The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

ST ELIZABETH'S MEDICAL CENTER 736 CAMBRIDGE STREET BRIGHTON, MA 02135 June 28, 2012
VIOLATION: MEDICAL STAFF - APPOINTMENTS Tag No: A0046
Based on review of credential files, the Governing Body failed to assure that all practitioners had privileges related to their appointment for 3 of 3 practitioners [Physician #7, Midwife #1, Certified Registered Nurse Practitioner (CRNP) #3] reviewed. Findings included:

1. Review of credential files on 6/28/12, revealed that the privileges of Physician #7 did not include privileges in Rehabilitation Services. The Physician's privileges were in orthopedic surgery. During an interview with the staff member in charge of physician credentialing, at the time of credential file review, the staff member said that Physician #3 was the Hospital's Director of Rehabilitation Medicine.

2. Review of the credential file of Midwife #1, on 6/28/12, indicated that the scope of practice and delineation of privileges for the Midwife lacked the following:

(1). A defined mechanism to monitor prescribing practices, including documentation of review with a supervising physician at least every three months;
(2). Protocols for the initiation of intravenous therapies and Scheduled II drugs;
(3). The frequency of review of initial prescription of controlled substances and the initial prescription of Scheduled II drugs, reviewed within 96 hours; and
(4). Documentation of protocol approval from Nursing Administration, although required.

Please refer to A395





3. Review of the credentialing files for CRNP #3 indicated that the CRNP was incorrectly credentialed to provide anesthesia evaluations and to obtain anesthesia consents. Review of the credentialing file indicated the CRNP had no license for the provision of anesthesia services (Certified Registered Nurse Anesthetist/ CRNA), and no experience on his/her resume in the area of anesthesia. The CRNP signed a form on 2/9/12, for "Advance Practice Practitioner Clinical Privilege Form- CRNA (Certified Registered Nurse Anesthetist) " which attested to the facts that the CRNP met criteria for the privileges requested, and is currently competent to exercise them..."

On 6/28/12 at 11:00 A.M., during an interview, the Chief Nursing Officer (CNO) said, that although the CNO had signed the delineation of privileges, the CNO did not read them thoroughly, and should not have approved them for this level of practice because the CRNP was not qualified to perform anesthesia evaluations under Federal Regulations.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0159
Based on review of policy and staff interview, the written Hospital policy for the psychiatric unit, reviewed during May 2012, did not address the use of a physical hold as a patient restraint for one of one patients in a total sample of 31.

Findings include:

The Hospital's policy, "Use of Restraint and Seclusion on Inpatient Psychiatry," indicated the following:

"Category I - Restraint applied for Violent/Self-Destructive Behavior. Restraint methods and material include medication restraints, mechanical restraints (quick release restraints), safety vests, safety belts, mitts, leather restraints, and soft wrist restraints used as a last resort for the management of violent or self-destructive behavior. Seclusion is also considered a Category I restrictive measure."

For Patient #40, record review on the psychiatric unit indicated the patient received a physical hold restraint by staff, on 6/6/12 and 6/7/12, for violent behavior. Record review indicated the Hospital did not obtain a physician's order for the restraint. Also, on 6/7/12, the physician did not see the patient for a face to face evaluation within one hour of the physical hold being initiated.

During interview subsequent to the survey on 7/2/12 at 2:00 P.M., Charge Nurse RN#8, on the Psychiatric Unit stated that it was the policy of the psychiatric unit to consider a physical hold a restraint, and that a physician's order should be obtained. Also, she stated that the physician should perform a one hour face to face evaluation of the patient.

Although staff on the psychiatric unit did consider a physical hold an actual restraint, the Hospital failed to include it in the Pychiatric Unit restraint policy.

Please refer to 0168 and 0178.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0166
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on record review and staff interview, the Hospital failed to include restraint usage on the patient's written plan of care for 2 active restrained patients (#9 and #10) in a total sample of 31 active patients, and 1 of 3 discharged restrained patients (#39) in a total sample of 9 discharged patients.

Findings included:

1. For Patient #9, the hospital failed to modify the Interdisciplinary Treatment Plan to include restraint usage.

Patient #9 was admitted on [DATE] with diagnoses of schizophrenia and agitation.

The patient was restrained as follows:
a) On 6/15/12 at 3:45 A.M. using a Posey vest;
b) On 6/17/12 at 8:15 A.M. using a medication restraint and a vest Posey;
c) On 6/19/12 at 12:00 A.M. using a medication restraint, and
d) On 6/20/12 at 12:00 A.M. using a Posey vest.

The above 4 incidents of restraint usage were not added to the treatment plan. The treatment plan included a check off box that states, "There were no restraints." This was checked off. The next check off box stated, "Restraint(s) occurred on ....", and was left blank. Also, another check off box stated," A restraint review has been completed and findings have been discussed by the team incorporated into the treatment plan of the patient." This was left blank.

During interview on 6/25/12, Unit Manager, RN (Registered Nurse) #7, stated the treatment plan should have been updated to include restraint usage, and at that time, added the 6/18/12 medication restraint to the treatment plan, and checked off the appropriate boxes. The other 3 incidents of restraint use were not added to the treatment plan at that time.

2. For Patient #39, the hospital failed to modify the Interdisciplinary Treatment Plan to include restraint usage.

Patient #39 was discharged on [DATE] with diagnoses of vascular dementia with delirium, insulin dependent diabetes, acute kidney failure, and anemia. The patient was restrained as follows:
a) 5/17/12 at 3:00 A.M. using a Posey vest, and
b) 5/18/12 at 12:30 A.M. using a Posey vest.

The above 2 incidents of restraint usage were not added to the Interdisciplinary Treatment Plan dated 5/17/12, and reviewed 5/24/12 and 5/31/12. The treatment plan included a check off box that states, "There were no restraints." This was checked off.





3. For Patient #10, the Hospital failed to modify the Interdisciplinary Treatment Plan to include all the incidents of restraint usage.

Patient #10 was admitted on [DATE] with diagnoses of bipolar disorder and mania.

The patient was restrained for the safety of staff and self as follows:
a) On 6/3/12 at 12:15 A.M. with a Posey vest when patient was delusional, restless, and hitting and kicking at staff.;
b) On 6/4/12 at 12:00 A.M. with a Posey vest due to patient grabbing a nurse around the neck and holding her head by the hair, and a medication restraint when patient continued with delusional, aggressive behavior and threats of violence;
c) On 6/5/12 at 12:30 A.M. with a Posey vest when patient was delusional, exhibiting aggressive behavior, and threatening to assault staff.;
d) On 6/6/12 at 9:26 A.M. with a physical hold for 4 minutes when patient exhibited aggressive behavior and kicking and pushing, and
e) on 6/7/12 at 3:30 P.M. with a physical hold for 10 minutes after patient attempted to attack staff.

Only the 6/4/12 incidents of physical and chemical restraint use were added to the treatment plan under "Restraint(s) occurred on ...."

During interview on 6/28/12, RN #14, stated the treatment plan should have been updated to include restraint usage for all 6 incidents.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0168
Based on record review and staff interview, the Hospital failed to ensure that physical restraints were implemented only when ordered by the physician for 1 of 2 active restrained patients (#10) in a total sample of 31 active patients.

Findings included:

For Patient #10, the Hospital failed to ensure that a physician's order was obtained when a physical restraint was implemented.

a) Record review on 6/26/12 indicated that on 6/6/12 at 9:15 A.M., Patient #10 was restrained in a physical hold for 4 minutes after becoming aggressive with kicking and pushing.

Review of the 6/2012 physician's orders indicated there was no physician's order on 6/6/12 for the physical restraint, despite there being a Physician Note, dated 6/6/12, at 9:36 A.M. indicating she had seen the patient.

On 6/9/12 at 11:30 A.M., Nurse #15 said she could not find a physician's order for the physical restraint used on 6/6/12, as required.

b) Record review revealed a nurse's note dated 6/7/12, written at 4:23 P.M., describing how patient #10 became delusional and psychotic, then attempted to attack staff. According to the note, the patient was contained by staff with a physical hold for approximately 10 minutes.

Review of the 6/2012 physician's orders indicated there was no physician's order on 6/7/12 for the physical restraint. There were Physician's Progress Notes on 6/6/12 and 6/7/12, discussing medication orders and recommendations, but no reference to the physical restraint used.

On 6/9/12 at 11:30 A.M., Nurse #15 said she could not find a physician's order for the physical restraint used on 6/7/12, as required.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0188
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on record review and staff interview, the Hospital failed to document in the medical record the patient's response to restraints for 2 of 2 (#9 and #10) active restrained patients in a total sample of 31 active patients. Findings included:

1. For Patient #9, the Hospital failed to document the patient's response to a Posey vest restraint.

Patient #9 was admitted on [DATE], with diagnoses of schizophrenia and agitation and placed in the Psychiatry Unit. According to nurses' notes on 6/19/12 at 12:00 A.M., the patient was restrained for safety with a Posey vest. The nursing notes indicated that the restraint was removed at 4:30 P.M. on 6/19/12.
The medical record did not include documentation that the patient's response to the restraint was monitored over a period of 14 hours and 30 minutes.

The Hospital's policy, "Use of Restraint and Seclusion on Inpatient Psychiatry," reviewed in 5/ 2012 indicated the following:

Every two hours, or more frequently, depending on the patient's condition, the patient will be monitored for:

a) Skin condition and circulation in the area of the body being restrained;

b) Comfort and proper fit of safety restraints

c) Needs for activities of daily living, i.e., food, fluids, toileting

d) Continued need for restraint and readiness to attempt less restrictive alternatives

e) Relief periods to remove/release restraints - for mitts and soft wrist restraints, range of motion should be performed on each restrained limb for 5 minutes

f) Assessment of overall physical and mental status

g) Vital signs.

The policy indicated that the above information would be summarized in a progress note every 8 hours.

In addition, the Hospital's online nursing documentation included an every 2 hour monitoring format to be completed when a restraint was used for safety purposes.

For Patient #9, neither the nursing progress notes nor the online format addressed the every 2 hour monitoring of the restraint use.





2. For Patient #10, the Hospital failed to document the patient's response to a Posey vest restraint.

Patient #10 was admitted to the Hospital 1n 5/2012, with diagnoses of bipolar disorder and mania and placed in the Psychiatry Unit. On 6/5/12, at 12:30 A.M., a physician wrote an order for a safety Posey vest to be applied. The 6/5/12 nurse's note indicated the patient had been verbally aggressive and threatening to assault staff. According to the nurse's note written at 3:58 A.M., the patient was currently sleeping, and that monitoring would continue.
The medical record did not include documentation that the patient's response to the restraint was monitored.

The Hospital's policy, "Use of Restraint and Seclusion on Inpatient Psychiatry," was reviewed as above in Example #1.

For Patient #10, neither the nursing progress notes nor the online format addressed the every 2 hour monitoring of the restraint use.
VIOLATION: MEDICAL STAFF CREDENTIALING Tag No: A0341
Based on record review and interview, the medical staff failed to examine the reappointment credentialing files of two physicians ( MD #2 and MD #4), to ensure the files had completed requests for robotic surgery privileging as previously granted in past reappointments. As a result, robotics surgery was not granted to MD #2 and MD #4, upon reappointment. However, the physicians continued to perform robotics surgery since 2011, although both were not privileged to do so. Findings include:

1. For MD #2, review of the credentialing file indicated the Physician was recredentialed from 5/11 through 5/2013, as an obstetrical/gynecologist with surgical privileges with a subspecialty in reproductive endocrinology. The last approval for robotics surgery was on 5/5/09 for two years, expiring in 5/2011. The robotics surgery privilege was not renewed in 5/2011.

Review of the surgical schedule for 6/26/12, indicated MD #2 was scheduled to perform a robotic assisted hysterectomy which the surveyor was scheduled to observe. On 6/24/12, at 9:30 A.M., during an interview with the Operating room scheduler, the surveyor asked the scheduler to show how he/she verifies the surgeon's delineation of privileges before booking a case, using MD #2 scheduled case as an example. The scheduler, using a computer based program, looked up the surgeon by name, and then by privileges. The scheduler was unable to verify that MD #2 had robotics privileges in the computer based system.

On 6/26/12 at 2:00 P.M., during an interview, the President of the Medical Staff and the Director of Quality and Safety said MD #2 lacked privileging for robotic surgery and the case had been changed to just a laparoscopic hysterectomy. The Director of Quality and Safety said a plan of correction had been developed to immediately address this oversight.

2. Review of the credentialing file of MD #4, indicated the Physician was reappointed from 3/2011 through 2013. In the file was an incomplete application for Robotics privileging. There was also a copy of an email sent to the Physician, requesting to complete the robotics application in section III, before it could be approved. Review of the form indicated it was not completed. The Physician was credentialed without robotics privileging.

Review of the operating room schedule indicated MD #4 was scheduled to perform procedures using robotics the week of June 25 -29, 2012.
VIOLATION: RN SUPERVISION OF NURSING CARE Tag No: A0395
Based on medical record review, interviews, and review of hospital credential files, the Hospital failed to ensure:
The scope of practice and delineation of privileges for one Registered Nurse Midwife (#1) was approved by Nursing Administration and/or was in accordance with the Massachusetts Board of Registration in Nursing (BORN) Regulations for Nurses Practicing in an Advanced Practice Role (244 CMR 4.00); and in addition, a Registered Nurse (RN) failed to evaluate 4 patients, (#3, #4, #5, and #7), in a total sample of 31 active patients for responses to medication administration and blood transfusions.

Findings included:

1. Review of the Massachusetts Board of Registration in Nursing (BORN) Regulations for Nurses Practicing in an Advanced Practice Role (244 CMR 4.00), subsequent to survey on 7/2/12, indicated the following:

According to 244 CMR 4.22(1): "All nurses practicing in an expanded role shall practice in accordance with written guidelines developed in collaboration with and mutually acceptable to the nurse and to:
(b) the appropriate medical staff and nursing administration staff of the institution employing the nurse."

According to 244 CMR 4.22(4)(a)(b): "A nurse practicing in an institution may not practice in an expanded role until:

(a) The governing body, including the medical staff and nursing administration staff of the institution, formally reviews and approves of the guidelines under which (the nurse) proposes to practice; and
(b) a Physician is designated who shall provide such medical direction as is customarily accepted in the specialty area."

"In addition to the requirements of 244 CMR 4.22(2), the guidelines pertaining to prescriptive practice shall:
(a) include a defined mechanism to monitor prescribing practices, including documentation of review with a supervising physician at least every three months;
(b) include protocols for the initiation of intravenous therapies and Scheduled II drugs;
(c) specify the frequency of review of initial prescription of controlled substances; the initial prescription of Scheduled II drugs must be reviewed within 96 hours; and
(d) conform to M.G.L. c. 94C, the regulations of the Department of Public Health at 105 CMR 700.000 et seq.., and M.G.L. c. 122, sections 80E or 80G, as applicable."

2. Review of the credential file of Midwife #1, on 6/28/12, indicated that the scope of practice and delineation of privileges for the Midwife lacked the following:

(1). A defined mechanism to monitor prescribing practices, including documentation of review with a supervising physician at least every three months;
(2). Protocols for the initiation of intravenous therapies and Scheduled II drugs;
(3). The frequency of review of initial prescription of controlled substances and the initial prescription of Scheduled II drugs, reviewed within 96 hours; and
(4). Documentation of protocol approval from Nursing Administration, although required.

During an interview with the Chief Nursing Officer (CNO), at 10:00 A.M. on 6/28/12, the CNO said that she was not aware that she needed to approve the Midwife's practice protocol. The CNO also said that no one brought the midwife's credential file to her for approval.

3. For Patient #3, review of the Physician's Order Form indicated that the patient had orders for Klonopin (an anti-anxiety medication), 1 milligram (mg), PRN (when needed), QID (four times a day), for anxiety, and Tylenol 650 mg, by mouth (po), PRN for pain.

A. Review of the Medication Administration Record (MAR) indicated the patient received Klonopin 1mg, four times a day, from 6/20/12 to 6/25/12. However, the patient's response to the Klonopin was not evaluated, as required.

During an interview at 1:45 P.M. on 6/25/12, RN #2 said that she did not evaluate patient's responses to all PRN medications, only pain medications.

Review of the Hospital's policy titled, "Assessment and Reassessment of Patients," under the section labeled "Reassessment, Standards of Practice," read: "Each patient may be reassessed for many reasons, including the following: to evaluate his or her response to care, treatment and services."

In an interview at approximately 10:30 A.M. on 6/28/12, the CNO said that all RNs were required to assess the patients' responses to all care and treatment, including PRN medications.

B. Review of Patient #3's MAR on 6/25/12, indicated that on 6/24/12 at 4:28 P.M., the patient was administered the medication Tylenol 650 mg, by mouth (po), for pain. RN #2 said that the patient's pain level was not documented as being assessed, nor was the response to the Tylenol documented.

4. For Patient #4, medical record review on 6/26/12, indicated that the patient had the following medication orders for alleviation of withdrawal symptoms:

a. Phenobarbital (to control seizures), 9 mg, po, at 9:00 A.M. and 9:00 P.M.; and
b. Morphine (for pain), 0.25 mg, po, every 3 hours.

Review of the patient's MAR with RN #4, on 6/26/12, indicated that the responses to the above medications were not documented. RN #4 said that she did observe the effect of the medication but did not document it in the patient's record.

5. For Patient #5, medical record review on 6/26/12, indicated that the patient received a blood transfusion on 6/24/12, that began at 9:05 P.M. and ended at 10:05 P.M.

Review of the Hospital policy titled "Transfusion of Blood Products, Neonate" read:

Step 9. The RN will obtain pre-transfusion vital signs (blood pressure, respirations, pulse, temperature) including a blood pressure."
Step 17. "The vital signs will be checked again, 15 minutes after the transfusion is initiated."
Step 20. "Additional vital signs will be obtained every half hour times one and then hourly until transfusion complete."
Step 21. "Post transfusion vital signs will be taken one half hour after the transfusion is complete."

Review of the Transfusion Record indicated that the infant's vital signs were taken just before the transfusion started, 15 minutes into the transfusion, and when the transfusion ended. However, the patient's vital signs were not taken one half hour times one (after the first 15 minutes), and then one half hour after the transfusion was complete, as required by Hospital policy.





6. For Patient #7, medical record review indicated that the patient had a physician's order to receive Opium/Belladonna (narcotic) Suppository, 60 mg per rectum (PR) every 6 hours prn for bladder spasms.

Review of the patient's MAR with Nurse Manager (NM) #1, revealed that Patient #7 received Opium/Belladonna Suppository, 60 mg PR at 11:48 P.M. on 6/25/12 for bladder spasms, but the nurse administering this medication did not observe and document the effects of this medication. NM #1 acknowledged that this nurse failed to follow the hospital's policy as she failed to document the effects.
VIOLATION: INFORMED CONSENT Tag No: A0955
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record review and interview, the Hospital failed to obtain a properly executed consent for one active patient ( #13), in a total sample of 31 active patients.

Findings included:

For Patient #13, the Hospital failed to obtain written informed consent for anesthesia prior to electroconvulsive therapy.

Record review on 6/26/12, indicated Patient #13 was admitted on [DATE], with a diagnosis of bipolar disorder. Record review indicated the patient had a legal guardian since 9/04 and a Rogers Guardianship Treatment Plan dated 8/11/11.

Further record review on 6/27/12 indicated that on 6/26/12 the patient received a scheduled ECT treatment. According to the patient's Rogers Guardianship Treatment Plan dated 8/11/11, the patient shall be treated with electroconvulsive therapy ,"every week to 4 weeks for maintenance, reserving the clinical option of returning to a short acute course to prevent relapse."

Further review of the Hospital's Policy for Consent to Treatment under Special Procedures indicated that a detailed informed consent discussion with the patient or the patient's surrogate decision maker must be conducted. According to the Hospital's Special Procedures, ECT treatments and any procedure in which anesthesia will be used require an informed consent. "Documenation of the informed consent process may be completed by the physician or their designee. The consent forms used for a Special Procedure has two parts, one consent form for the patient's medical record and a duplicate consent form for the physician. The physician and patient jointly review and sign the form, validating that the patient consents to the proposed procedure, examination and treatment."

The Hospital's Policy for ECT indicated that a patient would require general anesthesia while receiving ECT. Review of the patient's medical record indicated that the most recent patient's consent for anesthesia was dated 4/3/12 and was signed by the patient. There was no consent signed by the legal guardian for the anesthesia required on 6/26/12 in order to administer the ECT.

During interview on 6/28/12 at 3:00 P.M., RN #14 said that the ECT physician said that a separate consent form for anesthesia for each ECT treatment was not needed because in order to administer ECT, anesthesia was required.

On 7/2/12 at 4:50 P.M., Department of Public Health's legal staff said the Hospital should have obtained a written consent for anesthesia prior to the ECT treatment on 6/26/12 from the patient's legal guardian.
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
Based on medical record review, review of Hospital policies and procedures, and staff interviews, the Hospital failed to assure that drugs and biologicals were prepared and administered in accordance with physician orders for 2 Patients (#3 and #4) of 31 active records reviewed. Findings include:

1. For Patient #4, an infant in the Neonatal Intensive Care Unit (NICU), medical record review indicated that at 12:25 P.M. on 6/20/12, Neonatal Nurse Practitioner (NNP) #1 ordered the narcotic pain medication Morphine, 0.18 milligrams (mg) by mouth, STAT (immediately), and then every three hours.

Review of the patient's medication administration record (MAR) indicated that the Morphine was not given until 2:49 P.M., over two hours later. In an interview with Registered Nurse (RN) #4, the RN said that the infant was hospitalized for Neonatal Abstinence Syndrome [NAS- withdrawal for exposure to opiates (e.g., Heroin, Cocaine, Oxycodone) in utero]. The RN acknowledged that the Morphine was not administered to the patient for over two hours, creating a risk for withdrawal complications for the patient.

In an interview with NNP #1, the NNP said that the Morphine was ordered because the patient's NAS scores had increased from average scores of 4 to 7, to scores between 10 to 15, indicating that the patient was having increased symptoms of withdrawal (e.g., tremors, continuous or excessive crying, poor feeding, vomiting, fever, respirations greater that 60 per minute, sweating, jerking movements, and seizures).

2. For Patient #3, a patient with a history of pulmonary embolism (blood clots in the lungs), medical record review, indicated that the patient's physician ordered the medication Lovenox (prevents blood clots), 110 mg, daily, by subcutaneous injection. Review of Physician's Orders indicated that the patient had a prothrombin time (PT- a laboratory test to determine how long it takes for blood to clot), ordered at 2:12 P.M. on 6/19/12, the day after the patient's admission. In an interview with RN #2, at 2:00 P.M. on 6/25/12, the RN said that the PT had not been done. The time lapse was seven days since the order was written. The RN contacted the Hospital Laboratory for verification that the physician's order was completed. The Laboratory staff told the RN that the PT had not been drawn.

The patient had received the Lovenox for seven days without any monitoring of the patient's clotting time, creating a risk for an extended bleeding time for the patient.
VIOLATION: FORM AND RETENTION OF RECORDS Tag No: A0438
Based on record review and staff interview, the hospital failed to ensure that three patient records, (#6, #25 and #42) out of a total of 31 active records were accurately written. Findings include:

1. Review of Patient #6's clinical record reflected a physician's order to administer 5 units of Novolog insulin if the patient's blood sugar was between 250-299 pre-meal.

On 6/24/12 at 4:00 P.M., Patient #6's blood sugar was 287. The medication administration record, (MAR), reflected the nurse administered 3 units of Novolog insulin instead of 5 units as ordered.

After investigating this error, NM #1 stated to the surveyor on 6/27/12, at approximately 2:00 P.M, that the nurse who gave the insulin, gave 5 units of Novolog as ordered, but documented the wrong dose in the clinical record.





2. Record review of Patient #25 who was admitted with multiple diagnoses that included Pneumonia, Change of Mental Status and Dysphagia in 6/2012, and staff interview on 6/26/12 at 11:00 A.M., indicated that several medication orders were written to be given to the patient by Mouth (PO). This patient had a Tube Feeding and an order for Nothing by Mouth (NPO) written on 6/23/12. Interview with the Nurse Manager #2 revealed that staff would automatically crush the medication. The Nurse Manager called the Director of Pharmacy who revealed that the Pharmacy would only pull the Physician's Orders for Medications, and was not aware of the NPO order and Tube Feeding. The patient received one dose of Chewable Aspirin on 6/24/12 at 10:00 A.M.

3. Record review for Patient #42 who was admitted with volume depletion, dysphagia and sepsis on June 22, 2012 revealed that orders for medications were written" PO" by the Physician. There were no orders for "Crush Medications" as per hospital policy. According to staff interview on June 27, 2012 at approximately 12:00 P.M., with Nurse Manager #2, the staff would crush the medications written "PO", and the Pharmacy did not know the Patient had a Gastric Tube (GT) as indicated when she spoke to the Director Of Pharmacy. According to documentation, the resident received an enteric coated Aspirin, 81 mgs on June 26, 2012 at 10:00 A.M.

According to the Nurse Manager and the Director of Nursing the facility failed to assure that medication orders were complete and accurate.
VIOLATION: CONTENT OF RECORD - INFORMED CONSENT Tag No: A0466
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on record review and staff interview, the Hospital failed to obtain a properly executed consent for 4 active patients (#3, #13, #17 and #19) in a total sample of 31 active patients.


Findings included:

1. For Patient #13, the Hospital failed to obtain written consents for admission and treatment, anesthesia and for electroconvulsive therapy (ECT) treatment.

Record review indicated Patient #13 was admitted to the Hospital in 6/12, with a diagnosis of bipolar disorder. Record review indicated the patient had a legal guardian since 9/04 and a Roger's Guardianship Treatment Plan dated 8/11/11.

Review of the Hospital's Policy for Consent to Treatment (inpatient/outpatient procedures) indicated that if a patient is physically incapacitated or incompetent, and therefore is unable to sign the Consent of Treatment Form at the time of admission, a surrogate decision maker will be asked to sign the form on the patient's behalf. Admitting will be responsible for obtaining the signature of the patient or surrogate decision-maker within the first 24 hours of admission. The Hospital's Consent of Treatment Form (for admission) was signed by the patient on 6/26/12, and not by the legal guardian.

Further record review, indicated that on 6/26/12, the patient received a scheduled ECT treatment. According to the patient's Roger's Guardianship Treatment Plan dated 8/11/11, the patient shall be treated with electroconvulsive therapy ,"every week to 4 weeks for maintenance, reserving the clinical option of returning to a short acute course to prevent relapse."

Further review of the Hospital's Policy for Consent to Treatment under Special Procedures indicated that a detailed informed consent discussion with the patient or the patient's surrogate decision maker must be conducted. According to the Hospital's Special Procedures, ECT treatments and any procedure in which anesthesia will be used require an informed consent. "Documenation of the informed consent process may be completed by the physician or their designee. The consent forms used for a Special Procedure has two parts, one consent form for the patient's medical record and a duplicate consent form for the physician. The physician and patient jointly review and sign the form, validating that the patient consents to the proposed procedure, examination and treatment."

The Hospital's Policy for ECT indicated that a patient would require general anesthesia while receiving ECT. Review of the patient's medical record indicated that the most recent patient's consent for anesthesia was dated 4/3/12, and was signed by the patient. There was no consent signed by the legal guardian for the anesthesia required on 6/26/12 in order to administer the ECT.

The consent for ECT read, "Court Ordered," under the patient/guardian signature line, and was dated 6/26/12. The ECT consent form was not signed by the legal guardian. The ECT consent form indicated that up to 20 treatments could be administered up to 3 times a week, and if more than 20 treatments, further written consent would be obtained.

On 6/27/12 at 11:00 A.M., RN #9 said that she did not know why the legal guardian had not signed the (admission) Consent of Treatment Form.

On 6/28/12 at 3:00 P.M., RN #14 said that the ECT physician said that a separate consent form for anesthesia for each ECT treatment was not needed because in order to administer ECT, anesthesia was required.

On 7/2/12 at 4:50 P.M., Department of Public Health's legal staff said the Hospital should have obtained written consents for treatment on 6/25/12 and for anesthesia for the ECT treatment on 6/26/12 from the patient's legal guardian.

Please see A 0955.




3. Patient #17 was admitted to the hospital as a transfer from a community emergency room on [DATE], with diagnoses of gangrenous right leg and aspergillus pneumonia. The patient signed a consent for a right above the knee amputation on 4/20/12, which was also signed by the surgeon. The patient remained intubated after surgery and in the intensive care unit, sedated on mechanical ventilation.

Review of the medical record indicated a completed Medical Certificate for temporary guardianship, completed on 4/27/12, indicating the patient needed a proxy for medical decision making as the patient was cognitively unable while intubated and severely ill. Review of the medical record did not indicate that any further action was taken with the completed certificate.

On 5/1/12, the Hospital obtained a telephone consent for a flexible bronchoscopy from "a close friend, D.P." Review of the patient's record indicated there was no next of kin listed on the identification page just a "friend," who resided at a different address. On 5/3/12, this friend was contacted again and a telephone consent was obtained for placement of a central line. The consent was signed and dated by a witness and initialed but not dated by a physician.

According to the hospital policy for informed consent, for adult patients who are incompetent or incapacitated, consent for nonemergent treatment may be obtained from a surrogate decision-maker when there is no next of kin. The policy defines a surrogate decision maker as a patient's health care agent pursuant to a health care proxy or legal guardian. If a surrogate decision maker can not be contacted or there is no surrogate decision-maker, a member of the Quality and Safety Department should be contacted during regular business hours. After hours, the Administrator on call should be contacted

Record review failed to indicate that any member of the Quality and Safety Department had been notified on 5/1/12 or 5/3/12 of the lack of an appropriate person to give consent.

During an interview with the Chief of Surgery on 6/27/12 at 10:30 A.M., the Chief said he was aware of the case, and felt the patient needed to have the procedures done, and that staff got consent from the only person identified on the face the page. The Chief stated he was not sure why the medical certificate for temporary guardianship was still in the record and appeared not to be acted upon, but said it takes forever to get a family judge to approve a temporary guardianship.

4. Patient #19, admitted ,d+[DATE], had a total laparoscopic hysterectomy.

Record review indicated the patient was seen in Pre-Admission testing on 6/20/12 by a Certified Registered Nurse Practitioner (CRNP) #1 who performed a preanesthesia evaluation, and obtained the anesthesia consent.

Review of the department of anesthesia policy for Organization of the Department of Anesthesia, the section on skill levels and qualification of Personnel describes the department as being staffed by qualified physicians and certified registered Nurse Anesthetists. The policy describes a CRNA as licensed registered professional nurse in the state in which she practices, who has graduated from a nurse anesthesia education program that meets the standards of the Council on Accreditation of Nurse Anesthesia Programs, and has passed a certification examination of the Council, and is duly licensed by the State as a CRNA.

The policy also describes a Nurse Practitioner as a registered professional nurse who is licensed by the state in which she practices to furnish services as an NP in accordance with the laws of the state and be certified as an NP by a recognized national certifying body that had established standards for NPs.

The policy states that an anesthesia nurse practitioner can obtain an anesthesia consent, that is then cosigned by the physician anesthesiologist. In addition, the hospital policy for consent to specific treatments states that invasive treatments outside the scope of routine hospital care require a detailed informed consent discussion with the patient by the clinician performing the procedure or his/her designee (another qualified person).

Review of the CRNP #1 credentialing files indicated s/he was licensed as a family nurse practitioner. Further review indicated CRNP #1 had no anesthesia experience, and was not licensed as a CRNA.

Review of the anesthesia consent signed by Patient #19 on 6/20/12, indicated the CRNP discussed the nature of the anesthetic procedure, benefits, alternatives and risks. The CRNP also discussed an anesthesia plan of general anesthesia and a tap block. The CRNP used abbreviations throughout the consent such as PAT for preadmission testing and GA for general anesthesia. Abbreviations are not to be used, as patients are not aware of their meaning.

The CRNP does not meet the criteria of an anesthesia nurse practitioner by licensure, education or training, and is not appropriate to obtain informed consents.
















2. For Patient #3, medical record review, indicated that the medical record contained the following consent forms: Consent for Routine Newborn Medical Treatment and Consent to PICC (Peripherally Inserted Central Catheter) or Midline Catheter Placement.

A. Review of the Consent for Routine Newborn Medical Treatment indicated that although the infant's mother and a witness signed the consent, the consent lacked the date(s) each of the above persons signed the consent.

In an interview at 10:40 A.M. on 6/26/12, with the Chair of Pediatrics/Neonatology, and in an interview at 10:00 A.M. on 6/27/12, with the Chief Nursing Officer (CNO), both the Chair of Pediatrics/Neonatology and the CNO said that the consent should have been dated with the date the consent was signed.

B. Review of the Consent to PICC (Peripherally Inserted Central Catheter) or Midline Catheter Placement indicated the following:

a. The consent was for placement of a PICC line.
b. The consent indicated that the procedure was explained to the patient's mother by Neonatal Nurse Practitioner (NNP) #2, on 6/23/12.
c. The consent was signed by the patient's mother (the person authorized to give consent) and NNP #2 (the person witnessing the mother's consent) on 6/23/12.
d. The name of NNP #2 was crossed out and the name of the Chair of Pediatrics/Neonatology was written directly under the NNP's name and dated 6/25/12.
e. The date of the mother's signature remained 6/23/12.

In an interview at 11:00 A.M. on 6/26/12, the Chair of Pediatrics/Neonatology said that although the consent for PICC insertion was originally dated 6/23/12, the procedure was not performed until 6/25/12. The Chair of Pediatrics/Neonatology said that on 6/25/12, she obtained the consent. However, she said that she failed to change the date of the mother's consent, and to identify herself as the person who explained the nature of the procedure, risks involved, alternatives to the procedure, and possible complications.
VIOLATION: INFECTION CONTROL OFFICER(S) Tag No: A0748
Based on observations, review of Hospital policies and procedures, and staff interviews, the Hospital Infection Control Officer (CO) failed to consistently enforce Hospital policies that governed the control and prevention of infection. Specifically, use of non-safety hypodermic needles, implementation of policies for hand hygiene and disinfection of patient equipment, hand hygiene, and the continuous monitoring of sterile surgical instruments opened and prepared in advance of a surgical procedure, for 4 Patients (#2, #6, #24, #28) of 31 active inpatients reviewed. Findings included:

1. For Patient #2, observations of fingerstick blood sugar testing at 11:50 A.M. on 6/25/12, indicated that Registered Nurse (RN) #1, failed to follow Centers for Disease Control (CDC) Standards of Practice for hand hygiene and disinfection of glucometers, as follows:

In preparation to perform blood glucose testing for Patient #2, RN #1 removed the Unit's glucometer from the docking station and brought the glucometer and a container of strips to the patient's room. Once in the patient's room, the RN placed the glucometer and container of strips on the patient's bedside table. The RN then removed a pair of gloves from the clean glove box, without first performing hand hygiene, and donned the gloves, also without first performing hand hygiene.

After performing the fingerstick blood sugar test, RN #1, removed her gloves, picked up the glucometer and container of test strips, with now contaminated hands, and brought the glucometer and strips to the nurses' station. The RN placed the contaminated glucometer and container of strips back in the docking station, without first disinfecting the glucometer and disposing of the now contaminated container of strips. After Surveyor intervention, the RN disinfected the glucometer and docking station.

2. For Patient #24, observation of the initiation of dialysis in the patient's hospital room, at 1:30 P.M. on 6/27/12, indicated that RN #11 brought two containers of test strips, used to detect the presence of chlorine in the dialysis water, into the patient's room. RN #11 then placed the two containers on top of the portable RO (reverse osmosis) machine. After the patient's dialysis was initiated, the RN removed the containers from the portable RO. Upon Surveyor inquiry, the RN said she was going to return the containers to the clean supply cart. Due to Surveyor intervention, the RN disposed of the now contaminated containers of test strips.


3. Observations in the Labor and Delivery (L&D) Suite at 10:00 A.M. on 6/25/12, indicated that the Hospital failed to consistently ensure the use of safe needle devices or other technology that minimized the risk of injury to health care workers. Boxes of non-safety needles, gauges #16, #19, and #25 were found in the L&D Anesthesia Workroom. The needles were readily available for use.





4. Observation on 6/28/12 at 9:00 A.M., in the Pain Clinic indicated that the medication cart in the treatment room contained one box each of non-safety needles, gauges #18, #25 and #30. The needles were readily available for use and located in the bottom drawer of the cart.

5. During tour of the operating room (OR) suite on 6/25/12 at 9:30 A.M., OR #2 was observed to be set up for a case with the sterile field or surgical instruments open and exposed on the back table. The surveyor entered the room with the OR manager and found no staff in attendance in the room. On a tray the surveyor also observed two 0.25% , 20 milliliters vials of bupivicaine with the rubber stopper removed (barrier to prevent contamination). Within a few minutes, Registered Nurse (RN) #6, entered the room. When asked why s/he left the room unattended, RN #6 stated s/he went to speak with the surgeon and the scrub nurse went on coffee break. the surveyor asked if is was permissible and within operating room nursing standards of practice to leave an open surgical table unattended. The OR manager said "No, an open table with exposed instruments should not be left unattended." The OR manager said the field sterility could not be assured.

The surveyor then asked about the vials of medication without the rubber stopper. RN #6 said s/he was preparing the medication for injection into the patient for a joint injection. However, the patient was not in the room. The sterility of the medication could not be assured. The OR manager agreed.





6. For Patient #6, observations of fingerstick blood sugar testing at 11:30 A.M. on 6/25/12, indicated that Certified Nursing Assistant (CNA) #1, failed to follow Centers for Disease Control (CDC) Standards of Practice for hand hygiene and disinfection of glucometers, as follows:

After performing the fingerstick blood sugar test, CNA #1, removed her gloves, picked up the glucometer with now contaminated hands, and brought the glucometer into the patient's bathroom. The CNA, with her bare hands removed a germicidal wipe and wiped down the glucometer. The CNA discarded the soiled wipe and with her contaminated bare hands placed the glucometer back in the docking station which was located at the nurse's station.

The Nurse Manager of M7 said on 6/27/12, during interview, hands should be washed after removal of gloves and any time the glucometer is cleaned, gloves should be worn.





7. Removal of the Peripherally Inserted Central Catheter (PICC) line for Patient #28 was done by a Physician at approximately 11:30 A.M. on June 26, 2012. The removal was completed and the Physician requested a measuring tape to measure the line as removed. While waiting for the measuring tape the Physician's phone rang in his pocket and he took it out of his pocket with his glove on. Reminded that this was improper and the glove should be removed and hands washed before attempting another project. Although the Physician knew the necessity of measuring the PICC line when removed, the facility Policy for removal of a PICC line appeared incomplete. Discussion with the IV nurse on June 26, 2012 at approximately 10 A.M.and the Chief Nursing Officer at approximately 1 P.M. they agreed the Policy needed to be revisited and re-education for Infection Control be completed.





8. For Non Sampled Patient # A, observation of fingerstick blood sugar testing at 4:40 P.M. on 6/25/12, indicated that Certified Nursing Assistant (CNA) # 2, failed to follow Centers for Disease Control (CDC) Standards of Practice for hand hygiene and disinfection of glucometers, as follows:

CNA # 2 removed the glucometer testing device from the docking station and brought the device into Non Sampled Patient # A's room. CNA #2 then washed his/her hands. After performing the fingerstick blood sugar test, CNA #2, removed his/her gloves, washed his/her hands, then picked up the glucometer and brought the glucometer back to the docking station, located at the nursing station. The CNA then brought the unit into the Non Sampled Patient # B patient room. The CNA failed to disinfect the glucometer after usage and prior to using the device a second time in Non-Sampled Patient # B's room.

During interview with the Nurse Manager of 6 West on 6/25/12, at 5 :05 P.M., stated the glucometer should be disinfected with the environmental cleansing cloth between usage.
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
Based on observations, staff interviews and review of Hospital documentation e.g., policies, disinfection logs, and employee health records, the Hospital failed to develop a system for controlling infections and communicable diseases of personnel. The findings include:

1. The hospital failed to consistently monitor the sterilization system (Steris System 1-E) according to the manufacturer's directions for use.

Observation in the reprocessing area of the Respiratory Therapy Department on 6/26/2012 at 3:30 P.M., and also in the reprocessing area of the Operating Room on 6/27/2012 at 2:50 P.M., revealed an Reprocessing System was often used to perform high level disinfection (HLD)/sterilization of semi-critical equipment (items that contact mucous membranes or non-intact skin, i.e. bronchoscopes) after use.

According to the manufacturer's recommendations, a chemical indicator (a monitoring strip that verifies the minimum recommended concentration of the sterilant has been met to achieve HLD/sterilization) is used with each load cycle. When the bottle of chemical indicators is opened, it must be dated for use up to six months after opening or until the manufacturer's expiration date, whichever occurs first.

It was noted that the opened bottles of chemical indicators used to monitor the process had not been labeled with the date of opening.

Review of staff health records on 6/28/2012, revealed four of nineteen records reviewed did not contain evidence of influenza vaccination or signed declinations as required.

2. Review of staff health records and interview with the Employee Health Nurse, the Hospital failed to consistently ensure that staff assigned to the maternal and newborn areas had a demonstrated immunity to rubella, rubeola, and at a minimum tuberculosis (TB) skin testing was completed at time of hire.

Review of staff health records on 6/28/2012, revealed one obstetrical physician lacked demonstrated immunity to rubella or rubeola, and one Nurse Practitioner assigned to the Maternal/Newborn service lacked tuberculosis skin testing as required by hospital infection control policy.

3. The hospital failed to consistently meet its hospital policy immunization requirements for flu vaccination which requires staff recieve annual flu vaccination unless they sign a form declining such vaccination.

Review of staff health records on 6/28/2012, revealed four of nineteen records reviewed did not contain evidence of influenza vaccination or signed declinations as required.

Interview with the Employee Health Nurse on 6/28/12, the Hospital failed to consistently ensure that all credentialed personnel are vaccinated with seasonal influenza vaccine unless an individual declines vaccination.
VIOLATION: ANESTHESIA RECORD Tag No: A1003
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**



Based on record review and interview, the Hospital's anesthesia's service used a practitioner not qualified to administer anesthesia, to conduct pre-anesthesia assessments on one patient (#19) pre- operative patient, in a total sample of 31. Findings include:

1 According to the Pre-Anesthesia Evaluation Policy of the Department of Anesthesia, all patients receiving general, regional and monitored anesthesia shall have a pre-anesthesia evaluation and documented by a practitioner qualified and privileged to administered anesthesia, within 48 hours prior to surgery or a procedure requiring anesthesia services.

The pre-anesthesia evaluation (PAE) includes medical and anesthesia history, interview and physical exam, notation of anesthesia risk according to established standards of practice (ASA classification), identification of potential anesthesia problems, complications or contraindications to planned procedure; additional pre-anesthesia evaluation if applicable and as required in accordance with standards of practice( stress tests, etc), development of the patient's anesthesia care plan, including type of meds for induction mainteance and postoperative care, including the discussion of risk and benefits of delivery of anesthesia, some elements of the PAE may be performed prior to the 48 hour timeframe but not longer than 30 days prior. Review of these elements must be conducted and any appropriate updates documented within the 48 hour timeframe.

Patient #19, admitted [DATE], had a total hysterectomy under general anesthesia.
Review of the pre-anesthesia evaluation, completed on 6/20/12, indicated it was signed as done by the certified registered nurse practitioner (CRNP) who worked for the anesthesia service.

The pre-anesthesia evaluation included the following, a history and physical, an airway assessment and classification, an anesthesia plan and ASA classification, post operative pain management, an anesthesia and surgical risk statement: a combined perioperative risk assessment and a consent discussion to include risk benefits and alternatives, questions answered and consent for anesthesia was obtained by the CRNP.

Review of the CRNP credentialing file indicated the CRNP was a family nurse practitioner with no anesthesia experience or credentials.

On 6/26/12 at 9:30 A.M. the Pre-admission testing center nurse manager said anesthesia personnel are assigned each day to see and evaluate patients scheduled for pre-anesthesia evaluations.

On 6/27/12 at approximately 2:00 P.M., after the surveyor request, the OR manager provided a copy of the Pre-Admission Testing Center anesthesia coverage schedule for the week of June 18th through 22th. On 6/20/12, the CRNP was scheduled to cover the entire day for anesthesia.

On 6/27/12 at 10:30 A.M., during an interview, the Chief of Anesthesia said that the CRNP should not be doing any pre-anesthesia evaluations just the history and physicals. The chief said that the anesthesiologist sees the patients in the pre-op holding area and reviews the work done by the CRNP and adjusts the plan accordingly. The chief agreed that anesthesia consents were the responsibility of the qualified anesthesia staff.

See A0023.
VIOLATION: OUTPATIENT POST-ANESTHESIA EVALUATION Tag No: A1005
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record review and interview, the Hospital's anesthesia service failed to perform a post anesthesia evaluation, for three of three applicable (#17 , #19 and #22) general anesthesia surgical cases reviewed in a total sample of 31 patients, that was in compliance with the Post Anesthesia Evaluation Policy for the Department of Anesthesia.

Findings include:

1. According to the policy for post anesthesia evaluation, all patients receiving general, regional or monitored anesthesia shall have a post anesthesia evaluation completed and documented by a practitioner qualified to administer anesthesia, no later than 48 hours after surgery or a procedure requiring anesthesia. The elements of an adequate post anesthesia evaluation should be clearly documented and conform to current standards of anesthesia care, including: respiratory function, including rate, airway patency and oxygen saturation; cardiovascular function, including pulse rate and blood pressure; mental status; temperature; pain; nausea and vomiting and post -operative hydration.

2. Patient #19, admitted [DATE], had a total hysterectomy under general anesthesia. Review of the operative notes indicated the patient was a difficult intubation, requiring a glidoscope to assist with airway visualization in order to place an endotracheal tube for ventilation. The patient remained intubated and mechanically ventilated for a short time in the recovery room after surgery. Most patients are extubated in the operating room and go to the recovery room breathing on their own.

On 6/25/12 at 16:13 (4:15 P.M..) the anesthesiologist wrote the following post anesthesia evaluation note: "the postop vital signs (documented in nursing PACU record) pain and nausea and intravascular volume are/were appropriate for D/C from PACU/ Occurrence of Perioperative Critical Incident(s) see Anesthesia CQI note. Clinical "near miss" worthy of note-:none. Intraoperative awareness:none. Cardiovascular status acceptably stable for clinical situation. no apparent neurological deficits and mental status is/was appropriate in relation to the combines effects of previously administered sedating drugs. respiratory status:minute ventilation, oxygen and airway patency are/were appropriate for D/C from PACU ."

This note failed to objectively describe the patient's status in relation to the policy on evaluation. The reader would not know what the vital signs were, if the patient was still ventilated or breathing on his/her own, if the patient had regained consciousness from anesthesia, what was the pain level, had the patient been medicated, if breathing on their own, how well, what did the lungs sound like, or what was the fluid balance, loss to intake?

3. Patient #17 was admitted to the intensive care unit (ICU) on 4/20/12 with diagnosis of gangrenous left foot aspergillus pneumonia and respiratory failure. The patient was intubated and mechanically ventilated. The patient underwent a left leg above the knee amputation on 4/20/12 and placement of a trachestomy and a percutaneous gastric tube for feeding (PEG).

Review of the Post anesthesia care unit (PACU) notes indicated that on 4/21/12 at 3:30 A.M., the anesthesiologist wrote a Post-Anesthesia evalution note that was the exact same note as above, except the patient was appropriate for transfer to the ICU. There was no evaluation of the patient's physical or mental status as required in the post evaluation policy.

On 4/26/12, the patient had a flap closure of the right stump under general anesthesia. On 4/26/12 at 5:50 P.M., the anesthesiologist wrote a Post-Anesthesia Evalution note that was again identical to the previous one cited above. Again there was no evaluation of the patient's physical or mental status as required in the post evaluation policy.






4. Patient # 22 was admitted on [DATE] with diagnosis including staus post cerebrovascular accident, coronary artery disease, hypertension, coagulopathy and chronic renal insufficiency.

On 6/13/12, the patient underwent a quadruple coronary artery bypass graft. The only post anesthesia note in the patients record was a note by the physician in the post anesthesia care unit which was time stamped 7 hours after the start of the procedure.

On 6/15/12 the patient underwent a femoral exploration removal of the balloon pump and closure of the femoral artery. This procedure was performed under general anesthesia. The only post anesthesia note in the record was a note from the post anesthesia unit written 2 hours after the inducting of anesthesia.

The director of the surgical intensive care unit stated on 6/27/12 at 10:55 A.M., that a post anesthesia evaluation performed by a person who administered the anesthesia was not performed within 48 hours as required.