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Based on observation, interview, and record review, the facility failed to ensure the nursing department was organized and provided quality and competent nursing care to patients by failing to ensure:

1. Patient 4's condition was evaluated during the administration and dose adjustment of propofol (hypnotic agent) in accordance with the facility policy. This failure had the potential to result in unrecognized adverse reactions from medication dose adjustments (Refer to A395),

2. Registered Nurse (RN) 1, the primary circulating nurse in the operating room, received education and training to ensure skills and competency were adequate to perform all aspects of the position. This failure had the potential for items used during the surgical procedure to be left in the patient's body causing complications and infection for five of five records reviewed (Patients 10, 11, 12,13, and 16) (Refer to A944 and A951),

3. Patient 11, who was diagnosed with Stage III and IV pressure ulcers (full thickness skin loss) was repositioned routinely per the facility practices, (Refer to A 395),

4. A care plan was implemented to include an educational intervention for Patient 15, diagnosed with lice, and a care plan was implemented for her roommate, Patient 16 who was at risk of catching lice (Refer to A395),

5. A care plan was implemented for Patient 14 who had a suprapublic catheter, (a tube in the abdomen which drains urine directly from the bladder) (Refer to A 395),

6. A care plan was implemented for Patient 9 who was at risk of bleeding secondary to receiving warfarin (an anticoagulant) (Refer to A 395),

7. Infection control and prevention plans of care were developed and implemented for Patients 2 and 6 when they were identified as having a history or had tested positive for bacteria requiring specific isolation precautions (Refer to A 395),

8. Management of enteral tube feedings (use of a tube to feed patients, either into the nose to the stomach, or directly into the stomach) were performed by staff qualified and educated in that specific skill. This failure led to the facility's certified nursing assistants turning enteral feedings on and off when performing various bedside duties for the patients, without specific training, (Refer to A 397).

9. Preparation and administration of the medication propofol was in accordance with the physician's order for Patient 4 and Patient 5, (Refer to A405),

10. Carbepoetin alpha (an injectable medication used to treat anemia) was administered in accordance with the physician's order for Patient 2, (Refer to A405),

11. Intravenous narcotic pain medications were administered in the times recommended by the facility's reference documents for Patients 24 and 21, (Refer to A405),

12. The patients received the complete dosage of medication ordered by their physician for Patients 14 and 15, (Refer to A405) and;

13. Patient 16's heart rate was taken and documented when the physician's order for Metoprolol tartrate (a medication to treat high blood pressure), indicated the medication was to be held if Patient 16's heart rate was less than 70 (Refer to A405).


The cumulative effect of these systemic practices resulted in the failure of the facility to deliver statutorily mandated compliance with the Federal regulations for the condition of Participation: Nursing Services, to ensure quality patient care in the facility.

Based on interview, and record review, the facility failed to ensure surgical services were provided to all patients to ensure surgical services were supplied in a safe manner. The facility failed to consistently perform surgical counts by failing to ensure:

1. Registered Nurse (RN) 1, the primary circulating nurse in the operating room (OR) had the education and training necessary to perform all aspects of the job, (Refer to A944 and A951) and,

2. Surgical counts (the counting of instruments, needles, gauze or sponges) were conducted in accordance with the facility's policy and nationally accepted standards of practice. This failure led to the lack of implementing surgical counts during surgeries for five sampled patients,(Patients 10, 11, 12, 13, and 16) in the facility's Operating Room (OR), with the potential for medical items to be left in a body cavity causing injury to those patients, (Refer to A944 and A951).


The cumulative effect of these systemic practices resulted in the failure of the facility to deliver statutorily mandated compliance with the Federal regulations for the Condition of Participation: Surgical Services, to ensure quality patient care in the facility.

2. Observations of Patient 11 were conducted on July 23, 2013, at 10 a.m., noon, and 2 p.m., and on April 24, 2013, at 10 a.m., 2 p.m., and at 4 p.m. Patient 11 was observed lying on his back during these times.

A review of Patient 11's record was conducted. Patient 11 was admitted to the facility on June 21, 2013, with a diagnosis of multiple pressure ulcers (bedsores). The patient had a Stage IV pressure ulcer to the coccyx, (full thickness tissue loss with exposed bone, tendon or muscle that could also include undermining and tunneling).

Further record review indicated a wound vac was being utilized for Patient 11's stage IV pressure ulcer (a continuous suction device which drains excess bodily fluids via tubing from the area, promoting wound healing).

Patient 11 also was diagnosed with a Stage III pressure ulcer to the right heel (full thickness tissue loss with no bone, tendon or muscle exposure). Both pressure ulcers were surgically debrided (surgical removal of dead tissue) in the operating room at the facility.

An interview was conducted with Patient 11's Family Member (FM) on July 24, 2013, at 8:30 a.m. The FM stated, "(Patient 11) is always on his back, he is not turned. I have notified the staff multiple times about this and (Patient 11) still is not turned. Today I told the physician who oversees his wound care, he agrees (Patient 11) must be turned regularly."

A review of the facility's policy and procedure, "Pressure Ulcer Prevention and Treatment, (Release Date: 02/2013)," was conducted. The Prevention Components indicated, "Preventative and health skin care interventions are utilized and may include but not limited to: a. Reduce pressure, friction & shear, Repositioning at intervals determined per patients risk level and condition. A minimum of every 2 hours for those patients determined to be at moderate to high risk."



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Based on observation, interview, and record review, the facility failed to ensure:

1. The Registered Nurse evaluated the patient's condition during the administration and dose adjustment of the propofol (a sedative medication that is short-acting, administered intravenously in a controlled setting), in accordance with the facility policy. This had the potential to result in unrecognized adverse reaction from the medication dose adjustment for Patient 4; and,

2. The facility staff routinely repositioned the patient, diagnosed with both Stage III and IV pressure ulcers (full thickness skin loss), per the facility policy (Patient 11). This failure had the potential to result in the worsening of the patient's pressure ulcers.

Findings:

1. On July 24, 2013, Patient 4's record was reviewed. The physician's orders included:

"Propofol, IV (intravenous) drip, 100 ml (milliliter), Do Not Exceed 100 mcg/kg/min (micrograms/kilogram/minute), Initiate infusion at 5 mcg/kg/min - Increase rate in increments of 5 mcg/kg/min every 5 minutes to achieve desired sedation level - Titrate to Ramsay score of 3 - Discontinue at 10 mcg/kg/min every 10 minutes (dated July 23, 2013, at 10:44 a.m.), Start today, cont. (continuous)."

Ramsay Sedation Scale (RSS) - A scale that is used to determine the patient's level of sedation. The RSS scores are as follows:

1 - Patient is anxious and agitated or restless, or both;
2 - Patient is co-operative, oriented, and tranquil;
3 - Patient responds to commands only;
4 - Patient exhibits brisk response to light glabellar (between the eyebrows) tap or loud auditory stimulus;
5 - Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus; and
6 - Patient exhibits no response

The record indicated the patient's current weight was 109 kg.

The Nurses' Notes indicated on July 24, 2013:

"At 6:37 a.m., Patient 4's propofol rate was at 13 ml (milliliter) (per hour) (equivalent to 19.9 mcg/kg/min);

At 9 a.m., Sedation Vacation-Assessment for readiness to extubate sedation vacation...***VAP (Ventilator Associated Pneumonia) Bundle***; Comment: Propofol turned off, Pt (patient) becomes extremely agitated and fights the vent. Did not follow commands but moved all extremities restlessly. Propofol resumed at 20 mcg/kg/min. will titrate to ramsey[sic] scale of 3...

Comment: Pt on Propofol drip at 20 mcg/kg/min continues to fight vent. Vent alarms alarming. Pt extremely agitated. O2 (Oxygen) sats 97%. ramsey scale 6 (should actually indicate "1"). Increased drip to 30 mcg/kg/min. Continue to monitor."

(A VAP Bundle is a series of interventions related to ventilator care that, when implemented together, will achieve significantly better outcomes in preventing VAP.)

On July 24, 2013, at 10:25 a.m., Patient 4 was observed receiving Propofol by IV pump infusing at the rate of 30 mcg/kg/min (19.8 ml/hr).

On July 24, 2013, at 11 a.m. and 11:45 a.m., Patient 4's record was reviewed with Registered Nurse (RN) 6. RN 6 stated the patient was on 20 mcg/kg/min when she took over the patient's care from the night shift. She stated she performed a "sedation vacation" for the patient by turning the propofol off. RN 6 stated this was the same time she changed the bottle of propofol. She stated she had the medication off for approximately three minutes. RN 6 stated, since the patient became agitated, she turned the propofol back on at 20 mcg/kg/min, and had it running for approximately three minutes at this rate. RN 6 stated she increased the propofol rate to 30 mcg/kg/min, because the patient remained agitated (RN 6 increased the propofol by 10 mcg/kg/min, instead of 5 mcg/kg/min, per physician's orders).

On July 24, 2013, at 3 p.m., Patient 4's record was reviewed with the Chief Nursing Officer (CNO), Clinical Educator (CE), and RN 7 (Intensive Care Unit - ICU). The CE stated Patient 4's propofol orders implied the patient's propofol should be increased 5 mcg/kg/min every five minutes, until a Ramsay score of "3" was met.

On July 25, 2013, at 8:40 a.m., Patient 4's record was reviewed with the CNO and the CE. The record indicated RN 6 obtained a set of vital signs, including the oxygen saturation on July 24, 2013, at 9 a.m. (before the propofol was turned off and turned back on; and before increasing the medication). The next set of vital signs were taken at 10 a.m. (approximately 50 minutes after the propofol was turned back on and the dose increased).

In a concurrent interview, the CNO stated the RN should have allowed the propofol to run for five minutes before increasing the rate of the medication, in which it should have only been increased to 5 mcg, instead of the 10 mcg. The CNO stated the vital signs should have been taken when the medication was turned back on and "titrated (increased)."

The facility policy titled, "Propofol (Diprivan) Continuous Infusion Outside of the procedure/surgery area (dated November 2010)," was reviewed. The policy indicated:

"Dosing and Administration:

Titration: Increase by 5 micrograms/kg/min (0.3 to 3 mg/kg/hr [milligram/kilogram/hour]) every 5 minutes until desired level of sedation achieved. Infusion rates of 5-50 micrograms/kg/min may be required to reach adequate sedation...

Assessment/Monitoring:

...Vital signs including cardiac rhythm, blood pressure, and oxygen saturation should be monitored and documented every 15 minutes during active dose titration and at least every 2 hours when propofol is infusing but not being titrated..."

According to Lexicomp (a nationally-recognized drug reference):

"Propofol...Rate of Administration:

Administer slowly to minimize adverse effects (e.g., hypotension, respiratory depression)...For IV injection, administer in incremental doses...Adjust rate of continuous IV infusions according to individual requirements...

...Allow sufficient time between dosage adjustments for onset of peak response..."

The facility failed to assess Patient 4's condition in between restarting and adjusting the propofol.

Based on observation, interview and record review, the facility failed to ensure:

1. A care plan was developed that included an education intervention for Patient 15, diagnosed with lice, and a care plan was developed for her roommate, at risk of exposure to lice, Patient 16,

2. A care plan was implemented for Patient 14, who had a suprapubic catheter (a tube in the abdomen which drains urine directly from the bladder),

3. A care plan was implemented for Patient 9, who was at risk of bleeding secondary to receiving warfarin (an anticoagulant); and,

4. Infection control and prevention plans of care were developed and implemented for Patients 2 and 6 when they were identified as having a history or had tested positive for bacteria requiring specific isolation precautions. This failure had the potential to spread the infection to patients, staff, and visitors.

Findings:

A review of the facility policy, "Care Plan and Teaching Record, Multidisciplinary (Approval Date: 2011)," was conducted. The policy indicated, "It is the policy of (the facility) to develop a Care Plan and teaching record for each patient admitted at the hospital....The Care Plan and Teaching record will be initiated by an RN (registered nurse) within 8 hours of the patient's admission..."

1. An observation of Room 11 was conducted on July 23, 2013, at 8:30 a.m. A sign posted on the outside of the room indicated "Contact Precautions. An additional note on the sign indicated that head covering needed to be used. Patient 16 was observed in Bed A, Patient 15 was observed in Bed B.

A review of Patient 15's record was conducted. Patient 15 was admitted to the facility on July 13, 2013, to Room 11, Bed B, with a diagnosis of pancreatitis (infection of the pancreas). On July 18, 2013, at 3:56 p.m. the nursing note indicated, "Observed that patient has several head lice (pediculosis, known to transmit diseases), in the pillow and on the flat sheet while CNA (Certified Nursing Assistant) giving her a bedbath. Notified Dr and obtained order to isolate the patient and notify pharmacy for treatment."

A review of Patient 16's record indicated the patient was admitted to the facility on June 12, 2013. Patient 16 was in Room 11 when Patient 15 was admitted.

Further record review failed to show a care plan was implemented for Patient 15 to address the patient's lice, and for Patient 16 who was cohorted in the same room.

Further record review failed to show education for Patient 15 was implemented to specifically address the patient's lice and implications involved.

An interview was conducted with the Infection Control Practitioner (ICP) on July 23, 2013, at noon. The ICP stated a care plan for Patient 15 was not implemented nor was a care plan implemented for Patient 16, who was cohorted with Patient 15. The ICP further stated education for Patient 15 was not documented.

2. An observation of Patient 14 was conducted on July 23, 2013, at 10 a.m. Patient 14 was observed to have a catheter (tube draining urine from the bladder) which was draining dark amber urine.

A review of Patient 14's record indicated Patient 14 was admitted to the facility on July 18, 2013, with a diagnosis of calculi (stones) in the bladder. The patient had a suprapubic catheter placed prior to his admission to the facility.

Further record review failed to show that a care plan was implemented which addressed the patient's suprapubic catheter.

An interview was conducted with the Registered Nurse (RN) 4 on July 24, 2013, at 11:15 a.m. RN 4 stated a care plan which addressed Patient 14's suprapubic catheter was not implemented.



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4. On July 23, 2013, at 9:10 a.m., in the Intensive Care Unit (ICU), Room 21 had a sign posted outside of the room indicating the patient was on enteric contact precautions (requiring individuals to wear Personal Protective Equipment [PPE - gown and gloves], remove the PPE before leaving the room, and washing their hands with soap and water).

On July 24, 2013, at 9 a.m., Restorative Nursing Assistant (RNA) 1 was observed entering Patient 6's room (Room 21) wearing PPE. RNA 1 removed all PPE prior to leaving the room, and used alcohol based hand rub (ABHR). RNA 1 proceeded to Room 24, used ABHR and was about to put on PPE preparing to enter Room 24. Prior to putting on the PPE, RNA 1 was interviewed. RNA 1 stated he was not familiar with the difference between enteric contact precautions and the regular contact precautions. RNA 1 was not aware he should have washed his hands with soap and water upon leaving Room 21.

On July 24, 2013, at 9:40 a.m., Respiratory Care Practitioner (RCP) 1 was observed entering Patient 6's room (Room 21). RCP 1 put on PPE, drew blood from the patient, and removed all PPE prior to leaving the room. RCP 1 was not observed performing any hand hygiene after leaving the room. RCP 1 proceeded to walk back towards the laboratory. In a concurrent interview, RCP 1 confirmed she did not perform hand hygiene. RCP 1 was not aware of the difference between enteric contact precautions and regular contact precautions.

On July 25, 2013, Patient 6's record was reviewed. The patient's stool culture tested positive for clostridium difficile (a bacteria found in the intestinal cavity that required enteric precautions) on July 22, 2013, at 4:51 p.m. The patient's record did not contain a plan of care specifically addressing the positive clostridium difficile test results.

On July 25, 2013, at 10:15 a.m., Patient 6's record was reviewed with the ICP and the facility's Regional Director for Infection Control (RDI). The ICP and RDI were not able to find a plan of care specifically addressing the positive clostridium difficile test results.

b. On July 23, 2013, at 9:10 a.m., in the Intensive Care Unit, Room 18 had a sign posted outside of the room indicating the patient was on contact precautions, requiring individuals to wear Personal Protective Equipment (PPE - gown and gloves), while in the room. In addition, the sign indicated individuals should perform hand hygiene before entering and when exiting the room. Inside the patient's room, there were two individuals observed not wearing any PPE.

On July 24 and July 25, 2013, Patient 2 (the patient in Room 18) was observed walking with rehabilitation staff along the ICU hallways. The two individuals assigned to constantly watch the patient, were observed walking along the hallways.

On July 23, 2013, at 12:40 p.m., the ICP was interviewed. The ICP stated the two individuals in Patient 2's room needed to observe the patients at all times and were not required to wear PPE. The ICP stated the individuals watching the patient were expected to at least perform hand-hygiene protocols before entering and leaving the room. The ICP stated the facility did not have a current policy that addressed how these specific individuals would be provided information to prevent the spread of infection.

On July 25, 2013, at 10:15 a.m., Patient 2's record was reviewed with the ICP and the facility's Regional Director for Infection Control (RDI). Patient 2 was admitted to the facility on July 2, 2013, with a history of Methicillin Resistant Staphylococcus Aureus (MRSA - a bacteria resistant to a strong antibiotic). The ICP and RDI were not able to find documented evidence that the individuals required to watch the patient were provided information regarding infection control and prevention for Patient 2's history of MRSA on admission. Both were also unable to find a plan of care to prevent the spread of infection developed on admission.



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3. A review of Patient 9's record was conducted on July 24, 2013. Patient 9 was admitted to the facility on July 10, 2013, with the diagnosis of kidney failure.

The physician order dated July 21, 2013, indicated Patient 9 was taking the medication warfarin.

Warfarin is a medication commonly called a "Blood Thinner" used to treat blood clots and/or prevent new clots from forming. The Davis Drug Guide For Nurses (a drug reference guide) 2013 Edition, indicated patients who were taking the medication needed to have frequent laboratory tests to ensure blood levels were in a safe range. The guide indicated the medication Warfarin had side effects that included life threatening uncontrolled bleeding, adverse interactions with multiple medications, and bruising.

A review of Patient 9's record failed to show a care plan was implemented which indicated the nursing care, monitoring, and precautions needed for a patient that was taking the medication Warfarin.

During an interview with the CE (Clinical Educator), on July 24, 2013, at 2:45 p.m., he stated (the facility) "Doesn't usually care plan drugs like Warfarin, but the chart (record) should have indicated bleeding precautions."

Based on observation and interview, the facility failed to ensure management of enteral tube feedings (use of a tube to feed patients, either into the nose to the stomach, or directly into the stomach) were performed by staff qualified and educated in that specific skill. This failure led to the facility's CNAs (Certified Nursing Assistants) turning enteral feedings on and off when performing various bedside duties for the patients without the education to perform the task.

Findings:

An observation of Patient 25 was conducted on July 23, 2013, at 9:30 a.m. Patient 25 was observed with a
gastric tube (feeding tube from the abdomen directly to the stomach). The patient was receiving Glucerna 1.2 (a tube feeding solution), via an electronic pump.

CNA 1 was observed turning off Patient 25's tube feeding on July 23, 2013, at 9:35 a.m. A concurrent interview was conducted with CNA 1 who stated she placed the tube feedings on hold when she bathed or turned the patient and then restarted the tube feeding when she completed patient care.

An observation of Patient 5 was conducted on July 23, 2013, at 9:45 a.m. Patient 5 was observed to have a naso gastric tube (feeding tube from the nose into the stomach). The patient was receiving Pulmocare (a feeding solution), via an electronic pump.

CNA 2 was observed assisting Patient 5 with repositioning on July 23, 2013, at 9:50 a.m. A concurrent interview was conducted with CNA 2 who stated she placed the gastric tube feeding on hold and would restart tube feeding after she finished taking care of the patient.

An interview was conducted with CNA 3 on July 24, 2013, at 9:30 a.m. CNA 3 stated when giving patient care, she placed the tube feedings on hold and then restarted them. CNA 3 stated she was not educated to perform this task and learned the skill by watching other CNAs do it.

An interview was conducted with the Registered Nurse (RN) 2 on July 23, 2013, at 10 a.m. RN 2 stated only an RN or a Licensed Vocational Nurse can place a tube feeding on hold or restart the tube feeding.

An interview was conducted with the Clinical Educator on July 24, 2013, at 10 a.m. The Clinical Educator stated, "CNAs are not to turn naso gastric or gastric tube feedings on hold in order to conduct patient care and then restart them. The CNAs should have a licensed nurse perform that task as they have not been trained to turn tube feeding equipment on and off."

4. a. During a medication pass observation on July 24, 2013, at 9:25 a.m., Registered Nurse (RN) 2 was observed administering Dilaudid (a narcotic pain medication) 2 milligrams (mg) intravenous push (IVP) through a central venous line (CVL-an intravenous tubing inserted for continuous access to a central vein for administering fluids and medications) to Patient 24. The RN was observed administering the medication over a one minute duration.

At that same time, in an interview with RN 2, she stated, "I usually give this medication over 30 seconds to one minute."

b. During a medication pass observation on July 24, 2013, at 12:40 p.m., RN 2 was observed administering Dilaudid 2 mg IVP through a CVL to Patient 24. The RN was observed administering the medication over one minute and 30 seconds.

A review of MICROMEDEX, the facility's medication reference located on the nursing staff's computers, indicated, "Hydromorphone Hydrochloride [Dilaudid] Intravenous: ...administer slowly over at least 2 to 3 minutes. Monitoring...signs of respiratory depression, particularly in...debilitated patients..."

c. During a medication pass observation on July 24, 2013, at 3:30 p.m., RN 2 was observed administering Morphine Sulfate (a narcotic pain medication) 6 mg to Patient 21. The RN was observed administering the medication over two minutes and 15 seconds.

At that same time, RN 2 stated she did not dilute the morphine with sterile water.

On July 24, 2013, at 3:40 p.m., in an interview with the Director of Pharmacy (DOP) she stated, "When the medication is diluted it is easier [to ensure a more accurate administration time can be determined] to push over 4 to 5 minutes than if it is that little bit [meaning, 1 ml]."

A review of MICROMEDEX, the facility's medication reference located on the nursing staff's computers, indicated, "Morphine Sulfate...Intravenous; administer very slowly; alternatively, a strength of 2.5 to 15 mg may be diluted in 4 to 5 milliters (ml) of sterile water for injection and administer IV over 4 to 5 minutes.
Monitoring:signs and symptoms of respiratory depression..."

On July 25, 2013, at 1:50 p.m., an interview was conducted with the Clinical Educator (CE). The CE stated, "No, I don't go over IVP medications, they are RNs, they should know how to give it. That's not part of the orientation. I don't go over infusion times."



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5 a. An observation of Patient 14 was conducted on July 23, 2013 at 9:45 a.m. An intravenous bag (IV) labeled as Daptomycin IV 500 milligrams (an antibiotic) was observed. Medication was observed remaining in the glass vial attached to the Patient's IV bag. The IV bag was empty with no antibiotic remaining.

An observation of Patient 14's IV bag and the attached medication vile was conducted by Patient 14's Physician (MD) 1, on July 23, 2013, at 10:10 a.m. A concurrent interview was conducted with MD 1 who stated residual medication was remaining in the vial, which could result in an underdosage of the antibiotic.

A review of Patient 14's record was conducted. Patient 14 was admitted to the facility on July 18, 2013, with a diagnosis of digestive system disorders. The patient's surgical history included colostomy placement (system which drains stool into a bag through an opening in the abdominal wall). The patient was currently being treated for Vancomycin Resistant Enterococci (a bacteria resistant to Vancomycin an antibiotic) secondary to a rectal abscess.

An interview was conducted with the Director of Pharmacy (DOP) on July 24, 2013, at 4 p.m. The DOP stated when the vial of medication is attached to the IV bag the IV fluid is mixed with the medication in the glass vile which makes an open system. In order for the patient to receive the complete dose of the medication all the medication in the vial must be administered.

b. An observation of Patient 15 was conducted on July 24, 2013, at 9:15 a.m. An intravenous bag (IV) labeled as Vancomycin 1 Gram (an antibiotic) was observed. Medication was observed in the glass vial attached to the IV bag. The IV bag was empty with no antibiotic remaining.

A review of Patient 15's record was conducted. Patient 15 was admitted to the facility on July 13, 2013, with a diagnosis of pancreatitis (infection of the pancreas). The patient also had a history of Clostridium Difficile Colitis (infection of the colon).

An interview was conducted with the Registered Nurse (RN) 11 on July 24, 2013, at 9:25 a.m. RN 11 stated there was 5 to 10 cubic centimeters of medication remaining in the glass vial which was not infused, meaning Patient 15 did not receive the entire dose of the antibiotic.

An interview was conducted with the Director of Pharmacy (DOP) on July 24, 2013, at 4 p.m. The DOP stated when the vial of medication is attached to the IV bag the IV fluid is mixed with the medication in the glass vial which makes an open system. In order for the patient to receive the complete dose of the medication all the medication in the vial must be administered.

6. A review of Patient 16's record was conducted. Patient 16 was admitted to the facility on June 12, 2013, with diagnoses of stroke, irregular heart rhythms, and high blood pressure.

Further record review indicated Metoprolol tartrate, (for high blood pressure) ordered July 4, 2013, was to be administered via feeding tube one 50 milligram tablet every 12 hours, to be held for a heart rate of less than 70.

A review of the medication detail report indicated on July 19 at 9:04 p.m., on July 23, at 10:10 p.m. and on July 24, 2013, at 8:06 a.m., the Metoprolol tartrate was administered with no heart rate documented.

Further review of the medication detail report indicated on July 20, at 9:26 a.m. and on July 23, 2013, at 8:36 a.m., the Metoprolol tartrate was not administered with no heart rate documented.

An interview was conducted with the Registered Nurse (RN) 1 on July 24, 2013, at 2 p.m. RN 1 stated every medication which had parameters to follow must have the appropriate parameters documented.





25338

Based on observation, interview, and record review:

1. For Patient 4, the facility failed to ensure the patient received the propofol (a sedative medication that is short-acting, administered intravenously in a controlled setting) according to the physician's order. The patient failed to ensure the patient was not subjected to sudden and immediate withdrawal from the propofol administration according to facility policy. The facility failed to ensure the patient received the increase in propofol dosing according to the physician's order;

2. For Patient 5, the facility failed to prepare and administer the propofol in accordance with the physician's order;

3. For Patient 2, the facility failed to administer the darbepoetin alpha (an injectable medication used to treat anemia) in accordance with the physician's order;

4. For Patients 24 and 21, the facility failed to ensure intravenous narcotic pain medications were infused for the recommended time,

5. For Patients 14 and 15, the facility failed to ensure the patients received the complete dosage of medication ordered by their physician, and;

6. For Patient 16, the facility failed to ensure the patient's heart rate was taken and documented when the physician's order for Metoprolol tartrate (a medication to treat high blood pressure), indicated the medication was to be held if Patient 16's heart rate was less than 70.

These failures resulted in medication administration errors, which subsequently had the potential to result in ineffective care and treatment; and adverse health outcomes.

Findings:

The facility policy titled, "Propofol (Diprivan) Continuous Infusion Outside of the procedure/surgery area (dated November 2010)," was reviewed. The policy indicated:

"Dosing and Administration:

Titration: Increase by 5 micrograms/kg/min (0.3 to 3 mg/kg/hr [milligram/kilogram/hour]) every 5 minutes until desired level of sedation achieved. Infusion rates of 5-50 micrograms/kg/min may be required to reach adequate sedation...

Assessment/Monitoring:

...Vital signs including cardiac rhythm, blood pressure, and oxygen saturation should be monitored and documented every 15 minutes during active dose titration and at least every 2 hours when propofol is infusing but not being titrated...

Perform wake-up assessment daily to evaluate neurological status.
- Avoid abrupt discontinuation of propofol;
- Reduce infusion rate by 5 micrograms/kg/min every 5 minutes until the patient is arousable and can cooperate with the evaluation. Maintain this light level of sedation until the evaluation is completed;
- A neurological assessment must be performed during the wake-up period;
- Titrate the infusion back up to desired level of sedation once assessment complete.

Weaning from Ventilator - Before weaning patients from mechanical ventilation, decrease Propofol infusion by 5 micrograms/kg/min every 5 minutes to maintain light sedation, or a minimum score of Ramsay Scale 2. Propofol must be discontinued for a minimum of 15 minutes prior to extubation or discontinuation of mechanical ventilation."

Ramsay Sedation Scale (RSS) - A scale that is used to determine the patient's level of sedation. The RSS scores are as follows:

1 - Patient is anxious and agitated or restless, or both;
2 - Patient is co-operative, oriented, and tranquil;
3 - Patient responds to commands only;
4 - Patient exhibits brisk response to light glabellar (between the eyebrows) tap or loud auditory stimulus;
5 - Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus; and
6 - Patient exhibits no response

1. On July 24, 2013, Patient 4's record was reviewed. The patient physician's orders included:

"Propofol, IV (intravenous) drip, 100 ml, Do Not Exceed 100 mcg/kg/min (micrograms/kilogram/minute), Initiate infusion at 5 mcg/kg/min - Increase rate in increments of 5 mcg/kg/min every 5 minutes to achieve desired sedation level - Titrate to Ramsay score of 3 - Discontinue at 10 mcg/kg/min every 10 minutes (dated July 23, 2013, at 10:44 a.m.), Start today, cont. (continuous);

Propofol, IV inj(ection), 10 mg, To rapidly increase depth of sedation - Use only in patients[sic] where hypotension is not likely to occur (dated July 23, 2013, at 10:19 a.m.); start today, unsched(uled), prn (as needed);

Sedation Vacation-Assessment for readiness to extubate sedation vacation...***VAP (Ventilator Associated Pneumonia) Bundle*** (dated July 19, 2013, at 11:38 p.m.)."

(A VAP Bundle is a series of interventions related to ventilator care that, when implemented together, will achieve significantly better outcomes in preventing VAP.)

The record indicated the patient's current weight was 109 kg.

The Nurses' Notes indicated on July 24, 2013:

"At 6:37 a.m., Patient 4's propofol rate was at 13 ml (milliliter) (per hour) (equivalent to 19.9 mcg/kg/min);

At 9 a.m., Sedation Vacation-Assessment for readiness to extubate sedation vacation...***VAP (Ventilator Associated Pneumonia) Bundle***; Comment: Propofol turned off, Pt (patient) becomes extremely agitated and fights the vent. Did not follow commands but moved all extremities restlessly. Propofol resumed at 20 mcg/kg/min. will titrate to ramsey[sic] scale of 3...

Comment: Pt on Propofol drip at 20 mcg/kg/min continues to fight vent. Vent alarms alarming. Pt extremely agitated. O2 (Oxygen) sats 97%. ramsey scale 6 (should actually indicate "1"). Increased drip to 30 mcg/kg/min. Continue to monitor."

On July 24, 2013, at 10:25 a.m., Patient 4 was observed receiving Propofol by IV pump infusing at the rate of 30 mcg/kg/min (19.8 ml/hr).

On July 24, 2013, at 11 a.m. and 11:45 a.m., Patient 4's record was reviewed with Registered Nurse (RN) 6. RN 6 stated the patient was on 20 mcg/kg/min when she took over the patient's care from the night shift. She stated she performed a "sedation vacation" for the patient by turning the propofol off. RN 6 stated this was the same time she changed the bottle of propofol. She stated she had the medication off for approximately three minutes. RN 6 stated, since the patient became agitated, she turned the propofol back on at 20 mcg/kg/min, and had it running for approximately three minutes at this rate. RN 6 stated she increased the propofol rate to 30 mcg/kg/min, because the patient remained agitated (RN 6 increased the propofol by 10 mcg/kg/min, instead of 5 mcg/kg/min, per physician's orders).

On July 24, 2013, at 11:15 a.m., Patient 4's record was reviewed with the Director of Pharmacy (DOP). The DOP stated the physician's order indicated the propofol dose should be increased 5 mcg/kg/min every five minutes. The DOP stated the propofol, for Patient 4 who was receiving the medication at 20 mcg/kg/min, should not be abruptly stopped. The DOP stated patients on propofol were gradually weaned off propofol if there was a plan to discontinue the medication. The DOP was not familiar with how the "sedation vacation" order applied to the patients.

On July 24, 2013, at 3 p.m., Patient 4's record was reviewed with the Chief Nursing Officer (CNO), Clinical Educator (CE), and RN 7 (Intensive Care Unit - ICU). The CE stated Patient 4's propofol orders implied the patient's propofol could be increased 5 mcg/kg/min every five minutes, until a Ramsay score of "3" was met. The order also allowed the RN to decrease the propofol dose 10 mcg/kg/min every 10 minutes until the lowest dose was achieved. The CE stated the "sedation vacation" order was a process followed when a patient was being prepared to be weaned off from the ventilator (a machine designed to mechanically move air into and out of the lungs), in preparation to "extubate (removing a breathing tube)" a patient. The sedation vacation was not intended for the propofol to be suddenly put on hold or stopped. The sedation vacation was intended as a component of the VAP bundle.

In a concurrent interview, RN 7 was asked to demonstrate how a continuous propofol order and a "prn" propofol order could be administered to a patient using one IV pump and one bottle of the medication. RN 7 and the CE were unable to demonstrate how these two orders could be simultaneously administered. RN 7 stated it was not possible to administer both orders (continuous and prn) at the same time. RN 7 stated the "prn" order was not needed since the continuous administration order had an every five minute "titration" order you could use when needed for the patient.

On July 25, 2013, at 8:40 a.m., the CNO and the CE were interviewed. The CNO and CE stated Patient 4's propofol can be stopped during IV tubing and medication exchange, but not for sedation vacation. The CNO stated the RN should have allowed the propofol to run for five minutes before increasing the rate of the medication, in which it should have only been increased to 5 mcg, instead of the 10 mcg.

According to Lexicomp (a nationally-recognized drug reference):

"Propofol...Rate of Administration:

Administer slowly to minimize adverse effects (e.g., hypotension, respiratory depression)...For IV injection, administer in incremental doses...Adjust rate of continuous IV infusions according to individual requirements...

...In the absence of clinical signs indicating light anesthesia and until a mild response to surgical stimulation develops, titrate infusion rate downward to avoid administration at rates higher than clinically necessary...

...In the absence of clinical signs indicating light anesthesia and until a mild response to surgical stimulation develops, titrate infusion rate downward to avoid administration at rates higher than clinically necessary...
...Allow sufficient time between dosage adjustments for onset of peak response...

...Do not discontinue abruptly (may result in rapid awakening associated with anxiety, agitation, and resistance to mechanical ventilation). Titrate infusion rate so patient awakes slowly..."

2. On July 24, 2013, Patient 5's record was reviewed. The physician's orders included:

"Propofol, IV drip, 100 ml, Do Not Exceed 100 mcg/kg/min, Initiate infusion at 5 mcg/kg/min - Increase rate in increments of 5 mcg/kg/min every 5 minutes to achieve desired sedation level - Titrate to Ramsay score of 3 - Discontinue at 10 mcg/kg/min every 10 minutes (dated July 13, 2013, at 11:16 p.m.), Start today, cont. (continuous)."

The record indicated the patient's current weight was 90.4 kg.

The Nurses' Notes indicated on July 14, 2013, at 12:28 a.m., Patient 5's propofol rate was at 5 ml (milliliter) (per hour) (equivalent to 9.21 mcg/kg/min).

On July 24, 2013, at 2:10 p.m., RN 1 demonstrated the IV pump setting, with all of Patient 5's information. The IV pump indicated, for the patient to receive 5 mcg/kg/min as ordered by the physician, the infusion rate should have been 2.7 ml/hr, not 5 ml (per hour).

On July 25, 2013, at 9:20 a.m., RN 8 (ICU nurse that started and documented the propofol administration) was interviewed by phone. RN 8 stated for propofol orders, the dose concentration was retrieved from the facility electronic medical record's (EMR's) "library." She stated the entry "5 ml" in the nurses' notes represented the amount of propofol being infused in an hour (equivalent to 9.21 mcg/kg/min).

On July 24, 2013, at 2:30 p.m., the IV pump set with Patient 5's information was reviewed with the CNO and the DOP. Both stated, if the patient received the medication at 5 ml (per hour), the patient received the wrong medication dose.

3. On July 23, 2013, Patient 2's record was reviewed. The patient was admitted to the facility on July 2, 2013, with diagnoses that included kidney failure, requiring dialysis. The patient's physician order included, "Darbepotein alpha (Aranesp) subcutaneously injection (given through fatty tissues), 60 mcg (microgram) Q Thursday...Start 07/04/13 16:00 (4 p.m.), q7d (every seven days) ...Instruction: Target Hb (hemoglobin level) 11g/dl (grams per deciliter) for ESRD / HD (end-stage renal disease / hemodialysis) patients...dated July 3, 2013, at 9:57 a.m."

The record indicated Patient 2 received the medications on July 4 and July 18, 2013. There was no record the patient received the medication on July 11, 2013.

On July 23, 2013, at 10:50 a.m., Patient 2's record was reviewed with the Nurse Manager (NM). The record indicated the patient's hemoglobin level was 9.4 g/dl on July 11, 2013. The NM was unable to find documented evidence the medication (Aranesp) was administered on July 11, 2013. The NM provided a printout from pharmacy, which indicated the Licensed Vocational Nurse (LVN) 1 assigned to the patient on July 11, 2013, received the medication supply that day.

On July 23, 2013, at 3:55 p.m., Patient 2's record was reviewed with LVN 1. LVN 1 was unable to find documented evidence that the Aranesp was administered or any reason why the medication was not administered to Patient 2 on July 11, 2013. LVN 1 was unable to recall whether she administered the medication.

The facility policy titled, "Administration of Medications (dated February 2013)" was reviewed and indicated, "...Documentation...The individual administering the medication(s) must document all medications immediately after administration in the patient's medical record...If the medication is not administered ('held' due to blood pressure parameters, patient refused, etc), the appropriate documentation on the MAR (Medication Administration Record) including the reason must be recorded..."

Based on observation, interview and record review, the facility's Director of Dietary Services (DDS) failed to ensure safe practices for food handling were implemented as;

1. The three ounce green scoop, used in the kitchen by the dietary staff, was not air dried prior to being placed in rice to be served to two patients according to the facility's procedure, and,

2. Dietary Staff (DS) 1's hair was not completely covered with a hair net or cap.

These failures may potentially impact the health and safety of all the patients served oral diets.

Findings:

1. A tour and observation of the facility's kitchen was conducted with the Director of Dietary Services (DDS) on July 24, 2013, at 11:20 a.m. The food which was prepared for the lunch service was observed in open warming bins. The Cook was then overhead to ask the Dishwasher to hand her a "green scoop" to serve the cooked rice.

On July 24, 2013, at 11:50 a.m. the Dishwasher was observed placing her hand in a sink filled with sanitizing solution. The Dishwasher then pulled out a green scoop which was dripping with sanitizing solution, handed the scoop to the Cook, who then placed the scoop directly into the cooked rice located in the warming bin.

A concurrent interview was conducted with the DDS who stated to the Cook, "Throw that rice away."

The DDS further stated all items when placed in the sanitizing solution, (Oasis 146 Multi-Quat Sanitizer) must be air dried prior to use. The rice was prepared for two patients on special diets (Patients 25 and 26), and a substitute will be given.

2. An observation and tour of the facility's kitchen was conducted with the Director of Dietary Services (DDS) on July 24, 2013, at 11:30 a.m., through 12:20 p.m. Lunch was observed being cooked, prepared, and placed on trays to be distributed to the patients.

The Dietary Tech (DT) 1 was observed as she assisted with arranging the trays for service and placing drinks, other condiments and the meals onto the trays. During the lunch preparation time, DT 1's hair was protruding approximately 2 inches from her hair cap onto her forehead.

An interview was conducted with DT 1 on July 24, 2013, at 12:40 p.m. DT 1 stated her hair fell out from underneath her cap.

A review of the facility policy, "Food Safety Standards & Requirements, (Review Date: 01/27/2012)," was conducted. The guidelines indicated, "Hair restraints (hairnets, hats or caps) must cover hair sufficiently to prevent hair from falling onto food or food equipment and to minimize hand contact with hair."

Based on interview and record review, the facility failed to ensure the Registered Dietician (RD)'s recommendations in order to meet the patient's nutritional requirements, were communicated to the physician, an order was obtained, and implemented; and the reasoning of any inconsistencies were documented in the physician's order by failing to ensure:

1. The recommendation by the Registered Dietician (RD) 1 for Patient 14, to receive Ensure (a dietary supplement) was implemented,

2. The physician's order for a clear liquid diet and ice chips was consistently implemented for Patient 15,

3. RD 1's recommendation for Patient 1 was clarified with the patient's physician due to a disparity between RD 1's recommendation and the physician's order,

4. RD 1's recommendation for Patient 10 to receive Pro-Stat, (a protein supplement) was addressed by the physician,

5. RD 1's recommendation for Patient 3 to receive Benefiber, (a protein supplement) was addressed by the physician, and;

6. RD 1's recommendation for Patient 10 to receive Pro-Stat, (a protein supplement) was given on a consistent basis throughout the patients hospitalization.

These failures impacted the patient's nutritional needs and potentially their overall medical status.

Findings:

1. An interview was conducted with Patient 14 on July 23, 2013, at 11:15 a.m. Patient 14 was alert and stated, "My appetite is terrible."

A record review indicated Patient 14's was admitted to the facility on July 18, 2013, with a diagnosis of digestive system disorders. The patient's surgical history included colostomy placement (system which drains stool into a bag through an opening in the abdominal wall). Patient 14 also had surgical placement of a suprapubic catheter (tube which drains urine from the bladder through tubing to a drainage bag outside of the abdomen).

A dietary assessment was completed on July 19, 2013. Per the assessment, Patient 14 was deemed to be at a, "High Nutritional Risk." The patient's laboratory values per the assessment indicated, Albumin (protein): 2.6 grams per deciliter (a unit of measure)..."below normal limits." Patient 14's diet order on July 19, 2013, was a regular diet with thin liquids.

The recommendation of RD 1 was, "Ordering Ensure (dietary supplement) Chocolate TID (three times a day) with meals. ASAP (as soon as possible)."

Further record review conducted on July 23, 2013, reflected that the recommendation of RD 1 to add Ensure TID to Patient 14's diet was not implemented.

An interview was conducted with the Registered Nurse (RN) 4, on July 24, 2013, at 12:15 p.m. RN 4 stated if a dietician recommendation was made, the dietician would notify the nurse who notifies the physician. RN 4 further stated the physician was not notified of the RD's recommendation to add the Ensure to Patient 14's diet.

2. A review of Patient 15's record was conducted. Patient 15 was admitted to the facility on July 13, 2013, with a diagnosis of an infected pancreas, persistent nausea, vomiting and diarrhea. The physician's order dated July 16, 2013, at 11:29 a.m., indicated Patient 14 was to be on sips of clear liquid and ice chips.

Further record review indicated on July 19, 2013, Patient 14 drank 180 cubic centimeters (cc-a unit of measure) of milk.

An interview was conducted with RD 1 on July 24, 2013, at 10:50 a.m. RD 1 stated milk was not a clear liquid and should not have been given to Patient 14.



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3. On July 23, 2013, Patient 1's record was reviewed. The patient was admitted on July 11, 2013, with diagnoses that included acute respiratory failure. The patient was on NPO (nothing by mouth) status. The patient received her nutritional needs through tube feeding (TF).

The Registered Dietician (RD) 1's notes, dated July 19, 2013, was reviewed. The RD's recommendation included, "Suggest change the TF formula to Glucerna 1.2 at 65 ml/hr (milliliters per hour) x (for) 22 hr to provide 1430 ml fluids, 1716 kcals (kilo calories), 86 gm (grams) protein...High Risk...Goals: Meet est(imated) needs by 100%..."

The TF order dated July 19, 2013, was reviewed. The order indicated, "Glucerna 1.2...route: tube...50 ml/hr..."

On July 24, 2013, at 8:50 a.m., Patient 1's record was reviewed with RD 1. RD 1 stated she recalled informing the licensed nurse on duty of her TF recommendation on July 19, 2013. She stated the RDs or the licensed nurses could call the physicians to obtain nutritional orders. The RD stated if the physician gave a different order compared to the recommendation by the RD, the order would be documented in the patient's record.

The record did not contain documented evidence explaining the inconsistency in the RD's recommendation (to meet the patient's nutritional needs), compared to what the physician ordered on July 19, 2013.

On July 25, 2013, at 8:40 a.m., the Chief Nursing Officer (CNO) and Clinical Educator (CE) were interviewed. The CE stated since the licensed nurse obtained an order to change the TF, it was not necessary for the licensed nurse to document the reason for the disparity between the rate the RD recommended and the physician's order. The CE stated it was implied that the physician did not want the rate of 65 ml/hr. The CNO stated the RNs were the "messengers" of the RD's recommendation to the physician. The CE or the CNO was not able to find documentation that the licensed nurse discussed the RD's assessment, which indicated the specific TF rate would meet the patient's specific nutritional requirements.

On July 25, 2013, at 12 p.m., RNs 3 and 4 were interviewed. The RNs stated when an RD made recommendations, the RD could post the recommendations in the patient's record under "bulletin." The "bulletin" would enable the physician to review and address the recommendation. RNs 3 and 4 were not able to find an RD recommendation "bulletin" in Patient 1's record.



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4. The record for Patient 10 was reviewed on July 25, 2013. Patient 10 was admitted to the facility on February 2, 2013, with the diagnosis of respiratory failure.

The document titled "Dietary Initial Assessment" (an assessment completed by the RD (Registered Dietician) dated February 4, 2013, indicated, Patient 10 had pressure sores (an area of skin in which blood supply was impaired due to pressure).

The document indicated, "Albumin level of "2.4 g/dl (gram per deciliter-a unit of measure) below normal limits."

An albumin level is a blood test used to determine the amount of protein in the blood. The body uses protein to help wound healing. The normal range of albumin is 3.5 g/dl. to 5 g/dl. (facility laboratory reference).

The document further indicated "Recommendations: Ordering Pro-Stat 64 (a supplement that supplies protein to the body to assist with wound healing) BID (twice a day)...ASAP (as soon as possible)."

The document titled "Physician Orders" dated February 20, 2013, indicated, "Start Pro-Stat bid..."

This was 16 days after the RD recommended the Pro-Stat to start as soon as possible.

During an interview with the DDS (Director of Dietary Services), on July 25, 2013, at 10:15 a.m., she stated "The (Pro-Stat) recommendation should have been addressed by the physician (when recommendation was made)."

5. The record for Patient 3 was reviewed on July 24, 2013. Patient 3 was admitted to the facility on July 18, 2013, with the diagnosis of acute respiratory failure.

The document titled "Dietary Initial Assessment" dated July 19, 2013, indicated Patient 3 was a "High nutritional risk", and laboratory tests done indicating an albumin level of "3.4 g/dl. below normal."

The facility policy titled "Addendum to policy: H-NS-09-001 Nutrition Care Process" dated August, 2012, indicated, a patient was a high nutritional risk when identified as having the potential for a decline in nutritional status related to "...Tube feedings, significant weight loss, difficulty eating..."

The document further indicated "Recommendations: Consider ordering Beneprotein (a protein supplement) TID (three times a day)...when BUN ( a laboratory test indicating kidney function) is less than 100 mg/dl (milligrams/deciliter- a unit of measurement) at your convenience."

The document titled "Laboratory results" dated July 22, 2013, indicated Patient 3's BUN test result was 85 mg/dl.

The document titled "Laboratory results" dated July 23, 2013, indicated Patient 3's BUN test result was 70 mg/dl.

During an interview with the RD (Registered Dietician) 1, on July 24, 2013, at 8:50 a.m., she reviewed the record for Patient 3 and was unable to find documentation that the recommendation for Patient 3 to receive Beneprotein was acted upon.

RD 1 stated recommendations were "Directed to the physician." RD 1 stated "I rarely use that term (at your convenience)....it's vague."

6. The record for Patient 10 was reviewed on July 25, 2013. Patient 10 was admitted to the facility on February 2, 2013, with the diagnosis of respiratory failure, and discharged on May 9, 2013.

The document titled "Dietary Initial Assessment" dated February 4, 2013, indicated Patient 10 had pressure sores.

The document indicated" Albumin level of "2.4 g/dl (gram per deciliter-a unit of measure) below normal limits."

An albumin level is a blood test used to determine the amount of protein in the blood. The body uses protein to assist with wound healing. The normal range of albumin is 3.5 g/dl. to 5 g/dl. (facility laboratory reference).

The document further indicated the RD 1 had recommended "Pro-Stat 64" (a supplement that supplies protein to the body to assist with wound healing) BID (twice a day)...ASAP (as soon as possible)."

The document titled "Physician Orders" dated March 6, 2013, indicated " Pro-Stat, start today (3/6/13)."

During an interview with the DDS (Director of Dietary Services), on July 25, 2013, at 10:15 a.m., she reviewed the record and was unable to find documentation that indicated Patient 10 had received the nutritional supplement after March 5, 2013.

Patient 10 did not receive the nutritional supplement for 65 days.

The DDS stated "I don't know why the Pro-Stat was not given (to Patient 10)."

Based on observation and interview, the facility failed to ensure Room 11 was maintained in a safe and sanitary manner. This failure was observed as medical equipment and trash were located on the floor under and between the beds of Sampled Patients 15 and 16, presenting a safety hazard to Patient 15.

Findings:

During an observation of Patients 15 and 16, in Room 11, conducted on July 23, 2013, at 8:30 a.m., multiple items were observed on the floor between and under their two beds. Items observed included a syringe, two tops from medications vials, two needle covers, three covers from alcohol swabs, pieces of tape and paper.

While walking between the two beds, there was an audible noise as the surveyor's shoes stuck to the floor with each step. A black substance was observed on the floor between the patient's beds.

An observation of Patient 15 was conducted on July 23, 2013, at 8:35 a.m. Patient 15 was observed seated on the bed with her feet on the floor. The patient was barefoot. The items noted above were strewn about, near the patient's feet and bed.

A concurrent interview was conducted with the Certified Nursing Assistant (CNA) 4 who was taking care of Patient 16 in Bed A. CNA 4 stated the floor was sticky and the room had to be cleaned up.

2. On July 25, 2013 at 8:50 a.m., an observation of the facility's main patient hall way located on the north side of the facility was conducted. A large sharps container connected to a supply cart was observed without a lid with two large syringes with long needles were positioned approximately one inch from the top opening accessible to visitors and staff passing through the hall.

In an interview with the Licensed Clinical Social Worker (LCSW) at 8:52 a.m., she stated, "We will change it [meaning the sharps container]"

The facility's policy titled, "Waste Removal," dated 2/2010, indicated in regards to needles, syringes and blades: ...The sharps containers from all rooms will be taped closed when 3/4 full...


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Based on observation, interview and record review, the facility failed to ensure:

1. Four staff members put on appropriate Personal Protective Equipment (PPE) when entering rooms in which the patients were under isolation precautions due to various infectious disease processes, in addition two individuals were not provided information regarding infection control practices and,

2. A sharps container (containers which hold used syringes and other sharp medical equipment), located in a public hallway did not have a secured lid and the contents were accessible to the general public, including visitors and children.

These failures may potentially contribute to injuries in addition to the spread of infections and communicable diseases.

Findings:

A review of the facility policy, "Contact Precautions (Date: 05/2010)," was conducted. The policy indicated, "Use Contact Precautions for patients with known or suspected infections or evidence of syndromes that represent an increased risk of contact transmission. Contact Precautions also apply where the presence of excessive wound drainage, fecal incontinence, or other discharges from the body suggest an increased potential for extensive environmental contamination and risk for transmission.

The procedure indicated, "Don [put on] gloves upon entering a Contact Precautions room. Don gown upon entry into the room or cubicle whenever anticipating that clothing will have direct contact with the patient or potentially contaminated environmental surfaces or equipment in close proximity to the patient."

1. a. An observation of Room 11 was conducted on July 23, 2013, at 9:40 a.m. Posted on the outside of the room, a sign which indicated Contact Precautions was observed. Added to the sign was an additional note which indicated head covering needed to be used.

On July 24, 2013, at 9:15 a.m., the Clinical Educator was observed as he entered Room 11. The Clinical Educator did not don PPE or head covering as he walked over to Patient 15, lying in Bed B and spoke with the patient. The Clinical Educator proceeded to touch Patient 15's intravenous bag, hanging next to the patient's bed.

A review of Patient 15's record was conducted. Patient 15 was admitted to the facility on July 13, 2013, with a diagnosis of pancreatitis (infection of the pancreas). On July 18, 2013, at 3:56 p.m., the nursing note indicated, "Observed that patient has several head lice (pediculosis, known to transmit diseases), in the pillow and on the flat sheet while CNA (Certified Nursing Assistant) giving her a bedbath. Notified Dr and obtained order to isolate the patient and notify pharmacy for treatment."

An interview was conducted with the Infection Control Practitioner on July 23, 2013, at 4 p.m., who stated since Patient 15 had lice, in addition to Contact Precautions, the use of head covering was added to the precautions to implement.




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b. On July 23, 2013, at 9:10 a.m., in the Intensive Care Unit (ICU), a sign posted outside of Room 21 indicated the patient was on enteric contact precautions (requiring individuals to wear Personal Protective Equipment [PPE - gown and gloves], remove the PPE before leaving the room, and washing their hands with soap and water).

On July 24, 2013, at 9 a.m., Restorative Nursing Assistant (RNA) 1 was observed entering Patient 6's room (Room 21). RNA 1 put on PPE, then removed all PPE prior to leaving the room. RNA 1 used alcohol based hand rub (ABHR). RNA 1 proceeded to Room 24, used ABHR and was about to put on PPE and preparing to enter Room 24. Prior to donning the PPE, RNA 1 was interviewed. RNA 1 stated he was not familiar with the difference between enteric contact precautions and the regular contact precautions. RNA 1 was not aware he should have washed his hands with soap and water upon leaving Room 21.

On July 24, 2013, at 9:40 a.m., Respiratory Care Practitioner (RCP) 1 was observed entering Patient 6's room (Room 21). RCP 1 put on PPE, drew blood from the patient, removed all PPE prior to leaving the room. RCP 1 was not observed performing any hand hygiene after leaving the room. RCP 1 proceeded to walk back towards the laboratory. In a concurrent interview, RCP 1 confirmed she did not perform hand hygiene. RCP 1 was not aware of the difference between enteric contact precautions and regular contact precautions.

On July 25, 2013, Patient 6's record was reviewed. The patient's stool culture tested positive for clostridium difficile (a bacteria found in the intestinal cavity that required enteric (intestinal) precautions) on July 22, 2013, at 4:51 p.m.

On July 23, 2013, at 12:40 p.m., the Infection Control Preventionist (ICP) was interviewed. The ICP stated for patients on enteric contact precautions, it was expected that individuals leaving the room would wash their hands with soap and water for at least 15 seconds.

The facility's policy titled, "Management of the Patient with Clostridium Difficile (dated September 2012)" was reviewed and indicated:

"Purpose: To provide guidelines and prevent transmission of Clostridium difficile to patients, visitors, and facility personnel...

Policy...Contact precautions and proper hand hygiene will be followed for all patients with positive Clostridium difficile (C.Diff) stools during the diarrheal phase...Since alcohol is ineffective against spores, hands must be washed with soap and water for 15-20 seconds after removing PPE, instead of using the alcohol hand rub..."

c. On July 23, 2013, at 9:10 a.m., in the Intensive Care Unit, a sign posted outside of Room 18 indicated the patient was on contact precautions, requiring individuals to wear Personal Protective Equipment (PPE - gown and gloves), while in the room. In addition, the sign indicated individuals should perform hand hygiene before entering and when exiting the room. Inside the patient's room, there were two individuals observed not wearing any PPE.

On July 24 and July 25, 2013, Patient 2 (the patient in Room 18) was observed walking with rehabilitation staff along the ICU hallways. The two individuals assigned to constantly watch the patient, were observed walking along the hallways.

On July 23, 2013, at 12:40 p.m., the ICP was interviewed. The ICP stated the two individuals in Patient 2's room needed to observe the patients at all times and were not required to wear PPE. The ICP stated the individuals watching the patient were expected to at least perform hand-hygiene protocols before entering and leaving the room. The ICP stated the facility did not have a current policy that addressed how these specific individuals would be provided information to prevent the spread of infection.

On July 25, 2013, at 10:15 a.m., Patient 2's record was reviewed with the ICP and the facility's Regional Director for Infection Control (RDI). Patient 2 was admitted to the facility on July 2, 2013, with a history of Methicillin Resistant Staphylococcus Aureus (MRSA - a bacteria resistant to a strong antibiotic). The ICP and RDI were not able to find documented evidence that the individuals required to watch the patient were provided information regarding infection control and prevention for Patient 2's history of MRSA on admission. Both were also unable to find a plan of care to prevent the spread of infection developed on admission.

Based on interview and record review, the facility failed to have a system in place to ensure all staff have annual health screenings, influenza vaccines and the initial Hepatitis B vaccine documentation accessible for one employee (Cook 1).

Findings:

A review of the personnel file for the Cook 1 was conducted on July 25, 2013, at 1 p.m. Cook 1's employee file did not include a health screening examination, or documentation of the employee's influenza and Hepatitis B vaccines.

In an interview with Human Resource Director (HRD) at 1:40 p.m., she stated the documents were probably at the facility the cook worked at prior.

Based on interview and record review, the facility failed to ensure Registered Nurse (RN) 1, the primary circulating nurse in the operating room (OR) had the education and training necessary to perform all aspects of the job. RN 1 did not conduct surgical counts (the counting of instruments, needles, gauze or sponges) during surgeries on five of five records reviewed, with the potential for surgical items to be left in the patient's body causing injury to those patients.

Findings:

A review of the facility policy, "Counts: surgical sponges, Needles, Sharps, Instruments (Approval Date: 09/2011)," was conducted. The policy indicated, "to identify the procedure to follow for surgical counts in the operating room. There will be proper counts completed on all needles, sponge and general items used on the operative field. This count will be completed on any operative procedure where there is an incision and the location of the operative site is such that an item could accidentally be left in the wound."

The policy further indicated, "Circulating Nurse...documents the results of the count in the proper section of the Intra-Operative Nursing Record and signs the record."

1 a. The record for Patient 10 was reviewed on July 25, 2013. Patient 10 was admitted to the facility on February 2, 2013, with a diagnosis of respiratory failure.

The document titled, "Perioperative Record" (undated), indicated Patient 10 underwent an incision and drainage (a cut into the skin and removal of fluid) of a gluteal abscess (a collection of pus on the buttock).

The area on the document titled "Potential for injury related to retained foreign object. Sponge, Sharp & Instrument Counts" indicated, "N/A" (not applicable, did not apply to the procedure).

The document further indicated "Patient wound closed with correct counts" (the sponges, sharps (needles) and instruments used in the procedure were all accounted for at the end of the procedure).

b. The record for Patient 11 was reviewed on July 24, 2013. Patient 11 was admitted to the facility on June 21, 2013, with a diagnosis of pressure ulcers (bedsores). The patient had a Stage IV pressure ulcer to the coccyx, (full thickness tissue loss with exposed bone, tendon or muscle. May include undermining and tunneling).

A review of the Perioperative Record dated July 5, 2013, indicated Patient 11 was scheduled for a surgical debridement (surgical removal of dead tissue) of his Stage IV pressure ulcer.

The area on the document titled "Potential for injury related to retained foreign object. Sponge, Sharp & Instrument Counts" indicated, "N/A" (not applicable) on the section of the document which reflected the first, second, and third surgical counts. The final section which reflected, "Patient wound closed with correct counts," also indicated "N/A."

An interview was conducted with the Registered Nurse (RN) 1, on July 24, 2013, at 1 p.m. The document reflected that RN 1 was the Circulating Nurse during Patient 11's surgery. RN 1 stated, "I only do the surgical counts during abdominal surgeries."

c. The record for Patient 12 was reviewed on July 25, 2013. Patient 12 was admitted to the facility on March 3, 2013, with a diagnosis of an infected Stage IV pressure ulcer to the buttocks. Patient 12 was scheduled for a surgical debridement of the Stage IV pressure ulcer on March 7, 2013.

A review of the Perioperative Record dated March 7, 2013, was conducted. The area on the document titled "Potential for injury related to retained foreign object. Sponge, Sharp & Instrument Counts" indicated, "N/A" (not applicable) on the section of the document which reflected the first, second, and third surgical counts. The final section which reflected, "Patient wound closed with correct counts," also indicated "N/A."

An interview was conducted with the Registered Nurse (RN) 1, on July 24, 2013, at 1 p.m. The document reflected that RN 1 was the Circulating Nurse during Patient 12's surgery. RN 1 stated, "I only do the surgical counts during abdominal surgeries."

d. The record for Patient 13 was reviewed on July 25, 2013. Patient 13 was admitted to the facility on May 19, 2013, with a diagnosis of Stage IV pressure ulcer to the buttocks. Patient 13 was scheduled for a surgical debridment of the Stage IV pressure ulcer on May 23, 2013.

A review of the Perioperative Record dated May 23, 2013, was conducted. A review of the Perioperative Record dated March 7, 2013, was conducted. The area on the document titled, "Potential for injury related to retained foreign object. Sponge, Sharp & Instrument Counts" indicated, "N/A" (not applicable) on the section of the document which reflected the first, second, and third surgical counts. The final section which reflected, "Patient wound closed with correct counts," also indicated, "N/A."

An interview was conducted with the Registered Nurse (RN) 1, on July 24, 2013, at 1 p.m. The document reflected that RN 1 was the Circulating Nurse during Patient 16's surgery. RN 1 stated, "I only do the surgical counts during abdominal surgeries."

e. The record for Patient 16 was reviewed on July 25, 2013. Patient 16 was admitted to the facility on June 12, 2013, with the diagnosis gangrene of the left leg. The patient had a left above the knee amputation on June 18, 2013.

A review of the Perioperative Record (undated), was conducted. The area on the document titled "Potential for injury related to retained foreign object. Sponge, Sharp & Instrument Counts" on the section of the document which reflected the first, second, and third surgical counts was blank. The final section which reflected, "Patient wound closed with correct counts," was checked.

An interview was conducted with the Registered Nurse (RN) 1, on July 24, 2013, at 1 p.m. The document reflected that RN 1 was the Circulating Nurse during Patient 13's surgery. RN 1 stated, "There is no written documentation that the counts were done."

A review of the Job Description, "Registered Nurse: Operating Room (undated)," was provided by the Human Resources Director (HRD). The Education and Experience Requirements indicated, "Graduate of an approved Operating Room certificate program (preferred),One plus years clinical experience in operating room (preferred)."

A review of RN 1's personnel file was conducted with the HRD on July 25, 2013, at 4 p.m. RN 1's date of hire was November 25, 2008. A concurrent interview was conducted with the HRD who stated, RN 1 began to work as a circulating nurse on February 1, 2011. Prior to working as a circulating nurse at the facility the file did not reflect that RN 1 had training as a circulating nurse prior to starting the position.

Further review of RN 1's personnel file indicated he received two days of training as a surgical nurse from November 9, 2011, to November 11, 2011, 11 months after he began working as a circulating nurse. The evaluation documented following the two day training session indicated further training was recommended.

An interview was conducted with the HRD on July 25, 2013, at 4:15 p.m. The HRD stated RN 1 does not have a current surgical competency skills checklist or a current performance evaluation in his file which addressed his duties as a circulating nurse.

An interview was conducted with RN 1 on July 25, 2013, at 12:15 p.m. RN 1 stated other than the two day training he received in 2011, after he started working as a circulating nurse, he had not received any further training.

Based on interview and record review, the facility failed to ensure surgical counts were conducted in accordance with accepted standards of practice. This failure led to the lack of implementing surgical counts during surgeries for five sampled patients,(Patients 10, 11, 12, 13, and 16) in the facility's Operating Room (OR), with the potential for medical items to be left in a body cavity causing injury to those patients.

Findings:

A review of the facility policy, "Counts: surgical sponges, Needles, Sharps, Instruments (Approval Date: 09/2011)," was conducted. The policy indicated, "to identify the procedure to follow for surgical counts in the operating room. There will be proper counts completed on all needles, sponge and general items used on the operative field. this count will be completed on any operative procedure where there is an incision and the location of the operative site is such that an item could accidentally be left in the wound."

1 a. The record for Patient 10 was reviewed on July 25, 2013. Patient 10 was admitted to the facility on February 2, 2013, with the diagnosis of respiratory failure.

The document titled, Perioperative Record (undated), indicated Patient 10 underwent an incision and drainage (a cut into the skin and removal of fluid) of an gluteal abscess (a collection of pus on the buttock).

The area on the document titled "25. Potential for injury related to retained foreign object. Sponge, Sharp & Instrument Counts" indicated, "N/A" (not applicable, did not apply to the procedure).

The document further indicated "Patient wound closed with correct counts" (the sponges, sharps (needles) and instruments used in the procedure were all accounted for at the end of the procedure).


b. The record for Patient 11 was reviewed on July 24, 2013. Patient 11 was admitted to the facility on June 21, 2013, with a diagnosis of pressure ulcers (bedsores). The patient had a Stage IV pressure ulcer to the coccyx, (full thickness tissue loss with exposed bone, tendon or muscle. May include undermining and tunneling).

A review of the Perioperative Record dated July 5, 2013, indicated Patient 11 was scheduled for a surgical debridement (surgical removal of diseased tissue) of his Stage IV pressure ulcer.

The area on the document titled "25. Potential for injury related to retained foreign object. Sponge, Sharp & Instrument Counts" indicated, "N/A" (not applicable) on the section of the document which reflected the first, second, and third surgical counts. The final section which reflected, "Patient wound closed with correct counts," also indicated, "N/A."

An interview was conducted with the Registered Nurse (RN) 1, on July 24, 2013, at 1 p.m. The document reflected that RN 1 was the Circulating Nurse during Patient 11's surgery. RN 1 stated, "I only do the surgical counts during abdominal surgeries."

c. The record for Patient 12 was reviewed on July 25, 2013. Patient 12 was admitted to the facility on March 3, 2013, with a diagnosis of an infected Stage IV pressure ulcer to the buttocks.

A review of the Perioperative Record dated March 7, 2013, was conducted. The area on the document titled "25. Potential for injury related to retained foreign object. Sponge, Sharp & Instrument Counts" indicated, "N/A" (not applicable) on the section of the document which reflected the first, second, and third surgical counts. The final section which reflected, "Patient wound closed with correct counts," also indicated "N/A."

An interview was conducted with the Registered Nurse (RN) 1, on July 24, 2013, at 1 p.m. The document reflected that RN 1 was the Circulating Nurse during Patient 12's surgery. RN 1 stated, "I only do the surgical counts during abdominal surgeries."

d. The record for Patient 13 was reviewed on July 25, 2013. Patient 13 was admitted to the facility on May 19, 2013, with a diagnosis of Stage IV pressure ulcer to the buttocks.

A review of the Perioperative Record dated May 23, 2013, was conducted. A review of the Perioperative Record dated March 7, 2013, was conducted. The area on the document titled "25. Potential for injury related to retained foreign object. Sponge, Sharp & Instrument Counts" indicated, "N/A" (not applicable) on the section of the document which reflected the first, second, and third surgical counts. The final section which reflected, "Patient wound closed with correct counts," also indicated, "N/A."

An interview was conducted with the Registered Nurse (RN) 1, on July 24, 2013, at 1 p.m. The document reflected that RN 1 was the Circulating Nurse during Patient 13's surgery. RN 1 stated, "I only do the surgical counts during abdominal surgeries."

e. The record for Patient 16 was reviewed on July 25, 2013. Patient 16 was admitted to the facility on June 12, 2013, with the diagnosis gangrene of the left leg. The patient had a left above the knee amputation on June 18, 2013.

A review of the Perioperative Record (undated), was conducted. The area on the document titled "25. Potential for injury related to retained foreign object. Sponge, Sharp & Instrument Counts" on the section of the document which reflected the first, second, and third surgical counts was blank. The final section which reflected, "Patient wound closed with correct counts," was checked.

An interview was conducted with the Registered Nurse (RN) 1, on July 24, 2013, at 1 p.m. The document reflected that RN 1 was the Circulating Nurse during Patient 13's surgery. RN 1 stated, "There is no written documentation that the counts were done."

An interview was conducted with the Senior Director of Clinical Operations on July 25, 2013, who stated the facility followed the recommendations of the AORN (Association of perioperative Registered Nurses a nationally recognized organization).

A review of Chapter 1 of the 2013, AORN was conducted. The recommendations indicated, "Purpose...Counts for soft goods (e.g., radiopaque sponges, radiopaque towels); sharps; and instruments are performed to account for all items used on the surgical field and to less the potential for injury to the patient as a result of an RSI (Regained Surgical Instrument)...Retained surgical items are considered a preventable occurrence..."