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Based on review of three of five physician credentialing files (Physician #1, #2 and #3) and three of thee contracted nurse practitioners (NP #1, #2 and #3), medical staff bylaws, governing body bylaws and staff interviews, on 5/13/2011 at approximately 11:00 A.M., the Governing Body failed to appoint members of the existing medical staff, after consideration of recommendations of the medical executive committee, in compliance with its bylaws and in compliance with Standards of Practice as set forth in Massachusetts regulations Governing the Practice of Nursing in the Expanded Role, 244 CMR 4.22.
Findings include:

1. According to review of the Governing Body bylaws and Medical Staff Bylaws, the Governing Body is composed of a Board of Directors, currently consisting of seven members. A quorum is a majority of the Board. According to the the Governing Body bylaws, medical staff appointments/credentialing are accomplished through the Medical Staff Bylaws which are approved by the Board. Review of the Medical Staff Bylaws, revealed that upon completion of the application for staff membership, the Medical Director will request supporting documentation and evaluations from the applicant. Following receipt of supporting documentation, the Medical Director will present the applicant's file to the medical staff executive staff committee at the next regularly scheduled meeting. The medical staff executive committee will determine if the applicant meets all necessary qualifications for the category of staff membership and clinical privileges requested by the applicant. Within 45 days, the medical staff executive committee will forward its recommendations to the Governing Body.

At its next regularly scheduled meeting, (which meets quarterly by bylaw) the Governing Body will make a decision to appoint or reject the applicant. The decision will be sent to the Medical Director and by mail to the applicant within ten days of the decision. Reappointments are every two years.

2. Review of recredentialing file for Physician #1, who is the Director of Respiratory Services, revealed the Medical Director signed the request for clinical privileges on 1/11/2010, for only pulmonology medicine. The request did not include tracheostomy and ventilator management. On 1/13/2010, a member of the governing body signed off on the clinical privileges form and a reappointment letter was sent on 1/13/2010.

Review of the medical staff minutes revealed the medical staff met on 11/23/2009 and 1/28/2010. The minutes lacked any evidence that this physician was approved by the committee for recredentialing. In November 2009, the minutes mentioned that the recredentialing list was "reviewed." Updates such as who would not be conducting consults was noted.

Review of the Governing Body (GB) minutes revealed the GB met on 12/9/2009 but there was no evidence of any discussion of acceptance or rejection of any applicants for credentialing or recredentialing in the minutes. There was no meeting in January 2010.

There was no evidence of any meeting of the Governing Body to approve the applicant prior to the approval letter being sent..

3. Review of the recredentialing file for Physician #2, a nephrologist, revealed the request for clinical privileges was signed by the Medical Director on 2/13/2010. There was a copy of the reappointment letter to the physician from the Medical Director, dated 2/16/2010, in the file. Review of the Medical staff minutes revealed no evidence that the candidate was reviewed for candidacy and recommended for referral to the Governing Body for approval. A member of the Governing Body signed the approval on 2/17/2010. The approval letter was sent before the Governing body member had signed the approval. In addition, the Governing Body met on 12/9/2009 and not again until 3/23/2010. There was no evidence in the minutes that the Governing Body considered the recommendations of the medical staff and then approved the applicant.

4. Review of the initial credentialing file for Physician #3, a pulmonologist, revealed the Medical Director signed the request for clinical privileges on 5/27/2010. Review of the Medical Staff minutes revealed no evidence that the applicant was considered and recommended by the medical executive staff for approval in the minutes dated 3/25/2010 or on 5/27/2010. On 5/27/201, Physician #3 was on a list titled "Medical Staff Practitioner's Status Report." It listed the physician as having provisional privileges from 5/27/2010 through 5/27/2011. There was no evidence that Physician #3's qualifications were considered, discussed or formally approved by the medical executive committee.

Further review revealed a member of the Governing Body approved the physician for practice at the hospital on 5/26/2010. Review of Governing Body minutes revealed the Governing Body met on 3/23/2010 and 7/22/2010 but did not meet in May 2010. There was no evidence that the applicant was recommended to the Governing Body for consideration for approval. by the medical executive committee as per the bylaws.

The applicant was approved prior to meetings of the the Governing Body and without recommendations of the medical executive committee as per the bylaws.


5. Interview with the Medical Director on 5/16/2011 at 10:00 A.M. confirmed the credentialing process for physicians, nurse practitioners and physician assistants requires application, references, verification of required documents (license, insurance, Drug Enforcement Administration License (DEA) etc), and approval of the applicant through the Medical Executive committee. After the candidate is cleared in medical executive committee, the application is sent with a recommendation for approval from the Medical Director to the Governing Body for approval. Once approved by the Governing Body, the Medical Director notifies the applicant.

6. Standards of Practice as set forth in Massachusetts regulations Governing the Practice of Nursing in the Expanded Role, 244 CMR 4.22 specifies that a nurse may not practice in an expanded role within an institution until the approval of the governing body including the medical staff and nursing administrative staff, formally reviews and approves the guidelines under which she proposes to practice and is accepted. Such formally approval must be in writing and in accord with the bylaws.

Review of Nurse Practitioners' #1, #2 and #3 credentialing files revealed approval, in writing, for clinical practice, from the Medical Director only. There was no evidence of any approval from the nursing administration for the clinical practices requested by the three Nurse Practitioner candidates.

Review of NP #1 file, who was on staff since 6/2010 revealed no evaluation by nursing administration as of 5/16/2011 and review of NP #3's file revealed no clinical evaluation by nursing administration since her approval date of 5/28/2009 by one member of the Governing Body.

Interview with the Director of Nursing on 5/13/2011 at 11:00 A.M. confirmed the DON did not review and provide approval for clinical practice of the nurse practitioners during the credentialing or recredentialing process, as required.

Based on review of grievances, hospital policy and staff interview, the hospital failed to respond, in writing, to 12 of 21 complaints, identified as serious complaints, within 7 days as indicated in their policy. Findings include:

The hospital's Grievance Process for Serious Complaints indicated the following:

a) The administrator notifies the patient and/or family that the serious complaint has been received, verbally and in writing within one day.

b) Resolution of the serious complaint will be made in writing within seven days and will include: the name of the hospital contact person, the steps taken on behalf of the patient to investigate the complaint, the results of the complaint process and the date of completion.

A review of 21 grievances, identified by staff as serious complaints, revealed that 12 were not responded to, in writing, in seven days. The following are examples of the 12 complaints:

1. On 10/27/10, the facility received a family complaint that the patient was repeatedly found lying in feces when the family visited. The facility sent a one day letter acknowledging receipt of the complaint on 10/28/10. The next letter summarizing the results of the investigation and corrective actions taken was not sent until 11/17/10 which was 20 days after the day one letter.

During interview on 5/13/11, the administrator stated that the facility was never able to contact this family member by telephone and that had caused some of the delay.

2. On 12/8/10, the facility received a patient complaint that an agency nurse had threatened the patient with a restraint. The facility sent a one day letter acknowledging receipt of the complaint on 12/9/10. The next letter summarizing the results of the investigation and corrective actions taken was not sent until 12/23/10 which was 14 days after the day one letter.

3. On 3/22/11, the facility received a family complaint about poor patient accommodations during the hospital stay and the lack of urology staff. The facility sent a one day letter acknowledging receipt of the complaint on 3/22/11. The next letter summarizing the results of the investigation and corrective actions taken was not sent until 4/4/11 which was 13 days after the day one letter.

4. On 12/8/10, the facility received a patient complaint that a nurse had given medications with applesauce prior to scheduled surgery. The facility sent a one day letter acknowledging receipt of the complaint on 12/9/10. The next letter summarizing the results of the investigation and corrective actions taken was not sent until 12/23/10 which was 14 days after the day one letter.

5. On 11/2/10, the facility received a patient complaint about medication management, accommodations and C.P.M. (continuous passive motion). A one day letter was not sent. On 11/17/10 a letter was sent acknowledging receipt of the complaint and summarizing the results of the investigation and corrective actions taken. This was sent 15 days after receipt of the complaint.

6 During interview on 5/13/11 at 10:30 a.m., the Administrator confirmed that the policy was to respond to the complaint, in writing, within 7 days. The Administrator stated that many of the complaints in which the facility had been late in responding prior to 1/1/11, involved patients who had already been discharged from the facility. She stated that this made the investigations a more time consuming process. She stated that many complaints after 1/1/11, involved patients that were still in the facility which made it easier to respond in a timely manner (Six complaint during 4/11 and 5/11 had timely responses).

Based on observation and staff interview, the facility failed ensure that 30 of 30 sampled patients (#1 - #30) had personal privacy protected. Findings include:

During the tour of the East and West units on 5/10/11 and each subsequent survey day, the patients' last names were listed in public view on a white board across from the nurse's station. The white board contained the patients' last names, room numbers and the names of the assigned nurses and nurse aides. It was updated daily.

Based on interview on 5/16/11 at 11:00 a.m., the Nurse Manager on the East unit stated the names were listed on the white board so that the rehabilitation staff would be able to identify the nursing staff assigned to the patient for each day.

Interview with the Director of Nursing on 5/16/2011 at approximately 2:00 P.M confirmed she was in agreement that only room numbers and nurses names should appear on the white boards.

d. Patient #2 was admitted to the hospital on 5/4/11 with a PICC line in place and diagnoses including clostridium difficile infection, seizure disorder and status post cerebralvascular accident.

Record review on 5/11/11 revealed physician orders dated 5/4/11 that read, "may draw labs off PICC Line" and "PICC Line Care per protocol".

Review of the MAR (medication administration record) on 5/11/11, revealed a "PICC/ Midline/ Central Line IV Flowsheet." The external length measurement of the PICC was to be done on admission and with each dressing change. This order coincided with the hospital's written policy for the care of Peripherally Inserted Central Catheters. Dressing Changes were to be done on admission, weekly and as needed.

The external length of the PICC Line was not documented on the Flowsheet on admission on 5/4/11 or with a dressing change on 5/10/11. There was no assessment of the exposed length of the PICC to determine any migration.

Interview with the nursing clinical leader on 5/11/11, confirmed the hospital policy for the care of a patient with a PICC had not been implemented as required.




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2. For Patient #18, the Hospital failed to implement the care plan for blood flow rate during dialysis and Nystatin swish and swallow for treatment of oral thrush.

Patient #18, was readmitted to the Hospital after a short hospital stay on 4/30/2011, for chest pain. The patient has diagnosis of respiratory failure with tracheostomy, ventilator, renal failure with hemodialysis, multidrug resistant infection (MDRO) in the sputum and urine, right chest wall tunneled catheter for dialysis, atrial fibrillation, seizure disorder and history of c. difficile, a bowel infection.

Review of the hemodialysis treatment orders, dated 4/30-5/7/2011 and 5/7/2011 through 5/17/2011, revealed the patient was ordered to have a blood flow rate (BFR) of 350. Review of treatment sheets for 5/3/2011 and 5/12/2011 revealed the BFR was ran at 400 instead of 350.

Interview with Hemodialysis Nurse (HDRN) #2 on 5/10/2011 at approximately 10:00 A.M. confirmed that a physician order is required to run the BFR higher than ordered. HDRN #2 stated sometimes the physician's order a range of BFR but did not for Patient #18.

Patient #18 had a physician order on 5/9/2011 to receive Nystatin suspension 5 milliliters (mls) orally swish and swallow, four times a day for five days, for treatment of oral thrush. Record review revealed no doses were given on 5/9 and 5/10. Doses were indicated as held. Further record review revealed that the patient was taking oral food and fluid when not on the ventilator during weaning sessions.

Interview with the prescribing physician on 5/11/2011 at approximately 11:00 A.M. confirmed he was not aware the Nystatin was being held. The physician confirmed it was necessary to treat the patient's oral thrush and Nystatin could be given as a swish and spit when the patient was ventilated.

Interview with the Registered Nurse #1, on 5/13/2011 at approximately 3:00 P.M. revealed RN #1 did not give the medication on either day because the patient was back on the ventilator. Further interview confirmed RN#1 did not notify the physician to get a change in orders for the delivery of the Nystatin, leaving the patient's condition untreated for two days.









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Based on observation, record review, facility documentation and staff interview, the hospital failed to ensure that nursing care plans were developed, implemented and kept current for 5 of 30 sampled patients (#2, #18, #23, #24, #27).

The findings include:

1. For Patients #2, #23, #24 and #27, the hospital failed to follow their policy in providing nursing care and treatment of a PICC (peripherally inserted central venous catheter). The policy stated that the PICC line was to be flushed with 10 ml. (milliliters) of normal saline prior to administration of medication, 20 ml. of normal saline after administration of medication, or, if not used, flush daily with 20 ml. ( two 10 ml pre-filled syringes) of normal saline. Additionally, the hospital policy for changing the "MaxPlus Connectors" on the PICC indicated that the connectors must be changed every Monday, Wednesday, and Friday

a. Patient #23 was admitted with diagnoses which included acute respiratory failure and pneumonia.

Record review on 5/10/11 revealed that the patient had a PICC (peripherally inserted central catheter) in the right arm. The resident had been receiving intravenous antibiotics via the PICC.

Review of the MAR (medication administration record) on 5/10/11, revealed an order for the
the external length measurement of the PICC to be done on admission and with each dressing change. This order coincided with the hospital's written policy for the care of Peripherally Inserted Central Catheters. The external length of the PICC was listed as "0.5" on 4/29/11. The MAR indicated that the PICC dressing was changed on that date.

A subsequent PICC dressing change was noted on 5/7/11 on the 3 P.M.-11 P.M. shift. However, there was no assessment of the exposed length of the PICC to determine any migration.

Review of the MAR on 5/10/11, revealed that the MaxPlus Connectors were not changed on Monday 5/2/11, Wednesday 5/4/11, and Friday 5/6/11, per the hospital policy.

Review of the MAR for the period 4/29/11 through 5/8/11, revealed that the hospital "Flushing Protocol" of flushing the PICC was not being followed. According to the MAR, the PICC was only flushed 11 out of the total 28 required times from the time of admission through the 3-11 shift on 5/8/11.

The patient was observed on 5/10/11 at 2:20 P.M.. The right arm PICC was in place, with an intact transparent dressing. The dressing was clean, and dated as being changed on 5/7/11.

Interview with the nursing clinical leader on 5/10/11, acknowledged that the hospital policy for the care of a patient with a PICC had not been implemented as required.

b. Patient #24 was admitted with diagnoses which included sepsis secondary to endocarditis and staphylococcus bacteremia.

Record review on 5/11/11, revealed that the patient was admitted to the hospital with a PICC in the right arm. The patient was receiving intravenous antibiotics via the PICC upon admission to the hospital.

Review of the MAR, from the admission date of 4/22/11, through 5/11/11, revealed no documented external catheter length measurements as required by hospital policy.

Additionally, there was no evidence in the MAR to substantiate that nursing had changed the MaxPlus Connectors on Mondays, Wednesdays, and Fridays, from 4/22/11 through 5/11/11, per the hospital "Intravenous Site Care" policy.

Lastly, review of the MAR, from 4/22/11 through 5/11/11, revealed that PICC flushes were not performed 9 out of 30 required times from 4/22/11 to 5/1/11, and omitted an additional 14 out of 30 times from 5/2/11 to 5/11/11.

c. Patient #27 was admitted with diagnoses which included PEG tube dysfunction with resultant site infection, post-operative atrial fibrillation with history of previous atrial fibrillation, stroke, and coronary artery disease.

Record review on 5/12/11, revealed that the patient was admitted to the hospital with a right arm PICC. The PICC had been inserted at the transferring hospital, and was being used for infusion of TPN (total parenteral nutrition) at the time of record review.

There was no documentation in the record to confirm that the PICC had been assessed for proper placement prior to its use.

Interview with the clinical nurse leader on 5/12/11 at 11:55 AM, acknowledged that there was nothing in the patient's record that confirmed proper placement of the PICC.

Further record review on 5/12/11, revealed no evidence that nursing had documented the external length of the catheter upon admission, or, at the time of dressing change per hospital policy.

Review of the MAR from the period of 5/4/11 through 5/11/11, revealed that nursing failed to flush the PICC 10 out of 25 required times from 5/4/11 to 5/12/11.

Interview with the clinical nurse leader on 5/12/11 at 11:55 AM, acknowledged that nursing had failed to fully implement the hospital's policy for the care of the patient's PICC.

Based on review of three of three credentialing files for contracted nurse practitioners ( NP #1, #2, #3), the Hospital failed to ensure the Director of Nursing provided adequate supervision and evaluation of the clinical activities which occur within the responsibilities of the nursing services. Findings include:

1. Standards of Practice as set forth in Massachusetts regulations Governing the Practice of Nursing in the Expanded Role, 244 CMR 4.22 specifies that a nurse may not practice in an expanded role within an institution until the approval of the governing body including the medical staff and nursing administrative staff, formally reviews and approves the guidelines under which she proposes to practice and is accepted. Such formally approval must be in writing and in accord with the bylaws.

2. Review of Nurse Practitioners' #1, #2 and #3 credentialing files revealed approval, in writing, for clinical practice, from the Medical Director only. There was no evidence of any approval from the nursing administration for the clinical practices requested by the three Nurse Practitioner candidates.

3. See A-0046 for details.

Based on record review and staff interview, the facility failed to maintain medical records that were complete, dated, timed and authenticated in written form by the person responsible for providing the service, consistent with hospital policies and procedures for 5 sampled patients (#6, #7, #8, #9, #l0) in a total sample of 30 patients. Findings include:

1. For Patient #6, the facility failed to maintain timed and dated physician's orders for 5 orders between 3/17/11 and 5/10/11. For example, a telephone order for zinc oxide and Optifoam to tracheostomy site, change daily and as needed (prn) was written by the nurse on 3/20/11. The physician signed the order but it was not dated and timed. During interview on 5/12/11 with the Nurse Manager on the West unit confirmed that physician's telephone orders were not always timed and dated.

2. For Patient #7, the facility failed to maintain timed and dated physician's orders for 18 orders between 4/16/11 and 5/12/11. For example, a telephone order for Bactrim DS, 1 tablet by mouth twice a day was written by the nurse on 5/3/11. The physician signed the order but it was not dated and timed. During interview on 5/12/11 with the Nurse Manager on the West unit confirmed that physician's telephone orders were not always timed and dated.

3. For Patient #8, the facility failed to maintain timed and dated physician's orders for 8 orders between 4/17/11 and 5/10/11. For example, a telephone order for Sarna Lotion to arms, legs abdomen and back three times a day and prn for pruritis was written by the nurse on 5/2/11. The physician signed the order but it was not timed and dated.

4. For Patient #9, the facility failed to maintain timed and dated physician's orders for 8 orders between 4/17/11 and 5/11/11. For example, a telephone order to change nutritional supplements to: 1 bottle Ensure Plus @ breakfast only; 1 Enlive juice nutritional supplement @ lunch only was written by the nurse on 4/20/11. The physician signed the order but it was not timed and dated.

5. For Patient #10, the facility failed to maintain timed and dated physician's orders for 4 orders between 5/5/11 and 5/11/11. For example: on 5/6/11 at 1:15 P.M., a telephone order to administer one bottle of Ensure plus at breakfast and one ounce of Prostat orally, daily, was written by the Registered Dietitian. As of record review on 5/12/2011, the physician had not signed, dated or timed the order.

Based on record review and staff interview, the Hospital failed to ensure that all verbal ( given via telephone) orders were signed by the ordering physician within 48 hours in accordance with facility policy for 8 patients (#1, #6, #7, #8, #9, #10, #16 and #29) in a total active sample of 30. Findings include:

1. For Patient #6, the physician gave a verbal order on 3/20/11 for Ativan 5 milligrams (mg.) as needed (prn) by gastronomy tube every 6 hours for agitation. As of 5/10/11, the order was not signed. During interview on 5/12/11 with the Nurse Manager on the West unit confirmed that physician's verbal orders were not always signed within 48 hours.

2. For Patient #7, the physician gave a verbal order on 4/17/11, to discontinue the oximyzer. As of 5/12/11, the order was not signed. During interview on 5/12/11 with the Nurse Manager on the West unit confirmed that physician's verbal orders were not always signed within 48 hours.

3. For Patient #8, the physician gave a verbal order on 5/2/11, for Zofran 4 mg. via intravenous prn three times a day for nausea. As of 5/10/11, the order was not signed.

4. For Patient #9, the physician gave a verbal order on 4/20/11, to add "moist" to ground texture (Add extra sauce/gravy when applicable.) Continue all other recommendations. As of 5/11/11, the order was not signed.

5. For Patient #10, the physician gave a verbal order on 5/6/11 for 1 bottle Ensure Plus at breakfast and 1 ounce of Prostat by mouth daily. As of 5/11/11, the order was not signed.





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6. For Patient #1, the Hospital failed to maintain signed physician orders for 3 orders between 5/1/11 and 5/4/11. For example, a telephone order for changes in three medications (Lisinopril, Norvasc and Benadryl) was written by a nurse on 5/1/2011. As of 5/11/11 the physician had not signed the order. On interview on 5/11/11, the Director of Nursing confirmed the telephone order had not been signed within 48 hours as required.





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7. For Patient #16, a certified respiratory therapist wrote telephone orders on 4/15/2011 at 1:30 P.M. to increase the increase the F inspired oxygen to keep the saturation level greater or equal to 92% and at 2:00 P.M. to discontinue the tracheostomy mask wean until pulmonary comes in to reassess the patient on Monday. As of record review on 5/10/2011, the orders had not been authenticated by a physician as per hospital policy.

8. For Patient #29, the physician gave a verbal order via telephone for Duragesic patch 12.5 mcg change every 72 hours on 4/27/2011 at 11:00 A.M. As of record review on 5/12/2011, the order had not been authenticated by a physician, consistent with hospital policy.

Based on review of policies and procedures, medical records and staff interview, the hospital failed to ensure that all medical records contained all documentation necessary to monitor the patients' condition for 5 medical records (#2, #3, #4, #17 and #18) in a total sample of 30. Findings included:

1. Review of the hospital's Gastric and Enteral Tube Feedings Policy and Procedure read as follows: "document oral / tube feeding intake in medical record on the Medication Administration Record (MAR) and on Intake and Output Record ". The hospital's Intake and Output Policy directed that an accurate intake and output (I & O) be maintained on patients with enteral tube feedings and shift totals of I & O be completed at the end of each shift.

2. For Patient #2, who received tube feedings via gastrostomy tube for nutrition support, the hospital failed to maintain complete and accurate intake and output records as required by facility policy.

Medical record review for Patient #2 on 5/11/11 revealed the resident had a physician order dated 5/4/11 for Jevity 1.2 at 80 ml per hour via gastrostomy tube for nutrition support.

Review of the MAR and I & O records from 5/4/11 to 5/10/11 revealed I & O totals were not consistently maintained and totaled at the end of each shift on the following dates: 5/5, 5/6, 5/7, 5/8 and 5/9/11.

Interview with the nursing clinical leader on 5/11/11, acknowledged the missing documentation and lack of shift totals on the I & O records.

3. For Patient #3, who received tube feedings via nasogastric tube, the hospital failed to maintain complete and accurate intake and output records as required by facility policy.

Medical record review for Patient #3 on 5/16/11 revealed the patient had a physician order dated 5/6/11 for Glucerna 1.2 at 30 ml per hour. On 5/9/11 the physician changed the tube feeding to Nepro and increased the feeding rate to 40 ml per hour.

Review of I & O documentation revealed I & O totals were not consistently maintained and totaled at the end of each shift on the following dates: 5/6, 5/7, 5/8, 5/9 and 5/10/11.

4. For Patient #4, who received tube feedings via gastrostomy tube, the hospital failed to maintain complete and accurate intake and output records as required by facility policy.

Medical record review for Patient #4 on 5/11/11 revealed the patient had a physician order dated 4/11/11 for Glucerna 1.2 at 75 ml per hour. On 4/27/11 the physician ordered a puree diet with nectar thick liquids but to continue the tube feedings as previously ordered. On 5/10/11 the physician decreased the tube feeding to nocturnal feedings from 6:00 p.m. to 6:00 a.m.

Review of the MAR and I & O records revealed I & O totals were not consistently maintained and totaled at the end of each shift on the following dates: 5/4, 5/5, 5/6, 5/7, 5/8 and 5/9/11.

Interview with the Director of Nursing on 5/16/11 acknowledged that the hospital policy for maintaining accurate I & O documentation had not been implemented as required.




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5. For Patient #17, who received tube feeding via gastrostomy tube, the hospital failed to maintain complete and accurate intake and output records as per Hospital policy and the plan of care.

Review of the patient's plan of care for nutrition stated "monitor intake and output." The patient was ordered to receive Pivot 1.5 at 45 cc's per hour with water 200 cc flushes every six hours. The patient received nothing by mouth.

Review of the intake and output records revealed I & 0 data was not complete for many shifts and 24 hour totals were not done. For example; on 5/6, no water flushes were recorded after medications on the 3-11 and 11-7 shift; on 5/7, no fluid intake data was recorded at all; and on 5/9, there were no fluids of any kind recorded from 5:00 P.M. through 11:00 P.M. There were no 24 hour totals for any days.

6. For Patient #18, the Hospital failed to document accurate I & O when the patient was on a fluid restricted diet and failed to document inhalers.

Review of the patient's plan of care revealed the patient was on 1000 cc fluid restriction and was to be on strict I & O monitoring. The patient was ordered to receive Glucerna 1.2 tube feeding via gastrostomy tube at 40 cc per hour from 7:00 P.M. until 6:00 A.M. with 50 cc water flushes each shift.

Review of I & O records from 5/7 - 5/9/2011 revealed no 24 hour totals. On 5/7, the 7-3 shift did not include fluids from medication flushes through the patient's intravenous line (IV) and the 3-11 shift failed to include water flushes and all the tube feeding totals. On 5/8, the 3-11 shift did not include 2 hours of tube feeding totals, and no IV medications flushes. On 5/9, no flushes for any shift were documented, and 3-11 did not record any tube feeding intake. Oral intakes were recorded when the patient ate.

Review of the MAR revealed the patient was to receive a Combivent Inhaler two puffs four times a day when on ventilator. On 5/2, 5/3, 5/4, 5/9 and 5/10 at 6:00 P.M. all sign off blocks for administration were left blank. There was no indication that the inhaler was held due to the patient being on the ventilator.

Interview with the a East wing Nurse Manager on 5/13/2011 at approximately 11:00 A.M., confirmed that staff should circle the block when the medication is held for any reason and not just leave it blank.

Services Agreement for Blood and Blood Products: Standard 482.27 (b)(3)

Based on review of Services Agreement and interview with the Director of Nursing on 5/19/11, the Hospital did not ensure that the Service Agreement that governed the procurement, transfer, and availability of blood and blood components included notification from the contracted medical center to Whittier Rehabilitation Hospital within specific time frames when the contracted medical center had provided blood or blood components with the potential of transmitting HIV( human immunodeficiency virus) or HCV (hepatitis C virus). Findings include:

On 5/19/11, the surveyor reviewed the Services Agreement for blood and blood components between Whittier Rehabilitation Hospital and (the contracted medical center).

The Service Agreement did not state that contracted medical center blood bank would notify Whittier Rehabilitation Hospital;
1. Within 3 calendar days if the blood collecting establishment (contracted medical center) supplied blood and blood components collected from a donor who tested negative at the time of donation but tests reactive for evidence of HIV or HCV infection on a later donation or who is determined to be at increased risk for transmitting HIV or HCV infection
2. Within 45 days of the test, of the results of the supplemental (additional, more specific) test for HIV or HCV, as relevant, or other follow-up testing required by FDA
3. Within 3 calendar days after the blood collecting establishment supplied blood and blood components collected from an infectious donor, whenever records are available.

Patient Notification: Standard 482.27 (b)(6)(iii)

Based on policy review and interview with the Director of Nursing on 5/19/11, the Hospital did not ensure that the Hospital policy, "Notification of Blood Product Contamination" included instructions for maintaining patient notification in the patient's medical record that potentially HIV or HCV infectious blood or blood components had been administered. Findings revealed:

On 5/18/11, the surveyor reviewed the Hospital policy "Notification of Blood Product Contamination". The policy stated " If the physician is unavailable, declines to make notification, or later informs the hospital that he/she was unable to notify the patient, the blood bank (contracted medical center) will promptly make at least (3) attempts to notify the patient of the need for HIV/HCV testing and counseling". The policy did not indicate how the notification made by the contracted medical center blood bank and how it would be documented in the patient's medical record.

Notification to Legal Representative: Standard 482.27 (b)10

Based on policy review and interview with the Director of Nursing on 5/19/11, the Hospital did not ensure that the policy, "Notification of Blood Product Contamination" included information to notify parent or legal guardian if a minor received potentially infectious blood or blood products. Findings revealed:

On 5/18/ 11, the surveyor reviewed the Hospital policy, "Notification of Blood Product Contamination" The policy did not include any language for notification of parent or legal guardian if a patient was a minor and had received potentially infected blood or blood products.

Based on observation and interview, the facility failed to maintain the quality of Phoenix meter standard solutions used in dialysis to calibrate phoenix meters and failed to maintain quality of chlorine testing strips. Findings include:

1. Phoenix meters are used to measure ph (acid-base balance) and the conductivity ( measure of ability to conduct electricity in water) in the dialysate.

On 5/10/2011, at 11:15 A.M., observation in the dialysis unit revealed the Phoenix meter standard solutions for pH and conductivity were not labeled with the date they were opened for use. The conductivity standard solution bottle was labeled by the manufacturer to " discard 30 days after opening." The standard buffer solution for pH was labeled by the manufacturer to "discard 90 days after opening".

Interview with the hemodialysis dialysis Registered Nurse (HDRN #2), on 5/10/2011 at 11:30 A.M., confirmed HDRN #2 did not know when the bottles had been opened. HDRN #2 confirmed she works three days a week, on alternated days with HDRN #1 who is the lead dialysis nurse.

2. Continued observations on 5/10/2011 at 11:30 A.M. revealed two bottles of water check chlorine strips used to test the portable reverse osmosis (RO) machines post carbon tank for chlorine. Chlorine if present in RO product water is dangerous to dialysis patients, causing red blood cell lysis, severe anemia and death. Once bottles are opened, according to the manufacturer, the strips expire one year from date the bottle is opened. One of the two bottles was not labeled with the date opened.

Based on interviews and review of personnel files on May 12, 2011, the hospital had designated an Infection Preventionist (IP) to manage the Infection Control and Employee Health programs. However, the hospital failed to ensure that the individual designated was qualified through training, experience, or certification.

The Center for Disease Control (CDC) defined "infection control professional" as "a person whose primary training is in either nursing, medical technology, microbiology, or epidemiology and who has acquired specialized training in infection control."

Interview with the Infection Preventionist on May 12, 2011 at 11:10 AM, and confirmed through interview with the Director of Nursing Services on May 12, 2011 at 12:40 PM, revealed the IP had been employed as Manager of Infection Control/ Employee Health for less than one year. Although the IP was a Registered Nurse with over ten years of clinical experience, the IP did not have "specialized training" in infection control to meet the needs of this high risk, complex patient population.

5. Observations on 5/10/11 at 1:00 P.M. and 5/11/11 at 9:30 A.M. revealed that the registered nurses in Hemodialysis failed to follow standard infection control precautions per Hospital policy for the wearing of personal protective equipment, i.e. cover gowns and failed to date multidose vials when opened. For example;

The standard precautions policy, revised 3/26/2008, stated that staff must wear a gown to protect skin and prevent soiling of clothing during procedure and patient care activities that are likely to generate splashes or sprays of blood, body fluid secretions, or excretions or cause soiling of clothing. The General Infection Control Practices for Hemodialysis Policy, dated 12/1/2006, stated that standard precautions will be used in addition to other listed PPE when staff are changing and disposing of contaminated blood tubing or any other contaminated material associated with the treatment.

On 5/10/2011 at 1:00 P.M., Hemodialysis Registered Nurse (HDRN) #2 was observed terminating the dialysis of Patient #18 who had a tunneled central line catheter for dialysis. HDRN #2 was observed to wear the cover gown off so that the front of the gown was off the shoulders and drooping, leaving HDRN #2 shoulder and chest exposed to potential blood spray.

On 5/11/2011 at 9:30 A.M., HDRN #1 was observed terminating the dialysis of two nonsampled patients (NS A and NS B). NS A had a fistula and NS B had a central line. When HDRN #1 terminated each patient from treatment, no cover gown was used. This exposed the nurse's clothing to potential blood splatter from the dialysis catheters and from the arterial site of the fistula.

After the patients were discharged from dialysis, HDRN #1 was observed to remove the blood contaminated dialyzers and tubing from each dialysis machine without wearing a cover gown.

On the bedside table of NS B, a bottle of multidose heparin was observed in an emesis basin. The bottle was open and not dated with the date it was opened. Interview with HDRN #1 on 5/11/2011 at 2:00 P.M. confirmed all vials of multidose medication should be dated when opened, in accordance with hospital infection control policy.















































































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4. Observation and staff interview indicated the staff failed to follow the infection control standards for the prevention of cross contamination while handling contaminated dressing material during a dressing change on Nonsampled patient D (NS D) in room West 25 at 10:45 AM, May 11, 2011.

NS D,was admitted with Vancomycin Resistant Enterococcus (VRE) and Pseudomonas in a parirectal wound. The wound was incised and drained at an acute care facility and the patient was on precautions.

The Registered Nurse #1 failed to provide a bag for the used dressings. The RN irrigated the wound, completed the dressing change and was observed rolling up the soiled wet chucks which were under the patient and put them on a clean coffee table in the room. The RN then deposited the dirty sheet from the patient, on the clean overbed table, that belonged to the empty bed setup for the next patient.

Interview with the Clinical Registered Nurse (RN) Leader of the West Unit, at 11:15 A.M. on May 11, 2011, confirmed that re-education of the staff in Infection Control practice was needed.






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Based on observations of equipment, patient care practices/procedures, staff interviews, staff education tools, and review of committee minutes, the Hospital failed to ensure that staff consistently implemented infection prevention and control protocols.
Findings include:

1. The hospital failed to minimize the risk of cross contamination during fingerstick blood sugar (FSBS) testing procedures.

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.

i.) A CNA (# 2) was observed performing a FSBS procedure on May 11, 2011 at 12 Noon on the East Wing ( nonsampled Patient #C ).

The glucometer (device to measure blood sugar) was brought into patient NS C's room. The glucometer case (containing the meter, test strips, finger lancets, alcohol swabs, gauze, and band-aids) was placed on the overbed table. After direct contact with NS C, CNA #2 reached back into the glucometer case while wearing contaminated gloves to retrieve additional clean supplies to complete the procedure, thereby potentially contaminating the contents of the glucometer case. Following the procedure the glucometer was returned to the case. CNA #2 failed to clean the glucometer after use, increasing the risk of cross contamination between patients.

ii. CNA #1 was observed on 5/11/2011 at 12:00 P.M. to enter the hemodialysis unit with the glucometer case(containing the meter, test strips, finger lancets, alcohol swabs, gauze, and band-aids). CNA #1 handed the glucometer to HDRN #1 who donned gloves and performed a fingerstick on Nonsampled Patient C. HDRN #1 completed the test, handed the glucometer back the CNA #1, who put in back in the case without disinfecting the meter. CNA #1 was then observed to return the case with the glucometer in it to the East wing nurses station without disinfecting the glucometer.

Interview with CNA #1 on 5/11/2011 at 12:10 P.M., confirmed there were no more patients requiring fingerstick bloodsugars until 4:30 P.M. CNA #1 confirmed that no cleaning of the glucometer had occurred.

Review of the Staff Competency Testing for Blood Glucose Monitoring procedures, conducted at the hospital staff education program entitled "Health and Safety Rodeo 2011", revealed that cleaning of the glucometer between patients was not included in the staff education/competency testing.


On 5/11/2011 at 3:00 P.M., the Director of Nursing was notified of the observations.

2. The hospital staff failed to consistently follow hospital policy and procedure, "Transmission Based Isolation Precautions" (#ISP-002) in the selection and use of Personal Protective Equipment (PPE).

According to hospital policy and the Center for Disease Control (CDC) 2007 "Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare," patients with multi-drug resistant organisms (e.g. MRSA) are to be placed on standard precautions (minimum infection prevention practices that apply to all patient care, regardless of suspected or confirmed infection status of the patient. This practice includes barrier protection for the health-care worker who may have possible contact with blood or body fluids), and contact precautions (enhanced precautions used with patients known or suspected to have organisms transmitted by direct or indirect contact) to reduce the risk of transmission of pathogens.

i. Observations on the East Wing revealed physicians and staff improperly donned/wore Personal Protective Equipment (PPE) in precaution rooms.

Observations on May 10 and 11, 2011 revealed healthcare workers failed to secure their gown closures therefore the front of the gown was off the shoulders and drooping, leaving the healthcare workers shoulder and chest exposed to potential contamination.

These staff included:
an unidentified physician in Room 201 at 1:45 PM on May 10, 2011
an unidentified respiratory therapist in Room 203 at 2 PM on May 10, 2011
an RN, Case Manager, in Room 209 at 4:10 PM on May 10, 2011
an unidentified physician and nurse in Room 208 at 7:50 AM on May 11, 2011
an unidentified physical therapist in Room 209 at 9 AM on May 11, 2011
an unidentified staff person in Room 207 at 11:30 AM on May 11, 2011

ii. Observations on the East Wing on May 10 and 11, 2011, revealed twelve patients with tracheostomy tubes (a tube temporarily inserted through an incision on the front of the neck creating an opening directly into the airway), and eight of these patients had a multi-drug resistant pathogen (e.g. MRSA). However, these patients were placed on standard and droplet precautions (use of a standard surgical mask within three feet of the patient is required when caring for a patient with certain infections e.g. whooping cough or meningitis), instead of standard and contact precautions as required by the hospital policy and CDC guidelines. To adhere to the standard precaution, caring for a patient with a tracheostomy tube would require full face protection. Specifically, eye protection was not readily available on precaution carts and was not part of the equipment immediately accessible for staff use. The precaution carts lacked the PPE (i.e. face shields) necessary to create a barrier for staff while they provided direct patient care (e.g. suctioning, tracheostomy care) and treatment to the patients. Therefore, this lack of appropriate PPE increased the risk of a body fluid splash to staff.

iii.) According to interview with the Infection Preventionist on May 12, 2011 and review of training records on May 12, 2011, hospital staff "re-orientation" was held annually at the hospital training "Health and Safety Rodeo". Review of the educational materials used to train staff revealed the information was not consistent with hospital policy and CDC guidelines (e.g. training materials stated that a mask is used to protect the mucus membranes of the face of the health care worker). However a mask does not provide adequate eye protection.

3. Although the hospital collected data on infections and communicable diseases within the hospital, review of the minutes of the Pharmacy and Therapeutics/Infection Control Committee and the Quality Improvement Committee for a five month period from September 2010 to January 2011 revealed there was no evidence of trending, investigation, and analysis of the data in meeting minutes.

Based on review of the hospital's organ donation policy, the hospital's agreement with the Organ Procurement Organization (OPO) and 5 sampled death records, the hospital failed to implement its protocol for timely notification to the OPO for 2 of 5 sampled records (#36 and #37). The findings include:

1. Review of the hospital's Organ, Eye and Tissue Donation Policy revealed the hospital has a Memorandum of Understanding with the New England Organ Bank (NEOB), the federally approved organ/eye/tissue procurement organization in the region.

The policy reads that the hospital will notify the NEOB of individuals whose death is imminent or have died at the hospital. Section B (#7) of the agreement further reads: "when a patient becomes asystolic (absence of heart beat), referral to the OPO will occur within 1 hour of asystole".

2. Review of a sample of 5 death records revealed the facility failed to follow the policy to notify the OPO within 1 hour of asystole in 2 of 5 records.

a. For Record #36, nursing documented the resident was "found with no respiratory rate, no blood pressure" at 04:25 on 5/12/11 and the physician was "updated about the death". Nursing documented the donor bank was "updated at 06:50 regarding the patient's status". The Deceased Patient Log also revealed the notification to the NEOB occurred at 06:50 on 5/12/11. The notification to the NEOB did not meet the criteria for timely notification within 1 hour of asystole as defined in the policy.

b. For Record #37, nursing documented the resident was "noted to have absent respirations and pulse" at 19:10 on 12/13/10. Nursing documented the donor bank was notified at 21:30. The Deceased Patient Log also revealed the notification to the NEOB occurred at 21:30 on 12/13/10. The notification to the NEOB did not meet the criteria for timely notification within 1 hour of asystole as defined in the policy.

3. Interview with the Director of Nursing Services on 5/16/11 at 8:30 a.m. confirmed for Record #36 and Record #37, the notification protocol developed in consultation with the tissue and eye banks for "timely notification" within 1 hour of asystole was not followed.

Based on documentation review and staff interview, the hospital failed to ensure that all patient care staff, including medical staff, were trained on donation issues in cooperation with the Organ Procurement Organization as required.

The findings include:

1. Review of the facility's agreement with the Organ Procurement Organization (OPO) revealed the hospital has a current agreement with the New England Organ Bank (NEOB) a federally approved organ/eye/tissue procurement organization. Section 2 (d) of the agreement under Duties of the Facility, reads that the facility "shall familiarize the members of the facility staff with the currently prevailing brain death criteria and with any relevant facility policies and procedures". Further review of the OPO agreement with the Hospital, revealed that the OPO will conduct inservice education programs on organ and tissue donation for the hospital.

Review of the hospital's "Organ, Eye and Tissue Donation Policy" revealed the Utilization Review (UR) Director will be responsible for "coordinating in-service education at Whittier Rehabilitation Hospital regarding the organ/tissue donation policy and procedure".

2. Interview with the Director of Performance Improvement , on 5/16/2011 at 10:30 P.M. revealed physicians are provided an orientation book with all policies, procedures, forms and general orientation information. Interview with the Medical Director on 5/16/2011 at 11:00 A.M. revealed that medical staff received training on organ donation during orientation to the hospital.

3. Review of the medical staff orientation book revealed no evidence of training on organ donation and relevant facility policies and procedures on OPO for newly hired medical staff.

Based on record review and interview, the Hospital failed to provide 10 of 10 applicable sampled patients ( #16, #17, #18, #23, #24, #25, #26, #27, #29, #30), in a total active sample of 30, with a rehabilitation plan that specified the type, amount, frequency and duration of the therapies to be furnished to the individual in accordance with the requirements of 42 CFR 409.17 and the Hospital policy for Licensed Independent Practitioner Orders. Findings include:

1. The Hospital policy for Licensed Independent Practitioner Orders, revised on 7/1/2009, states the Physical medicine and rehabilitation services orders must include "prescription, frequency and intensity when applicable."

2. Record review for Patient #29, admitted on 4/26/11, revealed physician orders for physical,occupational and speech language therapy. Although the orders specified the specific type of service to be deliver such as physical or occupational therapy and the nature of service to be delivered, there was no amount, frequency and duration for each service ordered. There was only an order for "up to 15 hours of rehab weekly."

3. Record review for Patient #18, readmitted after a short hospital stay on 4/30/2011, revealed physician orders for physical and occupational therapy. Although the orders specified the specific services each therapy was to deliver, there was no amount, frequency and duration for each service ordered. There was only an order for "up to 15 hours of rehab weekly."

4. Record review for Patient #16, admitted 4/8/2011, revealed physician orders for physical, occupational, and speech -language therapy. Although the orders specified the specific services each therapy was to deliver, there was no amount, frequency and duration for each service ordered. There was only an order for "up to 15 hours of rehab weekly."

5. Record review for Patient #30, admitted 4/21/2011, revealed physician orders for physical. occupational and speech-language therapy. Although the orders specified the specific services each therapy was to deliver, there was no amount, frequency and duration for each service ordered. There was only an order for "up to 15 hours of rehab weekly."

6. Record review for Patient #17, admitted 4/1/2011, revealed physician orders for physical, occupational and speech-language therapy. Although the orders specified the specific services each therapy was to deliver, there was no amount, frequency and duration for each service ordered. There was only an order for "up to 15 hours of rehab weekly."

7. Record review for Patient #23, admitted 4/29/11, revealed physician orders for physical, occupational and speech-language therapy. Although the orders specified the specific services each therapy was to deliver, there was no amount, frequency and duration for each service ordered. There was only an order for "up to 15 hours of rehab weekly."


8. Record review for Patient #24, admitted 4/21/11, revealed physician orders for physical, occupational and speech-language therapy. Although the orders specified the specific services each therapy was to deliver, there was no amount, frequency and duration for each service ordered. There was only an order for "up to 15 hours of rehab weekly."

9. Record review for Patient #25, admitted 3/31/11, revealed physician orders for physical, occupational and speech-language therapy. Although the orders specified the specific services each therapy was to deliver, there was no amount, frequency and duration for each service ordered. There was only an order for "up to 15 hours of rehab weekly."

10. Record review for Patient #26, admitted 4/26/11, revealed physician orders for physical, occupational and speech-language therapy. Although the orders specified the specific services each therapy was to deliver, there was no amount, frequency and duration for each service ordered. There was only an order for "up to 15 hours of rehab weekly."

11. Record review for Patient #27, admitted 5/4/11, revealed physician orders for physical, occupational and speech-language therapy. Although the orders specified the specific services each therapy was to deliver, there was no amount, frequency and duration for each service ordered. There was only an order for "up to 15 hours of rehab weekly."

12. Interview with the Medical Director on 5/12/2011 at 9:00 A.M. confirmed that orders were not written for specific duration, frequency of each service provided. The 15 hours of rehabilitation per week was divided among each therapy ordered, at their discretion.