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"In all instances noted 105 CMR 130.121(A) the licensee shall notify the Department in writing of the requested licensure bed quota adjustment.

Prior to any increase in total bed number or number of beds in each specific service as a result of circumstances set forth in 105 CMR 130.121(A)(1), the licensee shall submit and receive Department approval of architectural plans that demonstrate that the location of the additional beds meets licensure requirements related to physical plant, and building fire and safety."

This requirement was NOT MET:

Based on observation, review of State Regulations for Hospitals, and interviews, the Hospital was not in compliance with State licensing requirements related to licensure of beds.
Findings included:

1. On 11/3/2010 at approximately 9:30 A.M., the hospital reported the inpatient census was 619. According to the Hospital's license, dated 8/16/2009, the hospital was licensed for only 597 beds.

2. Observation of the Reisman 12 inpatient unit, on 11/3/2010 at approximately 10:00 A.M., and confirmed by interview with the Nurse Manager, revealed that the Unit had 44 beds available for patient occupancy and 35 beds were occupied. Observation of the Reisman 11 inpatient unit revealed there were 42 beds available for occupancy and 32 beds were occupied.

According to a total licensed bed capacity form, submitted to the Department on 4/2/2010 by the Hospital, Reisman 11 had 29 licensed beds and Reisman 12 had 31 licensed beds.

3. Interview with the Nurse Manager of Reisman 12 on 11/3/2010 at 10:00 A.M., revealed that the unit had been flexing up to a 40 bed capacity for the past several months due to high emergency room volume.

Interview with Senior Director of Network Planning and Development, on 11/4/2010 at 12:00 P.M., confirmed that the Hospital had been using unlicensed beds because emergency room volumes had been high and she had been told they could "flex up and down" depending on their needs. The Senior Director confirmed that in 2003, the hospital had a bed reduction secondary to low census and that there have been no renovations to the Reisman Units.

4. Observation, confirmed by interview with the Neonatal Intensive Care Unit (NICU) Nurse Manager (NM) at 9:00 A.M. on 11/8/2010, revealed that the NICU had 24 semi-private rooms, equaling a total capacity to house 48 patients. However, the Hospital was only licensed for a capacity of 40 patients (16 NICU beds and 24 Special Care Nursery bassinets). The NICU NM said that they sometimes flexed up to a census of 48 patients, even though they were not licensed for that total capacity.



27110

Based on observations, interview with patients and staff, and review of documentation, from 11/3 to 11/15/2010, the Hospital failed to have an effective governing body legally responsible for the conduct of the hospital as follows:

Failure to ensure that all physicians practicing at the hospital were appointed to the medial staff. Please refer to A046.

Failure to ensure that all physicians were accountable for quality of patient care. Please refer to A049 and A940.

Failure to ensure patients' rights were met regarding consents for procedures. Please refer to A131.

Failure to assure that patients' rights were met regarding restraints. Please refer to A164.

Failure to assure that Nursing Services provided adequate patient care and supervision, which placed one patient in immediate jeopardy. Please refer to the Condition of Nursing, A385.

Failure to assure the security of patients' medical records. Please refer to A442.

Failure to assure the Surgical Services was provided in accordance with acceptable standards of practice. Please refer to A940, A945, A951, A952, A959.

Failure to assure pre-anesthesia evaluations were performed by a practitioner qualified to administer anesthesia. Please refer to A1003.

Failure to assure a post anesthesia evaluation was completed and documented by an individual qualified to administer anesthesia, for all patients who required anesthesia. Please refer to A1005.

Based on review of a Neonatal and Pediatric Clinical Collaboration Agreement, Medical Staff Bylaws, facility documentation, physician credential files, and staff interviews, the Governing Body failed to ensure that all physicians who practiced at the facility, were appointed to the medical staff. Findings included:

1. A listing of 32 requested practitioner credential files was submitted to the Director of Process Improvement and Regulatory Compliance on 11/8/2010, at approximately 2:30 P.M., for review on 11/9/2010.

2. Review of credential files, confirmed by interview with the Director of Professional Staff Affairs (DPSA) at 1:00 P.M, on 11/9/2010, revealed that five (#20, #21, #22, #23, #24) of 32 credential files requested were not found. Continued interview with the DPSA revealed that the missing credential files were physicians who were consulting sub-specialists who were on staff at another hospital.

During the interview the DPSA said, "According to the Massachusetts Board of Registration in Medicine (BORM) Regulation (243 CMR 3.05), consulting sub-specialists could provide consultation for patients at the hospital for no more than 30 days in one calendar year. Those physicians were not required to be credentialed at the hospital until their visits exceeded 30 visits." The DPSA added, " I monitor the number of visits for each physician on a daily basis."

The DPSA also said, "These physicians are not credentialed at this hospital. They will be credentialed when they reach 31 visits in one year." The DPSA added that she maintained a file on each of the consulting physicians and provided the files to this Surveyor.

3. Review of the files for consulting specialists #20, #21, #22, #23, and #24, at approximately 8:30 A.M. on 11/10/2010, revealed that the files only contained evidence of licensure and malpractice insurance, and lacked approval from the Governing Body.

4. Review of a Neonatal and Pediatric Clinical Collaboration Agreement at 10:30 A.M. on 11/10/2010, revealed that the agreement read, "Pediatric medical surgical subspecialties who provide episodic care will be credentialed in accordance with Medical Staff Bylaws and agreed upon guidelines."

5. Review of Medical Staff Bylaws, at 3:00 P.M. on 11/8/2010, revealed that consulting physicians were required to be credentialed at the hospital.

A. Under the section of the Medical Staff Bylaws labeled "2.6.2 Prerogatives" the prerogatives included but were not limited to:

"Exercise such clinical privileges as are granted to him/her pursuant to the process as set forth in the Credentialing Procedures Manual."

Review of the files of the consulting physicians, maintained by the DPSA, at 8:30 A.M. on 11/10/2010, revealed that the files lacked clinical privileges, approved by the Governing Body, although required.

B. Under the section of the Medical Staff Bylaws labeled "2.6.3 Obligations" the responsibilities of consulting staff included, but was not limited to:

"Assume and carry out responsibility within his/her area of professional competence for the daily care and supervision of each patient in the Medical Center for whom he or she is providing services."

Review of the files of the consulting physicians, maintained by the DPSA at 8:30 A.M. on 11/10/2010, revealed that the files lacked evidence of evaluation of the consulting physicians' clinical competence.

6. Review of a listing of all consulting specialty physicians, provided to this Surveyor by the DPSA, on 11/9/2010, at 1:00 P.M., revealed a total of 77 physicians that provided consultation at the Hospital. The DPSA said, "None of these physicians were credentialed at the Hospital."

Please refer to A340.

2. For Patient #40, the medical staff failed to assess the patient's individualized use of an insulin pump to include but not limited to: basal rate, the time and frequency of insulin coverage and dose based on blood sugar used by the patient, inspection of insertion site, type of equipment in use, last change of insulin vial in pump, type of insulin in use and availability of family to bring in supplies from home.

Patient #40 was admitted on 11/3/2010, for a ERCP (endoscopic retrograde cholangiopancreatography). The patient had comorbidities that included insulin dependent diabetes managed with an insulin pump.

Admission orders written on 11/3/2010 at approximately 6:00 P.M. stated to call the house officer if the patient's glucose was less than 60 or greater than 350. There were no orders to monitor blood sugars. At 7:00 P.M., the physician wrote an order that the patient may use her own insulin pump.

On 11/4/2010, at 11:14 A.M., the physician ordered a sliding scale insulin coverage with Humalog insulin for the patient. The physician also ordered finger stick blood sugars four times a day.

On 11/4/2010 at 1:00 P.M. , the insulin orders were updated again to include an order that read "starting 11/4/2010 at 13:00 give 12 units of Glargine Insulin at Breakfast." the sliding scale of insulin coverage was changed and all doses were reduced as follows:
BS 120-159 give 1 unit Humalog breakfast lunch dinner and bedtime
BS 160-199 give 2 units Humalog breakfast lunch dinner and bedtime
BS 200-229 give 3 units Humalog breakfast lunch dinner and bedtime
BS 240-279 give 4 units Humalog breakfast lunch dinner and bedtime
BS 280-319 give 5 units Humalog breakfast lunch dinner and bedtime
BS 320 -359 give 6 units Humalog breakfast lunch dinner and bedtime
BS 360-400 give 7 units Humalog breakfast lunch dinner and bedtime
BS greater than 400 call MD.

Review of the blood glucose /Insulin administration and documentation flow sheet revealed the following; on 11/3/2010 at 11 P.M., the patient's blood sugar was 423. The patient covered herself using the insulin pump with 4.5 units of Novalog.

On 11/4/2010 at 3:30 A.M., the blood sugar was recorded at 295 and the patient covered herself again with 2.9 units of Novalog, using her pump. At 8:00 A.M., the blood sugar was 173 and the patient self administered 0.5 units of Novalog. At 12:00 noon, the staff documented administering Gargline insulin 12 units that was ordered to be administered at breakfast.

The patient's blood sugar was 291 and no coverage was documented as being administered by staff according to physician orders or by the patient as self administered. At 4:00 P.M. the blood sugar was 237, and it was documented the patient received 3 units of Humalog. At 11:00 P.M., the patient's blood sugar 74. On 11/5/2010 at 2:30 A.M., the patient's blood sugar was 82 and at 8:00 A.M., the patient's sugar was 153. Per the physician's order the patient received 10 units of Glargine insulin but no insulin coverage for the blood sugar of 153. According to the coverage orders, the patient should have received one unit of Humalog. At 9:50 A.M., the physician ordered the insulin pump to be discontinued.

The physician's insulin coverage orders were unclear if the patient was to cover herself using the calculations of the insulin pump or the prescribed sliding scale. Review of the medical progress notes failed to identify how the patient managed her blood sugars on the insulin pump.

Interview with the Nurse Manager on 11/10/2010 at approximately 10:00 A.M. confirmed that the order to give Glargine insulin 12 units "starting at 13:00 (1:00 P.M.) on 11/4/2010, at breakfast" was written in a confusing manner by the physician and should have been clarified with the physician. The NM also confirmed that the staff did not follow orders for insulin coverage as written by the physician as the patient used he own insulin pump to cover her blood sugars as the patient did at home. The NM manage stated the physician did write a vague order stating the patient may use her own insulin pump but also confirmed the physician wrote insulin coverage orders that superseded the insulin pump order, that were not followed.




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3. Review of the Neurosurgeon Fellow's credential file indicated that there was no documentation regarding specifics portions of surgery the Fellow could conduct independently from the Attending Neurosurgeon.
Review of Discharge Patient #1's medical records indicated Attending Neurosurgeon #1 was not present in the Operating Room during the entire surgery. Discharge Patient #1's surgery began at 11:07 AM. Documentation indicated the Attending Neurosurgeon #1 entered the OR at 12:55 PM, one hour and forty minutes after the surgery began.





15020

Based on record review, observation, and staff interviews, the Governing Body failed to ensure that the medical staff was accountable for the quality of care provided to two (#40, #52) diabetic patients out of 72 active patients and one surgical discharged patient (#1) of 27 discharged patients.

Findings included:

Per Governing Body Bylaws, the Governing Body , (GB), is responsible to ensure the medical staff is accountable to the GB in providing quality of care.

1. For Patient #52, the medical staff did not address the quality of care for this patient's insulin pump therapy. The facility placed this patient in a jeopardy situation as this patient was admitted on 10/30/10 on an insulin pump, did not receive proper management for insulin pump therapy, had high blood sugars during the patient's hospitalization and as a result ran out of insulin on 11/4/10.
On 11/4/10 at 8:45 A.M. Patient #52 revealed to the surveyor that there was no insulin in Patient #52's insulin pump.

Interview with the patient on 11/4/10 at 10:00 A.M. revealed that the patient came into the hospital wearing an insulin pump. Since admission, the patient stated that the infusion set to the pump was never changed nor were the basal rates adjusted. The patient did not have any supplies to change the infusion set. The patient stated that last night, (11/3/10), the patient's pump alarmed, revealing the reservoir was low. This was a warning to indicate the insulin was running out.

Review of clinical record revealed an initial physician's orders dated 10/30/10 at 2305 (11:05 P.M.), which stated "Insulin SC per Insulin Flow sheet sliding scale". The Insulin SC sliding scale flow sheet reflected orders for a patient receiving insulin therapy via injections with coverage using Regular insulin.

The physician insulin orders did not correlate with insulin pump therapy. The orders did not address the management of insulin pump therapy.

On 10/31/10 the patient went to the operating room for a left open reduction internal fixation (ORIF). (Patient #52 was wearing an insulin pump)

Blood sugars from 10/31/10 after surgery - 11/2/10 at midnight ranged from 120 - 432.

On 11/2/10 the patient went to the operating room for a second surgery and had a left below the knee amputation. (Patient #52 was wearing an insulin pump).

Blood sugars from after this surgery on 11/2/10 ranged from 310-428.

From admission on 10/30/10 until 11/3/10 at 11:48 A.M. staff were relying on inappropriate physician insulin orders to manage this patient's diabetes. The patient was expected to self-manage the use of the patient's insulin pump through 2 surgeries and without supplies. Due to the poor management of the patient's diabetes while hospitalized, an endocrinology consult was ordered on 11/3/10.

Interview with the Director of Patient Safety on 11/4/10 revealed that except for the obstetrics department, there is a system-wide problem with the management of patients admitted to this hospital on insulin pumps. Current hospital policies and procedures for insulin pump therapy addresses the maternal floor patients only. The staff, including the physicians on other units are not comfortable dealing with patients on insulin pumps.

There was no accountability to ensure the medical staff was trained in the management of insulin pump therapy.

Based on review of the Labor and Birth and Consent for Delivery Following A Previous Caesarean Section, Medical/Surgical Procedure and Anesthesia consent forms and patient interview, the Hospital failed to ensure that Patients were provided with adequate information to make informed decisions regarding their care. The Hospital failed to inform patients of their health status and actively involving patients in care planning and treatment, and being able to request or refuse treatment as evidenced by interviews with 4 of 4 non-sampled patients (NS A, NS B, NS C and NS D).

Findings included:

1) Review of the Consent For Obstetrical Care and general information provided to Maternity Patients titled: About your care during labor and birth indicated that, Point 2 on page one of four, "Other clinicians in-training (i.e. medical students, student midwives, nurses or physician assistants) may be involved in caring for you. Students are always supervised by your doctor, midwife or nurse." However, the information does not state, nor did clinical observations indicate clinicians in training were identified to patients. Additionally, the consent did not indicate that patients have the right to refuse care provided by clinicians in training.

2) Review of the consent titled: Consent for Delivery Following a Previous Cesarean Section indicated that "I am aware that under the supervision of my obstetrician/nurse midwife, other clinicians, including anesthesiologists, pediatricians, resident doctors, clinical students and staff may be involved in or observe my care." This consent also did not indicate that such clinicians in training would be identified to patients and the patient had the right to refuse care provided by clinicians in training. The consent did not indicate that patients had the right to refuse clinicians permission to observe care provided to them.

3) Interview with nonsampled Patient A [NS A] and the Father of the Infant [NS B] who were completing admission paperwork for a scheduled Cesarean Section on 11/4/10 indicated that they were not made aware of who was a clinician in training when introductions were made. NS A and Father of the Infant said they were not informed they had the right to know who was a student, it was not specified who was a clinician in training during introductions and at what year of education the clinician was and that they had the right to refuse care provided by any clinician in training. NS A and Father of the Infant said they wanted to be together when the epidural was administered to NS A. The Father of the Infant said he never had an opportunity to express his request. Observation of the procedure revealed the Father of the Infant was not present for the epidural anesthesia administration procedure.

4) Review of the Medical/Surgical Procedure consent form indicated that under the section titled: "Trainees and Non Physician Practitioners" - that the Medical Center is a teaching facility. This means that non health care trainees, such as resident physicians, students and non physician practitioners such as Nurse Practitioners and Physician Assistants may be involved in or observe my care. All individuals are supervised by staff physicians. However, the patient is not informed of the status of the student in training, persons observing or that the patient has the right to refuse care provided by a health care trainee. Interviews on 11/3/10 with Nonsampled Patient C and D (NS C and NS D), in the Pre-Operative holding area revealed that the Patients were not aware that students may be observing the surgery and/or that the Patient had the right to refuse care by health care trainees during anesthesia administration and the surgical procedure.

5) Review of the Consent for Administration of Anesthesia indicated that, under the section titled: The Anesthesia Care Team is headed by a staff anesthesiologist who may supervise nurse anesthetist and/or resident doctors. The patient understands that resident doctors, nurses and clinical students/staff may also participate in my care in the perioperative period (the period before, during and after my procedure).

Interviews on 11/3/10 with NS C and NS D in the Pre-Operative holding area revealed that the Patients were not aware that students may be observing the surgery and/or that the Patient had the right to refuse care by health care trainees during anesthesia administration and the surgical procedure.

Based on observations, staff interviews and record reviews, the Hospital failed to develop and implement a procedure to ensure confidentiality of patients' EEG (electro-encephalogram) Telemetry records. The findings are:

On the first day of survey (11/3/10), observations and staff interviews on the 11th floor of the Farr Building revealed the Hospital had video and recording equipment installed in patient rooms on that unit. Per the 12:00 P.M. interview with the Nurse Manager of the Farr 11 Unit, both audio and video recordings were taken of patients during EEG monitoring.

On 11/15/10 at 9:30 A.M. surveyors visited the EEG Laboratory and interviewed EEG Technician #1 (the Senior technician) and EEG Technician #2 (who was tasked with "archiving" the telemetry recordings.)

The technicians explained that each of the patient rooms, equipped for EEG Telemetry monitoring, had camera and audio recording equipment mounted on the wall. As well as a computer server mounted behind the camera. According to EEG Technician #2, the computer server located in the individual patient room was utilized to store recordings for "thirty days." At the completion of 30 days, EEG Technician #2 explained the recordings were transferred to a server in the EEG Laboratory and a computer back-up disc was created. EEG Technician #2 confirmed that multiple patients' recordings were collected on the in-room computer server over a 30 day period. EEG Technician #2 had no explanation regarding the reason for waiting 30 days to move the data from the in-room computer to the laboratory.

Within the EEG laboratory, the "archive" server was located in a electrical maintenance area. The discs were stored in a file cabinet placed in a storage room within the EEG Laboratory. Per EEG Technician #2, four or five separate patients' recordings were stored on each disc. Per observation on 11/15 at 9:30 A.M., the maintenance room and storage room doors were open, surveyor was able to freely open the drawers of the file cabinet where the discs were stored as it was not locked, and two patients were seated in the laboratory waiting area. EEG Technician #2 stated it was not their practice to secure the cabinet or the rooms.

Review of the policy provided by the EEG technicians titled: Archiving and Storage of EEG Study Policy dated October 1, 2010, read as follows:

1. The EEG Studies are archived one month after study is completed.
2. The EEG studies are reviewed and the video is pruned of non seizure events.
3. The EEG studies are then copied over to the Neuro 6 server, which is the archive station.
4. The EEGs are then copied to a DVD ROM and also to a terabyte server which is the final storage site.
5. The DVDs are stored in a fire proof storage cabinet.
6. PatStudy is modified to allow access by the staff to the archived studies.

The EEG Department Policy contained no provisions for securing the information on the server located within the patient rooms. The doors in the EEG Laboratory were open and not locked, the file was not locked and there was no provision in the policy for securing the data in the laboratory beyond storing DVD's in a "fire proof storage."

2. On 11/3/10 at approximately 11:48 A.M. during the initial tour, patient #30 was observed by the surveyor, lying in bed, eyes were closed and the patient was not moving, Intravenous (I.V.) lines were running. The patient was restrained with bilateral wrists restraints and 4 side rails up. The patient also had a 1:1 sitter. At this time, the Clinical Unit Manger #6, revealed the following: the patient has wrist restraints because the patient has been pulling out the IV lines, at times had shown involuntary movement, and will also try to exit the bed.

Review of the medical record documentation indicated Patient #30 was 71 year old and was living alone at home with services, was transferred to the emergency room and subsequently admitted with diagnosis of altered mental status and urinary tract infection. The "Hospitalist Admit" note dated 11/2/2010 at 1:00 A.M. does not document the use of restraints.

The "Medicine Night float Admit Note" dated 11/2/10 at 06:30 A.M. by the PGY2 (resident MD) under MS(mental status) change, states the following;"Most likely metabolic due to UTI (urinary tract infection) in the setting of Alzheimer's and baseline poor mental status. Differential also includes stroke, seizure. Patient was evaluated by Neurologist in ED (emergency department) who elected not to do an magnetic resonance imaging (MRI) at this time. Right hemiparesis seems old.
- treatment of UTI with Bactrim
- f/u Neuro recommends (recs), possible EEG in the am
- consider Zyprexa or ativan for agitation
- restraints with sitter".

The admission orders on 11/2/2010 for the use of the limb restraints at 6:22 AM, reviewed on 11/4/10 by the surveyor, included an order for limb restraints x 2, expires in 24 hours. The reason was for "non-violent behavior related to a medical or surgical condition that results in interference with medical healing." Diagnosis was listed as acute confusional state (delirium,/encephalopathy, intoxication, acute brain injury). The order included a statement that a comprehensive review of the patient's clinical condition was done and the restraints ordered were the least restrictive intervention required to prevent harm to the patient/others. Subsequent review of these orders on 11/8/10 revealed this order was renewed every 24 hours as above through 11/8/10.

Review of physician progress notes from admission 11/2/10 through 11/9/10 failed to identify the need for the 4 siderails and the orders failed to specify which limbs were to be restrained and what specific behavior the restraints were used for as per the hospital policy.

Review of the nursing notes from 11/2/10 through 11/9/10 revealed that the patient bilateral wrists were restrained as a result of pulling out intravenous line and catheters. They further document that the resident had periods of agitation and thrashing in bed and tried to climb out of bed.

Review of the Restraint/Seclusion Flowsheet dated 11/2/10 through 11/8/10, identified the patient as having Limb restraint and 4 siderails.

Review of the Patient Observer Log for the Day-Evening and Night shift for 11/2/10 through 11/8/10 revealed the patient as trying to get out of bed, pulling at restraint, restless in bed as well as being calm, sleeping.

Observation of the patient on 11/4/10 at approximately 8:00 A.M. revealed the patient lying in bed with 4 siderails up, wrist restraints on and a 1:1 sitter and a pillow located between the patient's lower left extremities and the Sideril.
Interview with the 1:1 sitter who is PCT#1, regarding the restraints and whether they are released, stated only the nurse releases the restraints and that is usually when they provide care.

Interview with Nurse #12 revealed that they remove the wrist restraints when they give care or do range of motion and the patient has the ability to bend her arms. Nurse #12 confirmed that patient pulled at all lines, tubings and the restraints. She further stated that the patient throws her legs over the siderail and she is afraid she might get hurt so she added the pillow between the patient and the siderail.

On 11/8/10 the patient was observed in bed with the wrist restraints on and with 4 siderails up and 1:1 sitter.

For patient #30, the hospital failed to provide physicians documentation per hospital policy which contained the specific behaviors which put the patient at risk and required the use of restraints.






09115

Based on observation, interview and documentation review, the hospital failed to ensure restraint use was used only when the less restrictive interventions had been determined to be ineffective to protect 2 patients (#30 and #44) out of 4 restrained patients in a total of 72 active patients. Findings include;

1. Patient #44 was admitted through the emergency room, to the intensive care unit (ICU) with respiratory failure requiring mechanical ventilation via a tracheostomy on 11/3/2010. The patient had comorbidities that included cerebral vascular accidents (CVAs), atrial fibrillation, heart disease and clostridium difficile (a bowel infection).

Admission orders on 11/3/2010 at 8:10 P.M., included an order for limb restraints x 2. The reason was for "non-violent behavior related to a medical or surgical condition that results in interference with medical healing." Diagnosis was listed as acute confusional state (delirium,/encephalopathy, intoxication, acute brain injury). The order included a statement that a comprehensive review of the patient's clinical condition was done and the restraints ordered were the least restrictive intervention required to prevent harm to the patient/others.

According to the facility policy for Use of Restraints , CP-28, components of physician documentation require each order to contain a specific behavior which put the patient at risk such as pulling at lines and tubes, extreme risk of assault or self harm or aggression. The restraint intervention must be included into the plan of care. Documentation must include an evaluation of the patient immediate situation, reaction to the intervention, medical and behavioral condition and need to continue or terminate the intervention.

Observation of the patient on 11/5/2010 at 10:00 A.M., revealed the patient was restrained with bilateral wrist restraints. The patient also had a private aide for several hours a day. The patient was alert and restless. The patient was observed to try to move her left arm but had no movement in her right arm. Although the patient had a tracheostomy and was on a ventilator, the patient tried to communicate to the nurse but appeared aphasic. Interview with the registered nurse (RN) caring for the patient (RN #) confirmed the patient did not spontaneously move her right arm and confirmed the patient did not receive any intravenous sedation. RN # also confirmed that the patient was restrained to prevent her from pulling out the lines, tracheostomy and ventilator equipment.

Review of the physician progress notes from admission and the nursing assessment, dated 11/3/2010, failed to identify the patient's inability to move her right arm and the need to restrain it. The orders failed to specify which limbs were to be restrained and what specific behavior the restraints were used for as per the hospital policy.

Based on review of physician credential files, Medical Staff Bylaws, and staff interviews, the medical staff failed to periodically conduct appraisals of consulting staff physicians. Findings included:

1. Review of credential files, confirmed by interview with the Director of Professional Staff Affairs (DPSA) at 1:00 P.M. on 11/9/2010, revealed that five (#20, #21, #22, #23, #24) of 32 credential files requested, lacked periodic appraisals of the physicians performance. Continued interview with the DPSA revealed that the above files were those of physicians who were consulting sub-specialists to the Hospital.

Continued interview with the DPSA revealed that the above physicians were not credentialed at the hospital.

2. Review of Medical Staff Bylaws at 3:00 P.M. on 11/8/2010, revealed that consulting physicians were required to be credentialed at the Hospital and that all credentialed physicians were required to have periodic appraisals.

A. Under the section labeled "2.6.3 Obligations" the responsibilities of consulting staff included, but was not limited to:

"Assume and carry out responsibility within his/her area of professional competence for the daily care and supervision of each patient in the Medical Center for whom s/he is providing services."

Review of the files of the consulting physicians, maintained by the DPSA at 8:30 A.M. on 11/10/2010, revealed that the files lacked evidence of evaluation of the consulting physicians' clinical competence.

3. Review of the files for consulting specialists #20, #21, #22, #23, and #24, at approximately 8:30 A.M. on 11/10/2010, revealed that the files only contained evidence of licensure and malpractice insurance, and lacked approval by the Medical Staff.

4. Review of a listing of all consulting specialty physicians, provided to this Surveyor by the DPSA on 11/9/2010, at 1:00 P.M., revealed a total of 77 physicians. The DPSA indicated that none of the physicians were credentialed at the hospital and therefore lacked periodic appraisals by the medical staff.

Please refer to A046.

2. For Patient #40, the medical and nursing staff failed to assess the patient's individualized use of an insulin pump to include but not limited to: basal rate, the time and frequency of insulin coverage and dose based on blood sugar used by the patient, inspection of insertion site, type of equipment in use, last change of insulin vial in pump, type of insulin in use and availability of family to bring in supplies from home.

Patient #40 was admitted on 11/3/2010, for a ERCP (endoscopic retrograde cholangiopancreatography). The patient had comorbidities that included insulin dependent diabetes managed with an insulin pump.

Admission orders written on 11/3/2010 at approximately 6:00 P.M. stated to call the house officer if the patient's glucose was less than 60 or greater than 350. There were no orders to monitor blood sugars. At 7:00 P.M., the physician wrote an order that the patient may use her own insulin pump.

On 11/4/2010, at 11:14 A.M., the physician ordered a sliding scale insulin coverage with Humalog insulin for the patient. The physician also ordered finger stick blood sugars four times a day.

On 11/4/2010 at 1:00 P.M. , the insulin orders were updated again to include an order that read "starting 11/4/2010 at 13:00 give 12 units of Gargline Insulin at Breakfast." the sliding scale of insulin coverage was changed and all doses were reduced as follows:
BS 120-159 give 1 unit Humalog breakfast lunch dinner and bedtime
BS 160-199 give 2 units Humalog breakfast lunch dinner and bedtime
BS 200-229 give 3 units Humalog breakfast lunch dinner and bedtime
BS 240-279 give 4 units Humalog breakfast lunch dinner and bedtime
BS 280-319 give 5 units Humalog breakfast lunch dinner and bedtime
BS 320 -359 give 6 units Humalog breakfast lunch dinner and bedtime
BS 360-400 give 7 units Humalog breakfast lunch dinner and bedtime
BS greater than 400 call MD.

Review of the blood glucose /Insulin administration and documentation flow sheet revealed the following; on 11/3/2010 at 11 P.M., the patient's blood sugar was 423. The patient covered herself using the insulin pump with 4.5 units of Novalog. Review of the clinical record revealed no evidence that the physician was notified of the high blood sugars as per the physician orders.

On 11/4/2010 at 3:30 A.M., the blood sugar was recorded at 295 and the patient covered herself again with 2.9 units of Novalog, using her pump. At 8:00 A.M., the blood sugar was 173 and the patient self administered 0.5 units of Novalog. At 12:00 noon, the staff documented administering Gargline insulin 12 units that was ordered to be administered at breakfast.

The patient's blood sugar was 291 and no coverage was documented as being administered by staff according to physician orders or by the patient as self administered. At 4:00 P.M. the blood sugar was 237, and it was documented the patient received 3 units of Humalog. At 11:00 P.M., the patient's blood sugar 74. On 11/5/2010 at 2:30 A.M., the patient's blood sugar was 82 and at 8:00 A.M., the patient's sugar was 153. Per the physician's order the patient received 10 units of Gargline insulin but no insulin coverage for the blood sugar of 153. According to the coverage orders, the patient should have received one unit of Humalog. At 9:50 A.M., the physician ordered the insulin pump to be discontinued.

The physician's insulin coverage orders were unclear if the patient was to cover herself using the calculations of the insulin pump or the prescribed sliding scale. Review of the medical progress notes failed to identify how the patient managed her blood sugars on the insulin pump.

Interview with the Nurse Manager on 11/10/2010 at approximately 10:00 A.M. confirmed that the order to give Gargline insulin 12 units "starting at 13:00 (1:00 P.M.)on 11/4/2010, at breakfast" was written in a confusing manner by the physician and should have been clarified with the physician.





15020

Based on record review, observation, and staff interviews, the Hospital failed to ensure that the medical staff was accountable to the governing body (GB) for the quality of care provided to two of two patients (#40 and #52) , in a total active sample of 72, who required insulin pump therapy.

Findings included:

Review of the Medical staff current bylaws, revealed that the medical staff is accountable to the GB in providing quality of care.

1. For Patient #52, the medical staff failed to assess the patient's individualized use of an insulin pump to include but not limited to: basal rate, bolus rates, coverage and dose based on blood sugar used by the patient, inspection of insertion site, type of equipment in use, last change of insulin vial in pump, type of insulin in use and availability of family to bring in supplies from home. In addition, the initial physician's orders did not address the use of an insulin pump

Review of patient #52's clinical record on 11/4/10 revealed the patient was admitted to this hospital via the emergency department on 10/30/10 from a fall at home with diagnoses that included Left Charcot, chronic non-healing ulcer, left fractured hip and insulin dependent diabetes.

Review of the emergency department admission record dated 10/30/10 lacked any indication patient #52 was receiving insulin pump therapy.

Observation on 11/4/10 at 8:45 A.M. revealed that Patient #52 who was on an insulin pump, was not receiving any insulin. The reservoir in the insulin pump was empty.

Interview with patient #52 on 11/4/10 at 10:00 A.M. revealed that the patient came into the hospital wearing the insulin pump infusing Humalog insulin (fast-acting insulin). Since admission, the patient stated that the infusion set to the pump was never changed nor were the basal rates adjusted. The patient did not have any supplies to change the infusion set. The patient stated that "last night, (11/3/10), my pump alarmed, revealing the reservoir was low, indicating the insulin was running out".

Review of the clinical record lacked physician's orders to reflect appropriate management of insulin pump therapy.

Per insulin pump manufacturer's recommendations for the pump Patient #52 was using, revealed that :
-the pump only uses rapid-acting insulin
-the pump delivers rapid-acting insulin similar to the way the human pancreas delivers insulin. It delivers both basal and bolus insulin in very precise amounts.
-Basal insulin rates cover a patient insulin needs between meals and through the night.
-Bolus insulin doses are given when you eat food that contains carbohydrates or when you have high blood glucose levels.

Initial physician's orders did not address the use of an insulin pump. There was a physician's order dated 10/30/10 at 2305 (11:05 P.M.), which stated "Insulin SC per Insulin Flow sheet sliding scale".
The Insulin SC sliding scale flow sheet reflected:
Give regular insulin subcutaneous (sc) per a sliding scale as follows:
At breakfast, lunch or dinner
For blood sugar of 151-200 mg/dL give 2 units of regular insulin.
For blood sugar of 201-250 mg/dL give 4 units of regular insulin.
For blood sugar of 251-300 mg/dL give 6 units of regular insulin.
For blood sugar of 301-350 mg/dL give 8 units of regular insulin.

The above insulin order reflected a sliding scale for a patient who used injection therapy with regular insulin (a short acting insulin) to cover meals.

On 10/31/10 the patient's blood sugar at midnight was 251 and the patient received 3 units of Lispro (rapid-acting insulin) via the insulin pump. (MD order was to receive 4 units of regular insulin sc)

Further record review revealed from 10/30/10 - 11/3/10 physician orders for insulin therapy did not address insulin pump therapy.

Interview with the Director of Patient Safety on 11/4/10 revealed to surveyor, that except for the obstetrics department, there is a system-wide problem with the management of patients admitted to this hospital on insulin pumps. For example, current hospital policies and procedures for insulin pump therapy addresses the maternal floor patients only. The staff, including the physicians on other units are not comfortable dealing with patients on insulin pumps.

The Condition for Nursing Services was not met.

Based on observation, record review and staff interview, the Nursing Staff on all hospital medical-surgical units with the exception of the obstetrics units failed to provide adequate care for the management of diabetics on insulin pump therapy, resulting in an immediate jeopardy. Policies and procedures reviewed were inadequate to direct the safe care of patients. This effects all patients admitted on insulin pump therapy. In addition, nursing care plans were not developed, implemented and kept current for fifteen active patients ( #1, #2, #12, #13, #25, #35, #36, #37, #39, #40, #44 #45, #46, #52 #55), out of a sample of 72 active patients reviewed. Findings include:

1. The hospital failed to ensure that the nursing care was provided in a safe manner. As a result, for patient #52, the facility placed the patient's health and safety in immediate jeopardy as this patient was admitted on 10/30/10 on an insulin pump which ran out of insulin on 11/4/10 while hospitalized.

Staff lacked competency in the management of insulin pumps and failed to provide care consistent with the standards of practice for diabetic management of patients using insulin pumps. There was no system in place to manage insulin pump therapy from the time patient #52 was admitted through the emergency services through discharge.

Per Clinical Diabetes, volume 25, number 2, 2007, an insulin pump is a small, external medical device that delivers rapid- or short-acting insulin 24 hours a day. With most systems, the pump is attached to a thin plastic tube that has a soft cannula (plastic needle) that is inserted under the skin, usually on the abdomen; however, some patients insert the device into their legs, arms, or lower back. The infusion set (cannula and tubing) must be changed every 2-3 days according to each manufacturer's instructions.

Insulin pumps allow users to deliver a preprogrammed basal insulin dose continuously throughout 24 hours to maintain blood glucose control between meals and overnight. Bolus doses are also given by the user before meals based on blood glucose levels, food intake (specifically the amount of carbohydrate consumed), and physical activity. A supplemental or "correction" bolus of insulin is given to treat high glucose levels.

Patients have a variety of pumps to choose from, each offering unique features. Most insulin pumps allow users to program many different basal rates to allow for variations in life tyles and to accommodate varying insulin needs throughout the 24-hour period...regardless of the pump used, it is still up to the user to "tell" the pump what to do.

The hospital lacked policies and procedures to direct safe patient care to include:
-assessing patients coming into the hospital on an insulin pump for appropriate self management and reassess through-out hospital stay when changes of cognition occur (such as general anesthesia)
-appropriate insulin orders for insulin pump therapy (type of insulin, bolus and basal rates)
-appropriate orders to manage insulin pumps (supplies, when to change infusion set, assessing infusion site to prevent infection)
-monitoring the efficacy of the insulin pump therapy
-nutritional factors.

The Hospital was notified of immediate jeopardy on 11/03/2010 at 9:00 A.M. After submission and implemention of an acceptable plan of correction, immediate jeopardy was lifted, effective 11/10/2010 at 4:00 P.M.

2. For fifteen active patients ( #1, #2, #12, #13, #25, #35, #36, #37, #39, #40, #44 #45, #46, #52 #55) care plans were not developed, implemented and kept current.

Please see A395, A396 and A397

2. For Patient #40, the nursing staff failed to assess the patient's individualized use of an insulin pump to include but not limited to: basal rate, frequency of insulin coverage and dose based on blood sugar, inspection of insertion site, type of equipment in use, last change of insulin vial in pump, type of insulin in use and availability of family to bring in supplies from home.

Patient #40 was admitted on 11/3/2010, for a ERCP (endoscopic retrograde cholangiopancreatography). The patient had comorbidities that included insulin dependent diabetes managed with an insulin pump.

Admission orders written on 11/3/2010 at approximately 6:00 P.M. stated to call the house officer if the patient's glucose was less than 60 or greater than 350. There were no orders to monitor blood sugars. At 7:00 P.M., the physician wrote an order that the patient may use her own insulin pump.

Review of the initial nursing assessment, dated 11/3/2010 at 7:30 P.M., noted that the patient was a diabetic, had an insulin pump and checked blood sugars. No other information was obtained about the basal rate settings, when patient monitored her blood sugars were done, insulin coverage, skin assessment at the needle insertion site, last time insertion site changed, last time insulin vial was changed in pump or availability of supplies.

On 11/4/2010, at 11:14 A.M., the physician ordered a sliding scale insulin coverage with Humalog insulin for the patient. The physician also ordered finger stick blood sugars (BS) four times a day.

Please refer to A0396.

3. For Patient #44, the nursing staff failed to assess the patient's skin for bruising on a ongoing basis and failed to assess the the patient's mobility status as related to the need for bilateral wrist restraints.

Record review revealed that on admission on 11/3/2010 at approximately 8:00 P.M., the nursing admission note revealed the patient had a stage II pressure sore on the sacrum. the nursing assessment failed to include the pressure sore in the skin assessment section. The skin assessment section also noted no presence of bruises. The nursing assessment noted the patient had a history of past cerebral vascular accidents (CVA) but did not assess any functional limitations such as hemiparesis or communication deficits related to the CVA.

Observation of the patient on 11/5/2010 at 10:00 A.M., revealed the patient was restrained with bilateral wrist restraints. The patient was alert and restless. The patient was observed to try to move her left arm but had no movement in her right arm. Although the patient had a tracheostomy and was on a ventilator, the patient tried to communicate to the nurse but appeared aphasic. The patient was observed to have large bruises encompassing each forearm above the elbows. No blood pressure cuff was observed in use. Both arms and hands were edematous.

Review of nursing progress notes from 11/3/10 through 11/5/2010 revealed no mention of the arm bruises. On 11/4/2010 at approximately 1:00 P.M., the patient had an arterial line inserted for blood pressure monitoring and blood draws.

Interview with the registered nurse (RN) caring for the patient RN #20 confirmed the patient could not spontaneously move her right arm. RN #20 also confirmed that the patient was restrained to prevent her from pulling out the intravenous lines, tracheostomy and ventilator equipment. RN #20 stated she thought the bruises could have been caused by the blood pressure cuff.

4. For Patient #45, the nursing staff failed to assess the patient's current home medications upon admission to the emergency room or during the nursing comprehensive assessment done after admission.

Patient #45 was admitted via the emergency room with abdominal pain and pneumonia.

Record review revealed no review of home or current medications in the emergency room records and no review of current medications on the nursing assessment, as required. The emergency room physician wrote in the history and physical for current medications to " see the nursing notes."

Interview with the Stoneman 7 Nurse Manager (NM), on 11/8/2010, at approximately 10:00 A.M., confirmed that the patient's medication list should be obtained in the emergency room and if not, it should be done by the nursing assessment during admission to the unit. The NM confirmed there was no assessment of the patient's current home medication profile in the clinical record.







15020

Based on observation, record review and staff interview, the hospital failed to ensure a registered nurse supervised and evaluate the nursing care provided met the needs for 4 (#40, #44, #45, #52) out of 72 active patients. Findings include:

1. For patient #52, the facility placed this patient in immeidate jeopardy as this patient was admitted on 10/30/10 on an insulin pump, did not receive proper management for insulin pump therapy, did not follow a physician's order and as a result ran out of insulin on 11/4/10 and had high blood sugars. In addition, the initial physician's orders did not address the use of an insulin pump
This patient was using Humalog, a faster-acting insulin via an insulin pump. An interruption in insulin delivery may result in hyperglycemia (high blood glucose) within two-to-four hours and, subsequently, the rapid onset of diabetic ketoacidosis (DKA) within four-to-10 hours. The onset of stress or illness (caused by infection or an emotional event) can also result in a rise of blood glucose levels and the development of DKA).

A. During the initial tour in the hospital, on 11/3/10 at 1:30 P.M., NM #12, revealed that Patient #52 had been hospitalized for 4 days and had 2 surgeries since admission. NM #12 indicated there was a concern regarding the patient's insulin pump.

On 11/4/10 at 8:45 A.M. Patient #52 revealed to the surveyor that there was no insulin in Patient #52's insulin pump, (with the insulin pump being empty, the patient was not receiving a continuous infusion of insulin, which would result in the patient going into DKA). At that time, surveyor asked if the patient reported this to the staff and the patient replied, "I told a staff person, earlier that I needed insulin."

Upon this discovery, the surveyor reported this to Registered Nurse, (RN) #13. Observation at that time confirmed that the patient's pump was dry and had no insulin. RN#13 was unable to determine how long the patient was out of insulin. RN #13 left the room to notify the physician.

Interview with Patient Care Technician, (PCT) #2 at 9:15 A.M. on 11/4/10 confirmed that Patient #52 stated "I need insulin." The patient reported this to PCT #2 around 8:00 A.M. when the PCT was checking the patient's blood sugar. The blood sugar at that time was 227. The PCT was not aware the patient was on an insulin pump.

Review of the clinical record revealed a physician's order dated 11/3/10 at 11:48 A.M. for the patient to use an insulin pump and adjust for BS (blood sugars). On 11/3/10 at 1530 (3:30 P.M.), there was another physician's order to assist patient with changing insulin pump "tonight" when supplies are here.

Further interview with the patient on 11/4/10 at 10:00 A.M. revealed that the patient came into the hospital wearing the insulin pump. Since admission, the patient stated that the infusion set to the pump was never changed nor were the basal rates adjusted. The patient did not have any supplies to change the infusion set. The patient stated that last night (11/3/10) my pump alarmed, revealing the reservoir was low, indicating the insulin was running out.

Further interview with RN #13 on 11/4/10 at 11:00 A.M. revealed that currently the hospital only had policies and procedures to handle patients with insulin pumps on the maternity units. RN #13 stated that "the plan on 11/3/10 was to have the family bring in supplies and knew without supplies and/or a back-up plan, the patient would run out of insulin. The hospital did not stock insulin pump supplies. It's the responsibility of the patient to bring in their own insulin pump supplies. When the doctor's order to change the pump on 11/3/10 did not get followed, the nurse on duty should have notified the physician to obtain further orders to manage the patient's insulin requirements". This did not occur. As a result, the patient was not receiving insulin which is needed to sustain life for a Type 1 diabetic.

Once the doctor was notified, the insulin pump was removed and an alternative method to administer insulin was ordered.

B. Review of Patient #52's clinical record on 11/4/10 revealed the patient was admitted to this hospital via the emergency unit on 10/30/10 from a fall at home with diagnoses that included Left Charcot foot, chronic non-healing ulcer, left fractured hip and insulin dependent diabetes.

Review of the emergency department admission record dated 10/30/10 lacked any indication patient #52 was receiving insulin pump therapy.

Initial physician's orders did not address the use of an insulin pump. There was a physician's order dated 10/30/10 at 2305 (11:05 P.M.), which stated "Insulin SC per Insulin Flow sheet sliding scale."
The Insulin SC sliding scale flow sheet reflected:
Give regular insulin subcutaneous (sc) per a sliding scale as follows:
At breakfast, lunch or dinner
For blood sugar of 151-200 mg/dL give 2 units of regular insulin.
For blood sugar of 201-250 mg/dL give 4 units of regular insulin.
For blood sugar of 251-300 mg/dL give 6 units of regular insulin.
For blood sugar of 301-350 mg/dL give 8 units of regular insulin.

On 10/31/10, the patient's blood sugar at midnight was 251 and the patient received 3 units of Humalog insulin via the insulin pump. (MD order was to receive 4 units of regular insulin sc).

A Nursing Initial Patient Assessment dated 10/31/10 2:10 A.M. for Diabetes Assessment reflected this patient is a Type I diabetic, has an insulin pump, patient regulates self, not according to DOCTOR order. Interview on 11/8/10 at 8:00 A.M. with RN #19 (who did the nursing assessment) revealed that this patient was on an insulin pump and regulated the doses by self. The patient was using Humalog insulin in the pump. RN #19 continued to reveal that the physician insulin orders did not correlate with insulin pump therapy.

On 10/31/10, the patient went to the operating room for a left open reduction internal fixation (ORIF) (Patient #52 was wearing an insulin pump).

Blood sugars from 10/31/10 after surgery - 11/2/10 at midnight ranged from 120 - 432.

On 11/2/10, the patient went to the operating room for a second surgery and had a left below the knee amputation. (Patient #52 was wearing an insulin pump).

Blood sugars from after this surgery on 11/2/10 ranged from 310-428.

From admission on 10/30/10 until 11/3/10 at 11:48 A.M., staff were relying on inappropriate physician insulin orders to manage this patient's diabetes. The patient was expected to self-manage the use of the patient's insulin pump through 2 surgeries and without supplies. Due to the poor management of the patient's diabetes while hospitalized, an endocrinology consult was ordered on 11/3/10.

On 11/3/10, the patient was seen by endocrinologist #1. Progress note dated 11/3/10 reflected that the physician reviewed settings and pump use with the patient. The note continue to state, "needs site change tonight".

Interview with endocrinologist #1 on 11/4/10 at 11:50 A.M. revealed that endocrinologist #1 was called into consult last night. Endocrinologist #1 did not know this patient but when patient was seen last night, was aware the reservoir was low on insulin and needed to be changed. When the family did not bring in supplies, the staff should have called for further orders. The goal would be, for a patient who is admitted on an insulin pump, to continue with pump therapy as long as the patient was cognitively able to manage, supplies are available to change the infusion set every 72 hours and staff work with the patient to ensure the patient is able to manage. This did not occur.

On 11/3/2010 at approximately 9:00 A.M., the Hospital was notified that an immediate threat to the health and safety of patients who were admitted with insulin pumps.

On 11/10/2010, at 4:00 P.M., the Hospital submitted and had implemented an acceptable plan of correction and the immediate jeopardy was lifted.

2. For Patient #40, admitted on 11/3/2010, the nursing staff failed to administer insulin coverage in accordance with physician orders, failed to administer Glargine insulin at the ordered time, failed to have orders for monitoring of blood sugars during the first twelve hours of admission and failed to notify the physician when blood sugars were high in accordance with physician orders.

Patient #40 was admitted for a ERCP (endoscopic retrograde cholangiopancreatography). The patient had comorbidities that included insulin dependent diabetes managed with an insulin pump.

Admission orders written on 11/3/2010 at approximately 6:00 P.M. stated to call the house officer if the patient's glucose was less than 60 or greater than 350. There were no orders to monitor blood sugars. At 7:00 P.M., the physician wrote an order that the patient may use her own insulin pump.

On 11/4/2010, at 11:14 A.M., the physician ordered a sliding scale insulin coverage with Humalog insulin for the patient. The physician also ordered finger stick blood sugars four times a day.

On 11/4/2010 at 1:00 P.M. , the insulin orders were updated again to include an order that read "starting 11/4/2010 at 13:00 give 12 units of Glargine Insulin at Breakfast." the sliding scale of insulin coverage was changed and all doses were reduced as follows:
BS 120-159 give 1 unit Humalog breakfast lunch dinner and bedtime
BS 160-199 give 2 units Humalog breakfast lunch dinner and bedtime
BS 200-229 give 3 units Humalog breakfast lunch dinner and bedtime
BS 240-279 give 4 units Humalog breakfast lunch dinner and bedtime
BS 280-319 give 5 units Humalog breakfast lunch dinner and bedtime
BS 320 -359 give 6 units Humalog breakfast lunch dinner and bedtime
BS 360-400 give 7 units Humalog breakfast lunch dinner and bedtime
BS greater than 400 call MD.

Review of the blood glucose /Insulin administration and documentation flow sheet revealed the following; on 11/3/2010 at 11 P.M., the patient's blood sugar was 423. The patient covered herself using the insulin pump with 4.5 units of Novalog. Review of the clinical record revealed no evidence that the physician was notified of the high blood sugars as per the physician orders.

On 11/4/2010 at 3:30 A.M., the blood sugar was recorded at 295 and the patient covered herself again with 2.9 units of Novalog, using her pump. At 8:00 A.M., the blood sugar was 173 and the patient self administered 0.5 units of Novalog. At 12:00 noon, the staff documented administering Glargine insulin 12 units that was ordered to be administered at breakfast. The patient's blood sugar was 291 and no coverage was documented as being administered by staff according to physician orders or by the patient as self administered. At 4:00 P.M. the blood sugar was 237, and it was documented the patient received 3 units of Humalog. At 11:00 P.M., the patient's blood sugar 74. On 11/5/2010 at 2:30 A.M., the patient's blood sugar was 82 and at 8:00 A.M., the patient 's sugar was 153. Per the physician's order the patient received 10 units of Glargine insulin but no insulin coverage. According to the coverage orders, the patient should have received one unit of Humalog. At 9:50 A.M., the physician ordered the insulin pump to be discontinued.

At 1:20 P.M., on 11/5/2010, the flow sheet indicated the blood sugar was 225 and the patient received 1.5 units of Humalog which could only be delivered via the the insulin pump. Record review revealed the patient was kept NPO (nothing by mouth) since early in the morning on 11/5/2010 and had the ERCP in the late afternoon. The blood sugar at bedtime was 99.

On 11/6/2010 at 7:30 A.M., the patient received 1 unit of Humalog and 11 units of Glargine insulin for a blood sugar of 132. At 11:15 A.M., the patient's blood sugar was 46, requiring 12.5 grams of dextrose intravenously to increase the blood sugar to 170. At 4:00 P.M., the patient's blood sugar was 222 and the patient received Humalog insulin coverage of 3 units.

Interview with Nurse Manager (NM) #2, on 11/15/2010 at approximately 10:00 A.M. confirmed the coverage dose had to be given by insulin pump as it was not possible to draw up 1.5 units into a standard insulin syringe. The NM stated the pump was discontinued after 1:00 P.M. The NM also confirmed that the insulin coverage doses, as outlined above, were not consistent with physician orders.

On 11/7/2010, the patient's 8:00 A.M., blood sugar was 82 and the patient received 11 units of Gargline insulin. The patient was discharged home at at approximately 11:00 A.M. with directions to "resume the insulin pump when you return home and keep the follow up appointment with the diabetic management team that was already scheduled."

3. For Patient #55, the facility failed to ensure that the nursing care plan was implemented and consistent with the attending physician's order for a 1 liter fluid restriction, per day.

Patient #55 was admitted to the facility on 10/15/10 with diagnoses including SIADH (Syndrome of Inappropriate Antidiuretic Hormone), hyponatremia and depression.

Review of the physician orders revealed that on 10/15/10 the patient was ordered to receive a fluid restriction of 1 liter per day (no fluids on tray). On 10/18/10 the diet order was changed to regular, vegetarian, fluid restriction: 1 liter per day.

Interview with Registered Nurse (RN) #7 at 11:00 A.M. on 11/4/10, revealed the nurses do not keep track of the input and output (I&O's) for patients on that floor because the staff concentrate more on the patient's mental state and behaviors. The nurse stated the Hospital was unaware of the patient's fluid intake and did not know if the 1 liter fluid restriction was being maintained. RN #7 went on to say the patient had been on the diet for a while and was able to keep track of the fluid intake independently.

Interview with Patient #55 at 11:05 A.M. on 11/4/10 revealed that the patient does not keep track of the patient's fluid intake. The patient stated that sometimes the patient drinks low sodium V8 juice. Additionally, the patient stated "I should drink more water."

Interview on 11/4/10 at 11:15 A.M. with RN #8, revealed that Nurse Manager #1 felt that during rounds the fluid restriction had been discontinued, but that the order to discontinue had not been written.

4. For Patient #44, the staff failed to develop a care plan for areas identified in the nursing assessment and failed to obtain orders for treatment of a Stage II pressure sore.

Patient #44 was admitted through the emergency room, to the intensive care unit (ICU) with respiratory failure requiring chronic mechanical ventilation via a tracheostomy, on 11/3/2010, at approximately 10:00 P.M. The patient was transferred from another medical acute care unit of an outside hospital. The patient had comorbidities that included cerebral vascular accidents (CVAs), atrial fibrillation, heart disease, sepsis and Clostridium Difficile [(c-diff) a bowel infection].

According to the nursing admission note, dated 11/4/2010, the patient had a Stage II pressure ulcer of the sacrum with red surrounding tissue. The nursing assessment identified issues related to infection due to c.diff colitis, and methicillin resistant staphylococcus aureus (MRSA) bacteremia and pneumonia, history of cerebral vascular accident with communication problems, cognitive impairment, presence of gastrostomy tube for feeding and Foley catheter with history of recent urinary tract infections and agitation at times. The assessment also identified that the patient's two next of kin (adult children- one identified as the health care proxy) lived out of state.

Observation of the patient on 11/5/2010 at 10:00 A.M., revealed the patient was restrained with bilateral wrist restraints. The patient also had a private aide for several hours a day. The patient was alert and restless. The patient was observed to try to move her left arm but had no movement in her right arm. Although the patient had a tracheostomy and was on a ventilator, the patient tried to communicate to the nurse but appeared aphasic (unable to speak). Interview with the registered nurse (RN) caring for the patient (RN #20), on 11/5/2010 at approximately 10:15 A.M., confirmed the patient did not spontaneously move her right arm and confirmed the patient did not receive any intravenous sedation.

Review of the nursing care plan dated 11/3/2010, at 11:30 P.M., revealed only two problems were identified. One was for altered respiratory function with impaired gas exchange. Interventions listed include sedation as indicated, consider rotational therapy-, consider speciality beds and postioning, suction as needed.

The second care plan was for knowledge deficit with interventions that included assessing documenting patient/family learning needs and identifying whom teaching is to be directed, assess and document learning and teaching style of family/patient, encourage questions, define learning needs and provide information to patient/family in a way they can understand.

Review of the clinical record revealed no physician orders for the care of the pressure sore. Nursing notes indicated staff began treating the area on the 11-7 P.M. on 11/4/2010 with a normal saline wash and a Mediplex dressing. On 11/5/2010, DuoDerm gel was added to the wound under the Mediplex dressing. Interview with the Nurse Manager of the ICU on 11/5/2010 at approximately 12:00 P.M., confirmed there were no orders for the treatment of the pressure sore.

Further review of nursing progress notes revealed there were no nursing care plans to address the areas of infections related to Foley catheter use, history of UTI, pneumonia, MRSA sepsis or break in skin integrity. There were physician orders for the patient to be on contact and c.diff precautions. Interview with the Infection Control (IC) Nurse Educator, on 11/5/2010 at approximately 11:00 A.M., revealed that the care plans for infection control were done through "hospital protocols" such as orders for precautions. The Educator could not specify how this met the patient's individualized needs.

Review of the nursing care plan and nursing progress notes revealed no plans to address the areas of cognitive loss, communication deficit, agitation or restraints. Interview with RN #20, on 11/5/2010 at approximately 10:15 A.M., confirmed that restraints were documented per protocol on the restraint flow sheet with items such as release every two hours, with range of motion and repositioning. Review of nursing and physician progress notes and restraint flow sheets did not indicate patient response to the restraints.

5. For Patient #45, the nursing staff failed to develop a care plan for the following areas identified in the nursing assessment: patient with Crohn's disease having 6-8 diarrhea stools a day (placed the patient at risk for skin breakdown and fluid imbalance); patient has sleep apnea with decreased lung sounds at the lung bases, was also a smoker (nonsmoking hospital, scheduled for major surgery); the patient had pain; and bilateral lower leg edema.

Patient #45 was admitted 10/28/2010, with a diagnosis of colosplenic fistula and was scheduled for an exploratory laparotomy, subtotal colectomy, possible splenectomy, and possible diverting ileostomy on 11/2/2010.

Review of the nursing care plan dated 10/28/2010, at 11:30 A.M., only identified three areas for care planning: discharge planning; knowledge deficit; and pain. Although there was a physician order to administer a Nicotine patch daily, for the patient's smoking habit, there was no nursing care plan to address the patient's nicotine withdrawal, no nursing care plans to address the patient's potential risks for skin breakdown, fluid imbalance, sleep apnea, risk of infection due to smoking, edema or diarrhea.

Record review revealed that post operatively the patient had a short stay in the ICU for 24 hours. On 11/4/2010, the patient transferred back to the medical-surgical floor. Record review revealed the nicotine patch was not restarted after surgery.

Interview with the patient on 11/9/2010 at approximately 10:00 A.M., confirmed the patient wanted the Nicotine patch restarted as he did not want to return home and begin smoking again after such a big surgery. The patient confirmed no one had offered to restart the patch since the surgery and he found the withdrawal difficult.

6. For Patients #1, #2, #13, #25, #40, #44, and #45, the nursing care plans were all standardized plans and lacked individual approaches for each patient in the areas of pain, knowledge deficit, and/or discharge planning.

The outcomes and the interventions for each patient were identical in each record. The nursing care plans could easily be interchanged from one record to another. For example:

For "pain" the outcomes in each record all read as follows:

Pain Control; Prevention of harmful effects of unrelieved pain, and Pain relief to a level of comfort acceptable to the patient.

Interventions in each record were identical and included items such as:

Eliminate source of discomfort if possible; Instruct patient to report all episodes of pain; Monitor patient's response to pain treatment; Reassess before and after every intervention; Pain the 5th vital sign and assess every eight hours.

The outcomes and interventions for discharge planning and knowledge deficit were identical in each record as well. For example:

a. Patient #25 was admitted to the hospital with diagnoses including a history of perforated colon, fractured hip and diabetes insipidus. The patient had elective surgery for repair of a giant hernia with mesh implant.

Review of the patient's record and care plan on 11-8-2010, revealed that Patient #25 was a longtime resident of a facility serving people with developmental disabilities. The Hospital failed to develop and implement a care plan with goals and interventions that addressed the patient's unique learning needs.




15020

Based on observation, record review, facility documentation and staff interview, the hospital failed to ensure that nursing care plans were developed, implemented and kept current for fifteen active patients (#1, #2,
#12, #13, #25, #35, #36, #37, #39, #40, #44 #45, #46, #52 #55), out of a sample of 72 active patients reviewed. The findings include:

1. For patient #52, the facility placed this patient in immediate jeopardy by failing to provide adeqaute care and proper management for insulin pump therapy, failing to follow a physician's orders and as a result ran out of insulin on 11/4/10. As a result the patient had high blood sugars. In addition, the hospital failed to develop a nursing care plan to address the use, monitoring and care of an insulin pump.

Review of patient #52's clinical record on 11/4/10 revealed the patient was admitted to this hospital via the emergency unit on 10/30/10 from a fall at home with diagnoses that included insulin dependent diabetes.

Initial physician's orders did not address the use of an insulin pump. There was a physician's order dated 10/30/10 at 2305 (11:05 P.M.), which stated "Insulin SC per Insulin Flow sheet sliding scale."
The Insulin SC sliding scale flow sheet reflected:
Give regular insulin subcutaneous (sc) per a sliding scale as follows:
At breakfast, lunch or dinner
For blood sugar of 151-200 mg/dL give 2 units of regular insulin.
For blood sugar of 201-250 mg/dL give 4 units of regular insulin.
For blood sugar of 251-300 mg/dL give 6 units of regular insulin.
For blood sugar of 301-350 mg/dL give 8 units of regular insulin.

A Nursing Initial Patient Assessment dated 10/31/10, 2:10 A.M. for Diabetes Assessment reflected this patient was a Type I diabetic, had an insulin pump, patient regulated self, not according to DOCTOR order.

There was no care plan developed to manage this patient's diabetes and insulin pump therapy.

Interview on 11/8/10 at 8:00 A.M. with RN #19 (who did the nursing assessment) revealed that this patient was on an insulin pump and regulated the doses by self. The patient was using Humalog insulin in the pump (not regular insulin as ordered by the physician). RN #19 continued to reveal that the current physician insulin orders did not correlate with insulin pump therapy.

On 10/31/10, the patient went to the operating room for a left open reduction internal fixation (ORIF). (Patient #52 was wearing an insulin pump).

Blood sugars from 10/31/10 after surgery - 11/2/10 at midnight ranged from 120 - 432.

On 11/2/10 the patient went to the operating room for a second surgery and had a left below the knee amputation. (Patient #52 was wearing an insulin pump).

Blood sugars from after this surgery on 11/2/10 ranged from 310-428.

From admission on 10/30/10 until 11/3/10 at 11:48 A.M., staff were relying on inappropriate physician insulin orders to manage this patient's diabetes. The patient was expected to self-manage the use of the patient's insulin pump through 2 surgeries and without supplies. Due to the poor management of the patient's diabetes while hospitalized, an endocrinology consult was ordered on 11/3/10.

On 11/3/10 the patient was seen by Endocrinologist #1. Progress note dated 11/3/10 reflected that the physician reviewed settings and pump use with the patient. The note continue to state, "needs site change tonight."

The pump did not get changed as ordered. On 11/4/10 at 8:45 A.M., Patient #52 revealed to the surveyor that there was no insulin in the insulin pump. With the insulin pump being empty, the patient was not receiving a continuous infusion of insulin, which would result in the patient going into diabetic ketoacidosis (DKA). At that time, surveyor asked if the patient reported this to the staff and the patient replied, "I told a staff person, earlier that I needed insulin."

Upon this discovery, the surveyor reported this to Registered Nurse, RN #13. Observation at that point confirmed that the patient's pump was dry and had no insulin. RN#13 was unable to determine how long the patient was out of insulin. RN#13 left the room to notify the physician. The insulin pump was discontinued and new insulin orders were obtained.

Throughout this patient's hospitalization, a nursing care plan to address diabetes management for this patient was never developed.


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7. For Patient #12, medical record review at 8:30 A.M. on 11/15/2010, revealed that the patient had neck surgery performed on 10/5/2010. Review of a problem list included, but was not limited, to the following issues: history of falls; unsteady gait; double vision; needs a cane to walk; diabetes.

Continued review of the medical record revealed that the patient lacked care plans for prevention of infection of the surgical incision and monitoring the patient for high and/or low blood sugars.

The medical record contained a standardized care plan for "Risk to Fall/Injury Prevention" that listed the following categories: Patient/family education; Medication review; Cognition; Tethers/environmental hazards; mobility; Bowel/bladder; Syncope/seizure. However, the patient lacked a plan for injury/falls prevention as none of the categories or interventions under each category, were identified as a plan for the patient.

8. For Patient #35, medical record review at 2:35 P.M. on 11/3/2010, revealed that the patient had cesarean section (C-section) on 11/2/2010. The medical record lacked a care plan to prevent of infection of the surgical incision.

Interview with NM #4 at approximately 10:30 A.M., on 11/4/2010, revealed that Hospital policy required all patients who had surgery to have a care plan for prevention of infection of the surgical incision.

9. For Patient #36, medical record review at 10:45 A.M. on 11/4/2010, revealed that the patient had a cesarean section (C-section) on 10/31/2010. A nursing note read, "Nursing Diagnosis: Risk for infection related to cesarean birth." The medical record lacked a care plan to prevent infection of the surgical incision, although required by Hospital policy.

10. For Patient #37, medical record review at 9:15 A.M. on 11/4/2010, revealed that the patient (a first time parent) was very anxious and had a post delivery hemorrhage and a temperature of 100 degrees Fahrenheit (normal 98.6) by mouth. The medical record lacked a care plan with goals and interventions to address the post delivery hemorrhage.

A nurse's note identified the patient's anxiety as a barrier to learning. A standardized care plan for "Knowledge Deficit/Learning Facilitation was in the medial record. However, no interventions were identified on the care plan.

11. For Patient #39, medical record review at 2:30 P.M. on 11/4/2010, revealed that the patient had surgical procedure on 10/31/2010. The medical record lacked a care plan with goals and interventions for prevention of infection of the surgical incision, although required.

12. For Patient #46, medical record review at 10:20 A.M. on 11/8/2010, revealed the following identified patient issues: Respiratory distress syndrome; Nutrition Management; Anemia of Prematurity; Neurodevelopmental Support; and Parent Support.

Documentation concerning the above issues was in the form of Nursing Progress Notes. For example:

A. Under the heading 'Respiratory Distress Syndrome'
"Infant is currently on low flow nasal canula. Lung sounds are clear and equal. No spells so far this shift. Infant is on Lasix (a diuretic) every Monday. Wednesday, Friday.
Plan: "Continue to monitor infant's respiratory status."

B. Under the heading 'Neurodevelopmental Support'
"Infant is swaddled in an open crib. Temperature is stable. Infant is alert and active with cares and sleeps well in between care times."
Plan: "Continue to support developmental needs."

The medical record lacked care plans with goals and interventions to address the above identified issues, although required.

Based on observation, record review and staff interview, the facility failed to assign nursing personnel who were competent to provide nursing care to 2 diabetic patients on insulin pumps, (#40 and #52) out of 2 applicable patients, in a total active sample of 72.

Findings include:

1. For patient #52, the facility placed this patient in a jeopardy situation as this patient was admitted on 10/30/10 on an insulin pump which ran out of insulin while hospitalized on 11/4/10. Staff were not trained to manage a patient on insulin pump therapy.

Patient #52 was admitted to the hospital on 10/30/10 with diagnoses which included Left Charcot, chronic non-healing ulcer, left fractured hip and insulin dependent diabetes.

Observation on 11/4/10 at 8:45 A.M. revealed patient #52 who was on an insulin pump, had no more insulin being delivered via the pump. Interview with the patient at that time revealed early in the morning, the patient reported to a staff person the need for insulin.

Interview with patient care tech, (PCT) #2 at 9:15 A.M. on 11/4/10 who was assigned to care for this patient revealed that patient #52 stated "I need insulin". The patient reported this to PCT #2 around 8:00 A.M. when the PCT was checking the patient's blood sugar. The blood sugar at that time was 227. The PCT was not aware the patient was on an insulin pump nor was the PCT aware of the significance of what would occur if a patient on an insulin pump runs out of insulin. PCT reported to the nurse that patient #52 needed insulin.

Interview with RN #13, the nurse educator for the unit where patient #52 was currently receiving care, on 11/4/10 at 11:00 A.M., revealed that staff on the medical-surgical units do not routinely take care of patients on an insulin pump. Currently the hospital only had policies and procedures to handle patients with insulin pumps on the maternity units.

RN #13 continued to state, staff are educated on a case by case basis, informally. There has been no formal education programs to review insulin pump therapy during the last 3 years. The nurse who had been assigned to take care of patient #52 (RN#15) had been assigned to take care of this patient for the last 3 days.

Although there had been some discussion on how to manage this patient, RN #13 confirmed there needs to be a better hospital-wide system in place to address the management of patients on insulin pump therapy.

2. For Patient #40, interview with the Nurse Manager, on 11/10/2010 at approximately 10:00 A.M., revealed that although there were physician orders for sliding scale insulin coverage with Humalog insulin, the patient coverage her blood sugars with Novolog insulin from the insulin pump with different doses than prescribed, from 11/4/2010 at noon through 1:30 P.M. on 11/5/2010 after which the insulin pump was discontinued. In addition, nursing staff gave Gargline insulin at 1:00 P.M., on 11/4/2010 that was ordered to be given at breakfast. Gargline insulin is a 24 hour long acting insulin that needs to be given at the same time each day or it can cause hypoglycemia when given in shorter time spans.

Based on observations, staff interviews and record reviews, the Hospital failed to develop and implement a procedure to ensure security of patients' EEG (electro-encephalogram) Telemetry records. The findings are:

On the first day of survey (11/3/10), observations and staff interviews on the 11th floor of the Farr Building revealed the Hospital had video and recording equipment installed in patient rooms on that unit. Per 12:00 P.M. interview with the Nurse Manager of the Farr 11 Unit, both audio and video recordings were taken of patients during EEG monitoring.

On 11/8/10 at 4:30 P.M. an interview was held with the Director of Health Information Management, who was responsible for medical records. When questioned regarding maintenance of the video recordings, the Director revealed that the Medical Records Department managed all paper records and that individual departments were responsible for non paper records including video recordings.

On 11/15/10 at 9:30 AM surveyors visited the EEG Laboratory and interviewed EEG Technician #1 (the Senior technician) and EEG Technician #2 (who was tasked with "archiving" the telemetry recordings.)

The technicians explained that each of the patient rooms, equipped for EEG Telemetry monitoring, had camera and audio recording equipment mounted on the wall; as well as a computer server mounted behind the camera. According to EEG Technician #2, the computer server located in the individual patient room was utilized to store recordings for "thirty days." At the completion of 30 days, EEG Technician #2 explained he would transfer the recordings to a server in the EEG Laboratory; and create a computer disc back up. EEG Technician #2 confirmed that multiple patients' recordings were collected on the in-room computer server over a 30 day period. EEG Technician #2 had no explanation regarding the reason for waiting 30 days to move the data from the in-room computer to the laboratory.

Within the EEG laboratory, the "archive" server was located in a electrical maintenance area. The discs were stored in a file cabinet placed in a storage room within the EEG Laboratory. Per EEG Technician #2, four or five separate patients' recordings were stored on each disc. Per observation on 11/15/2010 at 9:30 A.M., the maintenance room and storage room doors were open, This Surveyor was able to freely open the drawers of the file cabinet where the discs were stored as it was not locked, and two patients were seated nearby, in the laboratory waiting area. EEG Technician #2 stated "it was not their practice to secure the cabinet or the rooms."

Review of the policy provided by the EEG technicians titled: Archiving and Storage of EEG Study Policy dated October 1, 2010, read as follows:

"1. The EEG Studies are archived one month after study is completed.
2. The EEG studies are reviewed and the video is pruned of non seizure events.
3. The EEG studies are then copied over to the Neuro 6 server, which is the archive station.
4. The EEGs are then copied to a DVD ROM and also to a terabyte server which is the final storage site.
5. The DVDs are stored in a fire proof storage cabinet.
6. PatStudy is modified to allow access by the staff to the archived studies."

The EEG Department Policy contained no provisions for securing the information on the server located within the patient rooms. The policy contained no provisions for back-up of the data during the first 30 days. The policy did not address provisions to ensure individual patient recordings were maintained separately prior to archiving. The policy did not address destruction of data. The doors were open and not locked, the file was not locked and their was no provision in the policy for securing the data in the laboratory beyond storing DVDs in a "fire proof storage."

Based on medical record review and review of policies the Hospital failed to ensure that the medical record contained information to justify and support the dialgnosis for 1 (#1) of 27 discharge records reviewed. Findings included:


1. Review of the Hospital policies and procedures regarding Correct Site and Universal Protocols indicated spine surgery requires an intraoperative x-rays with immovable marker(s) will be used to determine the exact location and level of surgery.

2. Review of Discharged Patient #1's Operative Report indicated no refernece to an intraoperative localizing x-rays that was required by Hospital policy to be used to determine the exact location and level of Discharged Patient #1's surgery.

Based on record review and interview, the hospital failed to obtain a properly executed consent for one active patient (#44), of 72 sampled patients. Findings include:

1. Patient #44 was admitted on 11/3/2010 to the intensive care unit (ICU), after being transferred from the ICU at another chronic hospital.

The patient was sedated and mechanically ventilated via a tracheostomy upon admission.

Record review revealed the admitting physician obtained telephone consent for treatment of the patient in the ICU from the patient's son. The ICU Consent for Adult Intensive Care Units, included permission to do a list of various procedures such as but not limited to arterial canulation, heart catheterization, tracheal intubation, ventilation, sedation, blood transfusion, removal of fluid from a body cavity, bronchoscopy and lumbar puncture.

Hospital policy for telephonic consent stated that if consent must be obtained from an individual other than the patient and the person is only available by phone, it should be noted on an approved consent form. The physician obtaining the consent should include date and time of the conversation, the person with whom he or she spoke, the relationship of that person to the patient, the procedure for which the consent was obtained and the significant aspects of the conversation. A witness must monitor the telephone conversation and the witness as well as the physician should sign the note on the consent form. The witness should be a nurse, representative of the Admitting Department, or other Hospital employee.

Review of the telephonic consent for ICU treatment for Patient #44 revealed the consent was not witnessed, the notation only stated consent was confirmed with "Health Care Proxy (HCP)- son by telephone." The consent failed to identify the name of the person the physician spoke to and the nature of the conversation. There was no time of the conversation documented and it lacked a complete date of the conversation. The date was written as 10/04 with no year. The 10 was changed to 11 with a slash through the 0.

Based on observations and interviews, the facility was not maintained to ensure acceptable levels of safety and quality. Findings included:

1. Observations in the Physical Therapy Department on the second floor of the Shapiro Building on November 9, 2010 at approximately 1:00 P.M. revealed a hydrotherapy pool for patient use. Review of the monthly contract pool maintenance service invoices revealed the service included pool cleaning and filter changes. However, there was no evidence of a system to ensure ongoing monitoring of pool sanitation (i.e., temperature, results of chemical and bacteriological testing).
2. Observations on the Farr 5 Unit on November 3, 2010 and on the Farr 3 Unit on November 10, 2010, revealed fabric panels approximately 3 x 3 feet mounted at the head of the patients' beds. These fabric panels were reproductions of popular art work in a dark blue/green color. The wall suction units were positioned adjacent to these fabric panels.

According to interview with the Director of Environmental Services on November 10, 2010, these panels were mounted approximately 10 years ago and they were cleaned by dampening a cloth with a hospital approved disinfectant which was then wiped across the fabric. This process would create a moist environment that did not allow the fabric to readily dry, increasing the risk for mold growth. Because of the darker colors of these panels, visible soiling would be difficult to discern and the fabric surface did not permit ease of cleaning or adequate disinfection of this permeable surface.

The hospital lacked a written cleaning schedule or manufacturer's recommendations for cleaning of this fabric.

Based on observations of the environment and equipment, patient care practices/procedures, review of disinfection logs, and staff interviews, the Hospital failed to ensure that staff consistently implemented infection prevention and control protocols and failed to maintain the East and West Campus kitchens in a sanitary manner.

The findings include:

The Hospital failed to maintain kitchens in a sanitary manner and failed to ensure that the high level disinfection (HLD) process was used per manufacturer's recommendations, to reprocess semi-critical items as evidenced by:

1. During the tour of the West Campus kitchen on 11/3/10 at 10:30 A.M. the following was observed:

a. Observation of the feeding room revealed that the blender used to make liquid feedings was never sanitized. Diet Aide #1 explained that after making each feeding the Aide would hand wash the blender in hot water and would then rinse it in cold water so that the milk would not curdle when making the next batch of feedings. The Aide explained that the blender was never sanitized.

b. The base of the oven in the production area was laden with a large build-up of a carbon substance. Interview with Sous-Chef #1 revealed that the ovens were to be cleaned each Saturday and that the oven had not been cleaned the previous weekend. Observation of the oven on the serving line was also laden with a carbon build-up.

c. The microwave and the area behind the microwave were dirty with splatterings.

d. The racks in the refrigerator which held the Jello had a build-up of old dirt and appeared to have not been cleaned.

e. The lids of the containers holding the rice, flour and Panko were dirty with fingerprints, dust and dirt.

f. The large mixer had not be thoroughly cleaned after it was last used. There was a layer of Panko on the back of the mixer. Interview with Sous-Chef #1 revealed that the mixer had been use 2 days prior and had not been cleaned after it was used.

g. Refrigerator #1 held a black lunch bag holding food belonging to staff.




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2.. During the tour of the East Campus kitchen on 11/3/10 at 10:30 A.M. the following was observed:

a. Three of the kitchen's walk-in freezers were not maintained at 0 degrees Fahrenheit (F) or below during stable times as required per facility policy. The policy read to "check and record temperature once a day (i.e. at opening of the operation or during other stable time)" and "complete corrective action column if temperatures are not in the proper range".

Observation of Freezers #1, #2 and #5 revealed temperatures of 6 degrees F, 15 degrees F and 12 degrees F respectively.

Review of the posted temperature logs for November 1 to November 3 revealed temperatures between 6 and 19 degrees F for Freezers #1, #2 and #5. On November 3, staff documented in the corrective action column that maintenance had been contacted.

Review of the October 2010 freezer temperature logs for Freezers #1, #2 and #5 revealed temperatures above 0 degrees F for each day of the month. For October 2010, the corrective action column was incomplete with only 12 entries indicating the units were in "defrost cycle".

Interview with Food Service Department management staff on 11/4/2010 at 4:15 p.m. confirmed the documented freezer temperatures were above 0 degrees F. consistently and corrective actions were incompletely documented.


b. Observation of the serving line revealed two pieces of equipment, the panini press and the grill, required additional cleaning as the equipment had a build-up of a carbon substance. The mounted fan opposite the serving line was dusty. Food Service Department staff present with the surveyor confirmed the observation.

c. Observation of the cafeteria on 11/3/10 at 2:55 P.M. and on 11/4/10 at 8:45 A.M. revealed the following:

--Flooring under equipment and around the perimeter of the serving line and the cafeteria was dirty.

--Two open display refrigerators had a build up of food debris along the front of the lower shelf of both units. The lower shelves of the reach-in refrigerators in the entree area were dirty with food debris.

--A mounted fan above the bread storage rack was dusty.

--Trash receptacles behind the serving line area had no covers to contain odors from food debris.

Food Service Department staff present with the surveyor at the time confirmed the observations.

3. The high level disinfection (HLD) process used to reprocess semi-critical items in the Endoscopy, Ultrasound, Obstetric/Gynecology, Echocardiology Departments, and the Beth Israel Deaconess HealthCare Lexington Center Satellite Unit was not consistently performed according to the manufacturer's guidelines.

a.) Observation and interview with staff in the Endoscopy Department on November 4, 2010 at 9:15 A.M. revealed that a Metricide OPA (ortho-Phthalaldehyde) solution was used in the Automated Endoscope Reprocessors for high level disinfection of the endoscopes between patient use. Metricide OPA requires regular testing with test strips to ensure the concentration of the solution is sufficient. In order to ensure the efficacy of the test strips, they are tested using a Pass/ Fail method described by the manufacturer using full strength and diluted Metricide OPA. There was no documentation to demonstrate that the step was included in the hospital's chemical monitoring and according to interview with the Endoscopy Director these quality control procedures were not performed on the test strips.

b.) Observations and staff interviews in the Ultrasound at 10:10 A.M., and the Obstetric/Gynecology at 11:30 A.M.and Echocardiology Departments at 12:15 P.M. on November 4, 2010 revealed that manual high level disinfection using Metricide (glutaraldehyde) solution for the vaginal probes and trans-esophageal endoscopes (TEE) was not performed in accordance with manufacturer's instructions.
Findings included:

i.) The temperature of the Metricide solution was not monitored to ensure the solution was maintained at a minimum of 77 degrees Fahrenheit (25 degrees Centigrade) as required by the manufacturer's guidelines. A thermometer was not available to monitor the temperature and according to interview with the Ultrasound Supervisor and the technician in the Obstetric/Gynecology Department temperature monitoring was not performed.

iii.)Also, according to the manufacturer's instructions, the probe/scope must remain immersed in the Metricide for a minimum of 45 minutes. According to staff interview the probes/scopes were immersed for 20 minutes.

iii.) Interview with the Ultrasound Supervisor and the technician in the Obstetric/Gynecology Department, revealed that after the disinfection process, probes/scopes were immersed once in a large volume of fresh water for at least one minute. However, the probes/scopes were not repeatedly immersed in a large volume of fresh water for one minute for a total of three separate immersions to ensure removal of chemical residue from the device. The probes were rinsed under running water in a sink.

iv.) According to the Clinical Manager in the Cardiology Department TEE scopes were immersed twice in a large volume of fresh water for at least one minute but failed to immerse the scope for the third rinse. Also, in accordance with the manufacturer's guidelines, test strips were to be discarded within ninety days of opening the container. The test strip bottle was opened, but had not been dated to monitor outdate.

v.) In the Ultrasound Department the vaginal probes were pre-cleaned and rinsed in the handwash sink instead of a utility sink. According to Ultrasound staff there were six high level disinfection stations in the Department and all used the same procedure.

c.) Observation and interview with staff in the Beth Israel Deaconess HealthCare Lexington Center Satellite Unit on November 9, 2010 at 2 P.M. revealed that Metricide solution was used to manually disinfect vaginal probes in the Obstetric/Gynecology Department and instruments used in Podiatry Services. However, the following steps were not performed in accordance with manufacturer's instructions.

i.) The temperature of the Metricide solution was not monitored to ensure the solution was maintained at a minimum of 77 degrees Fahrenheit (25 degrees Centigrade). A thermometer was not available to monitor the temperature and according to the Director of Ambulatory Services temperature monitoring was not performed.

ii) Also, according to the manufacturer's instructions, the probe/scope must remain immersed in the Metricide solution for a minimum of 45 minutes. According to staff interview the probes/instruments were immersed for 20 minutes.

iii.) Interview with the Director of Ambulatory Services, revealed that after the disinfection process, probes/instruments were immersed once in a large volume of fresh water for at least one minute. However, the probes/instruments were not repeatedly immersed in a large volume of fresh water for one minute for a total of three separate immersions to ensure removal of chemical residue from the device. The probes/instruments were rinsed under running water in a sink.


d.) The hospital failed to minimize the risk of cross-contamination during fingerstick blood sugar (FSBS) testing procedures.

i.) Observations on the Farr 2 Unit on November 8, 2010 at 11:30 A.M. revealed a breach in infection prevention practices. The patient care technician (PCT #4) brought the glucometer (a device that measures blood sugar levels) into the patient's room and placed the glucometer case (containing the meter, test strips, finger lancets, alcohol swabs, gauze, and band-aids) onto the patient's over-the-bed table. After direct contact with the patient, the PCT reached back into glucometer case repeatedly to retrieve additional supplies to complete the (FSBS) testing procedure. At the completion of this procedure, the PCT failed to clean the glucometer but did wipe the exterior of the glucometer carrying case. The patient (Non-Sampled Pt. #1) was on contact precautions (guidelines recommended by the Centers for Disease Control and Prevention for reducing the risk of transmission of important communicable microorganisms).

ii.) Observation on the Farr 5 Unit on November 8, 2010 at 11:35 A.M., revealed a PCT (#5) performed a FSBS procedure on a patient and failed to clean the glucometer after use.

Review of the Point of Care Testing (POCT) Program Policy and Procedure, and the Training and Competency Record for POCT, revealed there were no references to protocols for disinfection of the glucometer between patients.

Based on record review and interview, the Hospital failed to ensure that post discharge written instruction provided to one active patient (#2), in a total active sample of 72, included the timing and dosage of all medications and the wide effects of all medications. Findings include:

1. Patient #2 was ordered to be discharged home on 11/3/2010 at 2:30 P.M. status post partial cystectomy for bladder tumor removal.

Review of the printed discharge instructions revealed a list of discharge medications. Of the 25 medications prescribed, six did not have doses, frequency or other directions for use explained. For instance" The medication Nitroglycerin sublingual (under the tongue) was listed with no dose or directions for how to take or when, supplements such as Multivitamins, Vitamin B-12, Vitamin C and Vitamin D were listed with no dose and no frequency. "Oral" was the only direction.

Although the medications ordered on an as needed basis (PRN) for pain, stated the use in the directions, other regularly scheduled medications did not have a explanation of their wide effects. For instance: The patient was prescribed sustained released Isosorbide Dinitrate 40 milligrams (mg), but the discharge instructions did not say what he was taking it for (blood pressure). The patient was also prescribed Hydrocortisone 20 mg daily, and 0.5 mg at night, Ketoconazole 200 mg two tablets twice a day and Lasix 40 mg daily with no explanation of what the medications were for on the printed instructions as required.

Interview with the Nurse Educator on Reisman 12 on 11/4/2010 at approximately 11:30 A.M., confirmed that some of the discharge medications on the discharge instructions lacked dose and frequency and some lacked reasons for use.

Based on interviews and documentation review the Hospital was not in compliance with the Condition of Participation for Surgical Services as evidenced by the failure to ensure compliance with the following standards:
A-0945 Surgical Privileges;
A- 0951 Operating Room Policies;
A- 0952 Medical History and Physical examination
A-0959 Operative Report.


Based on review of documentation and interviews, the Hospital failed to ensure that peri-operative services were provided in accordance with acceptable standards of practice for 3 discharge records (Discharge Patient #1, #26 and #27), in a total sample of 27, and one Outpatient Record ( #5), in total sample of 5. The sample was expanded to include eight additional patients who underwent spine surgery from the same Attending Neurosurgeon and Fellow Neurosurgeon.

Findings include:

1.) The Hospital reported Discharged Patient #1 had the wrong site surgery during spinal surgery at level L4-L5 instead of level L5-S1 as planned. The surgery was performed by Attending Neurosurgeon #1 and the Neurosurgical Fellow.

Review of Discharged Patient #1's medical record indicated that Discharged Patient #1 had a history of intractable left sided lower leg pain caused by compression on the nerve from the compressed vertebrae. Neurosurgeon Surgeon #1 obtained consent to proceed with surgical decompression of the two vertebrae. Magnetic Resonance Imaging (MRI) revealed moderate L4-L5 degenerative disease with moderate symmetric bilateral neural foraminal narrowing (a hole through which nerves pass through the spinal cord) and markedly severe L5-S1 discogenic disease.

2.) Review of the Informed Consent form signed by Discharged Patient #1 for a left microdiscectomy of L5-S1 indicated the consent was obtained by the Physician Assistant on the day of surgery: 9/17/10. Documentation indicated the Physician Assistant and Attending Neurosurgeon #1 explained the condition of a herniated disc and had recommended a microlumbar discectomy at L5-S1. Review of the Informed Consent Form indicated the time was not documented and the Neurosurgery Fellow's name was not written on the consent designating the second surgeon who would participate in the surgical procedure.

3) Review of the Intraoperative Record, dated 9/17/10, indicated Discharged Patient #1 was brought into the OR at 10:29 AM. The Fellow Neurosurgeon entered the OR at 10:30 AM. A time out occurred at 11:07 AM and surgery began at 11:10 AM. Continued review of the Intraoperative Record indicated Attending Neurosurgeon #1 did not enter the OR until 12:55 PM, 2 hours and 25 minutes during which the Fellow Neurosurgeon was practicing without supervision from Attending Neurosurgeon #1. Attending Neurosurgeon #1 exited the OR at 1:30 PM, and at 1:50 PM Discharge Patient #1 and the Fellow Neurosurgeon left the OR.
Review of the Neurosurgeon Fellow's credential file indicated that there was no documentation regarding which portions of the surgical process the Fellow could conduct without supervision from the Attending Neurosurgeon.

4.) Review of the Peri-Operative Checklist indicated Discharged Patient #1's lower back was marked to indicate the site of surgery.

Review of the x-ray report dated 9/17/10 at 11:34 AM for two intraoperative radiographs of the lumbar spine indicated instrumentation of the lumbar spine at the L4-5 and the L5-S1 levels for pre-surgical site marking.

Attending Neurosurgeon #1 was interviewed in person on 11/4/10 at 1:00 PM and on 11/10/10 at 7:05 AM. Attending Neurosurgeon #1 said a metallic marker was placed and an x-ray was taken to confirm the site of surgery. Attending Neurosurgeon #1 said that Discharge Patient #1's initial incision was made a little longer than expected because the initial incision was made over S1-S2 and not L5-S1. Attending Neurosurgeon #1 said there was no nerve compression visualized and the surgical site was moved up one level (to L4-L5), with the nerve root identified and the disc visualized and decompressed.

The Neurosurgery Fellow was interviewed in person on 11/4/10 at 1:30 PM and 11/10/10 at 2:00 PM. The Neurosurgery Fellow diagrammed Discharge Patient #1's challenging anatomy which included the structures of the sacral and lumbar spine and nerve roots. The Neurosurgery Fellow said a process called "McGregors Line" was used to identify the area of L5-S1. The Neurosurgery Fellow said at the first point of localization (L5-S1), no disc was seen, so moved up one level on the spine where an inflamed nerve root was seen. The Neurosurgery Fellow said Discharge Patient #1's pelvic anatomy and the high take off of the nerve root may have been a contributing cause of the unintended level surgery.

Review of Hospital Policies and Procedures related to Surgery and/or Spine surgery indicated that Spine Surgery requires a two stage process:

Preoperatively the skin is marked anterior vs posterior and right vs left.

Intraoperatively x-ray with immovable marker(s) will be used to determine the exact location and level of surgery. X-rays will be reviewed by the surgeon for confirmation. The policy confirmed the surgeon should mark the site with cautery, stitch, or bone bite before removing the x-ray marker.

4) Review of the Operative Report indicated that it was dictated by Attending Neurosurgeon #1 three days after surgery, on 9/22/10 at 5:22 PM and not immediately after completion of the surgery as required by Hospital policies and procedures. Hospital policy requires the Operative Report be completed before a patient is transferred to the next level of care). Also, the Operative Report did not make reference to the localizing x-rays used to determine the exact location and level of surgery as required by Hospital policy.

Review of Hospital policies and procedures related to operative reports indicated a complete operative note shall be written or dictated immediately after completion of the surgery and before a patient is transferred to the next level of care.

5) Review of Discharged Patient #1's medical records indicated Attending Neurosurgeon #1 and the Neurosurgery Fellow performed a second surgery on Patient #1 on 9/29/10. Review of the medical record indicated that the Operative Reported dictated by Attending Neurosurgeon #1 was not completed until the following day, on 9/30/10 at 6:23 AM, which was not in adherence with Hospital policy before transferring to the next level of care.

6) The Hospital reported Discharge Patient #26 had wrong site surgery performed on 10/7/10. Review of Discharge Patient #26's medical record indicated Discharged Patient #26 was diagnosed with cervical spondylosis at C4-5, C5-6 and C6-7. An anterior cervical discectomy and fusion (ACDF) of C5-6 and C6-7 was planned and an informed consent was obtained from Discharged Patient #26 by Attending Neurosurgeon #2.

Attending Neurosurgeon #2 was interviewed on 11/10/10 at 8:00 AM. Attending Neurosurgeon #2 said Discharged Patient #26's MRI revealed abnormalities at C4-5, C5-6 and C6-7. Additionally, at C5-6, a large disc compression was noted. Attending Neurosurgeon #2 said Discharged Patient #26 was the second case of the day and due to an emergency, Discharged Patient #26 was moved to the third case of the day. Attending Neurosurgeon #2 said that this change in schedule may have contributed to fatigue and the resultant error. Attending Neurosurgeon #2 said surgical timeout was conducted, Attending Neurosurgeon #2 made the incision and marked the areas with needles because of Discharged Patient #26's short neck and body habitus. Attending Neurosurgeon #2 said Attending Neurosurgeon #2 looked at the film and then counted the cervical vertebra. Attending Neurosurgeon #2 said Attending Neurosurgeon miscounted the vertebra while looking at the x-ray film. Attending Neurosurgeon #2 said an x-ray was done postoperatively and Attending Neurosurgeon #2 looked at the film and noted the surgery was performed on the wrong level: C4-5.

7) The Hospital reported Discharged Patient #27 had wrong site surgery performed on 9/23/10. The report indicated the surgery was performed in error on Discharged Patient # 27's lumbar spine at levels L3-L4 instead of levels L4-L5 as planned. Review of Discharged Patient #27's medical record indicated that Neurosurgeon #1 and the Neurosurgeon Fellow were the same surgeons who operated on Discharged Patient #1 and had made a similar wrong surgical site error during cervical spine surgery.

The Informed Consent form dated 9/15/10 indicated Neurosurgeon #1 obtained consent from Discharged Patient #27. Review of the consent form indicated the time was not documented and Neurosurgeon Fellow's name was not on the consent listed as the second surgeon for the procedure. Review of the Pre-Operative Checklist indicated the operative site for Discharged Patient #27 was documented as lower back. Review of the Intraoperative Record indicated a time out was performed at 8:03 AM and indicated the Neurosurgery Fellow was present. Attending Neurosurgeon #1 entered the OR at 8:25 AM.

Review of the Operative Report indicated Attending Neurosurgeon #1 performed the operation with the assistance from the Neurosurgery Fellow.

During interview, Attending Neurosurgeon #1 said during the surgery Attending Neurosurgeon #1asked Neurosurgery Fellow to place the clamp on the pedicle. Attending Neurosurgeon #1 said there was miscommunication as to where to place the clamp on the pedicle. Attending Neurosurgeon #1 said Attending Neurosurgeon did not look down into the operative area and confirm placement of the clamp because this would involve moving the Neurosurgical Fellow's vison away from the area of the intended surgical site. Attending Neurosurgeon #1 said Attending Neurosurgeon #1 instructs/teaches other surgeons not to take their eyes away from the surgical site, because of the risk of loosing vision of the surgical site.

Interview with the Neurosurgery Fellow indicated Attending Neurosurgeon #1 instructed him/her to place the clamp over the pedicle (the segment between the transverse process and the vertebral body). The Neurosurgery Fellow said there was a miscommunication during the clamping/marking process. The Neurosurgery Fellow said the x-ray was 2 dimensional, and there was a lack of depth on the confirmation x-ray. The Neurosurgery Fellow said the communication between the Neurosurgery Fellow and Attending Neurosurgeon #1 along with the lack of depth of the x-ray contributed to the error.


7. The hospital reported a wrong side/site procedure on 11/15/10 that occured at an outpatient pain clinic. Outpatient Record #5. Outpatient Record #5 presented for a right hand, fourth digit, stellate ganglion block [a block is an injection of a medication to numb the nerve which transmits pain] to treat a complex regional pain syndrome. The Patient did not speak English and a translator was present. The Patient was not sedated for the procedure.

The Hospital failed to ensure that the policy was followed in regards to marking the correct site prior to the invasive procedure and conducting a time out which would have confirmed identification of the correct site.

Review of the Hospital Policy titled: Universal Protocol for Procedures Outside of the Operating Room indicated that invasive procedures being performed outside of the operating room will comply with the Universal Protocol which include:
1) Pre-procedure verification
2) Site marking
3) Time out before the procedure is initiated.

According to the Hospital report, during the time-out when the procedure was verified: Left VS. Right, the consent form was not referred to. Instead, the Patient was asked to move the hand that was causing pain. The Patient moved the left hand and not the right hand, and the left hand was injected.

After the procedure was completed and the Patient was in the recovery phase, the error was identified.

Based on staff interviews and review of the Neurosurgery-Spine Surgery Fellowship Program dated 4/21/09, the Hospital failed to identify specific surgical privileges indicating which part of spinal surgery the Fellow could perform independently from the Attending Neurosurgeon.

Findings include:

1. Review of the Neurosurgery-Spine Surgery Fellowship Program indicated the curriculum of the Non-Accreditation Council for Graduate Medical Education (ACGME ) fellowship and the ACGME fellowship were identical with the exception of call (on-call physician coverage hours). [ACGME is responsible for the Accreditation of post-MD medical training programs within the United States. Accreditation is accomplished through a peer review process and is based upon established standards and guidelines]. The program included an outline for an evaluation process to evaluate the Fellow's ability to obtain a history and physical, appropriate radiographs and formulate a treatment plan for patients. The program also indicated the Fellow will demonstrate competency in performing all surgical procedures relating to the spine, in particular, decompression of the neural elements of the cervical, thoracic and lumbar region as well as appropriate instrumentation techniques. The program indicated the Fellow's autonomy (independence) during surgical cases that would be assigned as warranted by skill and comfort level of the fellow with the Attending Neurosurgeon's assistance and presence.

2. Review of the Neurosurgeon Fellow's credential file indicated that there was no documentation regarding specifics portions of surgery the Fellow could conduct independently from the Attending Neurosurgeon.

3. Review of Discharge Patient #1's medical record indicated the primary surgeon (Attending Neurosurgeon #1) was not present in the Operating Room during the entire surgery. Discharge Patient #1's surgery began at 11:07 A.M. Documentation indicated the Attending Neurosurgeon #1 entered the OR at 12:55 P.M., one hour and forty minutes later.

4. Attending Neurosurgeon #1 was interviewed in person on 11/4/10 at 1:00 P.M. and on 11/10/10 at 7:05 A.M. Attending Neurosurgeon #1 indicated he was not in the OR when Discharge Patient 1's surgery began. Attending Neurosurgeon #1 said he was in the Hospital seeing patients and was readily available while the Fellow Neurosurgeon was operating on Discharge Patient #1.

Based on record review, review of hospital policies and procedures and staff interview, the surgical services failed to ensure staff in the operating room followed policies to assure the achievement and maintenance of high standards of medical practice and patient care for 1 surgical patient (#54), out of total of 72 active patient sampled and for 3 discharged patients (#1, #26 and #27) out of 27 discharged patient sampled.

Findings include:

1. Wrong level of spinal surgery was performed on Patient #1, level L4-L5 instead of intended level L5-S1.

Documentation in the operative report failed to indicate localizing x-rays were performed to identify the exact location and level of surgery as required by Hospital policies and procedures.

Review of Hospital Policies and Procedures related to Surgery and/or Spine surgery indicated that an intraoperative x-ray with immovable marker(s) will be used to determine the exact location and level of surgery. X-ray will be reviewed by the surgeon for confirmation. Once confirmed the surgeon should mark the site with cautery, stitch, or bone bite before removing the x-ray marker

2. A wrong level of surgery was performed on Patient #26, level C4-C5 instead of the intended level C6-C 7.

Attending Neurosurgeon #2 was interviewed on 11/10/10 at 8:00 AM. Attending Surgeon #2 said he miscounted the cervical vertebra.

3. A wrong level surgery was performed on Patient #27, L3-L4 instead of intended level L4-L5.

Interviews with Attending Neurosurgeon #1 on 11/4/10 at 1:00 PM and on 11/10/10 at 7:05 AM and with Neurosurgery Fellow on 11/4/10 at 1:30 PM and on 11/10/10 at 2:00 PM indicated there was a communication issue during the placement of the marking clamp during Patient #27's surgery. It was reported to the Surveyor by the Neurosurgery Fellow that the two dimensional x-ray had no depth and the Neurosurgeon Fellow was unable to establish the surgical marker because it was positioned high. Attending Neurosurgeon #1 said because of his style of teaching, he did not look into the incision and confirm placement of the clamp.



15020


4. For patient #54, an unnecessary X-ray was done because staff did not follow the proper procedure for instrument count.

Patient #54 had a kidney transplant on 11/9/10.

Review on 11/10/10 of the intraoperative record, dated 11/9/10, reflected closure count #1 for the small Bookwalter blades, was incorrect . Comments of the scrub person, #1 revealed "the small pan of bookie blades did not have a count sheet and was overlooked during counting. X-ray was taken, no blade was found on X-ray".

Interview with circulating nurse #1 on 11/10/10 at 8:50 A.M. revealed that this nurse was orienting a new nurse to the hospital during this surgery. At the end of this surgery, it was noted that there was no initial count for the pan of small Bookwalter retractor blades which were opened. "It was an oversight." Circulating Nurse #1 further stated that "every kit should have a count sheet and be counted when opened. In the past these blades had a count sheet but lately this pan of blades lacked a count sheet. If there is no count sheet, the nurse should write in the instrument(s) and count of the instrument(s)". Circulating Nurse #1 did not know for how long these blades had been lacking a count sheet and this was not reported to any staff to correct this situation.

Per policy titled Documentation of Counts, "clear concise documentation of counts is an important element of a comprehensive strategy to prevent the inadvertent retention of retained objects. Consistency in practice and documentation minimizes the chance of error and retention of a foreign body. All items will be counted unless urgency of the procedure". (This surgery was planned surgery).

Interview with Nurse Manager #10, on 11/10/10 at 9:00 A.M., revealed that staff did not follow hospital policy. All instruments should have a count sheet and be counted. Nurse Manager #10 was unaware of this situation and will insure this tray of small Bookwalter retractor blades will have a count sheet.

4. For Discharge Patient #17, record review revealed there was no pre-operative history and physical, in the record, prior to surgery, as required. The patient has a lumber 5-Sacral 1 microdisectomy on 9/30/2010.

5. For Discharge Discharge Patient #11, record review revealed there was no pre-operative history and physical, in the record, prior to surgery, as required. The patient had a removal of right neck nodule on 6/29/2010.





11993

Based on review of documentation, interviews and review of eight (#1, #11, #17, #25, #57, #58, #59 and #60) out of 27 discharged patient records, the Hospital failed to ensure that a History and Physical (H&P) Examination was completed and documented no more than 30 days before or 24 hours after admission or registration or that an updated examination of the patient, including any changes in the patient's condition, was completed and documented within 24 hours after admission or registration. Findings include:

1. Review of Hospital Policies and Procedures titled "Documentation of the Medical History and Physical Examination Prior to a Procedure" indicated that no patient shall be allowed into the operating room or procedure room, on either an inpatient or outpatient basis, without the completed medical history, physical examination and interval note, and pre-procedure assessment findings documented in the patient record.

2. The Director of Perioperative Services was interviewed on 11/9/10 at 10:00 A.M. The Director of Perioperative Services said a physician could have looked in three areas of the electronic record to review a history and physical (H&P) that had been previously performed, in order to meet the requirement for review, prior to surgery.

3. Review of Discharged Patients #1, #25, #57, #58, #59 and #60's medical records indicated the H&P was confirmed preoperatively, that the patient was examined and there were no changes. However, there was no documentation to indicate: the source of the H&P used for confirmation; date and time of the H&P; and/or a copy of the referenced H&P in the medical record, despite attestation on the Preoperative checklist that the Physician confirmed that the History and Physical has been reviewed, the patient examined and no interval changes were noted as required.

5.) For Patient #15, the Brief Operative note was not complete as it was not signed by the surgeon and lacked the type of anesthesia used during surgery. The patient underwent an exploratory laparoscopy and splenectomy on 11/3/2010.





13092

Based on review of three of 27 discharge records (#1, #7 and #8) and one (#15) active record in total sample of 72, review of the Brief Operative Report indicated the attending surgeon failed to write or dictate, an operative report immediately following surgery and failed to follow the Hospital's policies and procedures regarding operative reports.

Findings include:

1. Review of the Hospital's policy and procedure titled Documentation of Brief Operative Note and the Final Operative Report indicated a brief operative note shall be written immediately after the procedure and a complete operative note shall be written or dictated immediately after completion of the surgery and before a patient is transferred to the next level of care.

2. Review of Discharged Patient #1's medical record indicated the patient had surgery performed on 9/17/10 and the Operative repeort was not written until 9/20/10, at 5:22 PM. Continued review of Discharged Patient #1's records indicated spinal surgery was again performed on 9/22/10 and the dictated Operative Report was dictated by Neurosurgeon #2 three days later on 10/23/10 at 4:40 PM.

3. Review of Discharge Patient #7's medical record indicated the patient had surgery performed on 10/22/10 at 9:31 A. M. The dictated Operative Report was dictated by Neurosurgeon #2 on 10/23/10 at 4:40 P.M.

4. Review of Discharge Patient #8's medical record indicated the patient had surgery performed on 10/22/09. The dictated Operative Report, dictated by Neurosurgeon #2 was done, five days later on 10/27/09 at 10:37 A.M.

4. For Discharge Patient #16, review of the PAT Pre-Procedure Assessment Form at 10:00 A.M. on 11/10/2010, revealed that the patient was seen PAT on 9/17/2010 for a pre-anesthesia assessment and a surgical history and physical. Continued review of the Pre-Procedure Assessment Form revealed that general anesthesia was discussed with the patient and the patient's airway was assessed and a Mallampati score documented. The pre-anesthesia assessment (as described above) was signed as performed by a practitioner who was not qualified to administer anesthesia. The form lacked evidence of participation in the assessment by a practitioner qualified to administer anesthesia.

5. For Active Patient #62, review of the Pre-Admission Testing (PAT) Pre-Procedure Assessment Form revealed that the patient was seen in PAT on 11/2/2010 and the type of interview conducted was a pre-anesthesia assessment. Continued review of the Pre-Procedure Assessment Form revealed that the type of anesthesia (general anesthesia) was discussed with the patient and that the patient's airway was assessed and a Mallampati score (used by anesthesia staff to predict the ease of intubation) documented.
The pre-anesthesia assessment (as described above) was signed as performed by a practitioner who was not qualified to administer anesthesia. The form lacked evidence of participation in the assessment by a practitioner qualified to administer anesthesia.




15211


Based on medical record review and staff interviews, the facility failed to ensure that a pre-anesthesia evaluation was completed and documented by an individual qualified to administer anesthesia and was performed within 48 hours prior to surgery or a procedure requiring anesthesia services, for two of 72 active patients (#56 and #62) and three (#6, #8, #16) of 27 discharged patients. Findings included:

1. For Active Patient #56, review of the Pre-Admission Testing (PAT) Pre-Procedure Assessment Form (MC 9051) at 8:45 A.M. on 11/10/2010, revealed that the patient was seen in PAT on 10/4/2010 and the type of interview conducted was a pre-anesthesia assessment. Continued review of the Pre-Procedure Assessment Form revealed that the type of anesthesia [general anesthesia (renders the patient unconscious, unable to breathe on their own)] was discussed with the patient and that the patient's airway was assessed and a Mallampati score (used by anesthesia staff to predict the ease of intubation) documented.
Interview with Nurse Manager (NM) #8 at 9:00 A.M. on 11/10/2010, confirmed that the anesthesia portion of the assessment (as above), was only signed by a practitioner who was not qualified to administer anesthesia. The form lacked evidence of participation in the assessment by a practitioner qualified to administer anesthesia.

2. For Discharged Patient #6, review of the PAT Pre-Procedure Assessment Form at 8:30 A.M. on 11/15/2010, revealed that the patient was seen PAT on 8/31/2010, for a pre-anesthesia assessment and a surgical history and physical. Continued review of the Pre-Procedure Assessment Form revealed that general anesthesia was discussed with the patient and the patient's airway was assessed and a Mallampati score documented. The pre-anesthesia assessment (as described above) was signed as performed by a practitioner who was not qualified to administer anesthesia. The form lacked evidence of participation in the assessment by a practitioner qualified to administer anesthesia.

3.) For Discharge Patient #8, review of the PAT Assessment Form revealed the patient was seen in PAT on 10/7/10, for a pre-anesthesia assessment and surgical history and physical. Continued review of the Pre-Procedure Assessment Form revealed that general anesthesia was discussed with the patient and the patient's airway was assessed and a Mallampati score documented. The pre-anesthesia assessment (as described above) was signed as performed by a practitioner who was not qualified to administer anesthesia. The form lacked evidence of participation in the assessment by a practitioner qualified to administer anesthesia.

8. For Active Patient #2, the Post-op anesthesia assessment failed to address respiratory rate, airway patency, oxygen saturation, blood pressure, pulse, temperature, and postoperative hydration, although required by facility policy.

Patient #2 had a partial cystectomy under general anesthesia for a cancerous bladder tumor. The patient arrived in the PACU at 4:55 P.M. At 5:25 P.M., the nursing staff documented that the patient was arousable to calling his name, was unable to sustain oxygen saturation above 90% without supplemental oxygen and pain level was "tolerable." At 5:30 P.M., the anesthesiologist wrote a post anesthesia assessment note that stated the patient was awake, pain adequately controlled, patient breathing spontaneously, vital signs stable, as needed Zofran for nausea. May discharge to floor one PACU criteria are met.

There was no assessment of the patient's airway, lung sounds, oxygen saturation, hydration, respiratory or cardiac status as required.

9. For Active Patient #1, the Post-op anesthesia assessment failed to address respiratory or cardiac status, airway patency, oxygen saturation, blood pressure, pulse, temperature, and postoperative hydration, although required by facility policy.

Patient #1 had monitored anesthesia care with general anesthesia for the removal of portacath in the chest wall on 10/21/2010.

Record review revealed the patient arrived in the PACU at 3:50 P.M. At 4:00 P.M., the anesthesiologist wrote a post anesthesia note that stated "the patient was stable upon arrival to PACU status post MAC for port removal. Okay to dc (discharge) to floor."

There was no assessment of respiratory or cardiac status, oxygen saturation, hydration, blood pressure or pulse, temperature, as required.

10. Review of discharge record (DC) #17, revealed the post anesthesia assessment was written by a post graduate year 2 (PGY2) resident on 9/30/2010 at 10:30 A.M. Interview with the Director of Performance Improvement, on 11/10/2010 at approximately 2:00 P.M., confirmed that a PGY2 was not an individual qualified to administer anesthesia (board certified or eligible.)




15211


Based on medical record review, interviews, and review of policies and procedures, the facility failed to ensure a post anesthesia evaluation was completed and documented by an individual qualified to administer anesthesia, for six (#1, #2, #35, #37, #39, #56) of 72 active patients' records and three (#6, #12 and #17) of 27 discharged patients reviewed. Findings included:

1. Interview with Anesthesiologist #3, at 9:00 A.M. on 11/09/10, revealed that the post-anesthesia assessment, for Surgical patients, was routinely performed in the PACU, when the patient was recovered from anesthesia enough to participate in the assessment.

Interview with Anesthesiologist #3 at 9:00 A.M. on 11/9/2010, revealed that it was the policy of the Department of Anesthesia to adhere to the recommendations of the American Society of Anesthesiologists for routine post-anesthesia assessment and monitoring including monitoring/assessment of: respiratory function, including respiratory rate, airway patency and oxygen saturation; cardiovascular function, including pulse rate and blood pressure; mental status; temperature; pain; nausea and vomiting; and postoperative hydration

Upon Surveyor request for a copy of the Department of Anesthesia's policy for post-anesthesia evaluation, Anesthesiologist #3 provided a copy of two polices. One titled "Post Anesthesia Assessment" and the other titled "Post Anesthesia Recovery/Discharge Criteria." Both policies documented the PACU nurses' responsibilities for monitoring patients' post anesthesia recovery with criteria that defined when a patient could be discharged from PACU.

2. For Discharged Patient #6, medical record review at 3:00 P.M. on 11/10/2010, revealed that on 9/7/2010, the patient had back surgery for removal of a herniated disc and was administered general anesthesia for an approximate two hour operation.

Review of the Anesthesia Record revealed that at 1:09 P.M. Discharge Patient #6 was transferred from the Operating Room (OR) to the Post Anesthesia Care Unit (PACU).

A note written by Anesthesiologist #1 at 1:18 P.M. (only nine minutes after the patient left the OR) read, "Patient to PACU. Awake and alert. VSS (vital signs stable). No PONV (post operative nausea vomiting). Pain well controlled. No visible anesthetic complications. May be transferred to floor per PACU protocol."

Review of the PACU Post Anesthetic Score revealed that according to an assessment performed upon admission to PACU at 1:05 P.M. and again at 1:35 P.M., the patient's level of consciousness was documented as a score of 1, which indicated that the patient was "arousable on calling (the patient's name)."

Anesthesiologist #1's note, written at 1:18 P.M., indicated that Discharge Patient #6 was awake and alert. However, the PACU Score indicated that the patient was only "arousable on calling" until 1:35 P.M., 22 minutes after the Anesthesiologist's assessment.

Interview with Nurse Manager (NM) #8 at 9:40 A.M. on 11/9/2010, revealed that if a patient was awake and alert, a score of 2 (fully awake) would be documented on the PACU Anesthetic Score. Therefore the post anesthesia assessment was performed before the patient could participate in the evaluation, although required.

Also, the medical record lacked documentation that a practitioner, qualified to administer anesthesia, evaluated the patient after 1:18 P.M. and before the patient was transferred from the PACU to the surgical floor, at approximately 2:05 P.M.

Anesthesiologist #1's note failed to address respiratory rate, oxygen saturation, blood pressure, pulse, temperature, and postoperative hydration, although required by facility policy.

3. For Discharge Patient #12, medical record review at 8:30 A.M. on 11/15/2010, revealed that the patient was admitted to the hospital on 10/3/2009, with a diagnosis of (cervical spinal) cord impingement (pressure on spinal cord ) and complaints of double vision, unsteady gait, history of multiple falls, and chronic headaches.

On 10/5/2009, at approximately 7:37 P.M., the patient had a four hour neck surgery for a spinal fusion, performed under general anesthesia. The anesthesia postoperative assessment read, "Patient status post cervical anterior discectomy and fusion under general anesthesia. VSS. No N/V. Pain well controlled. Stable for transfer to floor when meets PACU criteria."

The assessment documented by Anesthesiologist #4 failed to address the patient's mental status, respiratory rate, airway patency, oxygen saturation, blood pressure, pulse, temperature, and postoperative hydration, although required by facility policy.

4. For Active Patient #35, medical record review at 8:55 A.M. on 11/4/2010, revealed that the patient had a surgical procedure on 11/2/2010. The post anesthesia evaluation performed on 11/3/ 2010 at 11:11 A.M. read, "VSS, ambulatory."

The assessment documented by Anesthesiologist #5 failed to include: respiratory function, including respiratory rate, airway patency and oxygen saturation; cardiovascular function, including pulse rate and blood pressure; mental status; temperature; pain; nausea and vomiting; and postoperative hydration, although required by facility policy.

5. For Active Patient #37, medical record review at 9:15 A.M. on 11/4/2010, revealed that the patient had a surgical procedure on 11/2/2010. The procedure was complicated by postoperative bleeding, a decrease in the patient's serum hemoglobin from 12.8 preoperatively to a postoperative hemoglobin of 10.2, and a temperature of 101 Fahrenheit (normal is 98.6) by mouth (PO).

The postoperative anesthesia note read, "Positive skin irritation from tape used to secure epidural."

The assessment documented by Anesthesiologist #5 at 11:34 on 11/3/2010, failed to include: respiratory function, including respiratory rate, and oxygen saturation; cardiovascular function, including pulse rate and blood pressure; mental status; temperature; pain; nausea and vomiting; and postoperative hydration, although required by facility policy.

Interview with the Director of Obstetrics Anesthesia on 11/3/2010 at approximately 9:30 A.M., indicated that the post-anesthesia assessment should have also included an assessment of the status of the lower limbs (i.e. numbness, tingling, movement).

6. For Active Patient #39, medical record review conducted at 2:30 P.M. on 11/4/2010, revealed that the record lacked a complete post-anesthesia evaluation. The postoperative anesthesia note documented on 11/2/2010 at 7:30 A.M., lacked an assessment of the patient's respiratory function, including respiratory rate, and oxygen saturation; cardiovascular function, including pulse rate and blood pressure; mental status; temperature; pain; nausea and vomiting; and postoperative hydration, although required by facility policy.

Under the section labeled "Patient Satisfaction" "yes" was checked. And under the section labeled "Review of Systems" only the box labeled "none of the above" was checked.

7. For Active Patient #56, Medical record review at 8:45 A.M. on 11/10/2010, revealed that the record lacked a timely and complete postoperative anesthesia evaluation. The post-anesthesia evaluation was documented on 11/8/2010, at 3:30 P.M., only 11 minutes after the patient arrived in the PACU and read, "Patient status post removal sternal plate. Awake and VSS. Baseline heart rate (90 - 100's). Pain at baseline 6-7/10. No PONV. No apparent anesthesia related complications."

Review of the PACU Anesthetic Score revealed that the patient was scored a #1 for consciousness upon arrival in PACU. The patient was not scored a #2 until 3:45 P.M., 15 minutes after the post-anesthesia assessment was documented.

The patient had received general anesthesia for a two hour surgical procedure of the chest. Additionally, the patient's surgical site was infected and the patient had an additional diagnosis Methicillin Resistant Staphylococcus Aureus (MRSA).

Further medical record review revealed that the patient had a strong cardiac history (high blood pressure,
heart attack, heart surgery) uncontrolled diabetes, and a history of substance abuse.

Interview with Anesthesiologist #3 at 9:00 A.M. on 11/10/2010, confirmed that due to the patient's medical and surgical histories, the type of anesthesia administered, and the procedure performed, the post-anesthesia assessment was performed too soon. The patient was not recovered enough from anesthesia to fully participate in the evaluation.