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Based on review of grievance/complaint files, the Complaint Activity Log and staff interview, the facility failed to investigate and respond to the patient/patient's family in 7 days, according to the hospital policy, for 9 of 11 (complaint #1, #2, #3, #5, #6, #7, #8, #9, #10) grievances/complaint reviewed on the Department of Public Health (DPH) side of the hospital. Findings include:

1. The hospital's policy for Patient Complaint, Mistreatment, Abuse and Neglect stated the following:

"Every complaint received will be subjected to a mutual review by the Patient Advocate or his/her designee and by the Director of Quality Management or his/her designee....

If the original allegation warrants a formal review by the Complaint Review Team, it shall be assigned to a fact finding investigation. For DPH complaints, a Decision Letter will be drafted by the Director of Quality Management and sent to the complainant and all pertinent parties within 7 business days and issued to the complainant and all pertinent parties.

If the original allegation alleges an illegal, dangerous or inhumane condition, it shall be assigned to a full, formal investigation....

A final report will be submitted to the Person In Charge within the 7 days or a letter to the complainant indicating why additional time is needed shall be sent with copies going to all parties to the complaint."

During interview on 1/8/13, at 11:30 A.M., the Director of Quality Management stated that all grievances and allegations of abuse and neglect were included in this policy.

2. For Grievance #1, the Complaint Activity Log indicated the complaint was received on 10/26/12 alleging that a patient had been sexually abused by a male caregiver in the hospital. The letter addressing the outcome of the complaint was not sent until 12/20/12 which was 37 days late.

During interview on 1/8/13 at 2:00 P.M., the Compliance Manager indicated that the Tewksbury Police and the District Attorney's Office had been involved in this investigation and this had slowed down the process. There were no updates in the complaint file to indicate any reason for the delay in investigating and processing the complaint. There was no letter to the complainant explaining the lengthy delay of the investigation.

3. For Grievance #2, the Complaint Activity Log indicated the complaint was received on 12/17/12 indicating the theft of an Ipod. An undated letter was found in the complaint file indicating that the hospital would be unable to complete the investigation in 7 days. The undated letter did not give a specific reason why the investigation would be delayed. As of 1/8/13, a letter addressing the outcome of the investigation was not sent out.

4. For Grievance #3, the Complaint Activity Log indicated the complaint was received on 11/27/12 alleging neglect and verbal abuse. An undated letter was found in the complaint file indicating that the hospital would be unable to complete the investigation in 7 days. The undated letter did not give a specific reason why the investigation would be delayed. As of 1/8/13, a letter addressing the outcome of the investigation was not sent out.

5. For Grievance #5, the Complaint Activity Log indicated the complaint was received on 11/13/12 alleging a staff person was rough during incontinent care. An undated letter was found in the complaint file indicating that the hospital would be unable to complete the investigation in 7 days. The undated letter did not give a specific reason why the investigation would be delayed. As of 1/8/13, a letter addressing the outcome of the investigation was not sent out.

6. For Grievance #6, the Complaint Activity Log indicated the complaint was received on 11/15/12 alleging a staff person refused care and called the patient names. An undated letter was found in the complaint file indicating that the hospital would be unable to complete the investigation in 7 days. The undated letter did not give a specific reason why the investigation would be delayed. As of 1/8/13, a letter addressing the outcome of the investigation was not sent out.

7. For Grievance #7, which was not found in the Complaint Activity Log, a written interview completed by a hospital investigator was found that indicated on 5/18/12, the patient alleged that a staff member sexually abused the patient while providing care. As of 1/8/13, a letter addressing the outcome of the investigation was not sent out.

8. For Grievance #8, the Complaint Activity Log indicated the complaint was received on 9/11/12 alleging a patient to patient physical assault. An undated letter was found in the complaint file indicating that the hospital would be unable to complete the investigation in 7 days. The undated letter did not give a specific reason why the investigation would be delayed. As of 1/8/13, a letter addressing the outcome of the investigation was not sent out.

During interview on 1/8/13 at 2:00 P.M., the Compliance Manager indicated that the Tewksbury Police and the State Police had been involved in this investigation and this had slowed down the process. There were no updates in the complaint file to indicate any reason for the delay in investigating and processing the complaint. There was no letter to the complainant explaining the lengthy delay of the investigation.

9. For Grievance #9, the Complaint Activity Log indicated that the complaint was received on 9/11/12 alleging sexual abuse. An undated letter was found in the complaint file indicating that the hospital would be unable to complete the investigation in 7 days. The undated letter did not give a specific reason why the investigation would be delayed. As of 1/8/13, a letter addressing the outcome of the investigation was not sent out.

During interview on 1/8/13 at 2:00 P.M., the Compliance Manager indicated that the Tewksbury Police and the State Police had been involved in this investigation and this had slowed down the process. There were no updates in the complaint file to indicate any reason for the delay in investigating and processing the complaint. There was no letter to the complainant explaining the lengthy delay of the investigation.

10. For Grievance #10, the Complaint Activity Log indicted the complaint was received on 5/28/12 alleging sexual abuse. An undated letter was found in the complaint file indicating that the hospital would be unable to complete the investigation in 7 days. The undated letter did not give a specific reason why the investigation would be delayed. The letter addressing the outcome of the complaint was not sent until 6/20/12 which was 10 days late.

11. During interview on 1/8/13, at 2:00 P.M., the Compliance Manager for the DPH side of the hospital indicated that due to the amount of complaints received the workload did not allow for the complaints to be investigated and processed in a timely manner.

During interview on 1/8/13, at 2:00 P.M., the Compliance Manager for the DPH side of the hospital indicated that some types of complaints required that the Campus Police or the local police and District Attorney's (D.A.) office be involved. For example, the local police and D.A.'s office wanted to be involved with any complaints that were a felony such as rape and sexual assault. He stated that the involvement of these offices in the investigation slows down the process and prevents meeting time deadlines.

Based on observation and interview, the Hospital failed to provide personal privacy during incontinence care for 1 patient (#25) out of 36 active sampled patients. Findings include:

Observation on 1/7/13 at 1:50 P.M., Patient #25 was in bed with his/her perineum exposed, Registered Nurse #2 and Nursing Assistant (NA) #2 were on either side of the bed. The door to this bedroom was only partially open and the privacy curtain was not pulled in a room which had 4 other patients in their beds. Directly across from Patient #25 was another patient in bed with an Occupational Therapy Aide performing left hand therapy, while Patient #25 was completely exposed.

During an interview with NA #2 on 1/7/13 at 2:05 P.M., the Surveyor asked her why this Patient's personal privacy was not protected? She stated, "We were in a hurry and did not pull the curtain."

During an interview with Nurse Manager #1 on 1/7/13 at 2:15 P.M., he stated that the nursing staff would be educated on all shifts regarding protecting all the patient's privacy.

Based on review of grievance/complaint files, the Complaint Activity Log and staff interview, the facility failed to investigate allegations of abuse within a reasonable time frame (7 days) according to the hospital policy, for 3 of 6 (complaint #7, #8 #9) abuse complaints reviewed on the Department of Public Health (DPH) side of the hospital. Findings include.

1. The hospital's policy for Patient Complaint, Mistreatment, Abuse and Neglect stated the following:

"Every complaint received will be subjected to a mutual review by the Patient Advocate or his/her designee and by the Director of Quality Management or his/her designee....

If the original allegation alleges an illegal, dangerous or inhumane condition, it shall be assigned to a full, formal investigation.

The DMH Office of Investigations or DPH Director of Quality Management shall assign an individual to conduct an inquiry if the complaint meets one of the following Investigative categories:

Medicolegal death
Sexual assault or abuse
Physical assault or abuse ...."

"A final report will be submitted to the Person In Charge within the 7 days or a letter to the complainant indicating why additional time is needed shall be sent with copies going to all parties to the complaint."

2. For Complaint #7, the hospital failed to complete an investigation of an allegation of sexual abuse. A written interview with a patient completed by a hospital investigator indicated that on 5/18/12, the patient alleged that a staff member sexually abused the patient during care. As of 1/8/13, there was no written, formal investigation of the complaint with a final outcome available. There were no updates in the file as to why the investigation had been delayed

During interview on 1/8/13 at 2:00 P.M., the Compliance Manager indicated that this case had initially been referred to the Tewksbury Police and the District Attorney's office. He said that neither of these offices pursued the complaint. The Compliance Manager stated that the complainant and involved staff were interviewed regarding the complaint but the results of the investigation were not documented in a final report.

3. For Complaint #8, the Complaint Activity Log indicated the complaint was received on 9/11/12 alleging a patient to patient physical assault in which the complainant was put in a headlock and punched in the face by another patient. An undated letter was found in the complaint file indicating that the hospital would be unable to complete the investigation in 7 days. The letter gave no specific reason why the investigation would be delayed. As of 1/8/13, there was no written, formal investigation of the complaint with a final outcome available. There were no updates in the file as to why the investigation had been delayed.

During interview on 1/8/13 at 2:00 P.M., the Compliance Manager indicated that initially the Tewksbury Police had been involved in this investigation because the complainant wanted to press charges against the assailant. The Compliance Manager stated that the hospital went ahead with their investigation and the complainant, assailant and involved staff were interviewed regarding the complaint but the interviews were not documented in the record. The results of the investigation were not documented in a final report.

4. For Complaint #9, the Complaint Activity Log indicated that the complaint was received on 9/11/12 alleging sexual abuse. An undated letter was found in the complaint file indicating that the hospital would be unable to complete the investigation in 7 days. The undated letter did not give a specific reason why the investigation would be delayed. The complaint file included a hospital Complaint Form which the patient had completed on 9/8/12. It included a form entitled, "Resolution of Complaint To Be Completed Within 7 Days". At the end of this form there was a place to indicate if the complaint was Substantiated, Substantiated in Part or Unsubstantiated. None of these 3 areas were checked off. The later form included interviews with the patient and the involved nurse. As of 1/8/13, there was no written, formal investigation of the complaint with a final outcome available.

5. During interview on 1/8/13, at 2:00 P.M., the Compliance Manager for the DPH side of the hospital indicated that some types of complaints required that the Campus Police or the local police and District Attorney's (D.A.) office be involved. For example, the local police and D.A.'s office wanted to be involved with any complaints that were a felony such as rape and sexual assault. He stated that the involvement of these offices in the investigation slows down the process and prevents meeting time deadlines because the hospital cannot proceed with their investigation until these office complete their investigations.

In addition, the Compliance Manager indicated that due to the amount of complaints received, the workload did not allow for the complaints to be investigated and processed in a timely manner.

Based on review of personnel files and staff interview, the Hospital failed to have Nursing Administration (the Chief Nursing Officer) review and approve 2 of 2 Nurse Practitioners scopes of practice. Findings include:

1. According to Massachusetts regulations governing the practice of nursing in the expanded role: 244 CMR 422(1) and (4a); "Development, Approval, and Review of Guidelines for Nurse Midwives, Nurse Practitioners and Nurse Anesthetists

(1) All nurses practicing in an expanded role shall practice in accordance with written guidelines developed in collaboration with and mutually acceptable to the nurse to:
(a) a physician expert by virtue of training or experience in the nurse's area of practice in the case of the nurse in the physician's office and the nurse in private practice; or (b) the appropriate medical staff and nursing administration staff of the institution employing the nurse.

(4) 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 of the institution, formally reviews and approves of the guidelines under which she proposed to practice..."

2. Review of the personnel files on 1/14/13 at 8:30 A.M., indicated Nurse Practitioner (NP) #2's file had scopes of practice for 10/18/11 and 8/29/12 that were not signed by the Chief Nursing Officer.

3. Review of the personnel files on 1/14/13 at 9:00 A.M., indicated NP #3's file had a scope of practice (guidelines for practice) for 8/29/12 that was not signed by the Chief Nursing Officer.

During an interview with the Chief Nursing Officer on 1/14/13 at 9:00 A.M., she said, "I do sign the Nurse Practitioner's credentialing files, but I do not sign the scopes of practice. This could easily be rectified by adding a signature space for the Chief Nursing Officer on their scopes of practice."

Based on observation, record review and interview, the Hospital nursing staff failed to supervise and evaluate nursing care for two patients (#28 and #32), in a total active inpatient sample of 36. Findings include:

1. For Patient #32, the registered nurses (RN) failed to determine the tube and cuff type of tracheostomy on admission and failed to obtain orders for the care and management of the cuff.

Patient #32 was admitted in 6/2010 with diagnoses of anoxic encephalopathy status post cardiac arrest and pneumonia . Upon admission the patient nursing assessment noted the patient had a "#6 shiley tracheostomy with cuff" as well as a gastrostomy tube for feeding. Patient was noted to be unresponsive. There were no further descriptions of the tracheostomy.

During an observation of the patient and the patient's environment on 1/9/13 at 12:45 P.M. with the Nurse Manager (NM) #3, the patient was observed to have a tracheostomy, consisting of two pieces, an inner and outer cannula, however, the inflation/deflation bulb was missing on the end of the small plastic cannula tube leading to the tracheostomy cuff. When the surveyor inquired if the patient had a cuffed tracheostomy in, the NM did not know. Inspection of the extra tracheostomy sets available in the room, indicated they were all cuffed tracheotomy tubes. The extra two tracheostomy tubes found in the bedside drawer, matched the patient's tracheostomy by lot number and size however, the inner cannulas were missing. Both were cuffed tracheostomy tubes. The nurse (RN #14), who was caring for the patient came in the room. When asked about the inflate/deflate bulb, RN #14 moved the tracheostomy dressing and said, "it is missing." RN #14 pointed to where the tubing had been removed from the tracheostomy.

Review of the Policy and Procedure for Care of the Tracheostomy, dated 6/2011, stated to determine tube and cuff type. For cuffed tracheostomy tubes, obtain orders from provider for (a) the amount of air to be used for inflation of the cuff and (b) inflation/deflation schedule including frequency and duration.

Connect a syringe to pilot balloon and slowly inflate cuff with ordered amount of air. Assess proper cuff inflation level. Erosion of the blood vessels or mucosa of the trachea may occur when cuff pressures are too high. Place a stethoscope above the tracheostomy tube and listen for minimal air leak at the end of inspiration. Document in Worklist/Care Plan and in Progress Note for unusual findings.

Review of the physician orders indicated there were no orders for the inflation/deflation of the cuff per the policy. After interview with Nurse Manager (NM) #3, on 1/9/13 at approximately 2:00 P.M., NM #3 found only one order involving the care of the tracheostomy, in the clinical record, dated 8/9/10. The order read "trach care per guidelines, has #6 2 piece shiley type trach 6.4 mm, i.d. (internal diameter) 10.8 mm o.d (outer diameter), may use inner cannula piece." There was no mention of care of the cuff, as per the hospital policy.

A RN nursing note on 3/20/11 at 6:27 A.M., noted that during routine tracheostomy care the inflation/deflation bulb was missing on the end of the small plastic cannula tube leading to tracheostomy cuff. The on call medical provider was notified, along with nursing supervisor. An addendum note,dated 3/21/11 at 2:00 A.M., written by the same nurse, indicated he had been informed by a day RN, that the bulb had been missing for sometime and this was not a new finding. However, this was the first mention of it in the clinical record. No further action was taken.

2. For Patient #28, the Hospital nursing staff failed to evaluate the intake and output, and observe that the patient had been in negative fluid balance 11 out of the last 16 days, placing the patient at risk for dehydration.

Patient #28, admitted 10/2012, has diagnoses of head injury secondary to gun shot wound, paraplegia, seizure disorder and Methicillin Resistant Staph Aureus (MRSA) infection in the urine. Record review and interview with staff indicated the patient is competent, alert and oriented and interviewable.

The patient has a Foley indwelling catheter for management of urinary incontinence. The care plan includes encourage fluids due to the catheter use and frequent urinary tract infections. Nursing staff monitor intake and output per policy due the catheter use.

Review of the intake and output documentation from 12/22/12 through 1/6/13, indicated the patient was in negative fluid balance (more fluid out than in) on the following days:
12/22 1000 cc (cubic centimeters) more out than in
12/24 1700 cc more out than in
12/26 1365 cc more out than in
12/27 440 cc more out than in
12/28 2000 cc more out than in
12/30 1800 cc more out than in
12/31 720 cc more out than in
1/3/13 440 cc more out than in
1/5/13 820 cc more out than in

Review of nursing notes only indicated that the patient had developed hematuria, on 1/6/13 believed to be secondary to anticoagulation medication and multiple re-catheterizations. The physician ordered use of a Texas condom catheter temporarily.

During an interview, on 1/8/13 at approximately 2:00 p.m., Nurse Manager #5 said she had not evaluated the patient's intake and output because she assumed he always drank well. NM #5 thought the difference may be in documentation of intake but couldn't be sure.

Based on record review and staff interview, the hospital failed to ensure that patients' care plans included all assessed medical problems and that care plans were implemented for 5 of 36 active patients( #10, #18, #21, #22, #31)

Findings include:

1. For Patient #31, the hospital failed to develop a care plan for medical areas of care.

Patient #31 was admitted on 7/24/09 with diagnoses of major depression, bipolar with psychotic features, insulin dependent diabetes mellitus, hypertension and obesity. According to the physician progress notes dated 12/12/12, the patient had frequent pain due to bilateral knee arthritis and a right foot sore area.

A review of the current care plan revealed that there was no care plan for the following medical areas: diabetes, hypertension, obesity and pain.

During interview on 1/14/13, the Unit Manager on D4 on the Mental Health side of the hospital, stated that diabetes and obesity had been on the care plan during 2009. He stated that there was a note on the old care plan that these two care areas had been updated on 12/22/09, but the revised care plans were not in the current medical record. He stated that there should be a care plan for hypertension and pain. The Unit Manager stated the care plan would be updated to include medical areas.

2. For Patient #22, the hospital failed to develop a care plan for medical areas of care.

Patient #22, was admitted on 11/19/12 with diagnoses of schizoaffective disorder, mild mental retardation, non-insulin dependent diabetes mellitus, hypertension and obesity.

A review of the current care plan revealed that there was no care plan for the following medical areas: diabetes, hypertension and obesity.

During interview on 1/8/13, RN #4 on the C5 Unit on the Departmental of Mental Health side of the hospital, stated that there should be a care plan for the patient's assessed medical needs. RN#4 stated the care plan would be updated to include medical areas.


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3. For Patient #10 the facility failed to ensure that the 1500 ml fluid restriction, as ordered by the physician, was implemented.

Patient #10 was admitted to the facility in 4/2012 with diagnoses including failure to thrive, psychosis, gastrointestinal reflux disease and leukocytosis.

Review of the dietitian's note of 12/20/12 indicated "albumin 2.1 - worsened to severely depleted with adequate Kcal/pro [kilocalorie/protein]intake; Na [sodium] 134 with new order for 1500 ml fluid restriction; Hgb [hemoglobin] 8.9 with repeat labs tomorrow."

Review of the 24 hour I&O [intake and output] record indicate that the following intakes were above the 1500 ml ordered:
12/29/12 - 2340 ml
12/30/12 - 2220 ml
1/1/13 - 2220 ml
1/2/13 - 2220 ml
1/3/13 - 2340 ml
1/4/13 - 2220 ml
1/7/13 - 1820 ml

During interview on 1/8/13 at 10:15 A.M., Unit Manager #2 said that the kitchen sends between 1140 ml and 1260 ml to the patient daily. The nursing staff do not have a specific amount of fluids which they are allowed to provide, but most of the medications are given with pudding. The Unit Manager was not aware that the patient had exceeded his/her fluid restriction.


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4. For Patient #21, the hospital failed to ensure the patient received a 11:30 A.M. medication and failed to notify the patient's physician if the patient had a fingerstick blood sugar over 350, as per the medical plan of care.

Record review on 1/8/13, indicated the patient had a current physician's order which read, "Insulin Lispro 20 units subcutaneous pre-meal (11:30 A.M.)." Review of the 12/12 Medication Administration Record (MAR), indicated that on 12/21/12, the patient did not receive the 20 units of insulin at 11:30 A.M. as per medical plan of care.

Further record review on 1/8/13 indicated the patient had a current physician's order, for fingerstick blood sugars fours times a day at 7:30 A.M., 11:30 A.M., 4:30 P.M. and at bedtime, and call the physician if the patient's blood sugar is less than 60 or greater than 350. Review of the 12/12 MAR, indicated that on 12/25/12, the patient had a blood sugar of 357 at bedtime. Further record review on 1/9/13, indicated that the hospital did not notify the physician of the patient's blood sugar of 357, as per medical plan of care.

On 1/10/13 at 1:40 P.M., Registered Nurse #4 said the the hospital did not administer the patient's insulin on 12/21/12 and failed to notify the patient's physician of the patient's blood sugar of 357, as per medical plan of care.

5. For Patient #18, the hospital failed to implement the medical plan of care which indicated that the patient's vital signs would be obtained on 12/19/12.

Record review on 1/9/13 indicated that the patient had a physician's order dated 12/18/12, which read,"Obtain orthostatic vital signs in A.M. 8:00, (12/19/12) and call attending physician with the result."According to the 12/12 MAR , orthostatic vital signs were not obtained on 12/19/12 at 8:00 A.M., as per the medical plan of care.

On 1/9/13 at 11:00 A.M., Registered Nurse #3 said the vital signs were not obtained on 12/19/12, as per the medical plan of care.

Based on observation, record review and staff interview, the hospital failed to ensure medications were administered in a timely manner and prepared as ordered for 1 patient (#29) in total of 36 active sampled patients. Findings include:

Patient #29 who has a diagnosis of diabetes had a current physician's order to receive Metformin 850 milligrams (mg) at 8:00 A.M. and 6:00 P.M. and 500 mg at 1:00 P.M. Metformin is an antidiabetic medication which should be administered with meals.

On 1/8/13 at 10:00 A.M., Licensed Practical Nurse (LPN) #1 was observed giving the 8:00 A.M. dose of Metformin to Patient #29.

In addition, Patient #29 had a physician's order to receive Enteric Coated Asprin 81 mg at 8:00 A.M., do not crush. On 1/8/13 at 10:00 A.M., Licensed Practical Nurse (LPN) #1 was observed crushing the Enteric Coated Asprin 81 mg, putting it in applesauce and administering it to Patient #29.

During interview on 1/8/13 at 2:30 P.M., LPN #1 said the patient had breakfast at 8:00 A.M., the Metformin was given late and that she should not have crushed the Asprin.

Based on a review of the hospital's Utilization Management Plan, a review of 4 sampled Notices of Noncoverage and staff interview, the hospital failed to insure that members of the Utilization Review Committee did not conduct reviews of patients with whom they were professionally involved for 2 (#3, #4) of 4 patients who received notices of determination of medically unnecessary care.

Findings include:

1. For Patient #3, the hospital failed to ensure that the physician reviewer of the necessity of care was not the attending physician.

On 12/31/12, the hospital's physician reviewer made a decision that the patient's admission of 12/28/12, was not likely to be covered by Medicare because the care was medically unnecessary.

A review of the Notice of Noncoverage revealed that the physician reviewer was also the attending physician for the patient.

During interview on 1/10/13, at 2:30 P.M., the Director of Quality Management indicated that this was an isolated event due to holiday coverage at the hospital and a shortage of covering physicians.

2. For Patient #4, the hospital failed to ensure that the physician reviewer of the necessity of care was not the attending physician.

On 10/16/12, the hospital's physician reviewer make a decision that the patient's continued was not likely to be covered by Medicare because the care was medically unnecessary.

A review of the Notice of Noncoverage revealed that the physician reviewer was also the attending physician for the patient.

Based on record review and interview, the Hospital failed to maintain equipment in an acceptable level of safety and quality related to 4 of 4 hydrocollators machines (a liquid heating device used to store and heat hot packs), in the Rehabilitation Treatment Rooms. Findings include:

1. On tour of the Rehabilitation Treatment Rooms with the Director of Rehabilitation for Department of Public Health (DPH) on 1/9/13, the following were found:

a. Observation in the A4 Rehabilitation Treatment Room at 9:45 A.M. and review of the hydrocollator temperature log indicated temperatures were not taken on 1/5/13, 1/6/13, 1/7/13, 1/8/13, and 1/9/13.

b. Observation in the A3 Rehabilitation Treatment Room at 10:20 A.M., and review of the hydrocollator temperature log indicated temperatures were not taken 10/25/12, 10/26/12, 10/29/12, 11/22/12, 11/ 29/12, 12/13/12, and 1/3/13.

c. Observation in the C3 - D3 Rehabilitation Treatment Room at 10:45 A.M. and review of the hydrocollator temperature log, indicated that the daily temperatures were not taken 11/13/12, 12/13/12, 1/3/13 and 1/4/13.

During an interview on 1/9/13 at 9:45 A.M. with the Director of Rehabilitation for DPH she stated, "The hydrocollator temperatures should be taken daily and were not."

2. Review of the Hospital's Procedure for the Application of Hydrocollator Steam Packs (Hot Packs), it states, "Maintain temperature of the water at approximately 150 degrees. Do not allow temperature to exceed 160 degrees."

Observations during the tour of the Rehabilitation Treatment Rooms with the Director of Rehabilitation for DPH on 1/9/13, which included review of the temperature sheets for the hydrocollators, indicated the Hospital's policy for maintaining its temperatures were not followed.

a. Review of the hydrocollator temperature sheets on 1/9/13 at 10:20 A.M. in the A3 Rehabilitation Treatment Room indicated elevated temperatures on the following dates:

- 161 degrees Fahrenheit (F) for 17 days in 11/12
- 161 degrees (F) for 16 days in 12/12
- 161 degrees (F) for 4 days in 1/13

b. Review of the hydrocollaor temperature sheets at 10:30 A.M. of the D2 Rehabilitation Treatment Room indicated elevated temperatures on the following dates:

- 162 degrees (F) for 4 days in 12/12
- 164 degrees (F) for 2 days in 12/12
- 162 degrees (F) for 2 days in 1/13
- 164 degrees (F) for 3 days in 1/13

During an interview on 1/9/13 at 10:40 A.M. with Rehabilitation Aide #1, she was asked, "How often do you take the temperature of the hydrocollator machine?" She stated, "We take the temperature every day Monday through Friday, and it should be 150 to 160 degrees." She was shown the temperature sheet of 162 and 164 degrees (F), and she stated, "Those temperatures are right on the edge." The Hospital's policy is to not exceed a temperature of 160 degrees (F).

During an interview and review of the manufacturer's guidelines for monitoring the hydrocollator temperature on 1/9/13 at 11:00 A.M. with the Director of Rehabilitation for DPH, the Surveyor asked where were the temperature sheets for the past 6 months (not just the past 3 months) for the hydrocollators on A3 and C3 and C5. She said that on A3 they were lost in the past, and on C3 - C5 they were disposed of.

During a tour of the A3 Treatment Room on 1/10/13 at 9:45 A.M. with the Biomedical Technician and the Director of Rehabilitation for DPH, the hydrocollator's stainless steel finish was worn away by the right hinges and inside the lid. There was a sediment build (from the water) by the water level edges of this hydrocollator. This would impact the ability to adequately clean this machine. The Surveyor asked the Biomedical Technician, "At what temperature do you want this machine maintained?" He stated, "Between 160 to 165 degrees (F) is the manufacturer's guidelines, so that is what I would maintain it at when we set the control in the back (of the hydrocollator) for the temperature." The Director of Rehabilitation stated that she would want the temperature to be lower.

3. Review of the manufacturer's guidelines for the hydrocollators under maintenance on page 20, it states, "The interior of the unit should be cleaned at least every two weeks..." or every 14 days.

Review of the Hospital's Policy on Rehabilitation Services Infection Control, dated 10/12, under E., it states, "The interior of hydrocollator units is cleaned monthly [or every 30 days] with the hospital approved quaternary disinfectant. The inside of the unit is cleaned and then allowed to air dry. It is then rinsed thoroughly with clean water for refilling. The exterior of the stainless steel hydrocollator units is cleaned with a hospital approved stainless steel cleaner and polish."

On tour of the Rehabilitation Treatment Rooms with the Director of Rehabilitation for DPH on 1/9/13 and review of the cleaning sheets for the hydrocollators indicted that the manufacturer's guidelines for cleaning, and the hospital policy for cleaning, were not done as follows:

a. Observation and review of the cleaning sheets at 9:45 A.M. of the A4 Rehabilitation Treatment Room indicated it had been cleaned on the following dates:
-6/13/12,
-10/5/12 (114 days later),
-11/5/12 (31 days later)
As of 1/9/13 (65 days later), it had not been cleaned.

b. Observation and review of the cleaning sheets at 10:20 A.M. of the A3 Rehabilitation Treatment Room indicated that it had been cleaned on 11/15/12. As of 1/9/13 (55 days later), it had not been cleaned. There were no temperature sheets prior to 11/15/12.

c. Observation and review of the cleaning sheets at 10:30 A.M. of the D2 Rehabilitation Treatment Room indicated that it had been cleaned on the following dates:
-10/14/12,
-11/9/12 (26 days later)
-1/4/13 (56 days later)

d. Observation and review of the cleaning sheets at 10:45 A.M. of the C3 - D5 Rehabilitation Treatment Room indicated that it had been cleaned on the following dates:
-10/26/12,
-11/14/12 (19 days later)
As of 1/9/13 (56 days later), it had not been cleaned.

During an interview on 1/9/13 at 9:57 A.M. with Rehabilitation Aide #2, she was asked, "How often do you clean and change the hydrocollator water?" She replied, "Every month."

During an interview on 1/9/13 at 10:40 A.M. with Rehabilitation Aide #1, she was asked, "How often do you clean the hydrocollator machine?" She stated, "Every month, and we take the temperature every day Monday through Friday, and it should be 160 degrees." When she was shown the temperature sheet of 162 and 164 degrees (F) she stated, "Those temperatures are right on the edge. The Hospital's policy is to not exceed a temperature of 160 degrees (F.)."

During an interview on 1/9/13 at 11:00 A.M. with the Director of Rehabilitation for DPH, regarding the manufacturer's guidelines for cleaning the hydrocollator, she stated that she was not aware that the hydrocollator needed to be cleaned every 2 weeks.

Based on observations, interviews, and review of the Hospital's policies/procedures, and infection control logs, the Hospital failed to consistently ensure an acceptable level of infection prevention practice. Findings included:

A. The hospital failed to sanitize the glucometer according to manufacture's directions for 3 of 12 nursing units.

On 8/26/2010, the Centers for Disease Control (CDC) issued requirements for Infection Prevention during Blood Glucose Monitoring and Insulin Administration, supported by the Food and Drug Administration (FDA), that state fingerstick devices should never be used for more than one person. Whenever possible, point of care (POC) blood testing devices, such as blood glucose meter and PT/INR anticoagulation meter, should be used only on one patient and not shared. If dedicating POC blood testing devices to a single patient is not possible, the devices should be properly cleaned and disinfected after every use as described in the device labeling. If the manufacturer does not specify how the device should be cleaned and disinfected then it should not be shared.

1. Observations in the A5, the Medically Enhanced Unit (MEU), on 1/8/2013 at 11:00 A.M., revealed (Non-sampled Patient #1) (NS) scheduled for a POC blood glucose test. Non-sampled Patient #1 was tested by RN # 5 using the glucometer. After use, the glucometer was returned to the glucometer case, without being cleaned, available for use on the next patient. According to RN #5, the glucometer was cleaned when visibly soiled and it was cleaned "nightly" by the night staff.

2. Observation in the Group Dining Room of the C3 Unit on 1/7/2013 at 11:20 A.M., revealed Non-sampled Patient # 2 scheduled for a POC blood glucose test. NS Patient #2 was assigned to Room 320. According to RN #1, Room 320 was used to cohort patients with Methicillan Resistant Staph Aureus (MRSA).

After the POC test was performed, RN #1 used an alcohol wipe to clean the area of the glucometer (approximately 1 inch by 1 inch), where the test strip had been inserted. RN #1 did not change the soiled gloves used for direct contact with the patient, nor did she clean the remainder of the glucometer. RN #1 then pushed the medication cart back to the medication room before removing the soiled gloves.

3. Observation on Unit C5 on 1/10/13 at 11:25 A.M. of a medication pass and finger stick blood glucose monitoring for Patient #21, revealed the contaminated glucometer was not cleaned after it was used. RN #10 used a lancet to pierce the 4th finger of the left hand of Patient #21, she obtained blood, and she put a drop of blood on a glucose test strip. The test strip was inserted into the glucometer and it read 245 milligrams per deciliter. RN #10 then put the contaminated glucometer into the wall holder without washing it.

B. The hospital failed to consistently adhere to the posted requirements for Personal Protective Equipment (PPE) with patients requiring Contact Precautions on 2 of 12 units. Contact precautions are a combination of approaches, including patient placement, PPE use, hand hygiene, and environmental cleaning. Contact Precautions are used to prevent transmission of infectious agents.

Traditional Contact Precautions are well described in the Center for Disease Control (CDC) literature. However, at this hospital, a modified approach to some multi-drug resistant organisms (MDRO's) had been adopted.

This modified approach had been instituted because of the number of colonized patients, the extended length of hospitalization, the environmental barriers of the hospital (very few private bathrooms) and the clinical needs of the patients.

The survey team later learned that the posted signs did not reflect the modified precaution model, but a more restrictive level of care. While the precaution postings read "gown and glove" for entry into the room, the policy and practice at the hospital was, instead, for standard precautions. The standard precaution requires barrier protection for any anticipated contact with blood or body fluid. Also, patients on this modified precaution model were, by policy, not restricted to their rooms, but were permitted in group activities and community dining.

Using this modified precaution model, the Infection Prevention program had been using MDRO surveillance to track and trend nosocomial infections. The Infection Control Committee reports and the Annual Infection Control Report of 2012 indicated no clusters of infections.

1. Observation in the C3 Unit on 1/7/13 at 2:00 P.M., revealed Nursing Assistant #1 (NA) having direct contact with the patient in Room #320 without appropriate PPE. According to the posting at the entrance to this private room, the patient was on Contact Precautions and NA #1 was required to don gown and gloves to enter this room. NA #1 failed to don a gown to have direct contact with this patient.

2. Observations on the C3 Unit on 1/8/2013 at 2:50 P.M., revealed the Occupational Therapist (OT #2) sitting directly on a patient's bed in Room #323 without any PPE. According to the posting at the entrance to the room, this room was a cohort of patients requiring Contact Precautions.

At 2:55 P.M., RN #7 entered Room #323, the cohort room, no PPE or hand hygiene practice was observed.

3. Observations on the D2 Unit on 1/8/13 at 9:50 A.M. revealed NA) #3 did not wash hands, did not put on a gown and did not use gloves when entering patient #29's room. NA #3 assisted patient #29 by touching the patient and the patient's bedding. After assisting the patient, NA #3 left the room and performed hand hygiene.

According to the interview with the Infection Preventionist (IP), on 1/10/13 at approximately 10:00 A.M., the hospital had been using a precaution model that would allow patients who were colonized with a multi-drug resistant organism to be placed on a modified contact precaution approach.

However, according to the IP, the precaution signs that had been posted and required barrier protection upon entry to the room were posted in error. The signs were "new" and reflected a more restrictive standard of care than the hospital policy required. Therefore, the signage did not represent what was clinically necessary for these colonized patients.



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2. During an interview on 1/9/13 at 8:30 A.M., Nurse #9 reviewed the tracheostomy care of Patient #7 on Unit A3. Nurse #9 showed the Surveyor the fluid resistant gown that was used (not an impervious gown as required) with this non-closed suction system (which increased the risk of employee exposure).


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C. The hospital failed to minimize cross contamination during a stage II pressure sore dressing change.

Treatment observation on the D2 unit on 1/8/13 at 10:45 A.M., revealed the following breeches in infection control techniques:

Registered Nurse (RN) #8 failed to set up a clean area when gathering supplies to perform the dressing change. RN #8 brought the treatment/medication cart into Patient #15's room. Removing items from the cart, RN #8 placed some items onto the bedside table which had snacks and a drink on the table and some items directly on the bed.

After putting on a pair of clean gloves, RN #8 cleansed the open area on the Patient's right buttock area and placed the soiled supplies onto the table. Next RN #8 applied a polymem dressing over the area. With the soiled gloved hands, RN #8 pulled off some strips of medipourous tape from a clean roll of tape and applied the tape to the dressing. After removing the soiled gloves, RN #8 picked up the roll of now soiled tape and placed it into the clean treatment cart.

During interview after the treatment was completed, RN #8 said the cart is used as both a treatment and medication cart. She removed the roll of tape from the cart and stated she could have done a better job keeping clean items from soiled items.

D. The Hospital failed to provide impervious barriers to staff.

Per Occupational Safety and Health Administration (OSHA), 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.

1. Observation in the Dialysis Unit on 1/9/13 at 1:15 P.M., during termination of Hemodialysis Patient #14, revealed the staff wearing disposable isolation non-impervious gowns. Per manufacturer's literature, these gowns are fluid resistant, but not impervious and are single use gowns.

During interview, the Hemodialysis Nurse, after removing Patient #14 from the dialysis machine, said "The gown I have on is what the hospital supplies us with, and one gown is used repeatedly throughout the day unless visibly soiled."

Per CDC RR-5 reference, dialysis staff should wear PPE appropriate to the anticipated potential exposure. Initiation and termination of dialysis is considered a time of high risk for spurting or spattering of blood and an impervious barrier should be provided to the staff.


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E. Although the majority of the kitchen was found to be clean, the Hospital failed to ensure that dishes and the dish machine were properly maintained and sanitized.

During observation of the dietary department, on 1/8/13 at 11:10 A.M., it was observed that the dietary aides were drying the patient trays using cloth towels. The dietary aides used the same towels to dry many trays prior to changing to a new towel. At the end of drying the trays, the dietary aides hung the wet towels up to dry near the end of the tray line.

During interview on 1/8/13 at 11:15 A.M., the Food Service Director said that the trays need to be hand dried because they are coming out of the dish machine wet.

During observation on 1/8/13 at 11:20 A.M., the final rinse of the dish machine was 124 degrees Fahrenheit. The final rinse should be 180 degrees Fahrenheit. At this point, the Food Service Director indicated that the machine had a back-up system using chemicals to sanitize the dishes. Observation revealed that the container holding the chemical sanitizer was empty and had to be refilled. Since the final rinse was not working properly and the chemical sanitizer was not filled the dishes were not being sanitized. Further observation on 1/9/13 at 10:30 A.M. revealed that the machine was at the correct temperature and the chemical sanitizer was full.

Based on record review and interview, the facility failed to ensure that all physicians had completed the required course offered or approved by the OPO and designed in conjunction with the tissue and eye bank community in the methodology for approaching potential donor families and requesting organ or tissue donation before they requested organ or tissue donation.

Findings include:

During interview on 1/14/13 at approximately 10:15 A.M., the Interim Chief Medical Officer and Physician #2 said that all physicians are responsible for pronouncing the death of the patient.

After pronouncing the death, all physician would call the next of kin to give their condolences and to approach the potential donor families to request organ or tissue donation.

The physicians said that all of the physicians have not completed a course or been trained as designated requestors.