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Based on review of manufacturer's directions for use (DFU), medical record review, hospital e-mail communication, and staff interviews, the hospital failed to provide informed consent to 7 of 17 Outpatient Pain Clinic Patients (#3, #4, #5, #11, #12, #13 and #14) from a total sample of 85 (54 inpatient, 17 outpatient, 14 closed) patients reviewed. Findings include:

1. Review of e-mail communication from the Pain Clinic Nurse Manager to the Chief of the Pain Service, dated 2/25/13, indicated an existing hospital policy required "off label" use of medications and/or devices to be included in the surgical or diagnostic notes or in the procedural consent.
2. Review of the manufacturer's directions for use (DFU) indicated the steroid medication Kenalog was "not for intravenous, intramuscular, intraoccular, epidural or intrathecal use." (Kenalog is an injectable steroid medication commonly used to reduce inflammation). The drug manufacturer changed the label on this medication in June 2011 to say that it was no longer recommended for injection into the epidural space (near the spine).
3. During interviews with the Chief of the Pain Service, Chief of Anesthesia, Pharmacists #1 and #2, and The Performance Improvement Director on 3/12/2013 at 10:15 A.M., it was agreed the hospital first became aware of the change in recommendations for this injectable medication in December 2012. According to the Chief of the Pain Service, after a review of other medication alternatives available to the service and an unsuccessful trial of alterative an medication, physicians decided to continue to use the Kenalog injectable steroid and to inform the patients of the off-label use. The Chief of the Pain Service said, a patient hand-out with frequently-asked-questions was designed and a re-designed informed consent to include this off-label use was proposed. The Chief of the Pain Service said that as of 2/1/13 the patients were to be informed of the off-label use.
4. For Outpatients #4 and #5, record reviews on 3/11/13, indicated neither the consent form nor the procedure note contained any documentation that the patients were informed of the off-label use of Kenalog. The patients' procedures, performed on 3/11/13, included the administration of Kenalog.
5. For Outpatients #3, #11, #12, #13, and #14, record reviews on 3/12/13 at 3:00 P.M., indicated neither the consent form nor the procedure note contained any documentation that the patients were informed of the "off-label" use of Kenalog. These patients' procedures were performed after 2/1/13, and included the administration of Kenalog.

Based on observations and staff interviews, the Hospital failed to ensure the security and confidentiality of patients' clinical records for patients serviced in 2 of 6 of the Hospital's outpatient satellites (#1, #6). Findings include:

1. The Hospital lacked sufficient safeguards to ensure that access to all information regarding patients in the satellites was limited to those individuals designated by law, regulation, and policy or duly authorized as having a need to know. The clinical records were not kept secure.

2. Observations in the Baystate Rehabilitation Care Adult & Pediatric Services (satellite #6) at approximately 11:30 A.M. on 3/11/13, indicated that over one thousand patients' clinical records were stored in a large room that was also an office. The clinical records were stored unlocked, on open shelves.

During interview at the time of the observation, the Outpatient Clinical Supervisor said that a contracted cleaning company cleaned the satellite after the satellite was closed and that no staff were present in the satellite during that time. The Outpatient Clinical Supervisor also said that the staff of the contracted cleaning company had access to the room containing the clinical records, although prohibited by Hospital policy.

3. Observations in the Baystate Breast and Wellness Center (satellite #1) at approximately 2:00 P.M. on 3/12/13, indicated that after the completion of physician exams, the patients' clinical records were placed in the Nurses' office. The clinical records were stored unlocked, on the nurses' desk.

During interview on 3/12/13 at 2:00 P.M., the Front Office Practice Supervisor said that the patients' clinical records were placed in the Nurses' office to be reviewed for accuracy and completeness and then scanned into the electronic clinical record system. The Supervisor said some records were left in the Nurses' office overnight. The Supervisor also said that the contracted cleaning staff cleaned the satellite after all staff had left the building for the day and that they had unsupervised access to the clinical records.

Based on observation, record review and interview, the Condition of Nursing Services is not met, as evidenced by (a) the failure of nursing staff to evaluate two patients (#42 and #45) for response to care provided: and for patient #42 failed to assess pretreatment water for chlorine for hemodialysis (b) failure of the nursing staff to ensure that nursing care plans were developed, implemented and kept current for four inpatients (#11, #12, #17, #26), and 1 Discharge Patient (#2), and (c) the failure of nursing staff to ensure that medications were administered according to hospital policy and national standards of practice, for 6 of 54 inpatients (#7, #8, #20, #25, #35, #46), placing patient safety at risk, from a total sample of 85 patients. Findings include;

A. Nursing staff failed to evaluate two patients (#42 and #45) for response to care provided to ensure they received adequate fluid/food intake to prevent the risk of dehydration and/or other complications and failed to accurately assess the pretreatment water for chlorine for patient #42 before starting hemodialysis. Findings include:

1. Patient #45, admitted 3/1/13, had admitting diagnoses of urinary tract infection, congestive heart failure (CHF), recent chronic Foley catheter insertion for urinary retention.
Record review indicated the patient was restricted to 1500 cubic centimeters (ccs) of fluid per day per physician's order. Nursing care plan for urinary tract infections, indicated nursing would monitor and assess intake and output, encourage po (oral) fluid intake as allowed by diet, monitor and document daily weight and monitor and document response to medications.
Review of the intake and output (I & 0) documentation indicated the patient's daily intake from 3/1/13 through 3/10/13 ranged from 440 ccs to only 840 ccs per day. This was 50% of the 1500 cc fluid restriction ordered. The patient's output ranged from 1000 ccs to 4200 ccs per day, with an average of 2400 ccs. The high output was secondary to Lasix (a diuretic) administration. The output being greater than the intake put the patient at risk of dehydration
Review of the patient's daily weights indicated the patient weighed 93 kilograms (kg) on admission on 3/1/13 and by 3/11/13 weighed 76.7 kgs. This is a 16.3 kg or 35.8 pound weight loss in ten days.
During an interview on 3/11/13 at approximately 12:00 P.M., the primary nurse ( RN #16) said s/he was not aware of the patient's poor intake being so far below the fluid restricted amount allowed by the physician and said the 16.3 kg weight loss was not a "gentle diuresis."
Nursing staff failed to assess the patient's intake to ensure it was adequate. Failure to provide adequate fluid intake along with the rapid diuresis placed the patient at risk for dehydration.

2. Patient #42, admitted 2/11/13 had a complicated hospital course with admission diagnosis of shortness of breath, followed by a cardiac catherization and a cardiac artery bypass grafting of three vessels for severe disease. The post operative period was complicated by acute renal failure requiring hemodialysis and nasogastric tube insertion for feeding due to intubation and mechanical ventilation.

(a)Record review indicated the patient currently had a left subclavian triple lumen catheter in place that was only being flushed and used for intermittent intravenous medication administration. The patient also had a right internal jugular catheter for hemodialysis only.

Record review indicated the patient was receiving a tube feeding at a rate of 40 cc/hour until 3/4/13 at 7:00 A.M. The tube feeding was put on hold pending extubation which occurred at 10:00 A.M. on 3/4/13. Review of the clinical records indicated no replacement fluids were planned or given until 3/5/13 when the mid level practitioner ordered the patient to have an oral diet.

The nursing care plan for fluid and electrolyte balance stated to assess and monitor intake and output and provide stabilizing IV fluids.

Review of the intake and output records indicated that the patient's only intake documented from 3/4/13 through 3/6/13 at 7:00 A.M., was the IV antibiotic fluids and flushes that amounted to approximately 60 ccs per 12 hour shift. On 3/6/13, the patient did consume some fluids but the intake was poor and remained less than 240 ccs per 12 hour shift for approximately four days.

During interview on 3/7/13 at approximately 1:30 P.M., the mid-level practitioner responsible for the patient's care during this period, said the patient did not get any fluid from 3/4/13 through 3/6/13 at 7:00 A.M. but was ordered a diet on 3/5/13 at 6:00 P.M. The practitioner said s/he was not sure why the patient did not receive any oral feedings after 3/6/13 at 6:00 P.M. The practitioner said the patient should have received some IV fluids during the period between 3/4/13 at 7:00 A.M. and 3/5/13 at 6:00 P.M.

Failure to assess the patient for fluid intake needs and failure to provide access and means for adequate fluid and food intake, placed the patient at risk for dehydration and other complications of a non-working bowel such as ileus.

(b) On 3/6/13 at approximately 10:00 A.M., Patient #42 was observed receiving hemodialysis at bedside using a portable reverse osmosis (RO) machine. The hemodialysis nurse (HDRN #1) upon request, showed the surveyor how s/he tested the RO for chlorine/ chloramines prior to initiating dialysis. HDRN#1 showed the surveyor the chlorine tests strips used to test the water. The strips were sensitive to 0.0 mg/ml of chlorine and were divided into results of 0.0, 0.02, 0.05, 0.1 and 0.2 and 0.5. HDRN #1 took a water sample, dipped a strip and read the results a "less than 0.1 mg/L." S/he did not compare the strip to any comparison chart. Surveyor asked how s/he determined the result and HDRN #1 replied " the strip did not change color, so I am estimating the result. We are looking for less the 0.1 mg/L so that is what I document as the result when the strip does not appear to change." Surveyor asked if the nurse had a comparison chart and HDRN #1 replied "No but there is one in the hemodialysis unit."

HDRN #1 was estimating the chlorine results which constitutes an unsafe practice as chlorine breakthrough could occur due to inaccurate analysis of results exposing the patient to chlorine.

Please refer to A395.

B. Nursing staff failed to ensure that nursing care plans were developed, implemented and kept current for four inpatients (#11, #12, #17, #26), and 1 Discharge Patient (#2). For example:
1. For Patients #11 and #26, medical record review indicated the problems identified in the nursing assessment lacked interventions in the care plan.

a. For Patient #11, medical record review on 3/4/13, indicated the following problems were identified upon admission: fetal status alteration; anxiety; and volume deficit. The medical record lacked interventions for these identified problems.

b. For Patient #26, medical record review on 3/6/13, indicated the nursing assessment had included the problems of moderate risk for skin breakdown, diabetes, depression and anxiety. Review of the POC indicated that it lacked a plan with goals and interventions for the above identified problems.

2. For Patient #12, medical record review on 3/4/13, indicated the patient had an unplanned cesarean section (C-Section - an operation to surgically remove the baby from the uterus). Potential complications for a C-Section listed in the medical record included infection and hemorrhage (bleeding). A nursing assessment documented on 3/3/13 identified that the patient had 2+ (moderate) edema of the right leg.

Review of the current Plan of Care (POC) indicated it did not include interventions for prevention for infection, hemorrhage, or fluid retention (edema).

3. For Patient #17, medical record review on 3/5/13, indicated the plan of care was not revised. Review of the patient's POC indicated the problem "Impaired gas exchange related to the presence of meconuim or pneumonia" was resolved on 3/4/13. However, the plan still included the following interventions: elevate the head of the bed 15 to 20 degrees; ensure chest physical therapy is done every 3 to 4 hours; and nasal continuous positive airway pressure to assist with breathing.

4. For Discharge Patient #2, the Hospital failed to follow the patient's plan of care relative to falls interventions.
The nursing care plan indicated the patient was not to be left alone in the bathroom and was to be supervised for all transfers and ambulation.
Review of the 1/28/12 Medical Progress Note indicated the patient sustained a right femur fracture and right rib fracture as a result of an unwitnessed fall (which occurred on 1/26/12).
Review of the Falls Investigation/Safety and Quality Review Form (regarding the 1/26/12 fall) indicated the patient was left alone in the bathroom by the personal care attendant.

Please refer to A396.

(C) Nursing staff failed to ensure that medications were administered according to hospital policy for medication administration, for 6 of 54 inpatients (#7, #8, #20, #25, #35, #46), placing patient safety at risk. For example:

1. For Inpatient #35, record review and interview indicated nursing staff administered an antibiotic, Flagyl, ordered every eight hours, two hours late. Record review indicated the medication was due to be given at 11:00 A.M. on 3/7/13. Review of the medication administration record (MAR), at 1:00 P.M. on 3/7/13, indicated the medication was highlighted in red, which indicated the medication had not been given. Interview with Registered Nurse (RN) #8, who was responsible for administering the medication, indicated s/he did not administer the medication at 11:00 A.M. as ordered and was now two hours late in providing the medication to the patient.

2. For Patient #8, observation on 3/4/13 at 12:00 P.M., indicated nursing staff left an open vial of the narcotic Fentanyl at the patient's bedside. Record review indicated the dose had been administered at 9: 15 A.M. that morning. The single dose vial remained in the patient's room for 2 hours and 45 minutes after it was administered. It was not been properly wasted and disposed of, creating a potential for diversion and cross contamination.

3. According to the hospital policy, reviewed on 3/14/13, syringes of medication not prepared under ISO 5 conditions (the special environment found under pharmacy medication hoods) must be discarded after 1 hour.

For Patient #25, observation in the Endoscopy Procedure room on 3/5/13 at 2:00 P.M., revealed a 3 cubic centimeter (cc) syringe, hand labeled as Propofol (short-acting, intravenously administered hypnotic agent) dated 3/5/13 at 12:00 P.M. The syringe was in a bucket on top of the anesthesia cart with numerous unopened supplies (hypodermic needles and syringes) and an unopened Propofol vial.

In an interview, during the observation, the Nurse Manager of Surgery said (s)he [the Certified Registered Nurse Anesthetist (CRNA)] has been told and told (not to leave drawn up medications on the anesthesia cart unsupervised). The medication Propofol was not prepared in the Pharmacy as it was not labeled with a Pharmacy generated label.

4. For Patient #46, the Hospital staff failed to administer medications timely to maximize patient health benefit and safety, in accordance with hospital policy.
Review of the medication administration record at 12:00 P.M. indicated the patient had received all of the scheduled 8:00 A.M. medications at 11:50 A.M., to include but not limited to, the following:
-Sinemet CR 50/250 milligrams (mg) ordered every 8 hours 8:00 A.M. - 2:00 P.M. and 10:00 P.M.
-Lasix 80 mg twice a day 8:00 A.M. and 5:00 P.M.
-Piperacillin 3.375 Intravenously (IV) every 8 hours 8:00 A.M. 4:00 P.M. and 10:00 P.M.
-Heparin 5000 units every 8 hours 8:00 A.M.- 4:00 P.M. - 10:00 P.M.

Missing these medications affects the health and safety of the patient. Sinment must be given to maintain therapeutic blood levels as it effects the patient's ability to function. A missed dose in the morning affects the patient's ability to eat, perform activities of daily living, or even speak. Administering doses of Lasix too close together can cause drops in blood pressure leading to falls or cardiac events. Antibiotics require even spacing to maintain therapeutic blood levels to combat infection. The same for Heparin to maintain the benefit of anticoagulation..

During an interview on 3/11/13 at 2:00 P.M., R.N. #15 said s/he was tied up getting another patient ready to go for a stress test and it made her/him late in giving medications. The surveyor inquired if anyone was helping and R.N. #15 said the charge nurse was assisting but s/he was still unable to give medications on time. Asked if any other patients were affected by this event and R.N. #15 said three other patients may have received medications up to two hours late. R.N. #15 said each nurse is assigned six patients to care for on the 12 hour shift and they take another nurse's patients (up to a total of 12) during breaks. There are 32 patients on the unit and up to three to four patient care technicians.

5. For Patient #7, medical record review on 3/4/13, indicated that although the newborn baby had physician's orders for Vitamin K administration and eye prophylaxis, to be given right after birth in the labor and delivery room, the medications were not documented as given in labor and delivery room records.

6. For Patient #20, RN #11 failed to adhere to Hospital policy for the administration of the Flu vaccine from a multidose vial. Review of the Hospital policy for medication administration indicated that medication from multiple dose vials should not be brought into patient care areas and administered at the patient's bedside. If a multidose medication vial was brought into a patient care area, the vial was to be used only for that patient.

Observations at 9:05 A.M. on 3/6/13, indicated that RN #11 brought a previously opened vial of Flu Vaccine into Patient #20's room, drew up the vaccine into a syringe, and administered the vaccine to the patient. RN #11 then placed the vaccine into a small plastic bag. The RN said (s)he was going to return the multidose vial of Flu Vaccine to the Pyxis (medication storage machine).

During interview on 3/6/13 at approximately 9:30 A.M., the Vice President of Quality Management said that Hospital policy required that multidose vials, brought into patient care areas must be used only for that patient and disposed after use.

Please refer to A405.

Based on observation, record review and interview, the nursing staff failed to (a) evaluate two patients (#42 and #45), for fluid intake to ensure they received adequate fluid/food to prevent dehydration and/or other complications and (b) failed to accurately assess the pretreatment water for chlorine for one of one observed hemodialysis patients (#42), in a total inpatient sample of 54. Findings include:

1. Patient #45, admitted 3/1/13, had admitting diagnoses of urinary tract infection, congestive heart failure (CHF), recent chronic Foley catheter insertion for urinary retention on last hospital admission on 2/21/13, diabetes, hypothyroidism and an automatic internal cardiac defibrillator.

The patient was observed on 3/11/13 at 11:00 A.M., to be seated in a fully reclined Geri-chair. The patient was alert and complained of feeling "like a blob." The indwelling Foley catheter collection bag was observed hanging off the arm of the chair at the level of the bladder. The collection bag was full of copius amounts of very clear colorless urine, in response to large doses of diuretics. There was no fluid for drinking in reach of the patient. The patient complained of a dry mouth.

The physician ordered the patient's fluid intake to be restricted to 1500 cubic centimeter (cc) a day due to congestive heart failure (CHF) and also ordered the patient to receive Lasix (a diuretic which would cause large dilute urine output), 40 milligrams intravenous push (IVP) twice a day, placing the patient at risk for dehydration. The patient also received the medication Diflucan 100 mg daily for a yeast urinary tract infection (UTI).

Review of the nutritional assessment, dated 3/4/13, indicated the patient was at risk for fluid imbalance, with a goal of gentle diuresis for CHF. Fluids were assessed as needed per the physician's order.

The nursing care plan for UTI stated to monitor and assess intake and output, encourage po (oral) fluid intake as allowed by diet, monitor and document daily weight and monitor and document response to medications.

Review of the intake and output (I & 0) documentation indicated the patient's daily intake from 3/1/13 through 3/10/13 ranged from 440 ccs to 840 ccs per day. This was 50% of the 1500 cc fluid restriction ordered. The patient's output ranged from 1000 ccs to 4200 ccs per day, with an average of 2400 ccs. The high output was secondary to Lasix administration. The output being greater than the intake put the patient at risk of dehydration

Review of the patient's daily weights indicated the patient weighed 93 kilograms (kg) on admission on 3/1/13 and by 3/11/13 weighed 76.7 kgs. This is a 16.3 kg or 35.8 pound weight loss in ten days.

During an interview on 3/11/13 at approximately 12:00 P.M., the primary nurse (RN #16) said she was not aware of the patient's poor intake being so far below the fluid restricted amount allowed by the physician and said the 16.3 kg weight loss was not a "gentle diuresis."

Nursing staff failed to assess the patient's intake to ensure it was adequate. Failure to provide adequate fluid intake along with the rapid diuresis placed the patient at risk for dehydration.

2. Patient #42, admitted 2/11/13, had a complicated hospital course with admission diagnosis of shortness of breath, followed by a cardiac catherization and a coronary artery bypass grafting of three vessels for severe disease. The post operative period was complicated by acute renal failure requiring hemodialysis and nasogastric tube insertion for feeding due to intubation and mechanical ventilation.

Record review on 3/4/13, indicated the patient currently had a left subclavian triple lumen catheter in place that was only being flushed and used for intermittent intravenous medication administration. The patient also had a right internal jugular catheter for hemodialysis only. The patient was extubated

Record review on 3/4/13, indicated the patient was receiving a tube feeding at a rate of 40 cc/hour until 3/4/13 at 7:00 A.M. The tube feeding was put on hold in anticipation of extubation and discontinuing the mechanical ventilation. This was accomplished at 10:00 A.M. on 3/4/13. Review of the clinical records indicated no replacement fluids were planned or given until 3/5/13 when the mid level practitioner ordered the patient to have an oral diet.

The nursing care plan for fluid and electrolyte balance stated to assess and monitor intake and output and provide stabilizing intravenous (IV) fluids.

Review of the intake and output records indicated that the patient's only intake documented from 3/4/13 through 3/6/13 at 7:00 A.M., was the IV antibiotic fluids and flushes that amounted to approximately 60 ccs per 12 hour shift. On 3/6/13, the patient did consume some fluids but the intake was poor and remained less than 240 ccs per 12 hour shift through 3/10/13.

During interview on 3/7/13 at approximately 1:30 P.M., the mid-level practitioner responsible for the patient's care during this period, said the patient did not get any fluid from 3/4/13 through 3/6/13 at 7:00 A.M. but was ordered a diet on 3/5/13 at 6:00 P.M. The practitioner said s/he was not sure why the patient did not receive any oral feedings after 3/5/13 at 6:00 P.M. The practitioner said the patient should have received some IV fluids during the period between 3/4/13 at 7:00 A.M. and 3/5/13 at 6:00 P.M. The practitioner also said nursing staff should have notified the medical team of the patient's poor intake over the past three days.

Failure to assess the patient for fluid intake needs and failure to provide access and means for adequate fluid and food intake, placed the patient at risk for dehydration and other complications such as a non-working bowel or an ileus.

3. On 3/6/13 at approximately 10:00 A.M., Patient #42 was observed receiving hemodialysis at bedside using a portable reverse osmosis (RO) machine. The hemodialysis nurse (HDRN #1) upon request, showed the surveyor how s/he tested the RO for chlorine/ chloramines prior to initiating dialysis. HDRN#1 showed the surveyor the chlorine tests strips used to test the water. The strips were sensitive to 0.0 mg/ml of chlorine and were divided into results of 0.0, 0.02, 0.05, 0.1 and 0.2 and 0.5. HDRN #1 took a water sample, dipped a strip and read the results a "less than 0.1 mg/L." S/he did not compare the strip to any comparison chart. Surveyor asked how s/he determined the result and HDRN #1 replied, "The strip did not change color, so I am estimating the result. We are looking for less the 0.1 mg/L so that is what I document as the result when the strip does not appear to change." Surveyor asked if the nurse had a comparison chart and HDRN #1 replied "No but there is one in the hemodialysis unit."

HDRN #1 was estimating the chlorine results which constitutes an unsafe practice as chlorine breakthrough could occur due to inaccurate analysis of results exposing the patient to chlorine.

During an interview, on 3/6/13 at 12:30 P.M., the Charge Nurse in the Hemodialysis unit said they only had "one" reader strip available for the chlorine/chloramine testing strips for all portable ROs (reverse osmosis) and for all the inpatient unit machines. There were nine portable ROs and 8 treatment bays in the inpatient unit.

The dialysis staff who performed hemodialysis at the bedside using portable ROs were estimating/guessing at the results of the chlorine/chloramine tests results due to no access to a reader comparison chart. This was an unsafe practice as a positive test for chlorine may be missed thereby placing patients in danger of chlorine exposure which can cause severe red blood cell hemolysis, anemia and even death
.
This presented a patient safety risk as staff were unable to accurately read the water test results to determine the safety of the water without a reader comparison strip for each RO when dialyzing patients on the hospital patient units. Staff were left to "guess" the chlorine result.

Based on record review and interview, the hospital failed to ensure that patient nursing care plans were developed, implemented and kept current by ongoing assessments of the patient's needs and the patient's response to interventions, and updating or revising the patient's nursing care plan in response to assessments for four inpatients (#11, #12, #17, #26), and 1 Discharge Patient (#2), in a total sample of 85 patients.

Findings include:

1. For Patient #11, medical record review on 3/4/13, indicated the following problems were identified upon admission: fetal status alteration; anxiety; and volume deficit. The medical record lacked interventions for these identified problems.

2. For Patient #12, medical record review on 3/4/13, indicated the patient had an unplanned cesarean section (C-Section - an operation to surgically remove the baby from the uterus). Potential complications for a C-Section listed in the medical record included infection and hemorrhage (bleeding). A nursing assessment documented on 3/3/13, identified that the patient had 2+ (moderate) edema of the right leg.

Observations of Patient #12's both feet and lower legs during interview at 3:38 P.M. on 3/4/13, indicated that both feet and legs were swollen.

Review of the current Plan of Care (POC) indicated it did not include interventions for fluid retention (edema).

In an interview at approximately 4:00 P.M. on 3/4/13, Registered Nurse (RN) #4, said that the patient lacked a written POC for fluid retention.

3. For Patient #17, medical record review on 3/5/13, indicated the plan of care was not revised. Review of the patient's POC indicated the problem "Impaired gas exchange related to the presence of meconuim or pneumonia" was resolved on 3/4/13. However, the plan still included the following interventions: elevate the head of the bed 15 to 20 degrees; ensure chest physical therapy is done every 3 to 4 hours; and nasal continuous positive airway pressure to assist with breathing.

During interview at approximately 10:00 A.M. on 3/5/13, the Neonatal Intensive Care Unit (NICU) Nurse Manager said that the patient no longer required those interventions.

Review of the POC also identified "Potential alteration in fluid volume related to water loss and inadequate nutritional intake." The interventions read: change nasogastric tube (NGT- feeding tube) every seven days; elevate head of bed 10 to 15 degrees; and provide non nutritive sucking when providing gavage feeding.

During interview at approximately 10:00 A.M. on 3/5/13, the Neonatal Intensive Care Unit (NICU) Manager said that the patient no longer required those interventions. Additionally, observations in the Neonatal Intensive Care Unit (NICU) at approximately 9:30 A.M. on 3/5/13, indicated that Patient #17 did not have a NGT in place.

4. For Patient #26, medical record review on 3/6/13, indicated the nursing assessment had included the problems of moderate risk for skin breakdown, diabetes, depression and anxiety. Review of the POC indicated that it lacked a plan with goals and interventions for the above identified problems.

In an interview, at approximately 11:00 A.M. on 3/6/13, The Director of Quality acknowledged that the patient lacked a POC for the above issues.


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5. For Discharge Patient #2, the Hospital failed to follow the patient's plan of care relative to falls interventions.

Discharge Patient #2, with diagnoses of altered mental status, weakness/fatigue and glaucoma, was admitted to the Hospital in 1/2012.

Review of the 1/25/12 Fall Risk Assessment indicated the patient exhibited confusion, required staff assistance with transfers and was a high falls risk. Further review of the assessment indicated the falls prevention care plan included: supervise patient in the bathroom and supervise the patient when transferring and ambulating.

Review of the 1/26/12 Medical Progress Note indicated the patient fell while ambulating out of the bathroom, sustaining a laceration on the back of the head (requiring staples to close the wound).

Review of the 1/28/12 Medical Progress Note indicated the patient also sustained a right femur fracture and right rib fracture as a result of the unwitnessed fall (which occurred on 1/26/12).

Review of the Falls Investigation/Safety and Quality Review Form (regarding the 1/26/12 fall) indicated the patient was left alone in the bathroom by the personal care attendant.

During interview with the Director of Performance Improvement on 3/7/13 at 2:45 P.M., it was discussed that the patient's falls care plan was not being followed by the personal care attendant as the patient was not being supervised in the bathroom, as planned, and supervision while the patient was transferring and ambulating was not being provided, as planned.

Based on record review and interview, the Hospital failed to ensure that staff administered medications according to hospital policy and national standards of practice, for 6 of 54 inpatients (#7, #8, #20, #25, #35, #46), from a total sample of 85 patients. Findings include:

Review on the Hospital's policy titled Standard Medication Administration Times, it stated, under, "1a. Time critical scheduled medications: those for which an early or late administration of greater than 30 minutes might cause harm or have significant negative impact on the intended therapeutic or pharmacological effects. Accordingly, scheduled medications identified within thirty minutes before or after their scheduled dosing time, for a total window of 1 hour."
Procedure, "Time critical medications included: a. Antibiotics"

1. Inpatient #35 was admitted to the Hospital on 3/4/13 to Unit 5A. This patient presented to the Hospital with abdominal pain, an elevated white blood cell count, and maroon stool (an sign of gastrointestinal bleeding). This Patient was empirically treated with intravenous Levofloxacin and Flagyl (antibiotics). This patient was subsequently diagnosed with diverticulosis without diverticulitis.

Review of the Physician's order of 3/5/13 indicated to administer the antibiotic Flagyl 500 milligrams (mg) intravenously every 8 hours for 5 days. The times for administration were 11:00 A.M., 7:00 P.M. and 3:00 A.M.

Review of the Electronic Medication Administration Record (E-MAR) on 3/7/13 at 1:00 P.M. indicated that Inpatient #35 had not received the 11:00 A.M. dose of Flagyl 500 milligrams intravenously.

During an interview with Registered Nurse (RN) #8 on 3/7/13 at 1:00 P.M., the Surveyor asked who was the Nurse taking care of Inpatient #35. RN #8 identified himself/herself as the Nurse taking care of Inpatient #35 and responsible for the patient's medications. The Surveyor asked RN #8 to look at the E-MAR with her. S/he checked the E-MAR for Flagyl which was in red, indicating it had not been given at 11:00 A.M. RN #8 stated, "I can give it now. It is due at 12:30 P.M." The Surveyor stated, "No, the Levofloxacin is due at 12:30 P.M. The Flagyl was due at 11:00 A.M., which was 2 hours ago." RN #8 stated, "Oh, it was due at 11:00 (A.M.). I forgot to give it." The antibiotic Flagyl was administered two hours late.



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2. For Patient #8, observation in the Surgical Intensive Care Unit (SICU) on 3/4/13 at 12:00 P.M., indicated an opened vial of medication in the patient's room. According to RN #1, the medication was Fentanyl (a potent narcotic analgesic), and a Schedule II medication (substances in this schedule must be locked and have a high potential for abuse which may lead to severe psychological or physical dependence). According to the E-MAR the medication was administered at 9:16 A.M. However, at 12:00 P.M. (2 hours and 45 minutes later), the single dose vial remained in the patient's room and had still not been properly wasted and disposed of, creating a potential for diversion.
According to the Nurse Manager this was not the policy or practice in the SICU but should have been a witnessed waste and disposal, immediately after use.
3. According to the hospital policy, reviewed on 3/14/13, syringes of medication not prepared under ISO 5 conditions (the special environment found under pharmacy medication hoods) must be discarded after 1 hour.
For Patient #25, observation in the Endoscopy Procedure room on 3/5/13 at 2:00 P.M., revealed a 3 cc syringe, hand labeled as Propofol (short-acting,intravenously administered hypnotic agent) dated 3/5/13 at 12:00 P.M. The syringe was in a bucket on top of the anesthesia cart with numerous unopened supplies (hypodermic needles and syringes) and an unopened Propofol vial.
In an interview, during the observation, the Nurse Manager of Surgery said (s)he [the Certified Registered Nurse Anesthetist (CRNA)] has been told and told (not to leave drawn up medications on the anesthesia cart unsupervised).

Additionally, the above observation indicated that the medication Propofol was not prepared in the Pharmacy as it was not labeled with a Pharmacy generated label.



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4. For Patient #46, the Hospital staff failed to administer medications timely to maximize patient health benefit and safety, in accordance with hospital policy.

Patient #46 was admitted on 3/10/13 in the late evening with diagnoses of pneumonia, congestive heart failure and Parkinson's Disease.

On 3/11/13 at 11:00 A.M., the patient was observed in bed with a family member at the bedside. The family member stated the patient had pneumonia and was very weak. The patient was awake and conversant, short of breath, with severe Parkinsonian tremors of the hands and arms. The head of patient's bed was elevated and the patient's color was gray.

Review of the medication administration record at 12:00 P.M. indicated the patient had received all of the scheduled 8:00 A.M. medications at 11:50 A.M., over three hours late, to include but not limited to, the following:
-Sinemet CR 50/250 milligrams (mg) ordered every 8 hours 8 A.M. - 2 P.M. and 10 P.M.
-Lasix 80 mg twice day 8 A.M. and 5 P.M.
-Piperacillin 3.375 Intravenously (IV) every 8 hours 8 A.M. 4 P.M. and 10 P.M.
-Heparin 5000 units every 8 hours 8 A.M.- 4 P.M. - 10 P.M.

Missing these medications affects the health and safety of the patient as timing is crucial to function for Sinemet. A missed dose in the morning affects the patient's ability to eat, perform activities of daily living, or even speak. Administering doses of Lasix too close together can cause drops in blood pressure leading to falls or cardiac events. Antibiotics require even spacing to maintain therapeutic blood level to combat infection. The same for Heparin to maintain the benefit of anticoagulation.

During an interview on 3/11/13 at 2:00 P.M., R.N. #15 said s/he was tied up getting another patient ready to go for a stress test and it made her/him late in giving medications. The surveyor inquired if anyone was helping and R.N. #15 said the charge nurse was assisting but s/he was still unable to give medications on time. Asked if any other patients were affected by this event and R.N. #15 said three other patients may have received medications up to two hours late. R.N. #15 said each nurse is assigned six patients to care for and they take another nurse's patients (up to a total of 12) during breaks. There are 32 patients on the unit and up to three to four patient care technicians.



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5. For Patient #7, a newborn infant, medical record review on 3/4/13, indicated that although the patient had physician's orders for Vitamin K administration and eye prophylaxis, at birth, the medications were not documented as given, upon the birth of the baby. During interview on 3/4/13 at approximately 4:00 P.M., RN #2 said Hospital policy required the medications to be documented when administered.

6. For Patient #20, RN #11 failed to adhere to Hospital policy for the administration of the Flu vaccine from a multidose vial. Review of the Hospital policy for medication administration indicated that medication from multiple dose vials should not be brought into patient care areas and administered at the patient's bedside. If a multidose medication vial was brought into a patient care area, the vial was to be used only for that patient.

Observations at 9:05 A.M. on 3/6/13, indicated that RN #11 brought a previously opened vial of Flu Vaccine into Patient #11's room, drew up the vaccine into a syringe, and administered the vaccine to the patient. RN #11 then placed the vaccine into a small plastic bag. The RN said (s)he was going to return the multidose vial of Flu Vaccine to the Pyxis (medication storage machine).

During interview on 3/6/13 at approximately 9:30 A.M., the Vice President of Quality Management said that Hospital policy required that multidose vials, brought into patient care areas, must be used only for that patient and disposed after use.

Based on medical record review and staff interview the hospital failed to ensure that all entries into patients' medical records were dated and timed for 3 (#11, #12, #42) of 54 inpatients and 1 (#10) of 17 outpatients, from a total sample of 85 patients reviewed. Findings include:

1. For Inpatient #11, review of the patient's Obstetrical Consent on 3/4/13, indicated that it lacked the time the consent was signed by the patient and the witness, and the date and time the consent was signed by the patient's midwife.

2. For Inpatient #12, review of the patient's Obstetrical Consent on 3/4/13, indicated that it lacked the time the consent was signed by the patient and the witness and the date and time the consent was signed by the patient's physician.

3. For Outpatient #10, medical record review on 3/12/13, indicated that although the surgeon signed and dated the consent, the time of the signature was not documented, as required.



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4. For Patient #42, the physician failed to document the time the surgical consent was obtained, as required.

Patient #42, was admitted on 2/11/13, with shortness of breath. The patient signed all of consents in the emergency room for admission care and treatment.

The patient's condition was serious and required an urgent cardiac catheterization. Review of the consent for the left heart coronary angiogram and left ventriculogram and possible stent placement, indicated the practitioner took a verbal consent from the patient "due to the urgency of the situation." The practitioner signed and dated the consent but did not indicate the time at which (s)he obtained the verbal consent.

Based on record review and interview, the Hospital failed to ensure that the medical record for one patient (#41) in a total in-patient sample of 54, contained physician orders for care delivered that was properly authenticated and complete. Findings include:

1. For Patient #41, the medical record (a) lacked a complete order for the application of Nystatin powder and (b) lacked a physician's order for treatment of skin wounds.

a. Patient #41 was admitted with diagnoses of congestive heart failure, diabetes, aortic stenosis, a right mid shin vasculitis, and right heel ulcer.

Review of the clinical record indicated the patient had utilized an outside wound clinic that was caring for the leg wounds and the patient did not want the hospital staff to touch the dressings. On 2/15/13, the attending physician ordered a wound care consult.

Record review indicated the wound care nurse provided dressing changes from 2/15/13 through 2/18/13, consisting of normal saline wash, Zerofoam to wound bed and dry sterile dressing with gauze wrap every Tuesday and Friday. Nursing staff did the dressing changes twice a week from there forward to 2/18/13. Record review indicated there were no physician orders to perform any wound care treatments.

On 2/28/13, the wound care nurse wrote a consult note where (s)he indicated (s)he entered orders for wound care into the CIS (communication information system) as discussed with the outside treating physician from another medical center. On 2/28/13, (s)he was called to see the patient due to development of another fluid filled blister of the right foot. (S)he documented treatment plans for all open areas and wrote nurse to nurse communications on the Physician order sheets as treatments. There was no physician authentication of the treatments planned and provided from 2/28/13 through 3/11/2013.

During an interview on 3/11/13 at 10:30 A.M., the wound care (WC) nurse said (s)he did not have prescriptive authority for ordering treatments. The WC nurse said (s)he did not get approval (a physician's order) for the recommendations (s)he made for wound care from the patient's attending physicians. The WC nurse said (s)he received directions for care from the community physician who was caring for the patient and felt that was appropriate but failed to clear it with the physicians who were caring for the patient during the hospital stay.

b. On 3/3/13, an order was entered into the medication administration record for Nystatin topical powder, one application topically twice a day. There was no indication where the powder was to be applied. Review of administration documentation indicated nurses were applying the powder to the perineum.

Additionally, this order was not complete, as it failed to identify the location where staff were to apply the Nystatin powder.

Based on observation, review of manufacturer's directions for use (DFU), record review and interview, the Hospital failed to ensure that supplies and equipment were maintained at an acceptable level of safety and quality. Findings include:

1. During observations in the hemodialysis water treatment room on 3/6/13 at approximately 12:00 P.M., the dialysis biotechnician said s/he tested the carbon tanks for chloramine/chlorine when s/she arrived in the morning at 8:00 A.M. and again at shift change around 1:00 P.M., in accordance with Hospital policy. The biotechnician said the chlorine test must show less than 0.1 milligrams/Liter (mg/L) of chlorine in the water for the water to be safe for dialysis to be started. The Biotechnician showed the surveyor the chlorine strips s/he used to test for chlorine. The strips were only sensitive to detect chlorine to 0.5 mg/ml as the lowest amount, not the required 0.1 mg/ml. The biotech stated these were the strips (s)he had been using for months.

These strips were not sensitive enough to ensure the water was free of chlorine to less than 0.1 mg/ml and thus did not ensure safe water for patient dialysis.

2. On 3/6/13 at approximately 11:00 A.M., during a tour of the heart and vascular cardiac care floor on MM 4, the blanket warmer was observed to be at 160 degrees. The temperature log on the door, noted the temperature was supposed to be no greater than 140 degrees, but had been at 160 degrees on March 1, 2, 3 and 4th. This created a risk for patient burns.

The Unit Manager said this should have been addressed earlier and s/he would have it taken care of immediately.



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3. Observation of the Baystate Rehabilitation Satellite for Adult and Pediatric Services at 10:00 A.M. on 3/11/13, indicated that the facility had two hydroculator machines (used to store warm packs).

During interview at approximately 10:15 A.M. on 3/11/13, the Outpatient Clinical Supervisor said staff cleaned the hydroculator machines monthly.

Review of the hydroculator manufacturer's directions for use (DFU) on 3/11/13, indicated that the hydroculator was supposed to be drained and cleaned every two weeks. The Rehabilitation Satellite for Adult and Pediatric Services failed to adhere to the Manufacturer's DFU, as required.

Based on observations, review of policies and procedures, and interviews, the Hospital failed to consistently ensure a sanitary environment and staff adherence to infection control policies and procedures to prevent transmission of infections and communicable diseases related to: medication administration; adherence to infection control policies and procedures; proper use of single dose and multidose medications; proper cleaning of equipment; proper waste and disposal of controlled substances; and proper labeling of mothers' breast milk, for 5 (#7, #12, #24, #35, #37) of 54 inpatients from a total sample of 85 patients. Findings include:

1. Observations, interviews, and review of the Hospital's policies and procedures on 3/5/13 at 11:10 A.M., and 3/7/13 at 9:38 A.M., indicated the Hospital failed to consistently ensure an acceptable level of infection prevention practice for hand hygiene prior to parenteral injection and administration of intravenous medications.

For Patient #37, observation of a medication pass on Unit 6B on 3/7/13 at 9:38 A.M., with Nurse #7 indicated the mobile computer on wheels (COW) keyboard contained debris and dust between the keys of the computer keyboard. RN #7, who failed to use proper hand hygiene during administration of medications, also used the soiled COW to prepare and administration a 1 liter bag of intravenous Normal Saline and parenteral injection of the medication Heparin (prevents blood clots) to the patient, creating a risk for cross-contamination of medications.

2. During observation of the water treatment room in the Hemodialysis Unit, on 3/6/13 at approximately 12:00 P.M., it was observed that there were no ultrafilters observed on the outlet water loop after the ultraviolet light, as required by AAMI, RD 62. (Association for the Advancement of Medical Instrumentation), which sets the standards for water treatment systems in hemodialysis units.

When water is passed through UV lights, the UV lights destroy bacteria. The destruction of bacteria releases endotoxins, which can cause infections in hemodialysis patients. Ultrafilters remove endotoxins from the water decreasing the risk of patient infection.
During an interview on 3/12/2013 with the Biomedical Technician and the Senior Engineer, they stated they were not in compliance with AAMI standards for Ultrafilters. The Senior Engineer said that the Hospital follows and complies with AAMI standards for water treatment systems.

Please refer to A749.

3. For Patient #24, observation in the Interventional Radiology (IR) Suite on 3/5/13 at 8:07 A.M., indicated an Anesthesia Resident (Physician #1) picked up two items that had been on the floor of the suite during the patient's procedure. One item was an extension tubing for the ventilator and the second item was a packaged "sterile" drape used to create a sterile field for the arterial line (A-line) insertion. Since the sterile drape was stored on the floor, it could no longer be considered sterile. Therefore, an unsterile drape was used with the A-line insertion procedure, creating a risk for cross contamination of the A-line.

4. Review of the Hospital "Breast Milk" policy indicated in order to prevent cross contamination and assure that infants receive the correct breast milk from the correct mother, a patient's nurse would print patient identification labels for the mothers to place on the milk bottles, immediately after pumping their breast milk. Before placing the breast milk bottles in the unit refrigerator or in Neonatal Intensive Care Unit's (NICU) freezer, the nurse was supposed to verify the milk with the mother and the label on the milk bottle.

For Patient #12, interview on 3/4/13 at approximately 3:30 P.M. indicated that the patient did not have the opportunity to label the bottle because RN #15 had not yet given her the labels. The patient said RN #15 took the unlabeled bottle of breast milk and placed it in the Unit refrigerator until the next morning (3/5/13).

Please refer to A749.

5. Review on the Hospital's policy titled "Standard Medication Administration Times", it stated, under, "1a. Time critical scheduled medications: those for which an early or late administration of greater than 30 minutes might cause harm or have significant negative impact on the intended therapeutic or pharmacological effects. Accordingly, schedule medications identified within thirty minutes before or after their scheduled dosing time, for a total window of 1 hour. Time critical medications include: Antibiotics"

For Inpatient #35, review of the Physician's order of 3/5/13 indicated to administer the antibiotic Flagyl 500 milligrams (mg) every 8 hours for 5 days. The times for administration were listed as 11:00 A.M., 7:00 P.M. and 3:00 A.M.

Review of the Electronic Medication Administration Record (E-MAR) on 3/7/13 at 1:00 P.M. indicated that Inpatient #35 had not yet received the 11:00 A.M. dose of Flagyl 500.

Please refer to A405.
6. According to the hospital policy, reviewed on 3/14/13, syringes of medication not prepared under ISO 5 conditions (the special environment found under pharmacy medication hoods) must be discarded after 1 hour.
Observation in the Endoscopy Procedure room on 3/5/13 at 2:00 P.M., revealed a 3 cc syringe, hand labeled as Propofol (short-acting, intravenously administered hypnotic agent) dated 3/5/13 at 12:00 P.M. The syringe was in a bucket on top of the anesthesia cart with numerous unopened supplies (hypodermic needles and syringes) and an unopened Propofol vial.
7. Review of the Hospital policy for medication administration indicated that medication from multiple dose vials should not be brought into patient care areas and administered at the patient's bedside. If a multidose medication vial was brought into a patient care area, the vial was to be used only for that patient.
For Patient #7, observations at 9:05 A.M. on 3/6/13, indicated that RN #11 brought a previously opened vial of Flu Vaccine into Patient #7's room, drew up the vaccine into a syringe, and administered the vaccine to the patient. RN #11 then placed the vaccine into a small plastic bag. The RN said (s)he was going to return the multidose vial of Flu Vaccine to the Pyxis (medication storage machine).
Please refer to A405.

Based on observations, interviews, and review of the Hospital's policies and procedures, the Hospital failed to consistently ensure an acceptable level of infection prevention practice for 5 (#12, #17, #24, #35, #37) of 54 inpatients and 1 (#15) of 17 outpatients from a total sample of 85 patients. Findings include:

1. For Outpatient #15, the Hospital failed to ensure an acceptable level of infection prevention practice related to hand hygiene prior to a parenteral injection.

Review of the Hospital's policy on Hand Hygiene stated, "Hand hygiene is the single most important means of preventing the spread of infection." under Procedure it states, "Alcohol rub agent will be used; a. Before direct contact with patients...c. Before inserting invasive devices... f. Between activities on the same patient... and g. After contact with contaminated equipment or surfaces."

Outpatient #15 was in day surgery on 3/5/13. This Patient had a tubal ligation under general anesthesia.

Observation on 3/5/13 at 11:10 A.M. in the Chestnut Post Anesthesia Care Unit (PACU) Suite C, revealed Outpatient #15, complained of post-operative lower abdominal pain.

Observation on 3/5/13 at 11:12 A.M. revealed Registered Nurse (RN) #3 failed to perform hand hygiene prior to obtaining Fentanyl (a pain medication) from the automated dispensing storage system, as required by Hospital policy. (S)he typed in his/her code to open this system, opened a drawer, obtained a 2 milliliter (ml) vial of Fentanyl 50 micrograms per ml, confirmed the Fentanyl count by typing on the keyboard, and then closed the drawer with dirty hands. She walked into this patient's PACU Bay and did not perform hand hygiene prior to preparing and administering the intravenous Fentanyl.

During an interview on 3/5/13 at 11:16 A.M., the Surveyor stated that there had been no hand hygiene prior to drawing up and administering the intravenous Fentanyl. RN #3 stated that (s)he thought (s)he performed hand hygiene and (s)he usually washed his/her hands.

2. For Inpatient #37, the Hospital failed to ensure an acceptable level of infection prevention practice related to hand hygiene prior to changing an intravenous bag, administering a subcutaneous injection, and giving medications via a nasogastric tube (NG-tube).

Inpatient #37 was admitted in 3/2013. This patient had the following pertinent diagnoses: Colon cancer with colon polyps, history of myocardial infarction, coronary artery disease, and diabetes mellitus.

During a medication pass on Unit 6B on 3/7/13 at 9:38 A.M., RN #7 rolled the mobile computer on wheels into Patient #37's room, and parked it near the end of this Patient's bed. The keyboard of this computer had debris and dust between the keys. RN #7 unlocked this computer by typing a code on the keyboard. With a portable hand held scanner, RN #7 scanned this Patient's identification bracelet. With unwashed hands, (s)he put an adhesive strip on a 1 liter intravenous bag of Normal Saline. (S)he then removed the old intravenous bag, and spiked the new intravenous bag with the intravenous tubing with dirty hands. (S)he put the automatic blood pressure cuff on this Patient's arm, and it read 135/67 with a pulse of 90 beats per minute. RN #7 then recorded this information in the computer via the soiled keyboard.

RN #7 failed to perform hand hygiene before (s)he scanned a 5,000 units per 1 milliliter (ml) vial of Heparin, drew up 1 ml into a syringe, and administered it into this Patient's left upper arm.

RN #7 then scanned, opened and crushed Asprin 81 milligrams (mg) and Lopressor 25 mg and put them in a medication cup without first perfroming hand hygiene. RN #7 then stated, "I will put warm water with the medications so it is easier to give through the NG tube." With his/her bare right hand, the RN touched the handle of the hot water faucet and failed to perform hand hygiene after touching the hot water handle. The RN again failed to perform hand hygiene before donning a pair of clean gloves and administer the dissolved medications to the patient, via the NG tube.

3. The Hospital failed to maintain the mobile computer on wheels (COW) in a sanitary manner.

For Patient #35, observation of a medication pass on Unit 6B on 3/7/13 at 9:38 A.M., with RN #7 indicated the mobile computer on wheels keyboard contained debris and dust between the keys of the computer keyboard. The nurse used the soiled COW for preparation and administration of patients medications, creating a risk for cross-contamination of medications.

During an interview with RN #7 on 3/7/13 at 9:55 A.M., (s)he stated that this computer on wheels was used for 4 patients in 2 rooms.



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4. During observation of the water treatment room in the hemodialysis unit, on 3/6/13 at approximately 12:00 P.M., it was observed that there were no ultrafilters observed on the outlet water loop after the ultraviolet light, as required by AAMI, RD 62. (Association for the Advancement of Medical Instrumentation), which sets the standards for water treatment systems in hemodialysis units.

When water is passed through UV lights, the UV lights destroy bacteria. The destruction of bacteria releases endotoxins, which can cause infections in hemodialysis patients. Ultrafilters remove endotoxins from the water decreasing the risk of patient infection.

During an interview on 3/12/2013 with the Biomedical Technician and the Senior Engineer, they stated they were not in compliance with AAMI standards for Ultrafilters. The Senior Engineer said that the Hospital follows and complies with AAMI standards for water treatment systems.



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5. For Patient #24, observation in the Interventional Radiology (IR) Suite on 3/5/13 at 8:07 A.M., revealed an Anesthesia Resident (Physician #1) picked up two items that had been on the floor of the suite during the patient's procedure.

One item was used as extension tubing for the ventilator, and the other was a packaged sterile drape used to create a sterile field for the arterial line (A-line) insertion. Sterile or clean equipment is no longer considered sterile or clean if it had been stored or dropped on the floor. Therefore, these items should not have been used and an unsterile drape was used with the A-line insertion procedure. This created a risk for cross contamination of the A-line.

Physician #1 failed to perform hand hygiene after removing his unsterile gloves and before donning sterile gloves to insert the arterial line.



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6. Review of the Hospital "Breast Milk" policy indicated in order to prevent cross contamination by assuring that infants received the correct breast milk from the correct mother, a patient's nurse would print patient identification labels for the mothers to place on the milk bottles immediately after pumping their breast milk. Before placing the breast milk bottles in the unit refrigerator or in Neonatal Intensive Care Unit's (NICU) freezer, the nurse was required to verify the milk with the mother and the label on the milk bottle.

For Patient #12, interview on 3/4/13 at approximately 3:30 P.M. indicated that the patient had pumped breast milk into a bottle. The patient said she did not label the bottle because the nurse had not yet given her the labels. The patient said the infant was not breast feeding very well and any pumped breast milk needed to be saved to bottle feed to the infant. The patient said RN #15 put the unlabeled breast milk in the Unit refrigerator until the next morning (3/5/13).

RN #15 failed to adhere to Hospital policy, thereby creating a risk for cross contamination by an infant receiving the wrong breast milk.

7. For Patient #17, observation of breast milk identification for the patient, on 3/5/13 at approximately 8:30 A.M., indicated that RN #4 failed to adhere to Hospital policy.

In order to assure that the right infant receives the right breast milk, Hospital policy required nursing staff to scan the labels on the breast milk bottle and the anklet on the infant's ankle, to assure that the two matched. The information on the label included the patient's name, and date and time of pumping.

Observation of RN #4, on 3/5/13 at approximately 8:30 A.M., indicated the RN scanned the breast milk label and then scanned a label that was taped to Patient #17's isolette. Not the patient's anklet. After intervention by the Surveyor, the RN scanned the infant's anklet.

During interview on 3/5/13 at approximately 9:15 A.M., the NICU Nurse Manager acknowledged that scanning a label taped to the isolette rather that the anklet on the patient's ankle could lead to an error if the label fell off the isolette and was placed on the wrong patient's isolette.

Observation in the NICU at approximately 10:00 A.M. on 3/5/13, indicated that 7 of 9 isolettes had a scanning label taped to each of the isolettes, providing a risk for the wrong patient to receive the wrong mother's milk.

8. Observations on the Wesson 4 Unit at 9:05 A.M. on 3/6/13, indicated that the computer screen and drawers of the Pyxis machine (used for storage of patients' medications) were soiled.

Review of Infection Control policy 47, Pyxis cleaning was supposed to be done by Pharmacy Technicians during their monthly unit inspections. At that time the Pyxis machines were to be "wiped clean."

During the observation, the Vice President of Quality Management said the front of Pyxis machine and the Pyxis computer screen were very soiled and looked like they had not been cleaned for some weeks.

Based on observations, record review and interview, the Hospital failed to implement policies for maintenance of the sterile surgical field and hand hygiene for 1 (#17) of 17 Outpatients. Findings include:

1. For Surgical Outpatient #17, the Surgical Technician failed to implement policies for maintenance of the sterile surgical field in an operating room in the Daly building.

a. According to the Hospital's Policy on Aseptic Technique Guidelines, for maintenance of a sterile field, stated under purpose, "Aseptic practices are implemented preoperatively, intraoperatively, and postoperatively to minimize wound contamination and reduce patient risks for surgical site infections." Under procedure "1. Scrubbed persons should function within a sterile field.. b. Personnel within the sterile field should wear appropriate surgical attire."

b. According to the Association of peri-Operative Registered Nurses, 2013, Surgical Attire Recommendation IV, states, "All personnel should cover head and facial hair, including sideburns and the nape of the neck, when in semirestricted and restricted areas...Hair acts as a filter when it is uncovered and collects bacteria...Head covering designed to contain hair and scalp skin will minimize microbial dispersal."

c. On 3/5/13 from 4:05 P.M. until 4:22 P.M., the Surveyor observed Surgical Technician #1 in operating room (OR) #8 preparing the sterile table and also in close proximity to the surgical incision with a surgical hood (head covering) which did not completely contain all his/her hair. Hair on the right side of his/her head was exposed by a 2 by 2 inch area. The surgical hood was ill-fitting.

During an interview with the Director of Surgery and Anesthesia on 3/5/13 at 4:22 PM., the Surveyor pointed out that the Surgical Technician's head covering did not contain all the hair. The Director of Surgery and Anesthesia said that the Surgical Technician's hair should have been completely covered.

d. Review of the Hospital's policy on Hand Hygiene stated, "Hand hygiene is the single most important means of preventing the spread of infection." under Procedure it states, "Alcohol rub agent will be used; a. Before direct contact with patients...c. Before inserting invasive devices... f. Between activities on the same patient... and g. After contact with contaminated equipment or surfaces."

On 3/5/13 at 3:05 P.M., Circulating Nurse (CN) #6 was getting OR #8, in the Daly Building, ready for Surgical Outpatient #17's surgery. CN #6 obtained a tongue blade from the cabinet, dropped it on the floor, and picked it up, contaminating her right gloved hand. She then touched on the OR table, and secured the back of the surgical gown of the Surgical Scrub Technician, with his/her contaminated gloved hands, contaminating the gown and the OR table.

CN #6 failed to removed the contaminated gloves, perform hand hygiene and don a new clean pair of gloves after contaminating his/her gloves by touching the floor.

During an interview with CN #6 on 3/5/13 at 3:05 P.M. the Surveyor discussed the breeches with the handwashing and touching the OR table in the OR. She said, "I did not wash my hands."

Based on record review and interview, the Hospital failed to ensure for 3 (#15, 16, and 17) of 17 outpatients and 1 (#29) of 54 inpatients that the History and Physical (H&P) was updated to include any changes in the patient's condition, and that the H&P was documented within 24 hours after admission or registration when the medical H&P was completed within 30 days before admission. Findings include:

1. For Patients #15, #16, #17, and #29, the hospital failed to ensure that the patients had an updated physical examination prior to surgery, as required.

Review of the Updated H&P Form indicated that it read, "I have examined the patient and reviewed the history and physical that was completed within the last thirty days and there are no changes unless they are noted below." However, this form was not completed, other than the surgeon's signature. The surgeon did not perform a brief physical. The medical record lacked documentation at a minimum of a heart and lung check by the Surgeon or the Anesthesiologist.

During an interview on 3/5/13 at 4:50 P.M. the Anesthesiology Director of Clinical Affairs was asked if (s)he performed a physical examination as part of the updated H&P. (S)he indicated the Pre-Anesthesia Form was the updated history and physical. This section of the form only contained pertinent laboratory results and interpretation of the electrocardiogram. When the Surveyor asked if a physical was done, (s)he stated that a physical is "not" done (such as listening to the patient's heart and lungs) unless there is a problem such as asthma.

During an interview on 3/6/13 at 10:30 A.M. the Medical Director of the Operating Room, was asked to explain to the Surveyor the medical record with the History and Physical Focused Form. (S)he stated that the Patient is asked if there had been any changes in their health since the last examination, and if there were no changes, then the form is signed as part of the updated H&P. When the Surveyor asked if the Surgeons actually do a physical exam as part of the updated physical, (s)he stated, "No, they do not do a physical prior to surgery, but if it was needed, then it would be discussed how it could be done."