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Based on record review and document review, observation, interviews and review of Governor Juan Luis Hospital Bylaws, it was determined the hospital failed to ensure the governing body was responsible for the actions of the hospital as an institution as evidenced by:

482.12- The Governing Body failed to ensure the hospital function was conducted in a proper manner to ensure that all services offered and provided met the Medicare Conditions of Participation.

Areas of noncompliance identified included:

482.13- Patient Rights: The hospital failed to protect and promote the rights of each patient and to ensure care in a safe setting.

482.21- Quality Assessment Performance Improvement: The hospital failed to ensure that improvement activities such as medical errors and problem prone areas were set as a priority.

482.22- Medical Staff: The hospital failed to ensure that the Medical Staff was accountable to the Governing Body for the quality of medical care provided to the patients.

482.23- Nursing Service: The hospital failed to ensure that nursing services were organized to consistently provide supervision of the necessary care and services to meet the needs of each patient.

482.24- Medical Record Service: The hospital failed to ensure the medical records were complete, accurate and the content of the record contained information necessary to provide care and services to meet patient's needs.

482.25- Pharmaceutical Services: The hospital failed to ensure procedures and policies were implemented to minimize drug errors including dispensing, disposition and distribution of all medications.

482.28- Food and Dietetic Services: The hospital failed to ensure that the dietary services were provided under the direction of a qualified food service director.

482.41- Physical Environment: The hospital failed to ensure that overall hospital environment, including equipment, were maintained to ensure patient safety.

482.42 -Infection Control: The hospital failed to ensure that the environment was sanitary to avoid sources and transmission of disease.

482.51- Surgical Services: The hospital failed to ensure that the provision of surgical services met professional standards of care related to the control of operating room humidity and completeness of operating room documents.

482.57- Respiratory Services: The hospital failed to ensure that respiratory services were managed and directed under the oversight of a qualified medical doctor or doctor of osteopathy.

The cumulative effect of this lack of oversight and systemic issues resulted in the Governing Body's ineffectiveness for the conduct of the hospital as an institution. This has the potential to affect the health, safety, and well-being of all the patients the hospital serves.


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Based on observation, medical record review, staff interview and review of policies and procedures, it was determined that the hospital failed to meet the Condition of Participation for Patient Rights, specific to the requirements for care in a safe setting for 3 of 3 patients on the psychiatric unit and for 3 of 3 patients relative to the use of chemical restraints. In addition, all patients did not have access to call bells in the emergency room bathroom areas and the surgical environment potentially was not safe. The hospital also failed to ensure that the rights information presented to patients is complete as evidence by:

1. Failing to provide evidence that the information provided to patients at the time of admission contained the updated information on visitation access. Please refer to A0117.

2. Failing to ensure that the grievance process time frame for review and response meets CMS standards. Please refer to A 0122.

3. Failing to provide a safe setting for those individuals on the psychiatric unit and in the Emergency Room. Please refer to A 0144.

4. Failing to ensure that interventions the patients received were the least restrictive methods to meet their needs. Please refer to A 0164.

5. Failing to ensure all surgical equipment/environment was maintained in safe operating order. Please refer to A 0724 and A 0940.

The combined cumulative effect of these systemic failures resulted in the hospital's inability to protect and promote the rights of patients.

Based on interview and document review, the hospital failed to inform each patient, or when appropriate, the patient's representative of the patient's rights, in advance of furnishing or discontinuing patient care whenever possible.

The findings are:

On 6/24 an interview with SP#34 at approximately 12:00PM revealed the revised Admission Handbook had not been received. The revised copy included information regarding patient rights, and was intended to be distributed to all newly admitted patients.

This standard continues to not be met.
Please refer to Complaint Survey findings of 4/21/11.

Based on interview and document review, the hospital failed to specify time frames for review of a grievance and the provision of a response.


The findings are:

The Grievance Policy and Procedure dated June 2011 was reviewed during an interview with SP #34 on 6/24 at approximately 12:00PM. It indicated the time frame for grievance resolution does not meet current CMS guidelines.

This standard continues to not be met.
Please refer to Complaint Survey dated 4/21/11.

Based on observation and interviews, the hospital staff failed to provide and maintain an environment that would promote patient safety and well being for those individuals on the psychiatric unit and in the emergency department. In addition, the hospital failed to ensure that patients received care in a safe setting as patients could not call for assistance while in the Emergency Department's bathrooms.

The findings include:

During a tour at 2:00 P.M. of the inpatient Psychiatric Unit with a census of 3 on 6/23/11 in the presence of hospital staff, the following observations were made:

1. Room 3007 was noted to have a piece of wall baseboard approximately 4 feet in length, fully separated from the wall and lying on the floor. This material had the potential to endanger the patient who resided in the room as well as staff and other patients on the unit.

2. Six patient rooms had an angled faucet and 2 rooms had an angled spout. These fixtures were a type that could support an individual's weight during a suicide attempt should a loop be placed around the faucet.

3. Room 3013 and 2 doors in the seclusion area revealed self closing mechanism arms on the top of the doors. These self closers were a type that could support an individual's weight during a suicide attempt, should a loop be placed around the self closing arm.

4. The locked double door entrance to the unit had a length of wood approximately 4 feet affixed to the floor in front of one door. This prohibited the door from being opened.

5. All patient rooms had breakaway shower curtain rods in the bathrooms; Rooms 3005 and the seclusion room shower did not break away when weight was applied to the rod. If the shower curtain rod does not breakaway, it could support an individual's weight during a suicide attempt.

6. On 6/21/11 at approximately 10:00 A.M., SP #15, from security was interviewed and indicated Panic Buttons were used to summon assistance in the event of patient/visitor's unruly behavior. These buttons were located on all units but the Discharge Unit, and in the Cardiac Rehab Center, and indicated 2 buttons were on order for these areas. It was stated that the system had not been operational since 6/9/11, and had been sent out for repair. When asked if staff had been alerted to this,s/he replied they had not been notified.
At approximately 10:56 A.M., SP #16 on the Psychiatric Unit was asked what the Panic Button located at the Nurses Station was used for. S/he verified the button was pushed when additional help was needed in the event of unmanageable behavior. When asked if it could be tested, s/he said security would need to be notified beforehand, it would only be a test, and proceeded to contact security. S/he was told some of the buttons may not be working, and security would follow up.

7. Observation of the Emergency Room (ER) with SP #13 and SP #14 on 6/20/11 at 1:20 P.M. revealed the following:

Two of two bathrooms in the waiting area did not have pull cords that activated the light for the nurse. The patient would need to push the button as the pull cord was not pushing the button down to activate the call system.

Two of two patient bathrooms inside the Emergency Room did not have pull cords to activate the call system for assistance. One bathroom in the Emergency Room did not have a pull cord to call for the nurse and the second bathroom's pull cord did not push the button down to ring for the nurse. SP #13 accompanying the tour confirmed the lack of pull cords for patients to call for assistance.

8. Observations of the surgical suites on 6/21 and 6/22/11 in the presence of hospital staff, identified significant issues due to condensation from humidity that had not been controlled for some time. Documentation reviewed identified that the operating room staff expressed concerns as to the effect the moisture had compromising patient safety.

Based on review of medical records and interview with staff, it was determined that the hospital failed to implement least restrictive interventions prior to administering a chemical restraint for 3 of 3 patients. Patient # 11, Patient #3 and Patient #2.

The findings include:

Patient #11

1. Patient #11 received a chemical restraint, Haldol an antipsychotic medication, prior to least restrictive interventions being implemented including pain management.

Patient #11 received Haldol, an antipsychotic medication and Cogentin, an anticholinergic that reduces the side effects of antipsychotic treatment. However, there was no nursing documentation of the behavior that was displayed to warrant the administration of Haldol and Cogentin. Additionally, although the patient had an order for pain medication as needed, there was no documentation that the patient was assessed for pain or offered pain medication prior to the Haldol and Cogentin being administered.

Review of the physician's note dated 5/29/11 at 12:14 P.M. indicated that the patient still required ventilator support due to desaturation and fatigue. Has increased agitation, not sleeping, anxious, Ativan not helping. Anxious give Haldol and Cogentin now.

Review of the Physician's Order Form dated 5/29/11 at 12:16 P.M. indicated Haldol 5 mg (milligram) via peg tube(feeding tube)/intramuscularly now and Cogentin 2 mg via peg tube/intramuscularly now. The Haldol and Cogentin were given at 1:00 P.M. on 5/29/11.

There was no description of the patient's behavior documented by nursing to warrant the administration of the Haldol and Cogentin as there were no Nurse's Notes documented from 5/26/11 at 5:45 P.M. until 6/9/11 at 6:00 A.M.

In addition, there was no documentation that the patient was assessed for pain prior to the Haldol and Cogentin being administered. The patient had an order for Percocet 5/325 one tablet every six hours as needed for pain. Review of the patient's Medication Administration Record revealed that the patient received the Percocet 5/325 on 5/26/11 at 7:00 P.M., on 5/27/11 at 1:30 P.M. and 7:00 P.M. and on 5/30/11 at 7:00 P.M. No pain medication was given on 5/28/11 or 5/29/11.


Patient #3

2. Patient #3 was escorted to the Emergency Room (ER) by police following a behavioral outburst at home on 6/19/11 at 9:50 P.M. The triage note written at 10:12 P.M. documented the patient's behavior as cooperative. The ER Nurses Note at 12:20 A.M. indicated the patient received Haldol 10 mg (tranquilizer), Ativan 1 mg (antianxiety medication), and Cogentin 2 mg IM (intramuscularly). There was no documentation in the record to describe what behavior was exhibited which would have warranted the use of these medications, or if any less restrictive interventions were used prior to the administration of medication.

Patient #2

3. Patient #2 was admitted to the Psychiatric Unit on 6/1/11 with a diagnosis of Chronic Paranoid Schizophrenia. The physician orders dated 6/1/11 included: Haldol 5 mg po (by mouth)/IM (intramuscularly) Q (every) 4h (hours) PRN (as needed) aggression, and Ativan 2 mg IM q 4 h PRN aggression. On 6/2, Ativan 2 mg IM PRN for restlessness was prescribed. On 6/8 Ativan 2 mg IM po q 4h PRN for agitation.

The June 2011 Medication Administration Record (MAR) noted the patient received Ativan 2 mg IM for aggression and Haldol 5 mg for agitation at 3:00 P.M. on 6/8/11.
There was no documentation which described what behavior the patient exhibited to justify the use of these PRN medications, or interventions to use the least restrictive approach before the use of medication.

Interview with SP # 16 on 6/20/11 at approximately 2:00 P.M. revealed there were no notes that described the behavior that warranted the use of the PRN medication . SP # 16 added this patient refuses most po (by mouth) medications and does not object to IM administration.

Interview with MD #9 regarding this patient's medications and orders on 6/20/11 at approximately 3:00 P.M. revealed the patient should not have been given the Haldol and Ativan at the same time, as there was a potential for harm. The MD added he/she would not have ordered Haldol for agitation or Ativan for aggression.

Based on interviews, and hospital documents, it was determined the hospital failed to meet the Condition of Participation of Quality Assessment Performance Improvement (QAPI) as evidenced by:

1. Failing to extend the scope of the Quality Assurance Performance Improvement activities to identify and reduce medical errors. Please refer to A0266.

2. Failing to use relevant patient care data available to monitor the safety practices and to identify areas improve patient care. Please refer to A0276.

3. Failing to set priorities for Quality Assessment Performance Improvement activities to include high risk problem prone areas. Please refer to A0285.

The combined cumulative effect of these identified concerns resulted in the failure of the effectiveness of the QAPI program to improve care.

Based on interview and record review, the hospital failed to identify and reduce medical errors for 1 applicable patient. Patient #14.


The findings are:

Interview with SP #26 revealed that the hospital failed to have any polices or procedures related to controlled substance disposition. It was confirmed that the hospital had no records or a system of reconciliation of controlled drugs. Medical record review for Patient #14 identified significant variations in the medication administration of a controlled substance over a period of time as evidenced by the documenation reviewed in the Omnicell records.

The facility failed to identify these errors. Please refer to A0490 and A0491.

Based on interview and hospital document review, the hospital failed to incorporate patient care data that had been collected to improve patient care.


The findings are:


The hospital had a prior survey which included findings that identified a failure to follow physician orders, and failure to ensure completion of the Braden Scale Assessments for skin. Interviews throughout the survey revealed staff were collecting data, however, these areas were still identified as not corrected. Please refer to A0395 and A0396.


During an interview with representatives of the Quality Assurance and Performance Improvement Committee, it was revealed staff were conducting audits, however, they did not identify areas of concern for example, wound care, or using the least restrictive method of restraint. The hospital did not analyze the data or use prior citations to implement any change.

Based on interviews and record reviews, the hospital failed to set priorities for its performance improvement activities that focus on high-risk, high-volume, or problem-prone areas; consider the incidence, prevalence, and severity of problems in those areas; and affect health outcomes, patient safety, and quality of care related to the physical environment and infection control.


The findings are:


Review of prior documentation and interviews noted problems in the Operating Room due to ceiling leaks and excessive humidity levels. These issues had known to the hospital for some time based upon environmental rounds and communications from the Operating Room staff. Staff had brought to leaderships attention on numerous occasions, their concerns regarding ceiling tile issues as well as the amount and effect that the condensation was having in the operating room on their equipment and the potential for injury to patients and staff. The hospital failed to identify this high risk problem prone area as a priority to improve patient care and safety. Please refer to A940 and A701.

Nursing services failed to set as a priority, the management and oversight of nursing services given knowledge that the prior survey had identified areas of concern not yet corrected. Interview with representatives of the Quality Assurance and Performance Improvement Committee revealed they have 3 staff reviewing records 5 days a week. Their findings are reported to the Head Nurses and then relayed to the Director of Nursing Services. Although the data was available, review of medical records still identified incomplete assessments, missing wound documentation and hospital staff still were not following policy regarding the conduct of Braden Assessments. Please refer to A395 and A396.

During an interview with representatives of the Quality Assurance and Performance Improvement Committee, it was revealed staff performed environmental rounds on a regular basis. Although the rounds were conducted, several areas of the hospital were not identified as high risk, high volume areas that presented a risk to patient safety. In particular, the environmental rounds failed to identify potential hazards in Psychiatric Unit. These included a door that was nailed shut, loopable appliances and ineffective breakaway shower rods. The Emergency Room was another area where safety concerns were not identified. Specifically, lack of operable call bell system. Please refer to A0144.

Another area of the environment not covered pertaining to problem prone area with high risk was dietary services. The potential for food-borne illness and sanitary breaches were not identified. Please refer to A0724 and A0747.

Based on review of medical records and interview with staff, it was determined that the hospital failed to meet the Condition of Participation for Medical Staff by the failure to ensure medical staff bylaws applied equally for all patients on the Discharge Unit, specifically Patient #13 and Patient #17 as evidenced by:

According to Article I, Section 1. Purpose of the Medical Staff Bylaws of the Hospital approved by the Board of Directors on 12/15/2010 it states " the medical staff work together as an organized body to promote uniform standard of quality patient care, treatment and services and to offer adivce, recommendations and input to the Chief Executive Officer and the Board."

1. Patient #13

The medical staff had not documented an assessment of the patient for six weeks from the patient's admission on 5/11/11 until 6/22/11. In addition, on 5/16/11 the patient had requested to speak with the physician, but there is no documentation that the physician ever complied with the patient's request.
Patient #13 was admitted/transferred to the Discharge Unit on 5/11/11 with the diagnosis of bilateral above the knee amputation.

Review of the patient's medical record on 6/22/11 revealed no assessment by the physician or physician assistant since the patient's admission to the Discharge Unit on 5/11/11.
Review of a Nurse's Note written on 5/16/11 indicated that the patient wanted to speak to the physician.
On 6/1/11 there are two Nurse's Notes documented at 4:20 P.M. and 5:20 P.M. indicating that attempts to reach the physician were unsuccessful.
Interview with SP #21 on 6/22/11 at 3:50 P.M. revealed that a medical staff person had reviewed the patient's medical record today, but had not written a note. SP #21 could not confirm that the physician ever spoke with the patient.

2. Patient #17
Patient #17 was admitted/transferred to the Discharge Unit in the hospital on 2/15/11 with multiple pressure ulcers. Physician orders included cleanse decubitus with normal saline and apply Silvadene cream with Duoderm covering. The order does not identify the location of decubitus, or the frequency of the treatment.

A Skin Risk Assessment Braden Scale was done on 2/23 with a score of 12, and 3/1 with a score of 8 (12 or less designates a high risk to develop pressure ulcers).

Review of the Medical Provider Notes dated 3/9, the patient also had a history of Alzheimer's and Hypertension. The physical exam noted a bandage on the left forearm, left knee, left and right shin, and decubitus. The Assessment and Plan for this patient included to admit to extended care unit for the following: Dementia, Malnourished; Severe Anemia (lower than normal number of red blood cells); Advanced Directives: DNR (Do Not Resuscitate); Urosepsis (Sepsis is a life-threatening bacterial infection of the blood; urosepsis is sepsis that complicates a urinary tract or prostate infection); Possible A fibrillation (abnormal heart rhythm); and Decubitus Ulcer: Cleanse with normal saline and apply Silvadene and Duoderm, continue wound care. On 3/11, SP #19 noted questionable A (atrial) fibrillation, question new onset, was discussed with (Physician name), no further treatment since patient is DNR.

A Nurses Note dated 3/9 documented the following: "Wound Care. Assessment: Patient is aware of his/her surroundings and responds to questions verbally and to pain with cries and grimaces. S/he has multiple pressure ulcers some are healed, other healing and some are in need of dressing. Plan: Take photos, record measurements, clean and dress with Iodosorb and Solosite as condition of wound dictates." There were no physician orders to correspond with this treatment.
On 3/9/11, a Wound Assessment form identified:
Stage II pressure ulcer on the sacrum which measured 5 x 6 cm;
Stage II pressure ulcer on the right hip which measured 2 x 2.5 cm;
Stage II pressure ulcer on the right elbow which measured 1.5 x 1 cm;
Unstageable pressure ulcer on the left lateral ankle which measured 3 x 1.5 cm;
Unstageable pressure ulcer on the right hip which measured 7 x 7 cm;
Stage II pressure ulcer on the right butt cheek which measured 3 x 1 cm;
Unstageable pressure ulcer on the right medial knee which measured 3 x 8 cm;
A total of 7 areas were noted.

On 3/15/11, a Wound Assessment form identified:
Stage II pressure ulcer on the sacrum which measured 4 x 4 cm;
Stage II pressure ulcer on the right hip which measured 1.5 x 1.5 cm and 2 x 1 cm;
Stage II pressure ulcer on the right medial knee which measured 2 x 1.5 cm;
Stage II pressure ulcer on the left lateral ankle which measured 2 x 1 cm;
Unstageable pressure ulcer on the left hip which measured 7 x 8.5 cm;
Stage III pressure ulcer on the left shin which measured 7.3 x 5 cm.
A total of 6 areas were noted.

On 3/21/11, a Wound Assessment form identified:
Stage II pressure ulcer on the right medial knee which measured 4 x 8 cm;
Unstageable pressure ulcer on the left hip which measured 7.8 x 9.5 cm;
A wound described as a contact burn on the left side which measured 3 x 6 cm and was also noted as a Stage II;
Unstageable pressure ulcer on the left anterior leg which measured 9 x 5 cm with necrosis, and copious, purulent and foul smelling drainage;
Stage II pressure ulcer on the sacrum which measured 6 x 4 cm with necrosis;
A total of 4 pressure ulcers and one contact burn wound.
On 3/21/11, a Registered Nurse wrote, "Assessment: Pt. (patient) have multiple ulcers on his/her body some are healing other are not. Plan: Take photo, record measurements, clean and dress the ulcers." Ten days later on 3/31/11, the same Registered Nurse documented, "Assessment: Left medial leg is very necrotic with milky malodorous drainage. The Sacrum and rt (right) hip shows signs of healing. Rt medial knee ulcer is granulated. The left hip and left lateral ankle have eschar tissue. Plan: clean and dress sacrum, rt hip and knee with Allevyn Ag, left hip and ankle with Solosite conformable and left medial leg with Iodosorb/ 4 x 4/kling."
On 3/31/11, a Wound Assessment form identified:
Stage IV pressure ulcer on the sacrum which measured 7 x 4 cm;
Stage II pressure ulcer on the right hip which measured 11 x 11 cm;
Stage III pressure ulcer on the right medial knee which measured 5 x 4 cm;
Unstageable, necrotic pressure ulcer on the left lateral ankle which measured 9 x 11 cm;
Unstageable pressure ulcer on the left hip which measured 9 x 11 cm;
Unstageable, pressure ulcer on the left shin with a copious amount of purulent, foul odor drainage.
A total of 6 pressure ulcers, and the sacral ulcer advanced to a Stage IV; there was no information regarding the contact burn..
Available Wound Assessments from 3/5/11 through 4/4/11 were reviewed. Dressing changes for the sacral pressure ulcer did not occur every 3 days, as per facility policy: 3/6/11 to 3/10/11, and 3/10/11 to 3/15/11. The left shin wound dressing was changed on 3/24/11 and 3/28/11, and noted the wound with copious, purulent, foul odor drainage, bone, muscle, and tendons were visible. There was no documentation to verify the other wounds had dressing changes except 3/5/11, the right hip wound had a dressing change, and 3/24/11, all wounds had dressing changes, and 3/28/11 the dressing was changed on the left shin.
On 3/31/11 The physician noted the patient was seen because of ulceration on leg; physical exam revealed a large necrotic ulcer involving the left leg with bone exposed. The physician also noted the spouse refused any surgical intervention, but added a consult for possible debridement would be requested.
A surgical consult on 3/31/11 revealed, "a large putrid, full thickness necrotic eschar involving the entire medial aspect of left lower leg, there is an abundant amount of purulent drainage coming from an opening involving the proximal aspect of the ulcer, the left foot has chronic dependent edema." The note further stated, "debridement is futile, amputation, i.e. left above the knee is indicated."
A surgical history and physical dated 4/5/11 documented left lower leg entirely consumed by active, infectious gangrenous process. An above the left knee amputation was performed on 4/5/11.
On 6/22/11 at approximately 1:40 P.M., an interview with SP #21 who was assisting with the electronic record review, revealed they do not perform routine skin assessments on this unit. S/he also verified there was no individualized Plan of Care for this patient that identified the exact number, location and stage of pressure ulcers, or included specific nursing interventions and equipment and treatments used to promote healing and prevent the development of additional ulcers. S/he added the wound nurse takes care of the wounds.
There was a lack of evidence to demonstrate the wounds for Patient #17 were assessed, monitored and treated. Please refer to A 0385, A0395 and A0396.

Based on observations, review of clinical records, review of policies and procedures and staff interviews, it was determined that the hospital failed to meet the Condition of Participation for Nursing Services as evidenced by:

1. There was a twenty-two day delay in nursing staff assessing Patient #10's left shoulder abscess and a month delay in staff notifying the physician and implementing interventions to address the patient's left shoulder abscess. Patient #10 required surgical debridement of the infected left shoulder and post-operatively was intubated, placed on a ventilator and transferred to the Intensive Care Unit. Additionally, there is a lack of nursing assessment and monitoring from 5/3/11 to 5/7/11 while the patient was in the Intensive Care Unit. Please refer to A0395.

2. Review of the hospital's Wound Care Policy dated September 2, 2006 and reviewed by the hospital on September 2, 2009 indicated that it is the responsibility of the hospital's Director of Nursing to ensure that the wound care protocols are instituted and followed for all residents/patients needing wound treatment. All patients admitted will be assessed for risk of developing a pressure ulcer using the pressure ulcer risk assessment (BRADEN SCALE) in the electronic documentation system, and reassessed daily. A complete wound assessment and documentation will be done weekly on all pressure ulcers until they are healed. The criteria to be included: site/location, stage, size (length, width and depth measured in centimeters) and appearance of the wound bed. Patient #1, Patient #11, Patient #12, Patient #13, Patient #14, and #17's pressure ulcers were not continually assessed, monitored or treated. Please refer to A0395.

3. Patient #1 experienced shortness of breath on 6/7/11 and there was no continuous nursing monitoring of the patient for eight days following this occurrence. Please refer to A0395.

4. There was a nine day delay in the wound consult being performed for Patient #11. Please refer to A0395.

5. Patient #11 was not assessed for pain management prior to receiving antipsychotic medication. Please refer to A0395.

6. Labs ordered by the physician were never collected for Patient #1. Please refer to A0395.

7. Nursing staff did not perform daily Skin Risk Assessments Braden Scales for Patient #1, Patient #8, Patient #9, Patient #13, Patient #14, Patient #17, Patient #20 and Patient #21. Please refer to A0395.

8. Patient #1 and Patient #8's Plan of Care did not identify pressure ulcers as a problem. Patient #9, Patient #10, Patient # 12, Patient #14, Patient #17, Patient #19 and Patient #20's Plan of Care did identify skin integrity as an issue but did not include interventions specific to the patients' needs to prevent or promote healing of the wounds. Please refer to A0396.


9. There was no physician's order for Patient #14 to receive wet to dry wound treatment. Please refer to A0395.

10. The facility failed to follow physician orders in regard to the administration of Phenobarbital for 1 of 47 Patients, Patient #14. The Patient received an excessive amount of medication on 202 occasions. The patient received less than the ordered dose on 121 occasions. The patient received medication less than three times daily (t.i.d.) on 31 days. Please refer to A0404.


Nursing Services were not organized based upon the combined cumulative findings which impacted on the provision of care and services to the patients of the hospital.

Based on observations, review of the hospital's policies and procedures, medical record reviews, and staff interviews, it was determined that for 11 of 47 patients the registered nurse did not continuously assess the patients' care needs related to pressure ulcers, pain management, medication administration, and did not assess the patients' response to interventions. The nursing staff failed to assess Patient #10's left shoulder abscess and delayed in notifying the physician and implementing interventions to address the patient's left shoulder abscess. While in the Intensive Care Unit, the nursing staff failed to assess and monitor Patient #10 from 5/3/11 to 5/7/11. The nursing staff failed to continually assess, monitor and/or treat Patient #1, Patient #11, Patient #12, Patient #13, Patient #14 and Patient #17's pressure ulcers. Patient #1 was not continuously monitored after experiencing shortness of breath. There was a nine day delay in the wound consult being performed for Patient #11. Nursing staff did not assess Patient #11 for pain prior to administering antipsychotic medication. Labs ordered by the physician were never collected for Patient #1. Nursing staff did not perform daily Skin Risk Assessments Braden Scales for Patient #1, Patient # 8, Patient #9 Patient #13, Patient #14, Patient $17, Patient # 20 and Patient #21.

The findings include:

1. Patient #10

A. There was a twenty-two day delay in nursing staff assessing the patient's left shoulder and a month delay in staff notifying the physician and implementing interventions to address Patient #10's left shoulder abscess.

Patient #10 was admitted to the hospital on 12/2/10 status post a Cardiovascular Accident and was transferred to the Discharge Unit on 2/15/11.

Review of the Medicine Progress Notes revealed the following information:

3/9/11 at 4:41 P.M. the Physician Assistant documented Extremities no swelling noted. Cleanse decubitus with Normal Saline and apply Silvadene with Duoderm. (The patient had a decubitus on the right ankle.)

4/12/11 at 3:14 P.M. the Physician Assistant documented extremities no swelling noted, Left shoulder abscess. The physician was contacted and indicated the following: obtain a culture of the wound, x-ray of left shoulder, surgery consult and recommended antibiotics. "If needing intravenous antibiotics will need to transfer to surgical unit, blood cultures x 2, Tylenol #3 2 tablets every 4-6 hours as needed for pain."

Review of the Nurse's Notes revealed the following Licensed Practical Nurses' documentation except where noted as documented by a Registered Nurse:

3/12/11 at 8:29 A.M. Patient has a reddened swollen area to left deltoid, seems to look like an abscess.

3/14/11 at 1:45 P.M. Doctor notified of blood work, prothrombin time (PT) and international normalized ratio (INR) results. No new orders.

3/21/11 at 2:45 P.M. Registered Nurse documented Wound Care Assessment: Pressure ulcers to right hip and lateral ankle. Both have granulation, but the hip has a hardness beneath the reddened area and there is slough in the ulcer above. The ankle has dark peri-wound skin. Plan: clean and dress with Solosite, changing every three days.

3/21/2011 at 4:10 P.M. Received patient lying in bed with eyes closed, respirations even and unlabored. No complaints voiced. No distress noted.

3/31/11 at 5:57 P.M. Doctor informed of PT and INR results. Coumadin 10 mg via gastric tube as ordered.

4/3/11 at 12:49 A.M. Patient awake skin cool to touch. Vomited a medium amount of undigested Glucerna. Care given, linen changed and made comfortable.

Review of the 4/4/11 Wound Assessment indicated that the patient had a right ankle pressure sore with minimal serosanguineous drainage. A right hip pressure ulcer that had moderate serosanguineous drainage and bleeding. A left shoulder pressure ulcer with moderate serosanguineous drainage and bleeding. Wet to dry gauze pads were applied.

Review of the subsequent Wound Assessments in the patient's medical record were dated 4/6/11, 4/7/11, 4/8/11 and 4/11/11 and only described the patient's right ankle. These Wound Assessments included no documentation about the patient's left shoulder or right hip wounds.

Additional review of the Nurse's Notes revealed the following Licensed Practical Nurses' documentation except where noted as documented by a Registered Nurse:

4/8/11 at 6:19 P.M. General condition remains unchanged.

4/12/11 at 10:19 A.M. Night nurse informed that patient left shoulder swollen and painful to touch. Assessed and found it to be true. Called doctor and he stated he would come to see the patient.

4/12/11 at 10:57 A.M. Warm compress applied to left shoulder.

4/12/11 at 2:33 P.M. Portable x-ray done on the left shoulder, wound culture and blood culture done. Surgical consult answered by surgeon.

4/13/11 at 12:35 P.M. Patient left unit via stretcher to Computerized axial tomography (CT) scan in no acute distress.

4/13/11 at 12:56 P.M. Patient returned to unit. No acute distress.

4/14/11 at 3:30 P.M. Register Nurse documented Wound Care Consult Assessment: Patient has a new wound to his left shoulder which resulted from an abscess. (It was reported). The other areas of concern are his right hip and right ankle. Plan: take photo of the affected areas, record measurements, clean and dress with Iodosorb.

4/17/11 at 12:00 P.M. Registered Nurse documented Wound Care Assessment: It was reported that patient's shoulder wound was still sloughy and draining a lot. The hip pressure ulcer remained unchanged. Plan: Continue same dressing. Note: Dressing change was done by Wound Care CNA supervised by floor nurse measurements not recorded.

4/23/11 at 7:41 A.M. Making rounds this morning and the patient said good morning nurse.

5/1/11 at 10:00 P.M. Patient awake skin warm to touch, changed, turned, repositioned and made comfortable. Abscess to left shoulder continues to drain foul brownish secretions. 10:00 P.M. Temperature 102 degrees Fahrenheit and Tylenol given via peg tube. Patient is to have nothing by mouth after midnight as going for a debridement of the abscess ulcer in the morning.

5/3/11 at 2:12 P.M. The patient left the unit for the operating room via stretcher assisted by the Operating Room technician.

Review of the 5/3/11 Operative Report revealed the following:

Severely Necrotic Wounds of the left shoulder and right hip. The left shoulder was prepped and draped. The wound was debrided sharply with a scalpel and scissors. The necrotic tissue was removed until healthy tissue was encountered. The underlying bone was exposed and appeared to be infected necrotic tissue. The wound was irrigated with saline and dressed. The attention was turned to the right hip wound which was prepped and draped. It too was debrided as described above.

On 5/4/11 the surgeon documented that the patient was transferred to ICU post-operatively secondary to respiratory failure, intubated and hemodynamically stable now. The wounds are still with foul odor and dressing with drainage present, no surrounding cellulitis seen.

The patient was extubated on 5/8/2011, wound cultures revealed Methicillin-resistant Staphylococcus Aureus (MRSA) and Klebsiella which were treated with intravenous Vancomycin and Zosyn. The patient was transferred to the medical floor.

Review of the hospital's Policy and Procedure: Guidelines for the Assessment and Reassessment of All Patients dated 5/1/09 indicated that the goal of assessment and reassessment is to determine the appropriate care, treatment, and services necessary to meet a patient's initial needs as well as his or her changing needs while in the hospital setting. The frequency and degree of detail performed in each episode of assessment/reassessment is dependent on the needs of the patient, outcome goals, and level of care being provided. All nursing personnel are responsible for the relay of identified changes in the patient's condition to the appropriate healthcare provider.

During an interview with SP #22 on 6/22/11 at 11:30 A.M., s/he confirmed that there was a month delay in staff notifying the physician and implementing interventions to address the patient's left shoulder abscess.

2. Patient #17

Patient #17 was first admitted to the hospital on 1/14/11 for multiple pressure ulcers and dehydration, and transferred to the Discharge Unit on 2/15/11. Physician orders included Cleanse Decubitus with normal saline and apply Silvadene cream with Duoderm covering. The order does not identify the location of decubitus, or how frequently the dressing should be changed.

A Skin Risk Assessment Braden Scale was done on 2/23/11 with a score of 12, and 3/1/11 with a score of 8 (12 or less designates a high risk to develop pressure ulcers).
Review of the Medical Provider Notes revealed on 3/9/11 that the patient also had a history of Alzheimer's and Hypertension. The physical exam noted a bandage on the left forearm, left knee, left and right shin, and decubitus. The Assessment and Plan for this patient included to admit to extended care unit for the following: Dementia, Malnourished; Severe Anemia (lower than normal number of red blood cells); Advanced Directives: DNR (Do Not Resuscitate); Urosepsis (Sepsis is a life-threatening bacterial infection of the blood; Urosepsis is sepsis that complicates a urinary tract or prostate infection); Possible Atrial Fibrillation (abnormal heart rhythm); and Decubitus Ulcer: Cleanse with normal saline and apply Silvadene and Duoderm, continue wound care. On 3/11/11, SP #19 noted questionable A (atrial) fibrillation, question new onset, was discussed with (Physician name), no further treatment since patient is DNR.
A Nurses Note dated 3/9/11 documented the following: "Wound Care. Assessment: Patient is aware of his/her surroundings and responds to questions verbally and to pain with cries and grimaces. S/he has multiple pressure ulcers some are healed, other healing and some are in need of dressing. Plan: Take photos, record measurements, clean and dress with Iodosorb and Solosite as condition of wound dictates." There were no physician orders to correspond with this treatment.
On 3/9/11, a Wound Assessment form identified: a Stage II pressure ulcer on the sacrum which measured 5 x 6 cm; a Stage II pressure ulcer on the right hip which measured 2 x 2.5 cm; a Stage II pressure ulcer on the right elbow which measured 1.5 x 1 cm; an unstageable pressure ulcer on the left lateral ankle which measured 3 x 1.5 cm; an unstageable pressure ulcer on the right hip which measured 7 x 7 cm; a Stage II pressure ulcer on the right butt cheek which measured 3 x 1 cm; an unstageable pressure ulcer on the right medial knee which measured 3 x 8 cm; and an unstageable pressure ulcer on the left lateral ankle which measured 3 x 1.5 cm. A total of 8 areas were noted.
On 3/15/11, a Wound Assessment form identified: a Stage II pressure ulcer on the sacrum which measured 4 x 4 cm; a Stage II pressure ulcer on the right hip which measured 1.5 x 1.5 cm and 2 x 1 cm, which indicated 2 areas; a Stage II pressure ulcer on the right medial knee which measured 2 x 1.5; a Stage II pressure ulcer on the left lateral ankle which measured 2 x 1 cm; an unstageable pressure ulcer on the left hip which measured 7 x 8.5 cm; and a Stage III pressure ulcer on the left shin which measured 7.3 x 5 cm. A total of 6 areas were noted.
On 3/21/11, a Wound Assessment form identified: a Stage II pressure ulcer on the right medial knee which measured 4 x 8 cm; an unstageable pressure ulcer on the left hip which measured 7.8 x 9.5 cm; a wound described as a contact burn on the left side which measured 3 x 6 cm and was also noted as a Stage II; an unstageable pressure ulcer on the left anterior leg which measured 9 x 5 cm with necrosis, and copious, purulent and foul smelling drainage; a Stage II pressure ulcer on the sacrum which measured 6 x 4 cm with necrosis; and a Stage II pressure ulcer on the sacrum which measured 6 x 4 cm. A total of 6 wounds.
On 3/21/11, a Registered Nurse wrote, "Assessment: Pt. (patient) have multiple ulcers on his/her body some are healing other are not. Plan: Take photo, record measurements, clean and dress the ulcers."
Ten days later on 3/31/11, the same Registered Nurse documented, "Assessment: Left medial leg is very necrotic with milky malodorous drainage. The Sacrum and rt (right) hip shows signs of healing. Rt medial knee ulcer is granulated. The left hip and left lateral ankle have eschar tissue. Plan: clean and dress sacrum, rt hip and knee with Allevyn Ag, left hip and ankle with Solosite conformable and left medial leg with Iodosorb/ 4 x 4/kling."
On 3/31/11, a Wound Assessment form identified: A Stage IV pressure ulcer on the sacrum which measured 7 cm x 4 cm; a Stage II pressure ulcer on the right hip which measured 11 x 11 cm; a Stage III pressure ulcer on the right medial knee which measured 5 x 4 cm; an unstageable, necrotic pressure ulcer on the left lateral ankle which measured 9 x 11 cm; an unstageable pressure ulcer on the left hip which measured 9 x 11 cm; and an unstageable, pressure ulcer on the left shin with a copious amount of purulent, foul odor drainage. A total of 6 wounds.
Available Wound Assessments from 3/5/11 through 4/4/11 were reviewed. Dressing changes for the sacral pressure ulcer did not occur every 3 days, as per facility policy: 3/6/11 to 3/10/11, and 3/10/11 to 3/15/11. The left shin wound was changed on 3/24/11 and 3/28/11, and noted the wound with copious, purulent, foul odor drainage, bone, muscle, and tendons were visible. There was no documentation to verify the other wounds had dressing changes except 3/5/11, the right hip wound had a dressing change, and 3/24/11, all wounds had dressing changes, and 3/28/11 the left shin had a dressing change.
On 3/31/11 The physician noted the patient was seen because of ulceration on leg; physical exam revealed a large necrotic ulcer involving the left leg with bone exposed. The physician also noted the spouse refused any surgical intervention, but added a consult for possible debridement would be requested.
A surgical consult on 3/31/11 revealed, "a large putrid, full thickness necrotic eschar involving the entire medial aspect of left lower leg, there is an abundant amount of purulent drainage coming from an opening involving the proximal aspect of the ulcer, the left foot has chronic dependent edema." The note further stated, "debridement is futile, amputation, i.e. left above the knee is indicated."
A surgical history and physical dated 4/5/11 documented left lower leg entirely consumed by active, infectious gangrenous process. An above the left knee amputation was performed on 4/5/11.
On 6/22/11 at approximately 1:40 P.M., an interview with SP #21 who was assisting with the electronic record review, revealed they do not perform routine skin assessments on this unit. S/he also verified there was no individualized Plan of Care for this patient that identified the exact number and stage of pressure ulcers, or included specific nursing interventions and equipment used to promote healing and prevent the development of additional ulcers. S/he added the wound nurse takes care of the wounds. There was a lack of evidence to demonstrate the wounds for Patient #17 were assessed, monitored and treated.

3. Patient #1

A. Patient #1's pressure ulcer was not continually assessed, monitored or treated.
Patient #1 was admitted to the hospital on 5/18/11 with Dehydration, Renal Failure and a History of Cervical Cancer.
Review of the Physician's Order Form dated 5/25/11 at 11:14 A.M. revealed an order for wet to dry dressings to vaginal/labial wound. Turn every two hours.
Review of the Physician Notes revealed the following:
5/25/11 at 11:32 A.M. Genitourinary (GU) labial ulceration.
5/26/11 at 9:05 A.M. GU Labial ulceration. Buttocks - sacral ulceration.
5/28/11 at 1:01 P.M. GU vaginal ulceration on labia.
6/9/11 at 9:30 A.M. Buttocks -sacral ulceration. GU -vaginal labial ulceration.
6/10/11 at 12:23 P.M. Cervical cancer and sacral and vaginal skin ulcerations.
6/13/11 at 9:51 A.M. Buttocks ulceration healing. GU labial ulceration.
6/15/11 at 8:11 A.M. Buttocks sacral ulceration encouraged patient to turn every two hours. GU reveals full ulceration.
6/16/11 at 9:47 A.M. Buttocks sacral ulcer Stage I-II. GU Labial draining ulcer (foul smelling).
6/17/11 at 11:45 A.M. Cervical cancer and sacral and vaginal skin ulcerations. Buttocks-sacral ulcer. GU-labial ulcer.
6/20/11 at 1:15 P.M. Buttocks - ulceration. GU ulceration on labia.
Review of Physical Assessments dated 5/18/11 through 6/19/11 completed by the nursing staff revealed inconsistent documentation of the presence of a sacral decubitus, vaginal ulceration and vaginal tenderness. On 6/5/11, the Physical Assessment indicated a Tegaderm is in place over the sacral decubitus.
Review of the Nurse's Notes on 5/25/11 at 11:30 A.M. revealed the following documentation: Patient refused to have naso-gastric (NG) tube inserted as per doctor's orders. She stated that she is not ready. She also refused to have dressing applied to vaginal area as per doctor's request. She stated she wants to be left alone.
On 6/22/11 at 9:00 A.M. SP #22 stated the Wound Policy and Procedure indicated that staff are suppose to document a wound assessment at least weekly including a description and measurements of the wounds. S/he also stated that nursing staff document the wound assessment and wound treatments in the Wound Assessment. Review of the patient's medical record revealed only one Wound Assessment dated 6/4/11. The Wound Assessment indicated that the patient had a Stage II sacral pressure ulcer which had minimal serosanguineous drainage and the dressing was dry and intact.
On 6/22/11 at 9:05 A.M. an interview was conducted with SP #23 who was caring for the patient. SP #23 stated that the order for wet to dry dressings to the patient's vaginal/labia wound was never clarified to determine how often the dressing was to be performed. SP #23 also stated that the patient had refused the wound treatment on 5/25/11; nursing staff did not perform the wound treatments and did not inform the physician that treatments were not being performed to the sacral or vaginal/labial area. SP #23 stated that s/he thought the wound care team was doing the Wound Assessments.
During review of the Nurse's Notes with SP #22 on 6/22/11 at 9:10 A.M., s/he confirmed that there were no Nurse's Notes documented about the patient's vaginal/labia wound or dressings after 5/25/11 through the last Nurse's Note documented in the medical record on 6/16/11.

B. Nursing staff did not perform daily Skin Risk Assessments Braden Scales for Patient #1.
Review of the hospital's Wound Policy and Procedure indicated that on a daily basis the nursing staff are to perform a Skin Risk Assessment Braden Scale. A score of less than fifteen would indicate that the patient was at risk for skin breakdown. The Skin Risk Assessment Braden Scale includes the following scores and predictors for pressure ulcer risk: score of 15-16 = low risk, score of 13-14 = moderate risk, and a score of 12 or less = high risk.
Review of the patient's Skin Risk Assessment Braden Scales revealed that they were not done every day. The review also revealed that when the Skin Risk Assessment Braden Scales were done the scores ranged from 16 on 5/18/11, 12 points on 6/3/11 and 13 points on 6/6/11.

C. Patient #1 experienced shortness of breath on 6/7/2011 and there was no continuous nursing monitoring of the patient for eight days following this occurrence.
On 6/7/11 at 10:30 A.M. the nursing staff documented that the patient was noted to be short of breath complaining of difficulty breathing. Nasal cannula placed at 3.5 liters of oxygen. Patient placed in upright position. Intravenous fluids stopped. The doctor ordered Lasix 40 milligrams (mg) intravenously which was given at 10:40 A.M. Patient assisted out of bed in chair for 10 minutes then assisted back in bed for pain medication that was given at 11:00 A.M. Will continue to monitor.
At 11:30 A.M., the nursing staff documented that the patient was lying calm in bed. Mild respiratory distress noted. Will continue to monitor. Call light in reach.
At 1:00 P.M. nursing staff documented the patient was resting quietly in bed with no distress. Will continue to monitor.
The next Nurse's Note was not documented until eight days later on 6/15/11 at 1:00 P.M.
During an interview with SP #22 on 6/22/11 at 9:15 A.M., s/he stated that nursing staff should have documented in the medical record after the patient's respiratory incident and during the eight day lapse.

D. Labs ordered by the physician were never collected from Patient #1.
On 5/18/11 the physician ordered stool cultures and stools for ova and parasite examination.
On 6/13/11 the physician ordered a urinalysis.
Review of Patient #1's medical record revealed no reports for the stool culture, stool for ova and parasite examination or the urinalysis. Although SP #23 stated during an interview on 6/21/11 at 9:05 a.m. that the patient did not have any stools since admission, review of the medical record revealed that the patient had stools on 5/28/11 and 5/29/11.

4. Patient #8
Medical Record Review done in the presence of hospital staff on 6/22/11 at 10:15 A.M. with SP #1 confirmed hospital policy was not followed pertaining to the Braden Assessment. Examples of the inconsistent skin assessments note the Braden was completed on 4/28 and not again unit 5/19; next done on 5/27 and again on 5/29.

5. Patient #9
Medical Record Review done in the presence of hospital staff on 6/22/11 at 9:30 A.M. and again at 10:30 A.M. with SP #25 and SP #1, confirmed hospital policy was not followed pertaining to the Braden Assessment. Examples of the inconsistent skin assessments note the Braden was completed on 6/4, 6/5, 6/6 nothing on 6/7 or 6/8 and no assessments from 6/13 through the day of the review on 6/22/11.

6. Patient #20
Medical Record Review done in the presence of hospital staff on 6/22/11 at 10:30 A.M. with SP #25 and SP #1 confirmed hospital policy was not followed pertaining to the Braden Assessment. The only evidence of the Braden Assessment being completed was on 6/14/11.

7. Patient #21
Patient # 21 was admitted to the hospital on 3/22/11, with a diagnosis of Hypertension, End Stage Renal Disease (Dialysis) and Hepatitis - B. A review of the patient's medical record noted the Physical Assessment forms and Nursing Notes revealed the patient's skin was intact until 4/4/11; the nurse documents that the patient had a skin tear in her sacral area.
Review of the Wound Assessment documentation indicated that the patient's wound was assessed on 4/4/11 and then not again until 4/22/11.
On 4/22/11 the Physician's order form states the following:
1. Clean sacral ulcer with wound cleaner. Dress with Allevyn Ag cream and 4 x 4 dressing.
2. Please turn patient every two hours to prevent decubitus.
Review of the medical revealed that there was no documented evidence that this patient was turned and positioned every two hours during her entire stay.
The wound care consult notes dated 4/26/11 states:
Sacral ulcer has silver scab; it is pink and has no drainage.
Again the Wound Assessment documentation indicated that the patient's wound was assessed on 5/9/11 and then not again until 5/22/11.
A surgical consult note dated 6/16/11 states: There is an ulcerative wound involving the sacrum, stage 2-3 that is presently without odor and without significant drainage.
During the medical record review done in the presence of hospital staff on 6/22/11 at 11:10 A.M. with SP #1 confirmed hospital policy was not followed pertaining to the Braden Assessment. Examples of the inconsistent skin assessments note the Braden was completed on 6/7/11, not again until 6/11/1; 6/16/11 and not again until 6/19/11.
During an interview with SP #32 on 6/23/11, s/he acknowledged that the staff should have documented that they were turning the patient every two hours and should have done daily wound assessment.

8. Patient #12
Patient #12's pressure ulcer was not continually assessed, monitored or treated. There was a nineteen day delay in the nursing staff's assessment of the pressure ulcer from 4/1/11 to 4/20/11. In addition, there was an eleven day delay in assessing the pressure ulcer from 5/16/11 to 5/27/11. There was a nine day lapse in treatment being provided from 5/18/11 until 5/27/11 and a five day delay in treatment being provided from 6/6/11 until 6/11/11.

Patient #12 was admitted to the hospital on 2/5/11 after tripping and falling.

Review of the patient's medical record revealed the following information:
The Physical Assessment forms and Nursing Notes revealed that the patient's skin was intact until 3/14/11 when a note indicated that the patient "has a hospital acquired pressure ulcer stage II in the coccyx measures 1.5 x 2.0 centimeters (cm) The wound bed has some yellow slough and eschar with wound edges looking pink. Treatment Plan: wound cleansed with dermal wound cleanser and Allevyn Ag Dressing 3 x 3 applied to wound. Dressing changed every day."
Review of the medical record revealed that there was a nineteen day delay in the nursing staff's assessment of the wound. Review of the Wound Assessment documentation indicated that the patient's wound was assessed on 4/1/11 and then not again until 4/20/11 when it was identified as being 4 x 5 cm with a depth of .30 with yellow slough.
There was an eleven day delay in assessing the pressure sore from 5/16/11 when it was described as 5 x 5.6 x 1.5 depth with yellow slough Stage IV until 5/27/11 when the wound had deteriorated to 8.5 x 6 x 2 cm with moderate serous drainage.
During review of the patient's medical record with SP #22 on 6/21/11 at 2:00 p.m. revealed that staff were to provide treatments as ordered by the physician at least every three days or as needed and to assess the wound including measurements at least every seven days.
In addition, SP #22 stated that the staff document in the Wound Assessment notes when they changed the patient's dressing. Review of the Patient's Wound Assessment documentation revealed a nine day delay in changing the dressing from 5/18/11 until 5/27/11. In June there was a five day delay in providing treatment from 6/6/11 until 6/11/11. Additionally, there is no measurement of the wound in the Wound Assessment or Nursing Notes from 5/27/11 through 6/20/11 and no documentation from nursing that a Wound Vac was applied on 6/14/11.
Interview with SP #22 on 6/21/11 at 2:00 P.M. confirmed the lack of continuous assessment of the wound and lack of treatment.

9. Patient #11
A. There was a nine day delay in the wound consult being performed and interventions being implemented for Patient #11.
Review of the Physician's Order Form revealed an order on 5/3/11 for "wound team for sacral wound" and on 5/4/11 for " Wound Team evaluation. "
However, review of the patient's medical record did not reveal a Wound Care Evaluation until 5/12/11. Patient has a sacral ulcer measuring 3.21 x 3 cm. It is granulated and have minimal amount of serous drainage. Plan: clean with Dermal wound cleanser, dress with Iodosorb, change the dressing every three days.

B. Patient #11's pressure ulcer was not continually assessed, monitored or treated.

On 5/12/11, the physician had ordered the wound to be cleansed and dress with Iodosorb and change dressing every three days. Review of the patient's Wound Assessments revealed the pressure ulcer treatment was performed on 5/15/11 at 4:00 P.M. but not again until 5/22/11.

On 6/7/11, the physician ordered Acticoat Dressing to sacrum every three days. Review of the patient's Wound Assessments revealed no documentation that a pressure ulcer wound treatment was performed for six days from 6/7/11 at 10:13 A.M. until 6/13/11 at 6:00 A.M.


C. Patient #11 was not assessed for pain or offered pain medication prior to staff administering antipsychotic medication.

Review of the physician's note on 5/29/11 at 12:14 P.M. indicated that Patient #11 still required ventilator support due to desaturation and fatigue. Has increased agitation, not sleeping, anxious, Ativan not helping. Anxious give Haldol and Cogentin now.

Review of the Physician's Order Form on 5/29/11 at 12:16 P.M. indicated Haldol 5 mg via peg tube/intramuscularly now and Cogentin 2 mg via peg tube/intramuscularly now. The Haldol and Cogentin were given at 1:00 P.M. on 5/29/11.

There was no nursing documentation that the patient was assessed for pain prior to the Haldol and Cogentin being administered. The patient had an order for Percocet 5/325 one tablet every six hours as needed for pain. Review of the patient's Medication Administration Record revealed that the patient received the Percocet 5/325 on 5/26/11 at 7:00 P.M., on 5/27/11 at 1:30 P.M. and 7:00 P.M. and on 5/30/11 at 7:00 P.M. No pain medication was given on 5/28/11 or 5/29/11.

There is no description of the patient's behavior documented by nursing to warrant the administration of the Haldol and Cogentin as there are no Nurse's Notes documented from 5/26/11 at 5:45 P.M. until 6/9/11 at 6:00 A.M.


10. Patient #13

A. Patient #13's pressure ulcer was not continually assessed, monitored or treated.

Patient #13 was admitted/transferred to the Discharge Unit on 5/11/11 with the diagnosis of bilateral above the knee amputation.

The patient was admitted/transferred to the Discharge Unit on 5/11/11 but it was not until fifteen days later that the left medial stump was assessed and measured.
Review of the patient's Wound Assessments does not begin until 5/17/11 indicated the following about the left medial stump wound:
5/17/11 Dressing was changed and there was minimal purulent drainage. Gauze pads used to dress the wound.
5/20/11 Dressing was changed and there was minimal purulent drainage. Gauze pads used to dress the wound.
5/26/11 at 6:00 P.M. Dressing changed. Minimal serous drainage 1.0 x 1.5 cm Stage II Plan: Use Dermal Wound Cleanser, Skin prep wipes, Iodosorb Adhesive foam 3 x 3.
Review of the patient's Wound Assessments and Nurse's Notes on 6/22/11 revealed no documentation about the patient's left medial stump wound for twenty-two days. The last Wound Assessment was documented on 6/1/11 indicated that a dressing had been applied to the patient's left stump, but no further Wound Assessments have been documented.

B. Nursing staff did not perform daily Skin Risk Assessments Braden Scales for Patient #13.
Review of the Wound Policy and Procedure indicated that on a daily basis the nursing staff are to perform a Skin Risk Assessment Braden Scale. A score of less than fifteen would indicate that the patient was at risk for skin breakdown. The Skin Risk Assessment Braden Scale includes the following scores and predictors for pressure ulcer risk: score of 15-16 = low risk, score of 13-14 = moderate risk, and a score of 12 or less = high risk.
Review of the patient's Skin Risk Assessment Braden Scales revealed that they were not done every day and the scores ranged from 3 points on 5/12/11, 16 points on 5/3/11, 10 points on 5/10/11, 18 points on 5/27/11, and 14 points on 6/2/11.

C. Nursing staff did not implement interventions to ensure that the medical staff communicated with the patient.
Review of the patient's medical record did not reveal any documentation from the physician or physician assistant.
A Nurse's Note on 5/16/11 indicated that the patient wanted to speak to the physician.
On 6/1/11 there are two Nurse's Notes documented at 4:20 P.M. and 5:20 P.M. indicating that attempts to reach the physician was unsuccessful.
Interview with the SP #21 on 6/22/11 at 3:50 P.M. revealed that a medical staff person had reviewed the chart today, but had not written a note. SP #21 could not confirm that the physician ever spoke with the patient.

11. Patient #14
A. There was no physician's order for wet to dry wound treatment.
Patient #14 was admitted to the Discharge Unit on 2/15/11 with the diagnosis of vegetative state.

Review of the 2/21/11 Wound Care Assessment indicted that a "sacral ulcer persists but remains granulated. Floor nurses to do wet to dry dressings."
On 3/9/11 Wound Care Nurse documented the wound was 3.5 cm x 1 cm with undermining 2 cm deep. Serous drainage. Floor nurses will do wet to dry daily dressings.
The next note documented i

Based on clinical record reviews and staff interviews, it was determined that the hospital did not ensure that nursing staff developed and kept current nursing care plans for 10 of 47 patients. Patient #1 and Patient #8's Plan of Care did not identify pressure ulcers as a problem. Patient #9, Patient #10, Patient #12, Patient #14, Patient #17, Patient #19 and Patient #20"s Plan of Care did identified skin integrity as an issue but did not include interventions specific to the patients' needs to prevent or promote healing of the patients' wounds. Patient #2 and #3's Plans of Care did not address the patients' behavior.

The findings include:

1. Patient #1
Patient #1's Plan of Care did not identify ulcers as a problem.
Review of the Physician's Order Form dated 5/25/11 at 11:14 A.M. revealed an order for wet to dry dressings to vaginal/labial wound. Turn every two hours.
Review of the Physician Notes revealed the following documentation:
5/25/11 at 11:32 A.M. Genitourinary (GU) labial ulceration.
5/26/11 at 9:05 A.M. GU Labial ulceration. Buttocks - sacral ulceration.
5/28/11 at 1:01 P.M. GU vaginal ulceration on labia.
6/9/11 at 9:30 A.M. Buttocks -sacral ulceration. GU -vaginal labial ulceration.
6/10/11 at 12:23 P.M. Cervical cancer and sacral and vaginal skin ulcerations.
6/13/11 at 9:51 A.M. Buttocks ulceration healing. GU labial ulceration.
6/15/11 at 8:11 A.M. Buttocks sacral ulceration encouraged patient to turn every two hours. GU reveals full ulceration.
6/16/11 at 9:47 A.M. Buttocks sacral ulcer Stage I-II. GU Labial draining ulcer (foul smelling).
6/17/11 at 11:45 A.M. Cervical cancer and sacral and vaginal skin ulcerations. Buttocks-sacral ulcer. GU-labial ulcer.
6/20/11 at 1:15 P.M. Buttocks - ulceration. GU ulceration on labia.
However, review of the patient's Plan of Care initiated on 5/19/11 did not identify ulcerations as a problem. Interview with SP #24 on 6/22/11 at 3:05 P.M. confirmed that the patient's Plan of Care did not address the patient's ulcerations.

2. Patient # 8
Review of the medical record for Patient # 8 identified a stage 2 pressure ulcer to the right sacrum noted 4/28/11. Nurses notes indicated several red areas to sacrum, heels and hips. On 6/13/11, the Stage 2 pressure area was noted to be 2x3 cm.( centimeters) Review of the patient's plan of care found the facility failed to identify the above mentioned pressure areas and to detail interventions to provide the necessary care for the compromised skin integrity. This was confirmed during the review with SP #1 on 6/22/11 at 10:15 A.M.

3. Patient #9
The medical record for Patient #9 noted a wound assessment dated 6/10/11 that identified a left buttock skin tear measuring 4 x 4 cm (centimeters) and a right (no location) skin tear that measured 13 cm x 5 cm. Review of the patient's Plan of Care found the only mention of the skin was to "exhibit dry and intact skin" initiated on 6/4/11. The Plan of Care did not reflect the skin tears nor were there any interventions to provide the necessary care for the compromised skin areas. This was confirmed during the review with SP #25 at 9:30 A.M. on 6/22/11.

4. Patient #10
Patient #10's Plan of Care did identified skin integrity as an issue but did not include interventions specific to the patient's needs to prevent or promote healing of the wounds.
Review of Patient #10's Plan of Care initiated on 5/4/11 revealed the identified problem of impaired skin integrity. Interventions included Skin Risk Assessment Braden Scale. The Plan of Care indicated that patients should be assessed on admission and patients with established pressure ulcers should be reassessed periodically. In addition, the Plan of Care included the following interventions to reduce pressure on bony prominences: bed cradles and heel and elbow protectors. Elevate effected extremity when appropriate. Maintain limbs in functional alignment.
During an interview with SP # 24 on 6/22/11 at 3:05 P.M. s/he confirmed that these were the only interventions documented for the patient's Plan of Care.

5. Patient #12
Patient #12's Plan of Care did identify skin integrity as an issue but did not include interventions to prevent or promote healing of the wounds.
Review of Patient #12's Plan of Care initiated on 2/5/11 revealed the identified problem of impaired skin integrity. Interventions included Skin Risk Assessment Braden Scale. The Plan of Care indicated that patients should be assessed on admission and patients with established pressure ulcers should be reassessed periodically. In addition, the Plan of Care included the intervention to collaborate with Dietitian for dietary needs.
During an interview with SP #24 on 6/22/11 at 3:05 P.M. s/he confirmed that these were the only interventions documented in the patient's Plan of Care.

6. Patient #14
Patient #14's Plan of Care did identify skin integrity as an issue but did not include interventions to prevent or promote healing of the wounds.
Review of Patient #14's Plan of Care initiated on 2/16/11 revealed the identified problem of wound prevention care. Interventions included Skin Risk Assessment Braden Scale. The Plan of Care indicated that patients should be assessed on admission and patients with established pressure ulcers should be reassessed periodically.
During an interview with SP #24 on 6/22/11 at 3:05 P.M. s/he confirmed that these were the only interventions documented for the patient's Plan of Care.

7. Patient #17
Patient # 17 admitted to an inpatient hospital stay on 1/15/11 and was identified as having multiple pressure ulcers. A plan of care was initiated at that time to address skin integrity. No specific interventions individualized to this patient were noted nor the location/stage of the existing pressure ulcers.

7. Patient #19
Patient #19 was presented to the emergency room on 6/12/11 with cellulitis of the left great toe. Measurements noted in the medical record recorded the patient had a pressure ulcer on the left ankle of 1 cm x 1 ? cm, left heel that was unstageable and a left great toe that was bloody without measurements. Although the Plan of Care dated 6/12/11 mentioned to "monitor s/s (signs and symptoms) impaired skin integrity", the Plan of Care was not revised to accurately reflect the present skin conditions nor were there an individualized interventions specific to the multiple existing pressure ulcers. This was confirmed with SP #1 at 9:10 A.M.

8. Patient #20
The medical record for Patient #20 was reviewed and noted that the Plan of Care dated 6/14/11 was not revised to reflect the risk factors noted in the wound consult of 6/14/11. The skin was described as having signs of broken down, pale and ashen. The only intervention in the Plan of Care is the same standard language used for all patients and not individualized to meet the needs of Patient #20. This was confirmed during the review with SP #1 and SP #25 at 10:30 A.M.

9. Patient #2
Patient #2 was admitted to the Psychiatric Unit on 6/1/11 with a diagnosis of Chronic Paranoid Schizophrenia. The physician orders dated 6/1/11 included: Haldol 5 mg po (by mouth)/IM (intramuscularly) Q (every) 4h (hours) PRN (as needed) aggression, and Ativan 2 mg IM q 4 h PRN aggression. On 6/2, Ativan 2 mg IM PRN for restlessness was prescribed. On 6/8/11 Ativan 2 mg IM po q 4h PRN for agitation.

On 6/20/11 at approximately 1:45 P.M., the Plan of Care was reviewed. There was no individualized Plan of Care that described this patient's specific behaviors related to aggression and/or restlessness to indicate what least restrictive approaches nursing should use prior to medication; and clarification of which medication should be used for restlessness or aggression.
An interview with SP #16 following the review confirmed there was no Plan of Care designed specifically to address this patient's behavior.


10. Patient #3
Patient #3 was was admitted to the Psychiatric Unit on 6/20/11 after a police escort into the Emergency Room following an alleged behavioral and assault outburst at home.
The Physician had ordered Haldol 10 mg (tranquilizer) every 4 hours for aggressive behavior. There was no individualized Plan of Care that described this patient's specific behaviors related to aggression, or if any less restrictive interventions were to be used prior to the administration of medication.
An interview with SP #16 following the review confirmed there was no Plan of Care designed specifically to address this patient's behavior.

Based on clinical record review, staff interviews and review of hospital policies it was determined that the facility failed to follow physician orders in regard to the administration of Phenobarbital for 1 of 47 Patients (Patient #14).

1. The Patient received an excessive amount of medication on 202 occasions.
2. The patient received less than the ordered dose on 121 occasions.
3. The patient received medication less than three times daily (t.i.d.) on 31 days.

The findings include:

On 6/20/11 a clinical record review was conducted for Patient #14. The patient had a physician's order for Phenobarbital 30 mg. (milligram) to be administered t.i.d. (three times daily). The Medication Administration Record was reviewed and revealed dates when the medication was not administered to Patient #14.

SP #26 was interviewed on 6/23/11 at 2:30 P.M. and said that the use of the Omnicell allows the pharmacy to print out a line listing of the Phenobarbital administered to the patient. A list from February 16, 2011 until June 23, 2011 was requested.

The physicians order was for 30 mg. of Phenobarbital to be administered to the patient three times daily (t.i.d.). SP #26 said that medication was placed into the Omnicell by pharmacy staff. The Phenobarbital was in 20 mg. (milligram) per 5 ml. (milliliter) liquid containers. S/he said that the nurse administering the medication would need to remove 2.5 ml. from a container and waste it with a witness present and document the wastage in the Omnicell machine. The dosage would then equal the 30 mg. as ordered by the physician

Upon assessing the computer documentation regarding the Phenobarbital administration to Patient #14, SP #26 said that it appeared there were numerous medication errors as listed on the computer line listing sheets. S/he also said that there appeared to be in excess of 300 medication errors for the 128 days that were printed. S/he also agreed that the patient had received medication doses in excess and below what the physician had ordered.
When questioned about how medications could be removed improperly from the Omnicell machine, s/he said that "we have an honor system."

Of the 128 calendar days Patient #14 was in the Discharge Unit, there were 202 occurrences of Phenobarbital for Patient #14 removed from the Omnicell machine that were in excess of the physician ordered dosage.

There were two additional occasions where the excess Phenobarbital was wasted and properly documented.

A review of the computer records revealed that the medications administered in excess of physician orders were documented from 2/18/11 to 6/23/11. (Cross reference to A491).

There were 121 occurrences where Patient #14 received less than the 30 mg. dose of medication as ordered from the Omnicell machine. According to pharmacy records, the patient received less that the required amount of Phenobarbital from 2/19/11 and 6/23/11. (Cross reference to A491) .

In addition, the facility failed to ensure that Patient #14 received physician ordered Phenobarbital t.i.d. For 31 documented days from 2/18/11 until 6/23/11, the patient received Phenobarbital medication less than prescribed or not at all. (Cross reference to A491)

On 6/24/11 at 12:00 P.M. during an interview with SP #14, s/he acknowledged that the nursing staff should properly document the medication administration when given, waste extra medication with a witness and also document why medications are not given.

A review of facility policy Medication Error, Revised March 2009, reviewed at 2:00 P.M. on 6/24/11 revealed that "A medication error is defined as a dosage given: Wrong dosage form, Wrong compounding or preparation technique, Omitted doses ... "

A review of facility policy Controlled Drug Management on Patient Care Units, Revised March 2009 reviewed on 6/24/11 at 2;30 P.M. revealed that "the nurse will use the waste option of the automated dispensing machine (Omnicell) if all or part of a control substance must be wasted. This must be witnessed by a second nurse/physician and cosigned in the automated dispensing system. The amount used is entered into the system ..."

Based upon medical record and document review and interviews, it was determined that the hospital failed to meet the Condition of Participation for Medical Records Services as evidenced by:

1. Failing to have medical records that contain complete information and/or documentation describing care provided and individual patients' response. Please refer to A0449.

2. Failing to ensure that all entries into the medical records are dated, completed and timed. Please refer to A0450.

3. Failing to ensure that all physician orders were signed timely. Please refer to A0454.

Based on clinical record reviews and staff interviews, it was determined that the hospital did not ensure that the medical records for 9 of 30 inpatients contained information to describe the patients' progress and response to medications and services. There was a lack of nursing documentation regarding Patient #1's vaginal/labia wound and an eight day lapse in nursing documentation after Patient #1 experienced shortness of breath. There was a twenty-two day delay in nursing staff documenting an assessment of Patient #10's left shoulder. Patient #11's medical record revealed a fourteen day lapse in nursing documentation from 5/26/11 until 6/9/11. There was a nineteen day lapse from 4/1/11 to 4/20/11 and an eleven day lapse from 5/16/11 to 5/27/11 in nursing documenting about Patient #12's pressure ulcer. There was a twenty-two day lapse in nursing documenting about Patient #13's left medial stump. Nursing staff did not document about Patient #14's sacral ulcer for several months. There was not consistent daily documentation of the Skin Risk Assessment Braden Scales according to facility policy for Patient #1, Patient #8, Patient #9, Patient #13, Patient #14, Patient #17, Patient #20 and Patient #21.

The findings include:

1. Patient #10

There was a twenty-two day delay in nursing staff documenting an assessment of Patient #10's left shoulder.

Review of the Nurse's Notes revealed the following Licensed Practical Nurses' documentation except where noted as documented by a Registered Nurse:

3/12/11 at 8:29 A.M. Patient has a reddened swollen area to left deltoid, seems to look like an abscess.

3/14/11 at 1:45 P.M. Doctor notified of blood work, prothrombin time (PT) and international normalized ratio (INR) results. No new orders.

3/21/11 at 2:45 P.M. Registered Nurse documented Wound Care Assessment: Pressure ulcers to right hip and lateral ankle. Both have granulation, but the hip has a hardness beneath the reddened area and there is slough in the ulcer above. The ankle has dark peri-wound skin. Plan: clean and dress with Solosite, changing every three days.

3/21/2011 at 4:10 P.M. Received patient lying in bed with eyes close, respirations even and unlabored. No complaints voiced. No distress noted.

3/31/11 at 5:57 P.M. Doctor informed of PT and INR results. Coumadin 10 mg via gastric tube as ordered.

4/3/11 at 12:49 A.M. Patient awake skin cool to touch. Vomited a medium amount of undigested Glucerna. Care given, linen changed and made comfortable.

Review of the 4/4/11 Wound Assessment indicated that the patient had a right ankle pressure sore with minimal serosanguineous drainage. A right hip pressure ulcer that had moderate serosanguineous and bleeding. A left shoulder pressure ulcer with moderate serosanguineous and bleeding. Wet to dry gauze pads were applied.

Review of the subsequent Wound Assessments in the patient's medical record were dated 4/6/11, 4/7/11, 4/8/11 and 4/11/11 and only described the patient's right ankle. These Wound Assessments included no documentation about the patient's left shoulder or right hip wounds.

Additional review of the Nurse's Notes revealed the following Licensed Practical Nurses' documentation except where noted as documented by a Registered Nurse:

4/8/11 at 6:19 P.M. General condition remains unchanged.

4/12/11 at 10:19 A.M. Night nurse informed that patient left shoulder swollen and painful to touch. Assessed and found it to be true. Called doctor and he stated he would come to see the patient.

4/12/11 at 10:57 A.M. Warm compress applied to left shoulder.

4/12/11 at 2:33 P.M. Portable x-ray done on the left shoulder, wound culture and blood culture done. Surgical consult answered by surgeon.

During an interview with Nursing SP #22 on 6/22/11 at 11:30 A.M. s/he confirmed that there was a twenty-two day lapse in staff documenting about the patient's left shoulder abscess.


2. Patient #1

A. There was an eight day lapse in nursing documentation after Patient #1 experienced shortness of breath.

On 6/7/11 at 10:30 A.M. the nursing staff documented that the patient was noted to be short of breath complaining of difficulty breathing. Nasal cannula placed at 3.5 liters of oxygen. Patient placed in upright position. Intravenous fluids stopped. The doctor ordered Lasix 40 milligrams (mg) intravenously which was given at 10:40 A.M. Patient assisted out of bed in chair for 10 minutes then assisted back in bed for pain medication that was given at 11:00 A.M. Will continue to monitor.
At 11:30 A.M., the nursing staff documented that the patient was lying calm in bed. Mild respiratory distress noted. Will continue to monitor. Call light in reach.
At 1:00 P.M. nursing staff documented the patient was resting quietly in bed with no distress. Will continue to monitor.
The next Nurse's Note was not documented until eight days later on 6/15/11 at 1:00 P.M.
During an interview with SP #22 on 6/22/11 at 9:15 A.M., s/he stated that nursing staff only document when something happens to a patient. S/he confirmed that nursing staff should have documented in the medical record after the patient's respiratory incident and during the eight day lapse.

B. There was a lack of nursing documentation regarding Patient #1 ' s vaginal/labia wound.
Patient #1 was admitted to the hospital on 5/18/11 with Dehydration Renal Failure and a History of Cervical Cancer.
Review of the Physician's Order Form dated 5/25/11 at 11:14 A.M. revealed an order for wet to dry dressings to vaginal/labial wound. Turn every two hours.
Review of the Physician Notes from 5/25/11 through 6/17/11 revealed that the patient had a Genital-urinary labial ulceration. Buttocks - sacral ulceration.
Review of Physical Assessments dated 5/18/11 through 6/19/11 completed by the nursing staff revealed inconsistent documentation of the presence of a sacral decubitus, vaginal ulceration and vaginal tenderness. On 6/5/11, the Physical Assessment indicated a Tegaderm is in place over the sacral decubitus.
On 6/22/11 at 9:00 A.M. SP #22 stated the Wound Policy and Procedure indicated that staff are suppose to document a wound assessment at least weekly including a description and measurements of the wounds. S/he also stated that nursing staff document the wound assessment and wound treatments in the Wound Assessment.
Review of the patient's medical record revealed only one Wound Assessment dated 6/4/11. The Wound Assessment indicated that the patient had a Stage II sacral pressure ulcer which had minimal serosanguineous drainage and the dressing was dry and intact.
During review of the Nurse's Notes with SP #22 on 6/22/11 at 9:10 A.M., s/he confirmed that there was no Nurse's Notes documented about the patient's vaginal/labia wound after 5/25/11 through the last Nurse's Note documented in the medical record on 6/16/11.

3. Patient #11

Patient #11's medical record revealed a fourteen day lapse in nursing documentation from 5/26/11 until 6/9/11. During this time the patient received Haldol, an antipsychotic medication and Cogentin, an anticholinergic that reduces the side effects of antipsychotic treatment. However, there was no nursing documentation of the behavior that was displayed to warrant the administration of Haldol and Cogentin. Additionally, although the patient had an order for pain medication as needed, there was no documentation that the patient was assessed for pain or offered pain medication prior to the Haldol and Cogentin being administered.

Review of the Physician's Order Form on 5/29/11 at 12:16 P.M. indicated Haldol 5 mg via peg tube/intramuscularly now and Cogentin 2 mg via peg tube/intramuscularly now. The Haldol and Cogentin were given at 1:00 P.M. on 5/29/11.

There is no description of the patient's behavior documented by nursing to warrant the administration of the Haldol and Cogentin as there are no Nurse's Notes documented from 5/26/11 at 5:45 P.M. until 6/9/11 at 6:00 A.M.

Review of the physician's note on 5/29/11 at 12:14 P.M. indicated that the patient still required ventilator support due to desaturation and fatigue. Has increased agitation, not sleeping, anxious, Ativan not helping. Anxious give Haldol and Cogentin now.

There was no documentation that the patient was assessed for pain prior to the Haldol and Cogentin being administered. The patient had an order for Percocet 5/325 one tablet every six hours as needed for pain. Review of the patient's Medication Administration Record revealed that the patient received the Percocet 5/325 on 5/26/11 at 7:00 P.M., on 5/27/11 at 1:30 P.M. and 7:00 P.M. and on 5/30/11 at 7:00 P.M. No pain medication was given on 5/28/11 or 5/29/11.

4. Patient #12
There was a nineteen day lapse from 4/1/11 to 4/20/11 and an eleven day lapse from 5/16/11 to 5/27/11 in nursing documenting about Patient #12's pressure ulcer.

Patient #12 was admitted to the hospital on 2/5/11 after tripping and falling.

Review of the patient's medical record revealed the following information:
The Physical Assessment forms and Nursing Notes revealed that the patient's skin was intact until 3/14/11 when a note indicated that the patient "has a hospital acquired pressure ulcer stage II in the coccyx measures 1.5 x 2.0 centimeters (cm) The wound bed has some yellow slough and eschar with wound edges looking pink. Treatment Plan: wound cleansed with dermal wound cleanser and Allevyn Ag Dressing 3 x 3 applied to wound. Dressing changed every day."
Review of the medical record revealed that there was a nineteen day delay in the nursing staff's assessment of the wound. Review of the Wound Assessment documentation indicated that the patient's wound was assessed on 4/1/11 and then not again until 4/20/11 when it was identified as being 4 x 5 cm with a depth of .30 with yellow slough.
There was an eleven day delay in assessing the pressure sore from 5/16/11 when it was described as 5 x 5.6 x 1.5 depth with yellow slough Stage IV until 5/27/11 when the wound had deteriorated to 8.5 x 6 x 2 cm with moderate serous drainage.
Interview with SP #22 on 6/21/11 at 2:00 P.M. confirmed the lack of nursing documentation of the patient's pressure ulcer.

5. Patient #13

There was a twenty-two day lapse in nursing documenting about Patient #13's left medial stump.
Review of the patient's Wound Assessments and Nurse's Notes on 6/22/11 revealed no documentation about the patient's left medial stump wound for twenty-two days. The last Wound Assessment was documented on 6/1/11 indicated that a dressing had been applied to the patient's left stump, but no further Wound Assessments have been documented.

6. Patient #14
Nursing staff did not document about Patient #14's sacral ulcer for several months.

On 3/9/11 Wound Care Nurse documented the wound was 3.5 cm x 1 cm with undermining 2 cm deep. Serous drainage. Floor nurses will do wet to dry daily dressings.
The next note documented in the medical record was on 4/14/11 and indicated that the floor nurses would do wet to dry daily dressings. Area is open, minimal serous drainage.
The next Nurse's Note regarding the pressure ulcer was written on 6/21/11 and indicated that the wound was 98% healed with a 2 cm opening, covered with Tegaderm.
During an interview with SP #21 on 6/22/11 at 3:30 P.M. confirmed there were no Nurse's Notes about the patient's sacral ulcer from 3/9/11 to 4/14/11 and then from 4/14/11 to 6/21/11.

7. There was not consistent daily documentation of the Skin Risk Assessment Braden Scales for Patient #1, Patient #8, Patient #9, Patient #13, Patient #14, Patient #17, Patient #20 and Patient #21.
Review of the Wound Policy and Procedure indicated that on a daily basis the nursing staff are to perform a Skin Risk Assessment Braden Scale. A score of less than fifteen would indicate that the patient was at risk for skin breakdown. Review of the patients ' Skin Risk Assessment Braden Scales revealed that they were not done every day. Please refer to A0395.

Based upon interviews and review of surgical medical records, the hospital failed to ensure that all entries in the record were complete, accurate or timed for 4 of 4 surgical records reviewed. (Patient # 4, 5, 6 and 7).

Evidence includes the following:

1. Patient #4
Patient #4 was reviewed on 6/21/11 which revealed the patient was admitted on 6/20/11 for same day surgery. Noted in the medical record were various forms that did not have the time recorded of the physician's entries. These forms included, Medication Reconciliation, Surgical Care Improvement Project Core Measures, Anesthesia Peri-Operative record, discharge order and discharge instruction sheet. Additionally, the form titled "Patient Safety 10/08" noted several areas that were not complete per hospital policy.

2. Patient #5
Patient #5's record was reviewed on 6/21/11 which revealed several physician entries that were not timed. This included Medication Reconciliation, Surgical Care Improvement Project Core Measures, Anesthesia Post-operative report and the Intra-operative Anesthesia record.

3. Patient #6
Patient # 6's record was reviewed on 6/21/11 which revealed the patient was admitted on 6/20/11 for same day surgery. Review of the form titled "Patient Safety 10/08" noted several areas that were not complete per hospital policy. Under the Pre-operative verification checklist, the item identification band and picture ID, Patient understanding confirms physician's order, physician order matches consent and patient and/or family member coincide with site/side verification was initialed only by 1 staff person. Interview with SP #1 on 6/21/11 at approximately 11:00 A.M. stated the policy was that staff individuals were to verify the items that had an asterisk as indicated on the form.
Additional forms that were not timed when signed by the physician included the discharge order of 6/20/11, discharge instructions, Medication Reconciliation form and Surgical Care Improvement Project Core Measure form.

4. Patient #7
Patient # 7's record was reviewed on 6/21/11 which revealed the patient was admitted on 6/20/11 for same day surgery. Review of the record identified inaccurate dates were recorded of the Patient Safety Form 10/08 where the physician noted the under the section titled "Surgeon/Practioner Verification" the date of 6/3/11 as well as the Pre Operative orders were written for 6/3/11. Surgery was performed on 6/20/11.
Also noted on this form were several areas that were not complete per hospital policy. Under the Pre-operative verification checklist, the item identification band and picture ID, Patient understanding confirms physician's order, physician order matches consent and patient and/or family member coincide with site/side verification was initialed only by 1 staff person.
Additionally, the medical record had various other forms that did not have the time recorded of the physician's entries. These forms included, Medication Reconciliation, Core Measures, Intra-operative Anesthesia record, discharge order and discharge instruction sheet.
Interview with SP #1 confirmed the missing medical entries that were not timed and or signed as well as the inaccurate dates on 6/21/11. The expectation according to SP #1 was that hospital policy would be followed relative to the documentation standards, policy and requirements.

Based on record review and interview, the hospital failed to ensure all orders were dated and timed promptly by the ordering practitioner for 1 of 7 sampled outpatient medical records.

The findings include:

Outpatient #7

1. Record review for Outpatient #7 indicated an order for PT (Physical Therapy) treatment sessions to consist of manual therapy, modalities, therapeutic exercises and activities to achieve treatment goals; frequency 2-3 x per week; duration 4 weeks. Further record review revealed start of care was 5/18/11.

The order was signed by the Physical Therapist on 5/18/11, time 10:13 A.M., the Physician's signature was noted to be 6/13/11.

Interview with MD #10, on 6/20/11 at approximately 11:00 A.M. confirmed the order was not obtained, signed and timed promptly.

Based on observation, document review and interview, it was determined that the hospital failed to meet the Condition of Participation for Pharmaceutical Services by failing to provide pharmaceutical services in accordance with acceptable standards of practice as evidenced by:

1. Failure to ensure a method for medication reconciliation of all controlled drugs distributed by the pharmacy and controlled drugs brought into the hospital by patients for administration during their hospital stay. This failure can lead to potential drug overdoses for patients and diversion of medications. Please refer to A491.

2. Failure to have current and accurate records and disposition for controlled medications. This lack of record keeping and reconciliation has the potential for drug diversion. Please refer to A494.

3. Failure to ensure that outdated, mislabeled and unusable medications were not available for patient use. This failure has the potential for harm to patients by not providing medications whose shelf life has not deteriorated. Please refer to A505.

4. Failure to ensure that drug administration errors were promptly reported to the patient' s attending physician. This failure could lead to a patient being
over/under medicated leading to patient harm. Please refer to A508.

Based on observation, staff interview and review of hospital policies, it was determined that the Pharmacy failed to ensure that pharmaceutical services were provided in a professional manner as identified by failure to ensure medication reconciliation for controlled medications administered to one of 37 patients and medications brought in by patients to be administered.

The findings include:

Interview with SP #26 on 6/23/11 at 3:30 P.M. revealed that although the pharmacy has policies and procedures to reconcile medications, the pharmacy failed to operationalize their policies for reconciliation of controlled medications.

On 6/20/11 at 3:00 P.M. SP #26 was interviewed regarding policies in the pharmacy department. S/he said that there were no policies or procedures to prevent a nurse from removing extra doses of medication from the Omnicell. S/he added that there is an honor system. S/he also said that nurses are required to ensure the count by signing out the medication needed for a patient. S/he was asked if anything would prevent a nurse from removing a stat dose and not administer it to a patient. S/he said that missing medications would be trended weekly and then the reports would then be sent to the Director of Nursing.

SP #26 said that the pharmacy has a policy to check the Omnicells regularly to ensure that expired medications are not distributed to patients. S/he further said that patients are allowed to bring in their own medications to be administered. The medications are inspected and then sent to the nursing units where they are distributed to the patient. Upon discharge, the medications are recounted minus the doses administered. Then, the medications are sent back to the unit and the nurse returns the controlled medications to the patient upon discharge. The Proof of Use Sheet is then filed in the Pharmacy.

A review of Phenobarbital medications administered to Patient #14 revealed that there were 202 doses which were signed out in excess of the 30 milligram (m.g.) dose and not recorded as having been wasted.

Of the 128 calendar days Patient #14 was in the Discharge Unit, there were 202 occurrences of Phenobarbital for Patient #14 removed from the Omnicell machine that were in excess of the physician ordered dosage.

There were only two additional occasions where the excess Phenobarbital was wasted and properly documented.

A review of the computer records revealed that the medications administered in excess of physician orders were documented on the following dates and times:

2/18/11 at 2:47 P.M., 2 UDC (Unit Dose Cups) equaling 40 mg.
2/19/11 at 5:25 P.M., 2 UDC equaling 40 mg.
2/21/11 at 1:17 P.M., 2 UDC equaling 40 mg.
2/21/11 at 5:41 P.M., 2 UDC equaling 40 mg.
2/22/11 at 9:33 A.M., 3-30 mg. tablets
2/23/11 at 8:09 A.M., 2 UDC equaling 40 mg.
2/25/11 at 8:37 A.M., 2 UDC equaling 40 mg.
2/25/11 at 2:19 P.M., 2 UDC equaling 40 mg.
2/28/11 at 12:06 P.M., 2 UDC equaling 40 mg.
2/28/11 at 4:42 P.M., 2 UDC equaling 40 mg.
3/1/11 at 9:11 A.M., 2 UDC equaling 40 mg.
3/3/11 at 11:58 A.M., 2 UDC equaling 40 mg.
3/5/11 at 8:45 A.M., 2 UDC equaling 40 mg.
3/9/11 at 9:32 A.M., 2 UDC equaling 40 mg.
3/9/11 at 5:16 P.M., 2 UDC equaling 40 mg.
3/10/11 at 4:33 P.M., 2 UDC equaling 40 mg.
3/11/11 at 8:55 A.M., 2 UDC equaling 40 mg.
3/12/11 at 9:13 A.M., 2 UDC equaling 40 mg.
3/12/11 at 3:59 P.M., 2 UDC equaling 40 mg.
3/13/11 at 8:05 A.M., 2 UDC equaling 40 mg.
3/14/11 at 9:14 A.M., 2 UDC equaling 40 mg.
3/14/11 at 5:23 P.M., 2 UDC equaling 40 mg.
3/15/11 at 10:20 A.M., 2 UDC equaling 40 mg.
3/15/11 at 6:10 P.M., 2 UDC equaling 40 mg.
3/16/11 at 8:44 A.M., 2 UDC equaling 40 mg.
3/17/11 at 5:06 P.M., 2 UDC equaling 40 mg.
3/18/11 at 9:20 A.M., 2 UDC equaling 40 mg.
3/18/11 at 8:47 A.M., 2 UDC equaling 40 mg.
3/19/11 at 4:41 P.M., 2 UDC equaling 40 mg.
3/20/11 at 11:53 A.M., 2 UDC equaling 40 mg.
3/20/11 at 5:03 P.M. .2 UDC equaling 40 mg.
3/21/11 at 4:50 P.M., 2 UDC equaling 40 mg.
3/22/11 at 8:23 A.M., 2 UDC equaling 40 mg.
3/22/11 at 4:46 P.M., 2 UDC equaling 40 mg.
3/23/11 at 9:37 A.M., 2 UDC equaling 40 mg.
3/24/11 at 9:06 A.M., 2 UDC equaling 40 mg.
3/24/11 at 4:48 P.M., 2 UDC equaling 40 mg.
3/25/11 at 8:50 A.M., 2 UDC equaling 40 mg.
3/25/11 at 1:15 P.M., 2 UDC equaling 40 mg.
3/25/11 at 4:30 P.M., 2 UDC equaling 40 mg.
3/26/11 at 8:56 A.M., 2 UDC equaling 40 mg.
3/26/11 at 1:06 P.M., 2 UDC equaling 40 mg.
3/27/11 at 8:45 A.M., 2 UDC equaling 40 mg.
3/27/11 at 1:24 P.M., 2 UDC equaling 40 mg.
3/28/11 at 1:27 P.M., 2 UDC equaling 40 mg.
3/28/11 at 4:33 P.M., 2 UDC equaling 40 mg.
3/29/11 at 12:37 P.M., 2 UDC equaling 40 mg.
3/29/11 at 5:52 P.M., 2 UDC equaling 40 mg.
3/30/11 at 1:37 P.M., 2 UDC equaling 40 mg.
3/30/11 at 4:55 P.M., 2 UDC equaling 40 mg.
3/31/11 at 10:23 A.M., 2 UDC equaling 40 mg.
3/31/11 at 5:16 P.M., 2 UDC equaling 40 mg.
4/1/11 at 8:30 A.M., 2 UDC equaling 40 mg.
4/1/11 at 5:01 P.M., 2 UDC equaling 40 mg.
4/2/11 at 8:52 A.M., 2 UDC equaling 40 mg.
4/3/11 at 8:30 A.M., 2 UDC equaling 40 mg.
4/4/11 at 8:21 A.M., 2 UDC equaling 40 mg.
4/4/11 at 5:33 P.M., 2 UDC equaling 40 mg.
4/5/11 at 11:57 A.M., 2 UDC equaling 40 mg.
4/5/11 at 5:04 P.M., 2 UDC equaling 40 mg.
4/6/11 at 9:43 A.M., 2 UDC equaling 40 mg.
4/7/11 at 9:24 A.M., 2 UDC equaling 40 mg.
4/8/11 at 8:33 A.M., 2 UDC equaling 40 mg.
4/8/11 at 4:55 P.M., 2 UDC equaling 40 mg.
4/9/11 at 8:58 A.M., 2 UDC equaling 40 mg.
4/10/11 at 8:34 A.M., 2 UDC equaling 40 mg.
4/11/11 at 8:27 A.M., 2 UDC equaling 40 mg.
4/11/11 at 4:32 P.M., 2 UDC equaling 40 mg.
4/12/11 at 7:42 A.M., 2 UDC equaling 40 mg.
4/12/11 at 4:39 P.M., 2 UDC equaling 40 mg.
4/13/11 at 8:40 A.M., 2 UDC equaling 40 mg.
4/13/11 at 4:47 P.M., 2 UDC equaling 40 mg.
4/14/11 at 8:58 A.M., 2 UDC equaling 40 mg.
4/14/11 at 4:16 P.M., 2 UDC equaling 40 mg.
4/15/11 at 8:30 A.M., 2 UDC equaling 40 mg.
4/15/11 at 12:58 P.M., 2 UDC equaling 40 mg.
4/15/11 at 5:08 P.M., 2 UDC equaling 40 mg.
4/16/11 at 8:20 A.M., 2 UDC equaling 40 mg.
4/16/11 at 12:09 P.M., 2 UDC equaling 40 mg.
4/16/11 at 4:36 P.M., 2 UDC equaling 40 mg.
4/17/11 at 9:10 A.M., 2 UDC equaling 40 mg.
4/17/11 at 6:10 P.M., 2 UDC equaling 40 mg.
4/18/11 at 12:52 P.M., 2 UDC equaling 40 mg.
4/18/11 at 3:13 P.M., 2 UDC equaling 40 mg.
4/19/11 at 9:25 A.M., 2 UDC equaling 40 mg.
4/19/11 at 12:42 P.M., 2 UDC equaling 40 mg.
4/19/11 at 3:17 P.M., 2 UDC equaling 40 mg.
4/20/11 at 8:36 A.M., 2 UDC equaling 40 mg.
4/21/11 at 8:29 A.M., 2 UDC equaling 40 mg.
4/21/11 at 1:34 P.M., 2 UDC equaling 40 mg.
4/21/11 at 5:19 P.M., 2 UDC equaling 40 mg.
4/22/11 at 8:07 A.M., 2 UDC equaling 40 mg.
4/22/11 at 1:26 P.M., 2 UDC equaling 40 mg.
4/22/11 at 4:35 P.M., 2 UDC equaling 40 mg.
4/23/11 at 8:35 A.M., 2 UDC equaling 40 mg.
4/24/11 at 9:27 A.M., 2 UDC equaling 40 mg.
4/25/11 at 8:33 A.M., 2 UDC equaling 40 mg.
4/25/11 at 12:54 P.M., 2 UDC equaling 40 mg.
4/25/11 at 5:05 P.M., 2 UDC equaling 40 mg.
4/26/11 at 2:13 P.M., 2 UDC equaling 40 mg.
4/26/11 at 5:15 P.M., 2 UDC equaling 40 mg.
4/27/11 at 8:29 A.M., 2 UDC equaling 40 mg.
4/27/11 at 4:42 P.M., 2 UDC equaling 40 mg.
4/28/11 at 8:55 A.M., 2 UDC equaling 40 mg.
4/28/11 at 12:06 P.M., 2 UDC equaling 40 mg.
4/28/11 at 4:15 P.M., 2 UDC equaling 40 mg.
4/29/11 at 9:00 A.M., 2 UDC equaling 40 mg.
4/29/11 at 12:41 P.M., 2 UDC equaling 40 mg.
4/29/11 at 4:12 P.M., 2 UDC equaling 40 mg.
4/30/11 at 12:01 P.M., 2 UDC equaling 40 mg.
5/1/11 at 8:53 A.M., 2 UDC equaling 40 mg.
5/1/11 at 4:35 P.M., 2 UDC equaling 40 mg.
5/2/11 at 9:53 A.M., 2 UDC equaling 40 mg.
5/3/11 at 8:23 A.M., 2 UDC equaling 40 mg.
5/3/11 at 12:06 P.M., 2 UDC equaling 40 mg.
5/4/11 at 9:32 A.M., 2 UDC equaling 40 mg.
5/5/11 at 1:00 P.M., 2 UDC equaling 40 mg.
5/5/11 at 4:12 P.M., 2 UDC equaling 40 mg.
5/6/11 at 9:11 A.M., 2 UDC equaling 40 mg.
5/6/11 at 11:49 A.M., 2 UDC equaling 40 mg.
5/6/11 at 4:18 P.M., 2 UDC equaling 40 mg.
5/7/11 at 8:36 A.M., 2 UDC equaling 40 mg.
5/8/11 at 9:44 A.M., 2 UDC equaling 40 mg.
5/9/11 at 8:56 A.M., 2 UDC equaling 40 mg.
5/10/11 at 9:44 A.M., 2 UDC equaling 40 mg.
5/10/11 at 1:09 P.M., 2 UDC equaling 40 mg.
5/11/11 at 7:58 A.M., 2 UDC equaling 40 mg.
5/12/11 at 8:48 A.M., 2 UDC equaling 40 mg.
5/12/11 at 12:32 P.M., 2 UDC equaling 40 mg.
5/12/11 at 2:47 P.M., 2 UDC equaling 40 mg.
5/13/11 at 9:09 A.M., 2 UDC equaling 40 mg.
5/14/11 at 8:41 A.M., 2 UDC equaling 40 mg.
5/15/11 at 7:49 A.M., 2 UDC equaling 40 mg.
5/15/11 at 1:24 P.M., 2 UDC equaling 40 mg.
5/16/11 at 8:26 A.M., 2 UDC equaling 40 mg.
5/17/11 at 8:53 A.M., 2 UDC equaling 40 mg.
5/17/11 at 5:17 P.M., 2 UDC equaling 40 mg.
5/18/11 at 9:27 A.M., 2 UDC equaling 40 mg.
5/18/11 at 9:54 A.M., 2 UDC equaling 40 mg.
5/19/11 at 8:11 A.M., 2 UDC equaling 40 mg.
5/20/11 at 8:45 A.M., 2 UDC equaling 40 mg.
5/20/11 at 5:33 P.M., 2 UDC equaling 40 mg.
5/21/11 at 8:28 A.M., 2 UDC equaling 40 mg.
5/22/11 at 8:15 A.M., 2 UDC equaling 40 mg.
5/23/11 at 8:54 A.M., 2 UDC equaling 40 mg.
5/24/11 at 8:59 A.M., 2 UDC equaling 40 mg.
5/25/11 at 8:27 A.M., 2 UDC equaling 40 mg.
5/26/11 at 8:27 A.M., 2 UDC equaling 40 mg.
5/26/11 at 4:54 P.M., 2 UDC equaling 40 mg.
5/27/11 at 8:53 A.M., 2 UDC equaling 40 mg.
5/27/11 at 5:54 P.M., 2 UDC equaling 40 mg.
5/28/11 at 9:31 A.M., 2 UDC equaling 40 mg.
5/29/11 at 8:42 A.M., 2 UDC equaling 40 mg.
5/30/11 at 9:36 A.M., 2 UDC equaling 40 mg.
5/30/11 at 7:12 P.M., 2 UDC equaling 40 mg.
5/31/11 at 9:07 A.M., 2 UDC equaling 40 mg.
5/31/11 at 9:13 A.M., 2 UDC equaling 40 mg.
5/31/11 at 5:32 P.M., 2 UDC equaling 40 mg.
6/1/11 at 8:48 A.M., 2 UDC equaling 40 mg.
6/1/11 at 5:06 P.M., 2 UDC equaling 40 mg.
6/2/11 at 5:40 P.M., 2 UDC equaling 40 mg.
6/3/11 at 9:38 A.M., 2 UDC equaling 40 mg.
6/3/11 at 5:53 P.M., 2 UDC equaling 40 mg.
6/4/11 at 9:18 A.M., 2 UDC equaling 40 mg.
6/5/11 at 9:34 A.M., 2 UDC equaling 40 mg.
6/6/11 at 9:21 A.M., 2 UDC equaling 40 mg.
6/6/11 at 1:24 P.M., 2 UDC equaling 40 mg.
6/6/11 at 5:46 P.M., 2 UDC equaling 40 mg.
6/7/11 at 9:37 A.M., 2 UDC equaling 40 mg.
6/7/11 at 12:46 P.M., 2 UDC equaling 40 mg.
6/7/11 at 5:18 P.M., 2 UDC equaling 40 mg.
6/8/11 at 8:12 A.M., 2 UDC equaling 40 mg.
6/9/11 at 8:53 A.M., 3 cups equaling 60 mg.
6/9/11 at 4:11 P.M., 2 UDC equaling 40 mg.
6/10/11 at 10:06 A.M., 2 UDC equaling 40 mg.
6/10/11 at 5:28 P.M., 2 UDC equaling 40 mg.
6/11/11 at 8:27 A.M., 2 UDC equaling 40 mg.
6/12/11 at 7:45 A.M., 2 UDC equaling 40 mg.
6/12/11 at 6:02 P.M., 2 UDC equaling 40 mg.
6/13/11 at 8:30 A.M., 2 UDC equaling 40 mg.
6/13/11 at 2:03 P.M., 2 UDC equaling 40 mg.
6/13/11 at 5:35 P.M., 2 UDC equaling 40 mg.
6/14/11 at 8:49 A.M., 2 UDC equaling 40 mg.
6/14/11 at 8:49 A.M., 2 UDC equaling 40 mg.
6/14/11 at 5:12 P.M., 2 UDC equaling 40 mg.
6/15/11 at 8:32 A.M., 2 UDC equaling 40 mg.
6/15/11 at 6:37 P.M., 2 UDC equaling 40 mg.
6/16/11 at 8:47 A.M., 2 UDC equaling 40 mg.
6/17/11 at 8:52 A.M., 2 UDC equaling 40 mg.
6/18/11 at 8:57 A.M., 2 UDC equaling 40 mg.
6/19/11 at 8:42 A.M., 2 UDC equaling 40 mg.
6/19/11 at 12:58 P.M., 3 UDC equaling 60 mg.
6/20/11 at 10:07 A.M., 2 UDC equaling 40 mg.
6/20/11 at 12:45 P.M., 2 UDC equaling 40 mg.
6/20/11 at 5:10 P.M., 2 UDC equaling 40 mg.
6/21/11 at 9:41 A.M., 2 UDC equaling 40 mg.
6/21/11 at 1:40 P.M., 2 UDC equaling 40 mg.
6/21/11 at 5:09 P.M., 2 UDC equaling 40 mg.
6/22/11 at 8:35 A.M., 2 UDC equaling 40 mg.
6/23/11 at 9:08 A.M., 2 UDC equaling 40 mg.
6/23/11 at 12:39 P.M., 2 UDC equaling 40 mg.

A review of hospital policy Medication Error, Revised March 2009, reviewed at 2:00 P.M. on 6/24/11 revealed that "A medication error is defined as a dosage given: Wrong dosage Wrong form, Wrong compounding or preparation technique, Omitted doses ..."

A review of hospital policy Controlled Drug Management on Patient Care Units, Revised March 2009 reviewed on 6/24/11 at 2: 30 P.M. revealed that "the nurse will use the waste option of the automated dispensing machine (Omnicell) if all or part of a control substance must be wasted. This must be witnessed by a second nurse/physician and cosigned in the automated dispensing system. The amount used is entered into the system ..."

A further interview of SP #26 on 6/22/11 at 2: 00 P.M. revealed that patients who bring narcotics into the hospital to be administered by nursing staff are first examined by a pharmacist, sent with a non-Formulary Narcotic Proof of Use Sheet to the nursing unit where the narcotics are to be stored in the Omnicell. The medications are to be subtracted from the original pharmacy Log Sheet. Upon discharge, the medications are returned to the pharmacy where there is reconciliation against what was brought in and used. The remaining medications are then returned to the patient or the patient's family.

A review of the "Non Formulary Proof of Use Sheets" against the "Log Sheets for Patients Own Medications Brought into Hospital narcotics only," revealed the following:

Patient #31- brought Alprazalem 18 0.5 mg. tablets into the hospital for administration. The log sheet lacks a disposition of the medication. There was no Non-Formulary Proof of Use sheet available to document the use or disposition of the medication.

Patient #32- brought 4 0.5 mg tablets of Clonazapam into the hospital for administration. The log sheet lacks a disposition of the medication. There was no Non-Formulary Proof of Use sheet available to document the use or disposition of the medication.

Patient #33-brought 60 5 mg. tablets of Adderall into the hospital for administration. The log sheet lacks a disposition of the medication. There was no Non-Formulary Proof of Use sheet available to document the use or disposition of the medication.

Patient #34-brought 27 Clonazapam 0.5 mg. tablets into the hospital for administration. The log sheet lacks a disposition of the medication. There was no Non-Formulary Proof of Use sheet available to document the use or disposition of the medication.

Patient #35- brought 53 60 mg. Phenobarbital tablets into the hospital for administration. The non Formulary narcotic Proof of Use Sheet which was present in the Pharmacy documented that 4 tablets used. However, the Pharmacy Log sheet does not indicate a disposition of the remaining medication.

Patient # 36 brought 62 0.5 mg. Clonazapam tablets into the hospital for administration. The log sheet lacks a disposition of the medication. There was no Non-Formulary Proof of Use sheet available to document the use or disposition of the medication.

Patient #37-brought 30 Vicodin 5/500 tablets into the hospital for administration. There was no Non-Formulary Proof of Use sheet available to document the use or disposition of the medication.

Patient #38-brought 15 Clonazapam 0.5 mg. tablets into the hospital for administration. There was no Non-Formulary Proof of Use sheet available to document the use or disposition of the medication.

Patient #39-brought 37 Phenobarbital 30 mg. tablets into the hospital for administration. There was no Non-Formulary Proof of Use sheet available to document the use or disposition of the medication.

Patient #40-brought 37 Hydrocodone/APAP 5/500 mg. tablets into the hospital for administration. There was no Non-Formulary Proof of Use sheet available to document the use or disposition of the medication.

Patient #41-brought 50 2. mg. tablets of Lorazapam in halves and quarter sections into the hospital for administration. There was no Non-Formulary Proof of Use sheet available to document the use or disposition of the medication.

Patient #42-brought 72 Hydrocodone 7.5 mg. tablets into the hospital for administration. There was no Non-Formulary Proof of Use sheet available to document the use or disposition of the medication.

Patient #43-brought 23 Ativan 0.5 mg. tablets into the hospital for administration. There was no Non-Formulary Proof of Use sheet available to document the use or disposition of the medication.

Patient #44-brought Vicodin 13 5 mg. tablets and Hydrocodone/ APAP 10/500 50 mg. tablets into the hospital for administration. There was no Non-Formulary Proof of Use sheet available to document the use or disposition of the medication.

Patient #45-brought 36 Hydrocodone/APAP 5-500 tablets into the hospital for administration. There was no Non-Formulary Proof of Use sheet available to document the use or disposition of the medication.

Patient #46-brought 25 Temazepam 30 mg. capsules into the hospital for administration. There was no Non-Formulary Proof of Use sheet available to document the use or disposition of the medication.

Patient #47-brought 40 Fioricet/Codeine capsules into the hospital for administration. The log sheet documents that 33 capsules were returned to the patient. However, no Non Formulary Proof of Use Sheet could be located nor was there any Pharmacist verification prior to discharge.

A review of hospital policy Omnicell Automated Dispensing Units, Revised March 2009 revealed that:

"It is a requirement of the regulatory agencies that the Pharmacy System Administrator establishes and maintains a mechanism for tracking all transactions. The Pharmacy System Administrator will maintain a record of all items administered to a patient for a minimum of 2 years as required for controlled substances. The generating and maintaining of these records include daily, weekly, monthly and bi annual procedures outlined in this section."

SP #26 agreed that the Pharmacy department did not maintain any record concerning the disposition of the controlled medications other that what s/he had presented to the surveyor that documented what medications had been received and approved for administration for Patients #31 through #47.

Based on observation, staff interview and review of hospital policies, it was determined that the facility failed to ensure that accurate records for the disposition of all controlled substances were maintained.

The findings include:

On 6/20/11 at 3:00 P.M. SP #26 was interviewed regarding policies in the pharmacy department. S/he said that there were no policies or procedures to prevent a nurse from removing extra doses of medication from the Omnicell. S/he added that there is an honor system. S/he also said that nurses are required to ensure the count by signing out the medication needed for a patient. S/he was asked if anything would prevent a nurse from removing a stat dose and not administer it to a patient. S/he also added that there is an honor system for the nurses and that it just wouldn't occur.

It was stated that missing medications would be trended weekly. S/he said that the reports would then be sent to the Director of nursing. The Director said that the pharmacy has a policy to check the Omnicells regularly to ensure that expired medications are not distributed to patients.

S/he further said that patients are allowed to bring in their own medications to be administered. The medications are inspected and then sent to the nursing units where they are distributed to the patient. Upon discharge, the medications are recounted minus the doses administered. Then, the medications are sent back to the unit and the nurse returns the controlled medications to the patient upon discharge. The Proof of use Sheet is then filed in the Pharmacy.

Patient #14 was admitted to the Discharge Unit on 2/16/11 A review of Phenobarbital medications administered to Patient #14 revealed that there were 202 doses which were signed out of the Omnicell in excess of the 30 milligram (m.g.) physician ordered dose and not recorded as having been wasted as of 6/23/11.

There were only two additional occasions where the excess Phenobarbital was wasted and properly documented.

A review of the computer records revealed that the medications administered in excess of physician orders were documented on the following dates and times:

2/18/11 at 2:47 P.M., 2 UDC (Unit Dose Cups) equaling 40 mg.
2/19/11 at 5:25 P.M., 2 UDC equaling 40 mg.
2/21/11 at 1:17 P.M., 2 UDC equaling 40 mg.
2/21/11 at 5:41 P.M., 2 UDC equaling 40 mg.
2/22/11 at 9:33 A.M., 3-30 mg. tablets
2/23/11 at 8:09 A.M., 2 UDC equaling 40 mg.
2/25/11 at 8:37 A.M., 2 UDC equaling 40 mg.
2/25/11 at 2:19 P.M., 2 UDC equaling 40 mg.
2/28/11 at 12:06 P.M., 2 UDC equaling 40 mg.
2/28/11 at 4:42 P.M., 2 UDC equaling 40 mg.
3/1/11 at 9:11 A.M., 2 UDC equaling 40 mg.
3/3/11 at 11:58 A.M., 2 UDC equaling 40 mg.
3/5/11 at 8:45 A.M., 2 UDC equaling 40 mg.
3/9/11 at 9:32 A.M., 2 UDC equaling 40 mg.
3/9/11 at 5:16 P.M., 2 UDC equaling 40 mg.
3/10/11 at 4:33 P.M., 2 UDC equaling 40 mg.
3/11/11 at 8:55 A.M., 2 UDC equaling 40 mg.
3/12/11 at 9:13 A.M., 2 UDC equaling 40 mg.
3/12/11 at 3:59 P.M., 2 UDC equaling 40 mg.
3/13/11 at 8:05 A.M., 2 UDC equaling 40 mg.
3/14/11 at 9:14 A.M., 2 UDC equaling 40 mg.
3/14/11 at 5:23 P.M., 2 UDC equaling 40 mg.
3/15/11 at 10:20 A.M., 2 UDC equaling 40 mg.
3/15/11 at 6:10 P.M., 2 UDC equaling 40 mg.
3/16/11 at 8:44 A.M., 2 UDC equaling 40 mg.
3/17/11 at 5:06 P.M., 2 UDC equaling 40 mg.
3/18/11 at 9:20 A.M., 2 UDC equaling 40 mg.
3/18/11 at 8:47 A.M., 2 UDC equaling 40 mg.
3/19/11 at 4:41 P.M., 2 UDC equaling 40 mg.
3/20/11 at 11:53 A.M., 2 UDC equaling 40 mg.
3/20/11 at 5:03 P.M. .2 UDC equaling 40 mg.
3/21/11 at 4:50 P.M., 2 UDC equaling 40 mg.
3/22/11 at 8:23 A.M., 2 UDC equaling 40 mg.
3/22/11 at 4:46 P.M., 2 UDC equaling 40 mg.
3/23/11 at 9:37 A.M., 2 UDC equaling 40 mg.
3/24/11 at 9:06 A.M., 2 UDC equaling 40 mg.
3/24/11 at 4:48 P.M., 2 UDC equaling 40 mg.
3/25/11 at 8:50 A.M., 2 UDC equaling 40 m.g..
3/25/11 at 1:15 P.M., 2 UDC equaling 40 mg.
3/25/11 at 4:30 P.M., 2 UDC equaling 40 mg.
3/26/11 at 8:56 A.M., 2 UDC equaling 40 mg.
3/26/11 at 1:06 P.M., 2 UDC equaling 40 mg.
3/27/11 at 8:45 A.M., 2 UDC equaling 40 mg.
3/27/11 at 1:24 P.M., 2 UDC equaling 40 mg.
3/28/11 at 1:27 P.M., 2 UDC equaling 40 mg.
3/28/11 at 4:33 P.M., 2 UDC equaling 40 mg.
3/29/11 at 12:37 P.M., 2 UDC equaling 40 mg.
3/29/11 at 5:52 P.M., 2 UDC equaling 40 mg.
3/30/11 at 1:37 P.M., 2 UDC equaling 40 mg.
3/30/11 at 4:55 P.M., 2 UDC equaling 40 mg.
3/31/11 at 10:23 A.M., 2 UDC equaling 40 mg.
3/31/11 at 5:16 P.M., 2 UDC equaling 40 mg.
4/1/11 at 8:30 A.M., 2 UDC equaling 40 mg.
4/1/11 at 5:01 P.M., 2 UDC equaling 40 mg.
4/2/11 at 8:52 A.M., 2 UDC equaling 40 mg.
4/3/11 at 8:30 A.M., 2 UDC equaling 40 mg.
4/4/11 at 8:21 A.M., 2 UDC equaling 40 mg.
4/4/11 at 5:33 P.M., 2 UDC equaling 40 mg.
4/5/11 at 11:57 A.M., 2 UDC equaling 40 mg.
4/5/11 at 5:04 P.M., 2 UDC equaling 40 mg.
4/6/11 at 9:43 A.M., 2 UDC equaling 40 mg.
4/7/11 at 9:24 A.M., 2 UDC equaling 40 mg.
4/8/11 at 8:33 A.M., 2 UDC equaling 40 mg.
4/8/11 at 4:55 P.M., 2 UDC equaling 40 mg.
4/9/11 at 8:58 A.M., 2 UDC equaling 40 mg.
4/10/11 at 8:34 A.M., 2 UDC equaling 40 mg.
4/11/11 at 8:27 A.M., 2 UDC equaling 40 mg.
4/11/11 at 4:32 P.M., 2 UDC equaling 40 mg.
4/12/11 at 7:42 A.M., 2 UDC equaling 40 mg.
4/12/11 at 4:39 P.M., 2 UDC equaling 40 mg.
4/13/11 at 8:40 A.M., 2 UDC equaling 40 mg.
4/13/11 at 4:47 P.M., 2 UDC equaling 40 mg.
4/14/11 at 8:58 A.M., 2 UDC equaling 40 mg.
4/14/11 at 4:16 P.M., 2 UDC equaling 40 mg.
4/15/11 at 8:30 A.M., 2 UDC equaling 40 mg.
4/15/11 at 12:58 P.M., 2 UDC equaling 40 mg.
4/15/11 at 5:08 P.M., 2 UDC equaling 40 mg.
4/16/11 at 8:20 A.M., 2 UDC equaling 40 mg.
4/16/11 at 12:09 P.M., 2 UDC equaling 40 mg.
4/16/11 at 4:36 P.M., 2 UDC equaling 40 mg.
4/17/11 at 9:10 A.M., 2 UDC equaling 40 mg.
4/17/11 at 6:10 P.M., 2 UDC equaling 40 mg.
4/18/11 at 12:52 P.M., 2 UDC equaling 40 mg.
4/18/11 at 3:13 P.M., 2 UDC equaling 40 mg.
4/19/11 at 9:25 A.M., 2 UDC equaling 40 mg.
4/19/11 at 12:42 P.M., 2 UDC equaling 40 mg.
4/19/11 at 3:17 P.M., 2 UDC equaling 40 mg.
4/20/11 at 8:36 A.M., 2 UDC equaling 40 mg.
4/21/11 at 8:29 A.M., 2 UDC equaling 40 mg.
4/21/11 at 1:34 P.M., 2 UDC equaling 40 mg.
4/21/11 at 5:19 P.M., 2 UDC equaling 40 mg.
4/22/11 at 8:07 A.M., 2 UDC equaling 40 mg.
4/22/11 at 1:26 P.M., 2 UDC equaling 40 mg.
4/22/11 at 4:35 P.M., 2 UDC equaling 40 mg.
4/23/11 at 8:35 A.M., 2 UDC equaling 40 mg.
4/24/11 at 9:27 A.M., 2 UDC equaling 40 mg.
4/25/11 at 8:33 A.M., 2 UDC equaling 40 mg.
4/25/11 at 12:54 P.M., 2 UDC equaling 40 mg.
4/25/11 at 5:05 P.M., 2 UDC equaling 40 mg.
4/26/11 at 2:13 P.M., 2 UDC equaling 40 mg.
4/26/11 at 5:15 P.M., 2 UDC equaling 40 mg.
4/27/11 at 8:29 A.M., 2 UDC equaling 40 mg.
4/27/11 at 4:42 P.M., 2 UDC equaling 40 mg.
4/28/11 at 8:55 A.M., 2 UDC equaling 40 mg.
4/28/11 at 12:06 P.M., 2 UDC equaling 40 mg.
4/28/11 at 4:15 P.M., 2 UDC equaling 40 mg.
4/29/11 at 9:00 A.M., 2 UDC equaling 40 mg.
4/29/11 at 12:41 P.M., 2 UDC equaling 40 mg.
4/29/11 at 4:12 P.M., 2 UDC equaling 40 mg.
4/30/11 at 12:01 P.M., 2 UDC equaling 40 mg.
5/1/11 at 8:53 A.M., 2 UDC equaling 40 mg.
5/1/11 at 4:35 P.M., 2 UDC equaling 40 mg.
5/2/11 at 9:53 A.M., 2 UDC equaling 40 mg.
5/3/11 at 8:23 A.M., 2 UDC equaling 40 mg.
5/3/11 at 12:06 P.M., 2 UDC equaling 40 mg.
5/4/11 at 9:32 A.M., 2 UDC equaling 40 mg.
5/5/11 at 1:00 P.M., 2 UDC equaling 40 mg.
5/5/11 at 4:12 P.M., 2 UDC equaling 40 mg.
5/6/11 at 9:11 A.M., 2 UDC equaling 40 mg.
5/6/11 at 11:49 A.M., 2 UDC equaling 40 mg.
5/6/11 at 4:18 P.M., 2 UDC equaling 40 mg.
5/7/11 at 8:36 A.M., 2 UDC equaling 40 mg.
5/8/11 at 9:44 A.M., 2 UDC equaling 40 mg.
5/9/11 at 8:56 A.M., 2 UDC equaling 40 mg.
5/10/11 at 9:44 A.M., 2 UDC equaling 40 mg.
5/10/11 at 1:09 P.M., 2 UDC equaling 40 mg.
5/11/11 at 7:58 A.M., 2 UDC equaling 40 mg.
5/12/11 at 8:48 A.M., 2 UDC equaling 40 mg.
5/12/11 at 12:32 P.M., 2 UDC equaling 40 mg.
5/12/11 at 2:47 P.M., 2 UDC equaling 40 mg.
5/13/11 at 9:09 A.M., 2 UDC equaling 40 mg.
5/14/11 at 8:41 A.M., 2 UDC equaling 40 mg.
5/15/11 at 7:49 A.M., 2 UDC equaling 40 mg.
5/15/11 at 1:24 P.M., 2 UDC equaling 40 mg.
5/16/11 at 8:26 A.M., 2 UDC equaling 40 mg.
5/17/11 at 8:53 A.M., 2 UDC equaling 40 mg.
5/17/11 at 5:17 P.M., 2 UDC equaling 40 mg.
5/18/11 at 9:27 A.M., 2 UDC equaling 40 mg.
5/18/11 at 9:54 A.M., 2 UDC equaling 40 mg.
5/19/11 at 8:11 A.M., 2 UDC equaling 40 mg.
5/20/11 at 8:45 A.M., 2 UDC equaling 40 mg.
5/20/11 at 5:33 P.M., 2 UDC equaling 40 mg.
5/21/11 at 8:28 A.M., 2 UDC equaling 40 mg.
5/11/11 at 8:15 A.M., 2 UDC equaling 40 mg.
5/23/11 at 8:54 A.M., 2 UDC equaling 40 mg.
5/24/11 at 8:59 A.M., 2 UDC equaling 40 mg.
5/25/11 at 8:27 A.M., 2 UDC equaling 40 mg.
5/26/11 at 8:27 A.M., 2 UDC equaling 40 mg.
5/26/11 at 4:54 P.M., 2 UDC equaling 40 mg.
5/27/11 at 8:53 A.M., 2 UDC equaling 40 mg.
5/27/11 at 5:54 P.M., 2 UDC equaling 40 mg.
5/28/11 at 9:31 A.M., 2 UDC equaling 40 mg.
5/29/11 at 8:42 A.M., 2 UDC equaling 40 mg.
5/30/11 at 9:36 A.M., 2 UDC equaling 40 mg.
5/30/11 at 7:12 P.M., 2 UDC equaling 40 mg.
5/31/11 at 9:07 A.M., 2 UDC equaling 40 mg.
5/31/11 at 9:13 A.M., 2 UDC equaling 40 mg.
5/31/11 at 5:32 P.M., 2 UDC equaling 40 mg.
6/1/11 at 8:48 A.M., 2 UDC equaling 40 mg.
6/1/11 at 5:06 P.M., 2 UDC equaling 40 mg.
6/2/11 at 5:40 P.M., 2 UDC equaling 40 mg.
6/3/11 at 9:38 A.M., 2 UDC equaling 40 mg.
6/3/11 at 5:53 P.M., 2 UDC equaling 40 mg.
6/4/11 at 9:18 A.M., 2 UDC equaling 40 mg.
6/5/11 at 9:34 A.M., 2 UDC equaling 40 mg.
6/6/11 at 9:21 A.M., 2 UDC equaling 40 mg.
6/6/11 at 1:24 P.M., 2 UDC equaling 40 mg.
6/6/11 at 5:46 P.M., 2 UDC equaling 40 mg.
6/7/11 at 9:37 A.M., 2 UDC equaling 40 mg.
6/7/11 at 12:46 P.M., 2 UDC equaling 40 mg.
6/7/11 at 5:18 P.M., 2 UDC equaling 40 mg.
6/8/11 at 8:12 A.M., 2 UDC equaling 40 mg.
6/9/11 at 8:53 A.M., 3 cups equaling 60 mg.
6/9/11 at 4:11 P.M., 2 UDC equaling 40 mg.
6/10/11 at 10:06 A.M., 2 UDC equaling 40 mg.
6/10/11 at 5:28 P.M., 2 UDC equaling 40 mg.
6/11/11 at 8:27 A.M., 2 UDC equaling 40 mg.
6/12/11 at 7:45 A.M., 2 UDC equaling 40 mg.
6/12/11 at 6:02 P.M., 2 UDC equaling 40 mg.
6/13/11 at 8:30 A.M., 2 UDC equaling 40 mg.
6/13/11 at 2:03 P.M., 2 UDC equaling 40 mg.
6/13/11 at 5:35 P.M., 2 UDC equaling 40 mg.
6/14/11 at 8:49 A.M., 2 UDC equaling 40 mg.
6/14/11 at 8:49 A.M., 2 UDC equaling 40 mg.
6/14/11 at 5:12 P.M., 2 UDC equaling 40 mg.
6/15/11 at 8:32 A.M., 2 UDC equaling 40 mg.
6/15/11 at 6:37 P.M., 2 UDC equaling 40 mg.
6/16/11 at 8:47 A.M., 2 UDC equaling 40 mg.
6/17/11 at 8:52 A.M., 2 UDC equaling 40 mg.
6/18/11 at 8:57 A.M., 2 UDC equaling 40 mg.
6/19/11 at 8:42 A.M., 2 UDC equaling 40 mg.
6/19/11 at 12:58 P.M., 3 UDC equaling 60 mg.
6/20/11 at 10:07 A.M., 2 UDC equaling 40 mg.
6/20/11 at 12:45 P.M., 2 UDC equaling 40 mg.
6/20/11 at 5:10 P.M., 2 UDC equaling 40 mg.
6/21/11 at 9:41 A.M., 2 UDC equaling 40 mg.
6/21/11 at 9:41 A.M., 2 UDC equaling 40 mg.
6/21/11 at 1:40 P.M., 2 UDC equaling 40 mg.
6/21/11 at 5:09 P.M., 2 UDC equaling 40 mg.
6/22/11 at 8:35 A.M., 2 UDC equaling 40 mg.
6/23/11 at 9:08 A.M., 2 UDC equaling 40 mg.
6/23/11 at 12:39 P.M., 2 UDC equaling 40 mg.

A review of facility policy Medication Error, Revised March 2009, reviewed at 2:00 P.M. on 6/24/11 revealed that "A medication error is defined as a dosage given: Wrong dosage form, Wrong compounding or preparation technique, Omitted doses ... "

A review of facility policy Controlled Drug Management on Patient Care Units, Revised March 2009 reviewed on 6/24/11 at 2: 30 P.M. revealed that "the nurse will use the waste option of the automated dispensing machine (Omnicell) if all or part of a control substance must be wasted. This must be witnessed by a second nurse/physician and cosigned in the automated dispensing system. The amount used is entered into the system ..."

A further interview with SP #26 on 6/22/11 at 2: 00 PM revealed that patients who bring narcotics into the hospital to be administered by nursing staff are first examined by a pharmacist, sent with a non-Formulary Narcotic Proof of Use Sheet to the nursing unit where the narcotics are to be stored in the Omnicell. The medications are to be subtracted from the original pharmacy Log Sheet. Upon discharge, the medications are returned to the pharmacy where there is reconciliation against what was brought in and used. The remaining medications are then returned to the patient or the patient's family.

A review of the "Non Formulary Proof of Use Sheets" against the "Log Sheets for Patients Own Medications Brought into Hospital narcotics only," revealed the following:

Patient #31- brought Alprazalem 18 0.5 mg. tablets into the hospital for administration. The log sheet lacks a disposition of the medication. There was no Non-Formulary Proof of Use sheet available to document the use or disposition of the medication.

Patient #32- brought 4 0.5 mg tablets of Clonazapam into the hospital for administration. The log sheet lacks a disposition of the medication. There was no Non-Formulary Proof of Use sheet available to document the use or disposition of the medication.

Patient #33-brought 60 5 mg. tablets of Adderall into the hospital for administration. The log sheet lacks a disposition of the medication. There was no Non-Formulary Proof of Use sheet available to document the use or disposition of the medication.

Patient #34-brought 27 Clonazapam 0.5 mg. tablets into the hospital for administration. The log sheet lacks a disposition of the medication. There was no Non-Formulary Proof of Use sheet available to document the use or disposition of the medication.

Patient #35- brought 53 60 mg. tablets into the hospital for administration. The non Formulary narcotic Proof of Use Sheet which was present in the Pharmacy documented that 4 tablets used. However, the Pharmacy Log sheet does not indicate a disposition of the remaining medication.

Patient # 36 brought 62 0.5 mg. Clonazapam tablets into the hospital for administration. The log sheet lacks a disposition of the medication. There was no Non-Formulary Proof of Use sheet available to document the use or disposition of the medication.

Patient #37-brought 30 Vicodin 5/500 tablets into the hospital for administration. There was no Non-Formulary Proof of Use sheet available to document the use or disposition of the medication.

Patient #38-brought 15 Clonazapam 0.5 mg. tablets into the hospital for administration. There was no Non-Formulary Proof of Use sheet available to document the use or disposition of the medication.

Patient #39-brought 37 Phenobarbital 30 mg. tablets into the hospital for administration. There was no Non-Formulary Proof of Use sheet available to document the use or disposition of the medication.

Patient #40-brought 37 Hydrocodone/APAP 5/500 mg. tablets into the hospital for administration. There was no Non-Formulary Proof of Use sheet available to document the use or disposition of the medication.

Patient #41-brought 50 2. mg. tablets of Lorazapam in halves and quarter sections into the hospital for administration. There was no Non-Formulary Proof of Use sheet available to document the use or disposition of the medication.

Patient #42-brought 72 Hydrocodone 7.5 mg. tablets into the hospital for administration. There was no Non-Formulary Proof of Use sheet available to document the use or disposition of the medication.

Patient #43-brought 23 Ativan 0.5 mg. tablets into the hospital for administration. There was no Non-Formulary Proof of Use sheet available to document the use or disposition of the medication.

Patient #44-brought Vicodin 13 5 mg. tablets and Hydrocodone/ APAP 10/500 50 mg. tablets into the hospital for administration. There was no Non-Formulary Proof of Use sheet available to document the use or disposition of the medication.

Patient #45-brought 36 Hydrocodone/APAP 5-500 tablets into the hospital for administration. There was no Non-Formulary Proof of Use sheet available to document the use or disposition of the medication.

Patient #46-brought 25 Temazepam 30 mg. capsules into the hospital for administration. There was no Non-Formulary Proof of Use sheet available to document the use or disposition of the medication.

#47-brought 40 Fioricet/Codeine capsules into the hospital for administration. The log sheet documents that 33 capsules were returned to the patient. However, no Non Formulary Proof of use Sheet could be located nor was there any Pharmacist verification prior to discharge.

A review of facility policy Omnicell Automated Dispensing Units, Revised March 2009 revealed that: "It is a requirement of the regulatory agencies that the Pharmacy System Administrator establishes and maintains a mechanism for tracking all transactions. The Pharmacy System Administrator will maintain a record of all items administered to a patient for a minimum of 2 years as required for controlled substances. The generating and maintaining of these records include daily, weekly, monthly and bi annual procedures outlined in this section."

Sp #26 agreed that the Pharmacy department did not maintain any record concerning the disposition of the controlled medications other that what s/he had presented to the surveyor. That documented that medications had been received and approved for administration for patients #31 through #47.

Interview with SP #26 on 6/23/11 at 3:30 P.M. revealed that although the pharmacy has policies and procedures to reconcile medications, the pharmacy failed to ensure that the policies for reconciliation of controlled medications were being followed.

Based on observation, staff interviews and review of hospital policies, it was determined that the facility failed dispose of expired, outdated and mislabeled medications.

The findings include:

1. Observation of the Medicine Room in the Emergency Room with SP #13 and SP # 14 on 6/20/11 at 1:20 P.M. revealed the following:

The Medication Refrigerator had two bottles of Alcon Tetracaine Hydrochloride 0.5% Sterile Ophthalmic Solution 2 milliliters (ml). The instructions on the bottle indicated Single Dose Discard Unused Portion. Neither of the bottles had a seal on the caps and SP # 13 stated s/he could not tell if these bottles had been used.

Also in the Medication Refrigerator was an opened 5 milliliter bottle of Flumazenil 0.5 milligram (mg) for IV use. The bottle was not dated when it was opened and SP # 29 stated since it had not been dated when it was opened s/he could not tell when it should be discarded. S/he also stated that opened bottles of multi-dose vials of intravenous medications were good for only thirty days.

Additionally, in the Medication refrigerator was an opened 10 milliliter bottle of Humulin 70/30 Insulin. The bottle was not dated when it was opened and SP # 13 stated that since the insulin has not been dated when it was opened s/he could not tell when it should be discarded. S/he repeated that opened multi-dose vials of insulin were to be used within thirty days.

Review of the hospital's Labeling Standards Policy and Procedure dated January 2007 and Revised March 2009 indicated that all drug containers shall be labeled and drug labels must be clear, consistent, legible and in compliance with local and federal requirements. Unit dose medication labels shall include expiration date if medication is not used within 24 hours and expiration time if medication expires in less than 24 hours. In addition, the policy indicates that intravenous admixture labels should include the beyond-use date if expiration is greater than 24 hours.

2. On 6/20/11 at 3: 30 P.M. SP #26 accompanied the surveyor on a tour of the Omnicell used as a night medication storage cabinet when the Pharmacy is closed. S/he said that Omnicells are checked monthly and periodically to ensure that outdated medications were removed and disposed of. S/he added that open medications were dated and had to be disposed of within 28 days after opening.

Inspection of the Omnicell revealed 4 1000 ml (milliliter) intravenous bags containing Potassium Chloride having a preparation date of 6/17/11 and an expiration date of 6/18/11.
Bottle of injectable Influenza Vaccine in 5 ml. (milliliter) bottle with an expiration date of 5/11.
2 bottles of Pneumococcal injectable vaccine with an expiration date of 5/11.
7 Wellbutrin SR (sustained release) 150 mg. (milligram) tablets with an expiration date of 5/11.
SP #26 at the time of the observation agreed that the expired medications should not have been in the Omnicell.
On 6/21/11 at 2:35 P.M during a tour of the Fast Track area with SP #33 an inspection of the Omnicell machine revealed that there were 8 containers of Alcon Tetracaine Hydrochloride 0.5% Sterile Ophthalmic Solution 2 milliliters (ml) single dose eye drops without any packaging.
Also in the same examining room as the Omnicell there was an open bottle of injectable Lidocaine 10 mg/ml open with no date. An open bottle of Xylocaine 2% 20 mg/ml with an expiration date of 6/16. SP #14 who was present acknowledged the observations.
On 6/21/11 at 3:45 P.M. in the Pediatric Unit a 20 ml. container of Albuterol Sulfate was open and had no date. 1 bottle of Ceftzoximine 1 gm. (Gram) with an expiration date of 6/21/11
On 6/22/11 at 1:30 P.M. in the Radiology Department 's Computer Tomography room, a 500 ml bag containing injectable Dextrose had an expiration date of 2/11.
On 6/22/11 at 3:15 P.M. in the labor and delivery Department 's Omnicell machine 2 12/3 ounce bottles of Poly Vitamin drops were open and undated. There was also a bottle of Ranitidine 150 mg/6 ml bottle open with no date.
On 6/23/11 at 6:55 A.M. in the PCU there was a Fluphenazine Decanoate 25 mg/ml in a 5 ml bottle with an open date of 5/4/11. This was witnessed by SP #33.
A review of hospital policy Inventory Inspection for Expiration dating Revised March 2009 was reviewed on 6/24/11 at 9:30 A.M. #3 Expired items, or items that expire within a month will be pulled from the shelves and the inventory clerk is notified of the need for additional stock. "
On 6/21/11 at 2:30 P.M., SP #26 was interviewed regarding Alcon Tetracaine Hydrochloride 0.5% Sterile Ophthalmic Solution 2 milliliters (ml) single use eye drops and the packaging and storage of this medication. S/he showed the surveyor the area where the medication is stored in the pharmacy. S/he said that it had no requirement to be refrigerated and that the medication is individually wrapped in paper and clear plastic. S/he said that if the packaging was removed, the medication should be discarded as it is for single use. When advised that the medication was stored unwrapped, SP #26 said that the medication stored in the fast Track Omnicell was stored without packaging, s/he said that they should all be discarded and that staff inappropriately stored the medication.

Based on clinical record review, staff interviews and review of hospital policies it was determined that the facility failed to notify the attending physician of medication errors in regard to the administration of Phenobarbital for 1 of 47 Patients (Patient #14).

1. The Patient received an excessive amount of medication on 202 occasions.
2. The patient received less than the ordered dose on 121 occasions.
3. The patient received medication less than three times daily (t.i.d.) on 31 days.

The findings include:

On 6/20/11 a clinical record review was conducted for Patient #14. The patient had a physician's order for Phenobarbital 30 mg. (milligram) to be administered t.i.d. (three times daily). The Medication Administration Record was reviewed and revealed dates when the medication was not administered to Patient #14.

SP #26 was interviewed on 6/23/11 at 2:30 P.M. and said that the use of the Omnicell allows the pharmacy to print out a line listing of the Phenobarbital administered to the patient. A list from February 16, 2011 until June 23, 2011 was requested and reviewed.

The physicians order was for 30 mg. of Phenobarbital to be administered to the patient three times daily (t.i.d.). SP #26 said that medication was placed into the Omnicell by pharmacy staff. The Phenobarbital was in 20 mg. (milligram) per 5 ml. Liquid containers. S/he said that the nurse administering the medication would need to remove 2 5 ml. from one of two containers and waste it with a witness present and document the wastage in the Omnicell machine. The dosage would then equal the 30 mg. as ordered by the physician.

Upon assessing the computer documentation regarding the Phenobarbital administration to Patient #14, SP #26 said that it appeared there were numerous medication errors as listed on the computer line listing sheets. S/he also said that there appeared to be in excess of 300 medication errors for the 128 days that were printed. S/he also agreed that the patient had received medication doses in excess and other doses less than what the physician had ordered.

When questioned about how medications could be removed improperly from the Omnicell machine, s/he said that "we have an honor system." Of the 128 calendar days Patient #14 was in the Discharge Unit, there were 202 occurrences of Phenobarbital for Patient #14 removed from the Omnicell machine that were in excess of the physician ordered dosage. The clinical record review also revealed that there were no physician notifications in regards to the medication errors.

There were two additional occasions where the excess Phenobarbital was wasted and properly documented.

A review of the computer records revealed that the medications administered in excess of physician orders were documented from 2/18/11 to 6/23/11. (Cross reference to A491).

There were 121 occurrences where Patient #14 received less than the 30 mg. dose of medication as ordered from the Omnicell machine. According to pharmacy records, the patient received less that the required amount of Phenobarbital from 2/19/11 and 6/23/11. (Cross reference to A491) .

In addition, the hospital failed to ensure that Patient #14 received physician ordered Phenobarbital t.i.d. For 31 documented days from 2/18/11 until 6/23/11, the patient received Phenobarbital medication less than prescribed or not at all. (Cross reference to A491)


On 6/24/11 at 12:00 P.M. during an interview with SP #14, s/he acknowledged that the nursing staff should properly document the medication administration when given, waste extra medication with a witness and also document why medications are not given.

A review of hospital policy Medication Error, Revised March 2009, reviewed at 2:00 P.M. on 6/24/11 revealed that "A medication error is defined as a dosage given: Wrong dosage form, Wrong compounding or preparation technique, Omitted doses ..."
The policy also documented that, "the physician is immediately notified of a medication error, and is responsible for implementing a treatment plan."

A review of hospital policy Controlled Drug Management on Patient Care Units, Revised March 2009 reviewed on 6/24/11 at 2: 30 P.M. revealed that "the nurse will use the waste option of the automated dispensing machine (Omnicell) if all or part of a control substance must be wasted. This must be witnessed by a second nurse/physician and cosigned in the automated dispensing system. The amount used is entered into the system ... "

Based on observations, review of policies and procedures and staff interviews, it was determined that the hospital failed to meet the Condition of Food and Dietetic Services as evidenced by:

1. The hospital does not have a Director of Food and Dietetic Services. Please refer to A0620.

2. The hospital did not ensure safe food handling practices. Please refer to A0622.

3. The hospital did not ensure that kitchen sanitation was maintained. Please refer to A0622.

Based on observations and staff interviews, it was determined that the hospital did not have a full-time employee who serves as director of the food and dietetic service. The director of the food and dietetic service would be responsible for the daily management of the dietary services and directing adequately trained personnel.

The findings include:

1. The position of Director of Food and Dietetic Services is vacant at this time.

On 6/20/11 at 10:05 A.M. SP #7 confirmed that the previous Director of Food and Dietetic Services left the hospital's employment on 4/19/11 and the hospital is presently seeking a candidate to fill the position. S/he stated that the Director of Food and Dietetic Services was a full time position that was responsible for the daily management of the dietary services. The Administrator of the Dietary Department is also the Administrator for the Maintenance Department, Security Department and Housekeeping Departments within the hospital.

2. A tour of the kitchen on 6/20/10 at 10:05 A.M. revealed the following:

The Panini machine had a heavy accumulation of grease.

Four convection ovens had a heavy accumulation of grease.

The metal can opener had a heavy accumulation of grease and metal shavings.

Stored on a rack was a stove top grill with a heavy accumulation of grease and two dirty dinner plates.

Stored on another rack were four pot lids that had dirt and grease on them.

A trash can lid was stored in the baking prep area on a shelf with two carafes and the blender.

The kitchen floors contained food debris under and behind equipment, residue on the floor tiles and missing grout between some kitchen tiles. SP #7 stated that the floors are mopped each night and power washed three to four times a year.

There was a buildup of food debris on both mixers, the Hobart and the Univex.

The skillet was found to have a heavy buildup of dry food debris on the bottom portion of the equipment.

Observation of the prep area revealed the staff covering pans of dough with plastic wrap without wearing gloves.

In a walk in dairy refrigerator the following were observed:

3 pound container of cream cheese was opened with no date and a heavy accumulation of mold.
4- ? gallon containers of frozen egg whites had no date of defrosting.
4- ? pound containers of provolone cheese were open, but with no date of opening.
3 -? pound packages of Swiss cheese were open, but with no date of opening.
4 packages of hamburger rolls with a date of 6/2/11.

The meat cooler was found to have a bag of frozen chicken and a box of frozen chicken open to the air. In the meat freezer a box of frozen chicken was found to be uncovered. Additionally, the stainless steel floor panels in the meat cooler were found to be lifting up from the floor. SP #7 stated s/he believed the hospital was working on having the panels repaired. However, this issue had been identified several years earlier as review of a 2/18/10 Executive Environmental Surveillance Rounds Report for Dietary Services revealed that "metal floors in freezers sagging or detached. The action was to repair/stabilization of metal floors."

Based on observations, staff interviews and review of the hospital's policy and procedures, it was determined that the facility did not have dietary personnel competent in their respective duties to ensure proper food storage and kitchen sanitation.

The findings include:

A tour of the kitchen on 6/20/10 at 10:05 A.M. revealed the following in the Dry Food Storage area:

Three cans of Heinz Tomato Ketchup were stored in the dry food storeroom. The cans had been dated by the Dietary staff with the date received which was 9/14/10. Observation of each of the cans revealed black marks on the cans lids and lip of the lids. SP #11 who was accompanying the Dietary tour stated that s/he did not know what caused the black marks. S/he also stated that the hospital did not have a policy and procedure regarding when items that did not have expiration dates would be considered expired and not to be used. SP #11 stated that s/he would consider six to nine months after the date written on the item as received to be the date that the item was expired and not to be used. S/he had the three cans of tomato ketchup removed from the store room.

Five cans of Sysco Tomatoes were found to be stored in the dry food store room. One can was dated 9/8/09, three cans were dated 1/5/10 and one can was dated 11/22/10. There was no expiration date on the cans of tomatoes.

A box of Sysco six pound cans of Tomatoes was observed with a 10/5/10 placement of order date on the box. A piece of the box was torn away and no expiration date could be found on the tomato cans or the box.

Two seven pound cans of B & M Original Baked Beans were dated 12/8/10 as being received and had expired on 3/26/11.

One three pound can of Campbell's Chicken Noodle Soup with the date being received of 8/10/10 was found to have expired on 5/26/11.

Twelve cans of 46 ounce V-8 Juice was dated as received on 5/18/10 and the cans which were still stored in the dry food storage area had expired on 6/18/11.

Eight boxes of Baking Soda with an expiration date of 7/5/10.

Glass containers of open Walnuts, Oats, Raisins, and Shaved Almonds had a date of 5/19 with no year documented.

A three pound container of sliced almonds was open, but with no date of opening.

Open bag of baking cocoa, but with no date of opening.

One bag of rigatoni and one bag of multi colored pasta, open but with no date of opening.

Open bag of Japanese bread crumbs, but with no date of opening.

Two three pound containers of Lyons Sliced Strawberry Topping were found to be dated 5/4/10, four containers were dated 8/30/10 and 2 cans were found to be dated 9/30/10. There were no expiration dates on any of the cans of Sliced Strawberry Topping.

Four six pound plastic containers of Jellied Cranberry Sauce were dated 11/21/10 and none of the four containers had expiration dates.

A box containing nine cans of 13.75 ounce Whole Red Pimentos were found not to have the date received or the date of expiration.

Five containers of Sun Sweet Prune Juice were stored in a box. Staff had written 4/13/11 as the date the prune juice was received. The containers of prune juice had 12/May/10 written as the expiration date. SP #11 stated she was unable to tell if the expiration date was 5/10/12 or 5/12/10.

Ten four pound Mint Jelly containers were dated 2/3/09 as being received and had no expiration date on the containers.

Five four pound Grape Jelly containers were dated 5/4/10 on the lids but had no expiration dates on the containers.

Two six pound nine ounce cans of Libby Peas and Carrots were dated as received on 9/28/10 and had no expiration date on the containers.

The sugar bin was found to be three quarters full of sugar and the scoop was found to be inside the sugar bin.

The flour bin and the sugar bin both had residue on the outside and lids of the containers.

There was a large build up of dust accumulated on the grill of the fan in the dry food storage area. The fan was observed to be running and the air flow was directed to the stored chocolate.

During the tour of the kitchen on 6/20/11, the Janitor's Closet across from the food serving area was found to be unlocked and when the door was opened there was a musty odor emitted from the room. On the floor of the Janitor's Closet were a dust pan and seven large reddish-brown dead insects similar in appearance to a cock roach. In the floor sink of the Janitor's Closet was a dry mop and another dead reddish-brown insect.

3. The ice machine was not cleaned.

On 6/20/11 at 10:30 A.M., the ice machine in the dry food storage area was found to have accumulated dust on the outside and debris on the inside ledge of the ice machine. When asked how often the machine was cleaned, SP #9 replied that it was not regularly cleaned.

Although dietary staff indicated the ice machine was not regularly cleaned, the hospital's Ice Machine Cleaning and Storage Policy and Procedure dated 8/2002 and reviewed by the hospital on 10/2008 indicated that monthly the ice machine will be shut down a minimum of three (3) days prior to schedule cleaning so that ice in storage will be used. Once the unit has been emptied, the manufacturers recommended solution will be added to the system and the self-cleaning process activated. While the system is self cleaning the harvest guard, outer side of chill plate and bin will be cleaned using approved sanitizer. The outside of the unit will be cleaned weekly. The filters on the ice machine will be changed monthly and the ice scoops will be cleaned and sanitized three times per week.

The hospital had previously noted this issue in the 2/18/10 Executive Environmental Surveillance Rounds Report for Dietary Services which revealed no maintenance log for the ice machine in the dry storage room. The action was to provide and maintain cleaning/maintenance log for the ice machine.

On 6/21/11 at 8:30 A.M., SP #8 stated that the Manitowoc Ice Machine in the dry food storage area is self cleaning and that staff clean the outside and the inside ledge, but to her knowledge the machine has not been cleaned since installed in 2010. SP #8 also stated that the Hoshizaki ice machine in the cafeteria has also not been cleaned, but that Maintenance staff change the filters on both ice machines. Observation of the Manitowoc Ice Machine in the dry storage area on 6/21/11 revealed that staff had cleaned the outside of the machine and the inside ledge was free of debris.

4. There was inconsistency in the staff's understanding about the level of sanitizer to be used in the three compartment sink.

Review of the hospitals' Standard Operating Procedures for Cleaning and Sanitizing Food Contact Surfaces Including Dish Machines and 3 Compartment Sinks indicated that for three compartment sinks staff were to test "the chemical sanitizer concentration by using an appropriate test kit."

Review of the June 2011 Nutrition Department Sanitizer Concentration Log for the three compartment sink revealed that the sanitizing water was tested at 6:00 A.M., 9:00 A.M., 11:30 A.M., 1:00 P.M., 3:00 P.M. and at 5:00 P.M. From 6/1/11 through 6/20/11 dietary staff had documented "300" as the sanitizer level of the three compartment sink.

Observation of the three compartment sink during the kitchen tour on 6/20/11 at 10:30 A.M. revealed differing ideas on the level of sanitizer to be used in the three compartment sink. The sanitizing agent used for the three compartment sink, Ecolab 22 Multi Quat Sanitizer, did not have instructions for the use of this product in three compartment sinks. There were also no instructions on the container of Ecolab 22 Multi Quat Sanitizer indicating at what level the sanitizer should be maintained to sanitize dishware.

On 6/20/11 at 10:35 A.M. dietary staff were asked about the process for maintaining the level of sanitizer in the three compartment sink:
SP #10 stated that s/he places the test strip into the sanitizing water and compares it to the sanitizing level chart, maintaining the orange color or 100 parts per million. SP #17 stated s/he maintains the sanitizing water to a range from 300-400 parts per million. SP #11 stated that training of the dietary staff about the proper sanitizing level for the three compartment sink would need to be performed.

During the kitchen observation on 6/21/11 , SP #8 stated that the process for washing dishes in the three compartment sink is to wash, rinse and then sanitize the dishes and set them to dry. S/he stated that usually the sanitizing level is between 200 and 300. S/he confirmed that the bottle of Ecolab 22 Multi Quat Sanitizer had a warning on the bottle "do not digest."

Interview with SP #11 on 6/23/11 at 10:00 A.M. revealed that Ecolab was contacted and would be forwarding information to indicate that the Ecolab 22 Multi Quat Sanitizer was safe for use in the three compartment sink and that the level of sanitizer should be 200 parts per million. SP #1 stated that s/he informed two staff of this information yesterday, but confirmed that s/he had not trained all the staff. In addition, s/he stated that s/he had not trained the kitchen attendant who was working in the dish room today as that staff member had been absent yesterday.

5. Observations of the kitchen on 6/21/11 at 8:10 A.M. revealed that staff were placing breakfast food onto Styrofoam plates and containers. During an interview with SP #12, s/he stated that there were not enough plates for all the patients' meals and the kitchen utilized Styrofoam plates as needed.

During an interview on 6/24/11 at 7:30 A.M., SP #8 stated that on 6/22/11 s/he had bought a case of ceramic dinner plates, 24 in number, but confirmed that the Dietary Department was still short the number of ceramic dinner plates needed for each patient. SP#8 stated that the kitchen will deliver 51 breakfast trays on the morning of 6/24/11, but that they had only 30 dinner plates. S/he confirmed that once all 30 dinner plates were used, the remaining patients would receive their food on Styrofoam plates.

Based upon observations, staff interviews and review of hospital documents, it was determined that the hospital failed to be constructed. arranged, and maintained to ensure the safety of patients.

Standard level deficiencies well as Life Safety Code deficiencies are noted for both the Governor Juan Luis Hospital and Virgin Island Cardiac Care. The cumulative effect that the facility does not meet the NFPA Life Safety Code Standard, therefore, the Condition of Participation , Physical Environment is not met as a system wide failure.

Please refer to Hospital Regulation Requirements and Life Safety Code K tag Statement of Deficiencies.

Based upon observation, review of hospital documentation, and interviews, the hospital failed to maintain the physical environment in the surgical arena to assure patient safety as it relates to ceiling tiles. Additionally all surgical equipment has not been inspected according to policy.

Evidence includes the following:

Surgical Environment:
Review of hospital correspondence regarding the leaking water noted the following:

3/16/07 ...all that is being done is wet ceiling tiles are changed ...at least 6 times ....this morning tile so saturated it may fall at any time " .
4/15/10 ... "ceiling between OR (operating room) 6 and OR 7 leaking for the past 2 weeks. Every time it rains, the tiles get saturated and water comes pouring down. The tiles are changed but the problem is not addressed. Last night there was so much water coming down ..."
3/19/11 ... "tile over Omnicell is again saturated with water it is bulging and is going to fall at any moment" .
4/13/11 ... "Wet tile to be changed in corridor between OR 6 and OR 7 due 5/12/11 " .
4/18/11 ... " Friday afternoon saturated ceiling tiles fell just as a surgical tech moved away from the area. Presently there are 2 tiles missing and a leaking ceiling " .
5/13/11 ... water is dripping from the ceiling and walls

Observations throughout the surgical arena on 6/21/11 and 6/22/11 noted numerous areas of pervasive rust on hospital equipment. Interview with SP #1 and SP #2 stated the water and condensation issues have been ongoing for some time.

Review of the Environmental Rounds conducted on 6/6/11 noted in the holding area #3 of the operating room, that there were wet/damaged ceiling tiles. The action required was " remove/replace wet/damaged ceiling tile(s)" without a due date.

Equipment inspection:
Operating room #5 during the tour on 6/21/11 at 8:05 A.M. had equipment identified as LEICA- F19 (equipment used for ophthalmology surgery) with an inspection due date of 7/10.

The C Curus Surgical System (also used in ophthalmology surgery) in room #5 also failed to have evidence that it had been inspected.

Based upon tour of the operating room in the presence of hospital staff on 6/21/11 at 3:10 P.M., the Steris Machine in the decontamination room failed to have evidence of the last inspection date.

Interview with SP #1 and the Surgical Technician verified the outdated/missing maintenance stickers.

Based on record review, interviews and observations it is determined that the hospital failed to ensure that the Life Safety from Fire requirements are met. The findings included in the K Tags included in this report prove that the facility is not in compliance with the NFPA requirements as stipulated in CFR 482.41 (b). Standards: Life Safety from Fire

Based on interviews, observations and record review, it was determined that the hospital failed to meet the requirements of the Life Safety Code standards as described in the K Tags included in this report.

The hospital may apply for waivers of specific provisions of the NFPA requirements. The hospital must offer sufficient proof that the waivers would not adversely effect the health and safety of the patients.

Based upon observations, interviews and review of hospital documentation, the hospital failed to maintain hospital equipment throughout the physical plant to ensure patient safety. Evidence includes the following:

Food Service Area
During a tour of the kitchen on 6/20/11 at approximately 10:15 A.M., the following was observed:
Near the walk-in refrigerator/freezer area, the ceiling had a black area of approximately 12 inches in diameter.
3 eschusons missing from ceiling sprinkler heads.
Ceiling light out.
2 ceiling light panels with cracks.
2 carbon monoxide tanks stored unchained in the dry storage area.
Floor fan in dry storage area with a heavy accumulation on vents and blades.
Ceiling light out in dry storage area.
In kitchen Stove hood contained a heavy accumulation of grease and dust.
These observations were acknowledged by the SP #7.

Laboratory
On 6/22/11 at 8:00 A.M. during a tour of the laboratory, the following was observed:
In the Chemistry area, an emergency overhead shower lacked an area to contain contaminated fluids.
In the Histology area, 1 chest type freezer contained a heavy accumulation of ice and mold; a blood culture machine contained a non-working thermometer inside
A Janitor closet located in the phlebotomy area contained 5 red cans, 1 full needle box, 1 full red trash bag, 2 full bags of trash, and 3 empty boxes stored on the floor.
These observations were acknowledged by the Director of the Laboratory.

Radiology
During a tour of the Radiology Department conducted on 6/22/11 at 2:00 P.M., the following was observed:
In a storage area near the sink, there was a coating of a black substance on the floor approximately 18 inches in diameter.
In the hallway of the Radiology Department there was a Janitor's closet with a floor sink having a heavy accumulation of dirt.

Pharmacy
On 6/23/11 at 11:30 A.M. SP #26 reported that a bell to alert staff that there was someone requiring assistance had been inoperable for a couple of years and never had been replaced.

Neonatal Intensive Care Unit (NICU)
On 6/23/11 at 7:50 A.M. in the NICU, a door leading to the soiled utility room was unable to be closed.

Labor and Delivery Room
In the Labor and Delivery department, an ice machine lacked an air-gap. SP #7 who accompanied the surveyor acknowledged the observations.


Dialysis Unit
The hospital failed to assure that the dialysis machines are maintained at an acceptable level of safety and quality. During a review of the preventive maintenance record for the following dialysis machines: Machine 8, 6, 9, 38 and 42, it was noted that there was no documented evidence that the internal transducers were checked for fluid or blood leaks.

An interview was conducted with SP#3, on 6/23/11 at 1:30 P.M. when asked to show where in the quarterly maintenance record is it documented that the internal transducer for each one of the dialysis machines are checked for fluid or blood leaks; s/he reviewed the maintenance records and stated that s/he could not find it.


Surgical
The surgical area was toured in the presence of hospital staff on 6/21/11 at 8:05 A.M. and 3:10 P.M. with the following noted.
Operating room # 5 where Caesarean Sections are performed, a rusted Bovie (equipment used for cautery) was noted along with an Intravenous (IV) pole. An Air Shield bed for newborn infants also was noted to have a rusted bottom.
A section of wall tile was noted missing by the left side of the door.
Room # 2 used for eye surgery was missing a tile at the back wall across from the head of the operating room table.
At 3:10 P.M. room #4 had an IV pole pitted and rusted, a Focrcetraid Bovie machine was also noted with rust.
The urology room #7, was noted to have a wall electrical outlet receptacle that was not attached to the wall.
On 6/22/11 at 7:25 A.M. the computer stand in room # 6 used for orthopedics was noted to be pitted with rust. The Gemini surgical lights over the operating room table was observed to have loose chipping paint with obvious rust.
In room # 1 the lights over the operating room table were noted to have rust around and near the screws.
The procedure cart in the Endoscopy room was rusted and also noted to have paint chipping and peeling at all drawers and trays. At the top of the procedure table, staff were able to place suction tubing to hang on the cart. Several inches of the rack-like device was totally rusted out and the remaining shelf like rack had peeling and lifting paint.
Review of the Environmental Rounds dated 6/6/11 noted "rust - excessive rust in entire department (operating room) found on medical equipment". Contained in the section called "action required" it indicates "facilities department to implement maintenance program" without a due date.
Review of hospital correspondence of 4/18/11 indicated..."concern with the amount of rust present in OR...furniture and equipment are very corroded. Our new beds, IV pole, Laparoscopic towers overhead lights Mayo stands ect are all rusted...noticed since using the "Dispatch";( cleaning solution) the corrosion has increased drastically. All metal surfaces in OR are corroding. This is a potentially serious infection control control and patient safety issue".
Interview with SP #1 and SP #2 confirmed the evidence of rust and other observations and stated that the rust has been a long standing issue. SP #2 indicated there had been an increase in the formation of rust since the facility switched to a cleaner called " Dispatch " . The solution " Dispatch " was noted to still be in use during the survey.
Please Cross Refer to A0115 & A0940.

During a tour of the kitchen on 6/20/11 at approximately 10:15 AM, the following was observed:
Near the walk-in refrigerator/freezer area, the ceiling had a black area of approximately 12 inches in diameter.
3 eschusons missing from ceiling sprinkler heads.
Ceiling light out.
2 ceiling light panels with cracks.
2 carbon monoxide tanks stored unchained in the dry storage area.
Floor fan in dry storage area with a heavy accumulation on vents and blades.
Ceiling light out in dry storage area.
In kitchen Stove hood contained a heavy accumulation of grease and dust.
These observations were acknowledged by the Environmental Director.

On 6/22/11 at 8:00 AM during a tour of the laboratory, the following was observed:
In the Chemistry area, an emergency overhead shower lacked an area to contain contaminated area.
In the Histology area, 1 chest type freezer contained a heavy accumulation of ice and mold; a blood culture machine contained a non-working thermometer inside
A Janitor closet located in the phlebotomy area contained 5 red cans, 1 full needle box, 1 full red trash bag, 2 full bags of trash, and 3 empty boxes stored on the floor.
These observations were acknowledged by the Director of the Laboratory.

During a tour of the Radiology Department conducted on 6/22/11 at 2:00 PM, the following was observed:
In a storage area near the sink, there was a coating of a black substance on the floor approximately 18 inches in diameter.
In the hallway of the Radiology Department there was a Janitor ' s closet with a floor sink having a heavy accumulation of dirt.

On 6/23/11 at 11:30 AM, SP #26 reported that a bell to alert staff that there was someone requiring assistance had been inoperable for a couple of years and never had been replaced.
On 6/23/11 at 7:50 AM in the NICU a door leading to the soiled utility room was unable to be closed.
In the Labor and Delivery department, an ice machine lacked an air-gap. The Director of Environmental Services who accompanied the surveyor acknowledged the observations.

Based on observations, review of the Infection Control Manual and Policy and Procedures as well as staff interviews, it was determined that the hospital failed to meet the Condition of Participation for Infection Control as evidenced by:

1. As of 6/23/11, the hospital's Infection Control Plan for 2011 had not yet been approved.

2. Nursing staff did not follow the standard of practice for hand washing/sanitizing and gloving. Please refer to A0749.

3. Nursing staff did not clean equipment as recommended by the manufacturer.

4. The hospital did not provide and maintain a sanitary environment to avoid sources and transmission of infections and communicable diseases. Unsanitary conditions were observed in the kitchen. Expired food was observed in the dry storage area. The ice machine was not cleaned. There was inconsistency in the staff's understanding about the level of sanitizer to be used in the three compartment sink. Unsanitary conditions were observed in the Emergency Department.

4. The chief executive officer, the medical staff and the director of nursing did not ensure the implementation of successful corrective action plans to address the sanitation issues within the hospital environment. Please refer to A0756.



The findings include:

1. Observation of the Glucometer on 6/22/11 at approximately 9:50 A.M. on the Cardiac Rehab Unit, revealed the appearance of dried blood on the exterior of the device. Interview with SP #30 revealed this was a multi-use Glucometer and it should be cleaned with alcohol wipes. When observing the Glucometer together, SP #30 acknowledged the appearance of dried blood on the exterior of the Glucometer.

Interview with the SP #31 on 6/22/11 at approximately 1:00 P.M. revealed the Glucometers were for multi-use, and staff should follow manufacturers recommendations between use.

Review of manufacturers recommendations indicated that an alcohol or ammonia based product should be used.

2. Observation of the acute hemodialysis unit on 6/22/11 between 1:20 P.M. and 1:30 P.M. 2 nurses were picking up a glove and using a glove to touch equipment but were not placing the glove on their hand.

3. The hospital's Infection Control Plan for 2011 has not yet been approved.

Review of the hospital's Infection Control Plan indicated that the latest plan had been approved in June 2010.

During an interview with the Infection Control Coordinator on 6/23/11 at 3:50 P.M., s/he stated that the 2011 Infection Control Plan had not yet been presented to the hospital's Board of Directors and should be presented sometime before August 2011.

4. Nursing staff did not follow the standard of practice for hand washing/sanitizing and gloving during the wound care for Patient #21.

Observation of the wound observation for Patient #21 on 6/23/11 at 2:25 P.M. revealed that SP #27 washed his/her hands prior to performing the wound treatment and then placed two pairs of gloves on his/her hands. SP #27 would then remove a glove after performing a portion of the wound treatment and then place another glove over the glove on his/her hand instead of removing all the gloves and cleaning his/her hands with sanitizing solution or by washing his/her hands with soap and water.

During an interview with the SP #31 on 6/23/11 at 3:50 P.M., s/he stated that the practice is not to double glove. S/he stated that staff should wash their hands or use hand sanitizer and use one pair of gloves.

5. Unsanitary conditions were observed in the kitchen.

A tour of the kitchen on 6/20/10 at 10:05 A.M. revealed the following:

The Panini machine had a heavy accumulation of grease.

Four convection ovens had a heavy accumulation of grease.

The metal can opener had a heavy accumulation of grease and metal shavings.

Stored on a rack was a stove top grill with a heavy accumulation of grease and two dirty dinner plates.

Stored on another rack were four pot lids that had dirt and grease on them.

A trash can lid was stored in the baking prep area on a shelf with two carafes and the blender.

The kitchen floors contained food debris under and behind equipment, residue on the floor tiles and missing grout between some kitchen tiles. SP #7 stated that the floors are mopped each night and power washed three to four times a year.

There was a buildup of food debris on both mixers, the Hobart and the Univex.

The skillet was found to have a heavy buildup of dry food debris on the bottom portion of the equipment.

Observation of the prep area revealed the staff covering pans of dough with plastic wrap without wearing gloves.

In a walk in dairy refrigerator the following were observed:

3 pound container of cream cheese was opened with no date and a heavy accumulation of mold.
4- ? gallon containers of frozen egg whites had no date of defrosting.
4- ? pound containers of provolone cheese were open, but with no date of opening.
3 -? pound packages of Swiss cheese were open, but with no date of opening.
4 packages of hamburger rolls with a date of 6/2/11.

The meat cooler was found to have a bag of frozen chicken and a box of frozen chicken open to the air. In the meat freezer a box of frozen chicken was found to be uncovered.

The sugar bin was found to be three quarters full of sugar and the scoop was found to be inside the sugar bin.

The flour bin and the sugar bin both had residue on the outside and lids of the containers.

There was a large build up of dust accumulated on the grill of the fan in the dry food storage area. The fan was observed to be running and the air flow was directed to the stored chocolate.

The Janitor's Closet across from the food serving area was found to be unlocked and when the door was opened there was a musty odor emitted from the room. On the floor of the Janitor's Closet were a dust pan and seven large reddish-brown dead insects similar in appearance to a cock roach. In the floor sink of the Janitor's Closet was a dry mop and another dead reddish-brown insect.

6. Expired food was observed in the dry storage area.

A tour of the kitchen on 6/20/10 at 10:05 A.M. revealed the following in the Dry Food Storage area:

Three cans of Heinz Tomato Ketchup were stored in the dry food storeroom. The cans had been dated by the Dietary staff with the date received which was 9/14/10. Observation of each of the cans revealed black marks on the cans lids and lip of the lids. SP #11 who was accompanying the Dietary tour stated that she did not know what caused the black marks. She also stated that the hospital did not have a policy and procedure regarding when items that did not have expiration dates would be considered expired and not to be used. SP #11 stated that she would consider six to nine months after the date written on the item as received to be the date that the item was expired and not to be used. She had the three cans of tomato ketchup removed from the store room.

Two seven pound cans of B & M Original Baked Beans were dated 12/8/10 as being received and had expired on 3/26/11.

One three pound can of Campbell's Chicken Noodle Soup with the date being received of 8/10/10 was found to have expired on 5/26/11.

Twelve cans of 46 ounce V-8 Juice was dated as received on 5/18/10 and the cans which were still stored in the dry food storage area had expired on 6/18/11.

Eight boxes of Baking Soda with an expiration date of 7/5/10.

Five containers of Sun Sweet Prune Juice were stored in a box. Staff had written 4/13/11 as the date the prune juice was received. The containers of prune juice had 12/May/10 written as the expiration date. SP #11 stated s/he was unable to tell if the expiration date was 5/10/12 or 5/12/10.


7. The ice machine was not cleaned.

On 6/20/11 at 10:30 A.M. the ice machine in the dry food storage area was found to have accumulated dust on the outside and debris on the inside ledge of the ice machine. When asked how often the machine was cleaned, SP #9 replied that it was not regularly cleaned.

Although dietary staff indicated the ice machine was not regularly cleaned, the hospital's Ice Machine, Water Pump and Refrigerator Cleaning - Infection Control Policy dated 4/2010 indicated that the purpose of the policy was to ensure cleaning and sanitary condition of the ice machines, water dispensing pumps and refrigerators. The external surfaces of the ice machine must be wiped using the hospital approved disinfectant or a cloth saturated with soap and water. (Refer to the Environmental Services Policy and Procedure Manual.

The hospital's Ice Machine Cleaning and Storage Policy and Procedure dated 8/2002 and reviewed by the hospital on 10/2008 indicated that monthly the ice machine will be shut down a minimum of three (3) days prior to schedule cleaning so that ice in storage will be used. Once the unit has been emptied, the manufacturers recommended solution will be added to the system and the self-cleaning process activated. While the system is self cleaning the harvest guard, outer side of chill plate and bin will be cleaned using approved sanitizer. The outside of the unit will be cleaned weekly. The filters on the ice machine will be changed monthly and the ice scoops will be cleaned and sanitized three times per week.

The hospital had previously noted this issue in the 2/18/10 Executive Environmental Surveillance Rounds Report for Dietary Services which revealed no maintenance log for the ice machine in the dry storage room. The action was to provide and maintain cleaning/maintenance log for the ice machine.

On 6/21/11 at 8:30 A.M., SP #8 stated that the Manitowoc Ice Machine in the dry food storage area is self cleaning and that staff clean the outside and the inside ledge, but to his/her knowledge the machine has not been cleaned since installed in 2010. SP #8 also stated that the Hoshizaki ice machine in the cafeteria has also not been cleaned, but that Maintenance staff change the filters on both ice machines. Observation of the Manitowoc Ice Machine in the dry storage area on 6/21/11 revealed that staff had cleaned the outside of the machine and the inside ledge was free of debris.

8. There was inconsistency in the staff's understanding about the level of sanitizer to be used in the three compartment sink.

Review of the hospitals' Standard Operating Procedures for Cleaning and Sanitizing Food Contact Surfaces Including Dish Machines and 3 Compartment Sinks indicated that for three compartment sinks staff were to test "the chemical sanitizer concentration by using an appropriate test kit."

Review of the June 2011 Nutrition Department Sanitizer Concentration Log for the three compartment sink revealed that the sanitizing water was tested at 6:00 A.M., 9:00 A.M., 11:30 A.M., 1:00 P.M., 3:00 P.M. and at 5:00 P.M. From 6/1/11 through 6/20/11 dietary staff had documented "300" as the sanitizer level of the three compartment sink.

Observation of the three compartment sink during the kitchen tour on 6/20/11 at 10:30 A.M. revealed differing ideas on the level of sanitizer to be used in the three compartment sink. The sanitizing agent used for the three compartment sink, Ecolab 22 Multi Quat Sanitizer, did not have instructions for the use of this product in three compartment sinks. There were also no instructions on the container of Ecolab 22 Multi Quat Sanitizer indicating at what level the sanitizer should be maintained to sanitize dishware.

On 6/20/11 at 10:35 A.M.. dietary staff were asked about the process for maintaining the level of sanitizer in the three compartment sink:
SP #10 stated that s/he places the test strip into the sanitizing water and compares it to the sanitizing level chart, maintaining the orange color or 100 parts per million. SP #17 stated s/he maintains the sanitizing water to a range from 300-400 parts per million. SP #11 stated that training of the dietary staff about the proper sanitizing level for the three compartment sink would need to be performed.

During the kitchen observation on 6/21/11 SP #8 stated that the process for washing dishes in the three compartment sink is to wash, rinse and then sanitize the dishes and set them to dry. S/he stated that usually the sanitizing level is between 200 and 300. S/he confirmed that the bottle of Ecolab 22 Multi Quat Sanitizer had a warning on the bottle "do not digest."

Interview with SP #11 on 6/23/11 at 10:00 A.M. revealed that Ecolab was contacted and would be forwarding information to indicate that the Ecolab 22 Multi Quat Sanitizer was safe for use in the three compartment sink and that the level of sanitizer should be 200 parts per million. SP #11 stated that s/he informed two staff of this information yesterday, but confirmed that s/he had not trained all the staff. In addition, s/he stated that s/he had not trained the kitchen attendant who was working in the dish room today as that staff member had been absent yesterday.


9. Unsanitary conditions were observed in the Emergency Room.

Observation of the Medicine Room in the Emergency Room with SP #13 and SP # 14 on 6/20/11 at 1:20 P.M. revealed the following:

The hopper in the Soiled Utility Room had plastic over it and was out of order. SP#13 stated that staff would empty urine, feces or vomitus in the bathrooms in the emergency room while waiting for the hopper to be repaired. SP #13 stated that the Maintenance Department was waiting for a part and the hopper has been out of commission for approximately two weeks.

The Janitor's closet in the emergency department area was not locked and a mop was noted in the floor sink and the drain cover was not covering the drain.

Review of the Emergency Room Environmental Rounds report dated 6/6/11 revealed the following issues were identified:

Soil Utility Room Hopper clogged needs minor repair, wet damaged ceiling tiles need to remove/replace all wet/damaged ceiling tiles, and broken handrails - need to repair/replace broken hand rails on unit, wall penetration - need to repair/paint patched walls.

Based upon observation and document review the hospital failed to ensure that acceptable standards of infection control practices were maintained by 2 nurses in the acute care dialysis unit.

Evidence includes the following:

On 6/22/11 at 1:20 P.M. during dialysis treatment observation, SP # 5 was observed touching the dialysis machine using a glove as a barrier without wearing it. Then s/he proceeded to put the same glove on to help patient hold fistula site.

On 6/22/11 at 1:30 PM during dialysis treatment observation, SP #6 was observed touching the dialysis machine using a paper napkin as a barrier.

During an interview with SP #5, s/he stated that his/her hands get wet with sweat and that makes it difficult for his/her to fully wear the glove each time s/he has to touch the machine.


The Hospital Infection Control Policy and Procedure Manual Code: ICP
Page 9 of 30, states the following:

Staff members must wear gloves when touching dialysis machine during or after treatment.

Based on observations, review of the Infection Control Manual and Policy and Procedures as well as staff interviews, it was determined that the chief executive officer, the medical staff and the director of nursing did not ensure the implementation of successful corrective action plans to address the sanitation issues within the hospital environment.

The findings include:

Review of the Annual Evaluation of the Effectiveness of the Hospital's Infection Control Program October 2008 - September 2009 revealed that the Infection Control Program is an organization-wide program that is responsible for the surveillance, prevention and control of healthcare associated infections (HAI). This program also institutes measures to prevent the transmission and acquisition of infections to patient, staff and visitors. Challenges of the Infection Control Program are: Consistently maintaining a high level of cleanliness in the hospital. The presence of soiled ceiling tiles and indications of water intrusion throughout the facility.

The review of the Evaluation of Infection Control Program Policy and Procedure dated March 2010 revealed the Infection Control Program data for each fiscal year will be analyzed. A report will be developed and submitted to the Infection Control Committee, Executive Staff, Performance Improvement Department and Medical Staff.

The review of the Environmental Services - Infection Control Policy and Procedure dated February 2010 indicated that sanitation within the hospital environment depends upon cleaning thoroughly and frequently. The hospital environment includes cleaning walls, floors, windows, beds, furniture, draperies (curtains), waste containers, bathrooms, stairs, elevators, storage spaces, unused spaces, closets and doors.

Review of the 2/18/10 Executive Environmental Surveillance Rounds in the Dietary Services area identified soiled floors, soiled vents, wet/damaged ceiling tiles, damaged lower sections of walls. In addition, the prepared foods in the Walk-in Cooler were observed to have a labeling issue and there was no maintenance/cleaning log for the ice machine in the dry storage room.

Review of the 6/6/11 Environmental Rounds Report revealed that the Hospital conducts environmental tours every six months in patient care areas to evaluate the effectiveness of previously implemented activities intended to minimize or eliminate risk in the environment. The Environmental Report indicated the following:

EMS/ER Patient Shower Room: Light in ER burnt out. Base on door is a trip fall hazard. Wall above door needs repairs. Floors stained and discolored.
EMS Office: Wet/damaged ceiling tile(s). Air Condition vent soiled. Hand soap dispenser broken.
Soiled Utility Room: Hopper clogged. Soiled hamper uncovered. Soiled utility room door found unlocked.
Ceiling Tile: Wet/damaged ceiling tiles.

Observations of the hospital environment from 6/20/11 through 6/24/11 revealed sanitation concerns in the Kitchen and Emergency Department.

During an interview with SP #7 on 6/23/11 at 1:20 P.M. s/he stated that there is a Work Order System in which items that need repair can be reported and then fixed. S/he stated that from February 2011 to May 2011, 99% of the work orders have been completed.

SP #7 did acknowledge that items may not be reported and therefore the Maintenance Department may not be aware of an issue. In addition, SP #7 stated that there has been a reduction of manpower from 30 to 15 employees in the Maintenance Department due to budget compressions and as a result they have tried to prioritize projects. Furthermore, s/he confirmed the position of Dietary Director is presently vacant, but that the hospital is in the process of interviewing candidates. S/he stated that s/he has recently been given the responsibility as Administrator of the Dietary Department.

During an interview with SP # 14 on 6/24/11 at 10:20 A.M. s/he stated that s/he is responsible for Nursing and Ancillary Services. S/he indicated that s/he meets with nursing leadership and ancillary department heads every two weeks. In addition, information is communicated from the nursing supervisors to him/her via e-mail, but this information is not continually saved in order to track and trend issues. SP #14 indicated that environmental issues are handled by the Director of Facility Management.

Based on record review and staff interview conducted on 6/23/11 and 6/24/11, it was determined that the hospital failed to notify in a timely manner, the organ donor network (Life Link Foundation) of individuals who died in the hospital.

The findings include:

A review of the Governor Juan Luis Hospital death list starting from 1/1/11 through 6/22/11, it was noted that the hospital staff failed to notify Life Link Foundation of 12 deaths in the hospital.

The hospital also did not have a system in place to ensure that all deaths are called into Life Link Foundation.

During an interview with SP #4, conducted on 6/23/11, s/he acknowledged that the staff is not reporting all hospital deaths to the Life Link Foundation and s/he is aware of it.

Based upon observation, document review and interview, it was determined that the hospital failed to meet the Condition of Participation for Surgical Services by failing to provide surgical services in accordance with acceptable standards of practice as evidenced by:

1. Failing to address a long standing known issue of excessive humidity in the operating rooms producing significant amounts of condensation on walls, floors and equipment. Please refer to A0940 This failure impacts on potential for bacterial growth and the potential for compromising the integrity of hospital equipment.

2. Failing to have a surgical roster that was accurate and current. Please refer to A0945.

3. Failing to have an operating room register that contained all of the required elements. Please refer to A0958.

On 6/21/11 at 8:02 A.M. the surgical service department was toured in the presence of hospital staff noting the following observations.
The operating room used for Caesarean Sections, room #5, had a humidity reading of 79%.
In room #4 at 3:10 P.M. humidity gauge read 71%.
In room #7, the urology room, no humidity gauge was found to track/monitor humidity readings.
Observations on 6/22/11 in operating room #6, the orthopedic room, at 7:25 A.M. noted the humidity gauge to read 99%. Operating room #1 had a humidity gauge that read 84%.
Interview with SP#2 during the tour on 6/21/11 indicated the humidity and temperature of the surgical arena is monitored by the orderly. The range for the humidity is to be between 30-60% to be acceptable and maintenance is notified when the reading are beyond the parameters of 30-60%.
Humidity tracking logs were reviewed for the month of April, May & June of 2011 which noted the following humidity ranges for each room.
Low of 42 % to a high of 99 % in Room #1
Low of 73% to a high of 99% in Room #2
Low of 57% to a high of 81% in Room #4
Low of 65% to a high of 95% in Room #5
Low of 67% to a high of 99% in Room #6
No humidity monitoring in Room #7.
Interviews with ST #1 and SP #2 during the tours of the surgical arena confirmed that humidity has been a long standing issue. Several pieces of communication were reviewed noting that Hospital leadership was aware of the ongoing issues of humidity. Examples of correspondence include the following:
10/27/09- " humidity in the Operating Rooms is all of out range ...OR have all starting sweating both walls and floor ...not good for equipment because of the condensation ...rust on equipment ...recurrent problem has potential to become infection control issue..thinking about mold ...similar situation but worse ...walls dripping and floors had so much water ...had to call housekeeping ...had to cover equipment ...not sure what long-term effects ...have on equipment ...please address urgently " .
3/9/10- "humidity OR 7 = 91%"
3/12/10= "humidity OR 6 = 90%"
3/17/10- "temperature and humidity are out of range"
5/13/11- "humidity in OR are all out of range ...between 92-96%. Water dripping from ceiling and walls. Surgery on hold until this is rectified" .
5/24/11- "humidity in the OR at 0700 was between 95% and 99%, floors walls and equipment including the anesthesia machines, overhead lights were dripping wet ...floors had a layer of water ...condensation keeps coming back ...don't know if any water went into machines ...had similar situation (5/13) had to re-sterilize all instruments because of the amount of condensation" .
5/24/11- "humidity improved at 0900 was between 77% and 85%...as a result of all this condensation is further increasing the amount of rust in the department ...would like the OR checked for mold and a plan to rectify this chronic humidity problem" .
According to American Institute of Architects, humidity ranges of 30% to 60% is desirable and the hospital policy indicates their range is also 30% to 60%.
The hospital failed to maintain acceptable standards of practice as it relates to operating room humidity.
Cross refer to A0724
Cross refer to A0144

Based upon observation, review of hospital documents and interview with staff, it was determined the the surgical services had not maintained the OR (operating room) physician privileges roster, in that the roster was not current, nor did it clearly specify the expiration date of the practioners privileges for 8 of 16 practioners listed in the roster. ( MD #1, MD #2, MD #3, MD #4, MD #5, MD #6, CRNA ( Certified Registered Nurse Anesthetist) #7, and MD #8.

Evidence includes the following:


A review of the binder used as the OR physician privileges roster was reviewed on 6/21/11 in the presence of facility staff. The binder contained copies of individual clinical privileges for reappointment/initial appointment.

Review of MD #1 noted the practioner to be approved for the period through 2011 without clarification of when in 2011 the appointment would again need to be reviewed. The Board Chair signed the existing reappointment 5/20/09.

Review of MD #2 noted the practioner to be approved through 2011 without clarification of when in 2011 the appointment would again need to be reviewed. The Board Chair signed the existing reappointment 4/22/09.

Review of MD #3 noted the practioner to be approved through 2011 without clarification of when in 2011 the appointment would again need to be reviewed. The Board Chair signed the existing reappointment 3/17/09.

Review of initial appointment for MD #4 valid for one year, noted the practioner to be approved through 2011 without clarification of when in 2011 the appointment would again need to be reviewed. The Board Chair signed the existing appointment 1/15/2010.

Review of initial appointment for MD #5 valid for one year, noted the practioner to be approved through 2011 without clarification of when in 2011 the appointment would again need to be reviewed. The Board Chair signed the existing appointment 1/15/2010.

Review of initial appointment for MD #6 valid for one year, noted the practioner to be approved through 2011 without clarification of when in 2011 the appointment would again need to be reviewed. The Board Chair signed the existing appointment 1/15/2010.

Review of initial appointment for Certified Registered Nurse Anesthetist (CRNA) #7 valid for one year, noted the practioner to be approved through 2011 without clarification of when in 2011 the appointment would again need to be reviewed. The Board Chair signed the existing appointment 4/23/10.

Review of MD #8 noted the practioner to be approved through 2010. There was no evidence of another reappointment in the file. The Board Chair signed the existing reappointment 6/25/08. Based upon the current practioner list, MD #8 was listed as an active member of the facility staff.

Interview with SP #1 on 6/21/11 at 8:30 A.M. and later at 11:45 A.M. noted the period of the appointment should be clarified to show when in 2011 it would require renewal according to the Bylaws of the Hospital.

Based upon observation, staff interview and document review, the hospital failed to provide an operating room register that was complete. Evidence includes the following:


Review of the Hospital's Operating Room List conducted on 6/21/11 revealed required information was missing from their List. The hospital uses a list of their operating room procedure schedule for each day as the "register." The List, found in a binder at the nurses station, did not include the following elements: the total time of the surgery; any assistants; names of scrub and circulating room personnel; the type of anesthesia used and the person administering the anesthesia and the pre and post operative diagnosis.

Interview with SP #1 and SP #2 on 6/21/11 at 110:00 A.M. verified that the schedule List is the operating room register. Later that same day at 4 P.M., SP #1 verified that the hospital List does not contain the elements as required through regulation.

Based on review of the hospital's policy and procedure and staff interview, it was determined that the hospital's policy and procedure for the ordering of laboratory and radiological tests did not meet the standard of practice for emergency services.

Review of the Policies and Procedures of the Emergency Room Fast Track effective 1 February 2007 and reviewed 1 September 2009 , revealed that nurses are able to write orders for lab tests and x-rays prior to being seen by the physician. Under the section titled "RN ( registered Nurse) Scope of Practice" ..." if appropriate and approved by MD ( Medical Doctor)/ PA (Physician Assistant), RN may write orders for x-rays and simple labs such as u/a (urinalysis) C&S (Culture and Sensitivity), urine pregnancy tests prior to physician or PA seeing patient ..."

On 6/24/11 at 7:55 A.M., an interview was conducted with SP #18 who was working in the Fast Track. SP #18 stated that nursing staff do not order laboratory tests or x-rays. S/he stated that physicians order the radiological and laboratory tests and the nursing staff escort the patients to radiology or to the Emergency Room to have the laboratory tests performed.

During an interview with the SP #14 on 6/24/11 at 8:30 A.M. s/he appeared surprised by the language of the Policy and Procedure allowing nursing staff to order tests. SP #14 stated that nursing staff are not permitted to write orders for x-rays or laboratory test. Another interview with SP #1, also confirmed that the policy should not have been part of the Fast Track Procedures and that it is not acceptable.

Based on staff interview and review of hospital documents, it was determined that the hospital failed to meet the Condition of Participation for Respiratory Services as evidenced by the following:

1. Failing to ensure that respiratory services were administered and supervised under the direction of a doctor of medicine or osteopathy. Please refer to A1153.

2. Failing to ensure that respiratory services were integrated into the hospital wide Quality Assessment Performance Improvement (QAPI) to ensure that patient's needs were being assessed, analyzed and tracked due to the lack of staff supervision by a doctor of medicine or osteopathy. Please refer to A1151.

Based on staff interview and review of facility documents, it was determined that the facility failed to ensure that patient's needs were being monitored through the hospital wide Quality Assessment Improvement Process. Evidence includes the following:

During an interview on 6/22/11 at 2:15 P.M. with SP #20, it was revealed that the Respiratory Department has not had a Director for over two years. The employee stated that there was a respiratory Technician serving as a supervisor and was working the night shift.

During an interview with the QAPI representative on 6/24/11 at 11:00 A.M., s/he said that there were no meeting minutes for the Respiratory Department. Three months of Performance Measures for Code Blue were presented. The Performance Measures were all submitted to the QAPI committee by the Chief Respiratory Therapist.

The only reports that are related to the QAPI program are the Performance Measures that lack any indication of being reviewed or approved by a member of the medical staff or how the respiratory department is incorporated into QAPI program. The employee stated that there was a respiratory Technician serving as a supervisor and was working the night shift.

Based on staff interview and review of hospital documents it was determined that the Respiratory Department lacked a qualified Director responsible to administer and oversee the services being provided.

The findings include:

On 6/22/11 at 2:15 P.M. an interview was conducted with SP #20. The employee was asked who from the medical staff was the Director of Respiratory. The employee said that the position has been vacant for approximately two years. The employee also said that the respiratory department has been run by the Chief Respiratory Therapist during this period.

During the interview with the employee, SP #14, who was also present, said that s/he was unaware that there was no physician appointed as Director of Respiratory Services.

On 6/24/11 at 1:00 P.M., a review of the Respiratory Department's performance measures for January, February and March 2011 was conducted; the review revealed that the performance measures were submitted by the Chief Respiratory Therapist with no oversight by a Director of Respiratory Services.