liter bottle of sodium chloride. These bottles were available for patient use. The noted temperature of the warmer was 155 degrees. Warmer #3 had a 1 liter bottle of sterile water. This bottle was available for patient use. The noted temperature of the warmer was 156 degrees. Warmer #2 had several 3 liter bags of irrigation fluids. These bags were available for patient use. The noted temperature of the warmer was 156 degrees.

The Consumer Product Safety Commission states an approximate one-second exposure to 160° degrees water would result in third degree burns. When the water was 130° degrees, an approximate half-minute exposure would result in third degree burns.

The Director of Surgical Services was interviewed on 3/08/10 between 1:43 PM to 3:45 PM. She stated that to her understanding, the above fluids were used to clean equipment and soften endotracheal tubes. She stated that it could be possible, in a rush, a staff member might grab the hot fluid and use it on a patient. The Director of Surgical Services removed the fluids from the warmers at the time of the observation.
The hospital failed to ensure patients were not placed at risk of receiving burns.

2. Patient #27 was a 70-year-old male who had a left total knee arthroplasty on 5/15/09.

A Physician's verbal order from Patient #27's Internal-Medicine physician, dated 5/18/09 at 6:30 AM, stated that staff were to give Narcan 0.4 mg IV first, then Haldol 2 mg IV second, and then Ativan 1 mg IV. The order continued to direct nursing staff to give Ativan 1 mg as needed as often as needed until the physician's arrival. Ativan 1 mg was given according to Patient #27's 5/18/09 M.A.R. at 6:50 AM. The nurse noted that a physician was in to see Patient #27 at 6:55 AM on 5/18/10. Patient #27's record did not contain any further Ativan orders and nursing staff gave excessive Ativan without physician orders as followed;

a. A nursing note dated 5/18/09 at 8:00 AM, stated Patient #27 was trying to get out of bed and at 8:20 AM the patient was given Ativan 1 mg IVP. This was confirmed by Patient #27's 5/18/09 M.A.R.

b. The 5/18/09 nursing note further documented that at 10:20 AM, Patient #27 was verbally abusive and continued to get out of bed. The note stated that Ativan 1 mg IVP was given. This was confirmed by Patient #27's 5/18/09 M.A.R. The 5/18/09 M.A.R. also documented the nurse gave Patient #27 Ativan 1 mg at 10:30 AM, 10:40 AM, and 11:00 AM.

c. Patient #27's 5/18/09 nursing notes further documented that at 4:15 PM, Patient #27 was verbally abusive and continued to get out of bed. The note stated Ativan 1 mg IVP was given. This was confirmed by Patient #27's 5/18/09 M.A.R.

d. The 5/18/09 nursing notes further documented that at 4:30 PM, Patient #27 was restrained by 3 staff members. The note documented that the staff used a "sheet" to prevent Patient #27 from "self harm." The note stated that Ativan 1 mg IVP was given. This was confirmed by Patient #27's 5/18/09 M.A.R.

e. Patient #27's M.A.R. documented that on 5/18/09 at 7:55 PM, Patient #27 was given Ativan 1 mg IVP. There was no documented nursing note as to why the Ativan was given.

f. A nursing note dated 5/18/09 at 10:00 PM, stated Patient #27 was restless, agitated and trying to get out of bed by crawling over the rails. The note stated that Ativan 1 mg was given. This was also documented on Patient #27's 5/18/09 M.A.R.

g. A nursing note dated 5/18/09 at 11:00 PM, stated Patient #27 was agitated and that Ativan 1 mg was given. This was also documented on Patient #27's 5/18/09 M.A.R.

h. A physician's verbal order dated 5/18/09 at 11:30 PM, ordered Ativan 2 mg IV x 1. Patient #27's M.A.R. did not document that the nurse had given the Ativan. However, Patient #27's M.A.R. documented that on 5/18/09 at 11:45 PM, Patient #27 was given Ativan 1 mg IVP again. There was no documented nursing note as to why the 11:45 PM Ativan was given.

i. Patient #27's M.A.R. documented he received Ativan 1 mg IV on 5/19/09 at 12:30 AM. There was no documented nursing note as to why the Ativan was given.

j. A Nursing note dated 5/19/09 at 2:00 AM, stated that Patient #27 was restless and IV Ativan was given. No dose was documented. The Ativan dose was not documented on Patient #27's M.A.R.

k. A Nursing note dated 5/19/09 at 5:00 AM, stated that Patient #27 was thrashing and required two staff members to hold him down. The note documented that Ativan was given. This was not documented on Patient #27's M.A.R. nor was any dosage amount found.

l. A Nursing note dated 5/19/09 at 6:00 AM, stated that Patient #27 was agitated. The note documented that Ativan was given. This was documented on Patient #27's 5/19/09 M.A.R. as 1 mg IVP.

On 5/19/09 at 6:38 AM, the patient was found unresponsive and pulseless. CPR was initiated and Patient #27 was transferred to another hospital where he did not recover from the cardiac arrest and passed away on 5/24/09.
Patient #27's record documented the patient had received 16 confirmed mg of Ativan in a 23 hour and 30 minute period. Further, The record contained an additional 2 mg of Ativan that was not confirmed as given.
The hospital's "PATIENT RESTRAINT POLICY," revised 6/05 stated that when chemical restraints were prescribed the order should include the maximum dose to be given in 24 hour period. The Nursing 2010 Drug Handbook stated that Ativan (a medication used for anxiety) should not exceed dosing of 10 mg a day. This recommendation was not followed.

On 3/11/09 at 2:18 PM, the hospital's Compliance Officer was interviewed. He stated that during a review of the case, it was identified that Ativan was used excessively.

3. Refer to A164 for the hospital's failure to ensure that patients who were restrained both physically and chemically, had a comprehensive assessment which included information to determine that less restrictive interventions were ineffective.

4. Refer to A166 for the hospital's failure to ensure hospital staff incorporated restraint usage into each patient's plan of care.

5. Refer to A167 for the hospital's failure to ensure safe and appropriate restraint techniques were defined by hospital policy.

6. Refer to A168 for the hospital's failure to ensure patients, who were physically restrained, had complete physician's order for the physical restraints.

7. Refer to A169 for the hospital's failure to ensure restraint orders were not written as PRN orders.

8. Refer to A178 for the hospital's failure to ensure patients, who had restraints applied for the management of violent behavior, received a face-to-face evaluation by an appropriately qualified person within 1-hour initiation of the intervention.

9. Refer to A196 for the hospital's failure to ensure direct care staff demonstrated competency with restraint application.

10. Refer to A207 for the hospital's failure to ensure staff who provided restraint training were qualified to teach the course.

11. Refer to A491 as it relates to the facility's failure to ensure out-patient clinics, who distributed patient samples, had properly documented obtaining and dispensing sample medications in accordance with accepted professional standards and that off-label use of a medication had been properly approved. This failure directly impacted Patients #28 - #31.

12. Refer to A500 as it relates to the facility's failure to ensure patient safety with a pharmacist review of medication orders prior to administration to patients. This failure directly impacted Patients #18 and #21.

13. Refer to A502 as it relates to the facility's failure to ensure all drugs were stored in a secure location in the Surgical Department, Labor & Delivery Department, and in the Out-Patient Clinic.

14. Refer to A503 as it relates to the facility's failure to ensure Schedule II, III, IV, and V drugs (controlled substances) were locked within a secure area in the Surgical Department and the Labor & Delivery Department.

15. Refer to A505 as it relates to the facility's failure to ensure outdated medication was not available for use.

16. Refer to A536 as it relates to the facility's failure to ensure proper safety precautions were utilized for Patient #38.

17. Refer to A747 for the hospital's failure to provide a sanitary environment and promote safe practices to avoid sources and transmission of potential infection.

The cumulative effect of these deficient facility practices impeded to ability of the facility to promote and protect the safety of patients.


27931

Based on interview and review of clinical records and policies, it was determined the hospital failed to ensure 1 of 1 patient (#27) reviewed, who was both physically and chemically restrained, had a comprehensive assessment related to the restrain use. This resulted in the patient not being assessed comprehensively assess for the use of restrains. Findings include:

1. Patient #27 was a 70-year-old male who had a left total knee arthroplasty on 5/15/09. His M.A.R. and nursing notes documented he was physically and chemically restrained with out comprehensive assessment related to the use of the restraints as follows:

A nursing note dated 5/18/09 at 6:22 AM, stated Patient #27 stated he could not breathe and took off his bi-pap. The patient was described as cussing at the staff, uncooperative, yanking tubing, trying to crawl out of bed over the side rails, and trying to hit staff. The note documented that a Code Green was called and at 6:25 AM, the patient was restrained on the floor by 8 staff members. The note stated that at 6:27 AM, the physician was told of the incident and chemical restraint orders (Ativan and Haldol) were obtained.

A Physician's verbal order from Patient #27's Internal Medicine physician, dated 5/18/09 at 6:30 AM, stated that staff were to give Narcan 0.4 mg IV first, then Haldol 2 mg IV second, and then Ativan 1 mg IV. The order continued to direct nursing staff to give Ativan 1 mg, as needed, as often as needed until the physician's arrival. Ativan 1 mg was given according to Patient #27's 5/18/09 M.A.R. at 6:50 AM. The nurse noted that a physician was in to see Patient # 27 at 6:55 AM.

However, Patient #27's M.A.R. and nursing notes documented he continued to be physically and chemically restrained as follows:

- 5/18/09 at 8:03 AM: a nursing note stated Patient #27 continued to try to get out of bed and was assisted to the floor.
- 5/18/09 at 8:20 AM: he was given Ativan 1 mg IVP.

A physician's verbal order, dated 5/18/09 at 8:40 AM, ordered Haldol IV/IM every 6 hours as needed for agitation.

- 5/18/09 at 8:55 AM: he was given Haldol 5 mg IV.
- 5/18/09 at 10:20 AM: he was given Ativan 1 mg IVP.
- 5/18/09 at 10:30 AM: he was given Ativan 1 mg IVP.
- 5/18/09 at 10:40 AM: he was given Ativan 1 mg IVP.
- 5/18/09 at 11:00 AM: he was given Ativan 1 mg IVP.
- 5/18/09 at 4:15 PM: he was given Ativan 1 mg IVP.
- 5/18/09 at 4:30 PM: he was given Ativan 1 mg IVP. His nursing note also documented Patient #27 was restrained by 3 staff members and staff used a "sheet" to prevent him from "self harm."

A physician's verbal order dated 5/18/09 at 5:00 PM, instructed the Haldol to be increased to 10 mg IV/IM every 4 hours, as needed, for agitation.

- 5/18/09 at 6:55 PM: he was given Haldol 10 mg IM.
- 5/18/09 at 7:55 PM: he was given Ativan 1 mg IVP.
- 5/18/09 at 10:00 PM: he was given Ativan 1 mg IVP.
- 5/18/09 at 11:00 PM: he was given Ativan 1 mg IVP and Haldol 10 mg IVP.

A physician's verbal order dated 5/18/09 at 11:30 PM, ordered Ativan 2 mg IV x 1. Patient #27's M.A.R. did not document that the nurse had followed the order. However, his MAR and nursing notes documented he received the following:

- 5/18/09 at 11:45 PM: he was given Ativan 1 mg IVP.
- 5/19/09 at 12:30 AM: he was given Ativan 1 mg IVP.
- 5/19/09 at 2:00 AM: he was given Ativan IVP. The dose was not documented.
- 5/19/09 at 3:00 AM: he was given Haldol 10 mg IM.
- 5/19/09 at 5:00 AM: he was given Ativan. The dose he received was not documented. Additionally, his nursing note stated he was thrashing and needed two staff members to hold him down.
- 5/19/09 at 6:00 AM: he was given Ativan 1 mg IVP.

On 5/19/09 at 6:38 AM, Patient #27 was found unresponsive and pulseless. CPR was initiated and he was transferred to another hospital where he did not recover from the cardiac arrest and passed away on 5/24/09.

Patient #27's record did not include comprehensive restraint assessment information (i.e. the risks associated with the use of the restraint, the introduction of less restrictive measures and alternatives attempted and the rationale for not using alternatives, an assessment of Patient #27's condition, needs, strengths, weaknesses, and preferences, and environmental factors) for any of the above listed restraints. Additional, the facility failed to consistently document an immediate and/or serious danger to the physical safety of the patient or others, which made the restraint use necessary.

The hospital's "Patient Restraint Policy," revised on 6/05, was reviewed. The policy did not direct staff to assess and document the risks associated with the use of the restraint, introduction of less restrictive measures and alternatives attempted and the rationale for not using alternatives, an assessment of the patient's condition, needs, strengths, weaknesses, preferences, and environmental factors or the immediate and/or serious danger to the physical safety of the patient or others.

The hospital's Compliance Officer was interviewed on 3/11/10 starting at 2:18 PM. He confirmed the policy was not descriptive and did not describe what a comprehensive restraint assessment should include. He further stated staff and physicians had failed to document a comprehensive restraint assessment for Patient #27.

The hospital failed to ensure Patient #27, who was restrained both physically and chemically, had a complete comprehensive restraint assessment.

Based on staff interview and review of medical records and hospital policies, it was determined the hospital failed to ensure hospital staff incorporated restraint usage into a patient's plan of care for 1 of 1 patient (#27) reviewed, who was physically and chemically restrained. This resulted in lack of knowledge with the process of restraint assessments, interventions and evaluations of restraint usage and had the potential to interfere with coordination of patient care. Findings include:

1. Patient #27 was a 70-year-old male who had a left total knee arthroplasty on 5/15/09. His record documented he was physically and chemically restrained as follows:

- A nursing note dated 5/18/09 stated at 6:25 AM, the patient was physically restrained on the floor with 8 staff members. The note further stated that at 6:27 AM, the physician was told of the incident and medication restraint orders were obtained. A Physician's verbal order from Patient #27's Internal-Medicine physician dated 5/18/09 at 6:30 AM, stated that staff were to give Narcan 0.4 mg IV first, then Haldol (a medication used for psychosis considered a chemical restraint) 2 mg IV second, and then Ativan (a medication used for anxiety and could be considered a chemical restraint) 1 mg IV. The order continued to direct nursing staff to give Ativan 1 mg as needed, as often as needed until the physician's arrival.

- Ativan 1 mg was given according to Patient #27's 5/18/09's M.A.R. at 6:50 AM.

- On 5/18/09 6:43 AM, a nurse noted that 6 staff members were still physically restraining Patient #27 while they administered the medications. The nursing note stated Patient #27 continued to try to get out of bed and at 8:03 AM, a second Code Green was called and Patient #27 was assisted to the floor and physically restrained.

- Patient #27's M.A.R. and nursing note dated 5/18/09 at 8:00 AM, stated Patient #27 was trying to get out of bed and at 8:20 AM, the patient was given Ativan 1 mg IVP.

A physician's verbal order dated 5/18/09 at 8:40 AM, ordered Haldol 5 mg IV/IM every 6 hours as needed for agitation.

- Patient #27's M.A.R. and nursing notes documented that Haldol 5 mg IV was given on 5/18/09 at 8:55 AM.

- The 5/18/09 nursing notes further documented that at 10:20 AM, Patient #27 was verbally abusive and continued to get out of bed. The note stated that Ativan 1 mg IVP was given. This was confirmed by Patient #27's 5/18/09 M.A.R.

- Patient #27's 5/18/09 M.A.R. documented he received Ativan 1 mg at 10:30 AM, 10:40 AM, and 11:00 AM.

- Patient #27's nursing notes documented that at 4:30 PM, he was restrained by 3 staff members. The note documented that the staff used a "sheet" to prevent Patient #27 from "self harm." The note stated that Ativan 1 mg IVP was given. This was confirmed by Patient #27's 5/18/09 M.A.R.

A physician's verbal order dated 5/18/09 at 5:00 PM, ordered the Haldol to be increased to 10 mg IV/IM every 4 hours as needed for agitation.

- Patient #27's 5/18/09 M.A.R. and nursing notes documented that at 6:55 PM, Patient #27 was verbally abusive and continued to try to get out of bed. The note stated that Haldol 10 mg was given IM.

- Patient #27's M.A.R. documented that on 5/18/09 at 7:55 PM, he was given Ativan 1 mg IVP. There was no documented nursing note as to why the Ativan was given.

- Patient #27's 5/18/09 M.A.R. and nursing notes dated 5/18/09 at 10:00 PM, stated Patient #27 was given Ativan 1 mg due to being restless, agitated and trying to get out of bed by crawling over the rails.

- Patient #27's 5/18/09 M.A.R. documented that Haldol 10 mg IVP and Ativan 1 mg was given at 11:00 PM. A corresponding nursing note stated Patient #27 was agitated and that Ativan 1 mg was given.

- Patient #27's M.A.R. documented that on 5/18/09 at 11:45 PM, Patient #27 was given Ativan 1 mg IVP. There was no documented nursing note as to why the Ativan was given.

- Patient #27's M.A.R. documented he received Ativan 1 mg IV on 5/19/09 at 12:30 AM. There was no documented nursing note as to why the Ativan was given.

- A nursing note dated 5/19/09 at 2:00 AM, stated that Patient #27 was restless and IV Ativan was given. However, this was not documented on Patient #27's M.A.R.

- Patient #27's M.A.R. and nursing notes dated 5/19/09 at 3:00 AM, stated that Patient #27 was restless and Haldol 10 mg was given.

- A nursing note dated 5/19/09 at 5:00 AM, stated that Patient #27 was thrashing and needed two staff members to restrain him. The note documented that Ativan was given. However, this was not documented on Patient #27's M.A.R.

- Patient #27's M.A.R. and nursing notes dated 5/19/09 at 6:00 AM, stated that he was agitated. The note documented that Ativan was given.

Patient #27's record documented he was physically and chemically restrained multiple times on 5/18/10 and 5/19/10. However, Patient #27's care plan was reviewed. The care plan had not been updated since 5/16/09 and it did not include the use of the chemical and physical restraints.

Additionally, the hospital's "Patient Restraint Policy," revised on 6/05, was reviewed. The policy did not include direction to staff to modify the patient's plan of care should restrain use become necessary.

The hospital's Compliance Officer was interviewed on 3/11/10 starting at 2:18 PM. He confirmed the policy was not current with the Federal CoPs and Patient #27's care plan was not updated.

The hospital failed to ensure hospital staff incorporated restraint usage into Patient #27's plan of care.

Based on staff interview and review of medical records and hospital policies, it was determined the hospital failed to ensure safe and appropriate restraint techniques were defined by hospital policy. This affected the care of 1 of 1 patient (#27) who was restrained using physical and chemical restraints. This resulted in the lack of direction for staff on how to respond and how to keep patients safe while restraints were being implemented. Findings include:

1. Patient #27 was a 70-year-old male who had a left total knee arthroplasty on 5/15/09.

A nursing note dated 5/18/09 at 6:22 AM, stated Patient #27 stated he could not breathe and took off his bi-pap. The patient was described as cussing at the staff, uncooperative, yanking tubing, trying to crawl out of bed over the side rails, and trying to hit staff. The note documented that a Code Green was called and at 6:25 AM, the patient was restrained on the floor by 8 staff members.

Further review of the patient record documented that a Code Green was called again for Patient #27 on 5/18/09 at 6:58 AM. The nursing note stated Patient #27 continued to try to get out of bed and a second Code Green was called and the patient was assisted to the floor. The nurse documented that Patient #27 had possibly sustained an injury to his operative knee. The 5/18/09 6:25 AM Occurrence Report was reviewed. It stated a Code Green was required to restrain Patient #27 who subsequently sustained a possible knee injury during the situation.

A hospital information sheet, undated, titled "Code Green Security" stated the following:

"In the Event [sic] you need security or assistance in handling an abusive patient, family member or visitor
- Push page button on the phone, and dial '4'
- Page 'Code Green' and location 3 times
- All available security/maintenance employees are to respond and will provide the required assistance"

However, the hospital's "Patient Restraint Policy," revised on 6/05 did not describe what a Code Green was and did not direct staff on how to respond or react to a violent patient. This was confirmed by the hospital's Compliance Officer during an interview on 3/11/10 starting at 2:18 PM.

The facility failed to ensure patient restraint policies were sufficiently developed to ensure staff implemented restraints in a safe manner.

2. Refer to A164 as it relates to the facility's failure to ensure restraint policies were sufficiently developed to ensure staff completed and documented comprehensive assessment information for restraint use.

3. Refer to A166 as it relates to the facility's failure to ensure restraint policies were sufficiently developed to ensure staff incorporated restraint usage into the patient care plans.

4. Refer to A168 as it relates to the facility's failure to ensure restraint policies were sufficiently developed to ensure staff had a complete physician's order for the physical restraints.

5. Refer to A169 as it relates to the facility's failure to ensure restraint policies were sufficiently developed to ensure chemical restraint orders were not written as PRN orders.

6. Refer to A178 as it relates to the facility's failure to ensure restraint policies were sufficiently developed to ensure patients were seen, face-to-face, by an appropriately qualified staff member within 1 hour of the initiation of restraint.

The hospital failed to ensure the restraint policy was sufficiently developed to ensure safe and appropriate restraint techniques were implemented.

Based on review of medical records, policies and procedures, and interviews with staff, it was determined the hospital failed to ensure that 1 of 1 patient reviewed, (#27) for whom physical and chemical restraints were used, had a complete physician's order for the physical restraints. This resulted in the lack of appropriate physician oversight in the use of restraints. Findings include:

1. The hospital's "Patient Restraint Policy," revised on 6/05, stated "Upon initiation of restraints and [sic] obtain a verbal or written order as soon as possible, not to exceed 1 hour after initiation." However, Patient #27's record documented he was physically and chemically restrained without physician's orders as follows:

a. Chemical restraints:
A Physician's verbal order from Patient #27's Internal Medicine physician, dated 5/18/09 at 6:30 AM, stated that staff were to give Narcan 0.4 mg IV first, then Haldol 2 mg IV second, and then Ativan 1 mg IV. The order continued to direct nursing staff to give Ativan 1 mg, as needed, as often as needed, until the physician's arrival. Ativan 1 mg was given according to Patient #27's 5/18/09 M.A.R. at 6:50 AM. The nurse noted that a physician was in to see Patient # 27 at 6:55 AM. However, Patient #27's M.A.R. and nursing notes documented he continued to receive Ativan, after he was seen by the physician and without a renewal of the Ativan order as follows:

- 5/18/09 at 8:20 AM: he was given Ativan 1 mg IVP.
- 5/18/09 at 10:20 AM: he was given Ativan 1 mg IVP.
- 5/18/09 at 10:30 AM: he was given Ativan 1 mg IVP.
- 5/18/09 at 10:40 AM: he was given Ativan 1 mg IVP.
- 5/18/09 at 11:00 AM: he was given Ativan 1 mg IVP.
- 5/18/09 at 4:15 PM: he was given Ativan 1 mg IVP.
- 5/18/09 at 4:30 PM: he was given Ativan 1 mg IVP.
- 5/18/09 at 7:55 PM: he was given Ativan 1 mg IVP.
- 5/18/09 at 10:00 PM: he was given Ativan 1 mg IVP.
- 5/18/09 at 11:00 PM: he was given Ativan 1 mg IVP.

b. Physical restraints:
- A nursing note dated 5/18/09 at 6:22 AM, stated Patient #27 stated he could not breathe and took off his bi-pap. The patient was described as cussing at the staff, uncooperative, yanking tubing, trying to crawl out of bed over the side rails, and trying to hit staff. The note documented that a Code Green was called and at 6:25 AM, the patient was physically restrained on the floor with 8 staff members.

- On 5/18/09 at 8:03 AM, a nursing note stated Patient #27 continued to try to get out of bed and a second Code Green was called and the patient was assisted to the floor.

- The 5/18/09 nursing notes documented at 4:30 PM, Patient #27 was restrained using a sheet. This required the assistance of 3 staff members to hold back Patient #27 "to prevent him from self harm."

- A nursing note dated 5/19/09 at 5:00 AM, stated Patient #27 was thrashing and needed two staff members to hold him down.

Patient #27's record did not include physician orders for any of the above listed restraints as required by the hospital's policy. The hospital's Compliance Officer was interviewed on 3/11/10 starting at 2:18 PM. He confirmed the policy was not followed.

The hospital failed to obtain orders for restraints.

Based on staff interview, review of medical records and hospital policies, it was determined the hospital failed to ensure restraint orders were not written as PRN orders for 1 of 1 patients (#27) for whom physical and chemical restraints were used. This resulted in the use of chemical restraints without consulting the physician, violation of patient rights, and had the potential to interfere with patient safety. Findings include:

1. Patient #27 was a 70-year-old male who had a left total knee arthroplasty on 5/15/09. His record documented PRN chemical restraints were ordered for Patient #27 as follows:

a. A physician's verbal order dated 5/18/09 at 6:30 AM, direct nursing staff to give Ativan 1 mg as needed, as often as needed, until the physician's arrival.

b. A physician's verbal order dated 5/18/09 at 8:40 AM, ordered Haldol IV/IM every 6 hours as needed for agitation.

c. A physician's verbal order dated 5/18/09 at 5:00 PM, ordered the Haldol to be increased to 10 mg IV/IM every 4 hours as needed for agitation.

The hospital's "Patient Restraint Policy," revised 6/05, identified anxiolytics (Ativan) and antipsychotics (Haldol) as chemical restraints. However, the policy did not identify that PRN chemical restraint orders were not acceptable. The hospital's Compliance Officer was interviewed on 3/11/10 starting at 2:18 PM. He stated that chemical restraints were not to be ordered as PRN.

The hospital failed to ensure restraint orders were not written as PRN orders.

Based on staff interview and review of medical records and hospital policy, the hospital failed to ensure 1 of 1 patient, (#27) who had restraints applied for the management of violent behavior, received a face-to-face evaluation by an appropriately qualified person within 1-hour after the initiation of the intervention. This resulted in the inability of the hospital to adequately assess patients for the causes of behaviors and treatment alternatives. Findings include:

1. The hospital's "Patient Restraint Policy," revised 6/05, identified anxiolytics (Ativan) and antipsychotics (Haldol) as chemical restraints. The policy stated a face to face evaluation of the patient restrained needed to be done only prior to each 24 hour renewal of the restraint order. The hospital's Compliance Officer was interviewed on 3/11/10 starting at 2:18 PM. He stated that it was assumed that patients who were restrained because of behavioral issues would receive a face-to-face evaluation by an appropriately qualified person within 1-hour after the initiation of the intervention.

However, Patient #27's M.AR. and nursing notes documented multiple restraints without a face-to face evaluation by an appropriately qualified person within 1 hour of initiation of the restraint as follows:

- 5/18/09 at 6:50 AM: he was given Ativan 1 mg.
- 5/18/09 at 8:03 AM: a nursing note stated Patient #27 continued to try to get out of bed and was assisted to the floor.
- 5/18/09 at 8:20 AM: he was given Ativan 1 mg IVP.

A physician's verbal order, dated 5/18/09 at 8:40 AM, ordered Haldol IV/IM every 6 hours as needed for agitation.

- 5/18/09 at 8:55 AM: he was given Haldol 5 mg IV.
- 5/18/09 at 10:20 AM: he was given Ativan 1 mg IVP.
- 5/18/09 at 10:30 AM: he was given Ativan 1 mg IVP.
- 5/18/09 at 10:40 AM: he was given Ativan 1 mg IVP.
- 5/18/09 at 11:00 AM: he was given Ativan 1 mg IVP.
- 5/18/09 at 4:15 PM: he was given Ativan 1 mg IVP.
- 5/18/09 at 4:30 PM: he was given Ativan 1 mg IVP. His nursing note also documented Patient #27 was restrained by 3 staff members and staff used a "sheet" to prevent him from "self harm."

A physician's verbal order dated 5/18/09 at 5:00 PM, instructed the Haldol to be increased to 10 mg IV/IM every 4 hours, as needed, for agitation.

- 5/18/09 at 6:55 PM: he was given Haldol 10 mg IM.
- 5/18/09 at 7:55 PM: he was given Ativan 1 mg IVP.
- 5/18/09 at 10:00 PM: he was given Ativan 1 mg IVP.
- 5/18/09 at 11:00 PM: he was given Ativan 1 mg IVP and Haldol 10 mg IVP.

A physician's verbal order dated 5/18/09 at 11:30 PM, ordered Ativan 2 mg IV x 1. Patient #27's M.A.R. did not document that the nurse had followed the order. However, his M.A.R. and nursing notes documented he received the following:

- 5/18/09 at 11:45 PM: he was given Ativan 1 mg IVP.
- 5/19/09 at 12:30 AM: he was given Ativan 1 mg IVP.
- 5/19/09 at 2:00 AM: he was given Ativan IVP. The dose was not documented.
- 5/19/09 at 3:00 AM: he was given Haldol 10 mg IM.
- 5/19/09 at 5:00 AM: he was given Ativan. The dose he received was not documented. Additionally, his nursing note stated he was thrashing and needed two staff members to hold him down.
- 5/19/09 at 6:00 AM: he was given Ativan 1 mg IVP.

Patient #27's record did not include documentation of a face-to-face evaluation by an appropriately qualified person within 1-hour after the initiation of the intervention for any of the above listed restraints.

The hospital's Compliance Officer was interviewed on 3/11/10 starting at 2:18 PM. He confirmed a face-to-face evaluation was not done for Patient #27.

The hospital failed to ensure a face-to-face evaluation was performed by a qualified individual for patients who were restrained.

Based on staff interview and review of hospital policies, patient records and personnel restraint training records, it was determined the hospital failed to ensure 100% of their direct care staff demonstrate competency with restraint application. This directly impacted 1 of 1 patient (#27) reviewed, who was restrained by staff members and had the potential to compromise the quality and safety of patient care. Findings include:

1. Patient #27 was a 70-year-old male who had a left total knee arthroplasty on 5/15/09.

A nursing note dated 5/18/09 at 6:22 AM, stated Patient #27 stated he could not breathe and took off his bi-pap. The patient was described as cussing at the staff, uncooperative, yanking tubing, trying to crawl out of bed over the side rails, and trying to hit staff. The note documented that a Code Green was called and at 6:25 AM, the patient was restrained on the floor by 8 staff members.

Further review of the patient record documented that a Code Green was called again for Patient #27 on 5/18/09 at 6:58 AM. The nursing note stated Patient #27 continued to try to get out of bed and a second Code Green was called and the patient was assisted to the floor. The nurse documented that Patient #27 had possibly sustained an injury to his operative knee. The 5/18/09 6:25 AM Occurrence Report was reviewed. It stated a Code Green was required to restrain Patient #27 who subsequently sustained a possible knee injury during the situation.

A hospital information sheet, undated, titled "Code Green Security" stated the following:

"In the Event [sic] you need security or assistance in handling an abusive patient, family member or visitor
- Push page button on the phone, and dial '4'
- Page 'Code Green' and location 3 times
- All available security/maintenance employees are to respond and will provide the required assistance"

However, the hospital's "Patient Restraint Policy," revised on 6/05 did not describe what a Code Green was and did not direct staff on how to respond or react to a violent patient. This was confirmed by the hospital's Compliance Officer during an interview on 3/11/10 starting at 2:18 PM.

The hospital's "Patient Restraint Policy," stated "When clinically indicated, the restraint procedure is implemented by an RN who is trained in restraint technique upon a physician's/licensed independent practitioner order." The hospital's Compliance Officer was interviewed on 3/12/10 starting at 8:33 AM. He stated that all direct care staff are trained in the application of restraints yearly using the Health Stream on-line educational system.

The Health Stream on-line course was reviewed. The course did not include the following:
- A description of what a Code Green.
- What a comprehensive restraint assessment included.
- Directions to staff on how patient care plans were to be modified when restraint was used.
- Training on the prohibition of PRN chemical restraint orders.
- Training on the required face-to-face evaluation of the patient restrained, by a qualified staff member with in 1 hour of the initiation of the restraint.

The hospital's Compliance Officer was interviewed on 3/12/10 starting at 8:33 AM and confirmed the course was a general overview of restraint use.

The Post-Surgical Supervisor was interviewed on 3/12/10 starting at 9:52 AM. She stated that she and her staff had not been trained beyond the Health Stream on-line course for restraint usage. When asked about restraint response she stated she did not know to modify the patient's plan of care, a comprehensive restraint assessment needed to be done, or that and a face-to-face assessment needed to be completed within 1 hour for patients who were restrained due to behavioral issues. She stated that she and the other staff had not been trained on how staff were to respond and react to a Code Green and that she had never been required to demonstrate her competency with restraint application.

A Surgical Unit CNA was interviewed on 3/12/10 starting at 10:07 AM. He stated he had worked at the hospital over the last 5 years. He stated he had not been trained beyond the Health Stream on-line course for restraint usage. When asked what a Code Green meant he could not provide an answer. He stated he had not been trained on how he was to respond and react to a Code Green and had never been required to demonstrate his competency with restraint application.

A Surgical RN was interviewed on 3/12/10 starting at 10:30 AM. She stated she had been working at the hospital for the last 2 years. She stated she had not been provided any restraint training beyond the Heath Stream on-line course. When asked, she could not recall what a Code Green was. When asked about restraint response she stated did not know how to modify the patient's plan of care, she did not know a comprehensive restraint assessment needed to be done, or that a face-to-face assessment needed to be done within 1 hour of a patient being restrained due to behavioral issues. She further stated she had not been required to competency with restraint application.

The hospital failed to ensure restraint training was comprehensive and that all direct care staff could demonstrate competency with restraint application.

2. Refer to A207 as it relates to the facility's failure to ensure staff that provided staff restraint training were qualified to teach the course.

Based on staff interview and review of medical records and personnel restraint training records, it was determined the hospital failed to ensure 1 of 1 staff, that provided staff restraint training was qualified to teach the course. This had the potential to compromise the quality and safety of patient care. Findings include:

1. The hospital's Compliance Officer was interviewed on 3/12/10 starting at 8:33 AM. He stated the Post-Surgical Supervisor, who no longer worked at the facility, had provided a training class on restraints to employees. Review of her file revealed she had no documented training that qualified her. Her record did not contain any evidence of continued education, expanded training, and/or experience in techniques used to address patients' behaviors and the use of restraints. This was confirmed by the hospital's Compliance Officer on 3/12/10 starting at 8:33 AM.

The hospital failed to ensure staff that provided restraint training were qualified to teach the course.

Based on staff interviews, review of medical records, hospital policies, and quality assurance documents, it was determined the hospital failed to fully identify internal systematic problems related to the medical care of 1 of 1 patient (#27) reviewed, who was restrained. This resulted in missed opportunities for the hospital to analyze and intervene with troubled patient care areas. Findings include:

1. Patient #27 was a 70-year-old male who had a left total knee arthroplasty on 5/15/09.

A nursing note dated 5/18/09 at 6:22 AM, stated Patient #27 stated he could not breathe and took off his bi-pap. The patient was described as cussing at the staff, uncooperative, yanking tubing, trying to crawl out of bed over the side rails, and trying to hit staff. The note documented that a Code Green was called and at 6:25 AM, the patient was restrained on the floor by 8 staff members. The note stated that at 6:27 AM, the physician was told of the incident and chemical restraint orders (Ativan and Haldol) were obtained.

A Physician's verbal order from Patient #27's Internal Medicine physician, dated 5/18/09 at 6:30 AM, stated that staff were to give Narcan 0.4 mg IV first, then Haldol 2 mg IV second, and then Ativan 1 mg IV. The order continued to direct nursing staff to give Ativan 1 mg, as needed, as often as needed until the physician's arrival. Ativan 1 mg was given according to Patient #27's 5/18/09 M.A.R. at 6:50 AM. The nurse noted that a physician was in to see Patient # 27 at 6:55 AM.

However, Patient #27's M.A.R. and nursing notes documented he continued to be physically and chemically restrained, including receiving excessive Ativan as follows:

- 5/18/09 at 8:03 AM: a nursing note stated Patient #27 continued to try to get out of bed and was assisted to the floor.
- 5/18/09 at 8:20 AM: he was given Ativan 1 mg IVP.

A physician's verbal order, dated 5/18/09 at 8:40 AM, ordered Haldol IV/IM every 6 hours as needed for agitation.

- 5/18/09 at 8:55 AM: he was given Haldol 5 mg IV.
- 5/18/09 at 10:20 AM: he was given Ativan 1 mg IVP.
- 5/18/09 at 10:30 AM: he was given Ativan 1 mg IVP.
- 5/18/09 at 10:40 AM: he was given Ativan 1 mg IVP.
- 5/18/09 at 11:00 AM: he was given Ativan 1 mg IVP.
- 5/18/09 at 4:15 PM: he was given Ativan 1 mg IVP.
- 5/18/09 at 4:30 PM: he was given Ativan 1 mg IVP. His nursing note also documented Patient #27 was restrained by 3 staff members and staff used a "sheet" to prevent him from "self harm."

A physician's verbal order dated 5/18/09 at 5:00 PM, instructed the Haldol to be increased to 10 mg IV/IM every 4 hours, as needed, for agitation.

- 5/18/09 at 6:55 PM: he was given Haldol 10 mg IM.
- 5/18/09 at 7:55 PM: he was given Ativan 1 mg IVP.
- 5/18/09 at 10:00 PM: he was given Ativan 1 mg IVP.
- 5/18/09 at 11:00 PM: he was given Ativan 1 mg IVP and Haldol 10 mg IVP.

A physician's verbal order dated 5/18/09 at 11:30 PM, ordered Ativan 2 mg IV x 1. Patient #27's M.A.R. did not document that the nurse had followed the order. However, his MAR and nursing notes documented he received the following:

- 5/18/09 at 11:45 PM: he was given Ativan 1 mg IVP.
- 5/19/09 at 12:30 AM: he was given Ativan 1 mg IVP.
- 5/19/09 at 2:00 AM: he was given Ativan IVP. The dose was not documented.
- 5/19/09 at 3:00 AM: he was given Haldol 10 mg IM.
- 5/19/09 at 5:00 AM: he was given Ativan. The dose he received was not documented. Additionally, his nursing note stated he was thrashing and needed two staff members to hold him down.
- 5/19/09 at 6:00 AM: he was given Ativan 1 mg IVP.

On 5/19/09 at 6:38 AM, Patient #27 was found unresponsive and pulseless. CPR was initiated and he was transferred to another hospital where he did not recover from the cardiac arrest and passed away on 5/24/09.

Despite ongoing multiple physical and chemical restraints, Patient #27's record did not include documentation of a complete comprehensive restraint assessment, orders for the physical restraints and the on-going use of Ativan (from 6:55 AM to 11:30 PM on 5/18/09), chemical restraint orders which were not PRN orders or documentation that a face-to-face evaluation was performed by a qualified staff member within one hour of the initiation of restraints. Further, his care plan, dated 5/16/09, did not include the use of the chemical and physical restraints.

Additionally, the hospital's "Patient Restraint Policy," revised on 6/05 did not define a safe and appropriate restraint and when asked about staff training, the hospital's Compliance Officer stated, during an interviewed on 3/12/10 starting at 8:33 AM., that all direct care staff were trained in the application of restraints yearly using the Health Stream on-line educational system.

However, the Health Stream on-line course was reviewed. The course did not include the following:
- A description of what a Code Green was.
- What a comprehensive restraint assessment included.
- Directions to staff on how patient care plans were to be modified when restraint was used.
- Training on the prohibition of PRN chemical restraint orders.
- Training on the required face-to-face evaluation of the patient restrained, by a qualified staff member with in 1 hour of the initiation of the restraint.

The hospital's Compliance Officer was interviewed on 3/12/10 starting at 8:33 AM and confirmed the course was a general overview of restraint use. When asked about staff who provided training on restraint use, the hospital's Compliance Officer stated the Post-Surgical Supervisor, who no longer worked at the facility, had provided a training class on restraints to employees. However, when reviewed, her personal file did not include documentation to support that she was a qualified trainer. Her record did not contain any evidence of continued education, expanded training, and/or experience in techniques used to address patients' behaviors and the use of restraints. This was confirmed by the hospital's Compliance Officer.

The hospital's undated "Framework For Root Cause Analysis and Action Plan," Hospital Peer Review, and Code Blue Team committee minutes for Patient #27 did not identify the following:

- Nursing staff did not have an ongoing order to give Ativan (from 6:55 AM to 11:30 PM on 5/18/09).
- Patient #27 was chemically and physically restrained.
- A complete comprehensive restraint assessment had not been completed for Patient #27.
- His plan of care was not updated to incorporate restraint usage.
- Hospital restraint policies did not define a safe and appropriate restraint.
- The hospital failed to obtain orders for restraints.
- The hospital failed to ensure restraint orders were not written as PRN orders.
- The hospital failed to ensure 100% of their direct care staff demonstrated competency with restraint application.
- The hospital failed to ensure a face-to-face evaluation was performed by a qualified individual.
- The hospital failed to ensure staff who provided restraint training were qualified to teach the course.

This was confirmed during an interview with the hospital's Compliance Officer during an interview on 3/12/10 starting at 8:33 AM.

The hospital failed to fully identify internal systematic problems related restraint use.

Based on medical record review, review of committee meeting minutes, policy review, and staff interview, it was determined the facility failed to ensure medial records contained complete documentation including appropriate dates, times, and signatures, and that all physician's orders were documented for 9 of 38 patients, (#1, #2, #5, #6, #15, #16, #17, #21, and #37) whose records were reviewed. Failure to ensure complete and accurate documentation had the potential impact coordination and care of patients. Findings include:

1. Patient #21 was a 6-day-old infant born in the facility on 3/04/10. He was originally admitted to the well baby nursery, but developed seizure-like activity and required respiratory support. He was admitted to the CCN on 3/06/10. Handwritten admitting orders, written and signed by the physician on 3/06/10 at 3:30 AM, included the initiation of the antibiotic Gentamicin 4 mg/kg intravenously every 24 hours. A subsequent telephone order from the physician was documented on 3/07/10 at 2:55 PM. This order was for a Gentamycin trough blood level to be drawn before every 3rd dose of medication.

On the "3 Day M.A.R." form initiated on 3/04/10 for Patient #21, CCN nurses documented he was given his first dose of Gentamicin on 3/06/10 at 3:25 AM, his second dose on 3/07/10 at 3:30 AM, and his third dose on 3/08/10 at 3:35 AM. The medical record for Patient #21 also contained a laboratory report for a Gentamicin trough which had been collected on 3/07/10 at 1:30 AM, prior to the second dose of medication. There was no order on the chart for this lab draw.

On 3/10/10 at 10:35 AM, Staff G, a CCN RN caring for Patient #21, reviewed the medical record. She confirmed that there was no order for the Gentamicin trough level drawn on 3/07/10. She stated the old standing orders were for a Gentamicin trough to be drawn prior to the second dose. A copy of the current "CCN Orders" form, undated, was reviewed. This form was utilized for infants admitted to the CCN and included an order for the "Gentamycin [sic] trough to be done before 3rd dose of Gentamycin [sic] and every 3 days throughout therapy." Staff G verified this order form was not found in Patient #21's medical record.

In addition, meeting minutes for the Perinatal Committee for 5/04/09 were reviewed. One agenda topic was "Nursery Orders." It was documented that all members of the committee voted to change the Gentamicin trough blood draw to prior to the 3rd dose of medication, rather than the 2nd dose. The "Gentamicin Dose and Administration for the Neonate" policy included an approval date of 3/11/10. During an interview with the Compliance Officer on 3/12/10 at 1:30 PM, he stated this date was incorrect. The approval of the change to the policy would have occurred during the May of 2009 Board Meeting.



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2. Patient #1 was a 51-year-old female who had an endoscopic assisted left carpal tunnel release on 3/08/10. Patient #1's discharge orders dated 3/08/10, was not timed nor signed by the physician. This was confirmed by the hospital's Director of Surgical Services on 3/09/10 during an interview that started at 2:15 PM.

3. Patient #2 was a 55-year-old female who had a laparoscopic cholecystectomy on 3/08/10. Patient #2's Anesthesia Record, that included medications given and the monitoring of the patient, dated 3/08/10, was not signed by the person providing the anesthesia. This was confirmed by the hospital's Director of Surgical Services on 3/09/10 during an interview that started at 2:15 PM.

4. Patient #5 was a 74-year-old male who had a right shoulder arthroscopy on 3/08/10. His H&P, dated 2/22/10, was not timed or signed. This was confirmed by the hospital's Director of Surgical Services on 3/09/10 during an interview that started at 2:15 PM.

5. Patient #6 was a 63-year-old male who had a right knee arthroscopy on 3/08/10. Review of the hospital's 3/09/10 Patient Diets log documented Patient #6 was on a low sugar diet. Patient #6's record did not contain an order for the specialized diet.

In addition, a "Nursing Note" dated 3/09/10 at 8:40 AM stated the nurse had received a verbal order to discontinue Patient #6's IV. However Patient #6's record did not contain a physician's verbal order for the discontinuation of Patient #6's IV on 3/09/10.

The above missing orders were confirmed with Patient #6's primary nurse on 3/09/10 at 4:30 PM.

6. Patient #15 was a 74-year-old female who had a left total knee replacement on 3/09/10. Her H&P was not dated, timed, or signed. This was confirmed by the hospital's Director of Surgical Services on 3/09/10 during an interview that started at 2:15 PM.

7. Patient #16 was a 69-year-old male who had a right total knee replacement on 3/09/10. Patient #16's Pre and Post Anesthesia Evaluation, dated 3/09/10, did not contain the times as to when the evaluations took place. This was confirmed by the hospital's Director of Surgical Services on 3/09/10 during an interview that started at 2:15 PM.

8. Patient #17 was a 79-year-old male who had a left shoulder arthroscopy on 3/09/10. Patient #17's record contained a Post-Anesthesia Evaluation that was not dated nor timed. Additionally, Patient #17's Pre-Anesthesia Orders were not dated nor timed. This was confirmed by the hospital's Director of Surgical Services on 3/09/10 during an interview that started at 2:15 PM.

9. Patient #37 was a 76-year-old female who had a plastic surgery procedure on 3/08/10. Her H&P was not dated nor timed. This was confirmed by the hospital's Director of Surgical Services on 3/09/10 during an interview that started at 2:15 PM.

The hospital failed to ensure medical records were complete and accurate.

Based on review of medical records, review of policies and procedures, observation, and staff interview, it was determined the facility failed to ensure safe and secure drug dispensing and storage. Failure to ensure safe dispensing of medication and appropriate drug storage had the potential to impact patient safety and increased the risk for drug diversion. Findings include:

1. Refer to A491 as it relates to the facility's failure to ensure pharmacy maintained control of distribution of sample medications for patients and the failure to properly approve an off-label use of medication.

2. Refer to A500 as it relates to the facility's failure to ensure patient safety with a pharmacist review of medication orders prior to administration to patients.

3. Refer to A502 as it relates to the facility's failure to ensure all drugs were stored in a secure location.

4. Refer to A503 as it relates to the facility's failure to ensure Schedule II, III, IV, and V drugs (controlled substances) were locked within a secure location.

5. Refer to A505 as it relates to the facility's failure to ensure outdated medication was not available for use.

The cumulative effect of these deficient systemic practices prevented the facility from ensuring supervision of dispensing and storage of medications throughout the facility.

Based on observations, interviews, and review of medical records it was determined the facility failed to ensure accepted professional standards were followed for the receipt and dispensation of sample drugs [and the administration of drugs during off-label use]. These failures impacted 2 of 2 outpatient clinics, who distributed patient samples [and 4 of 4 patients (#28, #29, #30 and #31) reviewed, whose records documented off label use of medication during surgery]. These failures had the potential to result in inadequate pharmacy control in the case of recalled or missing medications and the potential to impact quality of care and patient safety. Findings include:

1. The Director of Nursing for Redi Care provided a tour of the Redi Care on Columbus, on 3/10/10 beginning at 3:00 PM. Based on observations there were 12 medications readily available as patient samples. The Director of Nursing stated the facility did not maintain a record of the sample medications supplied or distributed, including lot numbers and expiration dates. The facility did not have a system in place to readily identify who was given which sample medications.

2. During a tour of the Taylor Crossing Redi Care on 3/11/10 at 9:30 AM, a cabinet of 4 sample medications was noted. The Office Manager for this Redi Care was present during the tour and stated the facility did not have a process in place for monitoring the samples received or distributed at the clinic, including lot numbers and expiration dates. They did not have a way to track which medication samples were supplied to which patients.

The hospital failed to ensure the pharmacy adequately maintained control of all medications supplied and distributed through the Redi Care Clinics.



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3. The records of Patients #28 - #31 were reviewed. The records documented they were all given Haldol 1 mg IV during their individual surgical procedures.

FDA web site information for Haloperidol , provided by the facility on 3/11/10, included Labeled Indications as schizophrenia, control of tics and vocal utterances of Tourette's disorder in children and adults and severe behavioral problems in children.

Unlabeled or Investigational uses included emergency sedation of severely-agitated or delirious patients and use as an antiemetic.

The FDA had not approved Haldol for surgical procedures. The Director of Pharmacy was interviewed on 3/12/10 at 12:26 PM. She confirmed that Haldol was being ordered and given intravenously presurgical. She also verified that the use Haldol intravenously was an off-label use of the medication and should be approved by the Pharmacy and Therapeutics Committee. She stated that the use of Haldol was not approved by the Pharmacy and Therapeutics Committee.

The hospital failed to ensure that the off-label use of Haldol was approved by the Pharmacy and Therapeutics Committee.

Based on medical record review and staff interview, it was determined the facility failed to ensure patient safety with a pharmacist review of medication orders prior to administration to patients for 2 of 37 patients (#18 and #21) whose records were reviewed. Failure to have a pharmacist review medication orders prior to administration (except in emergency situations) had the potential to lead to adverse drug reactions and medication errors. Findings include:

1. Patient #21 was a 6-day-old infant born in the facility on 3/04/10. He was originally admitted to the well baby nursery, but developed seizure-like activity and required respiratory support. He was admitted to the CCN on 3/06/10. Hand-written admitting orders, written and signed by the physician on 3/06/10 at 3:30 AM, included the antibiotics ampicillin 100 mg/kg IV every 12 hours and gentamicin 4 mg/kg IV every 24 hours.

Patient #21's medical record contained a document titled "3 Day M.A.R." The dates on the M.A.R. were 3/04/10, 3/06/10, 3/07/10, and 3/08/10. Times of the administration of medications would be documented in the appropriately dated column. The form contained a list of several pre-printed medications routinely given to infants, such as erythromycin ophthalmic ointment and hepatitis B vaccine. The ampicillin and gentamicin orders were hand-written in. Another "3 Day M.A.R." was found with the dates 3/09/10 and 3/10/10. Again, the ampicillin and gentamicin were hand-written in.

The process for completing the M.A.R. for the Perinatal Department was discussed with the Director of Pharmacy on 3/12/10 beginning at 11:40 AM. She stated the Perinatal Departments utilized a pre-printed M.A.R. with common medications specific to each department (i.e. Labor & Delivery and Nursery) already listed. Additional medications administered would then be added by hand. The order for the medication was to be faxed to pharmacy where it would be reviewed and added on a computer-generated M.A.R. The computer-generated M.A.R. would then be available for placement in the patient's chart. She stated that medication orders from the Perinatal Departments are not always faxed down. The Director of Pharmacy reviewed Patient #21's M.A.R. from 3/04/10 through 3/10/10. She stated it did not appear that pharmacy was aware of the addition of the ampicillin and gentamicin to Patient #21's medication regime as these medications were still hand-written on the second M.A.R. for the dates 3/09/10 and 3/10/10.



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2. Patient #18 was a 67-year-old female who had a cystoscopy with placement of lighted stents on 3/09/10. Patient #18 had a history of diabetes and was on insulin. On 3/09/10 at 6:17 PM, nursing took a verbal order from Patient #18's primary physician for insulin. The order was written as below:

Regular insulin, sliding scale 4 times a day as follows:

200-250 5 units
250-300 8 units
300-350 10 units
greater then 350 call physician.

Patient #18's M.A.R. reflected the above orders, and nursing was administrating the insulin as above.

On 3/10/10 at 2:35 PM, Patient #18's primary nurse was interviewed. When asked, the nurse as to how much insulin would be given for a blood sugar of 250 (i.e. 5 or 8 units) due to the conflicting order. Similarly, the nurse did not know how much insulin would be given for a blood sugar of 300 (8 or 10 units) or for 350 (10 units or none) due to the conflicting order.

On 3/10/10 at 2:35 PM, the Director of Pharmacy was interviewed. She was shown the insulin order and she stated that her department did not have the order on file.

The facility failed to ensure all medication orders were reviewed by pharmacy staff prior to administration.

Based on observations and interviews, it was determined the hospital failed to ensure all drugs were stored in a secure location in 6 of 9 departments (Nursery, PACU, Surgical Unit, Labor and Delivery, Post-Surgical Unit, and the Redi Care on Columbia) observed, with medications requiring storage. Failure to ensure medications were kept secure affected all patients, visitors, and staff in these locations and increased the risk of the diversion of medications. Findings include:

1. During an observation of the Nursery Department on 3/09/10 beginning at 11:50 AM, it was noted that routine medications, such as antibiotics, were stored in a drawer at the back of the nursery. Additional medications, such as Hepatitis B vaccine, were stored in a refrigerator in the isolation room. This room was separated from the main nursery behind a closed door. During an observation on 3/09/10 at approximately 3:15 PM, it was noted that the drawer of stored medications was located behind a curtain which had been pulled closed for patient and family privacy.

Neither the drawer of medication, nor the refrigerator, was in a secure location and able to be monitored at all times.

2. The Director of Nursing for Redi Care provided a tour of the Redi Care Clinic on Columbia on 3/10/10 beginning at 3:00 PM. During the tour an unlocked cabinet was found containing respiratory medications such as Duoneb, Pulmicort/Xopenex, and Albuterol. These medications were available to auxiliary staff and patients. When asked, Director of Nursing for Redi Care stated she did not know that the medications needed to be secured.



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3. During a tour of the hospital's Surgical Unit on 3/08/10 from 1:43 PM to 3:00 PM, medications were observed to be unsecured and available to auxiliary staff as follows:

a. Operating Room #8, a 3/4 full bottle of Chlorhexidine Gluconate 0.12% (mouth wash) was observed on a cart and available to auxiliary staff.

b. The anesthesia storage closet contained a bottle of Dyclonine 1% in bacteriostatic sodium chloride (a local anesthetic) that was on a shelf and available to auxiliary staff.

c. An anesthesia cart, located in the surgical hall, had 2 labeled prefilled syringes on the top of the cart and available to auxiliary staff. The Anesthesiologist was not working that day.

d. A medication cart in the hall of the surgical suite was observed to be unlocked. The cart contained medications which included, but were not limited to dexamethasone, cyanocobalamin, trichloracetic, heparin, silver nitrate, estrace, vasopressin, ciplodex, Kenalog, indigocarnmine, xylocaine, lidocaine, bupivacaine with epinephrine, epinephrine, and antibiotics that were available to auxiliary staff.

The Director of Surgical Services was interviewed during the observations. She stated that she only thought that medications needed to be secure from patients and not auxiliary staff.

4. During a tour of the hospital's PACU on 3/08/10 from 3:30 PM to 3:45 PM, medications were observed to be unsecured and available to auxiliary staff as follows:

a. A cabinet in the PACU was observed to be unlocked. The cabinet contained medications that included, but were not limited to Lasix, dexamethasone, Benadryl, Robinul, Flexeril, Reglan, and Phenergan that were available to auxiliary staff.

During the tour a PACU nurse was questioned about the medications. She stated that 6 nurses were working on the unit and the cabinet had only 2 keys to unlock it. She stated that it should be locked at all times.

The facility failed to ensure all medications were stored in a secure location.

8. Refer to A503 as it relates to the facility's failure to ensure Schedule II, III, IV, and V drugs (controlled substances) were locked within a secure area on the PACU, Surgical Unit, Labor and Delivery Unit, Post-Surgical Unit, and the Redi Care on Columbia.

Based on observations, interviews, and review of policy, it was determined the hospital failed to ensure Schedule II, III, IV, and V drugs (controlled substances) were locked within a secure area in 5 of 9 departments (PACU, Surgical Unit, Labor and Delivery Unit, Post-Surgical Unit, and the Redi Care on Columbia) observed, with medications requiring storage. Failure to ensure these medications were locked and secure had the potential to affect all patients, visitors, or staff in these areas and increased the risk of diversion of these medications. Findings include:

1. The hospital's policy, "Controlled Substance Management," approved 10/02, was reviewed. According to the policy, controlled substances were to be kept in a secure double locked cabinet which was kept locked except when in active use. During observations of the facility, controlled substances were not observed to be locked as follows:

a. On 3/09/10 from 9:21 to 10:43 AM, an anesthesia cart was observed to be left unlocked in the hallway of the Labor & Delivery Department. The cart contained controlled substances which included but were not limited to Fentanyl, a Schedule II medication and Promethazine, a Schedule V medication. At 10:40 AM, Staff A, the CRNA who was working in Labor & Delivery that day, returned to the cart while the surveyor checked for expired medications. He acknowledged that he had left his cart unsecured while he obtained supplies to restock it.

Additionally, on 3/10/10 at 10:35 AM, an anesthesia cart was again observed left unlocked in the hallway of the Labor & Delivery Department. In an interview on 3/10/10 at 10:35 AM, the CNA at the front desk stated that Staff B was the CRNA assisting laboring patients that day.

b. The Post-Surgery Supervisor provided a tour of the Post-Surgical Department on 3/10/10 from 9:00 AM to 9:45 AM. During the tour it was noted medication were stored in a box with a lock. However, the box of medications was found to be unlocked during the tour. The box contained controlled substances which included, but were not limited to Fentanyl, Demerol, Dilaudid, and Hydrocodone, all Schedule II drugs. During the tour the Post-Surgery Supervisor confirmed the medications should be secure.


c. The Director of Nursing for Redi Care provided a tour of the Redi Care on Columbia on 3/10/10 beginning at 3:00 PM. During the tour it was discovered that narcotic medications including, but not limited to Demerol, a Schedule II drug were not double locked.



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e. During a tour of the hospital's Surgical Unit on 3/08/10 from 1:43 PM to 3:00 PM, topical cocaine, a Schedule II drug, was observed to not be double locked in the anesthesia storage closet. The Director of Surgical Services was interviewed during the observation. She confirmed the topical cocaine was not double locked.

f. During a tour of the hospital's PACU on 3/08/10 from 3:30 PM to 3:45 PM, it was noted that controlled substances were not secured. Medications were stored in a box, in an open cabinet with a lock in place. However, the cabinet was unlocked. The medications contained in the box, included but were not limited to, Morphine Sulfate, Dilaudid, Fentanyl, Demerol, Hydrocodone, all Schedule II drugs.

During the observations a PACU nurse was questioned about the medications. She stated that 6 nurses were working on the unit and the cabinet had only 2 keys to unlock it. She stated that the narcotics should be double locked at all times.

The hospital failed to ensure all controlled substances were double locked.

Based on observations, staff interviews, and review of policies , it was determined the hospital failed to ensure outdated medication was not available for use in 3 of 9 departments (Labor and Delivery, Post-Surgical, and PACU) observed, supplying medications for patient use. Expired medications still accessible for patient use had the potential to impact the effectiveness of the medication therapy. Findings include:

1. The hospital's "MEDICATION STORAGE, INSPECTION AND REVIEW" policy, revised 6/17/09, was reviewed. It documented that expired medications would not be available for use. However, expired medications were observed to be available for use as follows:

a. On 3/08/10, beginning at 2:00 PM, a tour of the Labor & Delivery rooms was conducted. In Labor Room 1 an ampule of Narcan with an expiration date of 11/09 was found. The Director of Inpatient Services verified this outdated medication at the time of the observation.


2. On 3/09/10 at 10:40 AM, during a medication check of the anesthesia cart found in the hallway of the Labor & Delivery Department, a vial of atracurium with an expiration date of 9/09 was found. Staff A, the CRNA utilizing the cart verified the expired medication at the time of the observation.

3. The Post-Surgery Supervisor provided a tour of the Post-Surgical Department on 3/10/10 from 9:00 AM to 9:45 AM. During observation of the medication supply in the medication room, a Nicotine Transdermal patch which expired on 12/09 but was still available for patient use was noted. The Post-Surgery Supervisor verified the outdated medication at the time of the tour and removed the medication.



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4. During a tour of the hospital's PACU on 3/08/10 from 3:30 PM to 3:45 PM, 3 Bisacodyl suppositories which expired on 6/08 were in circulation for patient use. During the tour the Director of Surgical Services confirmed the medications were expired and disposed of them.

The hospital failed to ensure outdated medications were not available for patient use.

Based on policy review, interview, and observation, it was determined the hospital failed to ensure proper safety precautions were utilized for 3 of 3 staff, (C, D, and F) and 1 of 1 patient (#38) observed during an x-ray. Failure to utilize proper lead shields left individuals exposed to unnecessary radiation. Findings include:

Patient #38 was a 2-hour-old infant born via scheduled Cesarean section on 3/09/10. He was observed in a radiant warmer in the nursery from 3:24 PM to 3:40 PM. During this time, Staff C, the radiology technician, arrived to obtain a chest x-ray. At 3:40 PM, he returned to re-take the chest x-ray. Patient #38 was not provided with a lead gonad protection shield during either x-ray. In addition Staff D and F, RNs who were assisting with the x-ray, and Staff C, the radiology technician, were not wearing a lead shield and were exposed to the x-ray radiation. The lead shield was hung over the arm of the x-ray machine.

The hospital's policy titled "Portable Radiology Procedures in CCN," approved 10/02, was reviewed. It was documented in sections 2.3 and 2.4, under "Procedure," that the infant's reproductive organs would be shielded, and personnel around the infant would wear protective shields.

Staff E, a CCN RN, was interviewed on 3/09/10 at 11:50 AM. She stated the radiology technicians occasionally need to be reminded to place gonad shields on the infants.

The facility failed to ensure proper safety precautions were utilized during an x-ray.

Based on observations and staff interviews it was determined the hospital failed to ensure laboratory blood sampling collection equipment, which was available for patient testing, had not expired for 2 of 2 outpatient clinics. Additionally, the hospital failed to ensure that staff performed quality control tests on blood testing equipment for 1 of 2 outpatient clinics. The use of expired laboratory sample collection equipment and not performing quality control tests on blood testing equipment had the potential to result in incorrect laboratory results. Findings include:

1. During a facility tour of the hospital's Columbia Redi Care on 3/10/10 starting at 8:18 AM, the following expired blood collection laboratory equipment was observed:

a. Four-hundred and ninety 10 ml purple top tubes that had expired on 1/10.

b. One 5 ml purple top tube that had expired on 12/09.

c. Three 5 ml yellow top tubes that had expired on 1/10.

d. Two 5 ml green top tubes that had expired on 11/09.

The Columbia Crossing Redi Care Laboratory Technician was interviewed on 3/10/10 starting at 9:10 AM. He stated the above items were expired and removed them out of circulation.

2. During the tour the clinics I-STAT was observed. This piece of equipment tests blood chemistry levels such as sodium, potassium and chloride. The Columbia Redi Care procedure, that was not dated, stated each day staff were to run quality controls. This was not done for 1/19 to 2/7/10, 2/9, 2/11, 2/13, 2/15 to 2/27/10, 3/1, 3/4, 3/7, and 3/9/10 per the printed I-STAT QA testing results.

The Columbia Crossing Redi Care Laboratory Technician was interviewed on 3/10/10 starting at 9:10 AM. He stated that he has talked to the other Laboratory Technicians about doing the quality checks in the past and will continue to get them to be compliant with the daily checks.

3. During a facility tour of the hospital's Taylor Crossing Redi Care on 3/11/10 starting at 8:18 AM, the following expired blood collection laboratory equipment was observed:

a. A bag full (50 plus) pediatric purple top tubes that had expired on 2/10.

b. One 10 ml purple top tube that had expired on 1/10.

The Taylor Crossing Redi Care Laboratory Technician was interviewed on 3/11/10 starting at 8:30 AM. She stated the above items were expired and removed them.

The hospital failed to ensure supplies and equipment were maintained to ensure an acceptable level of quality.

Based on observations, review of policies, and staff interviews, it was determined the hospital failed to provide a sanitary environment and promote safe practices to avoid sources and transmission of potential infection in 7 of 10 departments toured, and for 1 of 2 patients, (#38) whose care was observed. This failure had the potential to affect all staff and patients working or receiving care in the facility. Failure to ensure proper infection control processes had the potential to impact the health of patients and staff. Findings include:

1. Patient #38 was a 2-hour-old infant born via scheduled Cesarean section on 3/09/10. She was observed in a radiant warmer in the nursery from 3:24 PM to 3:40 PM. During this time Staff F, the primary CCN RN for Patient #38, was seen collecting blood via a venous puncture and attempting to start an IV line. Staff F was not wearing gloves when working with Patient #38, a newborn who had not been bathed. Staff D, another CCN RN assisting with the blood collection, was also observed not wearing gloves while handling Patient #38.

At 3:32 PM, Staff D left Patient #38's warmer and went to check on a nursing mother who was behind a curtain. Within minutes Staff D returned to Patient #38's bedside and continued assisting with blood collection and starting the IV line. She was not observed to wash her hands or use alcohol based hand rub, while providing care between patients.

Between 3:24 PM and 3:32 PM, Staff C, a radiology technician, entered the CCN to obtain a chest x-ray on Patient #38. He was observed assisting in positioning Patient #38 onto the film for the x-ray. He did not wear gloves, wash his hands, or use alcohol based hand rub, before or after obtaining the x-ray. Staff C returned at 3:40 PM to retake the chest x-ray. He did not wash his hands upon entering or leaving the nursery.

The hospital's Labor & Delivery Department policy, "Hand Washing in the Perinatal Unit," approved 6/24/09, was reviewed. The policy documented that gloves should be worn when touching any body substances. It also documented, "Antimicrobial hand washing products should be used before invasive procedures, before and after direct patient contact in the nurseries..." In addition, the policy documented that hand washing was indicated between contacts with different patients.

The Perinatal Supervisor was present in the CCN during the observation on 3/09/10, and was interviewed on 3/10/10 at 11:20 AM. She explained that gloves are part of the standard precautions taken with every patient. They were to be used for exposure to blood and body fluids, including handling a newborn before its first bath. She also stated she expected staff to wash their hands before and after procedures, before contact with infants, and between cares for different infants. She stated ancillary staff entering the CCN were expected to wash their hands. She explained that Staff C did not wash his hands upon entering the CCN for the retake of the x-ray because he did not touch Patient #38.

The facility failed to ensure proper gloving and hand washing techniques were used to care for Patient #38.

2. A tour of the Nursery Department was conducted on 3/08/10 at approximately 2:30 PM. It was noted that the scale used to weigh infant diapers was located inside the isolation room. The door to the isolation room was closed. Staff E was the CCN RN on shift during the tour and she was interviewed on 3/08/10 at 2:35 PM regarding the process used to weigh an infant diaper. She explained the diaper was changed with gloved hands then carried to the scale in the isolation room. She acknowledged that the door to the isolation room remained closed much of the time and to get to the scale the door would be opened with gloves which had been used to change a diaper.

The facility failed to ensure the process for weighing an infant's diaper did not generate a source of contamination in the nursery.

3. Staff H, a surgical technician for Cesarean sections in the Labor & Delivery Department, was interviewed on 3/09/10 at 11:03 AM. She explained the process for doing the initial cleaning of surgical instruments used during Cesarean sections. She stated most of the time she used an enzymatic cleaner called Cleanzine. However, on 3/09/10 when she went to re-supply the stock in Labor & Delivery, Cleanzine was not available and she was told to use Prolystica instead. She explained that she was unsure of the specific dilution recommendation for either cleanser, but filled her sink with water and then added 5-6 pumps of the cleanser.

The facility failed to ensure detergents, used to clean medical instruments, were diluted in accordance with the manufacturer's recommendation.



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4. The hospital's outpatient Redi Care Clinic on Columbia was toured on 3/10/10 starting at 3:00 PM. The hospital's second outpatient Redi Care Clinic at Taylor Crossing was toured on 3/11/10 starting at 9:00 AM. It was noted that in 2 outpatient clinics, instruments used for patient care and exams were washed, sterilized and autoclaved.

The 2006 American National Standard for biological indicators for autoclaving, stated "Biological indicators should be used...for routine sterilizer efficacy monitoring at least weekly, but preferably every day that the sterilizer is in use." A biological indicator (spore test) is a devise used to monitor the sterilization process of the autoclave. It consists of a standardized population of bacterial spores. Biological indicators monitor the autoclaving cycle and ensure that all the parameters necessary for sterilization are present during the autoclaving process. Neither clinic used biological indicators to ensure autoclaved loads were accurate. The clinics did use a chemical indicator with each load that was autoclaved. However, without the use of weekly biological indicators, in conjunction with the chemical indicators, the clinics could not ensure that the parameters necessary for sterilization were met.

Additionally, over 1/2 of instruments that were autoclaved in the two clinics did not have any identification as to when they were ran and who ran the load. This could result in the inability to recall contaminated instruments.

Further, the clinics did not have a sterilizer standards information log, that would include; the lot number, the specific contents of the lot or load, including quantity, department, and specific description of the items, the exposure time and temperature if not provided on the sterilizer recording chart, and the name and initials of the operator.

The deficient practices were confirmed by the Director on Nursing of the Redi Care Clinics on 3/10/10 at 3:15 PM and the Office Manager of the Taylor Crossing Redi Care Clinic on 3/11/10 at 9:30 AM.

The hospital's Compliance Officer was interviewed on 3/11/10 starting at 8:18 AM. He stated that the hospital did not have policies for biological testing.

The hospital's Director of Public Relations and Government Affairs, who is also over the outpatient clinics stated on 3/11/10 at 11:15 PM that he was unaware of any policies for biological testing.

The hospital failed to ensure effective infection control monitoring of the autoclaving process for sterilizing instruments at the 2 outpatient clinics.

5. During a tour of the PACU on 3/08/10 starting at 3:30 PM, and during a tour of the Post Surgical unit on 3/10/10 starting at 9:00 AM, the emergency crash carts were inspected. Both carts had a Yankauer suction catheter (a rigid suction tip used to suction fluids from patients' mouths or other cavities that contain fluids) that was connected to other tubing leading up to a small suctioning device. The Yankauer suction catheter and the tubing were hanging off the cart, unwrapped and exposed to potential contaminants. The Yankauer suction catheters were removed by staff and thrown out at the time of the tour. On 3/10/10 at 9:10 AM, the Post Surgical Supervisor stated that her unit had done a mock code and the cart had not been cleaned up since that time.

The hospital failed to ensure patient care equipment was stored to ensure effective infection control.

6. The hospital's surgical suites were toured on 3/08/10 from 1:43 PM to 3:45 PM. Rooms 2, 4, and 5 were noted to have many tears in the linoleum. For example, room 2 had more than 50 one inch to three inch splits in the linoleum from equipment being moved across the floor. The Director of Surgical Services stated during the observations that housekeeping did a good job ensuring the floors were clean. However, when asked, she did not know how housekeeping ensured that blood, fluids, tissues, and dirt was cleaned out of each individual split in the floor.

Additionally, a stool in Room 8 was observed to have tape on the top of the seat. This tape was used to reduce the slickness of the stool. However, the tape could not be sanitized and cleaned thoroughly.

The hospital failed to ensure its surgical unit was maintained to ensure effective infection control.

7. The hospital's surgical unit was toured on 3/08/10 from 1:43 PM to 3:45 PM. An anesthesiologist was observed in the hall talking on his cell phone with his gloves on. After the phone call he placed the phone in its holder on his waist and returned to the surgical suite where a patient was being operated on. The anesthesiologist did not change gloves, wash his hands, or clean the phone before he returned to patient care.

A housekeeper was observed carrying a large bag of trash down the surgical hall, with gloves on after she had cleaned a dirty surgical suite. The housekeeper's cell phone rang and she answered it without taking off her gloves and washing her hands. After the call was completed, she placed the phone in her pocket. The Director of Surgical Services was asked during the observations if the unit had a cell phone policy. She stated no.

The hospital failed to ensure its surgical unit staff used cells phones appropriately to practice effective infection control.

8. The hospital's surgical unit was toured on 3/08/10 from 1:43 PM to 3:45 PM. During the tour 3 anesthesia medication carts were observed. In the carts it was noted that used multi-dose medication vials were being stored with unopened and clean multi-dose medication vials. During the observation, the Director of Surgical Services was asked how they ensured that cross contamination did not occur with the medications. She stated they could not ensure that this would not happen.

The hospital failed to ensure its surgical unit's medications were stored to promote effective infection control.

9. The hospital's Central Supply unit was toured on 3/08/10 from 3:10 PM to 3:25 PM. Central Supply is a department on the surgical unit. Central Supply cleans the instruments that were used during the surgical procedure. During the tour a large sink containing water, detergent and instruments was observed. The Central Supply Technician was interviewed on the dilution of the detergent to the water. He stated the he puts in a few squirts of detergent and fills the sink half way. The instructions on the "Select Plus" detergent stated that the dilution ratio was to be 2 ounces of detergent to 1 gallon of water. The Central Supply Technician could not ensure that he had been diluting the detergent per the manufacturer's recommendations.

10. The hospital's Out-Patient Wound Clinic unit was toured on 3/11/10 from 10:10 AM to 11:03 AM. During the tour each exam room contained buckets that contained water, detergent and instruments. A Wound Clinic LPN was interviewed on the dilution of the detergent to the water. She stated the she puts in a "squirt" of detergent and fills the bucket half way. The instructions on the "Select Plus" detergent stated that the dilution ratio was to be 2 ounces of detergent to 1 gallon of water. The Wound Clinic LPN could not ensure that she had been diluting the detergent per the manufacturer's recommendations.

The hospital failed to ensure detergents, used to clean medical instruments, were diluted per the manufacturer's recommendations.

11. The hospital's Out-Patient Wound Clinic unit was toured on 3/11/10 from 10:10 AM to 11:03 AM. During the tour a refrigerator, with patient medications in it, was observed in the IV Therapy Room. Also in the refrigerator were staffs personal drinks. The refrigerator contained an open can of Coke, a cup of coffee, and 2 opened bottles of water. When asked, during the tour, the Wound Clinic's Manager stated that the drinks should not have been there.

The hospital failed to provide a sanitary environment and promote safe practices and avoid sources and transmission of potential infections.

Based on staff interview and review of medical records and hospital policies, it was determined the hospital failed to ensure medical history and physicals were reviewed and updated prior to patient's surgeries for 8 of 12 patients, (#2, #4 - #6, #15, #16, #18 and #37) whose surgical medical records were reviewed. This resulted in the potential for surgical complications due to a lack of information regarding the patients' current heath conditions. Findings include:

1. The hospital's "HISTORY AND PHYSICAL MEDICAL POLICY," dated 6/31/09, stated when patients are admitted to the hospital an admission H&P included, "An appropriate assessment, to include a physical examination of the patient to update any components of the patient's current medical status that may have changed since the prior H&P or to address any areas where more current data is needed...This updated assessment should be recorded in the admission progress note or on the original H&P document." However, the policy was not implemented as follows:

a. Patient #2 was a 55-year-old female who had a laparoscopic cholecystectomy on 3/08/10. Her H&P, dated 3/01/10 at 12:51 PM, stated Patient #2 had a history of bladder problems, abdominal pain, and nausea. The record contained no documented evidence that the surgeon had reassessed Patient #2's health status before the surgery.

b. Patient #4 was a 77-year-old male who had a repair on his left middle finger on 3/08/10. His H&P, dated 2/28/10 at 10:20 AM, stated Patient #4 had a history of heart disease, hypertension, and thyroid issues. The record contained no documented evidence that the surgeon had reassessed Patient #4's health status before the surgery.

c. Patient #5 was a 74-year-old male who had a right shoulder arthroscopy on 3/08/10.
His H&P, dated 2/22/10 untimed and not signed, stated Patient #5 had a history of cancer and stomach/bowel problems. The record contained no documented evidence that the surgeon had reassessed Patient #5's health status before the surgery.

d. Patient #6 was a 63-year-old male who had a right knee arthroscopy on 3/08/10. His H&P, that was not dated or timed, stated Patient #6 had a history of diabetes and arthritis problems. The record contained no documented evidence that the surgeon had reassessed Patient #6's health status before the surgery.

e. Patient #15 was a 74-year-old female who had a left total knee replacement on 3/09/10. Her H&P, that was not dated, timed or signed, stated Patient #15 had a history of hypertension and had a stroke in the past. The record contained no documented evidence that the surgeon had reassessed Patient #15's health status before the surgery.

f. Patient #16 was a 69-year-old male who had a right total knee replacement on 3/09/10. His H&P, dated 10/21/09 that was untimed, stated Patient #16 had a history of benign prostate hypertrophy and arthritis. The record contained no documented evidence that the surgeon had reassessed Patient #16's health status before the surgery.

g. Patient #18 was a 67-year-old female who had a cystoscopy with placement of lighted stents on 3/09/10. Her H&P, dated 2/22/10 that was untimed, stated Patient #18 had a history of diabetes and thrombophlebitis. The record contained no documented evidence that the surgeon had reassessed Patient #18's health status before the surgery.

h. Patient #37 was a 76-year-old female who had a plastic surgery procedure on 3/08/10. Her H&P, that was not dated or timed, stated Patient #37 had a history of liver disease arthritis and thyroid issues. The record contained no documented evidence that the surgeon had reassessed Patient #37's health status before the surgery.

The hospital's Compliance Officer was interviewed on 3/12/10 starting at 2:30 PM. He confirmed the policy was not followed for the above patients.

The hospital failed to ensure patients' medical H&Ps were reviewed and updated prior to their surgery.