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Based on interview and record review, the Governing Body failed to ensure reappointment of NPs 1 and 2 was based upon provider qualifications when review of performance evaluation documentation showed the performance evaluations were incomplete and inaccurate and were based on flawed methods for creating performance evaluation summaries. This failure created the risk of substandard healthcare by medical staff members.

Findings:

The hospital's policy titled Ongoing Professional Practice Evaluation (OPPE) effective 5/7/14, read in part, "The information resulting from the OPPE shall be used in conjunction with other peer review evaluative methods to determine whether to continue, limit or revoke an existing privilege(s)."

The hospital's policy titled Credentialing Process effective 4/8/14, read in part, "Upon receipt of the application, the (hospital) will conform to the Credentials Verifications Methods and Requirements as delineated in attachments A and B, which includes: ...Obtain Quality Assessment Clinical Performance Profile recommendation of the department chair in a timely manner to permit adequate review and evaluation."

A list of allied health providers approved after 5/18/14, was requested and provided. From that list, NPs 1 and 2 were selected for review. Documentation showed both NPs were approved by the Governing Body on 5/30/14.

During a review of the credential and performance evaluation data for NPs 1 and 2, the files showed both providers were reappointed on 5/30/14. Both provider files contained performance review summary sheets for the year 2013, with a column containing a list of evaluation criteria and a column for the scores associated with the criteria. The criteria included such items as the number of patient encounters, the number of cases reviewed for the provider, the number of cases in which provider performance was found deficient and the number of errors made in prescribing. However, the scoring columns showed one NP had five patient encounters while the other NP had "0." All of the other criteria scores were "0" for both of the NPs. The bottom of each sheet was signed by the department chairperson on 5/14/14.

The NPs' patient rosters since 5/18/14, were requested for review. NP 1 saw 17 patients and NP 2 saw 30 patients between 5/18 and 6/14/14. The number of patients seen in 2013, by both NPs was requested. The 2013 data for NP 1 was provided from the electronic health record system and showed six patient encounters in 2013, while the data for NP 2 showed 666 patient encounters.

During an interview with Medical Staff Leader 1 on 6/17/14 at 1130 hours, he reviewed the provider performance evaluation summary sheets signed 5/14/14, for NP 1 and NP 2. The Medical Staff Leader concurred the documentation appeared incorrect. The Medical Staff Leader stated the data did not reflect the number of patients seen and there was no peer review data.

The Medical Staff Leader stated he believed peer review and performance quality assessment was done by the departments with which the NPs were associated and the reviews were in the department's files. The departmental files for NPs 1 and 2 were requested for review.

During a follow-up interview with Medical Staff Leader 1 on 6/17/14 at 1430 hours, he stated NP 1 provided services in the pediatric clinic, and records were kept on paper in that clinic. The Medical Staff Leader stated the OPPE data was abstracted via a computer program.

The Medical Staff Leader stated he believed visits that were documented on paper by NP 1 were not included in the data abstracted. The Medical Staff Leader stated it could be that the computer system was also not picking up data on services provided by NP 2 at the offsite inpatient psychiatry building.

During an interview with the Director of Accreditation on 6/17/14 at 1445 hours, she stated NP 1 provided services at the hospital but was actually employed by another entity, and there was no departmental personnel file for NP 1 at the hospital. The Director stated she was unable to state how many allied health staff at the hospital were employees of another entity and did not have departmental personnel files at the hospital.

During a second interview with the Director of Accreditation on 6/17/14 at 1510 hours, she stated any file for NP 2 would be housed at the inpatient psychiatry unit which was at a separate geographic location from the main campus. NP 2's file, or a summary of its contents, was requested, but was not provided at the time of the survey exit on 6/17/14 at 1600 hours.

Based on interview and record review, the hospital failed to ensure patients' grievances were responded timely when six of seven grievances reviewed were not completed within 30 days, and no investigation or response letter was documented for one grievance. This failure created the risk of unmet patient needs and persistent poor practices.

Findings:

1. The Patient Complaint Tracking log from May and June, 2014, was reviewed on 6/16/14. The log included seven grievances received between 5/6 and 5/16/14. Only one of the seven grievances was documented as "completed" within the 30 day time period for completion. There was no documented evidence six other grievances were completed within 30 days.

During an interview with the Administrator, Patient and Guest Services on 6/17/14 at 1300 hours, he stated the grievances were expected to be resolved within 30 days. The Administrator concurred there was a delay in resolving some of the grievances.

2. The file associated with the grievance of Patient 105 was randomly selected for review on 6/16/14. The grievance was received by the hospital on 6/6/14, and logged on the Patient Complaint Tracking document as "completed" on 6/7/14.

Patient 105's grievance showed she attempted to view and obtain her medical records, but was not allowed to do so by the Medical Records Department. A letter from the hospital to the patient acknowledging the complaint dated 6/7/14, showed the complaint was forwarded to the Medical Records Department, the complaint would be reviewed, and a response letter would be provided to the complainant. However, there was no evidence of an investigation or a response letter in the file.

During an interview with the Administrator, Patient and Guest Services on 6/17/14 at 1300 hours, he stated errors were made in processing the grievances as a clerk had accidentally checked the "completed" box; staff members misunderstood who was taking care of the complaint.

Based on interview and record review, the hospital failed to ensure informed consent for surgical procedures and care during hospitalization were obtained per their P&P for two of 23 sampled patients (Patients 86 and 91), creating the risk of the patients and/or the patient's family members not being allowed to make an informed decision about the procedures and care provided.

Findings:

Review of the hospital's P&P titled Consent for Care dated 4/8/14, showed medical treatment shall not be permitted unless the adult patient or a person legally authorized to act on his or her behalf, has given permission and signed the appropriate consent form at the point of service. Authorized consent forms included Conditions of Admission/Clinic Visit. The original copy of the completed consent form shall be placed in the appropriate section of the patient's health/medical record.

The P&P showed the interpreter used in obtaining informed consent from a patient must be identified on the consent form.

1. Review of Patient 86's medical record was initiated on 6/16/14, and showed the patient was admitted to the hospital on 6/3/14.

Review of the Conditions of Admission/Clinic Visit form showed the section for the patient's or responsible person's signature and their relationship to patient was left blank.

During an interview and concurrent medical record review with RN AD and RN AE on 6/16/14 at 1450 hours, they confirmed the finding.


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2. The medical record for Patient 91 was reviewed with RN AE on 6/17/14 at 0830 hours. The patient had a nasal biopsy procedure on 5/23/14. The Conditions of Admission form was in a language other than English. Review of the face sheet for the patient showed this other language was listed as "primary."

Review of the Authorization For and Informed Consent to Surgery formm dated 5/23/14, showed the form was in English. There was a boxed area on the form to show Interpreter Services were used or were not used to obtain consent. The "yes" or "no" boxes were not checked.

RN AE verified the above finding.

Based on interview and record review, the hospital failed to ensure two of 23 sampled patients (Patients 86 and 98) were informed of their rights to present or formulate the advance directives. This posed the potential for the patients and/or the patient's family members not being allowed to make their medical care decisions.

Findings:

Review of the hospital's P&P titled Advance Directives dated 4/8/14, showed adults who present for hospital admission shall be informed in writing that one method by which they may exercise their right to make health care decision is through the use of an advance health care directive. Upon hospital admission or early during the hospitalization when the general consent is initially obtained, each patient or patient surrogate will be asked whether the patient has an Advance Directive. The response will be noted in the appropriate field of the general consent from and in the automated electronic system. The patient, or the designee, will be provided a copy of the Advance Directive Brochure.

1. Review of Patient 86's medical record was initiated on 6/16/14, and showed the patient was admitted to the hospital on 6/3/14.

Review of the Conditions of Admission/Clinic Visit form showed the section to show the patient was asked if the patient had an advance directive and if not, was further information needed, was left blank.

During an interview and concurrent medical record review with RN AD and RN AE on 6/16/14 at 1450 hours, they confirmed the finding.


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2. The medical record for Patient 98 was reviewed on 6/17/14 at 1030 hours, with RN AE. The patient was admitted for treatment on 6/13/14.

Review of the Conditions of Admission/Clinic Visit form showed the section to show the patient was asked if they had an advance directive and if not, was further information needed, was left blank.

RN AE verified the above finding.

Based on observation, interview and record review, the hospital failed to identify the rationale for the use of a hand mitten restraint for one of three patients (Patient 100) reviewed for the use of restraints. This resulted in the potential for an unnecessary use of a restraint for this patient.

Findings:

Review of the hospital's P&P titled Restraints/Seclusion dated 10/8/13, showed the goal of the hospital is to move towards a restraint free environment:

* Utilizing the least restrictive form of restraint when restraint is necessary.

* Facilitation the discontinuation of restraint at the earliest possible time.

Restraint may only be used when less restrictive interventions have been determined to be ineffective and must be used in accordance with the safe and appropriate restraint techniques and order of a physician.

Review of Patient 100's medical record was initiated on 6/17/14, and showed the patient was admitted to the hospital on 5/22/14.

Review of History & Physical form dated 5/23/14 at 1154 hours, showed Patient 100's right upper extremity was flaccid (limp).

Review of the electronic nursing documentation in the section for Restraints dated 6/9/14 at 0600 hours, showed Patient 100 picked at the surgical site and actively attempted to injure self. The patient was restrained on both upper extremities with soft wrist restraints. Further documentation showed at 0800 hours, the patient was restrained on both upper extremities with soft wrist restraints with the addition of bilateral mittens.

Patient 100 continued to be restrained on both upper extremities with soft wrist restraints and bilateral mittens from 6/9/14 at 0600 hours to 6/12/14 at 1000 hours.

There was no documented evidence to show the reason a mitten was applied on Patient 100's right hand in addition to the soft wrist restraints.

During an interview and concurrent medical record review with RN AQ on 6/17/14 at 1100 hours, RN AQ stated Patient 100 was restrained on both upper extremities by using soft restraints and mittens to prevent the patient from pulling out a NGT. However, the RN confirmed the patient was unable to move the right upper extremity. When asked, RN AQ was unable to provide documentation to show the rationale for the use of mitten on the patient's right hand.

During a follow-up interview and concurrent medical record review with the Nurse Manager-ICU and the Clinical Nursing Director-ICU on 6/17/14 at 1340 hours, the Nurse Manager stated Patient 100 was able to move her right fingers; however, the Nurse Manager was unable to find a documented rationale for use of a mitten on the patient's right hand.

Based on interview and record review, the hospital failed to ensure a physician's order was obtained for the use of mittens for one of three patients (Patient 100) reviewed for the use of restraints. This resulted in the potential for the unnecessary use of restraints for this patient.

Findings:

Review of the hospital's P&P titled Restraints/Seclusion dated 10/8/13, showed restraint may only be used when less restrictive interventions have been determined to be ineffective and must be in accordance with the safe and appropriate restraint techniques and order of a physician.

Review of the hospital's Nursing Clinical Protocol titled Restraints: Non-Violent or Non-Self-Destructive Behavior (Non-Behavioral) revised 10/13, showed staff was to ensure the preprinted "Restraint Order" was completed and specified time limitation (not to exceed 24 hours) and type of restraint; notify the physician of the need for a new order for an expired order if the condition necessitating restraints persists.

Review of Patient 100's medical record was initiated on 6/17/14, and showed the patient was admitted to the hospital on 5/22/14.

Review of History & Physical form dated 5/23/14 at 1154 hours, showed Patient 100's right upper extremity was flaccid.

Review of the electronic nursing documentation in the section for Restraints showed Patient 100 was restrained on both upper extremities by using soft restraints and mittens on 6/12/14 at 0800 hours, and at 1000 hours.

Review of the pre-printed Restraint Order form showed a physician's order dated 6/12/14 at 0700 hours, to apply soft restraints to Patient 100's wrists. However, there was no documentation to show the physician had ordered the application of mittens on the patient's hands.

During an interview and concurrent medical record review with the Nurse Manager-ICU and the Clinical Nursing Director-ICU on 6/17/14 at 1340 hours, both staff confirmed Patient 100 was restrained on her upper extremities with soft wrist restraints and mittens on 6/12/14 at 0800 hours. The staff also confirmed there was no physician's order found for the mittens to be applied on Patient 100's bilateral upper extremities.

Based on interview and record review, the hospital failed to ensure reappointment for NPs 1 and 2 was based upon provider qualifications when review of performance evaluation documentation showed the performance evaluations were incomplete and inaccurate and were based on flawed methods for creating performance evaluation summaries. This failure created the risk of substandard healthcare by medical staff members.

Findings:

The hospital's policy titled Ongoing Professional Practice Evaluation (OPPE) effective 5/7/14, read in part, "The information resulting from the OPPE shall be used in conjunction with other peer review evaluative methods to determine whether to continue, limit or revoke an existing privilege(s)."

The hospital's policy titled Credentialing Process effective 4/8/14, read in part, "Upon receipt of the application, the (hospital) will conform to the Credentials Verifications Methods and Requirements as delineated in attachments A and B, which includes: ...Obtain Quality Assessment Clinical Performance Profile recommendation of the department chair in a timely manner to permit adequate review and evaluation."

A list of allied health providers approved after 5/18/14, was requested and provided. From that list, NPs 1 and 2 were selected for review. Documentation showed both NPs were approved by the Governing Body on 5/30/14.

During a review of the credential and performance evaluation data for NPs 1 and 2, the files showed both providers were reappointed on 5/30/14. Both provider files contained performance review summary sheets for the year 2013, with a column containing a list of evaluation criteria and a column for the scores associated with the criteria. The criteria included such items as the number of patient encounters, the number of cases reviewed for the provider, the number of cases in which provider performance was found deficient and the number of errors made in prescribing. However, the scoring columns showed one NP had five patient encounters while the other NP had "0." All of the other criteria scores were "0" for both of the NPs. The bottom of each sheet was signed by the department chairperson on 5/14/14.

The NPs' patient rosters since 5/18/14, were requested for review. NP 1 saw 17 patients and NP 2 saw 30 patients between 5/18 and 6/14/14. The number of patients seen in 2013, by both NPs was requested. The 2013 data for NP 1 was provided from the electronic health record system and showed six patient encounters in 2013, while the data for NP 2 showed 666 patient encounters.

During an interview with Medical Staff Leader 1 on 6/17/14 at 1130 hours, he reviewed the provider performance evaluation summary sheets signed 5/14/14, for NP 1 and NP 2. The Medical Staff Leader concurred the documentation appeared incorrect. The Medical Staff Leader stated the data did not reflect the number of patients seen and there was no peer review data.

The Medical Staff Leader stated he believed peer review and performance quality assessment was done by the departments with which the NPs were associated and the reviews were in the department's files. The departmental files for NPs 1 and 2 were requested for review.

During a follow-up interview with Medical Staff Leader 1 on 6/17/14 at 1430 hours, he stated NP 1 provided services in the pediatric clinic, and records were kept on paper in that clinic. The Medical Staff Leader stated the OPPE data was abstracted via a computer program. The Medical Staff Leader stated he believed the visits were documented on paper by NP 1 were not included in the data abstracted.

The Medical Staff Leader stated it could be that the computer system was also not picking up data on services provided by NP 2 at the offsite inpatient psychiatry building.

During an interview with the Director of Accreditation on 6/17/14 at 1445 hours, she stated that NP 1 provided services at the hospital but was actually employed by another entity, and there was no departmental personnel file for NP 1 at the hospital. The Director stated she was unable to state how many allied health staff at the hospital were employees of another entity and did not have departmental personnel files at the hospital.

During a second interview with the Director of Accreditation on 6/17/14 at 1510 hours, she stated any file for NP 2 would be housed at the inpatient psychiatry unit which was at a separate geographic location from the main campus. NP 2's file, or a summary of its contents, was requested, but was not provided at the time of the survey exit on 6/17/14 at 1600 hours.

Based on interview and record review, the hospital failed to ensure the medical records were complete and accurate for three of 23 sampled patients (Patients 86, 88 and 90). This could lead to lack of knowledge in providing care to these patients.

Findings:

1. Review of the hospital's P&P titled Legal Health/Medical Record dated 11/12/13, showed all entries should be made as soon as possible after the care is provided, or an event or observation is made. Pre-dating or backdating an entry is not permitted. When an error is made in a medical record entry, the original entry must not be obliterated, and the inaccurate information shall remain accessible.

When a pertinent entry was missed or not written in a timely manner, the author must meet the following requirements:

* Identify the new entry as a "late entry."

* Enter the current date and time- do not attempt to give the appearance that the entry was made on a previous date or an earlier time.

* Identify or refer to the date and circumstance for which the late entry or addendum is written.

* Document the current date and time.

* Write "addendum" and state the reason for the addendum referring back to the original entry.

1. Review of Patient 86's medical record was initiated on 6/16/14, and showed the patient was admitted to the hospital on 6/3/14.

The Authorization for and Informed Consent for Surgery or Special Diagnostic or Therapeutic Procedures form showed Patient 86 signed and consented for bone marrow biopsy and aspiration. The form was signed by MD AF on 6/4/14 at 0907 hours. However, there was no date and time to show when the patient signed the form. Further review showed the section of witness was left blank.

During an interview and concurrent medical record review was conducted with RN AD and RN AE on 6/16/14 at 1450 hours, both staff confirmed the Informed Consent for Surgery or Special Diagnostic or Therapeutic Procedure form was not completed as shown above.

A follow-up review of Patient 86's medical record was conducted on the next day, 6/17/14. The same above form showed Patient 86 signed and consented for the procedure on 6/4/14 at 0907 hours. The section for a witness signature was completed by MD AG and signed on 6/4/14 at 0907 hours.

During an interview and concurrent medical record review with the Assistant Nursing Director on 6/17/14 at 0835 hours, the Assistant Nursing Director was made aware the above Authorization for and Informed Consent for Surgery or Special Diagnostic or Therapeutic Procedures form for Patient 86 was altered.


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2. On 6/17/14, Patient 88's medical record review was conducted and showed the patient was a pediatric patient admitted to the hospital on 6/16/14, for a surgical procedure.

The Pediatric Admission form showed the patient's height was 5 feet 6 inches and the weight was 183 kg (equal to 402.6 pounds).

The Orthopaedic's Admission/Transfer Orders dated 6/16/14 at 0750 hours, showed the orders included the pain medications (morphine and Norco) and IV antibiotics. The sections on the order sheet for the physician to document the height and weight of the patient were left blank.

The Physician's Orders dated 5/6/14 at 0935 hours, showed the orders included IV fluid of 110 ml/hr and antibiotics. The sections on the order sheet for the physician to document the height and weight of the patient were left blank.

The Physician's Orders dated 6/16/14 at 1529 hours, showed the patient's weight was recorded, but the height was missing.

The findings were concurred with RN AN on 6/17/14 at 1000 hours. RN AN stated all the forms should be filled out. They should not be left blank.


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3. The medical record for Patient 90 was reviewed on 6/16/14, and showed the patient presented to the Emergency Department on 5/29/14, and was seen by members of the surgical team.

A note dated 5/29/14 at 0449 hours, by an attending physician read, "Surgery History & Physical Attending: I agree with above assessment. We have to consider the possibility of a tumor at the ampulla." However, there was no history and physical assessment above the physician's note. The History and Physical was written by the resident physician on 5/29/14 at 0945, five hours later.

During an interview with the Interim HIM Director on 6/16/14 at 1555 hours, she concurred the note of agreement by the attending physician was written prior to the history and physical examination note with which it stated agreement.

Based on observation, interview and record review, the hospital failed to develop a comprehensive system for identifying, investigating, and controlling infections and communicable diseases of patients and personnel was developed as evidenced by:

1. Surgical instrument processing and distribution for areas outside of the OR were not conducted in accordance with infection control standards in those areas to minimize the risk of infection in patients having surgical procedures outside of the OR.

2. Staff failed to follow the CDC's guidelines and the hospital's P&P for utilizing PPE in the patient care areas.

These created the increased risk of infections in hospital patients.

Findings:

1a. During an interview with RN AS, the Supervising SPD RN on 6/16/14 at 0950 hours, she stated the SPD staff picked up used instruments in some areas of the hospital and completed the entire processing of those instruments; however, other areas of the hospital initiated the processing of the instruments in their departments and staff from those areas and then brought the used instruments to SPD to complete the process. RN AS stated she did not provide oversight for the instrument processing done in other areas outside the SPD. RN AS stated she provided training years ago for staff in other areas, but not recently.

During a concurrent interview with SP Tech 1, she stated instruments arrived in the SPD from different areas of the hospital where the instruments were used outside of the OR. The Tech stated the instruments were already placed in peel packs with quality control indicators in the packs. The Tech further stated there was no list of which locations began the processing of the instruments and which did not.

On 6/16/14 at 1100 hours, during an observation of the SPD, CNA 1 dropped off a peel packed instrument for sterilization from another area. The instruments in the packs had a small piece of gauze placed on the tips. SP Tech 1 inspected those packs and told the CNA the packs were not acceptable and returned them to the CNA.

During an interview with Medical Aide 1 on 6/17/14 at 0920 hours, in the the UCC, he stated he initiated processing of instruments in the Urgent Care area. He stated a disinfectant solution was available for use on the instruments previously, but two months ago it was taken away.

Medical Aide 1 stated he did not know why the solution was taken away. The Aide stated since then he cleaned the instruments as best he could with water, hand soap, and a brush with normal saline. The Aide stated he then placed the instruments in a peel pack with a sterility indicator and took them to the SPD. The Aide stated the sterile processing staff who accepted the instruments did not provide instruction; they assumed he knew what he was doing. The Aide stated he received instruction in instrument processing years ago.

A staff RN in the UCC was interviewed on 6/17/14 at 0910 hours. The RN stated she immersed washed instruments in a basin to clean. The RN stated she put an uncertain amount of the water to the basin and added some liquid chlorine that she squeezed out from disinfectant wipes. The instruments would be immersed for couple minutes, wiped dry and then packed with a peel pack. The RN stated she only put the instruments in the peel pack, but no monitoring indicators. The RN stated the peel packaged instruments were sent to the hospital's SPD for disinfection.

The UCC staff RN stated she was unable to recall if she received training for handling and cleaning instruments. The RN further stated the UCC staff included RNs and CNAs who took the packaged instruments to the SPD. The SPD staff would exchange the packaged instruments for sterile instruments if available, or UCC staff would pick up the instruments when sterilized. The RN stated there was no mechanism to identify the instruments that returned from the SPD were the same instruments sent out from the UCC.

During an interview with the UCC Supervising RN on 6/17/14 at 1010 hours, she stated she was unsure whether staff received training in instrument processing; however, Medical Aide 1 stated he had training about six years ago. The Supervising RN was not sure if there was an instrument processing policy for the UCC.

On 6/17/14 at 1335 hours, during an interview, Infection Control Practitioner 1 stated the hospital administrative team made the decision to stop using reprocessed instruments in the UCC and instead utilized disposable instruments. The message was sent out to the management team in UCC. The Infection Control Practitioner 1 made a tour in the UCC area and found there were sufficient amount of disposable instruments stored in the center. The Infection Control Practitioner 1 was not aware the UCC staff continued to reprocess instruments.

Review of the hospital's documentation showed an Education Program topic titled Principle of Infection Control. The Standard Precautions listed included to wash reusable items with a detergent solution and transport to a central sterilization location for disinfection.

b. During a tour of the SPD on 616/14 at 0920 hours, closed metal carts were observed with bags of instruments on the shelves. The shelves were labeled with department destinations. There was a bag on the shelf labeled A3D.

In a concurrent interview with SP Tech 1, she removed an instrument from one of the bags and stated it was a screwdriver that was destined for the A3D orthopedic clinic.

There was a sheet accompanying the screwdriver indicating it was brought to SPD on 6/12/14. SP Tech 1 was asked if there was a log or system to track the instruments brought to and sent from the SPD to areas outside the OR. Tech 1 provided a binder containing tracking sheets to record which instruments were brought to and dispersed from the SPD; however, there was no documentation as to when the screwdriver was brought to the SPD. The SP Tech 1 stated the screwdriver should be documented on the log of instruments brought to SPD for processing.

c. On 6/16/14, six pages of the SPD's log of instruments brought from and dispersed to to areas other than the OR was reviewed. The log showed the instruments were received 129 times between 6/3 and 6/16/14. However, on only 32 dates were the instruments documented as dispersed back to a location. The majority of the instruments sent to SPD and processed were not documented as returned to another area.

During an interview with SP Tech 1 on 6/16/14 at 0950 hours, she concurred information was omitted from the SPD log. The Tech stated the system included writing the date and line number from the log on the instrument count sheets. The count sheets were to be kept for both items brought to the SPD and dispersed from the SPD. The items were stored in bins.

The count sheet bins were examined for instruments entering or leaving the department on 6/3/14; however, there were no count sheets for that date even though according to the log instruments were delivered. SP Tech 1 she stated the instrument count sheets for dates prior to 6/6/14 were missing.

d. On 6/16/14, review of the Central Service Sterilization Request Log dated 6/5/14, Control #37 showed documentation of B4A119, stream, and the CS receiver's initials-"ER."

During an interview with SP Tech 1 on 6/16/14 at 1010 hours, Tech 1 reviewed the Central Service Sterilization Request Log dated 6/5/14. Tech 1 stated documentation showed the CS staff "ER" received items for steam sterilization from the outpatient Cysto Room. SP Tech 1 stated the documentation showed a Cysto Room instrumental tray was processed by Sterred (not steam sterilization). However, SP Tech 1 reviewed all the tracking sheets but was unable to locate documentation showing an itemized list of the instruments sent for process from B4A119, the Cysto Room on 6/5/14.

On 6/16/14 at 1355 hours, the outpatient Cysto Room was visited. In an interview, Cysto Room ST stated the SPD staff picked up and returned the instruments and trays for this area. The ST stated the Central Service/Supply Miscellaneous Request sheet was utilized to track the pick-up and return of instruments and trays between the Cysto Room and the SPD; however, there was no standardization of how the sheet was used. The ST stated once the instruments and trays were returned to the unit, the Central Service/Supply Miscellaneous Request sheet was used to reconcile the instruments and trays to ensure the correct numbers of items were returned.

Review of the Central Service/Supply Miscellaneous Request sheet dated 6/13/14, showed documentation an instrument tray was listed on "item", but the amount was missing. The signatures for Requested and Received were both obtained.

e. During an interview on 6/16/14 at 1120 hours with the CV Tech in the cardiac catheterization laboratory, he stated he was trained how to process the instruments more than five years prior. The Tech stated he initiated the processing of the instruments five to six times per month. The Tech was able to describe the process; however, he was not able to find a basin marked to show gallons that were needed to mix the disinfectant solution.

f. During an interview on 6/17/14 at 1020 hours with HMA 1 in the Emergency Department, he was able to describe how to initiate the processing of instruments. HMA 1 indicated a disinfectant solution would be made up according to the instructions taped to the solution container to use "two squirts" of disinfectant. However, HMA 1 was unable to find a pump top for the disinfectant solution in the Emergency Department or the warehouse in order to dispense the two squirts. After a 15 minute search of the hospital, HMA 1 was able to find a pump dispenser.

2. According to the CDC's 2007 Guidelines for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings, IV. Standard Precautions, B.3.a.ii. showed to remove a gown and perform hand hygiene before leaving the patient's environment.

a. On 6/16/14 at 1355 hours, during the tour in the outpatient GI lab, the following was observed:

* MD AE donned a yellow PPE cover gown, walked out of GI room #3, entered GI room #1 and then left the GI lab still wearing the yellow PPE gown. Both GI rooms #1 and #3 had ongoing procedures.

* An EVS staff wearing gloves entered multiple rooms to collect trash after procedures. The EVS staff removed the dirty trash bags from a waste container, placed the bag in a larger bin for transport and replaced the bag liner in the waste container. The EVS staff touched a door knob in order to enter the next room. The EVS staff did not change gloves or conduct hand hygiene.

b. Review of the hospital's Infection Control P&P showed for contact precautions, the patient's visitors were required to wear gowns and gloves (PPE) in the patient's room.

On 6/17/14 at 0835 hours, the 8B pediatric inpatient unit was toured. A contact isolation sign was posted on the door of one patient room showing staff was to don isolation PPE prior to entering the room.

Inside the room, a visitor was observed standing at the bedside next to the patient. The visitor was not wearing gown and gloves. In a concurrent interview with RN AO, the RN stated the patient was identified with an ORSA (Oxacillin Resistant Staph Aureus) in a leg wound. The RN confirmed the patient was on contact isolation.


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Based on interview and medical record review, the hospital failed to ensure the surgical team implemented the P&P for the completion of the timeout/verification form prior to a procedure for three of 13 surgical patients reviewed (Patients 87, 92 and 96). This failure could lead to the potential for unsafe care for these patients.

Findings:

Review of the hospital's P&P titled Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery dated 8/13/13, showed the hospital practices a safe and uniform method of preventing procedural errors by meeting expectations of the Universal Protocol. The Universal Protocol includes to conduct a pre-procedure verification process; mark the procedure site; and a time-out is performed before the procedure.

Further review showed the elements of the Pre-procedure verification process included to verify the correct procedure, for the correct patient, and at the correct site. During the time-out, the team members agree at a minimum on the following:

* Correct patient identify;
* The correct site;
* The procedure to be done.

Review of the Pre-Operative/ Pre-Procedure Verification form showed the instruction for use included:

* All patients having an invasive procedure shall have the procedure site confirmed by the entire team before the procedure is performed.
* The form will be used for every invasive procedure to document verification of the intended patient, procedure, site, and laterality.
* The verification form must be completed in it's entirely.
* An incomplete verification form will result in postponement of the procedure until the documentation is complete.
* Any discrepancies notes during the verification process will result in an immediate halt to the procedure until all members of the team can resolve the discrepancy.

1. Review of Patient 87's medical record was initiated on 6/16/14, and showed the patient was admitted to the hospital on 6/10/14.

Review of the Radiological Requested Exam form dated 6/12/14 at 1047 hours, showed an ultrasound was requested for a right renal (kidney) biopsy.

The Authorization for and Informed Consent to Surgery or Special Diagnostic or Therapeutic Procedures form, signed by Patient 87 on 6/12/14 at 1014 hours, showed the patient consented for a needle biopsy of kidney to the right lower abdomen. The physician signed the form on 6/12/14 at 1045 hours.

The Pre-Operative/Pre-Procedure Verification form showed "Renal Biopsy" was a procedure to be performed on Patient 87. The form showed the procedure site was marked and all procedure team members were present for a time out process. However, there was no documented evidence to show the laterality of the procedure (right or left) was verified by the team members.

Review of the Procedure-Medicine Note showed an entry dated 6/12/14 at 1548 hours, that Ultrasound guided right transplant kidney biopsy was performed on Patient 87.

During an interview and concurrent medical record review with the Nurse Manager and RN AP on 6/17/14 at 0925 hours, they confirmed the Pre-Operative/Pre-Procedure Verification form did not show the laterality of the procedure performed on Patient 87 on 6/12/14.


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2. The medical record for Patient 92 was reviewed with RN AE on 6/17/14 at 0845 hours, and showed the patient was admitted to the hospital for a procedure on 5/26/14.

Review of the Authorization for and Informed Consent to Surgery form dated 5/26/14, showed the patient consented to the I&D of a nose abscess; however, no laterality was specified.

Review of the Universal Protocol for Procedures Performed Outside of the Operating Room form showed the procedure to be performed was an I&D of the right nare. There was no date and time for the procedure documented on the top section of the form.

The above finding was confirmed by RN AE and the Interim Director of HIM.

3. The medical record for Patient 96 was reviewed with RN AE on 6/17/14 at 1000 hours, and showed the patient was admitted to the hospital for a procedure on 6/14/14.

Review of the Authorization for and Informed Consent to Surgery form dated 5/26/14, showed the patient consented to a left oral gingivobuccal cheek biopsy on 6/14/14. There was no documentation to show the Universal Protocol for Procedures Performed Outside of the Operating Room form was completed for Patient 96 prior to the procedure.

The above finding was confirmed by RN AE and the Interim Director of HIM.

Based on interview and record review, the hospital failed to ensure the informed consents obtained prior to the surgical procedures were complete and accurate as per the P&P for seven of the 13 surgical patients reviewed (Patients 86, 87, 91, 92, 93, 96 and 97). This created the risk of the patients not being allowed to make decisions about their healthcare and the risk of substandard health outcomes.

Findings:

The hospital's P&P titled Consents for Care, dated 4/8/14, showed informed consent is obtained when a special procedure is to be performed for diagnostic or therapeutic purposes. The treating practitioner shall obtain a specific informed consent for that procedure. The interpreter who is used in obtaining informed consent from a patient must be identified on the consent form.

1. Review of Patient 86's medical record was initiated on 6/16/14, and showed the patient was admitted to the hospital on 2/25/14.

Review of the Authorization for and Informed Consent to Surgery or Special Diagnostic or Therapeutic Procedures form was signed by MD AF on 6/4/14 at 0907 hours. Patient 86 signed and consented for a bone marrow biopsy and aspiration. However, the section for the witness to the patient's signature was left blank, and no date and time was documented to show when the patient signed the form.

Further review of the form showed a section beneath the patient's signature area with check boxes to show "yes" or "no" for the use of an interpreter and if a blood transfusion form was required. These two sections were left blank.

Review of the second Authorization for and Informed Consent to Surgery or Special Diagnostic or Therapeutic Procedures form signed by Patient 86 on 6/16/14 at 1030 hours, showed the patient consented for bone marrow biopsy and aspiration. This form was also incomplete as the sections to document the use of interpreter services and to document if a blood transfusion form was required were left blank.

During an interview and concurrent medical record review conducted with RN AD and RN AE on 6/16/14 at 1450 hours, both staff confirmed the Informed Consents for Surgery or Special Diagnostic or Therapeutic Procedure were not completed per the P&P.

2. Review of Patient 87's medical record was initiated on 6/16/14, and showed the patient was admitted to the hospital on 6/10/14.

Review of the Authorization for and Informed Consent to Surgery or Special Diagnostic or Therapeutic Procedures form, signed by Patient 87 on 6/12/14 at 1014 hours, showed the form was not complete as the sections to document the use of interpreter services and to document if a blood transfusion form was required were left blank.

During an interview and medical record review with the Nurse Manager and RN AP on 6/17/14 at 0925 hours, the above was confirmed.


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3. The medical record for Patient 91 was reviewed with RN AE on 6/17/14 at 0830 hours, and showed the patient had a nasal biopsy procedure on 5/23/14. The Conditions of Admission form was in a language other than English. Review of the face sheet for the patient showed this other language was listed as "primary."

Review of the Authorization for and Informed Consent to Surgery form dated 5/23/14, showed the form was in English. Further review of the form showed the sections beneath the patient's signature area with check boxes to show "yes" or "no" for the use of an interpreter and if a blood transfusion form was required were left blank.

RN AE verified the above finding.

4. The medical record for Patient 92 was reviewed with RN AE on 6/17/14 at 0845 hours, and showed the patient was admitted to the hospital for a procedure on 5/26/14.

Review of documentation by Patient 92's physician dated 5/26/14, showed the I&D of the right nare was discussed with the patient; however, review of the Authorization for and Informed Consent to Surgery form dated 5/26/14, showed the patient consented to an I&D of a nose abscess. No laterality was specified on the consent.

RN AE verified the above finding.

5. The medical record for Patient 93 was reviewed with RN AE on 6/17/14 at 0900 hours, and showed the patient was admitted to the hospital for a procedure on 5/30/14.

Review of the Authorization for and Informed Consent to Surgery form dated 5/30/14, showed the sections beneath the patient's signature area with check boxes to show "yes" or "no" for the use of an interpreter and if a blood transfusion form was required were left blank.

RN AE verified the above finding.

6. The medical record for Patient 96 was reviewed with RN AE on 6/17/14 at 1000 hours, and showed the patient was admitted to the hospital for a procedure on 6/14/14.

Review of the Authorization for and Informed Consent to Surgery form dated 6/14/14, showed the sections beneath the patient's signature area with check boxes to show "yes" or "no" for the use of an interpreter and if a blood transfusion form was required were left blank.

RN AE verified the above finding.

7. The medical record for Patient 97 was reviewed with RN AE on 6/17/14 at 1015 hours, and showed the patient was admitted to the hospital for a procedure on 6/13/14.

Review of the Authorization for and Informed Consent to Surgery form dated 6/13/14, showed the sections beneath the patient's signature area with check boxes to show "yes" or "no" for the use of an interpreter and if a blood transfusion form was required were left blank.

RN AE verified the above finding.