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Based on observations, interview with patients and staff, and review of documentation, the governing body failed to oversee the medical staff to ensure that appropriate levels of care were provided to patients. Multiple care areas were not investigated or reported to the governing body.

Findings include:

1. On 10/16/09, the Chief Medical Officer of the Hospital delegated clinical privileges to three Registered Nurses for excisional debridement for inpatients and outpatients with a Physician or Physician Assistant order.

On 3/12/10, the surveyor reviewed the Governing Body By-Laws revised as of August 28, 2008 and meeting minutes of 3/12/09 through 3/11/10. Per review of the governing body by-laws and meeting minutes, there was no evidence this delegated responsibility had been approved by the Governing Body.

Interview with the Registered Nurse/Wound Care Coordinator (one of the three RN's with delegated privileges) on 3/12/10 confirmed there were no policies, procedures or protocols in place to provide direction and guidance in wound debridement. The RN/wound care coordinator indicated that there was no need for these, as each wound is different. The Vice President of Nursing, who was present for this interview, indicated she was not aware of the lack of procedures specifically related to excisional debridement.

The President of the Hospital, who sits on the Governing Body, was interviewed on 3/16/2010 at 5:15 PM and confirmed the hospital lacked a clear policy and/or oversight of wound debridement.

2. The Governing Body failed to formulate specific criteria for credentialing practitioners responsible for providing care to patients.

3. The governing body failed to ensure safe and adequate care was provided to hospital patients who required, intravenous therapy and wound management.

Refer to the findings throughout the letter.

The Condition for patient rights is not met.

Based on observations, staff interviews and record reviews, the Hospital failed to ensure that restraints were implemented only when based upon a comprehensive assessment that determined the restraint was a necessary intervention to protect a patient from harm due to a medical condition or symptom; and, that the least restrictive device was used to restrain the patient for the least amount of time.

Findings included:

1. For two patients (#3 and #9), from a total sample of 32 current patients reviewed, the Hospital failed to ensure that restraints were implemented only when based upon a comprehensive assessment that determined the restraint was a necessary intervention to protect a patient from harm due to a medical condition or symptom; and, that the least restrictive device was used to restrain the patient for the least amount of time. (Please refer to A154).

2. For one patient (#22) out of a sample of 32 current patient records reviewed, the hospital failed to comprehensively assess the use of a drug or medication as a chemical restraint. (Please refer to A 160)


3. For three current patients reviewed with restraint devices, (#3, #9 and #15) from a total sample of 32 current patients reviewed, the Hospital failed to ensure the least restrictive device was utilized for the least amount of time. (Please refer to A 165.)

4. Based on staff interviews, observation and record review, the Hospital failed to ensure that "Code Yellow" restraint policies were in accordance with safe and appropriate techniques. Additionally, the Hospital failed to ensure that staff were properly trained in the application and monitoring of restraint devices to prevent injury to patients. (Please refer to A 167.)

5. For one (#3) patient from a total sample of 32 current patients reviewed, the Hospital failed to ensure that restraints were implemented only when ordered by the physician. (Please refer to A 168).

6. The Hospital failed to ensure that staff were properly trained in the safe implementation of restraint devices. (Please refer to A 194).

The Condition for Quality Assurance is not met.

The Hospital failed to develop, implement and maintain an effective, ongoing, hospital wide quality assessment and improvement program that improved health outcomes and prevented and reduced medical errors.

At the time of survey the Conditions for Governing Body, Nursing and Infection Control were found not met. The Hospital's Quality Assurance Program failed to identify and address significant findings to improve health outcomes.

Refer to the deficiencies throughout this letter.

The Condition for Medical Staff was not met.

Based on observations,with staff, and review of documentation, the hospital medical staff failed to operate under the bylaws approved by the governing body. Findings include:

On 10/16/09, the Chief Medical Officer of the Hospital delegated clinical privileges to three Registered Nurses for excisional debridement for inpatients and outpatients with a Physician or Physician Assistant order.

Per review of the Medical Staff By-Laws, Rules and Regulations revised as of June 2008, there was no evidence that the Chief Medical Officer had the authority to delegate this privilege to Registered Nurses.

During the validation survey, 03/11/10 to 03/19/10, the Chief Medical Officer was unavailable for interview.

Interview with the Registered Nurse wound care coordinator #1 (one of the three RN's with delegated privileges) on 3/12/10 PM confirmed there were no policies, procedures or protocols in place to provide direction and guidance in wound debridement. The wound care coordinator indicated that there was no need for these as each wound is different. The Vice President of Nursing, who was present for this interview, indicated she was not aware of the lack of procedures specifically related to excisional debridement.

The Condition for Nursing Services was not met.

The Nursing Staff on all hospital units failed to provide adequate care for intravenous therapy and devices, wound care management and the prevention of pressure sores. The nursing service did not ensure that all their staff were qualified to care for wounds, intravenous therapy and devices. Policies and procedures reviewed were inadequate to direct the safe care of patients regarding above patient care areas.

The hospital failed to ensure that the nursing care was provided in a safe manner and that failure resulted in harm to patients.

Condition for Infection Control Not Met

Based on observation, interview and record review the Hospital failed to develop, implement and maintain an active, hospital-wide program for the prevention, control and investigation of infections and communicable diseases.

The Hospital provided the survey team with a copy of a policy titled, "Infection: Surveillance, Prevention, and Control Plan- 2009." (effective January 2009.) This plan was signed by the Chairperson of the infection control committee and the Chief Medical Officer.

The definition of the purpose of the plan specified that it was "to develop and maintain a written plan for Infection Control/Employee Health including an assessment of risk, population served and strategies to decrease risk. The plan will be updated at least annually and more often as needed."

The policy specifically indicated that it was the "responsibility is delegated to the infection control practitioner (ICP) to carry out the daily functions of the infection control program. The ICP has knowledge of and interest in infection control."

The functions of the infection control nurse included:
-consults on infection risk assessment, prevention, and control strategies.
-assists with product/procedure evaluation.
-plans education directed at interventions to reduce infection risks.
-conducts surveillance daily after review of 24-hour intershift and microbiology report.
-monitors infection control practices and employee compliance.
-ongoing consultation with all departments as needed.
-consults daily with Admissions for placement of patients.
-conducts hospital rounds weekly.

The observations and interviews appearing at A-749 provide specific information regarding the hospital's lack of the implementation of their own "Infection: Surveillance, Prevention and Control Plan -2009."

The Infection Control Practitioner did not offer the plan for 2010.

Based on record reviews and interviews, for one closed record reviewed, (#21), from a total of 4 closed records reviewed, the hospital failed to ensure that safe and appropriate plans for discharge were arranged and implemented.

Findings included:

1. Patient #21 was admitted to the hospital on 8/21/09 for short-term rehabilitation following a cerebrovascular accident. The patient's hospitalization was complicated by an episode of hypotension and hypovolemia requiring hospitalization at an acute care hospital on 10/4/09.

Upon return to the facility on 10/7/09, the patient was noted to have Stage II wounds on the buttocks and right hip, which deteriorated over the course of the hospital stay. The patient was eventually discharged home on 3/4/10 with extensive right hip and sacral/buttocks wounds that had exhibited signs and symptoms of infection. Visiting nurse services were arranged for upon discharge.

Record review of this discharged patient on 3/17/10, revealed that the family had received one teaching session regarding care for the wounds prior to discharge. On 2/23/10 at 1643, the Wound care coordinator documented instruction of changing the patient's dressings to the patient's spouse in anticipation of planned discharged home. According to the Wound care coordinator, the spouse displayed proper techniques with all dressings, and educated "re: S & S (signs and symptoms) of infection or deterioration of ulcers, and when to notify VNA (visiting nurse agency)/ MD." However, the Wound care coordinator did not document in her note how the patient's spouse would obtain treatment materials to perform the dressing changes following discharge.

Additionally, immediately prior to discharge on 3/4/10, there was no documented evidence showing that the hospital had informed the spouse that the wounds had shown signs and symptoms of infection.

The hospital completed a "Patient Care Referral Form" that was provided to the visiting nurse agency around the time of discharge on 3/4/10. The visiting nurse agency would provide wound and other nursing care to the patient at home. The following information was provided to the agency in order for them to provide on-going care and treatment to the patient's wounds upon discharge:

"Skin intact other than wounds as follows: Coccyx-10 cm. x 15 cm. x 2 cm. unstageable, serosanguinous drainage pink/yellow slough base with black areas."

"Left hip (actually right hip)-6 cm. x 9 cm. x 1 cm. pink/yellow slough base with serosanguinous drainage and small black area."

"Dressings-NS (normal saline) moistened gauze impregnated with Elta Hydrogel covered by DCD (dry clean dressing) change BID (twice daily) or PRN (as needed) soiling."

The clinical data provided to the visiting nurse agency on the Patient Referral Form, failed to include the significant finding of "foul odor," and an accurate description of the patient's extensive pressure ulcers during the nurse's 3/1/10, weekly wound assessment.

Review of the patient's record from the visiting nurse agency revealed an admission note documented on 3/5/10 at 1605. The registered nurse documented that there were several problematic issues with the patient's discharge from the hospital. The patient's wife attempted to get patient care supplies. However, the pharmacy told the spouse that the scripts could not be filled because the patient was still listed at the pharmacy as being in a "long-term care facility". Additionally, the nurse documented that there was an issue with the spouse obtaining dressing supplies for wound care. This problem occurred, according to the visiting nurse, because the hospital case manager failed to set up the dispensing of dressing change materials with the vendor.

Lastly, the visiting nurse noted that the initial physical assessment of the patient's wounds was not identical to the written description provided on Page 2 of the Patient Referral Form. The visiting nurse documented "right hip wound with probable infection." The visiting nurse asked the wife to view the wounds to provide comparison. According to the nurse's documentation, the wife was visibly upset after viewing the wounds, and made the statement: "Oh my God. They were not like that the last time I saw them." The visiting nurse noted that during the dressing change, "patient skin feels hot to touch." No thermometer was available to take the patient's temperature. However, the spouse indicated that her daughter would purchase one that evening.

The visiting nurse documented that their agency would provide nursing care until 2200. After 2200, the wife would be the caregiver for the patient. At 0800 the morning of 3/5/10, the visiting nurse would return to the patient's home to provide nursing care for the patient. The patient's spouse was instructed by the visiting nurse to monitor the patient's temperature and breathing pattern closely, and notify the visiting nurse agency with any questions or changes in the patient's condition.

On 3/5/10 at 0915, a case manager for the visiting nurse agency documented a call that she had received from the field nurse at the home of the patient. The case manager's note indicated "reports patient temp (temperature) elevated > (greater than) 101, w/ (with) RR (respiratory rate) > (greater than ) 40, foul odor emanating from covered wound." According to the case manager's note, the nurse "instructed to have patient transported via ambulance to local hospital ER (emergency room) for further evaluation."

At 1430 that same day, the case manager indicated that a call was placed to the hospital ER, and they informed the agency that the patient had been admitted.

Review of the patient record from the hospital dated 3/5/10 revealed that the patient was admitted with a diagnosis of sepsis likely caused from a urinary tract infection and the large decubitus ulcers on the buttocks/sacrum and right hip.

The Operation Report from the hospital surgeon, dictated by the surgeon at 1915, noted the presence of "multiple, huge decubitus ulcers, stage IV on the lower back, sacrum, and also on the right hip. " The note also mentioned that the patient had a non-functioning G-tube (gastrostomy) with a small catheter placed in. It was decided to debride the wound because of sepsis and also place a G-tube, because the one in place was not functional, and was leaking around the skin.

The Operation Report noted that the patient had a "large decubitus ulcer, stage V on the right hip." The surgeon indicated: "This is maybe 15 x 15 cm. deep into the joint, the whole right joint is basically infected with pus in it." The note also indicated, " He also has a large decubitus ulcer or the sacrum and lower back. This is about maybe 20 x 20 cm. It is the skin, subcutaneous soft tissue all the way down to the bone, even the bone is completely necrotic and infected and a lot of pus inside there so it was decided to debride this."

The report detailed that during debridement of the right hip, the "capsule of the joint was all infected with pus."

The left lower right back wound was surgically debrided next. The procedure detailed "debridement was done from the skin, subcutaneous tissue to the fatty tissue all the way down to the fascia and part of the coccyx, which was completely necrotic, was removed and sent to pathology."

According to the patient's hospital record, on 3/6/10 at 1045, the physician noted that the patient's sepsis was likely due to a urinary tract infection and the decubitus ulcers. He noted a "very poor prognosis." The physician had discussed the patient's prognosis with the wife, and she agreed that he be kept comfortable. A family meeting was planned to discuss making the patient "comfort measures only."

On 3/7/10 at 1230, the physician documented that he had again discussed the patient's poor prognosis with the family. The wife and daughter both understood how critical the patient's condition was. The family agreed with the physician to initiate a "comfort measures only order" .

The physician indicated that the antibiotics and tube feeding would be stopped, a morphine drip and scopolamine patch started, and a hospice consult initiated.

The patient remained on comfort measures only with pain managed via a morphine drip, and hospice care. The patient's condition continued to decline from 3/7/10 until 3/15/10. According to the hospital physician's note, on 3/15/10 at 1200, the patient was found without respirations, no audible heart sounds, and the pupils were fixed and dilated. The patient was pronounced dead at that time.

(Refer to A 800, A 817, A 820 and A 822.)

Based on staff interview and review of clinical privileges for excisional debridement delegated by the chief medical officer for 3 Wound Care Coordinator #1 and Wound Nurse #2 and #3 of 3 RN wound nurses, the governing body failed to ensure quality of care was provided for all patients.

Findings include:

Review of clinical privileges for Wound Care Coordinator #1 and wound nurses #2 and #3 revealed that the Chief Medical Officer delegated responsibilities for these nurses to be able to surgically debride wounds effective 10/16/09.

Record reviews and observation of the wound care coordinator's treatment of a patient's wound, revealed that the wound nurses were not exhibiting competency with this delegation.

Please see A-0385

Based on observation, staff interview and record review, for two patients (#3 and #9), from a total sample of 32 current patients reviewed, the Hospital failed to ensure that restraints were implemented only when based upon a comprehensive assessment that determined the restraint was a necessary intervention to protect a patient from harm due to a medical condition or symptom; and, that the least restrictive device was used to restrain the patient for the least amount of time. Additionally, the use of restraints was a routine aspect of the Hospital's fall prevention program. The findings are:

1. Patient #3 with a history of subdural hematoma and respiratory failure. Although, Patient #3 had a tracheostomy, the patient had been successfully decannulated on 3/10/10.

Patient #3 had been observed seated in a wheelchair in the bedroom, the afternoon of 3/12/10. It was noted that the patient was restrained with four devices. This elderly patient had a vest restraint applied to the upper torso and tied criss-cross behind the chair. Additionally, the patient had wrist restraints applied to both wrists that were tied to the wheelchair arms. Additionally, the patient had a waist restraint applied around the waist, below the vest restraint, and also tied criss-crossed behind the chair. The patient was sitting quietly and was pleasantly confused when spoken to by the surveyor.

Review of the patient's medical record revealed a generic form had been signed by the medical staff on 3/12/10 at 6:50 AM indicating that the patient required restraints due to "pulling lines/equipment" and "unsupervised transfers" (the only criteria listed). The form indicated the patient was to be restrained utilizing "mitts, vest and wrist" restraints.

There was no evidence a comprehensive assessment had determined that this patient required four restraint devices; nor, that the devices were the least restrictive interventions that could be utilized.

On 3/18/10 the patient was again observed seated in the wheelchair and restrained with a waist restraint. There were no orders for a restraint at that time.

2. Patient #9 had been in the hospital since November 2007. The patient had a history of respiratory failure, a diagnosis of paranoid schizophrenia, a tracheostomy and urinary catheter.

On the first day of survey, 3/11/10, the patient was observed in bed, restrained with a vest restraint. On the second day of survey, 3/12/10 at 9:55 AM, the patient was again observed in bed with a vest restraint applied. The bed was raised to the highest position. The patient was asleep and no staff were in the room. On 3/16/10 the patient was again observed in bed with a vest restraint applied. The patient was lying flat and both feet were dangling over the side of the bed.

Review of the medical record revealed the patient had been restrained daily with the vest restraint for at least the previous six months. A generic form was signed daily by the medical staff indicating the device was necessary for the patient. Subsequent interview with the 1A South Unit Nurse manager, on 3/16/10, confirmed there had been no attempts to reduce the device used to restrain the patient, nor to reduce the amount of time the patient was restrained.

3. The Hospital's fall prevention protocol directed nursing staff to assess all patients at the time of admission utilizing the Morse Falls Risk Assessment, and to reassess patients daily. A score below 50 determined a "falls caution" and above 50 determined a "high risk for falls." The guideline for staff noted that high risk patients were to have a self-release belt when out of bed; and if the patient removes the belt, to assess the need for a lap belt that criss-crosses in the back of the wheelchair. On 3/11/10, interview with registered nurse #4, the nurse stated all high-risk patients who get out of bed get a release belt; but if they remove it, they get a vest.

15218

Based on record review and staff interview, the Hospital failed to ensure that restraint policies and procedures addressed the use of drugs and/or medications as a restraint. For one patient (#22) out of a sample 32 current patient records reviewed, the hospital's staff failed to comprehensively assess the use of a drug or medication as a chemical restraint.

Findings included:

1. Review of the Hospital's policy and procedure titled "Restraints Policy" failed to address the use of drugs or medications as a restraint. The Hospital's policy stated they were "committed to prevent, reduce and strives to eliminate the use of restraints utilizing non-physical techniques as the preferred intervention. However, when there is an imminent risk of a patient harming himself or others, a restraint may become necessary." The policy defined restraints as "the direct application of physical force to a patient with or without the patient's permission, to restrict his/her freedom of movement. The physical force may be human, mechanical devices or a combination."

Interview with the Vice President of Nursing, on 3/16/10, confirmed that Hospital's policy failed to include the regulatory standard for the use of drugs or medication as a restraint.

2. Patient #22, had been admitted on 12/29/09 with diagnoses that included chronic obstructive pulmonary disease, compression fractures and pneumonia.

On 1/10/10 at 6:30 PM, the nurse's note documented that the patient had been resting in long naps and was awakened to participate in his care. After the patient was transferred to his wheelchair, the patient told the staff to get the patient's clothing and that the patient wanted to get out of the hospital. The nurse documented the patient continued to "escalate despite attempts of verbal reorientation and distraction."

From 7 PM to 7:20 PM, the nurse's note documented that the patient's combative and agitated behaviors persisted. At 7:20 PM, the nurse wrote that a "Code Yellow" (a patient behavior crisis) was initiated. A physician order was obtained and the patient was subsequently administered 2 milligrams of the antipsychotic medication Haldol, IM (intramuscular) while physically held (restrained).

Based on observations, staff interviews and record reviews, for three current patients reviewed with restraint devices, (#3, #9 and #15), from a total sample of 32 current patients reviewed, the Hospital failed to ensure the least restrictive device was utilized for the least amount of time. The findings are:

1. Patient #3 was seated in a wheelchair and observed in the patient's room in the afternoon of 3/12/10 restrained with four, separate devices. The elderly patient had a vest restraint applied to the torso and tied criss-cross behind the chair. Additionally, the patient had wrist restraints applied to both wrists that were tied to the wheelchair arms. Thirdly, the patient had a waist restraint applied around the waist, below the vest restraint, and also tied criss-crossed behind the chair. The patient was sitting quietly and was pleasantly confused when spoken to by the surveyor.

Review of the patients medical record revealed a generic form had been signed by the medical staff on 3/12/10 at 6:50 AM indicating that the patient required restraints due to "pulling lines/equipment" and "unsupervised transfers" (the only criteria listed). The form indicated the patient was to be restrained utilizing "mitts, vest and wrist" restraints.

There was no evidence a comprehensive assessment had determined that this patient required four restraint devices; nor, that the devices were the least restrictive interventions that could be utilized to prevent the patient from harm.

2. Patient # 15 had physician orders for various restraint devices for patient "safety." This patient had a fall out of bed while wearing the restraint device on 2/10/10.

Patient #15 was admitted to the facility diagnosed with anoxic brain damage due to severe diabetic ketoacidosis, respiratory failure, anemia, tracheostomy, gastrostomy feeding tube for nutrition, pancreatitis and renal insufficiency. Review of the medical record revealed that the patient had progressed with more alert mental status and increased activity with attempts to get out of bed. Orders for patient #15's restraint devices were documented on generic forms and included the use of a vest/posy and or mitts and occasionally wrist restraints to prevent the patient from pulling personal medical devices and tubes.

Review of the electronic medical record reported that on 2/3/10 the patient attempted to transfer out of bed and soft limb foam restraints were applied by the staff. On 2/4/10 the patient was removing lines/equipment; wrist and waist device in use. On 2/5/10 waist and bilateral wrist devices were documented in use. On 2/8/10 Chest/Posey vest was in use for attempting to transfer out of bed.

On 2/10/10 at 14:30 the patient was found face down on the floor. For 2/10/10 the restraint device in use was a Posey Vest device which was placed on the upper torso of the patient; and tied to the bed frame at the patient's waist level, to prevent the patient from getting up out of bed. Further record review indicated that the resident had agitation and complaints of pain. The portable x-ray obtained on 2/22 and 2/23 to rule out any injury that may have been related to the 2/10/10 fall indicated that the elbow on 2/22 was negative for fracture; however, on 2/22/10 x-ray result reported that a slight degree of subluxation may exist to the shoulder. Intervention to support the right shoulder included the use of sling for right arm for support or a tray table to support right arm.

The use of the restraint device fails to specify parameters for the use of the elected device is the least restrictive.

3. Patient #9 had been in the hospital since November 2007. The patient had a history of respiratory failure, a diagnosis of paranoid schizophrenia, a tracheostomy and urinary catheter.

On the first day of survey, 3/11/10, the patient was observed in bed, restrained with a vest restraint. On the second day of survey, 3/12/10 at 9:55 AM, the patient was again observed in bed with a vest restraint applied. The bed was raised to the highest position. The patient was asleep and no staff were in the room. On 3/16/10 the patient was again observed in bed with a vest restraint applied. The patient was lying flat and both feet were dangling over the side of the bed.

Review of the medical record revealed the patient had been restrained with the vest restraint daily, for at least the previous six months. A generic form was signed by the medical staff daily, indicating the device was necessary for the patient. Subsequent interview with the 1A South Unit Nurse manager, on 3/16/10, confirmed there had been no attempts to reduce the device used to restrain the patient, nor to reduce the amount of time the patient was restrained.

Based on staff interviews, observation and record review, the Hospital failed to ensure that "Code Yellow" restraint policies were in accordance with safe and appropriate techniques. Additionally, the Hospital failed to ensure that staff were properly trained in the application and monitoring of restraint devices to prevent injury to patients. The findings are:

1. On the first day of survey, 3/11/10, the surveyor observed a large duffel bag labeled "code yellow," stored on the shelf above the code cart on the second floor unit of the hospital. The Unit Manager on 2 A told the surveyor the bag was used for "disruptive patient behavior," and that the bag contained "restraints." The Manager stated they would call security for a code yellow.

On 3/18/10 AM the nursing educator was interviewed and stated that only nursing staff are trained regarding restraints by her department. On 3/18/10 AM the security chief was then interviewed. He acknowledged that the security staff responded to "code yellows;" but, stated the security staff would not apply restraints as "we're not trained to apply restraints." He was aware of at least two "code yellows" that security had responded to during the previous two years.

On 3/18/10 at 10:30 AM the surveyors accompanied the security chief to view the contents of the "code yellow" bag. The bag was opened by the Unit Manager on 2 A in the presence of the security chief and the surveyors. The bag contained a full set of four point, leather, restraints; as well as a full body restraint. Unit Manager on 2 A explained that the code yellow team was coordinated by Social Worker #1 who had trained some staff. Interview on 3/18/10 at 10:35 AM with RN # 2 who had attended the training revealed the training consisted of deescalation techniques and did not include proper application of the devices in the code yellow bag.

The Hospital policy titled: "Management of Behavior Crisis/Psychiatric Emergency Plan (Code Yellow)," developed August 2008 and revised October 2009 was then reviewed. The policy was co-signed by the Director of Social Work, the Medical Director and the Vice President of Nursing. The policy indicated the purpose of a code yellow was to "assist the out of control patient to establish control over his/her behavior or, if necessary, to control the patient." The policy noted that a staff person from the second floor would be assigned each shift to bring the "code yellow bag" containing restraints (to the location of the "code.") The policy additionally noted "If physical restraint (hands on) of the patient is indicated, the Team Leader or a staff member will direct the restraint activity." The policy further noted that a behavioral crisis (code yellow) form would be completed and forwarded to the Medical Director and chair of the safety committee.

The most recent "code yellow" staff training was conducted in January 2008.

Review of the medical record for patient #22 revealed a "code yellow" had been called on this patient on 1/10/10. According to the code yellow form, upon awakening at 6:30 PM, the elderly patient with chronic obstructive pulmonary disease and encephalopathy, asked for clothes and stated he/she was leaving the hospital. The patient became combative and staff called a "code yellow." The staff obtained an order for 2 milligrams of Haldol IM and the patient was physically held (restrained) while the chemical restraint was administered. (Refer to A 160).

Hospital staff were responding to what they determined to be a "behavior crisis" with these highly restrictive and dangerous devices with no formal training in the proper application or use of the devices. A code yellow had occurred in the hospital as recently as 1/10/10.

2. According to the medical record, patient #13 removed the ventilator while wearing mitt restraints on 9/07/09. The documentation revealed that wrist restraints were applied at that time. On 9/09/09 Wound nurse #1 was consulted for patient #13 due to skin tear on right wrist. Wound nurse #1 documented that the patient was in bilateral wrist restraints, that the patient's "right hand was edematous, there was a 2 by 4 centimeter blood filled blister and that there was partial tissue loss, pink and dry."

3. During evaluation of the Hospital's grievance process a complaint registered by Patient's #26's family was reviewed. Patient #26's family had complained that the patient's hands had turned "BLUE" and were cold because someone had restrained them too severely to the bed. Further review of the patient's complaint revealed that the family had determined that the patient had been admitted to the hospital around 2 PM which is when the patient's hands were restrained. At 6:30 PM, the family had called the nurse to the patient's room and that the nurse had agreed with the family that the patient's hands were over restrained and corrected the situation.

Review of the the hospital's grievance report dated 3/19/09, documented the patient was discharged at 3 AM the following morning and therefore were unable to follow up with the family. The staff providing direct care were interviewed by their supervisor, and although the grievance report confirmed the family had complained that the patient's hands were blue from the restraints, the staff nurse reported to the supervisor that "he went to check the patient at 5:30 PM and the patient's hands were not blue or cold."

Review of the closed record revealed the patient was admitted to the hospital and was ventilator dependent due to respiratory failure on 3/18/09. The nurse's note documented the patient had bilateral wrist restraints on to prevent the patient from removing the tracheostomy. In addition, the nurse documented and took a picture of a wound located under the left wrist restraint on 3/18/09 at 3:27 PM.

Review of the clinical record failed to include a physician's order for the use of the medical restraints (bilateral wrist restraints), and failed to show evidence that staff had assessed the patient following the implementation of the wrist restraints.

The Vice President of Quality was interviewed on 3/18/10. She confirmed that staff had failed to document per the hospital's policy and procedure for implementation and safe use of medical restraints. The hospital's policy indicated that staff were required to document the patient's condition following the application of the wrist restraints, which should have included vital signs, circulation, range of motion, skin condition, physical and psychological status, comfort, and recognizing criteria for discontinuation of the restraint and/or signs of any incorrect application of restraints.

Based on observation, staff interview and record review, for one, (#3), from a total sample of 32 current patients reviewed, the Hospital failed to ensure that restraints were implemented only when ordered by the physician. The findings are:

1. Patient #3 was a frail, elderly patient with a history of subdural hematoma and respiratory failure. Although, the patient had previously had a tracheostomy, the patient had been successfully decannulated on 3/10/10.

Patient #3 was observed seated in a wheelchair from 2:30 to 3:15 PM on 3/12/10 restrained with four, separate devices. The patient had a vest restraint applied to the torso and tied criss-cross behind the chair. Additionally, the patient had wrist restraints applied to both wrists that were tied to the wheelchair arms. Thirdly, the patient had a waist restraint applied around the waist, below the vest restraint, and also tied criss-crossed behind the chair. The patient was sitting quietly and was pleasantly confused when spoken to by the surveyor.

Review of the patient's medical record revealed a generic form had been signed by the medical staff on 3/12/10 at 6:50 AM indicating that the patient required restraints due to "pulling lines/equipment" and "unsupervised transfers" (the only criteria listed). The form indicated the patient was to be restrained utilizing "mitts, vest and wrist" restraints. There was no physician order for the use of a waist restraint.

On 3/18/10 the patient was again observed seated in the wheelchair and restrained with a waist restraint. There were no restraint orders for patient #3 at that time.

Based on observation and staff interview, the Hospital failed to ensure that staff were properly trained in the safe implementation of restraint devices. The findings are:

The Hospital policy titled: "Management of Behavior Crisis/Psychiatric Emergency Plan (Code Yellow)," indicated the purpose of a code yellow was to "assist the out of control patient to establish control over his/her behavior or, if necessary, to control the patient." The policy noted that a staff person from the second floor would be assigned each shift to bring the "code yellow bag" containing restraints (to the location of the "code"). The policy additionally noted "If physical restraint (hands on) of the patient is indicated, the Team Leader or a staff member will direct the restraint activity."

On 3/18/10 at 10:30 AM the surveyors viewed the contents of the "code yellow" bag. The bag contained a full set of four point, leather, restraints; as well as a full body restraint.

On 3/18/10 AM during interview, the security chief acknowledged that the security staff responded to "code yellows;" but, stated the security staff would not apply restraints as "we're not trained to apply restraints." He was aware of at least two "code yellows" that security had responded to during the previous two years.

On 3/18/10 at 10:30 AM, RN #3 explained that the code yellow team was coordinated by Social Worker #1 who had trained some staff. Interview on 3/18 at 10:35 AM with RN #2 who had attended the training revealed the training consisted of deescalation techniques and did not include proper application of the devices in the code yellow bag.

Review of the medical record for patient #22 revealed a "code yellow" had been called on this patient on 1/10/10. According to the code yellow form, the patient became combative and staff called a "code yellow." The staff obtained an order for 2 milligrams of Haldol IM and the patient was physically held (restrained) while the chemical restraint was administered. (Refer to A 160).

Hospital staff were responding to what they determined to be a "behavior crisis" with highly restrictive and dangerous devices with no formal training in the proper application or use of the devices.

Based on staff interview, observations and record reviews, the Hospital failed to ensure that adequate resources were allocated for assessing, improving and sustaining the Hospital's infection control program. The findings are:

On 3/18/10, 106 of the patients in the hospital were on precautions. The hospital had 212 licensed beds.

Per interview with the Infection Control Practitioner at 9:00 AM on 3/16/10, she was employed by the hospital full time and was responsible for all monitoring and surveillance of infections throughout the hospital; including at the two remote, in-patient satellites. The nurse was responsible for all data collection regarding infection control; as well as for the data entry, as she had no clerical support. The nurse was responsible for all infection control training for all staff in all departments throughout the hospital; including at the two remote, in-patient satellites. The infection control nurse was the resource to all hospital staff regarding the control of infections. The infection control nurse was also responsible for employee health and had one nurse to assist her with employee health duties. The employee health nurse was not a trained infection control nurse.

The Hospital failed to allocate adequate resources for the monitoring and control of infections. Refer to A 747 and A 749.

The medical staff failed to enforce their By-Laws:

Findings include:

The Medical Staff By-Laws require that the Pharmacy and Therapeutic Committee "shall meet at least once every three months" and have representatives from medicine, nursing, administration and pharmacy.

On 3/12/10 at 12:25 PM based on review of records and interview with the Director of Quality Assurance, the hospital failed to ensure that the Pharmacy and Therapeutic Committee met at least once in each quarter of the year and that the membership at each meeting consisted of, at minimum, a representative from medicine, nursing, pharmacy and administration.

The hospital had 11 Pharmacy and Therapeutic Committee meetings from January 31, 2007 until December 22, 2009 (11 meetings in 3 years). During 2008, the hospital's Pharmacy and Therapeutic Committee met only in the 2nd and 4th quarter (5/11/08, 11/12/08, and 12/10/08). At the Pharmacy and Therapeutic Committee meetings in 2008 and 2009, the hospital administration was represented at two of the eight meetings (5/21/08 and 12/22/09).

Based on record reviews, interviews, and review of the rules and regulations governing medical staff, the governing body failed to formulate specific criteria for credentialing practitioners responsible for providing care to patients.

Findings included:

Review of the Medical Staff Bylaws, "rules and regulations," " 3.1 Attending Physician of Record," revealed that "All inpatients admitted to an inpatient service of (hospital name) shall be assigned to an Attending Physician." Furthermore, the rules governing the Care of Patients by the attending physician noted, "Although the Attending Physician may assign certain specific responsibilities for the patient's care to a Physician Assistant or Resident, according to his/her clinical maturity and competence, the Attending Physician retains the ultimate responsibility for the patient's care and well-being."

In the case of Patient #21, the Attending Physician failed to ensure that duties and responsibilities delegated to the Physician Assistant, i.e. wound assessment, evaluation, and on-going treatment, were adequately monitored. Additionally, the Physician Assistant responsible for the patient's care, failed to provide adequate monitoring and supervision of the wound care nurses, who he delegated to provide excisional debridement, wound care, and assessment of the patient's wounds. The patient's wounds deteriorated over the course of the admission, and the patient was discharged home. In less than 24 hours following discharge, the patient was admitted to an acute care hospital with sepsis secondary to grossly infected buttocks, sacral, and right hip pressure ulcers. The patient's wounds required surgical debridement by a surgeon from the receiving hospital. The patient expired at the hospital ten days after admission to the acute care hospital, due to sepsis associated with the "severely infected" Stage IV pressure ulcers.

Interview with the V.P. of Quality and V.P. of Nursing on 3/17/10, acknowledged that members of the medical staff had failed to provide direct clinical oversight and monitoring of the hospital medical staff, who were responsible for providing care to this patient. Additionally, they acknowledged that there had been no direct examination and evaluation of the patient's wounds by the attending physician or PA immediately prior to or following the wound debridement by wound nurse #3. Wound Nurse #3 as well as other members of the wound care team lacked competency to do hands-on, excisional debridement of patient wounds. However, the nurses on this team were delegated the responsibility to provide the direct consultation regarding this and other patients' pressure sores. These nurses gave treatment recommendations to PAs and attending physicians who wrote and/or signed off on these recommendations by writing physician orders without direct examination of their patients' wounds.

Based on observation, record reviews and staff interviews, the facility failed to ensure 2 of 2 applicable nurses (LPN #1 and RN #1) were properly trained and competent to manage patients with intravenous (IV), and 3 (Wound Care Coordinator #1, Wound Nurse #2 and #3) of 3 wound care nurses received the proper training to provide surgical debridements of wounds.

Findings include:

A. Review of the current Nursing Department Orientation policy and procedure (which has been in effect since 1/96) revealed that within the first few days of employment, new staff completed a self-assessment of their competence for each section on the Assessment of Competency Tool (ACT). The new staff person was responsible for informing their preceptor of his/her learning needs; and validation of competence must be documented.

In addition, if a staff member was to insert IV's, the staff member must attend the hospital's IV certification program which included a self-learning module and observation of successful IV insertions.

1. LPN #1 was involved with the IV incident with patient #10 (See A-0395)

Review of the personnel record and education record for LPN #1 on 3/17/10 lacked documentation that this nurse was trained in IV management during the nursing orientation. The ACT dated 1/24/07 was blank for the IV management section. Although this LPN attended an educational presentation on 5/14/08, titled Peripheral IV workshop, the remaining educational and practice requirements for IV certification was not done.

Interview with LPN #1, on 3/17/10 at 3:00 PM. revealed that LPN #1 attended an IV certification program in May 2008. Since that program LPN #1 had inserted approximately 10 IV lines. LPN #1 explained to the surveyor that Patient #10 was administered IV Vancomycin on 2/24/10. LPN #1 confirmed that as the patient's nurse administering the IV medication, that proper procedure was not followed after removal of the IV line from the patient's foot. Per facility policy, if there is an infiltrate, apply warm soaks to aid absorption, elevate limb and notify the doctor.

LPN #1 stated, in retrospect, the physician should have been notified when the IV was pulled due to an infiltration; and, that a warm soak should have been applied to the site. This was not done.

Interview with the Vice-President of Nurses (VPN) on 3/18/10 confirmed that LPN #1 was not properly trained and assessed for competency to administer the IV medications or IV therapy.

2. Review of the personnel record for RN #1 who inserted an IV line into Patient #10's right foot, revealed the ACT self assessment was completed and the IV Certification was completed on 1/13/04. The IV certification reflected that RN #1 was aware that the Hospital's IV Certification Policy, effective April 2008 stated, that it was not acceptable to place an IV in the lower extremities; even when requested by a physician or PA. The hospital policy stated that "Venipuncture will not be performed in a patient's lower extremity except during a Code situation".

Interview with VP of Quality Assurance, on 3/17/10 at approximately 9:30 AM, revealed that currently the hospital does not provide periodic IV competency checks on IV certified nurses.

Interview with the VPN on 3/18/10 confirmed that RN #1 did not follow policy regarding insertion of an IV into a patient's lower extremity. (See A-0395)

B. On 10/16/09, the Chief Medical Officer of the Hospital granted clinical privileges to three wound care nurses for excisional debridement for inpatients and outpatients with a Physician or Physician Assistant order without the approval from the Governing Body.

1. Review of the Wound Coordinator #1's educational record revealed the lack of supervision and oversight to perform excisional debridement by a physician. There was no evidence this nurse was qualified to train other nurses for excisional debridement.

2. The educational records for wound care nurse #2 reflected this nurse had successfully demonstrated competency in conservative sharp debridement skills using sharp instruments in clinical setting by the Wound Coordinator #1 on 2/6/09. This was over 8 months prior to being granted clinical privileges from the Chief Medical Officer .

3. The educational records for wound care nurse #3 reflected this nurse had successfully demonstrated competency in conservative sharp debridement skills using sharp instruments in clinical setting on 11/6/07. This was almost 2 years prior to being granted clinical privileges from the Chief Medical Officer.

The President of the hospital, who sits on the governing body, was interviewed on 3/16/2010 at 5:15 PM and confirmed the hospital lacked a clear policy and/or oversight of wound debridement.

Based on observation, record review and staff interview, the hospital failed to ensure a registered nurse supervises and evaluates the nursing care for 8 patients (#5, 7, 8, 10, 14, 15, 17 and 25) out of a total sample of 32 current patients. Findings include:

1. For patient #10, the facility failed to ensure nurses followed the hospital's policy regarding Peripheral Intravenous, (IV), catheter insertion and evaluate the on-going administration of IV Vancomycin. As a result, patient #10 had a necrotic right foot.

Patient #10 was readmitted to this facility on 4/24/09 with diagnoses which included, Anoxic Brain Injury secondary to an air embolism over 9 years ago, Ventilator Dependent Respiratory Failure, (VDRF) and Methicillin-resistant Staphylococcus aureus (MRSA) and Vancomycin-resistant enterococci (VRE) colonization.

Observation on 3/16/10 at approximately 11:30 a.m. revealed the patient was lying in bed on a ventilator, non-responsive to verbal command, had severe upper extremity contractures and bilateral foot drop. The patient's right foot was elevated on a pillow, uncovered and in plain view. On the dorsal part of the patient's right foot around the navicular area and all the way down to the tips of all toes was black (necrotic eschar). The foot was foul smelling. The patient was dependent on staff for all aspects of care.

Wound Care Coordinator #1 assessed the patient's foot and recommended the area be
cleansed with dermal wound cleanser and covered with DCD (large Exu-dry) loosely and changed daily. An order for this recommendation was obtained by physician assistant #1 (PA).

Review of the patient's clinical record revealed on 2/23/10 at 2 PM, the attending physician wrote an order to administer Vancomycin 1 gram IV every 18 hours for 10 days and Levaquin 500 mg IV daily for 10 days. (Per the medication insert for Vancomycin, this medication is very irritating to tissue and must be given by a secure intravenous route of administration. Pain, tenderness and necrosis occur with inadvertent extravasation).

Between the time the IV orders were written on 2/23/10 at 2:00 P.M. and 2/24/10 at 10:50 P.M., there was no documentation to reflect an IV was inserted. On 2/24/10 at 10:50 P.M. RN #6 documented, "at change of shift patient's IV site infiltrated, site was pale and cool to the touch, PA #2 was notified. PA #2 assessed - no new orders, no concern. Warm clothes were applied, site improved. New IV site is in right antecubital..."

On 2/26/10 LPN #1 wrote a late entry note for 2/24/10 revealing "@ 1105 administered scheduled dose of Vancomycin @1200 checked on patient, no issues, went back to see patient at approximately 1310, patient's Vanco completed, patient's line was flushed, I observed patient's foot was pale and cool to touch, I removed saline lock and elevated pt's. foot, @ 1500 rechecked patient status of foot hadn't changed reported to oncoming shift".

Review LPN #1's education records on 3/18/10 at 9:00 A.M. lacked evidence that LPN #1 was properly trained to manage IV therapy. Interview with VPN at that time was not aware that LPN #1 had not received the proper training.

Late entry by Physician's Assistant #2 (PA) on 2/25/10 for 2/24/10 1800, (5 hours after the LPN observed the patient's foot was pale and cool to touch), "called to evaluate patient's right foot at site of infiltrated IV...right ankle positioned in equinovarus. No edema noted on foot. Mid dorsum of foot circular area at site of previous IV is pale, slightly cool, surrounding area of foot and leg and plantar surface is pink, question palpable dorsalis pedis pulse".

The patient was seen by a vascular surgeon on 2/25/10 and his progress note reflected ischemic right foot, question etiology, question infiltration of IV vs PVD vs embolism. Recommend amputation after demarcation. Per interview with the Vice President (VP) of Quality on 3/17/10 in the morning, it was determined that the ischemic right foot was caused by the IV infiltration of Vancomycin).

On 2/26/10 a nurse's note timed 11:55 P.M. reflected, "saline lock of right arm infiltrated and after 3 attempts, reinsertion was unsuccessful, MD notified, IV antibiotic discontinued and Linezolid and Levaquin were ordered for G-tube administration.

Interview with VP of Quality on 3/16/10 at approximately 3:00 p.m. revealed that the hospital staff had done an internal investigation of this incident, and on 3/15/10 reported this incident to the Department of Public Health. VP of Quality stated an IV was started on this patient on 2/23/10 by an RN #1. This nurse inserted a #24 Angiocath into the right foot but did not document the insertion in the clinical record.

Review of the hospital's IV Certification Policy, effective date of April 2008 states, "Venipuncture will not be performed in a patient's lower extremity except during a Code situation".

Review of the hospital's Peripheral IV catheter insertion policy dated 2009 states that nursing documentation includes: "record the date and time of the venipuncture; the type, gauge, and length of the cannula; the anatomic location of the insertion site; the length of the catheter; and the reason the site was changed. Also document the number of attempts at venipuncture (if more than one), the type and flow rate of the IV solution, the name and amount of medication in the solution (if any), any adverse reactions and actions taken to correct them..." (Review of nurses notes from 1/25/10 - 3/17/10, for this patient, regarding IV insertions lacked appropriate documentation information as required per policy)

Although an internal investigation was done and completed on 3/15/10, there was no plan in place at this time to prevent this incident from reoccurring again. There was nothing in place to assess and implement another access alternative for intravenous medications for this patient or any other patient who is difficult to obtain peripheral access and history of infiltrates.

Review of the internal investigation handed to the surveyor on 3/17/10 revealed an Action Plan as follows:

A. Nurse managers will audit 3 records per month for 6 months for patients with IV to assess appropriateness and timeliness of nursing documentation. Action plan based on this investigation

B. Vice President of Nursing (VPN) will revise policies and procedures for IV insertion and IV care. Revised policy will state that the lower extremity shall not be used for IV access unless IV is inserted by an MD or PA, or inserted during a Code. VPN will also review how hospital's policies are accessed and displayed in Lippincott.

Nurse manager shall educate all nursing staff on revised policy.

C. The involved nurse LPN #1 was educated on the importance of timely communication with medical staff on changes in condition.

Again, this action plan does not address patient #10 with regards to giving Vancomycin via a peripheral line.

Further review of the patient's clinical record from 1/25/10 - 2/23/10 revealed this patient had a history of IV infiltrates:

A nurse's note dated 1/25/10 and timed 2247, revealed "IV inserted in the left leg by PA, (physician's assistant). IV antibiotics started IV Vancomycin and Levaquin.

A PA, on-call progress note dated 1/26/10, 2300 revealed IV access lost. #20 placed right UE (upper extremity) with issue. A nurse's note at that time reflected, "new IV line placed in right arm by PA, due to L leg infiltrate.

A nurse's note dated 1/31/10 at 0353 revealed, "patient's IV in right hand infiltrated and swollen, IV removed, elevated right arm and applied warm compress. New IV #20 inserted in left hand.

A nurse's note dated 2/6/10 at 2220 revealed, saline lock discontinued this PM.

Interview with the VPN on 3/17/10 around 8:30 a.m. confirmed that nurses are not to insert an IV into any lower extremity unless it is a "code" situation. She further stated that current IV polices and procedures needed to be revised, documentation regarding IV insertion and monitoring were inconsistent and in some cases, absent and that there was a delay in notifying the medical staff on 2/24/10 when this patient's IV infiltrated. There was no investigation regarding previous infiltrations, nor was there any plan in place to address this type of incident from occurring again with this patient.

Further interview with VP of Quality on 3/17/10 around 9:30 A.M. revealed the facility doesn't monitor infiltrates. She did not know why RN #1 inserted a #24 Angiocath into the right foot and that there are no IV protocols in place to address proper insertions and access problems. Currently, there were no on-going IV competencies required for nurses once they become IV certified.

Interview with the LPN #1 on 3/17/10 around 3:00 P.M. revealed that on 2/24/10 after he administered the IV Vancomycin to patient #10, he flushed the line. When he noticed the patient's foot was pale he pulled the line and elevated the patient's right foot. (He did not apply warm soaks nor did he notify the patient's physician as required per policy).

Further interview with VP of Quality on 3/18/10 around 9:30 a.m. (after the survey reviewed LPN #1 education records and found that LPN #1 had not receive the proper IV training), the VP of Quality confirmed that IV competency of all staff involved with this incident was not looked at during the hospital's investigation.

Interview with the attending physician on 3/18/10 revealed that he had been involved with assessing and prognosis of this patient's right foot. He stated that when an IV order is written, it is up to the nurses to assess and decide placement of the IV and the size. He also stated that he is now aware that nurses are not to insert an IV in the lower extremities.

2. For patient #25, the facility failed to ensure nurses followed the hospital's policy regarding peripheral intravenous (IV) catheter insertion.

Patient #25 a long term patient at the hospital was dependent on the ventilator due to respiratory failure.

Review of the physician orders revealed on 7/6/09 that the patient was to be administered the antibiotic Primaxin 500 milligrams (1 Addvantage Vial) for an infection. On 7/7/09 at 6:30 PM, the nurse documented the antibiotic medication was administered through a peripheral intravenous (IV) in the right hand. At 10:00 P.M. the nurse documented the peripheral IV line was in the patient's right foot. There was no physician's order for the placement of the peripheral IV line in the patient's right hand or the right foot. In addition, there was no documentation as to who placed the peripheral line in the hand or the foot. There was no indication why the patient required the intravenous device be placed in the foot when this was in conflict with the policy of the hospital.

On 7/8/09, the nurse documented the peripheral line remained in the patient's right foot. On 7/9/09, the nurse's note revealed the physician ordered 1 liter of normal saline at 50 cc per hour to be administered due to review of new laboratory data and she documented that the IV remained in the patient's right foot. There was no documented evidence that the nursing staff assessed the patient's peripheral line on 7/10/09. On 7/11/09 at 2:00 P.M., the nurse recorded she had notified the physician that the patient's right foot was swollen. At 3:00 P.M., physician assistant #3 removed the IV. On 7/12/09, the IV assessment only reported that the IV line was in the "right.", but failed to identify the location of the peripheral line.

Review of the hospital's IV Certification Policy, effective date of April 2008 states, "Venipuncture will not be performed in a patient's lower extremity except during a Code situation".

Review of the hospital's Peripheral IV catheter insertion policy dated 2009 stated that nursing documentation included: "record the date and time of the venipuncture; the type, gauge, and length of the cannula; the anatomic location of the insertion site; the length of the catheter; and the reason the site was changed. Also document the number of attempts at venipuncture (if more than one), the type and flow rate of the IV solution, the name and amount of medication in the solution (if any), any adverse reactions and actions taken to correct them..." (Review of nurses notes from 7/6/09 - 7/12/09 regarding IV insertions for this patient lacked appropriate documentation information as required per policy)


3. Patient #8 was admitted to the hospital on 3/10/10 at 1412 According to the referring hospital discharge summary, the patient had a history of ulcerative colitis which required revision of the Koch pouch that failed and subsequent excision of the Koch pouch and creation of an end-ileostomy.

The 3/10/10 at 2305 nursing admission note documented the patient was not taking anything by mouth and was receiving TPN (total parenteral nutrition) via a PICC (peripherally inserted central catheter). The nurse noted the PICC line was in the patient's right arm, had two ports which were patent.

Review of the nursing kardex revealed the nurses could draw blood specimens from the central line. The hospital's blood sampling procedure from a central line noted after obtaining the blood specimen the line was to be flushed with normal saline as per the flushing procedures. According to the procedure a 10 ml syringe with 5 ml of normal saline was to be used for flushing and a Heparin flush (if ordered). The hospital's intravenous device care and management protocols noted the PICC was to be flushed after each use or every 8 hours with 5 cc's (cubic centimeters) of Heparin/Saline mixture 10 units/ml (milliliter.) The hospital policy allowed the nursing staff to mix the heparin to the ordered dilution if the premixed heparin was not available.

On 3/13/10, at 15:39 the nurse noted the red port of the PICC line was clogged and the PA (physician assistant) had instilled Cath-Flo and would return to flush it. The PA had not returned as of the end of the nursing shift and this information had been reported to the evening nurse for follow-up. At 20:14 on the same date, the nurse noted the PA was unable to flush the red port with cath flow and that the grey port was patent and the TPN was running through the port without difficulty.

The next documentation regarding the flushing of the red port was on 3/14/10 at 13:20 when the nurse attempted to the flush the red port with success and no resistance was noted.

On 3/18/10, the Unit patient care co-coordinator reviewed documentation of PICC line flushing with the surveyor and acknowledged there was no documentation regarding the flushing of the red port.

4. Review of Patient #7's clinical record on 3/11/10 revealed the physician had ordered on that date for the patient to be typed and crossed matched for 2 units of packed red blood cells.

Further review of the clinical record revealed the first unit of blood was started at 2020 and was infused by 2330 on 3/11/10. The second unit was started at 4:30 A.M. and infused by 8:30 A.M. on 3/12/10.

On 3/16/10, the Unit Patient Care Co-coordinator reviewed documentation in the electronic medical record with the surveyor. The Patient Care Coordinator was unable to locate a nurse's note regarding who had started the peripheral intravenous line or when it had been discontinued. Additionally, the Patient Care Coordinator stated the line needed to be flushed to ensure patency and a physician's order needed to be obtained for line flushes. The nursing staff was to document the flushes on the medication administration record. The Coordinator confirmed neither of these had been done.

5. Patient #5 was readmitted to the hospital on 2/27/10. The physician's progress note of 3/2/10 noted the patient had a history of recurrent ovarian cancer. The patient had a Porta-cath removed due to a MRSA (methicillin resistant staphylococcus aureus)infection and a new Porta-cath placed in the left upper quadrant.

The hospital's intravenous device care and management protocols noted if the Porta-cath was accessed it should be flushed after each use or every eight hours with a 5 cc solution of Heparin/saline/10 units per milliliter.

Review of the electronic medical record on 3/12/10 with the Patient Care Coordinator revealed the nursing staff were utilizing the Port for administration of antibiotic and blood transfusions. On 3/12/10 the nurse noted "Portacath to left upper chest wall deaccessed by this RN at 1100 prior to discharge." The coordinator acknowledged there was no evidence it had been flushed prior to removal of the Huber needle nor evidence of flushing after each use or every eight hours as per hospital's intravenous device procedures.

6. Patient #14 was admitted to the hospital with diagnoses of respiratory failure, spina bifida and hydrocephalus.

The 3/9/10 nurse's admission note noted the patient had a PICC line, which had two ports, in the right antecubital area which was patent. The only other assessment of the PICC line was a measurement of the arm circumference where the PICC was located.

On 3/16/10, the Unit Nurse Manager acknowledged there was no documentation of the exposed portion of the central catheter on admission. This would be necessary to ensure the catheter remained properly placed and had not migrated.

7. Patient #17 was admitted to this facility for rehabilitation with diagnoses of bilateral lower extremity fractures, leg wound with skin graft, hypothyroidism, hyperlipidemia, hypertension, diabetes and osteoarthritis. The leg wound included a Jackson-Pratt drainage tube and external fixator brace and knee stabilizer. This patient required an acute emergency evaluation on 2/26/10 for a fever and delirium.

The hospital evaluation discharge report and readmission information dated 3/2/10, identified this patient with a secondary suprainfection of a left leg hematoma. The Jackson-Pratt drain was removed due to foul smelling odor and bacterial culture results.

The patient was readmitted to the facility with a peripherally inserted central catheter (PICC) for the administration of intravenous antibiotic medication to treat the infection.

Record review on 3/16/10, revealed the resident had a PICC line which had been inserted while in the acute hospital. A copy of the patient's radiology chest x-ray dated 3/3/10 contained in the medical record confirmed positive placement of the catheter in the SVC (superior vena cava).

Per standards of nursing care practice, in addition to verifying tip placement in the SVC,before starting the infusion, the external length of the catheter required a baseline measurement. Without the baseline length, the facility would not be able to determine if the catheter had migrated at any time following insertion.

There was no documented external catheter length upon readmission on 3/2/10 or following the scheduled dressing change. Interview with the B1 unit Nurse Manager on 3/18/10, and review of the electronic medical and written record, confirmed that no measurement was documented during the nursing assessment or during dressing change. This measurement was necessary to determine any potential catheter migration.

8. Patient #15 was admitted to the hospital diagnosed with anoxic brain damage due to severe diabetic ketoacidosis, respiratory failure, anemia, tracheostomy, gastrostomy feeding tube for nutrition, pancreatitis and renal insufficiency. The patient's condition required close monitoring of medications including insulin adjustment, blood levels, laboratory test results, respiratory status and mental status changes.

Renal consultation on 2/1 and 2/3/10 advised further monitoring. Concerns included possible negative fluid balance based on documented intake and output. Plan to reassess free water needs, decrease sodium and increase intravenous fluid and free gastrostomy feeding water flushes pending further laboratory results.

Physician orders on 2/1/10 included to discontinue intravenous 1/2 NS (half strength normal saline) and change to D5W (5 % dextrose and water per liter) intravenous fluids at 75 cc per hour. On 2/2/10 the D5W solution was increased to 100 cc per hour.

The patient's medical status remained compromised due to abnormal laboratory test results including an elevated sodium (Na) 159 (normal 136 -145) and BUN /creatinine level 112/4.49 (normal 8-26; 0.44- 1.00). Intravenous fluids in addition to formula feedings were prescribed. On 2/2/10 the Na level remained elevated at 155.

On 2/3/10, per laboratory result the Sodium level was 157. A Physician Assistant note dated 2/4/10, indicated that previous increases in sodium levels may have been attributed to incorrect IV solution provided to the patient in error. Normal saline (sodium and water) was administered instead of the dextrose and water solution. Per review of the incident documentation on 2/3/10, medication administration policy was not followed for patient identification prior to initiating intravenous fluids.
This was confirmed per interview with the C1 unit nurse manager on 3/19/10.

Based on record review, interview and observation the Hospital failed to ensure for 9 (#'s 1, 2, 6, 8, 10, 13, 14, 17, and 21) patients identified with open skin wounds of 32 active medical records reviewed that the nursing staff assessed the patient's nursing care needs. There was a failure to develop and implement a plan of care, in conjunction with the medical staff, to provide the necessary care and services to promote wound healing.

Findings include the following:

1. Patient #21 was admitted to the facility on 8/21/2009. Prior to his admission to the facility, the patient had been admitted to an acute care hospital on 7/21/09 after suffering a cerebrovascular accident. The patient transferred to a short-term rehabilitation facility on 8/8/09. While at the short-term rehabilitation facility, the patient was transferred emergently to an acute care hospital due to respiratory failure, and was diagnosed with pneumonia. A tracheostomy was performed on 8/18/09, and the patient was transferred to the facility. The patient was admitted for respiratory failure, status post cerebrovascular accident with right hemiparesis, aphasia, facial paralysis, and urinary tract infection. The patient was admitted for rehabilitation following the stroke. The plan was for the patient to receive short-term rehabilitation, and then return home with his family.

On 10/4/09, the patient was transferred to an acute care hospital for hypotension and hypovolemia, and unresponsiveness. He was treated with IV fluids, and broad spectrum antibiotics secondary to a urinary tract infection.

The patient returned to the facility on 10/7/09. Record review on 3/17/10 indicated that the patient was receiving treatment with antibiotics for the organism C. difficile. The nurse's admission assessment of 10/7/09 noted the presence of three Stage II pressure ulcers, one on the right hip, and one each on the left and right buttocks.

Review of the admission orders revealed an order for the treatment Critic-aid to buttocks daily. No other treatments or pressure relief interventions were ordered upon admission.

Nursing documentation of the wounds present upon re-admission to the hospital on 10/7/2009 were included with pictures of the wounds as follows:

-Right hip: Stage II, 0.5 cm. (centimeters) length x 1.0 cm. width x 0 cm. depth. The nurse indicated that the area was "slight open and moist, no drainage. The assessment indicated that there were "healed pink areas adjacent to open areas."

-Right buttock: Stage II, 1.0 cm. length x 0.5 cm. width x 0 cm. depth.

-Left buttock: Stage II, 2.0 cm. length x 1.0 cm. width, 0 cm, depth. The nursing assessment for the buttocks wounds indicated that there was "slight serous drainage" from the wound.

On 10/8/09 at 1536, the wound nurse documented her assessment of the patient's buttocks wounds. Her note indicated that the patient had an "unstageable" pressure ulcer across buttock, right side, 4 x 6 cm x no measurable depth. Patient is brown skin. This area much darker in color with scattered partial tissue loss. "Right side 3 x 2 cm. of darker skin color, flaky." The treatment recommended by the wound nurse included:

-Dermal wound cleanser and skin prep edges.
-Allevyn foam dressing
-Change every 72 hours and contact the wound care nurse for any changes or concerns. No additional pressure relief interventions were noted in the wound nurse's evaluation for this high risk patient.

There was also no mention of the resident's Stage II, right hip wound identified on admission, in the wound nurse's documentation of 10/8/09 at 1536.

On 10/15/09, the nutritional consultant reviewed the patient's nutritional status and indicated that the patient was NPO (nothing by mouth), remained on Fibersource HN at 70 cc (cubic centimeters) per hour continuously, Prostat 30 cc daily, Vitamin C 500 mg. (milligrams) BID (twice daily). She indicated that the patient had "butt unstageable wound." The note referred to a photo of the wound taken 10/12/09.

Review of the wound assessment and photo of 10/12/09 revealed the following:

Right buttock pressure ulcer: 6.5 cm. length x 3 cm. width x 0 cm. depth
Left buttock pressure ulcer: 2 small irregular shaped " open areas" 1 x 2, and 1 x 2. (No unit of measure was indicated).

The registered nurse assessing the patient's wounds on 10/12/09 indicated that the wounds were "clean, dry, no odor, no drainage, pink base."

On 10/19/09, a photo was taken of the patient's left buttock pressure ulcer. No staging or measurement of the wounds were available. The licensed practical nurse who performed the assessment documented: "small serous drainage." Review of the photo of the patient's left buttock, revealed multiple Stage II wounds of various size, with a small amount of bloody drainage on the gauze. There was no weekly assessment available of the right buttock or right hip ulcers that were identified upon re-admission on 10/7/09.

On 10/26/09 the nurse indicated "photo doc done of right and left buttocks." The registered nurse indicated that there were "several open areas." However, there was no other clinical assessment of the stage, size, appearance, pain, or indication presence of drainage which are part of the weekly wound assessment. The photo revealed multiple Stage II wounds, bright red in appearance on the right and left buttocks, in various stages of healing. There was also an irregular shaped wound on the coccyx that was red at the center with white tissue surrounding it.

On 10/27/09 at 1420, the patient was seen and examined by a physician, and the case was discussed with the physician assistant. However, there was no documentation regarding the status of the patient's bilateral buttocks, and right hip pressure ulcers.

An assessment of the patient's right hip pressure ulcer was performed by the licensed practical nurse on 10/30/09. The re-assessment of the right hip wound on this date, was the first one conducted since the patient's re-admission on 10/7/09. The pressure ulcer measured 0.5 cm x 0.5 cm. in diameter. The assessment of the wound for depth was blank. Review of the photo of the wound revealed noticeable depth below the wound edges. The nurse noted that the wound was "beefy red over bony prominence." No other clinical data regarding the wound was included in the nurse's assessment. The nurse documented in the electronic medical record that photo documentation had been done. She indicated that a message was left for the wound nurse. The nurse's note indicated that she had reported her findings to the physician assistant. The nurse documented that she had cleansed the wound with dermal wound cleanser, and applied an Allevyn adhesive dressing.

On 11/2/09 at 1229, the wound nurse documented that she was asked to evaluate the patient's buttocks/right hip wounds. She indicated that the right buttock wound "is resolving. She noted that partial tissue loss was scattered with epithelial tissue at the edges. The wound nurse also noted that the patient ' s right hip wound was "unstageable," measured 2 cm. x 2.5 cm. with partial tissue loss and a dark purple, 1 cm. round center. The nurse documented that the patient was acutely ill, with a low grade temperature, and remained positive for C. difficile.

Recommendations by the wound nurse on 11/2/09 included the following:

-Continue Critic Aid AF to buttock/coccyx
-Allevyn adhesive to right hip every 72 hours
-Rectal tube or fecal pouch to protect skin
-Contact wound nurse with any changes or concerns

The Registered Nurse performed the weekly assessment of the patient's right hip wound on 11/9/09. The photo and assessment of the wound, revealed one, large, unstageable wound measuring 2 cm. in length x 2 cm. wide. No depth assessment was documented. Review of the wound photo revealed a large crater-like semi-circular ulcer. The large concave center of the wound was black in appearance with bright red at the edges, at one o'clock and six o'clock. The remaining edges were noted to have white, macerated-looking, or pale pink tissue. Additionally, there was another, undocumented, irregularly-shaped, Stage II ulcer proximal to the larger ulcer. Fifty percent of this wound presented as a bright red ulcer at the left wound margin toward the center, with the center to the right margin showing pale pinkish white tissue.

Electronic documentation of the patient's wounds indicated "photo doc done. Continue to monitor." No further nursing documentation of this patient's deteriorating wounds was noted in the medical record. There was no evidence that any member of the medical team responsible for the patient's care was notified of the continued decline of the wounds.

The hospital's policy for licensed nurses' assessment of wounds included measuring, assessing, and documenting clinical findings along with taking a photo of the wound every Monday. Record review for Patient #21 revealed no evidence that an assessment of the patient's right hip and buttocks pressure ulcers were performed weekly on Monday 11/16/09 per the hospital's policy.

On 11/23/09, a photo and measurements of the patient's wounds were noted as follows:

-Right buttock: 8 cm. wide x 4 cm. in long x (no depth documented)
-Coccyx: 3 cm. wide x 1.5 cm. x (no depth documented).
-Right hip: 8 cm. x 4 cm. x (no depth documented)

Review of the photo of the right hip wound, revealed an increase in size to 8 cm. length x 4 cm. wide, x (no depth documented). Overall, the wound had increased in size significantly since the last time it was assessed by nursing on 11/9/09. The wound presented as a large, irregular shaped area with white to pale pink color at the wound borders. The large concave, crater-like portion to the right had a large, dark center and a reddened circular shaped segment at two o'clock. Immediately to the left of the large, crater-like wound was another open (unstaged) area running north and south, which had not been present on the 11/9/09 photo documentation and assessment. The wound was a deep, dark, red color. Immediately to the left of it were scattered open areas that presented in the photo as Stage II ulcers.

The photo and documentation of the coccyx and right buttocks wounds on 11/23/09 are as follows:

-Right buttock: 8 cm. wide x 4 cm. long x (no depth documented)
-Coccyx: 3 cm. x 1.5 cm.

The right buttock wound photo and documentation noted a significant deterioration in the size, depth, and appearance of the wound, in compared to the wound documentation of 11/1/09. There were a total of five distinct, irregularly shaped wounds, with observable depth. The one at the outer right side was the largest, with the center of the wound nearly covered with an off-white colored material. Immediately to the left of it were three other wounds that were mostly bright red at the center. To the left of those wounds was another moderately sized area of white material, with a red open area at 11 o'clock.

The nurse who conducted the assessment and documentation of the wounds, indicated in her note "R (right) hip, butt (buttocks) wounds see 11/23 photos."

Other information required for the weekly wound assessment was not available. The nurse's documentation of the patients wounds, failed to address any additional interventions to relieve pressure or promote healing of the patient's deteriorating pressure ulcers. There was no documented communication with the patient's medical providers regarding the change in the condition of the wounds.

On 11/27/09 at 1634, the wound nurse documented that she was asked to see the patient regarding "worsening Stage II on buttocks." The wound nurse's evaluation of the patient noted, " Pt (patient) presents with worsening incontinence dermatitis, not " Stage II "pressure ulcer. Pt is incontinent of large amounts of loose stool throughout 24 hour period." She indicated that the patient had used up days for fecal management tube, and that this was no longer an option. The wound nurse indicated that "current treatment is Criticaid Clear." The following recommendations were made:

-Discontinue Criticaid Clear
-Apply Coloplast thick moisture barrier paste generously to all denuded areas on buttocks. Re-apply BID (twice daily) with hygiene.
-Do not clean down to base of denuded tissue-leave a light layer of barrier cream in place and remove soiled top layer only.
-Maintain strict turning schedule.
-Will follow as needed. Please call with questions.

Additional pressure relief for this patient was not documented as part of the wound nurse 's recommendations.

An assessment of the patient's wounds was performed by the registered nurse on 11/29/09. The nurse documented that the photo was of the left and right buttocks and coccyx. There were no required measurements/descriptions of the wounds included in the nurse's assessment. The nurse documented " several open areas, " and " incontinence associated dermatitis.

Review of the photo revealed multiple, irregularly shaped wounds that were pale pink to bright red at the centers. The "Wound Type" assessment revealed "Pressure Ulcer" had been crossed out. All of the wounds appeared to be coated with a white topical barrier agent, and obscured the overall characteristics of the wound.

The right hip photo revealed measurements of 8 cm. x 5 cm. x (no depth documented). The wound remained irregular in shape, and the large concave crater area had a dark brownish-black color at the center. This wound had merged with the long, open wound running north and south immediately to the left. The color of a large portion of the wound center and edges took on a white fibrous to pale pink appearance, except for the two larger portions of the wound. There was no other required assessment information regarding the wound, i.e. drainage, smell, etc.

The weekly assessment of the right hip wound was performed on 12/7/09. The wound measured 8 cm. x 4 cm. x (no depth recorded). The large area of dark, brownish-black material had spread to the smaller area immediately adjacent to the left. There was an additional area of dark, brownish colored material to the left of the large area, surrounded by beefy red-colored tissue. The entire wound periphery was noted to have a dark colored outline surrounding it, that was darker than the patient's natural skin tone. There were no other descriptions or assessment data available.

A nurse's note on 12/11/09 at 1515, indicated that the " buttocks wound appears to be worsening, pt (patient) seen by wound nurse. No new orders. Continue to monitor. "

On 12/11/09 at 1551, a nurse from the wound team evaluated the patient's buttocks and right hip wounds. The wound nurse indicated in her note, "asked to see pt. for unstageable pressure ulcer on right hip and buttocks." She recommended discontinuing the present treatment to both right hip and buttock wounds. Her recommendation was to begin cleansing the wounds with dermal wound cleanser, skin prep edges, apply normal saline moistened gauze impregnated with Elta Hydrogel, and cover with a dry clean dressing twice daily and as needed for soiling. The wound nurse indicated that she would excisionally debride the necrotic tissue from the buttock and right hip necrosis as needed next week.

On 12/15/09 at 1420, the wound nurse who had seen the patient on 12/11/09 documented her excisional debridement of the patient's right hip and right buttock "unstageable" pressure ulcers. She indicated in her note that "universal protocol" was followed using #15 scalpel and scissors. The nurse wrote that "moderate amount of necrotic tissue debrided from right hip and right buttock ulcer. Both ulcers were debrided to expose adipose tissue."

The wound nurse recommended, "continue use of Hydrogel to continue with autolytic debridement."

There was no documented evidence that the wound nurse communicated her treatment and findings, following the wound debridement, to the physician assigned to provide medical care for this patient.

Weekly documentation of the patient's coccyx and right buttock wound on 12/28/09, revealed an increase in size (presumably from the debridement) to 9.0 cm. length x 12 cm. width. The photo documentation revealed the right buttock wound as a large, irregularly shaped ulcer. The center portion presented as dark, brownish-black in color. The remainder of the wound was beefy red with whitish yellow material throughout.

Two smaller, circular-shaped ulcers were noted at 11, and 12 o'clock orientation to the large, right buttock ulcer.

The patient's right hip weekly wound assessment, revealed an increase in size (presumably from the debridement) to 5 cm. length x 9.5 cm. width x (no depth recorded). The nurse documented a moderate amount of serosanguinous drainage. The wound presented as a large crater-like ulcer with significant depth, with yellow and brownish-black tissue at the center. The wound margins were comprised of white, pale yellow and pink tissue. A darker colored tissue surrounded the outermost aspect of the entire wound.

Weekly documentation of the patient's coccyx and buttock wounds on 1/4/10 revealed that the wound had increased in size to 12 cm. length x 11 cm. width x (no depth documented). The right buttock and coccyx wound had merged together, and the majority of the wound tissue appeared pale pink to beefy red, with large areas of whitish-colored tissue, The large area of brownish-black material remained. However, part of it appeared to have been debrided, leaving an area of whitish-yellow tissue.
The nurse's assessment included, "large amount dng (drainage) serosang (serosanguinous) with fluorescent green."

The right hip wound measured 5 cm. length x 9 cm. width x (no depth recorded). The nurse conducting the assessment indicated the presence of a moderate amount of serosanguinous drainage with fluorescent green. The photo of the wound presented as a large crater like ulcer, with pale whitish to yellow tissue, and scattered areas of dark brownish black. The large area of brownish-black tissue noted at the previous assessment remained at the outer right aspect of the wound. The wound was nearly absent of any granulation tissue. The wound edges consisted of mainly white fibrous-looking tissue.

The nurse indicated on the weekly wound assessment that the patient was seen by a physician on that day. However, there was no documentation surrounding the physician's evaluation and treatment of the patient. There was no evidence that the patients ' wounds were assessed at the time of the physician visit.

A second registered nurse from the hospital's wound care team documented a visit on 1/8/10 at 1548. She indicated that she had assessed the condition of the patient's right hip and coccyx wounds.

The right hip was noted to have a small amount of pale yellow drainage, and the wound bed "has necrotic adipose tissue covering base." She also documented that his coccyx "remains with necrotic adipose tissue as well as beefy, red granulation tissue at edges." She indicated that at that time, a "conservative approach to debridement using the Hydrogel (Eltagel) is being used."

There was no evidence in the wound care nurse's note, documenting whether or not the physician had been notified of her findings, or the worsening of the patient's right hip and buttocks/coccyx wounds.

Weekly assessment of the patient's wounds was performed on 1/11/10. The right "sacrum" (buttock/coccyx) pressure ulcer measured 11.0 cm. length x 8.0 cm. length x (no depth documented). The nurse noted " moderate drainage-serosang./green, no odor." Review of the photo revealed no substantial change in the wound, except for the presence of beefy red colored tissue surrounding the area of dark, brownish-black tissue.

The right hip wound measured 5.0 cm. length x 9.5 cm. width x 0 cm. depth. The nurse noted moderate serosanguinous/green drainage with no odor. The photo revealed a large area of yellowish-brownish-black tissue at the center with a small black area at six o'clock. The wound edges were white to pale pink. There were scattered areas of red tissue at twelve o'clock.

There was no evidence in the nurse's documentation to indicate that the patient's physician was notified of the green drainage.

The weekly wound assessment was performed on 1/18/10. The "coccyx" (buttocks) wound measured 10 cm. length x 13 cm. width x (no depth documented). The area was noted to have increased significantly since the wound assessment of 1/11/10. No other wound assessment data was included in the wound documentation. The wound presented with a large area of brownish-black material on the proximal part of the right buttock, with a large beefy-red area to the right of it. The coccyx wound remained open with yellowish material at the center. The left buttock wound had not changed significantly.

There was no evidence that the physician was notified regarding the presence of green drainage, and significant increase in the size of the coccyx/buttock wound.

On 1/22/10 the wound care nurse who had provided care for the patient on 1/8/10 was consulted due to concerns over "green drainage," and positive pseudomonas/ e-coli cultures.

The wound nurse described the right hip with small amount pale green drainage on the old dressing, with no odor or erythema.

The coccyx/right buttock wound was assessed by the wound nurse to have "moderate serosanguinous drainage. No erythema, no odor." Per the wound nurse's documentation," each wound was covered with thick, leatherly necrotic tissue, separating at edges, revealing pink granulation tissue."

This wound nurse was assisted by the wound nurse who had debrided the patient's wounds on 12/15/09. Her note indicated that she proceeded to excisionally debride the right hip wound using a #15 scalpel and forceps, using "universal protocol." The right hip wound was noted to have a large amount of necrotic tissue debrided to level of fascia, 20 % fascia. According to the wound nurse's note, the remainder of the wound remained covered by adipose tissue, edges with epithelial tissue. According to the note, following the debridement, the wound measured 6 x 9 x 2 cm.

The coccyx/right buttock wound was excisionally debrided for a large amount of thick, tan, necrotic tissue down to necrotic tissue. Following the debridement, the wound measured 8.5 x 13 x 1 cm. Seventy percent of the wound contained beefy red granulation tissue, with 30 percent adipose tissue, mainly over the coccyx.

The wound nurse documented that she had discussed the use of acetic acid to treat the pseudomonas-infected wound with the physician assistant assigned to this patient.
The previous treatment to both wounds was discontinued. A new order was obtained to use 0.25 % acetic acid solution, moist gauze loosely packed, and cover with dry clean dressing, change three times daily.

There was no evidence in the nurse's note that the physician assistant visually assessed the resident's deteriorating right hip and right buttock/coccyx wounds.

The weekly assessment of the patient's wounds was conducted on 1/25/10. The coccyx/buttocks ulcer measured 9 cm. length x 12 cm. width x 1.5 cm. depth. The wound photo revealed a significant increase in necrotic tissue, with dusky-colored tissue surrounding the wound. A large area of beefy red tissue was noted to the left, below the large area of soft, yellowish-green necrosis. The coccyx wound appeared black in color with yellowish-green tissue to the left.

The hip pressure ulcer measured 6 cm length x 9.5 cm width x 2 cm. depth. The picture of the wound was distorted and difficult to visualize.

On 1/26/10 at 1610, the licensed practical nurse documented that the family were in to do a "care day." The nurse explained different aspects of the patient's care to the family, including jejunostomy tube feedings, feeding pumps, and the status of the patient's wounds. The family was described as "weepy" concerning the patient's wounds, and his capacity to heal. The nurse informed them that the wound nurse had recently changed the treatment orders, and that time was necessary to evaluate if the new treatment wound show improvement. According to the note, " nursing demonstration and cueing took place but lack of patient's family's hands on related to care-requires another care day for them to demonstrate competency."

On 1/27/10 at 1347, the wound care nurse documented that she had a lengthy discussion with the daughter to discuss the status of the wounds, plan of care, different options, and visiting nurse services, and possible wound vacuum placement in the future.

The weekly wound assessment of the patient's buttocks/coccyx, and right hip wounds, was conducted on 2/1/10. The right hip wound measured 8.5 cm. length x 6.5 cm. width x 1 cm. depth. The wound was comprised of mostly dark blackish-yellowish-brown necrotic tissue. Approximately 20 percent of the wound was beefy red.

The coccyx/buttock wound measured 9 cm. length x 11 cm. width x 0.75 cm. depth. Fifty percent of the wound presented as pale yellowish-white necrosis. A small black area was noted at the left side of the area of necrosis. The remainder was beefy red in appearance.

Weekly assessment of the wound was performed on 2/8/10. The right hip measured 8 cm. length x 6 cm. width x 1 cm. depth. The wound appeared as a large concave ulcer with a large amount of yellow slough at the center. A moderate amount of beefy red tissue was noted at six o'clock. No other assessment findings were included on the wound assessment form.

The coccyx/buttocks wound measured 9 cm. length x 11 cm. width x .75 cm. depth. The wound appeared to have increased over the left buttock, with a large area of brownish -black tissue at the center, and right of center. No other assessment data was noted in the weekly wound assessment.

On 2/11/10 at 2148, the nurse manager of the wound team documented her assessment of the patient's wounds. She indicated that acetic acid dressings had been used since 1/22/10, and that the wound bases had improved after 2 weeks of acetic acid use. The wound care manager advised resumption of the prior Elta Hydrogel dressing and moist normal saline gauze twice daily.

Weekly assessment of the patient's wounds was performed by the nurse on 2/15/10. The coccyx wound measured 11 cm. length x 15.5 cm. x (no depth recorded). The nurse noted "Stage III pressure ulcer, yellow slough tissue. Refer to wound documentation report."

The photo did not include the entire wound. However, the right buttocks coccyx presented with a large area of yellowish-brown, necrotic tissue towards the center, and a large area of beefy, red tissue to the right, lateral aspect.

The right hip measured 9 cm length x 6 cm. width x 2 cm. depth. The nurse indicated that the wound was a Stage III pressure area, yellow slough tissue. Approximately 85 percent of the wound was comprised of yellowish brown slough, and 15 percent dusky pink tissue proximal to the outer part of the wound.

No other assessment data was noted in the weekly wound assessment for this patient with multiple deteriorating pressure ulcers.

There was no documented evidence that the patient's physician was notified of the continued decline in the patient's wounds.

On 2/15/10 at 2317, the nurse documented that the family came in, and was taught how to administer the patient's tube feeding. Aspects of care surrounding the tube feeding were discussed.

On 2/19/10 at 1746, the wound nurse documented her lengthy discussion with the patient's wife about "discharge plan and dressing changes/selections. A plan was formulated for the wife to come into the hospital on Tuesday 2/23/10.

The weekly assessment of the patient's wounds was performed by the nurse on 2/21/10. The right hip wound measured 8 cm. length x 6 cm. width x (no depth recorded). The wound presented as a large, crater-like wound that appeared to be tunneling at nine o'clock. Seventy-five percent of the wound was covered with yellowish-brown slough that was lifting at the edges. The remaining lower portion of the wound from five to seven o'clock was white, to pale pink in color.

The left and right buttocks/coccyx wounds were noted to be 9.0 cm. length x 11 cm. width x (no depth documented). The wounds appeared similar to the photo noted on 2/15/10.

On 2/22/10 at 1708, the wound nurse who had performed the excisional debridement on 1/22/10, returned to perform another debridement of the patient's buttocks/coccyx, and right hip wounds. The wound nurse documented that, using universal protocol, a #15 scalpel and forceps, the patient's right hip and sacral area were debrided to "level of necrotic tendon on right hip and adipose tissue on sacral area. According to the wound nurse's note, no bleeding or odor were noted.
There was no documented evidence that the wound nurse notified the physician in regards to the findings of her excisional debridement, to " level of necrotic tendon " on the right hip.

On 2/23/10 at 1643, the wound nurse documented instruction of changing the patient's dressings to the patient's wife in anticipation of his planned discharged home. According to the wound nurse, the wife displayed proper techniques with all dressings, and educated "re: S & S (signs and symptoms) of infection or deterioration of ulcers, and when to notify VNA (visiting nurse agency)/ MD." The note indicated that the wife demonstrated understanding.

On 3/1/10 the last weekly wound assessment was performed by the nurse assigned to provide care to the patient. This assessment was performed three days prior to the patient's discharge on 3/4/10.

The right hip wound (labeled "left hip" ) measured 6 cm length x 9 cm. width x 1 cm. depth. Moderate, yellow serosanguinous, drainage with " foul odor " noted.

Sixty percent of the wound appeared as beefy-red tissue. The remainder of the wound was comprised of pale white to yellowish -brown tissue.

The coccyx wound measured 10 cm. length x 15 cm. width x 2 cm. depth, was irregularly shaped, with a moderate amount of serosanguinous/yellow drainage. The nurse noted that the wound had a "foul odor," with pink and yellow tissue at the base with black areas.

There was no documented evidence in the nurse's note, that the physician responsible for the patient's care was notified of the presence of a potential infection in the wounds.

On 3/2/10 at 1114, the PA (physician assistant) responsible for the patient's care wrote his assessment note for the patient. He indicated that the plan for the patient ' s skin was to " cont. (continue) with wound care" There was no documentation to indicate that the PA had visually inspected or assessed the patient's wounds, or that he was aware of the clinical findings of the nurse on 3/1/10. The disposition for the patient indicated, "plan to d/C (discharge) home over the next week, home teaching to be done."

On 3/4/10 at 1430, the nurse indicated that the patient was discharged home via ambulance, with his belongings, and a list of medications given to the patient ' s wife and daughter.

The PA entered a progress note on 3/5/10, which detailed the patient's discharge home. In addition to the clinical data, and review of systems for the patient, the PA noted a plan that included "SKIN-wound care." No further clinical assessment of the patient ' s wounds was entered regarding this patient's extensive, deteriorating wounds, documented to have a foul smell on 3/1/10, three days prior to discharge.

The hospital completed a "Patient Care Referral Form" that was provided to the visiting nurse agency around the time of discharge on 3/4/10. The visiting nurse agency would provide wound and other nursing care to the patient in his home. The following information was provided to the agency in order for them to provide on-going care and treatment to the patient's wounds:

"Skin intact other than wounds as follows: Coccyx-10 cm. x 15 cm. x 2 cm. unstageable, serosanguinous drainage pink/yellow slough base with black areas."

"Left hip (actually right hip)-6 cm. x 9 cm. x 1 cm. pink/yellow slough base with serosanguinous drainage and small black area."

"Dressings-NS (normal saline) moistened gauze impregnated with Elta Hydrogel covered by DCD (dry clean dressing) change BID (twice daily) or PRN (as needed) soiling."

The V.P. of Quality was interviewed on 3/16/10, regarding the status of this patient, who had been discharged from the hospital on 3/4/10. She informed the surveyor that she was currently conducting an investigation into a complaint made by the hospital that admitte

Based on observation, interview and record review, the Hospital failed to ensure that non-employee licensed nurses who were working in the hospital dialysis service received adequate supervision by the Hospital Nursing staff including the evaluation of the clinical services that were provided

Findings include the following:

The acute hemodialysis services provided to patients in this Hospital were arranged through a contractural arrangement with a national hemodialysis company. The hemodialysis company assigned licensed nurses and patient care technicians to provide the acute hemodialysis treatments.

Interview with the VP of Nursing on 3/12/10 indicated that the Hospital staff did not participate in the performance evaluation of the contracted hemodialysis staff that provided hemodialysis treatment to hospital patients. The VP of Nursing indicated that they had considered it the responsibility of the contracted hemodialysis company. The hospital had designated the nurse manager on the unit where the hemodialysis was performed to be the contact person for the hemodialysis staff and management.

On 3/12/10 at 1000, four patients were observed receiving hemodialysis treatments. The area was staffed with one hemodialysis registered nurse and one PCT (patient care technician.) It was observed that the dialysate solution for one of the patients being dialyzed was labeled as opened and prepared on 3/10/10. Additives had been added to change the bath from 2K to 3K. The only notation of the change was handwritten on the plastic dialysate jug which noted the date and initials of the person who changed the bath. The nurse stated she was not assigned routinely to this unit, but it was company practice to save and use the excess solution. However, the PCT stated although it was company policy, she always discarded any solutions left at the end of the day.

On 3/19/10 at 1030 A.M., two patients were observed in the dialysis area with one nurse from the contracted hemodialysis service providing care. This nurse was not the same nurse observed on 3/12/10. When questioned by the surveyor regarding the procedure for adjusting hemodialysis baths, the nurse stated baths were adjusted according to the patient's blood laboratory results. Additives were observed to be documented on a label which was adhered to the container, for example changing a 2K bath to a 3K or 4K. The nurse stated prior to 3/19/10, the hemodialysis staff were saving these baths for future use but are now discarding them. The dialysis nurse was unable to locate the procedure for this process in the policy and procedure manual and contacted the dialysis clinical supervisor for the procedure. The VP of Nursing was informed of this discussion with the dialysis nurse and a lack of this procedure being available for the staff.

Based on observations, record review and staff interview, the facility failed insure blood transfusions and intravenous medications were administered per facility policy for 7 patients (#5, 7, 10, 14, 15, 17, and 25) out of a sample of 32 active records.

Findings include:

1. For patient #10, the facility failed to ensure nurses followed the hospital's policy regarding Peripheral Intervenous, (IV), catheter insertion and evaluate the on-going administration of IV Vancomycin. As a result, patient #10 has a necrotic right foot.

Patient #10 was readmitted to this facility on 4/24/09 with diagnoses which include, Anoxic Brain Injury secondary to an air embolism over 9 years ago, Ventilator Dependent Respiratory Failure, (VDRF) and Methicillin-resistant Staphylococcus aureus (MRSA) and Vancomycin-resistant enterococci (VRE) colonization.

Observation on 3/16/10 at approximately 11:30 a.m., the patient was lying in bed on a vent, non-responsive to verbal command, had severe upper extremity contractures and bilateral foot drop. The patient's right foot was elevated on a pillow, uncovered and in plain view. On the dorsal part of the patient's right foot around the navicular area all the way down to the tips of all toes was black, necrotic eschar. The foot was foul smelling. The patient was unable to make needs known.

The wound nurse #2 looked at the patient's foot at that time and recommended the area be cleansed with dermal wound cleanser and covered with DCD (large Exu-dry) loosely and changed daily. An order for this recommendation was obtained by the physician's assistant (PA).

Review of the patient's clinical record revealed on 2/23/10 at 2 PM, the attending physician wrote an order to administer Vancomycin 1 gram IV every 18 hours for 10 days and Levaquin 500 mg IV daily for 10 days. (Per the medication insert for Vancomycin, this medication is very irritating to tissue and must be given by a secure intravenous route of administration. Pain, tenderness and necrosis occur with inadvertent extravasation).

Between the time the IV orders were written on 2/23/10 at 2 PM and 2/24/10 at 2250, there was no documentation to reflect an IV was inserted. On 2/24/10 at 2250 an RN nurse's note stated, "at change of shift patient's IV site infiltrated, site was pale and cool to the touch, PA was notified. PA assessed - no new orders, no concern. Warm clothes were applied, site improved. New IV site is in right antecubital..."

On 2/26/10 a late entry note for 2/24/10, an LPN #1 nurse's note was entered into the computer revealing "@ 1105 administered scheduled dose of Vancomycin @1200 checked on patient, no issues, went back to see patient at approximately 1310, patient's Vanco completed, patient's line was flushed, I observed patient's foot was pale and cool to touch, I removed saline lock and elevated pt's. foot, @ 1500 rechecked patient status of foot hadn't changed reported to oncoming shift".

Late entry on 2/25/10 for 2/24/10 1800, (5 hours after the LPN observed the patient's foot was pale and cool to touch), "called to evaluate patient's right foot at site of infiltrated IV...right ankle positioned in equinovarus. No edema noted on foot. Mid dorsum of foot circular area at site of previous IV is pale, slightly cool, surrounding area of foot and leg and plantar surface is pink, question palpable dorsalis pedis pulse".

The patient was seen by a vascular surgeon on 2/25/10 and his progress note reflected ischemic right foot, question etiology, question infiltration of IV vs PVD vs embolism. Recommend amputation after demarcation. Per interview with the VP of Quality on 3/17/10 in the morning, it was determined that the ischemic right foot was caused by the IV infiltrate of Vancomycin).

On 2/26/10 a nurse's note timed 2355 reflected, "saline lock of right arm infiltrated and after 3 attempts, reinsertion was unsuccessful, MD notified, IV antibiotic discontinued and Linezolid and Levaquin were ordered for G-tube administration.

Interview with VP of Quality on 3/16/10 at approximately 3:00 p.m. revealed that the hospital staff had done an internal investigation of this incident, and on 3/15/10 reported this incident to Department of Public Health. She stated an IV was started on this patient on 2/23/10 by an RN #1. This nurse inserted a #24 Angiocath into the right foot but did not document the insertion in the clinical record.

Review of the hospital's IV Certification Policy, effective date of April 2008 states, "Venipuncture will not be performed in a patient's lower extremity except during a Code situation".

Review of the hospital's Peripheral IV catheter insertion policy dated 2009 states that nursing documentation includes: "record the date and time of the venipuncture; the type, gauge, and length of the cannula; the anatomic location of the insertion site; the length of the catheter; and the reason the site was changed. Also document the number of attempts at venipuncture (if more than one), the type and flow rate of the IV solution, the name and amount of medication in the solution (if any), any adverse reactions and actions taken to correct them..." (Review of nurses notes from 1/25/10 - 3/17/10 regarding IV insertions lacked appropriate documentation information as required per policy)

Although, an internal investigation was done and completed by 3/15/10, there was no plan in place at this time to prevent this incident from reoccurring again with this patient. There was nothing in place to assess and implement another access alternative for intravenous medications for this patient or any other patient who is difficult to obtain peripheral access and history of infiltrates.

Review of the internal investigation handed to the surveyor on 3/17/10 revealed an Action plan as follows:

A. Nurse managers will audit 3 records per month for 6 months for patients with IV to assess appropriateness and timeliness of nursing documentation. Action plan based on this investigation

B. Vice President of Nursing (VPN) will revise policies and procedures for IV insertion and IV care. Revised policy will state that the lower extremity shall not be used for IV access unless IV is inserted by an MD or PA, or inserted during a Code. VPN will also review how hospital's policies are accessed and displayed in Lippincott.

Nurse manager shall educate all nursing staff on revised policy.

C. The involved nurse LPN#1 was educated on the importance of timely communication with medical staff on changes in condition.

Again, this action plan does not address patient #10 with regards to giving Vancomycin via a peripheral line.

Further review of the patient's clinical record from 1/25/10 - 2/23/10 revealed this patient had a history of IV infiltrates:

A nurse's note dated 1/25/10 and timed 2247, revealed "IV inserted in the left leg by PA, (physician's assistant). IV antibiotics started IV Vancomycin and Levaquin.

A PA, on-call progress note dated 1/26/10, 2300 revealed IV access lost. #20 placed right UE (upper extremity) with issue. A nurse's note at that time reflected, "new IV line placed in right arm by PA, due to L leg infiltrate.

A nurse's note dated 1/31/10 at 0353 revealed, "patient's IV in right hand infiltrated and swollen, IV removed, elevated right arm and applied warm compress. New IV #20 inserted in left hand.

A nurse's note dated 2/6/10 at 2220 revealed, saline lock discontinued this PM.

Interview with the VPN on 3/17/10 around 8:30 a.m. confirmed that nurses are not to insert an IV into any lower extremity unless it is a "code" situation. She further stated that current IV polices and procedures needed to be revised, documentation regarding IV insertion and monitoring were inconsistent and in some cases, absent and that there was a delay in notifying the medical staff on 2/24/10 when this patient's IV infiltrated. There was no investigation regarding previous infiltrations, nor was there any plan in place to address this type of incident from occurring again with this patient.

Further interview with VP of Quality on 3/17/10 around 9:30 a.m. revealed the facility doesn't monitor infiltrates. She did not know why RN #1 inserted a #24 Angiocath into the right foot and that there are no IV protocols in place to address proper insertions and access problems. Currently, there are no on-going IV competencies required for nurses once they become IV certified.

Interview with the LPN #1 on 3/17/10 around 3:00 p.m. revealed that on 2/24/10 after he administered the IV vanco to patient #10, he flushed the line. When he noticed the patient's foot was pale he pulled the line and elevated the patient's right foot. (He did not apply warm soaks nor did he notify the patient's physician as required per policy).

Surveyor asked to review LPN #1's education record. On 3/18/10 around 9:00 a.m. VPN handed surveyor LPN #1 education records. These records lacked evidence that he was properly trained to manager IV therapy. Interview with VPN at that time was not aware this did not receive the proper training. IV competency was not looked at during the hospital's investigation of this incident.

2. For patient #25, the facility failed to ensure nurses followed the hospital's policy regarding peripheral intravenous (IV) catheter insertion.

Patient #25 a long term patient at the hospital and was dependent on the ventilator due to respiratory failure.

Review of the physician orders revealed on 7/6/09 the patient was to be administered an antibiotic (Primaxin) for an infection. On 7/7/09 at 6:30 PM, the nurse documented the antibiotic medication was administered through a peripheral intravenous (IV) in the right hand. At 10 PM the nurse documented the peripheral IV line was in the patient's right foot. There was no physician's order for the placement of the peripheral IV line in the patient's right hand or the right foot. In addition, there was no documentation as to who placed the peripheral line in the hand or the foot. There was no indication why the patient required the intravenous device be placed in the foot when this was in conflict to the policy of the hospital.

On 7/8/09, nursing documentation revealed the peripheral line remained in the patient's right foot. On 7/9/09, the nurse's note revealed the physician ordered 1 liter of normal saline at 50 cc per hour to be administered due to review of new lab data and she documented that the IV remained in the patient's right foot. There was no documented evidence that the nursing staff assessed the patient's peripheral line on 7/10/09. On 7/11/09 at 2 PM, the nurse recorded she had notified the physician that the patient's right foot was swollen. At 3 PM, physician assistant #3 removed the IV. On 7/12/09, the IV assessment only reported that the IV line was in the "right.", but failed to identify the location of the peripheral line.

Review of the hospital's IV Certification Policy, effective date of April 2008 states, "Venipuncture will not be performed in a patient's lower extremity except during a Code situation".

Review of the hospital's Peripheral IV catheter insertion policy dated 2009 states that nursing documentation includes: "record the date and time of the venipuncture; the type, gauge, and length of the cannula; the anatomic location of the insertion site; the length of the catheter; and the reason the site was changed. Also document the number of attempts at venipuncture (if more than one), the type and flow rate of the IV solution, the name and amount of medication in the solution (if any), any adverse reactions and actions taken to correct them..." (Review of nurses notes from 7/6/09 - 7/12/09 regarding IV insertions for patient #25 lacked appropriate documentation information as required per policy)


3. Patient #8 was admitted to the hospital on 3/10/10 at 14:12 P.M. According to the referring hospital discharge summary, the patient had a history of ulcerative colitis which required revision of the Koch pouch that failed and subsequent excision of the Koch pouch and creation of an end-ileostomy.

The 3/10/10 23:05 nursing admissions documentation noted the patient was not taking anything by mouth and was receiving TPN (total parenteral nutrition) via a PICC (peripherally inserted central catheter). The nurse noted the PICC line was in the patient's right arm, had two ports which were patent.

Review of the nursing kardex revealed the nurses could draw blood specimens from the central line. The hospital's blood sampling procedure from a central line noted after obtaining the blood specimen the line was to be flushed with normal saline as per the flushing procedures. According to the procedure a 10 ml syringe with 5 ml of normal saline was to be used for flushing and a Heparin flush (if ordered). The hospital's intravenous device-care and management protocols noted the PICC was to be flushed after each use or every 8 hours with 5 cc's (cubic centimeters) of Heparin/Saline mixture 10 units/ml (milliliter.) The hospital policy allowed the nursing staff to mix the heparin to the ordered dilution if the premixed heparin was not available.

On 3/13/10, at 15:39 the nurse noted the red port of the PICC line was clogged and the PA (physician assistant) had instilled Cath-Flo and would return to flush it. The PA had not returned as of the end of the nursing shift and this information had been reported to the evening nurse for follow-up. At 20:14 on the same date, the nurse noted the PA was unable to flush the red port with cath flow and that the grey port was patent and the TPN was running through the port without difficulty.

The next documentation regarding the flushing of the red port was dated 3/14/10 at 13:20, the nurse's note reported that she was successful in her attempts to flush the red port and there was no resistance.

On 3/18/10, the Unit patient care co-coordinator reviewed documentation of PICC line flushing with the surveyor and acknowledged there was no other documentation regarding the flushing of the red port or a physician's order.

4. Review of Patient #7's clinical record on 3/11/10 revealed the physician had ordered on that date for the patient to be typed and crossed matched for 2 units of packed red blood cells.

Further review of the clinical record revealed the first unit of blood was started at 20:20 and was infused by 23:30 on 3/11/10. The second unit was started at 4:30 and infused by 8:30 on 3/11/10.

On 3/16/10, the Unit Patient Care Co-coordinator reviewed documentation in the electronic medical record with the surveyor. The Patient Care Co-coordinator was unable to locate a nurse's note regarding who had started the peripheral intravenous line or when it had been discontinued. Additionally, the Patient Care Co-coordinator stated the line needed to be flushed to ensure patency and a physician's order needed to be obtained for line flushes. The nursing staff was to document the flushes on the medication administration record. The Co-coordinator confirmed neither of these had been done.

5. Patient #5 was readmitted to the hospital on 2/27/10. The physician's progress note of 3/2/10 noted the patient had a history of recurrent ovarian cancer. The patient had a Porta-cath removed due to a MRSA (methicillin resistant staphylococcus aureus)infection and a new Porta-cath placed in the left upper quadrant.

The hospital's intravenous device care and management protocols noted if the Porta-cath was accessed it should be flushed after each use or every eight hours with a 5cc solution of Heparin/saline/10 units per milliliter.

Review of the electronic medical record on 3/12/10 with the Patient Care Co-coordinator revealed the nursing staff were utilizing the Port for administration of antibiotic and blood transfusions. On 3/12/10 the nurse noted "Portacath to left upper chest wall deaccessed by this RN at 1100 prior to discharge." The Co-coordinator acknowledged there was no evidence it had been flushed prior to removal of the Huber needle nor evidence of flushing after each use or every eight hours as per hospital's intravenous device procedures.

6. Patient #14 was admitted to the hospital with diagnoses of respiratory failure, spina bifida and hydrocephalus.

The 3/9/10 nurse's admission note noted the patient had a PICC line, which had two ports, in the right antecubital area which was patent. The only other assessment of the PICC line was a measurement of the arm circumference where the PICC was located.

On 3/16/10, the Unit Nurse Manager acknowledged there was no documentation of the exposed portion of the central catheter on admission. This would be necessary to ensure the catheter remained properly placed and had not migrated.

7. Patient #17 was admitted to this facility for rehabilitation with diagnoses of bilateral lower extremity fractures, leg wound with skin graft, hypothyroidism, hyperlipidemia, hypertension, diabetes and osteoarthritis. The leg leg wound included a Johnson-Pratt drainage tube and external fixator brace and knee stabilizer. This patient required an acute emergency evaluation on 2/26/10 for a fever and delirium.

The hospital evaluation discharge report and readmission information dated 3/2/10, identified this patient with a secondary superinfection of a left leg hematoma. The Johnson Pratt drain was removed due to foul smelling odor and bacterial culture results.

The patient was readmitted to the facility with a peripherally inserted central catheter (PICC) for the administration of intravenous antibiotic medication to treat the infection.

Record review on 3/16/10, revealed the resident had a PICC line which had been inserted while in the acute hospital. A copy of the patient's radiology chest x-ray dated 3/3/10 contained in the medical record confirmed positive placement of the catheter in the SVC (superior vena cava).

Per standards of nursing care practice, in addition to verifying tip placement in the SVC ,before starting the infusion, the external length of the catheter required a baseline measurement. Without the baseline length, the facility would not be able to determine if the catheter had migrated at any time following insertion.

There was no documented external catheter length upon readmission on 3/2/10 or following the scheduled dressing change. Interview with the B1 unit Nurse manager on 3/18/10, and review of the electronic medical and written record, confirmed that no measurement was documented during the nursing assessment or during dressing change. This measurement was necessary to determine any potential catheter migration.

Based on record review and staff interview, the hospital failed to have current and complete records of all scheduled drugs.

Findings include:

Based upon record review, and confirmed on 3/15/10 interview at 10 AM with the Director of Pharmacy, the hospital failed to have a Biennial Inventory of Controlled Substances as required by U.S. Department of Justice, Drug Enforcement Administration, 21 CFR, Parts 1300 to end, Massachusetts 247 CMR 1.00 to end and 105 CMR 700.006 (E) Inventory Requirements.

Based on observations, the hospital failed to secure all medications in an appropriate manner.

Findings include:

1. On 3/11/10 the surveyor observed that all emergency crash carts in all nursing units of the hospital were sealed with a non-specific purple plastic seal. The purple plastic seals did not bear specific identification information nor were the seals numbered. The non-numbered seals are available from a national distributor. The hospital failed to have a system in place that could identify specific hospital installed seals that locked/secured the medications within the emergency/crash carts.

2. On 3/12/10 at 2 P.M. the surveyor observed that the emergency/crash cart in the Radiology suite did not have a seal locking/securing the emergency, ("crash") cart. The surveyor notified that Director of Pharmacy that the cart did not have a seal.

Based on observations on four of five inpatient units at the main campus (1A, 1B, 1C and 2C), the outpatient unit and employee health, the hospital failed to remove outdated and beyond date drugs and biologicals.

Findings include:

1. On 3/11/10 at 10:45 AM in the "1A" nursing station the surveyor observed three open and not dated bottles of Lifescan SureStep Pro Glucometer Test Strips. The manufacturer states that once the bottle is opened, the strips are to be discarded 120 days after opening. The open and not-dated bottles are considered beyond use date (out of date).

2. On 3/11/10 at 11:06 AM in the "1B South" nursing station the surveyor observed two open and not dated bottles of Lifescan SureStep Pro Glucometer Test Strips. The manufacturer states that once the bottle is opened, the strips are to be discarded 120 days after opening. The open and not-dated bottles are considered beyond use date (out of date).

3. . On 3/11/10 at 11:45 AM in the "1C South" nursing station the surveyor observed one open and not dated bottle of Lifescan SureStep Pro Glucometer Test Strips. The manufacturer states that once the bottle is opened, the strips are to be discarded 120 days after opening. The open and not-dated bottle is considered beyond use date (out of date).

4. On 3/11/10 at Noon in the Respiratory Cart on "1C South" the surveyor observed an open and not dated vial of 20% Acetylcysteine Solution. The manufacturer states that open vials must be refrigerated and discarded after 96 hours. The open and not-dated vial is considered beyond use date (out of date).

5. On 3/11/10 at 1:51 PM in the "2C South" nursing unit medication refrigerator the surveyor observed a bottle of Cephalexin Oral Suspension 250mg/ 5 ml with an expiration date of 3/3/10. The bottle was beyond use date and out of date.

6. On 3/11/10 at 2:45 PM in the "OPD" medication storage room refrigerator the surveyor observed an open multi-dose vial of Humulin R Insulin with an open date of 12/30/09 and an open, not-dated, multi-dose vial of Tubersol PPD (Tuberculin Purified Protein Derivative). The Humulin R Insulin's manufacturer state that the insulin should be discarded 28 days after opening. The open multi-dose vial of Humulin R Insulin was beyond use and out of date. The manufacturer of the Tubersol PPD state that the vial is not to be used 30 days after opening. The open and not-date vial of Tubersol PPD is considered beyond use date (out of date).

7. On 3/16/10 at 2:45 PM in the Employee Health medication storage room refrigerator the surveyor observed an open, not-dated, multi-dose vial of Tubersol PPD (Tuberculin Purified Protein Derivative). The manufacturer of the Tubersol PPD state that the vial is not to be used 30 days after opening. The open and not-date vial of Tubersol PPD is considered beyond use date (out of date).

Based on a review of laboratory emergency services and confirmed through interview with the laboratory technical director at 10:30 AM on March 17, 2010, the hospital did not have emergency laboratory services available on site 24 hours a day, 7 days a week. Findings revealed the following:

- Emergency laboratory procedures (STAT testing), as defined by the hospital, are blood gases, hematocrits, potassium, and prothrombin times.
- According to the laboratory technical director, for the past ten years, hematocrits, potassium, and prothrombin times are services that are contracted and performed by a local hospital.
- Therefore, there are no provisions for on-site testing of these three analytes after regular laboratory hours (Monday - Friday 6 AM to 5:30 PM and Saturday/Sunday 7AM - 3:30 PM).

Based on observations, staff interview and record reviews, for the remote in-patient satellite located at another acute hospital, ("C"), the hospital failed to ensure food service storage, preparation and service was adequate to prevent food bourne illness. The findings are:

The main kitchen of an acute hospital (hospital "C") supplied meals and nourishment to the patients at the remote satellite Unit located within that acute hospital. During the initial tour of the "C" Hospital main kitchen, on 3/11/10, with a follow up visit on 3/15/10, the following areas were observed in the kitchen with concerns for food safety during food storage, food preparation, food service and clean up.

The tour was conducted with the dietary food manager, corporate Chef and corporate accounts manager on 3/11/10 at approximately 12:00 PM with a follow-up visit on 3/15/10 at approximately 9:00 AM.

1. The air conditioning vent covers were observed to have a built up layer of grime and dust on the exterior of the vent. The vent was located approximately 10 feet off the floor. Air would blow against the wall and it was observed that the tile wall had a build-up of dust. Directly under the vent was the hot food production area, where food preparation took place daily. The food manager acknowledged the concerns of dust and grime blowing into a food production area.

2. It was observed that a ceiling vent had peeling paint. This vent was located over the food tray line.

3. The ice cream freezer/chest had a build up of ice on the interior of the freezer. There was also a syrup type substance on the interior of the freezer. Interview with the corporate chef revealed that the ice cream freezer was scheduled to have been defrosted on 3/11/10. The chef acknowledged that the freezer had not been defrosted as scheduled.

4. The interior of the milk chest had a broken container of prune juice, which left a pool of syrup substances on the bottom of the chest.

5. The tray line refrigerator, used during tray line service, was observed to have a build up of dirt and grime in the gasket and bottom of the unit.

6. The main kitchen freezer had 6 opened boxes of frozen vegetables exposing the frozen food to the extreme cold air.

7. All the kitchen refrigerator and freezers racks were observed to have a build up of grime and dirt on all surface areas. Interview with the food management team on 3/15/10, revealed that there was no documented evidence when the shelves were lasted cleaned.

8. Observation of the dry pot and pan area revealed there were numerous (too many to count) steam table pans stacked wet before being thoroughly dried. Interview with the food management team revealed there was no system to ensure that pots and pans, that go through the dish machine, are thoroughly dried prior to being placed on the storage racks for the next use.

A master cleaning schedule was reviewed with the corporate chef. It was identified to the surveyor that the master cleaning schedule had not been used for 2 months.

Based on record review and interview with staff, the facility failed to conduct a comprehensive nutritional assessment to include daily fluid needs for proper hydration status for 1 (#15) sampled patient from a total of 36 patient records reviewed.

Review of the hospital policy for nutrition screening and nutrition assessment revealed that the purpose was to screen patients for nutritional risk upon admission and provide appropriate and timely nutrition care based on the Levels of Nutrition Risk, and reassessed based on the hospital's Standards of Practice for Nutritional Assessment which included but not limited to the patient's physical, psychosocial, nutrition, hydration, functional, and cultural variables and conditions.

Nutritional risk criteria was divided into three levels that all specify an initial assessment be initiated within 2 business days of admission. The patient's condition and criteria stated in the levels of Nutrition Risk and Nutrition Care determine frequency of follow-up note and or reassessment.

Level III High Risk / Comprehensive Nutritional Assessment and Follow-up in 7 to 10 days.

Level II Moderate Malnutrition / Limited Nutritional Assessment and Follow-up within 7 to 16 days.

Level II Mild Malnutrition / limited Assessment and Follow-up 14 to 18 days.

Level I Minimal Risk or No Malnutrition Follow-up 14 to 21 days / Brief Nutritional Screen and No Assessment.

Per hospital policy, components of a Comprehensive Nutritional Assessment includes: patient age, sex, diet order, height, weight, Ideal Body Weight, (% of IBW and adjustments if indicated), pertinent laboratory values, estimated energy and protein needs, food intake and or tolerance to tube feedings, need for nutritional education, nutrition recommendations and nutrition care plan.

The clinical record of Patient #15, admitted 1/27/10 with diagnoses of anoxic brain damage due to severe diabetic ketoacidosis, respiratory failure, tracheostomy, history of pancreatitis, renal insufficiency with a gastrostomy feeding tube and nutrition formula at 55 cubic centimeters (cc) per hour, was reviewed.

The initial nutritional assessment, dated 1/29/10, identified patient #15 with several nutritional criteria as a Level III: High Risk and required a comprehensive nutritional assessment. This patient was identified with a stage II pressure ulcer (left Buttock) upon admission and received all nutrition via gastrostomy feeding tube with NPO (nothing by mouth). Assessment data included the patient's estimated need for 2089 calories and 91 grams of protein (1.2 gram per kilogram ideal body weight) with vitamin/minerals provided from nutrition feeding formula. The present formula provided 2160 calories and 86 gram of protein at the current rate (55 cc) and total volume of feeding. The patient's risk factor included a low serum albumin level reported at 1.6 (normal range 3.5 -5.0). The patient's condition required close monitoring due to abnormal laboratory test results and pending renal consultation. The nutritional recommendations included additional Vitamin C for wound healing, (500 mg. twice a day), to obtain a Zinc level; and to monitor weights, laboratory results, skin condition and renal function. Continue current formula (Nutren 2.0) and reduce the hourly administration rate to 45 cc. The nutritional assessment was not comprehensive as it did not address fluid hydration needs. On 1/29/10 the rate of formula was decreased to 45 cc per hour.

Review of the electronic medical record for intake and output data reported the patient's total daily fluid intake for 1/31 to 2/5/10 as 1569 ml intake / 2100 ml output;1401/1691;2190/1500; 2795/850; 6025/2600; 3482/1100. There was no evidence of an assessment for this patient's estimated fluid needs (i.e. 20-35 cc / kg body weight) included in the comprehensive nutritional assessment.

Renal consultation on 2/1 and 2/3/10 advised further monitoring. Concerns included possible hypernatremia, infection and negative fluid balance based on documented intake and output. Plan to reassess free water needs, decrease sodium and increase intravenous fluid and free gastrostomy feeding water flushes pending further laboratory results.

The patient's medical status remained compromised due to abnormal laboratory test results including an elevated sodium (Na) 159 (normal 136 -145) and BUN /creatinine level 112/4.49 (normal 8-26; 0.44- 1.00). Intravenous fluids in addition to formula feedings were prescribed. On 2/2/10 the Na level remained elevated at 155. On 2/8/10 the nutritional tube feeding was changed per physician order to a formula designed for compromised renal patients. In addition, a medical progress note dated 2/9/10 indicated the patient's PICC line was discontinued due to infection (Staph epidermis in blood cultures) and the patient continued on antibiotic medication via peripheral IV. The patient was treated for anemia (two blood transfusions) and altered renal status.

According to the facility's Level III nutritional risk criteria, a nutritional re-evaluation was to be completed within 7 to 10 days of the initial assessment of 1/29/10. The next nutritional note was dated 2/18/10, twenty days later and not according to standards of practice for nutrition care reassessment within 7 to 10 days. The nutritional progress note dated 2/18/10 reported the patient continued on the renal formula at 45 cc per hour with fluctuating weights (180 to 204 pound range), questioned fluid balance, and the amount of actual infused formula. There was no mention of fluid or free water needs. The patient's laboratory data reflected renal insufficiency (elevated BUN/ creatinine and hyperkalemia). Interview with facility Dietitian #1 confirmed that hydration needs were not addressed in the patient's comprehensive nutritional assessment and should have been included.

Based on observations, staff interview and record reviews, for the remote in-patient satellite located at another acute hospital, ("C"), the hospital failed to maintain dietary equipment and supplies to ensure acceptable levels of safety and quality.

Findings include the following:

One of the remote inpatient units operated by the hospital was located within an another acute hospital ("C"); and the "C" hospital kitchen provided food services to the remote satellite unit.

The tour of the Main "C" kitchen was conducted with the dietary food manager, corporate Chef and corporate accounts manager on 3/11/10 at approximately 12:00 PM with a follow-up visit on 3/15/10 at 9:00 AM.

Interview with the dietary management team on 3/15/10 at approximately 9:00 AM, revealed that there was no formalized system in place to ensure that broken equipment was repaired as quickly as possible. The team also indicated that there was no "Maintenance Prevention Program" in place at the time of the interview. The current system was if there was a need for the maintenance department, a dietary staff member would send a message to the maintenance department via e-mail, however there was no documentation in place to identify or track when the requests for repair were completed.

1. Throughout the main kitchen, the ceilings were noted to be dirty with grease and grime. All the supporting cross braces were dirty and rusty. Interview with the dietary management team on 3/15/10 indicated that maintenance staff had washed the kitchen's ceiling tiles about 1 year ago, but there was no plan in place to fix or replace the supporting cross braces.

2. All the ceiling vents were dirty and one ceiling vent had peeling paint. This vent was positioned over the tray line where meal service was conducted.

3. In the large grocery storage room there was a HVAC duct that was horizontal along the ceiling from the left side of the room to the right. The insulation that was wrapped on the outside of the duct was held together by adhesive tape; however the tape was hanging off the duct. The floor had debris and had not been swept since Friday 3/11/10. The racks were observed to be dirty with a build up of dirt and grime.

4. The exterior of the walk-in refrigerator "A" was observed to have a black substance on the lower right side of the refrigerator door, which was sticky to the touch. To the right of the refrigerator door was a floor drain that had missing tiles around it.

5. The exterior plastic guard on the corner of walk-in refrigerator "B" was broken.

6. The entrance to the Mop/chemical room had broken tiles.

7. In the uniform room, there was a hole in the ceiling approximately 2 inches in diameter. There was water dripping through the hole into a bucket on the floor. Dietary management team was unable to identify were the water was coming from.

8. The exterior of the large mixer was observed to have missing paint and rusty areas on the mixer base.

9. Freezer "B" had a build up of ice on the interior of the door and the gasket was dirty and broken on the bottom of the door.

The Hospital failed to maintain their kitchen equipment and storage areas to ensure an acceptable level of safety and quality.

Based on observation, record review and interview, the Hospital failed to ensure that there was an infection control program that monitored, investigated and implemented a hospital wide surveillance system inclusive of all services and departments.

Findings include the following:

1. There were pervasive violations of infection control practices observed throughout the survey. The hospital failed to implement policies and procedures related to maintaining a clean environment, maintaining the medication delivery system in a clean and sanitary manner, controlling the spread of infection through the appropriate handling of soiled linens, disposing of body fluids, transporting of body fluids to the laboratory, monitoring the use of antibiotics, monitoring the procedures staff were following for patients on precautions.

The survey team, throughout the survey, observed hospital staff from nursing, respiratory, laboratory and housekeeping who did not follow basic infection control policies.

These observations include:

-During the initial facility tour on 3/11/10 at approximately 9:30 AM, 7 bags of soiled linen were observed piled up on the floor between units 2 CN and 2 CS. During the unit tour, RN #7 was interviewed and stated "no other place to put it!," referring to the bags of soiled linen on the floor.

-During the initial tour of the facility, on 3/11/10 at 9:30 AM, on the 2A unit it was observed many pieces of patient care equipment were dirty and unsanitary including: the code cart, the 3 "COW" (computer on wheels including the key board), pill crusher and suction machine. The tour was conducted with the unit manager on 2 A who observed the dirty patient care equipment and acknowledged the unsanitary equipment.

-- Survey staff observed the 3/11/10 noon meal distribution at satellite #1 in-patient unit. (The hospital had a remote, in-patient satellite located within another acute hospital) It was noted that nursing staff placed used (dirty) patient meal trays from breakfast onto the noon meal food cart prior to serving all of the (clean) lunch meals.

-The Personal Service Attendant (PSA) on satellite #1's patient unit attempted to deliver a patient's meal tray to a room on 3/11/10 that was identified as a precaution room. The PSA was instructed by the nurse that he could not serve the tray at that time; and, the nurse was unable to handle the meal tray as she was providing care. The nurse was in the patient's room with the privacy curtain drawn, wearing a precaution gown and gloves. The PSA left the meal tray on top of the soiled linen cart just outside this patient's room. When the nurse completed the care and attempted to remove the soiled linen from this patient's room, the meal tray was still on top of the soiled linen cart. The Nurse instructed the PSA to pick up the meal tray and she opened the linen container and disposed the precaution linen. The nurse returned to the room and again came to the doorway, wearing the precaution gown and gloves. She collected the meal tray from the PSA with gloved hands. When interviewed this nurse reported that she had removed one pair of gloves after providing care and disposing of the linen. She indicated that she still had one "clean" pair on. She stated that she often wears two pairs of gloves when providing patient care. There was no evidence of handwashing after the completion of one task prior to starting another. These observations were discussed with the program manager and food service director of the facility on 3/11/10, who confirmed that staff failed to follow infection control standards of practice.

-On 3/12/10 at 11:00 AM on unit A, it was observed that one medication cart had red splatters (? blood) around the base of the cart.

-On 3/12/10 at approximately 11:15 AM in room 123, a sign was observed on the exterior of the door identifying that one or both of the patients who resided in the room were on contact precautions due to an infection. The sign did not specify which patient was on Contact Precautions. It was observed that a CAN (Certified Nursing Assistant) was providing care to one of the patients. The CNA was wearing a yellow precaution gown; however, while leaning over the patient, the precaution gown was falling off.

-On 3/12/10 at 11:00 AM on unit 1B, 3 medication carts were observed in the hallway. All three were dirty, dusty and stained with an unknown substance. At the same time a nurse was observed dragging a bag of dirty linen down the hallway, along the floor.

-- On 3/12/10 during meal observation on the A wing Nursing (at the Main Hospital) unit at 11:45 AM staff were observed placing "dirty" patient meal trays in the food cart with meal trays that had not been served.

-On 3/12/10 at 3:30 PM, it was observed that the respiratory therapist had donned a precaution yellow gown and gloves and entered room 165 with the respiratory cart. The patient had been identified as having MRSA and C-difficile infection with contact precautions. The respiratory therapist was observed touching something near the floor then returned to her cart and began touching the cart with the contaminated gloved hand. Interview with the respiratory therapist revealed that she wheeled the respiratory cart into multiple patient's rooms to give treatments. She indicated that after each use she wipes down the scanner and cart; however, that was not observed by the surveyor.

-On 3/12/10 at approximately 3:30 PM, an employee was observed walking in the service corridor holding a bag of trash and a red precaution bag with a plastic urinal and its contents. The housekeeping staff proceeded to throw the trash into the trash receptacle and then went into the lower level restroom. Upon exiting the restroom, the employee expressed that he needed to dispose of the red bag in the hazardous waste disposal. Further interview with the employee reported that he collected the trash and hazardous red bag from the HBO (Hyperbaric) room as the staff/ patients cannot leave the room. The employee had disposed of the contents of the urinal in the common restroom. The practice was not according to infection control practices and increased potential risk to the employee and spread of infections.

-On 3/12/10 at approximately 12:12 PM, nursing staff was observed exiting a patient room carrying a red precaution bag with liquid waste. The nurse carried the red bagged waste to the soiled linen room for disposal. The nurse exited the soiled utility room without the red bag and had removed disposable gloves. The nurse proceed to leave the soiled utility room without washing her hands. The sink unit was observed and had not been used. This nurse proceeded away from a service corridor area out into a common sitting and patient nourishment area to then wash her hands in the sink. This practice increases the potential for cross contamination and spread of infection.

These observations were discussed with the Infection Control Nurse who agreed that improper infection control practices had occurred.

-On 3/16/10 at 11:30 AM, in room 160A, it was observed that the patient had a sign on the outside of the room that indicated this patient was on Contact Precautions due to an infection. The surveyor looked into the room and noted two visitors, sitting in chairs, visiting the patient. The visitors were not wearing the proper protective equipment while visiting with the patient.

-On 3/16/10 at approximately 11:35 AM, a sign was observed on the outside of room 150 that indicated that the patient was on Contact Precautions due to an infection. Inside the patient's room, the patient was wearing a yellow protective gown, while two visitors stood next to the patient. The two visitors were observed not wearing the proper protective equipment as directed on the precaution sign.

-On 3/16/10 at approximately 11:40 AM, it was observed that two staff nurses, wearing plastic aprons and plastic gloves were performing care to patient #13, who was identified as requiring Contact Precautions due to an infection. Interview with the staff nurse indicated that they could use either the yellow gown or the white plastic aprons.

-On 3/16/10 at approximately 11:45 AM, it was observed that a staff nurse was in room 1C, 154. The staff nurse was wearing a plastic apron and gloves. The patient was identified as requiring Contact Precautions for an infection. It was also observed that there were 2 visitors sitting at the foot of the bed without protective equipment.

-On 3/18/10 at 11:50 AM, it was observed on unit 1C, room 152 there was a sign indicating that the patient in the room was on Contact Precautions for an infection. It was further observed that 2 visitors were leaning over the patient's bed and one visitor was cutting the patients nail's. Neither of the visitors were wearing protective equipment including gowns or gloves. Staff were observed walking back and forth in the hall; and no one corrected or interrupted the visitors while providing direct care to the patient.

- At the main hospital campus, throughout the survey visit, laundry personnel were observed collecting laundry from the patient unit during meal service. Open bags of soiled linen were observed stored on floor, often seen dragged along the floor surface, to then be disposed of into the large mobile linen container for transport to the basement soiled room for storage.

-Dirty soiled linen bags were observed on the floor of the 2 A unit at 12:08 on 3/18/10.

-Housekeeping staff were observed dry mopping a precaution patient room at approximately 11:45 on 3/12/10 during the noon meal distribution. As the housekeeping staff completed mopping the pile of debris and dirt, the pile was swept into the hall outside the patient room and then collected for disposal.

-The utility cart with open buckets of water and mops were in the corridor with the food carts and medication carts as nursing staff completed their tasks.

- Throughout the survey it was observed that the nursing staff administering medications wheeled the portable medication carts in and out of all patient rooms, including the rooms of patients on precautions. It was explained by the VP of Nursing that the nurses had to scan the identification bracelet on each patient prior to administering medications. The scanning devices were fixed to the computer system on the medication cart. It was observed that the nurses stayed in the room with the cart to prepare and administer the medications. The policy called for the nurses to clean the medication carts after leaving the rooms. As noted above, the medication carts in the facility were noted to be visibly dirty. It was unclear how the medication carts would be visibly soiled when the nursing staff was directed to clean them after leaving the bedside of each patient on precautions.

- Observation on 3/11/10 around 2:10 PM. at the remote in patient unit, at Tufts a laboratory technician (contracted from Tufts) leaving a patient's room (who was on precautions for VRE) with her phlebotomy equipment and placed her equipment on the top of a soiled linen hamper. She removed removed her old gloves and gown, discarded them and went down the hall to get a clean gown and pair of gloves. After putting on a new pair of gloves and gown, proceeded to take the phlebotomy equipment into another patient's room who was on precautions. She placed the equipment on this patient's overbed table and proceeded to draw this patient's blood. She placed the phlebotomy equipment on the counter on the nurses station and removed her gloves and gown. No hand washing was observed through-out this observation.

Interview with the laboratory technician at that time stated she had no place to put down the phlebotomy equipment prior to putting on a gown and gloves nor while she draws patient's blood. She continued to state that "it's important for her to protect herself" but said nothing about cross containing patients or others.

Interview with the nurse unit manager on 3/11/10 around 2:00 p.m. revealed that maintaining proper infection procedures is difficult with the set-up on this unit. There are no places in the hallway for staff to place equipment which should not go into a patient's room who's on precautions, such as the phlebotomy kits. She stated that she will put over the bed tables in hallways for staff to use. She further stated that she would talk to the laboratory supervisor regarding this incident.

- Additional observation on 3/15/10 around 3:50 p.m. at the remote in-patient unit located at Tufts, revealed a nursing assistant placing a blood glucose monitoring kit on top of a soiled linen cart. She put on a pair of gloves, picked up the glucose monitoring kit, and the kit on the bedside table of a patient who was on precautions.

Interview with the unit manager on 3/15/10 around 5:00 p.m. revealed that over the bed tables were put in the corridors for staff to place their equipment on as they put of protective equipment before entering a patient's room who's on precautions. She will educate this nursing assistant.

- Observation of the wound care coordinator during a skin assessment of patient #19 on 3/17/10 around 11:15 a.m. revealed the following breeches of infection control techniques:

Upon entering this patient's room, the wound care coordinator put on a plastic apron which did not cover her upper extremities. She was wearing a lab coat. Patient #19 was on precautions for MRSA and C-difficile and required a full gown when providing patient contact.

No handwashing was observed as she donned on a pair of gloves.

She proceeded to do a skin assessment and started at the patient's feet. She lifted the patient's feet and inspected the feet for open areas. Bilateral thighs showed erythremia secondary to skin grafts.

She proceeded up to the abdominal area which was covered with an abdominal binder. She removed the abdominal binder and the dressings which were applied to this area. (patient #19 was status post diaphragmatic hernia repair complicated by dehiscence with evisceration) She started touching this area and picking at the scab sites. She placed the "dirty" dressings on the patient's bed and left the area. She returned with a plastic bag and placed the dirty dressings into the bag.

She changed her gloves and washed the surgical site with a wound cleanser squirted on a 4 by 4. She swiped the bottom abdominal fold area which had a scabbed area with a 4 by 4 and then with the same 4 by 4 she wiped the top of the abdomen surgical wound. (Thus, cross-contaminating the wound) As she was cleaning the wound, her upper arms covered by her lab coat which touched the bedding then touched the wound area.

She applied xeroform dressings over the entire abdomen wound and covered it with a dry protective dressing. She fastened the binder in place and proceeded to continue with the skin assessment.

Interview with the wound nurse co-coordinator at the end of the entire skin assessment process acknowledged she did not wear the appropriate gown to prevent the spread on infection because she get's "too hot" wearing the appropriate coverage.

-Observation on 3/17/10 around 3:00 p.m. on 1 South A unit revealed an opened medication cart in the corridor with medications accessible to the public. Thre were no staff members in sight.

On top of the medication cart were 2 specimen containers. One container had a stool sample in it and the other had a urine sample. There were several opened, emptied unit dose medication wrappers spread out on top of the cart and on top of these wrappers were plastic spoons. The pill crusher was dirty with caked on "old crushed medications".

Approximately 2 minutes later a staff nurse came down the hall and explained to the surveyor that LPN #1 was responsible for this medication cart. She closed the medication cart at that time.

Approximately 5 minutes after the surveyor observed this unattended medication cart, LPN #1 came down the hall with biohazard plastic bags. He placed the stool sample into one bag and then he placed the urine sample into the other bag. He left the area again and returned with a cooler in which he placed the specimens into the cooler. He then placed the cooler on to the floor and proceeded to pick up the spoons and placed them into the spoon holder on the medication cart. He discarded the opened medication wrappers. He washed his hands, put on gloves and proceeded to clean the top of the medication cart. The LPN #1 stated, "I know, I should not have placed the specimens onto the cart, it was wrong".

Surveyor intervened at that point to discuss the replacing the dirty spoons back into the spoon holder for re-use. At that point, LPN #1 discarded the spoons.

-On 3/12/2010, at 10:30 AM, on the New England Sinai at Caritas Carney unit, several commodes were observed stored in a corner of a multipurpose common room , on top of extra pillows and a low bed. The nurse manager confirmed at this time that these pillows were to be used for positioning patients who required additional support while in bed or chair.

- On 3/16/2010, at 11:50 AM, on the outpatient rehabilitation unit, New England Sinai at The Striar Jewish Community Center YMCA unit, seven bags of soiled linen were observed stored in a area adjacent to a patient treatment area. The outpatient director of services was unaware of what the linen pick up schedule was or how long the soiled linen was stored on the floor on the room.

- The hydrocolator had excessive rust on its interior as well as unknown floating material on its surface. The temperature log for both the hydrocolator and the cold pack had entries for only two days during the month of March, 2010, three days for the month of February, 2010. The clinic operates three days weekly.


2. Interview with the Hospital infection control nurse on 3/16/10 at 9 am revealed that there was no infection control data maintained on a day to day basis. The infection control nurse was not able to provide current information regarding the status of all infections in the hospital. She explained that she tracks the laboratory data related to culture reports. She is able to enter that data into a computer program for analysis.

The survey team asked the infection control nurse about her involvement in monitoring infections where there were no cultures obtained. She indicated that there was no way for her to monitor these infections. Survey staff asked the infection control nurse how she would identify an issue with infections where there were no culture results obtained. She acknowledged that there was currently no system in place to identify, on a daily basis the treatment of potential and actual infections in the hospital.

The infection control nurse does not receive any information regarding the use of antibiotics in the hospital. She does not receive or maintain a list of the antibiotic medications used. She indicated that she recognized that this was an area that needed to be reviewed but that she had not initiated any review. The infection control nurse indicated that she was unable to access the medication information from the pharmacy on her computer. Later in the survey the infection control nurse reported that she had been allowed access to the pharmacy medication information.


3. Survey staff discussed with the infection control nurse the use of the congregate large multi-tiered storage units located at the end of each of the wings of the nursing units. These carts were used for the storage of the personal protective equipment used by staff used to care for patients who have infections requiring precautions. These supplies are critical for the care of the patients on precautions as the staff is required to wear personal protective equipment when entering their rooms to provide care. At the time of the survey 95 of the 187 patients in the hospital were on precautions. (These numbers did not include the satellite unit at Carney Hospital as they use individual precaution carts outside of each room where the patient requires precautions.) The storage of the gowns and masks at the end of the hallways meant that the staff when responding to a patient on precautions had to collect the appropriate equipment from the cart at the end of the hall and put it on prior to providing care. This was the case when routine care was being provided and also when the patient had called for assistance or when the ventilator alarms triggered.

It was also noted that the staff used these carts for the storage of miscellaneous patient care supplies. On 3/16/10 at 10:30 am it was noted that the large precaution supply cart located on the 1 A wing had a pink (wash basin) container of patient care supplies (shampoo, lotions, deodorant) stored on the bottom shelf.

4. Patient #16 was admitted to the facility on 3/4/10, with diagnoses that included respiratory failure, status post left lung mass, status post thoracotomy and bilateral iliac aneurysm. The patient was fed exclusively via feeding tube.
On 3/15/10, the medical staff ordered the antibiotic, Vancomycin 1 gram every 12 hours for 7 days and Zosyn 3.375 gm every 8 hours for 7 days via peripheral intravenous line. Review of the medical record revealed that on 3/16/10, the antibiotics were discontinued.

On 3/18/10, the Vancomycin was again ordered and was to be started immediately. At 12:00 noon, the nurse administered the antibiotic via the peripheral intravenous line. On 3/18/10 the 7-3 staff nurse was interviewed. She was not able to identify to the surveyor why the patient was receiving the Vancomycin. At 4 PM on 3/18/10 the physician's assistant was interviewed as to why the patient was receiving the Vancomycin. The physician's assistant did not order the antibiotic, however, she did indicate that the physician was concerned about aspiration pneumonia and that the patient was running a low grade temperature.

The nursing staff caring for the patient and administering the intravenous antibiotic were unaware of why this patient required this medication.

5. Patient #2 was admitted to this Hospital on 3/3/10 after being transferred from an acute care hospital. The patient had medical diagnoses which included respiratory failure requiring intubation. At the time of admission the patient had a tracheostomy in place.

After the review of the patient's medical record survey staff proceeded to the patient's room. It was noted that there were two red precaution signs posted outside of the room. The surveyor asked a member of the nursing staff what precautions needed to be taken prior to entering the patient's room. Patient #2 occupied the bed near the door and the roommate occupied the bed near the window. The nursing staff member informed the surveyor that both of the patients would be on precautions for the same organism and that those entering the room would follow the directions on the precaution signs.

After reviewing the patient's medical record on 3/18/10 it was unclear why the patient required precautions as there were no reports in the record that indicated they were necessary. The physician assistant was asked it there was information regarding the patient's infections status that was not available in the medical record. He reviewed the record and confirmed that the patient had been cultured and all the reports were negative. He indicated that precautions are initiated with input for the infection control nurse.

Interview with the infection control nurse on 3/18/10 at 4:10 PM. revealed the following:

The patient was admitted to room 242A on 3/3/10. The patient in 242B was cultured for VRE (Vancomycin Resistant Enterococci) on 3/2/10 as the staff had determined that his previous roommate had a positive culture for VRE. The infection control nurse indicated that patient #2 should not have been admitted to room 242A when the other patient in the room was being actively ruled out for VRE and the patient being admitted had no history of or current infections including drug resistant infections.

On 3/9/10 the patient in 242B had a positive culture for VRE and patient #2 in room 242A had a negative culture for VRE. The infection control nurse indicated that the admission department had been contacted and told to move patient #2 out of room 242. This room change did not occur and at the time of record review patient #2 remained in room 242.

The infection control nurse indicated on 3/18/10 that the physician assistant had ordered another VRE culture for patient #2 as he had been in the room with the roommate with the known positive culture since admission.

The infection control nurse acknowledged that the patient should not have been admitted to room 242 but was unable to explain how this happened. This patient who had completed an acute care hospitalization without acquiring an infection was placed in a room with a patient being ruled out for a drug resistant infection which was eventually confirmed. When the staff had a second chance to move this patient from this environment it did not happen.

Based on review of 32 of 32 current clinical records, 4 of 4 closed clinical records, and staff interviews, the Hospital failed to provide evidence of discharge planning evaluations, appropriate interventions and on-going reviews. The findings are:

Thirty-six of 36 current clinical records reviewed contained no evidence of discharge planning assessments and/or interventions.

Interviews with the Director of Case Management, the Vice President of Quality to whom Case Management reported; and the Supervisor of Social Service, on 3/16/10 at 1100, all confirmed that case managers discharge planning documentation was maintained in the "Midas" electronic software program and not included in the permanent, legal medical record (either written or electronic). The VP of Quality and the Director of Health Information Management (Medical Records Librarian) had access to the Midas program; however, no other staff could access the program. Subsequently, the Director of Health Information Management (Medical Records Librarian) was interviewed on 3/16/10 at 1330 and confirmed the information in the Midas Program had not been routinely printed and included in the permanent record. Information regarding the status of patient's discharge planning evaluations and service needs was not available to other staff involved in the patient's care, including the physician.

Based on one closed record reviewed, (#21), from a total of 4 closed records reviewed, the Hospital failed to ensure that safe and appropriate plans for after hospital care were arranged and implemented. The findings are:

Patient #21 was a patient who was admitted with diagnoses which included diabetes, peripheral vascular disease, a history of a stroke in July 2009 with right hemiparesis and aphasia. The patient had been cared for in an acute hospital at the time of the stroke, and moved to the long term care hospital immediately following. The patient remained in the LTC hospital until March 4, 2010 when he was discharged to home with services from the visiting nurse.

Review of the records from the visiting nurse/case manager revealed documentation, dated 3/4/10 at 4:05 PM, noting that patient #21 had been discharged to home that day after a lengthy hospitalization. The visiting nurse/case manager documented "several issues surrounding discharge process" as follows:

1. Family was unable to fill patient #21's prescriptions as Medicaid had not been notified he was no longer in the hospital.
2. There were no supplies for the wound dressing provided by the hospital; nor had they arranged for a vendor to provide the necessary supplies.
3. The written referral sent from the hospital mis-identified the patient's wounds.
4. The elderly wife was identified as the caregiver; however, informed the visiting nurse she had not been instructed regarding blood sugar testing nor administration of insulin.

The visiting nurse again visited the patient's home the following morning and found he had an elevated temperature and a foul odor was emanating from the covered wound. The patient was sent to the local hospital emergency room and admitted to the acute hospital with sepsis secondary to severe decubitus ulcer. The patient subsequently expired on 3/15/10.

The hospital failed to ensure appropriate post hospital plans were developed and implemented.

Based on one closed record reviewed, (#21), from a total of 4 closed records reviewed, the Hospital failed to adequately arrange for the initial implementation of the patient's discharge plan. The findings are:

Review of the records from the visiting nurse/case manager revealed documentation, dated 3/4/10 at 4:05 PM, noting that patient #21 had been discharged to home that day after a lengthy hospitalization. The visiting nurse/case manager documented "several issues surrounding discharge process" as follows:

1. Family was unable to fill patient #21's prescriptions as Medicaid had not been notified the patient was no longer in the hospital.
2. There were no supplies for the wound dressing provided by the hospital; nor had they arranged for a vendor to provide the necessary supplies.

The hospital discharge planner failed to arrange for the necessary supplies and medications to ensure adequate post hospital care.

Based on staff interviews and record review, the Hospital failed to maintain an accurate, current inventory of patients who had wounds and/or pressure sores to ensure that appropriate quality of care was provided. The findings are:

The Vice President of Nursing and Quality, and Wound Care Coordinator #1, were interviewed on 3/16/10. The most recent listing of hospital patients who had wounds/pressure sores, that administrative staff could provide at that time, was a list of patients for whom the Wound Care nurses had been consulted as of 2/2/2010; six weeks earlier. There was no more current list available as of 3/16/10.

According to the Vice President of Quality, staff also conducted a hospital wide "prevalence round," but only once every six months. The next prevalence report was due the month of March 2010. The Hospital could provide no evidence of a process to capture the existence of wounds and/or pressure sores for whom the wound nurse had not been consulted; other than these six month rounds. Additionally, review of the Hospital's quality assurance nursing tracers for the period of January through November 2009, indicated that wound consults were generated for the wound nurse only 50% of the time with the development of new pressure ulcers. Despite the hospital's own quality assurance data indicating that reliance upon a listing of patients consulted by Wound Care nurses would not be inclusive of all pressure sores, the Hospital failed to revise the process to gather more inclusive data. During interview with the Vice President of Quality on 3/18/10, she indicated the hospital had no recent quality assessment projects on wound care as the prevalence audits had indicated that the rates had dropped.

A revised wound census report was provided to surveyors on 3/18/2010 following the completion of the six month prevalence rounds. This report was also not accurate as it failed to identify patients #22 and #25, although both had pressure ulcers per surveyor observations and/or record reviews.

The hospital failed to analyze medication errors.

Findings include:

Based on review of records on 3/12/10 at 12:25 PM interview with the Director of Quality Assurance, the hospital failed to ensure that the Pharmacy and Therapeutic Committee met at least once in each quarter of the year and that the membership at each meeting consisted of, at minimum, a representative from medicine, nursing, pharmacy and administration. The hospital had 11 Pharmacy and Therapeutic Committee meetings from January 31, 2007 until December 22, 2009 (11 meetings in 3 years). During 2008, the hospital's Pharmacy and Therapeutic Committee met only in the 2nd and 4th quarter (5/11/08, 11/12/08, and 12/10/08). At the Pharmacy and Therapeutic Committee meetings in 2008 and 2009, the hospital administration was represented at two of the eight meetings (5/21/08 and 12/22/09). Medication errors are reported through the Pharmacy and Therapeutic Committee. The lack of official meetings of the Pharmacy and Therapeutic Committee effected the hospital's ability to analyze quality related events.

Based on observation, record review and staff interview, the facility failed to prepare and administer medications for 3 patients, (T3, T4, and #13) in accordance with accepted standards of practice, out of a sample 32. Findings include:

1. For Patient T4, RN#4 failed to administer a medication via nasogastric tube (NGT) per facility's policy.

Patient T4 had a current physician's order to give Lopressor 50 milligrams (mg) every 8 hours via NGT, hold for a systolic blood pressure less than 90 and heart rate less than 50.

RN #4 was observed on 3/15/10 at 2:30 PM administering Lopressor 50 mg. Prior to administering this medication, RN #4 crushed and mixed the Lopressor with tap water. RN #4 drew-up the mixed Lopressor into a 60 milliliter (ml) syringe, leaving the plunger in the syringe. RN #4 after uncapping the NGT, attached the syringe to the NGT and pushed the medication down the tube. After administering the medication, RN #4 detached the syringe from the NGT and drew up approximately 30 ml of tap water into the syringe. RN #4 reconnected the syringe to the NGT and pushed the tap water down the tube. After disconnecting the syringe, RN #4 recapped the NGT and placed the syringe at the patient's bedside.

Review of the facility's policy and procedure for Nasogastric tube instillation reveals that prior to administering medication via NGT, the tube should be checked for patency and placement. Medications and flushes should not be given as a push, give by gravity.

Interview after the administration observation with RN #4 confirmed proper procedure was not followed.

2. For Patient T3, the facility failed to administer Colace as ordered.

Patient T3 had a current physician's order to give Colace 100 milligrams everyday via gastrotomy tube (G-tube) dated 3/4/10.

Review of the clinical record from 3/4/10 - 3/11/10 revealed this patient received this medication only 2 times, on 3/5 and 3/6/10.

Interview with nurse manager #1 confirmed patient #3 did not receive the Colace on 3/7, 3/8, 3/9, 3/10 and 3/11 as ordered. Nurse manager #1 further stated the staff were holding the medication because this patient was having loose stools but the physician should have been notified after holding the medication 3 times. This did not occur.

4. For Patient #13 the hospital nursing staff failed to administer medications through the gastrostomy tube per hospital policy.

Patient #13 was admitted to the hospital on 4/30/09 with multiple medical diagnoses which included acute respiratory failure and Parkinson disease. At the time of record review on 3/18/10, the patient continued to require mechanical ventilation. The patient received all nutrition, fluids and medications through a gastrostomy tube.

On 3/17/10 at 8:50 AM the nurse assigned to this patient was observed by survey staff while his medications were prepared and administered via his gastrotomy tube.

The nurse was observed as she poured the patient's medications into separate containers (5 different medications) and then mixed 4 of them into one cup for administration. The nurse then picked up the Asepto syringe from the patient's over-bed table and drew up the medications into the syringe. The nurse then started to administer them through the patient's gastrostomy tube . She abruptly stopped herself before attaching the syringe to the gastrostomy tube. She indicated that the patient frequently has a high residual and that she needed to check what it was. The nurse then emptied the mixture of medications from the syringe back into the cup. She then attached the empty syringe to the gastrostomy tube, aspirated it, and determined that she was able to administer the medications. The nurse pushed the gastric contents of the syringe back into the patient, drew up the medications that had been put back into the cup, attached the syringe to the gastrostomy tube and pushed them with pressure on the plunger of the syringe into the patient's stomach. The nurse then removed the syringe, drew up approximately 45 cc's of water, re-attached it to the gastrostomy tube and pushed the water through the tube into the patient's stomach.

At the conclusion of this procedure the nurse realized that she had not included the poured dose of Digoxin with the other medications she had mixed together. The nurse added some water to the Digoxin, drew it up into the Asepto syringe and pushed it into the gastrostomy tube. The nurse did not flush the gastrostomy after administering the Digoxin.

This observation was discussed with the VP of Nursing on 3/18/10. The policy of the hospital indicated that each medication should be administered separately and not as one mixture. The VP of Nursing confirmed that the policy that we were reviewing was the current hospital policy

Based on one closed record reviewed, (#21), from a total of 4 closed records reviewed, the Hospital failed to ensure that safe and appropriate plans for after hospital care were arranged and implemented. The findings are:

Patient #21 had diabetes, a history of a stroke in July 2009 with right hemiparesis and aphasia; and peripheral vascular disease. The patient had been cared for in an acute care hospital at the time of the stroke, and moved to the long term care hospital on 8/21/09. The patient remained in the long term care hospital until 10/4/09, at which time he was transferred to an acute care hospital secondary to hypotension and hypovolemia. The patient returned to the long term care hospital on 1/7/10, and remained there until 3/4/10, at which time the patient was discharged home with services from the visiting nurse.

Review of the records from the visiting nurse/case manager revealed documentation, dated 3/4/10 at 4:05 PM, noting that patient #21 had been discharged to home that day after a lengthy hospitalization. The visiting nurse/case manager documented "several issues surrounding discharge process" as follows:

The elderly spouse was identified as the caregiver; however, informed the visiting nurse he/she had not been instructed regarding blood sugar testing nor administration of insulin.

The hospital discharge planner failed to ensure the primary caretaker had been instructed regarding the patient's care needs.

Based on staff interviews, the Hospital failed to ensure that patients' families were informed of their freedom to choose among providers of post-hospital care. The findings are:

On 3/11/10, the RN Manager of the satellite unit at hospital C reported that six of the twenty patients on the unit were awaiting placement at skilled nursing facilities. On 3/15/10 the case manager for that satellite unit, (LPN #2), was interviewed. The case manager was asked to explain the process for locating post hospital care. The case manager stated: "We don't have to have (the patient's/family's) input. They (QIO) told us that. As long as I find a bed within 25 miles; they have to take it. Technically, we don't need their input, and they know that." When the surveyor expressed surprise at the lack of choice, the case manager added: "well, if they said someone in their family died in a nursing home then I would try to avoid it."

On 3/16/10 the Supervisors of Case Management and Social Work, as well as the Vice President of Quality to whom they reported, were interviewed. The management staff stated that the statements of the LPN case manager at the remote satellite did not reflect the policy of the hospital. The management staff stated that hospital patients are allowed choice in post hospital care; however, the only supervision of remote case managers such as LPN #2 was required attendance at a once monthly staff meeting.

The hospital failed to ensure that the LPN case manager, who worked independently at a remote location from the main campus, was providing patients and families freedom of choice.