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Based on medical record review, interviews, and review of Hospital credential files, the Hospital failed to ensure: (a) the scope of practice and delineation of privileges for two of two (#1, #2) Certified Registered Nurse Anesthetists (CRNA) was approved by Nursing Administration; and (b) a Registered Nurse (RN) failed to evaluate one patient, (#28), in a total sample of 38, for response to a Cardizem drip and to make adjustments as needed.

Findings included:

1. Review of the Massachusetts Board of Registration in Nursing (BORN) Regulations for Nurses Practicing in an Advanced Practice Role (244 CMR 4.00), subsequent to survey on 11/14/11, indicated the following:

According to 244 CMR 4.22(1): "All nurses practicing in an expanded role shall practice in accordance with written guidelines developed in collaboration with and mutually acceptable to the nurse and to:
(b) the appropriate medical staff and nursing administration staff of the institution employing the nurse."

According to 244 CMR 4.22(4)(a)(b): "A nurse practicing in an institution may not practice in an expanded role until: (a) the governing body, including the medical staff and nursing administration staff of the institution, formally reviews and approves of the guidelines under which (the nurse) proposes to practice; and (b) a physician is designated who shall provide such medical direction as is customarily accepted in the specialty area."

Review of the credential files of CRNAs #1 and #2, in the Administrative Conference Room, from 8:30 A.M. to 9:00 A.M. on 11/10/11, indicated that the scope of practice and delineation of privileges for both CRNAs lacked approval from Nursing Administration, although required.

Interviews with the Vice President of Nursing and Director of Quality and Risk in Administrative Office #1, at 10:00 A.M. on 11/10/11, confirmed that the CRNAs' scope of practice and delineation of privileges were not approved by Nursing Administration.



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2. For Patient #28, the Coronary Care Unit (CCU) Nursing Staff failed to evaluate Patient's #28's response to a Cardizem drip and make appropriate interventions as needed. Interview with R.N. #7, on 11/8/2011 at approximately 10:00 A.M., indicated that a standard Cardizem drip consisted of 100 milligrams (mg) of the heart medication Cardizem, in 100 milliliters (mls) of normal saline, infused at a rate of 5 mls per hour according to the patient's blood pressure (BP) and heart rate (HR).

Also, the Hospital failed to obtain parameters for BP and heart rate HR to titrate a Cardizem intravenous drip although the physician's order stated to titrate for BP and HR.

Record review indicated Patient #28 was admitted to the CCU in 11/11, with diagnoses of rapid atrial fibrillation and congestive heart failure.

Physician orders, dated 11/7/2011, received verbally by a RN at 9:50 P.M., and cosigned by the physician at 10:00 P.M., stated to "start a standard Cardizem drip and titrate per BP and HR." There was no BP and HR specified as a therapeutic goal or range to obtain.

Record review indicated that at 12:00 A.M. on 11/8/11, Patient #28 's BP was 100/78 with a HR= 88; at 2:00 A.M., the BP=122/74 with HR =88; at 4:00 A.M., the BP =106/76 with the HR =88 and at 8:00 A.M., the BP was 114/72 and the heart rate was 102.

Patient #28's Cardizem drip was documented at 10 mls per hour from 10:00 P.M. on 11/7/11 to 8:00 A.M. on 11/8/11, and remained unchanged. The heart rhythm was documented as atrial fibrillation and was unchanged since 10:00 P.M. on 11/7/11.

The nursing staff failed to obtain parameters for BP and HR to titrate a Cardizem intravenous drip although the physician's order stated to titrate for BP and HR.

Based on record reviews and staff interviews, the Hospital failed to ensure that nursing care plans were developed and implemented for 8 active patients (#3, #4, #6, #9, #10, #11, #16, and #18), out of a total sample of 38 active patients reviewed. The findings included:

1. For Patient #3, admitted in 10/11, medical record reviewed indicated the patient had medical diagnoses that included anorexia nervosa, chronic obstructive pulmonary disease (COPD), Crohn's Disease, arthritis, celiac spruce (mal-absorption), hypertension, Congestive Heart Failure (CHF), and hypothyroidism.

Further review of the medical record indicated that the hospital failed to develop and implement effective nursing care plans with goals and interventions related to potential weight loss, respiration difficulties, pain, inflammation, skin care, diarrhea, and/or fluid overload (for potential lower extremity edema), although required.

Interview with the Psychiatric Unit Nurse Manager on 11/8/11 at 3:45 P.M., acknowledged the patient should have had a nursing care plan for the above identified issues.

2. For Patient #9, admitted in 11/11, medical record review on 11/8/11, revealed that the patient had diagnoses that included Diabetes Mellitus Type I, and an elevated cholesterol.

Further review of the medical record revealed the Hospital failed to develop and implement effective nursing care plans with goals and interventions related to the potential effects of hypo/hyperglycemia, and for reducing cholesterol levels, although required.

Interview with the Director of the Psychiatric Unit on 11/9/11 at 8:20 A.M. acknowledged the patient should have had a nursing care plan for the above identified issues.

3. For Patient #10, admitted in 11/11, medical record review on 11/7/11, revealed that the patient had diagnoses that included hypertension.

Further review of the medical record revealed the Hospital failed to develop and implement an effective nursing care plans with goals and interventions for hypertension, although required.

Interview with the Director of the Psychiatric Unit on 11/9/11 at 8:20 A.M. revealed that the patient should have had a nursing care plan for the above, identified issue.

4. For Patient #11, admitted in 11/11, medical record review on 11/7/11, revealed that the patient had diagnoses that included hypertension, GERD (Gastroesophageal Reflux Disease), and hyperlipidemia.

Further review of the medical record revealed that the Hospital failed to develop and implement effective nursing care plans with goals and interventions for hypertension, GERD and elevated lipids in the blood, although required.

Interview with the Director of the Psychiatric Unit on 11/9/11 at 8:20 A.M. revealed that the patient should have had a nursing care plan for each of the above identified issues.

5. For Patient #16, admitted in 11/11, medical record review on 11/7/11, revealed that the patient had diagnoses that included mild mental retardation, sinusitis, and GERD (Gastroesophageal Reflux Disease).

Further review of the medical record revealed the hospital failed to develop and implement effective nursing care plans with goals and interventions for cognitive impairment, sinusitis, and GERD, although required.

Interview with the Director of the Psychiatric Unit on 11/9/11 at 8:20 A.M. revealed that the patient should have had a nursing care plan for each of the above identified issues.

6. For Patient #18, admitted in 10/11, medical record review on 11/8/11, revealed that the patient had diagnoses that included non-insulin dependent Diabetes Mellitus, obesity, asthma, and kidney disease.

Review of a Hospital "Event Report" dated 11/6/11, indicated the patient had an unwitnessed fall on the hospital unit without injury. There was no evidence the Hospital developed and implemented a falls prevention plan of care.

(Please refer to A 467).

Interview with the Director of the Psychiatric Unit on 11/9/11 at 8:20 A.M., revealed that the patient should have had a nursing care plan for each of the above identified issues.


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7. For Patient #6, the hospital failed to assess and develop a care plan to address the patient's open wounds, located on the patient's left lower leg.

Patient #6 was admitted in 11/11 with a dressing which covered the left lower leg from the ankle to below the knee. Review of the medical record, on 11/7/11, revealed a nursing assessment dated 11/4/11 which read, "open wounds to left leg covered with dressing." There was no indication the dressing was removed and the wounds were assessed. There was no treatment ordered by the physician to treat the wounds on the left leg.

Interview with the Director of Critical Care Unit (CCU) and Medical/Surgical unit on 11/8/11 at 2:00 P.M. revealed that when any patient is admitted with a dressing, the dressing should be removed, area assessed, and if needed an order from the physician should have been obtained to treat the wound.

Interview on 11/8/11 at 2:35 P.M. with the nurse who did the nursing assessment, RN #11, revealed that on 11/6/11 (2 days after the dressing was noted), RN #11 removed the dressing and treated the wound without a physician's order. There was no plan of care for this wound nor was there any documentation to reflect the dressing was removed, the wounds were assessed, and a treatment performed.

Please see A-0467




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8. For Patient #4, the Hospital failed to develop a plan of care and obtain a physician's order for the treatment of a pressure area.

Patient #4 was admitted to the hospital in 11/11, after being found lying on the floor in his/her home.

Review of the emergency room report revealed that "there are some pressure areas on [the patient's] left ankle."

Review of the nurses' notes and interview with Nurse #6 on 11/8/11 at 8:15 A.M., revealed that the nurses had been treating the area with a dry protective dressing.

On 11/8/11 at 8:45 A.M., the Hospitalist documented that the patient had an "open area (left) lateral ankle secondary to shearing." At that time, the physician ordered a treatment of "Aquagel to the (left) lateral ankle, cover with 4" by 4" (gauze), cover with Kling (gauze wrap)."

Further interview on 11/8/11 at 8:50 A.M. with Nurse #4, confirmed that the nurses had not obtained an order to treat the area prior to the patient's 3rd day of admission.

Based on record review and interview, the Hospital failed to follow facility policy for Transfusion of Packed Red Blood Cells and Blood Products, for 2 of 2 patients receiving blood products to include: (a) monitoring of vital signs, for one Patient (#41) and (b) inaccurate documentation of hang time/finish times for fresh frozen plasma (FFP) for one Patient (#2), in a total sample of 38 active records reviewed.

Findings include:

1. Patient #2 was admitted to the Coronary Care Unit (CCU) on 11/6/11 with a diagnosis of acute gastrointestinal bleeding. Record review indicated Patient #2 was to receive 2 units of FFP on 11/6/11.

According to the Hospital's policy titled "Transfusion of Packed Red Blood Cells and Blood Products" revised on 6/23/2011, FFP was to be infused at a rate of 200-300 cubic centimeters (cc's) per hour. Each unit of FFP contained approximately 250-300 cc's. Blood products must be hung within fifteen minutes of leaving the Lab refrigerator and the Lab would usually only release one blood product at a time. Staff were to observe for transfusion reactions during the transfusion. If two products were being infused simultaneously, and a reaction occurred, the Lab would not be able to tell which unit of blood caused the reaction.

The CCU Nurse Manager said on interview on 11/8/11 at approximately 10:00 A.M., that only one blood product should be hung at a time to avoid confusion in assessing for transfusion reactions.

Review of the blood transfusion slips, dated 11/6/11, indicated the first unit of FFP was initiated at 21:50 (9:50 P.M.). The slip indicated the first unit finished at 23:00 (11:00 P.M.). The second FFP transfusion slip, indicated the second unit was initiated at 22:15 (10:15 P.M.) and ended at 23:15 (11:15 P.M.). The problem was the documentation indicated the two units of FFP were transfused together, for 45 minutes, between 10:15 P.M. and 11:00 P.M.

Interview with the CCU Nurse Manager on 11/8/11 at approximately 10:00 A.M., could not verify that the FFP was administered one unit at a time, as required by Hospital policy.



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2. For Patient #41, the Hospital failed to obtain the patient's vital signs every 5 minutes for the first 15 minutes, and every hour thereafter, during a blood transfusion.

Review of the facility policy for Transfusion of Packed Red Blood Cells and Blood Products indicated that "vital signs should be taken every 5 minutes for the first 15 minutes, then every hour for the duration of the transfusion."

Review of the record revealed an 11/8/11 physician order for a blood transfusion. Review of vital sign documentation indicated vital signs were taken at 2:59 P.M., 3:00 P.M., 3:05 P.M., 3:10 P.M., 3:15 P.M. and lastly at 7:16 P.M. The patient's vital signs were not monitored hourly, between 3:15 P.M. and 7:16 P.M., as required by facility policy.

Based on record review and staff interviews, the Hospital failed to ensure that eight Patients (#12, #19, #20, #21, #31, #32, #33, and #34) out of a sample of 38 active records, had medical record entries which were dated and/or timed by the person responsible for providing or evaluating the service provided. Findings include:

1. Interviews with the Director of Maternal Newborn and Surgical Services at approximately 2:00 P.M. on 11/8/2011, the Senior Vice President of Patient Care, at approximately 4:00 P.M. on 11/8/11, and the Vice President of Nursing, at approximately 8:00 A.M. on 11/9/11, indicated that facility policy required all medical record entries to be timed and dated.

2. For Patient #12, medical record review indicated that although the surgical informed consent was dated by the physician, it lacked documentation of the time the consent was obtained.

3. For Patient #19, review of the informed consent indicated that although the surgical informed consent was dated by the surgeon, it lacked documentation of the time the consent was obtained.

4. For Patient #20, review of the informed consent indicated that although the surgical informed consent was dated by the surgeon, it lacked documentation of the time the consent was obtained.

5. For Patient #21, review of the surgical informed consent indicated that although the consent was dated by the surgeon, it lacked documentation of the time the consent was obtained.

6. For Patient #31, review of the informed consent for a colonoscopy (an endoscopic examination of the large bowel and the distal part of the small bowel) indicated that although the consent was dated by the physician, it lacked documentation of the time the consent was obtained.

7. For Patient #32, review of the informed consent for a colonoscopy indicated that the consent lacked documentation of both the date and time the consent was obtained by the physician.

8. For Patient #33, medical record review indicated that the surgical informed consent lacked documentation of both the date and time the consent was obtained by the surgeon.



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9. For Patient #34, record review indicated the informed consent for cardioversion, dated 11/8/11, was signed by the physician but lacked documentation of the time the consent was obtained. In addition, the consent for procedural sedation, dated 11/8/11, obtained by another physician was also signed and not dated, although required.

Based on review of medical records, and patient and staff interviews, the Hospital failed to ensure that all medical records contained all documentation necessary to monitor the patients' condition for 9 of 38 active patient records reviewed (#6, #12, #15, #18, #28, #41, #42, #43 and #44). Findings included:

1. For Patient #18, who had an unwitnessed fall in the Hospital, the Hospital failed to maintain a complete and accurate written account of the fall, in Nursing Notes, as required by Hospital policy.

Interview with Patient #18 on 11/8/11 at 9:30 A.M., revealed the patient said that he/she fell in the unit's kitchen on 11/6/11, without injury.

Review of the medical record for Patient #18, indicated the patient had diagnoses that included bipolar disorder, post traumatic stress disorder (PTSD), obesity, and Non-insulin Dependent Diabetes Mellitus. A nurse's note, dated 11/7/11 at 5:30 P.M., stated the patient was to be assessed "for risk of fall due to a previous fall." There was no evidence of any documentation regarding the patient's fall on 11/6/11.

Upon Surveyor inquiry on 11/8/11, a Hospital "Event Report," dated 1/6/11 at 3:30 P.M., was provided and indicated that the patient had a fall in the unit's kitchen.

Interview with the Director of the Psychiatric Unit on 11/9/11 at 8:20 A.M., acknowledged the missing nursing documentation.

Please refer to A 396.


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2. For Patient #6, the Hospital failed to ensure an assessment and treatment, for the patient's open wounds on the left lower leg, was documented.

Patient #6, was admitted on 11/4/11, with a dressing which covered the left leg from the ankle to below the knee. Review of the clinical record indicated a nursing assessment dated 11/4/11, which said, "open wounds to left leg covered with dressing." There was no indication the dressing was removed and the wounds were assessed. The record also lacked a physician's order to treat the leg wound.

Interview on 11/8/11 at 2:35 P.M. with Registered Nurse (RN) #11, revealed that on 11/6/11, (two days after the dressing was noted), RN #11 removed the dressing and treated the wound without a physician's order. There was no Nursing documentation to reflect the dressing was removed, the wounds were assessed and a treatment was done, as required.



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3. Interviews with RN #12, at 4:20 P.M. on 11/7/11, and the Vice President (VP) of Nursing and the Director of Quality and risk at approximately 10:00 A.M. on 11/9/11, revealed that Hospital policy required an evaluation of the effect of PRN (as needed) medications within one hour of patient administration.

4. For Patient #15, the Hospital failed to ensure that the patient was evaluated within one hour of receiving a physician prescribed PRN pain medication. Medical record review indicated a physician's order for the medication Demerol (a narcotic administered for pain), 25 milligrams (mg), by the intravenous (IV) route, PRN.

Review of the patient's medication administration record (MAR) and concurrent interview with RN #12, revealed that on 11/6/11 at 11:38 P.M., and on 11/7/11 at 3:48 A.M., Demerol 25 mg, IV was administered to the patient. However, an evaluation of the effect of the Demerol was not documented, within one hour of patient administration, as required by Hospital policy.

5. For Patient #42, the Hospital failed to ensure that the patient was evaluated within one hour of receiving a physician prescribed, PRN, anti-anxiety medication. Medical record review indicated a physician's order for the medication Vistaril (an anti-anxiety medication), 25 mg, PRN.

Review of the patient's MAR and progress notes, and concurrent interview with RN #13, revealed that on 11/8/11 at 9:10 A.M., Vistaril 25 mg, was administered to the patient. However, an evaluation of the effect of the Vistaril was not documented, within one hour of patient administration, as required by Hospital policy.

6. For Patient #43, the Hospital failed to ensure that the patient was evaluated within one hour of receiving the physician prescribed PRN, anti-anxiety medication. Medical record review indicated a physician's order for the medication Ativan 1 mg, PO (by mouth), PRN.

Review of the patient's MAR and progress notes, and concurrent interview with RN #13, indicated that on 11/8/11 at 10:30 P.M., Ativan 1 mg, PO, was administered to the patient. However, an evaluation of the effect of the Ativan was not documented.

7. For Patient #44, the Hospital failed to ensure that the patient was evaluated within one hour of receiving the physician prescribed, PRN, anti-anxiety medication. Medical record review on 11/9/11 revealed a physician's order for the medication Ativan 1 mg, PO, PRN.

Review of the patient's MAR and progress notes, and concurrent interview with RN #13, indicated that on 11/8/11 at 12:00 P.M., Ativan 1 mg, PO was administered to the patient. However, an evaluation of the effect of the Ativan was not documented, within one hour of administration of the medication to the patient.



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8. For Patient #28, the Hospital failed to obtain parameters for blood pressure (BP) and heart rate (HR) in order to titrate a Cardizem intravenous drip, although the physician's order stated to titrate according to BP and HR.

Record review indicated Patient #28 was admitted to the coronary care unit on 11/7/11 with diagnoses of rapid atrial fibrillation and congestive heart failure.

Physician orders, dated 11/7/2011, received verbally by a RN at 9:50 P.M., and cosigned by the physician at 10:00 P.M., stated to "start a standard Cardizem drip and titrate per BP and HR." There was no BP and HR specified as a therapeutic goal or range to obtain.

Record review indicated that at 12:00 A.M. on 11/8/11, Patient #28's BP was 100/78 with a HR= 88; at 2:00 A.M., the BP=122/74 with HR =88; at 4:00 A.M., the BP =106/76 with the HR =88 and at 8:00 A.M., the BP was 114/72 and the heart rate was 102. Patient #28's Cardizem drip was documented at 10 milliliters (mls) per hour from 10:00 P.M. and remained unchanged. The heart rhythm was documented as atrial fibrillation and unchanged since 10:00 P.M. on 11/7/11.

Interview on 11/8/2011, at approximately 10:00 A.M., R.N. #7, indicated that a standard Cardizem drip consists of 100 milligrams of Cardizem in 100 mls of normal saline, infused at a rate of 5 mls per hour. RN #7 said that there should have been ranges of blood pressure and heart rate specified by the physician, for guidance to the nurses, for accurate titration of the medication.

Based on review of pharmacy records and staff interview, the Hospital failed to ensure the Pharmaceutical services were administered in accordance with accepted professional principles. Finding include:

1. Code of Professional Conduct for Registered Pharmacists, Pharmacies and Pharmacy Departments [247 CMR 9.01 (14)] reads, "A pharmacist shall keep a perpetual inventory of each controlled substance in Schedule II which the pharmacist has received, dispensed or disposed of in accordance with the law. This inventory must be reconciled at least once every ten days".

2. Review of the inventory for Schedule II controlled substances on 11/8/11 at 10:30 A.M., revealed that this inventory was only reconciled when each controlled substance was dispensed from the pharmacy. This reconciliation was not conducted at least every 10 days as required. Interview with the Director of Pharmacy at that time, confirmed reconciliation was done only when each medication was dispensed which was not every 10 days for some of the Schedule II controlled substances. The only time controlled substances were reconciled was at the time an order was received for that particular medication and dispensed, which at times were beyond 10 days. There was no system in place to ensure that all controlled substances were reconciled at least every 10 days.

Based on observation, staff interview and review of pharmacy audits, the Hospital failed to ensure outdated drugs were removed from one out of two code carts in the Critical Care Unit, (CCU). Findings include:

1. Inspection on 11/7/11 at 10:30 A.M. in the CCU, revealed in the CCU code cart, the following medications had expired on 10/11:

-2 out of 2 vials of Narcan (opioid antagonist)
-5 out of 5 vials of Adenosine (antiarrhythmic)
-1 out of 1 Emergency kit of Glucagon (antihypoglycemic)
-2 out of 3 Flumazenil vials (benzodiazepine antagonist)

2. Interview on 11/8/11 at 10:15 A.M., with the Director of Pharmacy, revealed that every month a pharmacist was assigned to do inspections throughout the hospital to ensure medications were stored properly, and outdated medications were removed from patient use.

Review of the inspections audits from 1/1/11 - 11/1/11 revealed that the audits were not consistently done as assigned. For example; there were no monthly audits done for CCU. The last audits for the Emergency Room and the Maternity/Newborn Units were done in August 2011. Code cart audits were last done in 5/2011 on North 3 (a Medical/Surgical unit), and in 6/2011 for the Greylock Unit (a Mental Health Unit).

Further interview with the Director of Pharmacy confirmed the inspections had not been done as required.

Based on observations, review of Hospital policies and procedures, manufacturer's directions for use (DFU), and staff interviews, the Hospital Infection Control Officer (ICO) failed to consistently enforce Hospital policies that governed the control and prevention of infection. Specifically, implementation of policies for disinfection of patient equipment, surgical skin preps, and the continuous monitoring of sterile surgical instruments opened and prepared in advance of a surgical procedure. Findings included:

1. Interview with the Vice President of Nursing and Director of Psychiatric Services at approximately 9:00 A.M. on 11/9/11, revealed that facility policy required glucometers (used to take blood sugar levels) and the box the glucometers were housed in, to be disinfected with bleach after each patient.

Interview with RN #13 at 8:30 A.M. on 11/9/11, indicated that when implementing the blood glucose testing policy and procedure, the RN would bring the storage box containing the glucometer to a patient's room. The RN said that (s)he would place the box on the patient's bedside table, don clean gloves, remove the glucometer, and use the glucometer to scan the patient's wristband. The RN said (s)he would then obtain the patient's blood sample, place the blood on the test strip, place the strip into the glucometer, and obtain and document the patient's blood sugar level into the glucometer. The RN said (s)he then would place the now contaminated glucometer back into the now contaminated storage box.

The RN added that (s)he would use an alcohol wipe to disinfect the glucometer and the storage box. Review of the glucometer manufacturer's DFU at 1:00 P.M. on 11/7/11, revealed that glucometers were not to be disinfected with alcohol and that bleach wipes, with a 1:10 bleach ratio, were to be used to disinfect glucometers. Interview with the Vice President of Nursing at 9:00 A.M., revealed that Hospital policy required the storage box and the glucometer to be disinfected with bleach wipes, not alcohol.

RN #13 failed to adhere to Hospital policy and effectively disinfect the glucometer and storage box. Thereby, RN #13 created a risk of staff and/or patient cross-contamination from blood-borne organisms.

2. In the Surgical Suite, review of the Hospital policy and procedure "Surgical Site Preparation" on 11/8/11, read, "Using sterile supplies, scrub the skin starting at the site of the incision with a circular motion to the periphery and discard (the sponge). Never bring a soiled sponge back to the (area of the incision). Apply prep solution with a sponge on a sponge stick and apply in the same fashion (as above)."

Observation of a hand prep, at 9:30 A.M. on 11/8/11, revealed that RN #14 did not scrub the hand to the elbow in a circular fashion, (from the incision to the periphery), as required by Hospital policy. After scrubbing the hand, the RN used up and down motions, from the hand to the elbow and back to the hand. The RN also applied the prep solution in up and down motions, from the hand to the elbow and back to the hand. The Director of Maternal Newborn and Surgical and Surgical Services acknowledged that RN #14 failed to perform the skin prep in accordance with Hospital policy.

3. Interview with the Director of Maternal Newborn and Surgical Services at 2:30 P.M. on 11/10/11, revealed that surgical instruments opened and prepared for use, in advance of a surgical procedure, were required to be continuously monitored by a staff member, to ensure the instruments were not inadvertently contaminated.

Observations in operating room (OR) #3, at 9:00 A.M. on 11/8/11, revealed that the instruments for a total knee replacement (TKR) procedure had been opened and set-up on two sterile, draped tables. Observations also revealed that a surgery staff member was not present in the room to continuously monitor the instruments opened on the sterile field. Concurrent interview with RN #5, confirmed that the instruments had been set-up for at least 15 minutes, and no staff had been assigned to remain in the room to ensure that the instruments did not become contaminated. Continued interview with RN #5, revealed that the RN could not ensure that the unmonitored TKR instruments remained sterile.

Based on record review and interview, the Hospital failed to ensure one Patient (#34), in a total sample of #38, who underwent a procedure under deep sedation/anesthesia, received; (a ) a pre-anesthesia evaluation by a person qualified to do anesthesia and (b) was administered the medication Etomidate and monitored by a person qualified to administer anesthesia.

Findings include:

Review of the medical records indicated that Patient #34 was admitted to the emergency room from the physician's office, via the emergency medical system, on 11/7/11 for sustained ventricular tachycardia and a malfunctioning automatic internal defibrillator. Patient #34 was conscious but weak and dizzy. After several attempts to chemically cardiovert (change the heart rhythm with medications), record review indicated Patient #34 received synchronized cardioversion (a therapeutic dose of electric current to the heart at a specific moment in the cardiac cycle), after receiving the anesthetic drug Etomidate. (Etomidate is a hypnotic drug given intravenously for the intended purpose of general anesthesia induction and has a rapid recovery time to the patient's pre-induction baseline.)

Review of the pre-anesthesia evaluation indicated it was incomplete and lacked information. The evaluation was performed by the emergency room physician on 11/7/11, and the form indicated it was for "pre-moderate sedation." Under history and physical the word "reviewed" was written with no indication of any medical history or current problems. Under allergies, "reviewed" was written but no presence or absence of allergies was indicated. Pertinent history said only "V-tach." Anesthesia risk classification was listed as ASA II. There was no evaluation of the airway as required. The anesthesia plan was for Etomidate 8 milligrams intravenously and "L/MAC" or local/ monitored anesthesia care. The assessment was signed by the ER physician on 11/8/11 but not timed as required. The planned procedure was to deliver an electric shock to Patient #34's chest in order to convert the heart's rhythm from a potentially lethal arrhythmia to a normal rhythm. This can be a painful procedure so patients are usually heavily sedated or lightly and briefly anesthetized.

According to the facility policy on Sedation/Analgesia and Anesthesia Care, dated 9/21/2011, conscious sedation is drug induced depression of consciousness during which patients respond purposefully to verbal commands, either alone or with tactile stimulation. Deep sedation/analgesia is drug induced depression of consciousness during which patients cannot be easily aroused but respond purposefully following repeated or painful stimulation. The ability to independently maintain ventilatory function may be impaired. General anesthesia is a drug induced loss of consciousness during which patient are not arousable even by painful stimuli and ventilatory function is often impaired.

Review of the "conscious sedation" record revealed the patient was given Etomidate 9 mg, IV at 5:06 P.M., and it was initialed as given by a registered nurse (RN #15). The patient's blood pressure dropped to 65/12 (normal was 120/80), after the Etomidate was administered. At 5:10 P.M., RN #15 documented Patient #34 as being unresponsive, unarousable and not moving. Patient #34 was documented as remaining in this state until 5:20 P.M. Patient #34 was by definition, under deep sedation to light anesthesia. Only two RNs were documented as being in the room on the conscious sedation procedure record. Review of the operative report, dictated by the cardiologist, did not mention any other physician in attendance.

Per the Hospital policy, a trained and credentialed staff member, may monitor the patient throughout moderate sedation. Patients requiring deep sedation or anesthesia will be monitored by an anesthesia staff member (physician or certified registered nurse anesthetist.)

Review of the Administration Guidelines for IV Sedation/Analgesia agents used for Conscious Sedation and Analgesia revealed that Etomidate was to be administered by personnel trained in general anesthesia only.

Interview with the Nurse Manager in charge of Emergency Services on 11/9/2011 at approximately 2:00 P.M., indicated the Emergency Room physician, who performed the pre-anesthesia evaluation, was not a qualified anesthesiologist and should not have performed the pre-anesthesia evaluation. The NM said that RN #15 was not a certified nurse anesthetist, and should not have administered the Etomidate.

Based on medical record reviews and staff interviews, the facility failed to ensure a post anesthesia evaluation was completed and documented by an individual qualified to administer anesthesia, for five (#12, #14, #19, #20, #33) of 38 active patients reviewed. Findings included:

1. For Patient #12, a patient who received epidural anesthesia (affecting only a part of the body, such as the lower half of the body), medical record review indicated that the post-anesthesia evaluation lacked an assessment of the patient's respiratory (respiratory rate, airway patency, oxygen status), cardiovascular (pulse, blood pressure), and pain status, although required. The post anesthesia evaluation only addressed the fact that the patient was doing well and had no anesthesia complications.

2. For Patient #14, a patient who received epidural anesthesia, review of the medical record indicated that the post anesthesia evaluation lacked an assessment of the patient's cardiovascular, respiratory, and pain status, although required. The post anesthesia evaluation only addressed the fact that the patient was doing well and had no issues related to anesthesia.

3. For Patient #19, a patient who received general anesthesia (anesthesia characterized by unconsciousness, muscle relaxation, and loss of sensation over the entire body), review of the medical record indicated that the post anesthesia evaluation lacked an assessment of the patient's cardiovascular, respiratory, and pain status, although required. The post anesthesia evaluation only addressed the fact that the patient had no issues related to anesthesia.

4. For Patient #20, a patient who received general anesthesia, review of the medical record indicated that the post anesthesia evaluation lacked an assessment of the patient's cardiovascular, respiratory, mental, and pain status, although required. The post anesthesia evaluation only addressed the fact that the patient was doing well and had no anesthesia complications.

5. For Patient #33, a patient who received general anesthesia, review of the medical record indicated that the post anesthesia evaluation lacked an assessment of the patient's cardiovascular, respiratory, mental, and pain status. Further medical record review revealed that once the surgeon started to perform the surgery, a decision was made not to proceed with the scheduled surgical procedure, due to the seriousness of the patient's condition. The patient was then transferred to an area Trauma Center.

6. Interview with the Director of Maternal Newborn and Surgical Services at 2:00 P.M. on 11/7/11, and 1:30 P.M. on 11/8/11, confirmed that the post-anesthesia assessments lacked documentation of all required fields.

Based on record review and interview, the Hospital failed to maintain evidence for three of three respiratory therapists (RT) out of six total RTs, of competency to perform emergency intubation.

Findings include:

Review of the Hospital's Respiratory Policy and Procedure for Endotracheal Intubation, revised on 9/25/11, indicated that intubations are to be done by the RT in an emergency situation. The intubation is to be done orally by a trained RT who had completed training at the Hospital.

The Nurse Manager (NM) of Emergency Services during an interview on 11/8/11 at 12:00 P.M., said that Respiratory Services falls under her supervision. The NM said that the Respiratory Department follows the American Association of Respiratory Care (AARC) Practice Guidelines for management of airway emergencies, as a practice standard.

The AARC practice guidelines state that only Training Level II personnel may perform tracheal intubation and airway stabilization. These personnel require maintenance of training in advanced management of airway emergencies - ACLS and /or pediatric advanced life support (PALS) and /or neonatal resuscitation program (NRP). To maintain operator competence, certain procedures (such as endotracheal intubation) need to be reinforced as often as every 3 months. Level II providers should be credentialed as an RT, physician, registered nurse, or doctor of osteopathy. Level II providers should also have the following capabilities; advanced electrocardiography (EKG) monitoring and dysrhythmias (irregular and sometimes fatal heart rhythms) recognition, establishing ventilation via transtracheal catheter and cricothyroidotomy (small opening in the cartilage of the throat to create an airway), emergency treatment of hemothorax ( blood pooling around the lungs) with large bore needle, preparing patients for emergency transport, use of continuous and transport mechanical ventilators, and evaluating oxygenation, ventilation, and acid-base balance from blood gas reports.

Review of personnel files for RT #1, revealed no competencies for intubation. Interview on 11/9/11 at approximately 9:00 A.M., RT #1 said she had worked at the Hospital for over 30 years and worked full time. RT #1 said she did not track the number of intubations she had performed year to year. RT #1 stated on average, she performed 6-8 intubations a year, the last intubation one month ago in the emergency room, at the physician's request. RT #1 said she had not been trained to monitor the EKG for dysrhythmias, did not know how to correct a hemothorax, or do a cricothyroidotomy in an emergency. RT #1 said that the physician is always there, running the code (cessation of heart beat or breathing causing the emergency).

Review of the personnel file for RT #2 indicated he worked per diem, 12 hours a week. RT #2 had no ACLS (advanced cardiac life support) as required in the job description, and there was no evidence of an competency in endotracheal tube intubation. Review of the Respiratory Therapy schedule indicated that when RT #2 worked, he worked 12 hours 7:00 P.M. to 7:00 A.M., as the only RT in the Hospital.

Review of the personnel file for RT #3 indicated no competencies of endotracheal intubation, as required. RT #3 worked full time. There was no evidence of any advanced training to monitor the EKG for dysrhythmias, or how to correct a hemothorax, or do a cricothyroidotomy.

Interview on 11/8/11 at approximately 2:00 P.M., the ER NM said that there was no formal or informal tracking of the number of intubations performed by the respiratory therapy staff to monitor competency. The ER NM said the only observations of intubations in the personnel files are physician observed intubations either in the emergency room or the operating room. The ER NM said she believed the RT were training Level I providers by AARC practice guidelines and Training Level I personnel could intubate patients.

According to AARC practice guidelines, Training Level I personnel, (physicians, RTs, DO, RN), should be trained in clearance of foreign body airway obstruction, emergency airway secretion evacuation techniques, and basic life support (BLS) at frequent intervals not to exceed one year. Level I personnel assist the primary (Level II) members by assessing the patient for airway emergencies, respiratory and cardiac arrest, activating the resuscitation team, administering BLS, clearing the airway obstruction, providing mouth to mask ventilation, assisting with tracheal intubation, etc. Level I personnel by AARC standards may not perform intubations. Only personnel with Training Level II credentialing, training. and medical skills listed about may perform endotracheal intubations, safely.