The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

TUFTS MEDICAL CENTER 800 WASHINGTON STREET BOSTON, MA 02111 Feb. 4, 2014
VIOLATION: FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE Tag No: A0724
Based on observations, staff interviews and review of equipment logs, the Hospital failed to ensure the emergency equipment was maintained at an acceptable level of quality and safety in the Cardiology and Neurology clinics.
Findings include:

1. On 1/28/14 at 1:40 P.M., a tour of the Outpatient Cardiology Clinic on 6 South was conducted. During inspection of the clinic's code cart, the suction machine canister was observed to have a significant coating of dust on the top cover. The suction machine had no suction tubing in place from the suction inlet of the machine to the center suction port of the suction canister. Additionally, review of the code cart checklist revealed that the suction machine was not listed on the checklist for staff to ensure that it functioned properly.

The Director of Clinical Services, who was present during the tour, said on 1/28/14 at 1:45 P.M., that the Hospital would add the suction machines to the code cart checklists so that staff in each of the outpatient clinics would check them regularly to ensure that they functioned properly.

2. On 1/31/14 at 10:45 A.M., a tour of the Outpatient Neurology Clinic on the 12th floor of the Biewend Building was conducted. During inspection of the code cart, it was observed that the suction machine, when turned on by the Clinic Nurse Manager, did not function properly. Review of the code cart checklist revealed that the suction machine was not checked by staff to ensure that it functioned properly. The Clinic Nurse Manager had another staff member immediately call down to the biomedical equipment department to bring a replacement suction machine to the clinic.

Interview with the Director of Clinical Services, who was present at the time, said on 1/31/14 at 11:00 A.M., that the Hospital would add the suction machines to the code cart checklists so that staff in each of the outpatient clinics would check them regularly to ensure that they functioned properly and were available for use in the event of a "code blue" (emergency).
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
Based on observations of the environment of care, staff interviews, review of the Hospital's policies/procedures, review of the Centers for Disease Control (CDC) and Prevention Infection Control (IC) Standards for Hand Hygiene, review of the Association of periOperative Registered Nurses (AORN) Standards and Recommended Practices, review of the Hospital's Exposure Control Plan, review of Hospital disinfection logs, and review of manufacturer's directions for use (MDFU), the Hospital failed to consistently ensure staff adherence to Infection Control Standards for 2 of 3 Nonsampled Patients (NS #1, NS #2) and 5 Inpatients (#4, #9, #31, #32, #33), from a sample of 49 Inpatients. Findings included:

1. The Hospital failed to ensure that entries into the high level disinfection (HLD) logs were complete, contained accurate temperature readings, and followed MDFU.
HLD is a cleaning process that should destroy all microorganisms, except for bacterial spores, used to reprocess semi-critical items (items that contact mucous membranes or non-intact skin) in the Endoscopy Unit.

Surveyor #5 interviewed Endoscopy Technician (Endo Tech) #1 in the Reprocessing Area at 11:10 A.M. on 1/29/14. Endo Tech #1 said HLD was done using an automated endoscope reprocessor (AER). According to the MDFU, the temperature of the HLD solution must reach a minimum of 25 degrees centigrade in order to be effective in a 5 minute AER cycle. Endo Tech #1 said she took the temperature reading from the AER machine's visual monitor and entered the results into the HLD log. Review of the HLD log indicated multiple entries of temperatures less than 25 degrees centigrade, which did not meet the minimum temperature to ensure HLD in the AER had occurred.

Surveyor #5 conducted a random sampling of seven log entries that failed to meet the temperature requirements, and correlated the readings with the AER results tape. The readings were found to meet the required temperature parameters. Endo Tech #1 said she entered the temperature manually into the log and was uncertain of the minimum temperatures required for use of the HLD solution.

Despite the AER reaching the minimum temperature as required, the manual log did not consistently reflect an acceptable temperature. Endo Tech #1 said she did not routinely check the tapes to ensure the temperature requirements were met.

2. The Hospital failed to adhere to the policy to prevent Ventilator Associated Pneumonia (VAP) for two of three mechanically ventilated Inpatients (NS #1, NS #2).

According to the Hospital policy titled "Prevention of Ventilator Associated Pneumonia," patients who were mechanically ventilated were to be positioned with the head of the bed at a 30-45 degree angle, unless medically contraindicated. Maintaining the patients' beds at this level assists with prevention of aspiration and encourages full expansion of the lungs.

Observations in the Surgical Intensive Care Unit (SICU), on 2/4/14 at 9:20 A.M., Surveyor #5 observed two inpatients receiving mechanical ventilation. The head of the bed for NS #1 was observed in a 24 degree position and the head of the bed for NS #2 was observed in a 27 degree position.

3. The Hospital failed to consistently adhere to the Hospital's Exposure Control Plan, for transport of medical waste.

The Surveyor interviewed the Supervisor of the Central Processing Department (CPD) at 9:00 A.M. on 1/29/14. The Supervisor said the hospital used large red and white bins to transport body parts. The Supervisor said the transport bins were returned to the CPD for reprocessing. The transport bins lacked any biohazardous labels.

Review of the Hospital's Bloodborne Pathogen Exposure Control Plan indicated biohazardous labels must be affixed on containers/bags that transport blood or body parts or other potentially infective material.

4. The Hospital failed to consistently maintain equipment or the patient's environment at an acceptable level of safety and quality.

Surveyor #5 toured the Surgical Intensive Care Unit (SICU) with the Nurse Manager at 10:08 A.M. on 1/27/14. Surveyor #5 observed Patient Rooms #10 and #5. The Patient Rooms had visibly soiled floors; the areas under the hand-hygiene dispensers had areas of dark discoloration and soiling. In Patient Room #5, the base of the IV pole was visibly soiled with areas of dark debris. The seat of the chair in Room #5 had a long slit in the upholstery so the chair would not be able to be effectively disinfected between patients.

Surveyor #5 interviewed the Environmental Services Worker (ESW #1) at 10:40 A.M. on 1/27/14. ESW #1 said she was assigned to the SICU 40 hours per week and that the "special project " team conducted a deep cleaning 1-2 times per year.

Surveyor #5 interviewed the Director of Hospitality in the SICU at 10:45 A.M. on 1/27/14, who provided patient satisfaction data, including room cleanliness from the latest quarterly report (ending 11/30/13). However, no responses from the SICU had been returned and included in the data. The Director of Hospitality said the SICU was the next unit scheduled for a deep cleaning.

5. The Hospital failed to monitor a Patient food refrigerator for 11 of 28 days.

Surveyor #5 toured the Pediatric Bone Marrow Transplant (BMT) Unit at 8:25 A.M. on 2/3/14 and interviewed the Nurse Manager (NM). The BMT, NM said the patient rooms were equipped with a room refrigerator. The BMT, NM said the temperature of the refrigerators was monitored daily while the room was occupied. According to the BMT, NM, Room #5 had been occupied continuously since 1/6/14. The Refrigerator Log for Room #5 indicated temperature entries for 11 of the 28 days, 17 days were not recorded.

6. The Hospital failed to provide equipment that could be disinfected between patients.

Surveyor #5 toured the Pediatric Bone Marrow Transplant (BMT) Unit at 8:25 A.M. on 2/3/14 and interviewed the Nurse Manager (NM). The BMT NM said the unit cared for patients up to 21 years of age. The BMT NM said it was a rare instance that a patient would need to be shaved and an that an electric shaver was available for patient use. The BMT patient would not be permitted to use a safety razor because of the risk of bleeding. The BMT NM said the electric shaver would be cleaned with a bleach wipe between patients.

However, review of the MDFU of the electric shaver during the unit tour, indicated the MDFU did not include directions for cleaning. Thus, the electric shaver was not designed for multiple patients' use. Additionally, there was no Hospital policy specific to use of an electric shaver.





7. CDC IC Standards for Hand Hygiene required hand hygiene to be performed prior to and after patient contact, prior to and after contact with the patient's environment, and prior to donning gloves and after glove removal.

For Inpatient #4, observation of medication administration at 10:45 A.M. on 1/27/14, on Unit Proger 5, indicated Registered Nurse (RN) #1 failed to adhere to CDC IC Standards for Hand Hygiene as follows:

-Once in Inpatient #4's room, RN #1 handled the bed controls to adjust the level of the bed and also adjusted the patient's pillow. RN #1 failed to perform hand hygiene before and after the above activities.

-Using a hand-held scanner, RN #1 scanned the bar code on each medication and on the patient's identification bracelet. With now-contaminated hands, RN #1 opened Inpatient #4's oral medication packets and put the medications into a medication cup. RN #1 failed to perform hand hygiene before opening the medications.

-Inpatient #4's nurse call button fell on the floor. RN #1 picked the call button up off the floor and placed it back on Inpatient #4's bed. The RN failed to perform hand hygiene, as required.

-With now-contaminated hands, RN #1 removed a pair of gloves from the clean glove box and donned the gloves. RN #1 failed to perform hand hygiene before donning the gloves, as required. RN #1 then administered the medication Heparin (helps prevent blood clots) by the subcutaneous (sc-below the skin) route, to Inpatient #4.

8. For Inpatient #9, observations on 1/27/14 between 11:25 A.M. and 12:20 P.M., Surveyor #5 and Surveyor #7 observed Inpatient #9's central venous catheter (CVC) being removed and another CVC inserted into Inpatient #9's internal jugular vein.

The Surveyors observed Physician #1 fail to follow acceptable standards of hand hygiene during the removal and re-insertion of Inpatient #9's CVC. The Surveyors observed Physician #1 wash his hands prior to entering Inpatient #9's room. The Surveyors observed Physician #1 change his gloves repeatedly during the procedures; don new gloves, including sterile gloves; frequently obtain clean and sterile supplies from the clean central line supply cart; and remove gloves, which were visibly contaminated with blood. The Surveyors observed that, with the exception of when he first entered Inpatient #9's room, Physician #1 did not perform hand hygiene, in accordance with IC Standards of practice (e.g., prior to each time he accessed the central line supply cart and before each time he donned and after each time he removed gloves).

9. For Inpatient #32, observations in the Pre-operative Holding Area on 1/29/14 at 8:30 A.M., indicated that RN #7 failed to adhere to CDC IC Standards for Hand Hygiene as follows:

After performing hand hygiene and donning clean gloves, RN #7 touched Inpatient #32's over-the-bed table and changed it to a lower height. In preparation to insert an intravenous (IV) line, RN #2 applied a tourniquet to the patients left forearm and placed a clean barrier (Chux) under Inpatient #32's left hand.

RN #7 then opened clean supplies [sterile IV catheter (Angiocath), sterile sponges, Tegaderm, alcohol wipe], held Inpatient #32's left hand, inserted the IV and connected the IV tubing.

RN #7 failed to remove the gloves and perform hand hygiene before and after adjusting the height of the patient's over-the-bed table, before and after touching the patient's skin to apply the tourniquet, and before opening the clean and sterile IV supplies.

RN #7 inserted Inpatient #32's IV with potentially cross-contaminated gloves.

10. For Inpatient #33, observations in Operating Room (OR) #2, at 9:05 A.M. on 1/29/14, indicated that both RN #6 and Physician #10, donned gloves without first performing hand hygiene. RN #6 then failed to perform hand hygiene after removing the gloves.

11. Review of SaniCloth HB disinfectant wipes' MDFU on 1/29/14, indicated that the surface being disinfected must "remain visibly wet for 10 minutes," in order for effective disinfection of that surface to occur.

Observations in OR #2, on 1/29/14 at 9:40 A.M., between surgical cases, indicated that Anesthesia Technician (AT) #1, failed to follow MDFU. AT #1 used only one SaniCloth HB wipe to disinfect the anesthesia machine, anesthesia cart, anesthesia medication administration pump, and heart monitor leads. The above items were ineffectively disinfected as they were only visibly wet for approximately one and not 10 minutes.

12. For Inpatient #31, observations in OR #2 at 9:45 A.M. on 1/29/14, indicated the following:

a. While opening sterile supplies in order to set-up the sterile surgical table, Surgical Technologist (ST) #1 dropped a sterile package of sterile surgical gloves on the floor. ST #1 then picked-up the gloves and placed them on top of another package of sterile gloves and a sterile gown. The OR Clinical Nursing Director immediately took the gloves and gown and threw them in the trash. The OR Clinical Nursing Director confirmed that sterile items dropped on the floor are no longer sterile and that by placing the dropped, now-contaminated gloves on top of other sterile items, contaminated the items. The OR Clinical Nursing Director confirmed that ST #1 should have disposed of the dropped package of gloves.

b. Review of AORN Recommended Practice for Surgical Hand Scrub, using an alcohol-based surgical hand rub steps 8 to 10, subsequent to survey on 2/12/14, read:

"(Step 8). Apply the product to the hands and forearms according to the manufacturer's written instructions.

(Step 9). Repeat the product application process as directed.

(Step 10). Rub thoroughly until completely dry."

For Inpatient #31, observations in OR #2 on 1/29/14 at 10:22 A.M., indicated that after performing the surgical hand scrub with the alcohol-based surgical hand rub product Avagard, Physician #10 entered the room from the scrub area. While waiting to don the sterile gown and gloves, Physician #10 waved both arms in the air to dry the Avagard.

During the observation, the Clinical Nursing Director of the Operating Room said that arms and hands disinfected with Avagard should not be waved in the air to dry the Avagard. The OR Clinical Nursing Director confirmed that waving disinfected arms and hands in the air created air currents that contained dust and other contaminants that served to contaminate the surgically scrubbed hands and arms.

13. Observations in the OR Suite, in the scrub area outside OR #12, on 1/29/14 at 11:15 A.M., indicated that Physicians #11 and #12 had just completed a surgical scrub with Avagard. Both Physicians were standing at the scrub sinks having a conversation while waving their arms and hands in the air to dry. Physicians #11 and #12 did not rub their arms and hands dry, in accordance with AORN Recommended Practice for Surgical Hand Scrub, using an alcohol-based surgical hand rub.

14. Observations in OR #11, on 1/29/14 at 11:20 A.M., indicated that ST #2 waved his hands and arms in the air after completing a surgical scrub with Avagard. ST #2 failed to rub his arms and hands dry, in accordance with AORN Recommended Practice for Surgical Hand Scrub, using an alcohol-based surgical hand rub.

15. Review of the Central Processing Department (CPD) policy titled "Traffic Control" on 1/29/14 read, "Personnel assigned to decontamination may not move into any other CPD areas unless they don a clean precautions gown after removing the decontamination attire. Personnel from any CPD area may not enter decontamination unless they put on a precautions gown."

Observations in the former Day Surgery CPD area on 1/29/14 at 2:15 P.M,. indicated that Central Processing Technologist (CPT) #1 was working in the decontamination side of CPD. After removing the personal protective equipment (PPE-impervious gown, gloves), CPT #1 entered into the clean side of CPD. CPT #1 failed to wear a clean precautions gown over her scrub suit before entering the clean CPD area, as required by Hospital policy.

During the observation, the Director of Clinical Operations said that CPT #1 failed to follow Hospital policy.

Additionally, review of CPT #1's Training and Assessment Listing on 1/29/14, indicated that the CPT had completed "Attire and Traffic Pattern" training on 7/12/13.

16. During interview, in the clean area of the former Day Surgery CPD, on 1/29/14 at 2:15 P.M., CPT #1 said high level disinfection (HLD) was done using an automated endoscope reprocessor (AER). CPT #1 said manufacturer's directions for use (MDFU) required the temperature of the HLD solution to reach a minimum of 25 degrees centigrade in order to be effective, in a 5 minute AER cycle. CPT #1 said she tested the disinfectant (Rapicide OPA/28) to ensure it met an effective strength and the proper temperature, before processing each endoscope. CPT #1 said she documented the results of each test on the Disinfectant Efficacy Monitoring Log.

Review of the Disinfectant Efficacy Monitoring Log, dated from 1/3/14 to 1/29/14, on 1/29/14, indicated the following:

-CPT #1 failed to consistently document the minimum recommended concentration of the Rapicide OPA/28 on the log. The Disinfectant Efficacy Monitoring Log for 1/3/14 through 1/29/14, indicated pass or fail monitoring. However, the log didn't discern if the AER cycle or the Rapicide OPA/28 sterilant had passed or failed. Therefore, it was unable to be determined if the Rapicide OPA/28 concentration was at a strength to effectively disinfect the endoscopes or if it needed to be replaced.

-CPT #1 failed to document an efficacy result (Pass/Fail) on the Disinfectant Efficacy Monitoring Log for the following days: 1/7/14 at 9:20 A.M.; 1/9/14 at 4/26 P.M.; 1/9/14 at 4:45 P.M.; 1/10/14 at 3:41 P.M.; 1/14/14 at 8:22 P.M.; 1/14/14 at 9:40 A.M.; 1/29/14 at 1:06 P.M.; and 1/29/14 at 1:11 P.M.

-CPT #1 documented both pass and fail on the Disinfectant Efficacy Monitoring Log for the following days: 1/9/14 at 9:00 A.M.; 1/9/14 at 12:10 P.M.; 1/15/14 at 11:20 A.M.; and 1/24/14 at 1:45 P.M. Therefore, it was unable to be determined if the efficacy of the sterilant was a pass or a fail.
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observations, review of Hospital policies and procedures, medical record reviews, and staff interviews, the Hospital failed to ensure that medications were administered accurately, in accordance with the written orders of the practitioner responsible for the patient's care, in accordance with accepted standards of practice, and in accordance with the Hospital's medication administration policies, for 8 Inpatients (#4, #6, #7, #8, #9, #12, #25, and #49) from a total sample of 49 Inpatients. Findings included:

1. For Inpatient #49, Registered Nurse (RN) #11 was observed preparing Inpatient #49's 9:00 A.M. medications on 1/28/14 at 9:40 A.M., on the North 6 Unit. Included with the Patient's 9:00 A.M. medications was an order for the anticoagulant Heparin 5,000 units subcutaneously (sc), to be given every 12 hours. RN #11 was observed drawing up the Heparin, using a needle and syringe, from a vial of Heparin containing 5,000 units per 1 ml. (milliliter). RN #11 drew up the Heparin solution into a 1 ml syringe and handed it to the surveyor to inspect. The syringe, as observed by Surveyor #12, contained only 0.9 ml of Heparin (4,500 units) instead of the ordered dose of 5,000 units/1 ml of the medication. The vial of Heparin was examined by Surveyor #12 and found to have solution remaining in the vial. Surveyor #12 then informed RN #11 that she had not drawn up the entire 5,000 units/ ml of Heparin as ordered, and that she had only 0.9 mls (milliliters) or 4,500 units of Heparin in the syringe.

During interview on 1/28/14 at 9:50 A.M., RN #11 said that she thought she had drawn up the entire vial of Heparin. RN #11 was then observed inserting the needle into the vial of Heparin, drew out the remaining 0.1 ml of medication, and administered 1ml of Heparin 5,000 units/ml to the patient.





2. Review of Hospital -Wide Policy #4006 for Patient Care Orders on 2/4/14, indicated the following: "Range medication orders: these orders are discouraged and should only be written when necessary. Parameters must be included to indicate the appropriate choice of a dose within the prescribed range."

A. For Inpatient #4, a patient with diagnoses that included [DIAGNOSES REDACTED].M. on 1/27/14, on Unit Proger 5, indicated the following:

Review of the physician's orders for Inpatient #4, on 1/27/14 read:

-"Labetolol (lowers blood pressure), 10 to 20 milligrams (mg) IV (intravenously), q (every) 4 hours prn (as needed) for a systolic blood pressure (SBP) greater than 140."

The above order did not identify specific parameters to guide the nurse when to administer 10 mg or 20 mg of Labetolol. During interview at 10:00 A.M. on 1/27/14, the Professional Development Manager said, "Judged on the last dose of Labetolol, the RN would determine if the patient's blood pressure was too low or if the Labetolol didn't have any effect. The nurse would then decide which dose to administer."

-"Dilauded (relieves pain) 0.5 to 1.5 mg, IV, q 2 hours prn for pain, moderate to severe."

The above order did not identify specific dosing parameters to guide the nurse when to administer 0.5 mg., 1.0 mg, or 1.5 mg of Dilaudid. During interview at 10:00 A.M. on 1/27/14, the Professional Development Manager said, "Based on the patient's pain relief after the last dose of Dilaudid, the RN would decide which dose to administer." The Professional Development Manager acknowledged this was not within the nurse's scope of practice.

-Percocet (for pain) had two similar orders: "1 tablet for moderate pain;" "2 tablets for moderate pain, not to exceed 4 grams in 24 hours." Again, the physician did not identify specific parameters to guide the nurse when to administer one tablet or two tablets. Both orders were for "moderate pain."

Review of the Medication Administration Record (MAR) for administration of the pain medication Percocet on 1/27/14, read as follows:

"On 1/24/14 at 9:43 P.M., two tablets administered; on 1/25/14 at 4:25 A.M., two tablets administered; on 1/25/14 at 11:50 A.M., two tablets administered; on 1/25/14 at 7:19 P.M., two tablets administered; on 1/26/14 at 2:48 A.M., two tablets administered; and on 1/26/14 at 10:48 A.M., two tablets administered."

Inpatient #4 was consistently administered two tablets of Percocet, although the order also called for "Percocet one tablet for moderate pain." The Professional Development Manager said that the RN would decide which dose to administer." The Professional Development Manager acknowledged that this was not within the nurse's scope of practice.

The Professional Development Manager acknowledged that physicians prescribe medication and their doses and nurses administer the medications. Nurses do not prescribe medications and their doses.

Review of The Hospital-wide policy titled "Medication Administration and Safety, #4081" on 1/29/14, read:

"Time Critical Medications are those scheduled medications where early or delayed administration of maintenance doses of greater than 30 minutes before or after the scheduled dose may cause harm or result in substantial suboptimal therapy or pharmacological effect."

"The 30 minute Time Critical administration rule applies to:
-Medications with a dosing schedule more frequently than every 4 hours;
-Antibiotic medications via the IV route;
-Parkinson medications;
-Immunosuppressive (reduce a patient's ability to fight infection) agents;
-Medications that must be administered apart from other medications (e.g., antacids);
-Certain medications that require administration within a specified period of time (e.g., insulin); and
-Short acting opioids (narcotics)."

For Inpatient #4, medical record review on 1/27/14, indicated the following medications were to be administered at 9:00 A.M.:

Xanax (anti-anxiety), 0.5 mg, 9:00 A.M.; Tenormin (heart medication), 100 mg, 9:00 A.M.; Colace (stool softener), one tablet q 12 hours; Pepcid (antacid), one tablet, BID; Folic Acid (Vitamin C), one tablet, 9:00 A.M.; Heparin 5000 units, sc, TID; Ativan (for alcohol withdrawal) 1.5 mg, q 4 hours.

All the above medications were not administered to Inpatient #4 until 10:45 A.M. on 1/27/14. During interview at 11:15 A.M. on 1/27/14, the Professional Development Manager said that medications (except those that met the 30 minute requirement), were to be administered within one hour before or after the scheduled dose.

According to Hospital policy, the Pepcid and Ativan (both on the 30 minute administration list), were administered one hour and 25 minutes late and the remaining medications (Xanax, Colace, Tenormin, Folic Acid, and Heparin), were administered 45 minutes after the one hour limit.

B. For Inpatient #6, a patient with diagnoses that included [DIAGNOSES REDACTED]

-Ampicillin, 3 grams (gm), IV, q 6 hours (12:00 A.M., 6:00 A.M., 12:00 P.M., 6:00 P.M.);
-Heparin 5,000 Units, sc, q 8 hours (12:00 A.M., 8:00 A.M., 4:00 P.M.); and
-KCL (potassium chloride) 10 milliequivalents (meq), IV, q 1 hour for 4 doses (the start date and time was documented as 1/27/14 at 2:00 A.M.).

Review of the Medication Administration Record on 1/27/14, indicated that the above medications were not administered in accordance with Hospital policy and physician orders, as follows:

-The 6:00 A.M. Ampicillin 3 gm, IV was not administered until 9:15 A.M. on 1/27/14, two hours and 45 minutes late. Hospital policy required IV antibiotics to be administered within 30 minutes, before or after the scheduled dose.

-The 8:00 A.M. Heparin 5000 Units, sc was not administered until 9:15 A.M., 15 minutes late. Hospital policy required medications to be administered within one hour before or after the scheduled dose.

-The following refers to the physician's order for KCL, 10 meq, q 1 hour for 4 doses, to start 1/27/14 at 2:00 A.M. Hospital policy required medications with a dosing schedule more frequently than every 4 hours, to be administered within 30 minutes before or after the scheduled dose.

The 2:00 A.M. dose was not given until 4:18 A.M., one hour and 48 minutes late.
The 3:00 A.M. dose was not given until 4:56 A.M., one hour and 26 minutes late.
The 4:00 A.M. dose was also recorded as being given at 4:56 A.M., the same time as the 3:00 A.M. dose.
The 5:00 A.M. dose was not given until 6:26 A.M., 54 minutes late.

Review of a nurse's note, dated 1/27/14, indicated that the Ampicillin was late being administered because the KCL was being administered through the patient's only IV.

Consultation with the Department's Consultant Pharmacist, subsequent to survey on 2/6/14, indicated that Ampicillin and KCL are compatable medications and could be administered simultaneously.





3. Inpatient #7 was admitted to the Hospital in 1/2014 with diagnoses including abdominal pain, hemicolectomy (bowel resection) and intra-aortic balloon pump (a surgically implanted device that provides artificial heart compressions).

Review of the physician orders revealed that there were 2 different orders for Dilaudid. The orders were as follows:
-Dilaudid 0.5 mg intravenous every 2 hours as needed for pain
-Dilaudid 1 mg intravenous every 2 hours as needed for pain.
The orders for the medication failed to indicate the parameters under which each dose of the medication should be given.

During interview on 1/28/14 at 10:15 A.M., Registered Nurse (RN) #9 confirmed that the two orders were administered as written and further said that it was the nurse's decision which order to follow.

4. Inpatient #8 was admitted to the Hospital in 1/2014, with diagnoses including abdominal abscess and fistula and pelvic ischium osteo[DIAGNOSES REDACTED] (infection of pelvic bone).

Review of the physician orders revealed that there were 2 different orders for Dilaudid. The orders were as follows:
-Dilaudid 2 mg oral tab every 3 hours as needed for pain
-Dilaudid 4 mg oral tab every 3 hours as needed for pain.
The orders for the medication failed to indicate the parameters under which each dose of the medication should be given.

During interview on 1/28/14 at 10:30 A.M., RN #9 confirmed that the two orders were administered as written and further said that it was the nurse's decision which order to follow.

5. For Inpatient #9, observation by Surveyor #5 and Surveyor #7 on 1/27/14 between 11:25 A.M. and 12:20 P.M., revealed Inpatient #9's central venous catheter (CVC) being removed and another CVC inserted into Patient #9's internal jugular vein. Prior to the removal of the catheter, at approximately 11:45 A.M., Surveyor #5 and Surveyor #7 heard Physician #1 verbally order Fentanyl (pain medication) 50 micrograms to be administered to Inpatient #9 and observed RN #2 administer the Fentanyl intravenously, to Inpatient #9.

Review of Inpatient #9's Physicians' Orders, the next day on 1/28/14, indicated there was no order written on 1/27/14 for the bolus of Fentanyl and no documentation of the medication having been administered to Inpatient #9. After surveyor inquiry on 1/28/14, a late entry for the Fentanyl was entered into the electronic medical record.

Surveyor #7 interviewed the Professional Development Manager, the Manager of the Surgical Intensive Care Unit (SICU), and the Director of Informatics at approximately 8:20 A.M., on 1/28/14. The Professional Development Manager, SICU Nurse Manager, and the Director of Nursing Informatics said it was the expectation the staff document all medications administered to patients, and confirmed there was no record of Nurse #2 administering Fentanyl 50 micrograms intravenously to Inpatient #9 on 1/27/14.





6. Inpatient #12 was admitted to the Hospital in 1/2014 with diagnoses including colon inertia (slow metabolism) and re-feeding syndrome (occurs when a previous malnourished patient is fed a high carbohydrate diet).

Review of the physician orders on 1/28/14 read:

"Morphine 1-2 milligrams (mg) IV (intravenously) q (every) 4 hours prn (as needed) for pain for 7 days." The order had a start date of 1/27/14 and a stop date of 2/3/14.

The order for the above medication did not include parameters indicating the appropriate dose within the prescribed range for treating varying levels of pain.

During interview on 1/29/14 at 9:45 A.M., Registered Nurse #13 indicated that it was up to the nurse to decide the dosage of morphine within the prescribed range to treat the patient's pain.




7. For Inpatient #25, medical record review on 1/28/14, indicated the following:

Review of the Medication Administration Record (MAR) on 1/28/14, indicated the patient had two separate orders for Oxycodone (relieves pain) as follows:

"Oxycodone 5 mg (1 tablet) orally, every three hours as needed for pain, and Oxycodone 10 mg (2 tablets) orally, every three hours as needed for pain."

The physician's order did not identify specific dosing parameters to guide the nurse when to administer 1 or 2 tablets of Oxycodone.
VIOLATION: MEDICAL RECORD SERVICES Tag No: A0450
Based on staff, patient/family interviews, and medical record reviews, the Hospital failed to ensure that all patients medical record entries were complete, dated, timed, and authenticated in written or electronic form, by the person(s) responsible for providing or evaluating the service provided, for 4 (#6, #22, #23, #38), of 49 Inpatients and 1 (#12), of 13 Outpatients. Findings include:

1. For Inpatient #6, medical record review on 1/27/14, indicated that although the Intra-operative Record was signed by Registered Nurse (RN) #14, the date and time of the entry was not documented.

2. For Inpatient #22, medical record review on 1/28/14, indicated that the following consents for Cardiac Catheterization lacked the name of the operating physician or the date and/or time of the patient/family's signature as follows: for 11/29/13, the time of the patient's signature was not documented; for 12/26/13, no time or date of the patient's signature was documented; for 1/3/14, the consent lacked the name of the operating physician; for 1/10/14, no time of the patient/family signature was documented; and for 1/22/14, no time of the patient/family signature was documented.

During interview in the Cardio-Thoracic Intensive Care Unit (CTU), on 1/28/14 at 9:30 A.M., the Clinical Nursing Director confirmed that the above Cardiac Catheterization Consent Forms lacked a place for the time of the patient/family signature to be documented.

3. For Outpatient #12, medical record review on 2/3/14, indicated that the Consent for Cardiac Catheterization lacked the time the patient signed the consent.

4. Review of the Medical Staff Bylaws on 1/29/14 read as follows: "Medical Student notes should be read and constructively critiqued and then co-signed on the same day with a brief addendum. Medical student admission notes as the sole admission note are not acceptable."

During interview at 10:45 A.M. on 1/28/14, Physician #9 said that Hospital policy required Residents to supervise and co-sign all medical students' medical record entries. Physician #9 said that teams, comprised of Attending Physicians, residents, interns and medical students, were developed and that medical students were under the direct supervision of Residents.

5. For Inpatient #23, medical record review on 1/28/14, indicated that medical record entries regarding Inpatient #23's daily progress, written by Medical Student #1, were not co-signed by a Resident, as required by Hospital policy. The entries were made on 1/21/14, 1/22/14, 1/23/14, and 1/24/14.

During interview at 10:45 A.M. on 1/28/14, Physician #9 confirmed that the above medical record entries were not co-signed by a supervising resident, as required.

Additionally, Inpatient #23's surgical consent lacked the time of the patient's signature.





6. For Inpatient #38, observation on 1/29/2014 at 10:22 A.M., revealed that RN #8 inserted a peripherally inserted central catheter (PICC) line (a catheter which is inserted into a vein and ends at the upper chest vein near the heart for the purpose of providing hydration and nutrition).

Review of the medical record indicated that the Informed Consent Form for the PICC Line was dated 1/27/2014 at 5:00 P.M. and authorized another Nurse, RN #12, for the procedure. The consent was signed by the Patient's Mother.

Interview with Inpatient #38's Mother on 1/30/2014 at 2:15 P.M., indicated that RN #8 contacted her by telephone to notify her that another attempt would be made by her to insert the PICC line. During interview, Inpatient #38's Mother said that she consented to the procedure.

Review of the medical record indicated that RN #12 failed to document the failed attempts to insert the PICC line along with relevant clinical information about the procedure.
VIOLATION: CONTENT OF RECORD - INFORMED CONSENT Tag No: A0466
Based on review of documentation, interviews and review of Hospital Policy, the facility failed to ensure that staff followed Hospital Policy Guidelines for obtaining telephone consent for the insertion of a Peripherally Inserted Central Catheter [PICC line]. Findings include:

1. For Inpatient #38, observation on 1/29/2014 at 10:22 A.M., revealed that Registered Nurse (RN) #8 inserted a PICC- line (a catheter which is inserted into a vein and ends at the upper chest vein near the heart for the purpose of providing hydration and nutrition).

Review of the medical record indicated that the Informed Consent Form - Consent to insert the PICC Line was dated 1/27/2014 at 5:00 P.M. (two days prior to this procedure) and authorized by another Nurse, RN #12, for the procedure. The consent was signed by the Inpatient 38's Mother.

Interview with Inpatient #38's Mother on 1/30/2014 at 2:15 P.M., indicated that RN #8 contacted her by telephone to notify her that another attempt to insert the PICC line would be made by RN #8. During interview, Inpatient #38's Mother said that she consented to the second procedure. However, RN #8 failed to document the telephone consent, obtain a witness to monitor the conversation, and sign the form.

Review of the Hospital-Wide Policy titled "Informed Consent", part IV, section on Telephone Consent, indicated that "if consent from an individual other than the patient was required and that person was available only by telephone, consent may be obtained by telephone. In the case of telephone consent, a witness must monitor the telephone conversation between physician and the individual authorized to consent on behalf of the patient and sign the form."

Review of the medical record indicated that documentation of the telephone consent was not documented and witnessed, as required by Hospital Policy.
VIOLATION: PATIENT RIGHTS: INFORMED CONSENT Tag No: A0131
Based on record review and staff interview, the Hospital failed to:

a. Activate the health care proxy for 1 of 2 incapacitated Inpatients (#29); and
b. Notify the Probate and Family Court Department of a change in the Rogers Treatment Plan for 1 Inpatient (#2), from a total of 49 inpatients.

Findings include:

1. For Inpatient #29 the Hospital failed to activate the patient's Health Care Proxy. The Health Care Proxy was completed prior to Inpatient #29's admission and a copy was placed in Inpatient #29's medical record.

Inpatient #29 was admitted to the Hospital in 1/2014, with diagnoses including cerebral vascular accident (CVA-stroke) and failure to thrive.

Upon arriving at the Emergency Department, a nurse's note indicated the family had reported that Inpatient #29 did not recognize them and was experiencing shortness of breath. Inpatient #29 was admitted to the hospital for "further evaluation and workup of this change in mental status, shortness of breath and failure to thrive."

On 1/27/14, the patient's daughter and the physician signed a consent for the insertion of PEG (a percutaneous endoscopic gastrostomy, a tube surgically inserted into the stomach for liquid nourishment), which was to be inserted later that week.

According to documentation in the medical record, Inpatient #29 had not regained his/her ability to make informed health care decisions. The Hospital did not activate the Health Care Proxy as required by Massachusetts State Law.

During interview on 1/29/14 at 9:20 A.M., Registered Nurse #12 said that the Health Care Proxy had not been activated prior to the administration of the PEG tube, although Inpatient #29 had been deemed unable to make informed decisions.





2. For Inpatient #2, the Hospital failed to obtain a copy of the Rogers Monitor Treatment Plan (a court approved treatment order for the use of antipsychotic medications) to ensure that the court approved treatment orders were implemented.

Record review on 1/27/14, indicated that Inpatient #2 was admitted to the Hospital during 12/2013, with a diagnosis of schizophrenia. Further record review indicated that Inpatient #2 had a Legal Guardian with a Rogers Monitor Treatment Plan, which indicated the dosage and dose range of antipsychotic medications which was not in Inpatient #2's medical record.

On 1/27/14 at 11:30 A.M., Registered Nurse #5 said she was unaware Inpatient #2 had a Rogers Treatment Plan and did not know what antipsychotic medications were to be administered to Inpatient #2. After surveyor inquiry, on 1/27/14 at 11:50 A.M., Registered Nurse #5 said the Rogers Treatment Plan, which indicated the dosage and dose range of antipsychotic medications, was not in Inpatient #2's record as required.

Review of current Physicians' Orders on 1/27/14, indicated that Inpatient #2 had orders for Clozapine (antipsychotic medication) 600 milligrams (mg) at bedtime and Risperdal (antipsychotic medication) 4 mg at bedtime.

Review of the 1/27/14 Medication Administration Record (MAR), indicated that Inpatient #2 received Clozapine 600 mg at bedtime and Risperdal 4 mg at bedtime, from 1/24/14 to 1/26/14.

On 1/27/14 at 11:45 A.M., Registered Nurse #15 said Inpatient #2 received Clozapine and Risperdal at bedtime and was unaware that Inpatient #2 had a Rogers Treatment Plan.

On 1/27/14 at 2:30 P.M., Unit Manager #4 said he did not know why Inpatient #2's Rogers Treatment Plan was not in the record as required and was unaware of the antipsychotic medications Inpatient #2 could receive under the Rogers Treatment Plan.

After Surveyor #3's inquiry, the Hospital obtained Inpatient #2's Rogers Treatment Plan from the Legal Guardian. On 1/28/14, review of Inpatient #2's recently acquired Rogers Treatment Plan, dated 12/4/13, indicated Inpatient #2 was to receive the antipsychotic medication, Clozapine, with a dosage and dose range of 300 - 600 milligrams a day. The Rogers Treatment Plan did not indicate that Inpatient #2 could receive an alternative and/or any additional antipsychotic medication.

Further review of the 1/2014 MAR, indicated, after Surveyor #3's inquiry, the hospital obtained a physician's order on 1/27/14, to discontinue Risperdal 4 mg at bedtime.

On 1/28/14 at 9:30 A.M., Unit Manager #4 and Registered Nurse #5 said after reading Inpatient #2's Rogers Treatment Plan, Inpatient #2 should not have received the antipsychotic medication Risperdal from 1/24/14 to 1/26/14, because the antipsychotic medication was not indicated in the Rogers Treatment Plan. The only medication Inpatient #2 could receive under the Rogers Treatment Plan was Clozapine. In addition, Unit Manager #4 and Registered Nurse #5 said in order to change the Rogers Treatment Plan and add another antipsychotic medication (Risperdal), the Legal Guardian would have to present the new antipsychotic medication to the Court.

On 1/28/14 at 9:49 A.M., Social Worker #1 said he thought that the medical students working on the psychiatric unit were responsible to obtain the Rogers Treatment Plan from inpatients' Legal Guardians and place the Plan in the inpatients' records. Social Worker #1 also said there was no assigned staff person responsible for obtaining a Rogers Treatment Plan and placing the legal document in the inpatients' records. Social Worker #1 was not aware if Inpatient #2's Legal Guardian was notified of the new antipsychotic medication.
VIOLATION: OPERATIVE REPORT Tag No: A0959
Based on medical record review and interview, the Hospital failed to ensure that all Brief Operative Notes described the techniques, findings, and tissues removed or altered, for 3 (#4, #6 and #30) of 5 surgical Inpatients from 49 Inpatients and 1 surgical Outpatient (#13) of 13 Outpatients reviewed. Findings included:

1. For Inpatients #4 and #6, medical record review on 1/27/14, indicated that the Brief Operative Note lacked the findings and techniques of the inpatients' surgeries, as required.

During interview on 1/27/14 at 10:20 A.M., on Unit Proger 5, the Professional Development Manager confirmed the Brief Operative Notes for Inpatients #4 and #6 lacked documentation of the techniques, findings, and tissues removed or altered. The Professional Development Manager also confirmed that the Hospital's Brief Operative Note Form lacked a category for "Findings," under which operating physicians would document the techniques, findings, and tissues removed or altered.

2. For Inpatient #30, medical record review on 1/29/14, indicated that the Brief Operative Note, failed to document the techniques, findings, and tissues removed or altered, as required.

3. For Outpatient #13, medical record review on 2/3/14, indicated that Brief Operative Note, lacked the techniques and findings of the patient's surgery.

During interview, in the Post Anesthesia Care Unit (PACU), on 2/3/14 at 11:30 A.M., the PACU Manager confirmed that the above Brief Operative Note did not document the techniques, findings, and tissues removed or altered during surgery. The PACU Manager acknowledged that the Hospital's Brief Operative Note Form didn't contain a section titled "Findings" in which physicians would document their findings and the tissue removed or altered.
VIOLATION: OPO AGREEMENT Tag No: A0886
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record review, review of the Hospital's death register and Organ Procurement Organization Policy, and staff interviews, the Hospital failed to ensure that timely notification (within one hour) of a patient's death to the organ bank was conducted consistently for 3 of 3 death records (Inpatients #43, #44, #45) from a total of 49 inpatients reviewed. Findings included:

On 1/29/14 at 1:15 P.M., the Hospital Relations Coordinator from the organ bank was interviewed regarding the Hospital's timely referral rate. The coordinator said that the goal for timely referrals was 100 %. Following a decline in timely referral rates (74% in March 2013 and 74 % in May 2013), the Coordinator said that a training session was provided by the organ bank in August 2013, to clinical staff and anyone involved in death reporting or referral to the organ bank. Review of the training session revealed "All patient deaths need to be reported immediately to the Admitting Office." The training session also educated staff that "The reason for this is that the Hospital was required by federal law to report all patient deaths to the (contracted organ bank) within one (1) hour of death so that they could determine if there was a potential for tissue donation."

The Organ Bank Coordinator (OBC) explained that all deaths were to be reported to the organ bank. She explained that the unit where the patient expired was required to report to the Hospital Admitting Department, and in turn, the Admitting Department was required to notify the organ bank of the patient's death. The coordinator from the organ bank further explained that Unit Coordinators were typically the individuals on the unit who notified the Admitting Department when a patient expired. Because Unit Coordinators didn't work the night shifts, the OBC explained, timely reporting to the Admitting Department was not always achieved. As a result, timely notification to the organ bank often went beyond the one hour timely notification requirement.

1. For Inpatient #44, review of the Death Register on 1/30/14, revealed that Inpatient #44 expired on [DATE] at 4:50 A.M. The Admitting Department listed the time of referral to the organ bank as 6:15 A.M., 25 minutes over the one hour requirement.

2. For Inpatient #45, review of the Death Register on 1/30/14, revealed that Inpatient #45 expired on [DATE] at 5:19 P.M. The Death Register documented that the organ bank was not notified of the patient's death until 7:38 P.M., one hour and 19 minutes over the one hour requirement.

3. For Inpatient # 43, review of the Death Register on 1/30/14, revealed that Inpatient #43 expired on [DATE] at 3:11 P.M. There was no documented evidence in the Death Register that the Hospital Admitting Department notified the organ bank of the patient's death.

Registered Nurse (RN) #12, a Unit Educator, was interviewed on 1/31/14 at 9:10 A.M., regarding the Unit Coordinator Forum that was held on 8/20/13, to educate staff regarding timely notification to the Admitting Department following a patient's death. RN#12 said that the Unit Coordinators were instructed by her that the Admitting Department must be notified of a patient's death within one hour of death. RN#12 also said that she recognized that allowing the Unit Coordinators an hour to report a patient death to the Admitting Department might delay timely notification to the organ bank.

The Q.M. (Quality Management) RN was interviewed on 1/30/14 at 3:30 P.M., regarding the Hospital's Organ Procurement Organization policies. The Q.M. RN said that she recognized that the Hospital was not compliant with their policy that required timely notification to the organ bank within one hour of death. She said that she would address this through the Hospital's Quality Management Department.

The Hospital failed to ensure that timely notification, within one hour of death, was carried out per the requirement and the Hospital's Organ Procurement Organization Policy.
VIOLATION: MEDICAL STAFF Tag No: A0338
Based on observation, record review and interviews the Hospital failed to have an organized Medical Staff that was responsible for the quality of medical care provided to one Inpatient (#1) in a total sample of 49 inpatients, that resulted in a significant decline in Inpatient #1's neurological status. Findings include:

1. The Hospital was found to be in Immediate Jeopardy from 1/6/14 to 1/24/14, related to the conditions of Patient Rights and Medical Staff. The Hospital failed to ensure staff followed policies and procedures regarding proper patient positioning for central line removal. As a result, Inpatient #1 suffered an air embolism (air entry into the bloodstream), cardiac arrest, and subsequent severe neurologic compromise (brain damage).

2. Review of the Central Venous Catheter (CVC) Policy and Procedure on 1/24/14, clearly defined the number of central line insertions (fifteen) that must be monitored by a supervising physician. However, the policy did not specify the number of observations or oversights required for the removal of a central line by Interns (PGY1-post grad year one out of medical school) and Residents (PGY2 and beyond).

3. During interview on 1/24/14 at 11:10 A.M., the Medical Director of the Medical Intensive Care Unit (MICU) and the Chief Medical Officer said that the current training for removal of a central line for Interns and Residents was incorporated into the basic course for central line insertion. However, the training did not include any hands-on training in the Simulation Lab for central line removal.

4. The Hospital's Corrective Action Plan (CAP) regarding the training and procedure for central line removal was not fully implemented at the time of the Complaint Survey on 1/24/14. The parts of the CAP not fully implemented included:
a. Facility-wide re-education for hospital clinicians on Reducing the Risk of Air Embolism Associated with a CVC.
b. Updating of the Hospital's Central Line Insertion Training Program to incorporate the central line removal segment into a hands-on experience and incorporate CVC removal questions into a written test.
c. Utilizing the Simulation Lab for removal training for first year medical residents.
d. Implementing the central line removal competency sign-off similar to the insertion competency.
VIOLATION: NURSING CARE PLAN Tag No: A0396
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record review, staff interview, and review of Hospital policy, the Hospital failed to ensure the care plan was current for 1 Outpatient (#11) in a total sample of 13 Outpatients and 1 Inpatient (#6) in a total sample of 49 Inpatients.

1. For Outpatient #11, the Hospital failed to ensure Outpatient #11's mental health treatment care plan was updated and current.

Record review on 1/30/14, indicated that Outpatient #11 had been receiving outpatient mental health services since 2005. Review of the outpatient mental health treatment care plans indicated that Outpatient #11's last care plan was dated 8/12/12.

According to the outpatient mental health progress notes, Outpatient #11 was last seen at the outpatient mental health service on 9/19/13. Further review of the progress notes indicated that Outpatient #11 was moving to another state. Outpatient #11's mental health treatment care plan was not updated or reviewed since 8/12/12.

On 1/30/14 at 11:00 A.M., Outpatient Therapist #1 said he had failed to update and revise Outpatient #11's mental health treatment care plan since 8/12/12. Outpatient Therapist #1 said it was the Hospital's policy to review treatment plans every quarter and once a year and he could not explain why he did not update Outpatient #11's mental health treatment care plan.





2. For Inpatient #6, the Hospital failed to ensure that the patient's problem list was updated and current.

Medical record review on 1/27/14, indicated that Inpatient #6 was admitted on [DATE] for surgery that included an abdominal hysterectomy (removal of uterus) and removal of the left ovary and tube.

Review of Inpatient #6's problem list, (the basis of a patient's care plan), on 1/27/14, indicated the following problems, all dated 11/29/13:

-Obstructive [DIAGNOSES REDACTED] (obstructive jaundice - a condition in which there is blockage of the flow of bile from the liver. This results in an overflow of bile and its by-products
into the blood. Bile contains bilirubin. Bilirubin is yellow, and gives the characteristic yellow appearance of jaundice in the skin, eyes, and mucous membranes);
- Ascites (accumulation of fluid in the abdominal cavity);
- Postmenopausal bleeding;
-Congestive heart failure (heart failure causing an accumulation of fluid in the lungs);
- Nutritional deficiency (unspecified); and
- Anemia (low red blood cell count).

During interview on 1/27/14 at 5:00 P.M., the Professional Development Manager said that the problem list was that of the patient's previous admission and had not been updated this admission, as required. Also, the problem of uterine bleeding was no longer current, as Inpatient #6 had a total hysterectomy and a left ovary and tube removal on 1/22/14, the day of this hospital admission.
VIOLATION: ORGANIZATION OF NURSING SERVICES Tag No: A0386
Based on review of two of two credentialing files for Nurses Practicing in the Expanded Role [Certified Registered Nurse Practitioner (CRNP) #1 and Certified Registered Nurse Anesthetist (CRNA) #1], the Hospital failed to ensure that Nursing Administration provided adequate supervision and evaluation of the clinical activities which occurred within the responsibilities of the Nursing Services. Findings include:

1. Standards of Practice as set forth in the Code of Massachusetts Regulations (CMR) that governed the practice of Nurses practicing in the Expanded Role, 244 CMR 4.00, specified that "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 the appropriate medical staff and nursing administration staff of the institution employing the nurse."

"A nurse practicing in an institution may not practice in an expanded role until:

a. The Governing Body, including the medical staff and nursing administrative staff, formally review and approve the guidelines under which the nurse proposes to practice; and
b. A physician is designated to provide medical direction as is customarily accepted in the specialty area."

2. Review of CRNA #1's and CRNP #1's credentialing files on 2/3/14, indicated approval of each nurse's clinical practices, in writing, from their Supervising Physician, their Department Chair and each nurse. However, there was no evidence of any approval from Nursing Administration for the clinical practices requested by the two Nurse candidates. In addition, there was no evaluation of their clinical activities which also occurs within the responsibilities of the Nursing Services.

3. During an interview with the Chief Nursing Officer (CNO) on 2/3/14 at approximately 2:00 P.M., the CNO said she did not approve the guidelines for the above nurses, who were practicing in the expanded role. The CNO said she was not aware she had to approve the guidelines.
VIOLATION: INFORMED CONSENT Tag No: A0955
Based on medical record review, and patient and staff interviews the Hospital failed to obtain a properly executed consent for 2 (#22, #23) of 49 Inpatients and 1 (#12) of 13 Outpatients undergoing invasive procedures. Findings included:

1. For Inpatient #23, the Hospital failed to ensure the patient received a fully informed consent, in order for the patient to make an informed decision regarding his/her 1/26/14 surgery.

(A well informed consent process would include discussion that physicians, other than the operating practitioner, including but not limited to residents, would be performing important tasks related to the surgery. Important surgical tasks included: opening and closing patients' operative site, dissecting tissue, removing tissue, harvesting grafts, transplanting tissue, implanting devices and placing invasive lines).

For surgeries in which residents would perform important parts of the surgery, discussion was encouraged to include:

- That physicians who were in approved post graduate residency training programs would perform portions of the surgery, based on their availability and level of competence;

- That it would be decided at the time of the surgery which residents would participate and that the choice of resident would depend on the resident's competence; the knowledge the operating practitioner/teaching surgeon had of the resident's skill set; and the patient's condition; and

- That residents performing surgical tasks would be under the supervision of the operating practitioner/teaching surgeon.)

Review of the Operating Room Record on 1/28/14, indicated that Physicians #13 (an attending physician) and #14 (a surgical resident), along with Physician Assistant (PA) #1, assisted Physician #7 (the operating physician of record) with performing parts of Inpatient #23's, 1/26/14 cardiac surgery.

During interview on 1/28/14 at 11:30 A.M., Inpatient #23 said that "(S)he didn't know that other physicians or staff assisted his/her surgeon to perform the surgery and that (s)he saw a lot of people in the room, but (s)he didn't know who they were or what they did." Inpatient #23 also said "(s)he knew who his/her surgeon was after (s)he saw the surgeon's name on his identification badge."

At the time of giving his/her consent for surgery, Inpatient #23 was not informed that practitioners, other than his/her surgeon of record, would be performing parts of his/her surgery.

2. For Inpatient #22, medical record review on 1/28/14, indicated the 1/3/14 consent for cardiac catheterization, lacked the name of the physician who would be performing the procedure. That section of the consent form was blank.

3. For Outpatient #12, medical record review on 2/3/14, indicated that Physician #5, a physician receiving additional training (a fell owship) in Interventional Radiology, obtained the patient's consent. However, Physician #5 documented his name on the consent form as the operating physician, and not the name of the Operating Physician who actually performed the procedure.

Observation in the Cardiac Catheterization Suite on 2/3/14 at 8:45 A.M., indicated that Physician #5 was not present in the Cardiac Catheterization Operating Room and did not participate in the procedure. Physician #7, also a physician performing a fell owship in Interventional Radiology, performed parts of the patient's procedure with the operating physician. Neither Physician #7's name or the Operating Physician's name was documented on the consent.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0178
Based on record review and interviews, the Hospital failed to ensure face-to-face assessments were conducted in person, within 1-hour after the initiation of four-point physical restraint for one Inpatient (#24), in a sample of 49 Inpatients and two Outpatients (#2 and #3), in a sample of 13 Outpatients. Findings included:

1. For Inpatient #24, review of Emergency Department (ED) record on 1/27/14, indicated Inpatient #24's Physician Orders/Documentation Restraint Form, dated 3/2/13 at 11:45 A.M., revealed Inpatient #24 was physically aggressive and wrist and ankle restraints were ordered. The Physician Orders/Documentation Restraint Form indicated the standard of care was utilized because of an outburst or imminent physical aggressive, assaultive, or destructive behavior that posed an imminent danger to the patient or others. Above the area where the Physician signed, dated, and timed the Form, was the following statement, "I have conducted a face-to-face assessment of the patient and reviewed the plan of care."

The Form indicated Inpatient #24 was restrained at 12:00 P.M. on 3/2/13, 15 minutes after the Form was signed, with the order and the statement from the physician of having completed the face to face assessment. The form indicated Inpatient #24 remained restrained for 2 hours and 45 minutes. There was no documentation to indicate a face-to-face evaluation was completed within 1-hour after Inpatient #24 was restrained.

2. Outpatient #2's ED record, dated 1/9/14, indicated that at 1:00 P.M., the Physicians' Order/Documentation for Restraint Use Form, indicated the ED Physician signed for the use of a restraint. However, the order was incomplete as it did not indicate the type of restraint to be implemented, the behavior present that warranted use of the restraint, and the alternative measures attempted prior to implementation of the restraint. The Form indicated Outpatient #2 was physically restrained, but no additional information to indicate when he/she was re-assessed or when the restraints were removed. The Physicians' Order/Documentation for Restraint Use Form, indicated that at 1:30 P.M. on 1/9/13, Outpatient #2 was restrained.

The Physician who signed the incomplete Physicians' Order/Documentation for Restraint Use Form, documented that he had conducted a face-to-face assessment of the patient and reviewed the plan of care, 30 minutes prior to when Outpatient #2 was actually physically restrained. There was no documentation of a face-to-face assessment within 1-hour after Outpatient #2 was restrained.

3. Outpatient #3's ED record, dated 1/21/14, indicated that at 1:15 P.M., the Physicians' Order/Documentation for Restraint Use Form, was signed by the physician. The Form indicated Outpatient #3 was to be restrained with ankle and wrist restraints and was also to receive medication as a restraint. The Physician signed, dated, and timed the Form, below the statement, "I have conducted a face-to-face assessment of the patient and reviewed the plan of care." However, this form was signed 15 minutes before Outpatient #3 was actually restrained. There was no documentation of a face-to-face assessment within 1-hour after Outpatient #3 was restrained.

During interview at 4:30 P.M. on 1/28/14, Surveyor #7 interviewed the ED Nurse Manager (NM). The ED NM said the ED used pre-printed Forms for physicians to write a restraint order. The forms included a statement regarding having completed a face-to-face assessment within one hour after the assessments were conducted.

Surveyor #7 reviewed Inpatient #24, Outpatient #2, and Outpatient #3's ED records with the ED NM. The NM said the physicians' signature, date, and time documented on Order/Documentation Forms was to indicate when the restraint was ordered and was not the documentation the face-to-face assessment being completed after the patient was restrained. The NM was unable to provide documentation that indicated face-to-face assessments were completed within 1-hour of a patient being restrained. The NM said the Form was not being used properly.
VIOLATION: INFECTION CONTROL Tag No: A0747
Based on review of Hospital documents, observations, record review, and interview, the Hospital failed to be in compliance with the Condition of Infection Control specific to: failure to adhere to Infection Control (IC) Standards of Practice, failure to adhere to manufacturer's directions for use (MDFU), failure to provide sanitary environment; failure to adhere to Hospital infection control policies [i.e., handwashing, insertion of intravenous (IV) lines, insertion of central venous catheters (CVC), and medication administration]. Findings included:

1. Observations, staff interviews and review of equipment logs in the Cardiology Clinic at 1:40 P.M. on 1/28/14 and the Neurology Clinic on 1/31/14 at 10:40 A.M., indicated the Hospital failed to ensure the emergency equipment was maintained at an acceptable level of cleanliness, quality and safety.

Please refer to A724.

2. Observations on the Surgical Intensive Care Unit (SICU) on 1/27/14 at 10:10 A.M. and the Pediatric Bone Marrow Transplant Unit (BMTU) on 2/3/14 at 8:30 A.M., indicated unsanitary environmental and IC issues.

Please refer to A749.

3. Observations, staff interviews, review of Hospital documents and policies and procedures, and review of National IC and Operating Room Standards throughout the duration of survey, from 1/27/14 to 2/4/14, indicated the Hospital failed to consistently enforce policies that governed the control and prevention of infection specifically related to documentation of high level disinfection (HLD) logs, hand hygiene, insertion of IVs and CVCs, measures to decrease the risk of ventilator associated pneumonia, medication administration, proper use of surgical attire, and proper use of the surgical hand rub.

Please refer to A749