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1 BOSTON MEDICAL CENTER PLACE

BOSTON, MA 02118

NURSING SERVICES

Tag No.: A0385

Not met.

Based on observation, record review and interview, the Condition of Nursing Services is not met, as evidenced by the nursing department failure to ensure that two of two contracted hemodialysis registered nurses ( RN #4 and RN #5) received orientation and read only access to the Hospital's computerized medical record system before being allowed to independently care for hemodialysis patients. Without medical record access to verify laboratory results, RN#4 relied on verbal information, which was later found to be inaccurate, on Patient #6's Hepatitis B status and documented a negative result on the dialysis flow sheet on 3/1/13, when in fact, the patient was Hepatitis B positive by history and serology results documented in the clinical record by late afternoon on 3/1/13. RN # 5, also without documentation of orientation to computer access and to Hospital orientation, confirmed by interview, did not verify the Hepatitis B results in the medical record for the next dialysis treatment, and documented the same negative result as written on the previous treatment sheet. This pattern continued for an additional seven treatments, through 3/16/13, which allowed a total of five dialysis machines to be exposed to Hepatitis B. These contaminated dialysis machines were then used to dialyze 13 other patients without the benefit of a terminal disinfection with bleach between each use, as required by Hospital policy for machines with Hepatitis B exposure. This caused 5 of the 13 patients, who were susceptible to Hepatitis B, due to lack of immunity, to be exposed to potential Hepatitis B infection. These five patients now require 6-12 months of monitoring to detect if they will develop Hepatitis B disease.

The nursing department also failed to ensure contract dialysis staff received read only computer access for clinical record review while caring independently for dialysis patients for one (#6) of nine full time dialysis registered nurses and six of six ( #9, #10, #11, #12, #13 and #14) per-diem registered dialysis nurses. This predisposed the contract dialysis nursing staff to committing the same type of documentation errors as they could not verify laboratory results with a source document (the clinical record).

See Tag AO398 for details.

SUPERVISION OF CONTRACT STAFF

Tag No.: A0398

Based on record review and interview, the nursing department failed to ensure that two of two contracted hemodialysis registered nurses ( RN #4 and RN #5) had received orientation and read only access to the Hospital's computerized medical record system before being allowed to independently care for hemodialysis patients. Without medical record access to verify laboratory results, RN#4 relied on inaccurate verbal information on Patient #6's Hepatitis B status and documented a negative result on the dialysis flow sheet when in fact the patient was Hepatitis B positive by history and serology. RN # 5, also without computer access and Hospital orientation, did not verify the Hepatitis B results in the medical record for the next dialysis treatment, and documented the same negative result as written on the previous treatment sheet. This pattern continued for an additional seven treatments which allowed Hepatitis B exposed dialysis machines to be shared with 13 other patients without the benefit of a terminal disinfection with bleach between each use as required for machines with Hepatitis B exposure. This caused 5 of the 13 patients who were susceptible to Hepatitis B due to lack of immunity, to be exposed to potential Hepatitis B infection. The nursing department also failed to ensure dialysis staff received read only computer access for clinical record review while caring independently for dialysis patients for one (#6) of nine full time dialysis registered nurses and six of six ( #9, #10, #11, #12, #13 and #14) per-diem registered nurses. Findings include:


1. Record review indicated Patient #6 was admitted 2/28/13 for same day surgery for a 2-vessel cardiac bypass and aortic valve replacement. The patient was taken to the Surgical Intensive Care Unit (SICU) post operatively. Record review indicated in the pre-operative surgical evaluation that the patient had a history of hepatitis B. On 3/1/13, post operative day (1), the renal service was consulted as the patient was a long standing hemodialysis patient. The renal consult also noted the history of Hepatitis B. The consult note was signed by the renal resident at 1:45 P.M. and contained a statement that the patient was seen and examined in the SICU during a hemodialysis treatment. The Critical Care Data Tracking Sheet , completed by the admitting nurse in the SICU, under other history, also listed the diagnosis of history of Hepatitis B.

The initial renal orders on 3/1/13 included a dialysis treatment in the SICU for four hours. Review of the dialysis treatment sheet indicated the treatment was started by RN #4 at 10:40 A.M., using machine number 126. Dialysis notes indicated RN #4 drew bloods for Hepatitis B surface antigen (HBsAg) and antibody (HBsAb) at 12:30 P.M. At 12:45 P.M., RN #4 documented the physician was in to see the patient. the front page of the treatment sheet had a place to document the laboratory results. In the space for hepatitis labeled "HBsAg" a '"---" was documented..

During an interview on 4/3/13 at 8:30 A.M., RN #4 said the "----" documented in the HBsAg indicated the patient was negative for Hepatitis. RN #4 said s/he did not have any access to the computerized medical record on that day and did not get access until today.. On 3/1/13, RN #4 said s/he got a verbal report from the primary nurse in the SICU and the nurse told him/her that the patient's Hep B status was negative. RN #4 said s/he did not ask to see the laboratory report because the policy was to get the information from the nurse or ask the nurse to access the lab reports on the computer. RN #4 said when the physician came to the unit to see the patient, there was no discussion about the patient's Hepatitis B status.

RN #4 stated s/he had completed his/her dialysis orientation in January 2013 but had not received a Hospital orientation. RN #4 stated s/he did not receive any training on read only access to the Hospital's clinical computer system. Review of RN #4's personnel and training file indicated that Hospital Orientation Checklist was completed and signed on 4/2/13 with an indication that s/he had not attended a hospital computer training course and as of 3/20/13 had no access to the clinical computer record.

2. Record review indicated the patient was dialyzed again in the SICU on 3/2/13 by RN #5, using machine number 124. Review of the treatment sheet indicated RN #5 documented the HBsAg result as negative. Review of the clinical record, under laboratory results, indicated the Hepatitis B surface antigen and antibody results from the tests drawn the previous day at 12:30 P.M. were posted. The patent was reactive (positive) for Hepatitis B surface antigen which is expected in a patient with Hepatitis B infection.

During an interview on 4/3/13 at 9:00 A.M., RN #5 said s/he was a traveling nurse working with the contract dialysis company on a thirteen week contract and s/he did not have computer access. RN #5 said s/he gets all the laboratory results from the primary nurse and uses the results from the previous daily nursing flow sheets but the Hepatitis B results are not on those. RN #5 stated s/he will then use the previous dialysis flow sheet for the Hepatitis B results which is in the patient's paper record. RN #5 confirmed s/he also cared for the patient on 3/14/13 and again on 3/16/13 when it was discovered that the patient was in fact Hepatitis B positive. When asked what s/he did differently on 3/16/12, RN #5 said s/he was working with RN#2 who had computer access and checked the Hepatitis B status in the laboratory section of the computerized clinical record and immediately saw the issue. The clinical coordinator was notified, the machine sequestered , physicians notified and a drill down started to identify other effected machines and patients.

Review of the training and personnel file for RN #5 indicated s/he had all the dialysis competency orientation but no hospital orientation was evident and there was no indication of training for read only computer access for the computerized clinical records.

3. During an interview on 4/2/13 at 11:00 A.M., the dialysis unit Clinical Coordinator (CC) said that hemodialysis nurses should have computer access to look up laboratory reports but if they do not, the expectation is they ask other nursing staff to print out the current lab reports or open the computerized clinical record so the contract nurse can read the results. The CC said s/he does not track who has access or who does not.

3. At surveyor request, list of all dialysis nursing staff was provided with status of their clinical computer access. The list indicated that 6 of 6 per-diem dialysis nurses did not have read only access to the computerized clincal records until 4/3/13, following inquiries by the complaint survey team. RN #5, who cared for Patient #6 on 3/4/13, 3/12/13 and 3/16/13, did not have computerized medical record access until 4/3/13 One of six per-diem RNs (RN #9) did not have access until 4/3/13, his/her access having expired on 8/29/12 and one other full time RN (RN #6) did not get access until after s/he cared for Patient #6 on 3/4/13, according to interview on 4/3/13 at 2:30 P.M.

4. During an interview on 4/3/13 at 2:00 P.M., the Hospital Nurse Educator #1, said the dialysis nurse manager is supposed to arrange to send new staff to hospital orientation and to a computer training course when they are scheduled. This is the responsibility of the dialysis contract company.

INFECTION CONTROL PROGRAM

Tag No.: A0749

6. During an interview on 4/3/13, the Hospital Patient Safety and Risk Management Team provided documentation that identified the dialysis machines that were used by Patient #6, who had Hepatitis B, then were used on 13 other patients without a disinfection process completed per Hepatitis B terminal use disinfection policy. Effected machines were Machine #115, #124, #125, #126 and #127.

According to the policy titled "Infection Control and Isolation Measures for Known or Unknown Hepatitis B surface Antigen Positive Patients", each antigen positive (HBsAg) patient will undergo dialysis in a separate room and use a separate dialysis delivery system, equipment, instruments and supplies designated and labeled for the Hepatitis B patient.

When it is determined that dedicated equipment is no longer needed ( patient discharged or recovers function and no longer needs dialysis), a terminal cleaning will be performed. this consists of:
a. bleach and heat disinfection of the internal fluid pathway of the hemodialysis machine
b. external surfaces of the machine and the portable RO (reverse osmosis) machine are thoroughly cleansed with a 1:100 bleach solution
c. the Biomed team will inspect the dialysis machine's internal transducer protectors for blood strikethrough and replace the transducers if any evidence of blood contamination.

Normal disinfection procedures of machines for non-hepatitis B patients consists of the following:
a. All hemodialysis machines must be disinfected at least every 72 hours.
b. All machines in use are to be hot water disinfected at the end of each treatment day
c. All machine are to receive an acid rinse (vinegar) daily and a weekly Bleach disinfection.
d. all machines are to receive an external disinfection with 1:100 bleach solution between each patient.

Review of the disinfection and cleaning logs for dialysis machines #115, #124, #125, #126 and #127 which were the hepatitis B contaminated machines shared with 13 non -infected patients, 5 who were susceptible to infection by lack of immunity, indicated the following:
a. One of five machines was not bleached weekly, as required. Machine #124 was bleached on 3/1/13 and 3/16/13 but not on 3/7/13.
b. Four of five machines had no documentation of a daily acid rinse and/or external disinfection between uses. Machine #115 was used on 3/9 and 3/11/13 but there was no documentation in the log that the acid rinse or external disinfection was completed after each use. For Machine #125, used on 3/9, 3/11, 3/13 and 3/14 there was no documentation of external disinfection between uses. For Machine #126, used on 3/8, 3/9, 3/11, 3/13, and 3/14, there was no documentation of external disinfection or acid rinse, as required. For Machine #127 used on 3/5/13, there was no documentation of an acid rinse or external disinfection after use as required.

During an interview on 4/2/13 at approximately 11:00 A.M., the Dialysis Unit Clinical Coordinator who reviewed the logs with the surveyor, said, s/he does not review the logs for compliance or completeness, it is the only place staff document the tasks and there are no observational audits done to ensure staff are complying with disinfection processes.

Although the dialysis staff did not know about the Patient's Hepatitis B status until 3/16/13, review of the disinfection logs indicated the staff failed to follow routine disinfection procedures such as weekly bleach disinfection, acid rinses daily and external disinfection of the machines, increasing the risk of cross contamination.






27110


Based on observations, interviews, and review of the Dialysis Service policies and procedures, the Hospital failed to consistently ensure an acceptable level of infection prevention practice in the Dialysis Unit.

1. In the Dialysis Unit on 4/2/13 at 3:30 P.M., the surveyor observed Registered Nurse #2(RN #2)discontinuing dialysis on Patient #1.

According to standards, full barrier protection(gloves, impervious gown, and face shield)is used during initiation and discontinuation of a dialysis treatment because of the high risk of a blood exposure. However, RN #2 was observed in a fluid resistant gown, wearing a surgical mask and eyeglasses instead of an impervious gown and full face protection. Interview with the Clinical Coordinator of the Dialysis Unit confirmed that the impervious gown, readily available in the Dialysis Unit, and full face protection is required personal protective equipment.

Review of the policy titled "Patient Care During Dialysis" 9-2009 indicated a fluid resistant barrier garment could be used where "blood contamination is a greater possibility" during patient care procedures. However, this policy is not in compliance with the Occupational Safety and Health Administration (OSHA )requirement that Personal Protective Equipment (PPE) will be considered "appropriate" only if it does not permit blood or other potentially infectious materials to pass through to or reach the employee's work clothes, street clothes, undergarments, skin, eyes, mouth, or mucous membranes under normal conditions of use and for the duration of time which the protective equipment will be used.

2. In the Dialysis Unit on 4/2/13 at 3:10 P.M., the surveyor observed two staff members from Patient #2's inpatient unit, bring an IV solution to the beside of Patient #2. This patient was on Contact Precautions, and neither staff performed hand hygiene prior to entering or when leaving Patient #2's cubicle.

3. In the Dialysis Unit on 4/2/13 at 3:30 P.M., the surveyor observed Patient Care Technician #1 completing conductivity testing on a dialysis machine. After completing the test the dialysis water was disposed of into the hand washing sink. According to the policy "Infection Control in the Hospital Dialysis Setting" 3-2011, handwashing sinks are dedicated for hand washing purposes only.

4. In the Dialysis Unit on 4/2/13 at 4:00 P.M., the surveyor observed that Patient #2 was being observed by a 1:1 Nursing Assistant because of a previous attempt to disrupt a dialysis treatment. Nursing Assistant #1 was seated in the treatment area approximately four feet from Patient #2, observing the patient. However, Nursing Assistant #1 was drinking from a water bottle while stationed in the treatment area and stored the bottle on top of a soiled laundry container. According to Infection Prevention standards no food or fluids are consumed in treatment areas.

5. In the Dialysis Unit on 4/2/13 at 4:00 P.M., the surveyor observed a consultant physician (Physician #1)visiting Patient #2. This patient was on Contact Precautions and the physician was required to gown while visiting the patient. At the completion of Physician #1's visit to the Patient #2, the privacy curtain was opened. The surveyor observed that Physician #1 had failed to secure the precaution gown. The untied precaution gown had drooped down to expose the Physician #1's white lab coat.