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.

ST VINCENT HOSPITAL 123 SUMMER STREET WORCESTER, MA 01608 Feb. 22, 2011
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
Based on observation and documentation review the Hospital failed to ensure that non-hospital owned equipment was inspected for safety prior to use for 1 of 5 applicable patients (Patient #7).

Findings included:

The Hospital's Policy/Procedure related to Non-Hospital Owned Equipment indicated that clinical equipment brought into the Hospital had to be inspected to ensure that it functioned properly. The nurse assigned to the patient was responsible for ensuring the Biomedical Department was notified when patients brought equipment from home. Once inspected a yellow sticker was placed on the Unit.

On 2/22/11 a list of patients (Patients #6, #7, #8, #9, and #10) with orders for continuous positive air pressure (CPAP) were supplied by the Respiratory Department.

During a tour of the Medical/Surgical Units conducted on 2/22/11 with the Director of Risk Management present the CPAP units of Patients #6, #7, #8, #9, and #10 were viewed. Observation determined that Patient #7 had a CPAP unit brought from home.

Observation of Patient #7's CPAP unit indicated there was no yellow sticker. The serial number was provided to the Biomedical Department and it was determined the unit had not been inspected prior to being used.
VIOLATION: PROGRAM DATA, PROGRAM ACTIVITIES Tag No: A0283
Based on interview and documentation review the Hospital failed to ensure that: 1. the Hospital Internal Investigation for one of one applicable patients (Patient #1) analyzed all aspects of care; and 2. surgical Mortality and Morbidity meeting minutes evidenced that cases reviewed were appropriately analyzed to determine if there were opportunities for improvement.

Findings included:

On 2/8/11 the Hospital reported that Patient #1, a post-operative patient with a diagnosis of obstructive sleep apnea (pauses in breathing that occur during sleep), was found unresponsive with a small amount of vomitus coming from the side of the mouth after receiving narcotic medication for a 28 hour period. Also, equipment used to monitor sleep apnea was not in use when Patient #1 was found. Patient #1 was resuscitated but expired several days later. An autopsy was performed and indicated the cause of death was aspiration pneumonia.

1. The Hospital Internal Investigation was reviewed with the Director of Risk Management. Documentation indicated a Root Cause Analysis (RCA) was conducted on 12/21/10, there were meetings. The Hospital Internal Investigation/RCA determined:
1) It was not possible to determine the cause of Patient #1's event;
2) The lack of continuous pulse oximetry monitoring was determined not to be a contributing factor because the event occurred 28 hours post-op and continuous monitoring would have been discontinued after 24 hours because Patient #1 was stable;
3) Communication regarding continuous pulse oximetry monitoring had not been clear;
4) Dilaudid was administered at the top range dose of 2 mg and was never decreased when Patient #1's level of pain decreased;
5) The total volume of Dilaudid stocked (2 mg) appeared to the nurses on the electronic medication administration record screen and the dosing range of 1-2 mg became visible when the nurse clicked on dosing instructions which the nurses did not view;
6) There was a lack of compliance with the 30 minute re-assessment after pain medication administered;
7) Patient #1 did not have the CPAP unit on prior to the incident on 12/2/10 and there was no documentation as to why not;
8) Staff knowledge of OSA and monitoring was inadequate, and
9) A policy for managing OSA patients was being developed at the time of the Incident but had not been completed/implemented.

The Hospital Internal Investigation did not include a comprehensive review of all medications ordered for Patient #1, a review of the timeline and doses of sedating medications administered to Patient #1, and/or a review of nursing assessments prior to Patient #1's Incident.


2. Review of General Surgery Mortality and Morbidity (M&M) Meeting Minutes, dated 7/26/10 to 2/14/11 (18 sets of minutes in all), indicated that all but 2 meetings were hand-written. Review of the content of each meeting indicated that at each meeting several cases were briefly summarized however; the minutes did not indicate if the cases were analyzed to determine if care was appropriate, or if there were any follow-up actions or opportunities for improvement identified.

The Chief Medical Officer (CMO) was interviewed throughout the survey and said M&M meetings were robust, included analysis of cases, and determined if their were opportunities for improvement. The CMO said the minutes did not reflect the content of the meetings.
VIOLATION: PROGRAM DATA, PROGRAM ACTIVITIES Tag No: A0283
Based on interview and documentation review the Hospital failed to ensure that the corrective action plan had been fully implemented in a timely manner.

Findings included:

The Vice President (VP) of Quality and Safety and the Director of Quality were interviewed together on 2/22/11 at 11:10 A.M. and the Corrective Action Plan was reviewed.

Review of the Corrective Action Plan and related documentation revealed the following actions were called for:

1) Actions completed: instructions to Anesthesiologists that post-operative orders need to specify the type of monitoring required and the length of time monitoring is required; program the electronic medication administration record to have a pop-up and hard stop requiring the nurse to enter the pain scale score before the medication is administered; re-education for nursing staff involved in the Incident regarding pain re-assessment; switching stock Dilaudid doses from 2 mg/unit to 1 mg/unit, and development of a new Biomedical Log to track equipment inspected by patient name.

2) Actions implemented: re-education for all nursing staff regarding pain re-assessment; change post-operative Dilaudid orders from 1-2 mg to 0.5- 1 mg for severe pain; Notification to RT of all patients admitted on CPAP therapy who will be responsible for ensuring CPAP is used as indicated; post-operative patients with OSA will be placed on Hospital owned CPAP machines with respiratory rate monitoring/alarms built into the machines.

3) Actions not completed: Distribution of a safety alert regarding the use of Dilaudid with acknowledgement and sign-off required (developed for the March, 2011 Drug of the Month distribution); Completion and implementation of the policy regarding peri-operative management of patients diagnosed with OSA that (in draft form and awaiting approval); house-wide education of the policy regarding peri-operative management of patients diagnosed with OSA (developed and pending completion of the policy); development and implementation of a specific orderset to address monitoring of patients with obstructive sleep apnea (in draft form), and development of a nursing competency for OSA that includes monitoring requirements for patients receiving narcotics.

During the survey the VP of Quality and Patient Safety and the Director of Quality said a meeting regarding the Investigation and Corrective Action Plan was held and the team made the decision to discontinue use of dose ranges for narcotics effective immediately. The Pharmacy had taken on the responsibility of hard stopping any new narcotic orders with ranges. Communication had been initiated to all physicians regarding the decision to stop dose ranging for narcotics.
VIOLATION: RN SUPERVISION OF NURSING CARE Tag No: A0395
Based on documentation review, the Hospital failed to ensure that: 1. post-operative vital signs were taken as ordered; 2. a physician order was obtained prior to administering oxygen, and 3. pain medication was administered in accordance with physician orders.

Findings included:

1. Review of the Lumbar Spine Surgery Doctor's Orders, dated 12/1/10 and timed 1:40 P.M. indicated that vital signs and pulse oximetry were ordered to be taken upon arrival to the unit, every hour times 2, every 2 hours times 2, and every 4 hours times 24 hours.

Review of medical record documentation indicated that Patient #1 was transferred to the Medical/Surgical Unit at approximately 8:00 P.M.

Review of electronic nursing documentation, dated 12/1/10 and 12/2/10, indicated that vital signs and pulse oximetry were taken/documented at approximately 8:15 P.M. and 11:49 P.M. on 12/1/10. On 12/2/10 vital signs and pulse oximetry were taken at approximately 3:48 A.M., 6:21 A.M., 7:00 A.M. 11:00 A.M., 3:20 A.M., 6:15 P.M., and 7:10 P.M.

The nursing staff did not take Patient #1's vital signs and pulse oximetry as ordered.

2. Review of nursing documentation, dated 12/1/10 and 12/2/10, indicated the following:
> vital signs taken at 8:15 P.M. on 12/1/10 indicated that Patient #1 was receiving 4 liters of oxygen via nasal cannula.
> vital signs taken at 3:48 A.M. on 12/2/10 indicated that Patient #1 was receiving 2 liters of oxygen via nasal cannula.

Review of admission physician orders, dated 12/1/10, indicated there was no order for oxygen administration once Patient #1 was admitted to the Medical/Surgical Unit.

3. Medical record documentation indicated that on 12/1/10 Patient #1 had an elective laminectomy and spinal fusion. Patient #1 was then admitted to the Medical/Surgical Unit for monitoring.

Physician's Orders, dated 12/1/10, indicated that the following was ordered for pain management:
> Acetaminophen 650 milligrams (mg) every 4 hours as needed by mouth for mild pain rated as 1-3 (the patient rates their level of pain on a scale of 1-10 with 0 representing no pain and 10 representing the worst possible pain);
>Vicodin 1-2 tablets every 4 hours as needed by mouth for mild pain (1-3) and 2 tablets for moderate pain (4-6);
>Percocet 1 tablet by mouth as needed for moderate pain (4-6) and 2 tablets for severe pain (7-10), and
>Dilaudid 1-2 mg (narcotic analgesic used for moderate to severe pain; normal dose ranges are 1-4 mg every 4-6 hours as needed; side effects include sedation, hypotension, respiratory depression, and nausea/vomiting) intravenous every 3 hours as needed for severe pain (7-10).

Review of the electronic Medication Administration record, dated 12/1/10 and 12/2/10, indicated that

On 12/2/10 Dilaudid 2 mg was administered at approximately 10:29 A.M. for pain rated as 6/10.

On 12/2/10 Percocet 2 tablets were administered at approximately 12:49 P.M. for pain rated as 5/10.

On 12/2/10 Dilaudid 2 mg was administered at 3:17 P.M. for pain rated as 6/10.

On 12/2/10 Vicodin 2 tablets were administered at 4:50 P.M. for pain rated as 7/10.