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Based on interview with staff, in 1 of 1 interview (A), the facility failed to ensure there is a QAPI program in place to oversee the facility. The effect of this deficiency affects 49 facility-identified patients who were treated by the Diabetic Educator, all 31 inpatients, and all 367 outpatients treated at this facility during the survey.

Findings include:

Per surveyor 18816 interview with CPCO A on 10/12/11 at 11:45 AM there is no official organizational QAPI committee to oversee the facility. Per CPCO A, there are no meeting minutes to define the committee and scope. See tag A264.

Per surveyor 18816 interview with CPCO A on 10/12/11 at 11:45 AM, there is no official QAPI monitoring and evaluation of adverse patient care events. See tag A267.

Based on interview with staff, in 1 of 1 interviews (A), there is no QAPI program in effect to oversee the entire facility with a defined plan. The effect of this deficiency affects 49 facility-identified patients who were treated by the Diabetic Educator, all 31 inpatients, and all 367 outpatients treated at this facility during the survey.

Findings include:

Per surveyor 18816 interview with CPCO A on 10/12/2011 at 11:45 AM there is no official organizational committee that has developed the scope and plan for the facility; including identifying indicators for improving health outcomes, adverse outcomes, monitoring Pt care and safety, tracking, trending and analyzing data, with periodic evaluation.

Based on interview with staff, in 1 of 1 interviews (A), there is no QAPI improvement activities in effect to oversee the entire facility nor identified in response to an actual adverse patient outcome event. The effect of this deficiency affected 49 facility-identified patients who were treated by the Diabetic Educator, all 31 inpatients, and all 367 outpatients treated at this facility during the survey.

Findings include:

Per interview with CPCO A on 10/11/11 at 9:00 AM, and confirmed in interview with IPC E on 10/11/11 at 2:55 PM and follow up interview on 10/12/11 at 9:00 AM, ICP E discovered on 8/30/11, RNCDE B was using demonstration insulin pens on multiple Pts and herself when performing diabetic education.

Per the facility's investigation, although the needles were changed between patients, the pens were reused, and the solution in the pens were injected in the patient. IPC E learned that RNCDE B had never been trained on the safe injection practices introduced in 2007 by the CDC.

Per interview with RNCDE B and RDCDE C on 10/11/11 at 10:20 AM RNCDE C said in her practice, the demonstration insulin pens were never used on herself or the Pts. RNCDE B confirmed she used the demonstration pens on herself as well on the Pts for several years. RNCDE B stated she would clean the membrane on the pens and change out the needles each time, but did not clean the outside of the pens, and confirmed the solution in the pens would be injected during the demo.

Per surveyor 18816 interview with CPCO A on 10/12/2011 at 11:45 AM, there is no official QAPI efforts in place that are used to surveil, track, or evaluate adverse patient events.

Based on observation, review of personnel files and interview with staff, in 1 of 1 staff (I) the facility failed to ensure staff are qualified for duties performed, and have job descriptions related to their duties. The effect of this deficiency potentially affects all 31 inpatients and all 367 outpatients treated at this facility during the survey.

Findings include:

Per surveyor 18816 observation on 10/11/11 at 11:50 AM, MD H was performing a circumcision in the nursery with a staff assisting. During the observation, surveyor 18816 asked RN M, at the nursing station, who the assisting staff was. RN M stated it was (I) the UC. Surveyor 18816 asked how UC I was qualified to assist and RN M answered UC I was NNR (Neonatal Resuscitation) certified.

On 10/11/11 between 2:30 PM and 3:30 PM, surveyor 18816 reviewed the personnel file for UC I. The job description did not include assisting in circumcisions. This was confirmed in interview with OBM J on 10/11/11 at approximately 3:30 PM. Surveyor 18816 questioned OBM J on RN staff knowing any limitations of UC I's NNR certification, OBM J could not confirm the RN staff knew any limitations on UC I's NNR certification.

Per surveyor 18816 interview with RN O on 10/12/11 at 10:10 AM, RN O instructs staff in NNR. RN O stated in interview, UC I can be certified in the basics of NNR including cardiopulmonary resuscitation, but is not trained in intubation or giving medications.

Per surveyor 18816 review of personnel files on 10/11/11 between 2:30 PM and 3:30 PM, the personnel files for RNCDE B and RDCDE C, who perform diabetic education, did not include job descriptions for the position of Diabetic Educator, and specific competencies related to Diabetic Educator. This was confirmed in interview with DFN F on 10/11/11 at 2:45 PM.

Based on tour, observation, review of P&P, review of facility documents, review of personnel files and interview with staff, in 5 of 5 interviews (A, B, C, E and I) the facility failed to ensure there is an effective IC program to investigate, prevent and control potential infection and cross contamination.

Findings include:

In 4 of 4 interviews the facility failed to ensure there is IC oversight, effective policies and staff training in safe injection practices. See tag A748.

In 4 of 4 interviews the facility failed to ensure there is an IC surveillance program for prevention and control of potential infection and cross contamination. See tag A749.

In 4 of 4 interviews the facility failed to ensure there is a hospital wide quality program that oversees IC training and issues. See tags A392 and A756.

The cumulative effect of these deficiencies affects all 31 inpatients and all 367 outpatients treated at this facility during the survey.

Based on review of P&P, review of personnel files, and interview with staff, in 4 of 4 interviews (B, C E, and K) the facility failed to ensure there is IC oversight for the Diabetic Educator outpatient department; there are effective IC policies in place to prevent and control potential cross contamination; and ensure staff training for safe injection practices. The effect of this deficiency affects 49 facility-identified patients who were treated by the Diabetic Educator, all 31 inpatients, and all 367 outpatients treated at this facility during the survey.

Findings include:

Facility policy titled Circumcision, dated 12/10, reviewed by surveyor 18816 on 10/11/11 at approximately 1:00 PM revealed under Intervention "Prepare supplies needed....Sterile gloves...." There are no other PPE (personnel protective equipment) addressed in the policy. This is confirmed in interview with ICP C on 10/11/11 at approximately 3:00 PM.

Facility policy titled Standard Infection Control Practices, dated 1/06, reviewed by surveyor 18816 on 10/12/11 at approximately 8:30 AM revealed under Procedure "B. Personal Protective Equipment 1. Gloves must be worn when touching blood, body fluids, mucous membranes, and non-intact skin or for handling items or surfaces soiled with blood or body fluids. 2. Face protection must be used whenever the possibility of spraying/splashing of blood or body fluids is anticipated. Devices include safety glasses and masks, full face shields, or work station shields. 3. Moisture resistant apparel (cover gown) should be used whenever the possibility of spraying./splashing/spilling of blood or body fluids to the arms or torso is anticipated."

Per surveyor 18816 observation on 10/11/11 at 11:50 AM MD H was performing a circumcision without the benefit of a gown or mask. UC I, assisting MD H, did not have on a gown and the mask was not tied tightly under the chin.

Surveyor 18816 interview with RNCDE B and RDCDE C on 10/11/11 at 10:20 AM, affirmed there has been no IC surveillance in the Diabetic Education Outpatient area prior to 8/30/11, and no surveillance between 8/30/11 to 10/11/11. During this interview, RNCDE B and RDCDE C stated there are no policies in place for using an insulin demonstration pen. This failure of surveillance of the Diabetic Educaton Outpatinet area was confirmed with ICP B, Infection Control Officer on on 10/12/11 between 9:00 AM and 10:30 AM.

Per surveyor 18816 review of personnel files on 10/11/11 between 2:30 PM and 3:30 PM, the files for RNCDE B and RDCDE C have no documentation of safe injection practice recommended by the CDC in 2007 related to 1 needle, 1 syringe and 1 patient, to prevent cross contamination and potential infection of multiple patients.

Per interviews with ICP E and EM K on 10/12/11 between 9:00 AM and 10:30 AM, there has been no safe injection practice training conducted at the facility. Per ICP B, there is a computer based training program on safe injection practices that will be set to go live as of 10/12/11. RM K provided surveyor 18816 evidence that the the computer based training on safe injection practice is live and staff were notified on 10/12/11 to complete the training within 30 days.

Based on interview with staff, tour of the facility, observation and review of P&P, in 4 of 4 interviews (A, B, C, and G) the facility failed to ensure there is an IC surveillance program for prevention and control of potential infection and cross contamination. The effect of this deficiency affects 49 facility-identified patients who were treated by the Diabetic Educator, all 31 inpatients, and all 367 outpatients treated at this facility during the survey.

Findings include:

Facility policy titled Expiration Date/Time Management Medications, dated 08/11, states under Policy B. "All multi-dose vials will be dated with expiration date."

Facility policy titled Blood Glucose Monitoring, dated 01/10, states under Procedure B. 3. "Control solutions will be labeled with the date opened."

Per surveyor 18816 interview on 10/11/11 at 10:20 AM with RNCDE B and RDCDE C, there has been no IC surveillance in the Diabetic Education Outpatient Department prior to, or after, 8/30/11. RNCDE B confirmed in interview the Demonstration Insulin Pens(DIP) had been injected into multiple Pts, and in own self, over several years. RNCDE B stated the needles had been changed between Pts, and the outside of the pens are not cleaned after use.

Per the SolorStar Training Pen, the barrel states "Water-Do not inject. Containing non-sterile water. Does not contain insulin." The Lilly Saline KwikPen states on the barrel "Not for Human Use". The package insert for the Lilly pen states in bold red ink "Do not inject the demonstration dose into a person. The KwikPen is for demonstration purposes only."

Per surveyor 18816 interview on 10/11/11 at approximately 11:00 AM, RNCDE B was asked why Pts were injected with the non-sterile water, against manufacturer's advice, RNCDE B stated it was considered an "off-label" practice, describing "off-label" as akin to medications that are used yet not approved for that use by the Federal Drug Administration. During this interview, RNCDE B stated there was no training or competency for a Diabetic Educator at the facility related to insulin pen teaching, and there had been no safe injection practice training. Surveyor 18816 questioned RNCDE B during this interview if blood testing was done to ensure she was not a source or contracted a contagious disease, from using the insulin pens; RNCDE B stated, to date (10/11/11), no testing had been done on her because she considered "it was a low priority."

Per CPCO A on 10/11/11 at 9:00 AM, review of Pts receiving Diabetic Education between 2001 and 2011, by RNCDE B and RDCDE C, revealed there were 49 Pts identified that used the DIP on themselves during the education sessions. CPCO A provided documentation that of the 49 Pts, 13 could not be contacted due to disconnected phone, or no answer. The remaining 36 Pts were offered blood testing to rule out infectious disease. Per CPCO A during the same interview, on 10/11/12 at 9:00 AM, as of that time, no Pts tested with infectious disease.

Tour of the facility on 10/11/11 between 10:15 AM and 12:15 PM revealed the following:

At 10:15 AM in the Diabetic Education Outpatient Department the following Glucometer kits containing glucose testing strips were found intermixed with outpatient supplies and demonstration supplies:

2 Ascendia Breeze Exp (expired) 12/07; 1 AccuChek Active exp 10/10; 1 AccuChek Active exp 7/06; 5 AccuChek Aviva esp 6/09; 1 Precision Xtra Strips exp 2/09; 2 Ascensia Contour exp 1/08; 1 Prodigy Auto Code exp 6/10; 1 AccuChek Compact exp 7/11; 1 OneTouch Ultra Strips exp 7/11; 1 TruTrack exp 1/09; 2 TruTrack exp 6/10; 1 OneTouch Ultra Mini exp 7/11 and 1 OneTouch Ultra Strips exp 8/11. A penlet for testing blood glucose was intermixed with Pt monitor kits. This was confirmed by RNCDE B on 10/11/11 at 10:15 AM, adding portions of kits are kept for reference if a Pt calls with a question. RNCDE B could not confirm the penlet was not used on patients.

At approximately 11:30 AM on the 3rd floor medication room there is an open 1% lidocaine MDV(multidose vial) that is not dated. This was confirmed at the time of observation with APNP G and CPCO A.

At approximately 11:40 AM the medication room in unit P5 contained undated open glucometer controls.

At 11:50 AM MD H is observed performing a circumcision and is not wearing a mask or gown, UC I, assisting MD H is not wearing a gown, and the mask is not tied tightly under the chin. This was confirmed at the time of observation with APNP G and CPCO A.

At approximately 12:10 PM the Emergency Room clean utility room has undated open glucometer controls and there are three supply trays for Intravenous Starts next to the handwashing sink without a barrier to prevent contamination from splash. This was confirmed at the time of observation with APNP G and CPCO A.

At 12:15 PM the Urgent Care testing room has undated open glucometer controls and rapid strep testing solutions open and not dated.

These observations were confirmed by APNP G and CPCO A.

Based on review of facility documentation, review of personnel files, and interview with staff, in 4 of 4 interviews (A, B, C and E) the facility failed to ensure there is a hospital wide quality program that oversees infection control and staff training. The effect of this deficiency affects 49 facility-identified patients who were treated by the Diabetic Educator, all 31 inpatients, and all 367 outpatients treated at this facility during the survey.

Findings include:

Per surveyor 18816 interview with CPCO A on 10/11/11 at 11:45 AM there is no organizational quality committee overseeing the entire facility, and overseeing infection control.

Per surveyor 18816 interview with ICP E on 10/12/11 at 9:00 AM, ICP E discovered RNCDE B was using a demonstration insulin pen on multiple Pts and herself on 8/30/11. ICP E provided a timeline that included multiple meetings with various staff on 8/31/11, 9/1/11, 9/2/11, 9/6/11, 9/7/11, 9/8/11, 9/13/11 and 9/14/11. There are no minutes for any of the meetings held with administrative leaders, there are no minutes of IC committee meeting minutes related to the incident. ICP E stated there have been no IC meetings since 9/14/11, since the focus was on making surveillance rounds, contacting and testing Pts, adding there is a scheduled meeting 10/12/11 to discuss results of Pt testing involved in the mulituse of the demonstration insulin pen. The timeline did not include details of any action plan with goals and timelines.

On 10/11/11 CPCO A provided an Action Plan to surveyor 18816 at approximately 9:00 AM. Per interview with CPCO A, upon receipt of the Action Plan, there are no specific timelines to accomplish the recommendations other than contacting MDs on 9/15/11 and the Governing Board on 9/9 and 9/25/11; and there are no designated responsible staff for various tasks identified. CPCO A said there are not actual minutes of any meetings held regarding the incident.

Surveyor 18816 discussed the Action Plan with ICP B on 10/11/11 at 2:55 PM. One item identified as an 'Outstanding' action is listed under #3."Document re-education of Diabetic educator in employee files." Per interview, ICP B confirmed the re-education was not documented in RNDCE B's file. Item #4 "Conduct facility wide education on safe practice and implement protocol forms" was discussed with ICP B, revealing the facility wide training had not been completed at the time of interview. #5 "Observe staff in action with injections", per ICP B there has been no additional injection observations, including observations of RNCDE B and safe injection practices.

Per surveyor 18816 review of personnel files for RNCDE B and RDCDE C on 10/11/11 between 2:30 PM and 3:30 PM found no evidence of safe injection practice training; and no documentation of hospital based competencies for CDE. This was confirmed in interviews with DFN F and EM K on 10/11/11 at approximately 3:30 PM.

There is no safe injection practices training for all facility staff implemented as of 10/11/11. Per documentation provided to surveyor 18816 on 10/12/11 at 10:40 AM the computer based safe injection practice training program went live to all staff. This is confirmed with EM K on 10/12/11 at 10:45 AM.

Based on interview with staff, in 1 of 1 interviews (A), there is no QAPI program in effect to oversee the entire facility with a defined plan. The effect of this deficiency affects 49 facility-identified patients who were treated by the Diabetic Educator, all 31 inpatients, and all 367 outpatients treated at this facility during the survey.

Findings include:

Per surveyor 18816 interview with CPCO A on 10/12/2011 at 11:45 AM there is no official organizational committee that has developed the scope and plan for the facility; including identifying indicators for improving health outcomes, adverse outcomes, monitoring Pt care and safety, tracking, trending and analyzing data, with periodic evaluation.

Based on interview with staff, in 1 of 1 interviews (A), there is no QAPI improvement activities in effect to oversee the entire facility nor identified in response to an actual adverse patient outcome event. The effect of this deficiency affected 49 facility-identified patients who were treated by the Diabetic Educator, all 31 inpatients, and all 367 outpatients treated at this facility during the survey.

Findings include:

Per interview with CPCO A on 10/11/11 at 9:00 AM, and confirmed in interview with IPC E on 10/11/11 at 2:55 PM and follow up interview on 10/12/11 at 9:00 AM, ICP E discovered on 8/30/11, RNCDE B was using demonstration insulin pens on multiple Pts and herself when performing diabetic education.

Per the facility's investigation, although the needles were changed between patients, the pens were reused, and the solution in the pens were injected in the patient. IPC E learned that RNCDE B had never been trained on the safe injection practices introduced in 2007 by the CDC.

Per interview with RNCDE B and RDCDE C on 10/11/11 at 10:20 AM RNCDE C said in her practice, the demonstration insulin pens were never used on herself or the Pts. RNCDE B confirmed she used the demonstration pens on herself as well on the Pts for several years. RNCDE B stated she would clean the membrane on the pens and change out the needles each time, but did not clean the outside of the pens, and confirmed the solution in the pens would be injected during the demo.

Per surveyor 18816 interview with CPCO A on 10/12/2011 at 11:45 AM, there is no official QAPI efforts in place that are used to surveil, track, or evaluate adverse patient events.

Based on interview with staff, in 1 of 1 interviews (A), there is no QAPI improvement activities in effect to oversee the entire facility nor identified in response to an actual adverse patient outcome event. The effect of this deficiency affected 49 facility-identified patients who were treated by the Diabetic Educator, all 31 inpatients, and all 367 outpatients treated at this facility during the survey.

Findings include:

Per interview with CPCO A on 10/11/11 at 9:00 AM, and confirmed in interview with IPC E on 10/11/11 at 2:55 PM and follow up interview on 10/12/11 at 9:00 AM, ICP E discovered on 8/30/11, RNCDE B was using demonstration insulin pens on multiple Pts and herself when performing diabetic education.

Per the facility's investigation, although the needles were changed between patients, the pens were reused, and the solution in the pens were injected in the patient. IPC E learned that RNCDE B had never been trained on the safe injection practices introduced in 2007 by the CDC.

Per interview with RNCDE B and RDCDE C on 10/11/11 at 10:20 AM RNCDE C said in her practice, the demonstration insulin pens were never used on herself or the Pts. RNCDE B confirmed she used the demonstration pens on herself as well on the Pts for several years. RNCDE B stated she would clean the membrane on the pens and change out the needles each time, but did not clean the outside of the pens, and confirmed the solution in the pens would be injected during the demo.

Per surveyor 18816 interview with CPCO A on 10/12/2011 at 11:45 AM, there is no official QAPI efforts in place that are used to surveil, track, or evaluate adverse patient events.