HospitalInspections.org

Based on review of hospital policies, procedures, 2012 Quality Plan, medical records, audits, manufacturer's guidelines, Association of periOperative Registered Nurses' (AORN) Perioperative Standards and Recommended Practices and interviews, it was determined the hospital failed to comply with the provisions of the Governing Body, that require accountability for the quality of care, as evidenced by:

A0263: the quality program failed to implement and maintain an effective program;

A0286: the quality program failed to identify opportunities to improve patient care processes and patient outcomes for 4 of 4 patients (Pts #10, 14, 15 and 25);

A0385: the hospital failed to ensure nursing services were supervised and evaluated;

A0395: nursing failed to supervise and evaluate the care of 4 of 4 patients requiring additional monitoring and assessments (Pts #10, 14, 15 and 25); and

A0405: the nursing staff failed to follow accepted hospital policies and procedures for medication administration for 4 of 4 patients (Pts #10, 14, 15 and 25) reviewed on titration medications.

The cumulative effect of these systemic deficient practices resulted in the hospital's failure to meet the requirements for the Condition of Participation for the Governing Body.

Based on review of the 2012 quality plan, medical records, rapid response team (RRT) audits, policies, procedures, manufacturer's guidelines, Association of periOperative Registered Nurses' (AORN) Perioperative Standards and Recommended Practices and staff interviews, it was determined the quality program failed to implement and maintain an effective program as evidenced by failing to identify that:

A0286: the quality program identify opportunities to improve patient care processes and patient outcomes for 4 of 4 patients (Pts #10, 14, 15 and 25).

The cumulative effect of these systemic deficient practices resulted in the hospital's failure to meet the requirements for the Condition of Participation for QAPI .

Based on review of medical records, policies/procedures, hospital documents and staff interviews, it was determined the hospital failed to ensure nursing services were supervised and evaluated, as evidenced by failing to:

A0395: supervise and evaluate the care of 4 of 4 patients requiring additional monitoring and assessments (Pts #10, 14, 15 and 25);

A0405: follow accepted hospital policies and procedures for medication administration for 4 of 4 patients (Pts #10, 14, 15 and 25) reviewed on titration medications;

The cumulative effect of these systemic deficient practices resulted in the hospital's failure to meet the requirements for the Condition of Participation for Nursing Services.

Based on review of the 2012 quality plan, medical records, rapid response team (RRT) audits, policies, procedures, manufacturer's guidelines, Association of periOperative Registered Nurses' (AORN) Perioperative Standards and Recommended Practices and staff interviews, it was determined the quality program failed to identify opportunities to improve patient care processes and patient outcomes, as evidenced by failing to identify that:

1. nursing did not reassess and take action for Pt #14, until 6 hours after a documented blood pressure of 72/40 on 09/15/12 at 0700;

2. nursing did not document monitoring and the intra-procedural vital signs every 5 minutes during the bronchoscopy for Pt #14 on 09/15/12;

3. nursing did not closely monitor and document patients' clinical symptoms, response to vasopressor infusions, and vital signs every 15 minutes after initiating Levophed (Norepinephrine) drips (Pt #'s 14 and 25);

4. nursing did not closely monitor Pt #10's sedation infusion during the initial 15 minutes of a new infusion (Versed) to assess the patient's clinical symptoms and response to the infusion;

5. the rate of infusion, RASS score and vital signs (BP's) were not monitored according to policy, hourly during a Versed infusion for Pt's #10 and 15;

6. the staff did not appropriately check the functioning of the intubation equipment, which malfunctioned and resulted in Pt #14 not being intubated;

7. the medical staff failed to obtain a consent for the bronchoscopy performed on Pt #14 on 09/15/12;

8. the staff did not clean, disinfect and store the bronchoscope by adhering to professionally acceptable standards of practice and according to manufacturer's instruction;

9. the staff monitored the temperature for the Cidex solution; and

10. the staff tested the Cidex Solution Test Strips for Quality Control performance per manufacturer's recommendations.

Findings include:

Review of the 2012 Quality Plan revealed: "...Goals and Objectives...Identify known, suspected or potential opportunities to improve patient care processes, outcomes, and hospital operations...Monitor the performance of processes that involve risks or may result in adverse events...Analyze undesirable patterns or trends in performance and adverse events...Governance, Authority and Accountability: The Governing Board (GB) bears ultimate responsibility for assuring the quality and appropriateness of patient care and hospital operations provided by its leaders, physicians and other clinicians and support staff. The GB shall ensure that there is an on-going systematic interdisciplinary mechanism to measure, assess and improve the hospital's ability to do the right thing and to do it well for suspected or potential opportunities to improve patient care processes and outcomes and hospital operations...."

An interview with the Quality Manager (QM) and Chief Clinical Officer (CCO) on 10/17/12 verified the hospital is currently conducting audits of the RRT Forms. Pts # 14 and #25 had RRT evaluations. The hospital's audit of Pt #14 and #25 RRT Forms did not identify the deficient practices in items #1, #2, #3, #6, and #7 (below), during their audits. Audits for Pt #14 and #25 determined the "documentation reflects quality and continuity of care...and recommended no action." The QM and CCO verified these findings on 10/17/12.

1. Refer to A0395 #1 regarding failure to reassess and take action for Pt #14, until 6 hours after a documented blood pressure of 72/40 on 09/15/12 at 0700.

Pt #14's RRT audit form indicated: "...Appropriate medical monitoring with early recognition and treatment of complications...no recommended action...." The audit determined care was appropriate. The audit findings were confirmed by the QM and CCO on 10/18/12.

2. Refer to A0395 #2 regarding the failure to document monitoring and the intra-procedural vital signs every 5 minutes during the bronchoscopy for Pt #14 on 09/15/12.

The QM explained during an interview on 10/18/12, that the hospital was conducting audits of all procedures, including Bronchoscopies. She gets reports from the Charge Nurses every morning who report all procedures. When asked about the deficiencies identified with Pt #14's Bronchoscopy, she was unaware that Pt #14 had a procedure and no audit was conducted.

3. Refer to A0395 #3 regarding the failure to closely monitor and document patients clinical symptoms, response to vasopressor infusions, and vital signs every 15 minutes after initiating Levophed (Norepinephrine) drips (Pt #'s 14 and 25.

The audit of Pt #14's RRT Form for 09/15/12 did not identify deficiencies and take actions. The same RN was taking care of Pt #25 on 10/03/12 during the RRT evaluation and again the hospital did not identify problems and/or take actions.

4. Refer to A0395 #4 regarding the failure to closely monitor Pt #10's sedation infusion during the initial 15 minutes of a new infusion (Versed) to assess the patient's clinical symptoms and response to the infusion.

5. Refer to A0395 #5 regarding the failure to require that the rate of infusion, RASS score and vital signs (BP's) were monitored hourly during a Versed infusion for Pt's #10 and 15.

6. Review of Pt #14's medical record revealed the Discharge Summary included: "...Discharge Diagnoses...Fail attempted intubation due to equipment malfunction...The patient was seen emergently by Dr. (name) and attempt was (sic) intubation was tried multiple times but was aborted due to malfunctioning equipment...I spoke with the ER MD at (name of acute care hospital) and the patient was transferred.

An interview with the CCO on 10/17/12, confirmed the laryngoscope handle from the bronchoscopy cart needed a new battery and the Respiratory Technician on duty did not know how to change it out when the RRT was called for Pt #14.

7. Refer to A0353 #1 and see item #2 above regarding the failure to obtain a consent for the bronchoscopy performed on Pt#14 on 09/15/12.

8. Refer to A0749 #1 and item #2 above regarding failure to clean, disinfect and store the bronchoscope by adhering to professionally acceptable standards of practice and according to manufacturer's instruction.

9. Refer to A0749 #2 and item #2 above regarding the failure to monitor the temperature for the Cidex solution.

10. Refer to A0749 #3 and item #2 above regarding the failure to test the Cidex Solution Test Strips for Quality Control performance per manufacturer's recommendations.
.

Based on review of medical records, policies/procedures, medical staff bylaws, rules, regulations and staff interviews, it was determined the medical staff failed to enforce its bylaws as evidenced by:

1. failing to obtain a consent for the bronchoscopy performed on Pt #14 on 09/15/12;

2. failing to require Versed intravenous (IV) infusion administration orders were administered in accordance with a complete medication order for 2 of 2 patients (Pt's #10 and 15); and

3. failing to require Levophed IV infusion administration orders were administered in accordance with a complete medication order for 2 of 2 patients (Pt's #10 and 25).

Findings include:

1. Review of the medical staff bylaws approved 01/18/11, required: "...Each Medical Staff Member shall...3.4.2 Abide by the Medical Staff Bylaws and Rules and Regulations, and by all other standards, policies and rules of the Hospital and Board...."

Review of the hospital policy titled Bronchoscopy/Endoscopy Procedures required: "...A standard consent will be signed for Bronchoscopy/Endoscopy procedures...It is the physician's responsibility to obtain the informed consent...."

Review of Pt #14's medical record indicated on the RRT form dated 09/15/12, that the patient had a Bronchoscopy. The physician noted in an undated progress note that a "Bronch for Aspiration" was performed. The medical record did not contain any documentation of consent for the Bronchoscopy.

The CCO confirmed on 10/18/12 that Pt #14's medical record did not contain a consent for the Bronchoscopy performed on 09/15/12. No documentation by the physician indicating the procedure was needed emergently was in the medical record.

2. Refer to tag A0405 # 1 regarding the failure to require that Versed intravenous (IV) infusions be administered in accordance with a complete medication order (Pt's #10 and 15).

3. Refer to tag A0405 #7 regarding the failure to require that Levophed intravenous (IV) infusions be administered in accordance with a complete medication order (Pt's #14 and 25).

Based on review of medical records, policies/procedures, and staff interviews, it was determined a registered nurse failed to supervise and evaluate the care of 4 of 4 patients requiring additional monitoring and assessments (Pts #10, 14, 15 and 25) as evidenced by failing to:

1. reassess and take action for Pt #14, until 6 hours after a documented blood pressure of 72/40 on 09/15/12 at 0700;

2. document monitoring and the intra-procedural vital signs every 5 minutes during the bronchoscopy for Pt #14 on 09/15/12;

3. closely monitor and document patients clinical symptoms, response to vasopressor infusions, and vital signs every 15 minutes after initiating Levophed (Norepinephrine) drips (Pt #14 and 25);

4. closely monitor Pt #10's sedation infusion during the initial 15 minutes of a new infusion (Versed) to assess the patient's clinical symptoms and response to the infusion; and

5. require that the rate of infusion, RASS score and vital signs (BP's) were monitored hourly during a Versed infusion for Pt's #10 and 15.

Findings include:

The hospital policy titled Assessment-Reassessment Nursing required: "...Reassessment...A registered nurse will reassess each patient according to the patient needs and as needed...the frequency of the reassessment shall be based upon the RN's judgement, physician order, and/or patient status...The reassessment should include but not be limited to: review of compromised systems, vital signs...Reassessment information should be well documented...."

1. Patient #14, an elderly patient was admitted on 08/28/12 with a wound infection, suspected gangrene necrosis, after an open reduction internal fixation of the left ankle. The patient also had the following diagnoses: diabetes type 2; severe peripheral arterial disease; chronic obstructive pulmonary disease; aspiration pneumonia; history of cerebrovascular accident with left paresis; acute and chronic kidney disease; iron-deficiency anemia; and gastrointestinal bleeding.

On 06/15/12, the RN assigned to Pt #14 documented at 0800 that the patient had a "lot of phlegm" and that the patient "...keeps trying to cough it up unsuccessfully, repositioned pt...will continue to monitor...." At 0700-0800 hours the certified nursing assistant (CNA) documented a BP of 72/40, heart rate (HR) 99, and respiratory rate (RR) 16. Registered nurse documentation included: "...1200...Pt is pale and c/o of shortness of breath. Pt is still on 2L (liters) O2 (oxygen). Pt's phlegm is moderate in amt (amount) but pt is having great difficulty coughing it up and clearing his airway. Will continue to monitor...1315 hours...Pt still having difficulty coughing up phlegm...RT (respiratory therapy) and...Charge nurse are in room and RT...is now NG (nasogastric) suctioning the pt...O2 sats are in the 80's...received orders for ABG's (arterial blood gases) and put pt on non-rebreather...1403...pt transferred to room 103 (higher level of observation). Documentation on the Rapid Response Team Form included: "...Time called 1400...BP 70/46, HR 108, RR 33, and O2 saturation 88%...Bronchoscopy performed...Albuterol Neb (nebulizer) given...Levophed gtt (drip) started @ 1500...1600 Pt sent to (name of acute care hospital)...."

No nursing reassessments were documented after the initial BP of 72/40 at 0700, until five (5) hours later at 1200. No repeat vital signs were documented until two (2) hours later at 0900 on the MAR, when the RN held 3 blood pressure medications due to a BP of 82/52 (no other vital sign parameters were documented at this time). The next vital signs taken for Pt #14 was 5 hours later at 1400 when the RRT was called and the BP was 70/46. The RN did not call the physician for over 6 hours after the patient's morning BP of 72/40 and the morning assessment identified the patient was "unsuccessfully coughing up phlegm."

On 10/17/12 at 1415 hours, the RN (Employee #6) caring for Pt #14 on 09/15/12, was interviewed. She explained the CNA's obtain vital signs for the patients. She could not recall if the CNA reported the morning BP of 72/40. She confirmed she did not notify the physician of the BP of 72/40 or the 0900 BP of 82/52 when 3 BP medications were held. She confirmed she did not notify the physician of a change in condition at 1200 when the patient was pale and short of breath, having difficulty clearing his airway. She could not find documentation of vital signs in the medical record after the 0700 and 0900 readings.

On 10/17/12 at 1400 hours, the CNA (Employee #5) caring for Pt #14 on 09/15/12 was interviewed. She confirmed she takes BP's for the patients she is assigned to. She signed the vital sign record indicating she took Pt #14's BP. She explained that a BP of 72/40 was very abnormal and she most certainly would have notified the RN of the low BP.

The CCO confirmed during an interview on 10/18/12, that the RN did not take action for a BP of 72/40, reassess, monitor or document findings according to hospital policies.

2. Review of the hospital policy titled Bronchoscopy, Endoscopy Pre, Intra, and Post-Procedure Nursing Monitoring and Documentation required: "...Intra-Procedure Vital signs must be obtained and documented every five (5) minutes or more often if deemed necessary...."

Review of Pt #14's RRT record indicated the patient had a bronchoscopy performed. Review of the physician's progress note indicated that a bronchoscopy was performed.

The CCO confirmed on 10/18/12, that the medical record did not contain nursing documentation of the bronchoscopy for pre, intra, or post procedural documentation.

3. Review of the hospital policy titled Adult Norepinephrine (Levophed) IV Drip Protocol required: "...Clinical Assessment and Care...Prior to Starting Infusion...Confirm physician order. Blood pressure must be monitored frequently...Beginning the Infusion...RN must remain at the bedside while titration is in progress. Document VS (vital signs) and dose changes on Norepinephrine Critical Care Flow Sheet during initial and active titration. Closely monitor the patient for the initial 15 minutes of infusion...."

Review of the hospital policy titled Drug Calculations: Vasopressor required: "...Documentation: Document the rate, patient response to medication in the Nurses' Notes. Patients on vasopressor therapy being titrated require every 15 minute vital signs unless ordered otherwise...."

Review of Pt #14's medical record revealed the RRT was called at 1400 on 09/15/12 due to complaints of shortness of breath.

A physician's order was documented by an unknown person, from an unknown physician on 09/15/12 at 1445, which read: "...Levophed IV start at 2 mcg (micrograms)/ hr (hour) and titrate to keep MAP (mean arterial pressure) of 60 or SBP (systolic blood pressure) 90...."

Documentation on the RRT record indicated "Levophed gtt (drip) started at 1500." Documentation on the nursing notes for 09/15/12, revealed: "...1410...Dr ordered Levo at 2mcg per minute. Pt BP still going down (no BP documented)-O2 sat @ 70% Levo turned up (no dose documented)...."

Nursing documented a BP of 70/46 when the RRT was called, the next documented BP 98/49, was 75 minutes later at 1615 when the patient was sent emergently to another acute care hospital.

Nursing did not document vital signs and dose changes for Levophed during the initial and active titration according to policy.

An interview with the RN (Employee #7) who initiated the Levophed drip for Pt #14 on 09/15/12, was conducted on 10/17/12 at 1500 hours. He explained he was "too busy" to document according to the Levophed policy. He confirmed he did not document the Levophed drip onto the MAR and did not document the dose adjustments and BP's according to policy.

Review of Pt #25's medical record revealed the RRT was called on 10/03/12 at 1145 hours due to hypotension and a change in mental status. Vital signs at this time were BP 83/47, HR 75, RR 12. Review of the nurses's notes revealed: "...10/03/12...1130...Second assessment...pt BP low (no BP documented), called Dr...1145...Pt unresponsive...1200...BP still low (no BP documented)...1230...BP running at (high) 80's (low) 90. Pt still unresponsive...1255...BP 91/54 (no other vital sign parameters documented) Started Levo to keep SBP (above) 95...1319...Pt left via stretcher levo hanging (no dose documented)...."

Review of the graphic record for 10/03/12, revealed a BP was documented for the 0700-0800 (90/62) and 1100-1200 (101/51) hours. RN (Employee #7) did not document vital signs and dose changes for Levophed during the initial and active titration according to policy.

The CCO confirmed the RN did not document assessments, monitoring, and vital signs as required by policy, during an interview on 10/18/12.

4. Review of the policy titled First Dose Administration, Monitoring and Review revealed: "...it is the policy of the hospital to assure patient safety with respect to medications in administering, monitoring the patient's response, and review of orders for all first dose medications...for all first dose of medication a patient has never received before, nursing shall initiate the 'First Dose' monitor procedure...nurse will handwrite new medication order onto scheduled MAR including medication name, dosage, frequency, and any additional comments...entered onto the 'new medication orders' section of the MAR...these entries include areas to document 'First Dose- Yes or No', 'Education- Yes or No', 'Reaction- Yes or No', and the 'Type of reaction if yes is selected...for all First Dose Medications...the nurse...will educate the patient to the possible side effects and evaluate all pertinent safety information regarding the patient including, but not limited to, all patient allergies, lab results, and vital signs, as well as the monitoring parameters for the specific medication...the patient must be monitored for ADRs for at least the first hour after administration...."

Review of the hospital policy titled Policy/Protocol For: Versed: IV Administration revealed: "...Intravenous sedation (Versed)...shall be administered and monitored according to the guidelines outlined...A Richmond Agitation Sedation Scale (RASS) should be calculated immediately prior to initiation...and then every 4 hours thereafter...maximum dose is 10 mg/hr, unless specifically ordered by the physician...Scope...a registered nurse (RN) may initiate and Titrate (down only) the intravenous infusion of Versed...Medication can be increased at increments ONLY upon physician discretion/order to achieve greater level of sedation...perform baseline assessment...LOC (level of consciousness)...Vital Signs (VS): Blood Pressure (BP), apical heart rate (HR), respiratory rate, cardiac output (CO) and thermodynamics if monitoring tools in place...baseline rhythm strip...skin color, peripheral perfusion, body temp...heart and lung sounds...medication is calculated/infused in milligrams per kilogram per hour (mg/kg/hr)...the medication is to be ordered by mg/kg/hr...increase titration of medication ONLY with discretion/order of physician...document VS and dose changes on the frequent vital sign section of the flowsheet during initial and active titration...closely monitor the patient for the initial 15 minutes of the infusion to assess LOC, VS, chest discomfort, shortness of breath (SOB), ST segment variation indicative of ischemia, rhythm changes (especially tachycardia, ventricular arrhythmia)...CO...reassess VS with each titration adjustment...once desired response is achieved with stable vital signs, the infusion can be maintained at a set rate and vital sign assessment interval may be changed to every hour...if VS assessment warrants making adjustments to the infusion rate, frequency of VS needs to return to frequency of active titration...."

Review of Pt #10's medical record and the form titled Versed Protocol Flowsheet identified the patient was not monitored or assessed at 15 minute intervals with the initiation of the drip. The Versed drip was started on 9/24/12 at 1115 hours. No clinical assessment of the patient's heart and lung sounds, vital signs, LOC prior to the initiation of the drip was documented. The form titled Assessment Flow Record identified the first assessment of all body systems for that day was documented at 0730 hours. The next assessment was documented at 1145 hours. The 1145 assessment was the regular required q 4 hour assessment completed. No 15 minute interval assessment of VS or LOC after the drip was initiated was documented. Review of the form titled Versed Protocol Flow Sheet identified the drip was started at 1115 hours at 2 mg /hr with a RASS scale of -1. No vital signs were documented on initiation of the drip through the first 9 hours of the drip infusing.

The RN (Employee # 7) confirmed in an interview on 10/17/12, that he did not monitor the patient at 15 minute intervals after initiation of the Versed drip for Pt #10 and he did not document vital signs for 8 hours and 45 minutes, from 1115 through 1900 hours.

The CCO confirmed in and interview conducted on 10/19/12 at 0900 hours, that nursing did not document monitoring or assessments every 15 minutes with the initiation of a new versed drip for patient #10.

5. Refer to Policy/Protocol for Versed administration in #4 above for requirements for hourly monitoring of rate of the drip, RASS score and vital signs.

Review of Pt #10's medical record revealed the form titled Versed Protocol Flow Sheet did not contain documentation of dates, times, drip rates, RASS score and or vital signs hourly as required per hospital policy:
9/24/12- no documentation of vital signs from 1115 hours through 1900 hours (8.75 hrs).
9/26/12- no documentation of vital signs 2100 and 2200 hours.
9/27/12- no documentation of vital signs 0200, 0230 hours, 2000, 2100 and 2300 hours.
9/28/12- no documentation of vital signs 0200 and 0300 hours.
9/28/12- no documentation of rate of infusion, RASS Scale Score and vital signs at 1900 hours.

Review of Pt #15's medical record revealed the form titled Versed Protocol Flow Sheet did not contain documentation of dates, times, drip rates, RASS score, and vital signs hourly as required per hospital policy:
10/1/12- 1530 hours through 10/3/12 at 0630 hours no nursing documentation of the date, time, rate of infusion, RASS score and vital signs was in the medical record.
10/3/12- 0730 through 1700 hours and 2100 hours - no documentation of vital signs.
10/3/12- 0830 hours, 1000, 1200 noon, 1400, 1600, 1800 and 1900 hours- no documentation of rate of infusion, RASS Scale score and vital signs.
10/4/12- 0700 hours and 1000 through 1740- no documentation of vital signs.
10/4/12- 0800 hours, 1800 and 1900 hours no documentation of rate of infusion, RASS score and vital signs.
10/5/12- 12 midnight through 0200 hours, 0400, 0500, 0700, 1000, 1100, 1400, 1500, 1600, 1800 1900, 2100, 2200 and 2300 hours - no documentation of vital signs.
10/6/12- 12 midnight through 2225 hours- no documentation of vital signs.

The CCO confirmed in an interview conducted on 10/19/12, that the Versed Protocol Flowsheets for Pt #'s 10 and 15 did not contain documentation of the infusion rate, RASS score and vital signs as required by policy.

Based on review of hospital policies/procedures, medical staff rules and regulations, medical records, and staff interviews, it was determined the nursing staff failed to follow accepted hospital policies and procedures for medication administration for 4 of 4 patients reviewed on titration medications as evidenced by (Pts #10, 14, 15 and 25):

1. failing to require that Versed intravenous (IV) infusions be administered in accordance with a complete medication order (Pt's #10 and 15);

2. failing to require that first dose administration of medication (Versed infusion) was monitored and effects of the medication on the patient reviewed (Pt # 10);

3. failing to require that a Versed drip (Midazolam Hydrochloride) was titrated upward only with specific physician orders as per hospital policy (Pt's #10 and 15);

4. failing to require close monitoring for Pt #10 for the initial 15 minutes of a new infusion (Versed infusion) to assess the patient's clinical symptoms and response to the infusion;

5. failing to require that the rate of infusion, RASS score and vital signs (blood pressures) were monitored hourly during Versed infusions (Pt's #10 and 15);

6. failing to document administration of Levophed for Pt #14 on the medication administration record (MAR) as required by policy; and

7. failing to require that Levophed intravenous (IV) infusions be administered in accordance with a complete medication order (Pt's #14 and 25).

Findings include:

1. Review of the hospital policy titled, Medication Management- Medication Safety Management Plan, revised January 2010 revealed: "...the required elements of a complete medication order are: name of drug, strength, route, frequency, allergies, height and weight...titrating orders must include clinical goal to be achieved (i.e. parameters), criteria for evaluating the patient's status (e.g., vital signs, lab values, blood levels) and dosages to be administered to achieve clinical goal...taper orders must include the amount by which the drug is to be reduced at each dosage interval...medication orders that are incomplete, illegible or unclear will be clarified with the prescribing physician before they are implemented...incomplete is defined as missing one or more required elements of complete orders...."

Review of Medical Staff Rules and Regulations revealed: "...orders must be stated clearly, written legibly, and be complete to be carried out...."

Review of medical record for Pt #10 revealed the following physician orders:
09/24/12; 1040 hours "...Versed drip 2 milligrams per hour (mg/hr) IV start now...."
09/24/12; 1250 hours "...keep RASS (Richmond Agitation Sedation Scale) score -2 or -3...."
09/26/12; 1015 hours "...Titrate Versed drip to RAS (sic) -1 to-2...."
09/28/12; "...Keep Pt RASS score 0 to-1...."

Review of medical record for Pt #15 revealed the following physician orders:
10/1/12; "...Midazolam 15 mg/hr IV...."
10/2/12; 1100 hours "...Versed decrease to 13 mg/hr now...decrease Versed by 1 mg q 6 hrs till off...."
10/3/12 at 1000 hours "...Continue Versed gtt to keep RASS score between 0 + -2...."

The Chief Clinical Officer confirmed in an interview on 10/19/12 at 0900 hours, that the nursing staff initiated and maintained Versed drip orders for 2 of 2 patient's (Pt's # 10 and 15) with incomplete physician orders. Titrating orders did not include clinical goals (parameters) to be achieved and there were no criteria identified for evaluating the patient's status (vital signs).

2. Review of the hospital policy titled First Dose Administration, Monitoring and Review revealed: "...it is the policy of the hospital to assure patient safety with respect to medications in administering, monitoring the patient's response, and review of orders for all first dose medications...for all first dose of medication a patient has never received before, nursing shall initiate the 'First Dose' monitor procedure...nurse will handwrite new medication order onto scheduled MAR including medication name, dosage, frequency, and any additional comments...entered onto the 'new medication orders' section of the MAR...these entries include areas to document 'First Dose- Yes or No', 'Education- Yes or No', 'Reaction- Yes or No', and the 'Type' of reaction if yes is selected...for all First Dose Medications...the nurse...will educate the patient to the possible side effects and evaluate all pertinent safety information regarding the patient including, but not limited to, all patient allergies, lab results, and vital signs, as well as the monitoring parameters for the specific medication...the patient must be monitored for ADRs (adverse drug reactions) for at least the first hour after administration...."

Review of the medical record for patient # 10 contained the form titled Medication Administration Record. This form had 7 columns with the following headers: No: (medical record #), Medication, Start/Stop, Adm, 9/24 0700 to 9/24 18:59, 9/24 1900 to 9/25 06:59, 00:00 to 00:00 and 6 rows. The following handwritten information was filled onto the last row of the form and into the last box in the column titled Medication: "...Versed drip start 2 mg/ hr to keep RASS score @ -2 or -3...." The following information was filled in under the column titled 9/24 07:00 to 9/24 18:59 along the same row as the Versed drip: "...1115 AW/AA. There was no information documented along with the Versed drip to indicate first dose (Yes or No), Reaction (Yes or No) and patient education.

The Chief Clinical Officer confirmed in an interview conducted on 10/19/12 at 0900 hours, the patient was not monitored closely for adverse drug reactions for at least the first hour of administration.

The Director of Pharmacy confirmed in an interview conducted on 10/19/12 at 0945 hours, the policy for First Dose administration was not followed. The nurse did not identify the dose/concentration, that this was a first dose medication, patient response/ADR and patient education about the medication.

3. Review of the policy and procedure titled Policy/Protocol For: Versed: IV Administration revealed: "...this medication is to be administered in the Step-Down Unit Only, where patient is on a cardiac monitor, and must be administered on an infusion pump...simple sedation for the purpose of ventilatory management of the ventilated patient...ordered by a credentialed physician...Intravenous sedation (Versed)...shall be administered and monitored according to the guidelines outlined...A Richmond Agitation Sedation Scale (RASS) should be calculated immediately prior to initiation...and then every 4 hours thereafter...maximum dose is 10 mg/hr, unless specifically ordered by the physician...Scope...a registered nurse (RN) may initiate and Titrate (down only) the intravenous infusion of Versed...Medication can be increased at increments ONLY upon physician discretion/order to achieve greater level of sedation...Validate solution concentration per physician order...Versed in concentration of 1 mg/ml or 1,000 mcg/ml...perform baseline assessment...LOC (level of consciousness)...Vital Signs (VS): Blood Pressure (BP), apical heart rate (HR), respiratory rate, cardiac output (CO) and thermodynamics if monitoring tools in place...baseline rhythm strip...skin color, peripheral perfusion, body temp...heart and lung sounds...medication is calculated/infused in milligrams per kilogram per hour (mg/kg/hr)...the medication is to be ordered by mg/kg/hr...increase titration of medication ONLY with discretion/order of physician...document VS and dose changes on the frequent vital sign section of the flowsheet during initial and active titration...closely monitor the patient for the initial 15 minutes of the infusion to assess LOC, VS, chest discomfort, shortness of breath (SOB), ST segment variation indicative of ischemia, rhythm changes (especially tachycardia, ventricular arrhythmia)...CO...reassess VS with each titration adjustment...once desired response is achieved with stable vital signs, the infusion can be maintained at a set rate and vital sign assessment interval may be changed to every hour...if vs assessment warrants making adjustments to the infusion rate, frequency of VS needs to return to frequency of active titration...."

Review of the form titled: Versed Protocol Flow Sheet, in the medical record for Patient # 10 identified the following dates and times the Versed drip was titrated upward, without a specific physician order to increase the rate:
9/24/12 at 1315 hours- drip increased to 3 mg/hr from 2 mg and same RASS score of -1.
9/26/12 at 2100 hours- drip increased to 3 mg/hr from 2 mg for same RASS score of +1.
9/27/12 at 0230 hours- drip increased to 1.5 mg from 1 mg for same RASS score of -1
9/27/12 at 0600 hours- drip increased to 2 mg from 1.5 mg for same RASS score of -1.
9/27/12 at 1000 hours- drip increased to 3 mg from 2 mg for same RASS score of -2.

Review of the form titled Versed Protocol Flow Sheet, in the medical record for Patient # 15 identified the following dates and times the Versed drip was titrated upward without a specific physician order to increase the rate.
10/4/12 at 0400 hours to 13 mg/hr from 7 mg the previous hour RASS score +1
10/6/12 at 0220 hours to 2 mg/hr from 1 mg for an unchanged RASS Score of 0
10/6/12 at 1000 hours to 4 mg/hr from 3 mg for same RASS score of 0
10/6/12 at 1300 hours to 5 mg/hr from 4 mg for RASS score of - 2

The DON confirmed in an interview conducted 10/19/12 at 0900 hours, that the nursing staff did not follow hospital policy and obtain a specific physician order when titrating the Versed drip upward.

4. Refer to Tag 0395 #4 regarding the failure to closely monitor Pt #10's sedation infusion during the initial 15 minutes of a new infusion (Versed) to assess the patient's clinical symptoms and response to the infusion.

5. Refer to Tag 0395 #5 regarding the failure to require that the rate of infusion, RASS score and vital signs (BP's) were monitored hourly during a Versed infusion for Pt's #10 and 15.

6. Review of the hospital policy titled Medication: Administration and Documentation required: "...Upon administration of the medications, the nurse will document in the MAR...."

Review of Pt #14's medical record revealed the nursing documentation indicated two different times for initiating the Levophed drip for Pt #14. Nursing documented the Levophed drip was started at 1500 on 09/15/12 on the RRT form. The nurses' narrative notes indicated it was initiated at 1410 on 09/15/12. Nursing did not document the administration time of the Levophed on the Medication Administration Record (MAR).

An interview with the RN (Employee #7) who initiated the Levophed drip for Pt #14 on 09/15/12, was conducted on 10/17/12 at 1500 hours. He explained he was "too busy" to document according to the Levophed policy. He confirmed he did not document the Levophed drip onto the MAR.

7. Refer to #1 above regarding the hospital policy titled Medication Management and the Medical Staff Rules and Regulations.

Pt #14's medical record contained the following order: "...Levophed IV start at 2 mcg (micrograms)/ hr (hour) and titrate to keep MAP (mean arterial pressure) of 60 or SBP (systolic blood pressure) 90...." This physician's order was documented by an unknown person, from an unknown physician on 09/15/12 at 1445.

Documentation on the RRT record indicated "Levophed gtt (drip) started at 1500." Documentation on the nursing notes for 09/15/12 revealed: "...1410...Dr ordered Levo at 2mcg per minute...."

The order is written for mcg/hour and nursing documented initiating the drip at mcg/minute. No order clarification was documented and no reference to the protocol/policy was in the order.

The Chief Clinical Officer explained in an interview on 10/18/12, that the hospital has a protocol for Levophed. The protocol was reviewed and included the following: "...Clinical Assessment and Care...Prior to Starting Infusion...Confirm physician order. Seek clarification for any question...Beginning the Infusion...Increase by 0.03 mcg.kg/min every 2 minutes or specific MD order...."

Pt #14's Levophed order did not reference the protocol, the protocol instructed nurses to increase by 0.03mcg.kg/min. Nursing did not document the infusion as mcg/kg/min nor did they have a specific order on how to titrate the medication.

Pt #25's medical record contained the following physician order: "...Start Levophed gtt to keep SBP (greater than) 95...." Nursing documentation for the administration of the Levophed drip included: "...10/03/12...1255...BP 91/54-Dr ordered levo-started levo to keep SBP (above) 95...."

Pt #25's Levophed order did not reference the protocol, the order did not reference a policy or protocol, the protocol instructed nurses to increase by 0.03 mcg. kg/min. Nursing did not document the starting dose of Levophed nor did they have a specific order on how to titrate the medication.

The Levophed orders were reviewed with the Chief Clinical Officer on 10/18/12.

Based on acceptable standards of practice, manufacturer's recommendations, hospital policy and procedure, observation on tour, and staff interviews, it was determined the infection control officer failed to identify the policy and procedure for bronchoscopy's cleaning and disinfection, and did not follow the manufacturer's guidelines for the control of infections as evidenced by the failure to:

1. clean, disinfect and store the bronchoscope by adhering to professionally acceptable standards of practice and according to manufacturer's instruction;

2. monitor the temperature for the Cidex solution; and

3. test the Cidex Solution Test Strips for Quality Control performance per manufacturer's recommendations.

Findings include:

1. Association of periOperative Registered Nurses' (AORN) Perioperative Standards and Recommended Practices 2010 Edition, revised November 2010, p 405, Recommendation I requires: "...Flexible endoscopes...cleaned and stored...manufacturer's written instructions...Failure to follow...could result...ineffective cleaning...creating a risk of infection...warranty may be void if...not followed...."

AORN Recommendation V, p. 409, requires: "...Brushing accessible channels removes particulate matter...."

AORN Recommendation IX, p. 411, requires: "...Flexible endoscopes should be stored hanging in a secure vertical position...decreasing the potential development...microbial growth...Proper storage facilitates drying...decreases potential for contamination...."

Recommendation IX.b. p. 411, requires: "...Flexible endoscopes should be reprocessed before use if unused for more than five days...."

Olympus Bronchofiberscope instructions and Reprocessing requires: "...Improper and/or incomplete reprocessing or storage can present an infection control risk, cause equipment damage or reduce performance...While the endoscope is submerged, brush the channel...Location A, Location B...Hang...in the storage cabinet with the Distal End handing freely...straight as possible...."

Hospital policy IC-153, titled "Bronchoscopy" requires: "clean and disinfect the bronchoscope in accordance with the manufacturer's recommendations...."

Observations while on tour conducted on 10/17/12, revealed a large bronchoscopy cart that contained a light source and supplies needed for the procedure. One drawer was lined with a towel; the bronchoscope lay on top of the towel with the drawer closed.

Respiratory Technician (Employee #8), confirmed during an interview conducted on 10/17/12, that the scope is returned and stored in the drawer after cleaning and high- level disinfection with Cidex. The scope is not hung and is not disinfected again prior to next use.

Respiratory Technician (Employee #28), confirmed during an interview conducted on 10/18/12, that she did not clean the bronchoscope by brushing the channels.

2. Instructions on the Cidex solution bottle revealed: "...is indicated...High Level Disinfection when used or reused...maximum of 14 days at 25 degrees Celsius...immersion time...at least 45 minutes...."

Employee #8 confirmed during the interview conducted on 10/17/12, that he checked the solution with a test strip for PH prior to each bronchoscopy procedure, however, he was unaware the temperature of the Cidex was required to be monitored.

3) The insert for the Cidex Solution Test strips revealed the following for Quality Control Procedures: "...recommend...testing of positive and negative controls be performed on each newly opened test strip bottle...serve to minimize errors between different users, use of out dated materials, or product that has been improperly stored or handled...."

Hospital policy RT-606 titled "Cleaning, Disinfection & Sterilization" requires: "...Conduct quality control monitoring...follow manufacturer's instructions...requires checks and documentation of the efficiency of the disinfectant product...."

Respiratory Technician (Employee #28), confirmed during an interview conducted on 10/18/12, that she was not aware of the Quality Control checks on the Cidex Test Strips.

The QM confirmed during an interview conducted on 10/18/12, that she was unaware of the policy and/or process of the bronchoscopy procedure.

The CCO confirmed the above findings.