HospitalInspections.org

Based upon staff interview and review of facility documents, the hospital failed to ensure services furnished in the hospital under contracts, permitted the hospital to comply with all applicable conditions of participation and standards for the contracted services.

The findings were:

An interview with the Human Resources Professional conducted on 10/27/2010 at approximately 1:00 p.m. revealed the hospital did not maintain personnel files on staff that were provided by an outside agency. S/he stated that when staff were provided from the system's staffing agency, the personnel file at the agency, in another city, was the only one maintained.

An interview with the Director of Quality and the Quality Specialist conducted on 10/27/2010 at approximately 1:30 p.m. revealed the list of contracted services did not contain a listing for the contracted staffing provided by Banner Staffing. It was revealed that contracts, if reviewed, were done so at a departmental level and no hospital-wide evaluation of contracted services was conducted.

When asked to provide any documentation of evaluation of contracted services, the Director of Quality stated there were no such documents to review.

Based upon review of facility documents and staff interview, the hospital failed to ensure services performed under a contract were provided in a safe and effective manner. Specifically, the hospital failed to have a mechanism to evaluate the quality of each contracted service.

The findings were:

An interview with the Director of Quality and the Quality Specialist conducted on 10/27/2010 at approximately 1:30 p.m. revealed contracts, if reviewed, were done at a departmental level and that no hospital-wide evaluation of contracted services was conducted nor was documentation provided to the Quality department of these evaluations.

When asked to provide any documentation of evaluation of contracted services, the Director of Quality stated there were no such documents to review.

Based on staff interview and review of facility documents, the hospital failed to maintain a list of all contracted services, including the scope and nature of the services provided.

The findings were:

An interview with the Director of Quality and the Quality Specialist conducted on 10/27/2010 at approximately 1:30 p.m. revealed the list of contracted services maintained did not contain a listing for Banner Staffing, a separate entity from the hospital that provided nurses to the hospital when needed.

Based on medical record and policy/procedure review and staff interviews, the facility failed to ensure there was a properly executed informed consent for the surgical procedures, as well as for possible administration of blood and blood products, prior to surgery for sample patients #25, #26, #27, #28, #29 and #30, as required by facility policy/procedures and medical staff rules and regulations. The failure created the potential for negative patient outcomes.

The findings were:

Reference Tag A 0955 for findings related to failure to ensure properly executed informed consents were obtained and documented for surgical procedures and possible administration of blood and blood products prior to to surgery.

Based upon staff interview and a tour of the hospital the hospital failed to ensure that patients receiving care included the use of non-expired supplies.

The findings were:

A tour of the hospital's emergency department was conducted in the presence of the Director of Emergency Services as well as the Emergency Department's Clinical Nurse Specialist on 10/26/2010 at approximately 9:30 a.m. It was discovered that in the room where trauma patients received care, plastic containers were observed that contained supplies needed for emergent procedures. The containers were closed with zip ties that prevented supplies from being separated from the container. The outside of the containers had no indication of when supplies within the container expired.

Upon opening a container labeled "Thoracentesis" it was observed that it contained the following expired supplies:
Four pairs of sterile gloves with an expiration date of 6/30/10
One Pericardiocentesis and Thoracentesis set with an expiration date of August 2010
Two glass vacuum bottles with an expiration date of June 2010
One 250 milliliter bag of normal saline solution with an expiration date of June 2010.

Upon opening a container labeled "Central Line" it was observed to contain the following expired supplies:
One Sterile guidewire with an expiration date of April 2010
Two Tegaderm occlusive dressings with expiration dates of November 2009
One Tegaderm occlusive dressings with expiration dates of May 2009

An intravenous tray in a patient room contained two 16 gauge angiocatheters used to obtain intravenous access for medication administration with an expiration date of July 2010.

A clean utility room in the Emergency Department contained procedure carts used to provide supplies when procedures were done in examination rooms.

A cart referred to as the "Hand Cart" contained the following expired supplies:
One Box of 7-0 nylon sutures with expiration dates of July 2010
Numerous 4-0 Ethilon silk sutures with expiration dates of July 2010

A cart used for Ear, Nose, and Throat emergencies contained the following expired supplies:
One bottle of iodoform packing strips with an expiration date of September 2010
One box of Rhino Rockets (used to treat epistaxis) with an expiration date of January 2010

A cart referred to as the "Suture Cart" contained the following expired supplies:
One box of 4-0 Vicryl sutures with an expiration date of July 2010.

A package labeled Precip pack (used for the delivery of an infant in the Emergency Department) contained the following expired supplies:
One umbilical cord clamp with an expiration date of December 2006
One umbilical cord clamp with an expiration date of March 2010
One package of 4x4 gauze sponges with an expiration date of February 2009
One package of sterile gloves with an expiration date of 6/30/2010

The room also contained a pediatric atrium (used to collect air or fluid after chest tube insertion) with an expiration date of May 2010. The atrium had a post-it note on it that stated, "Expired - only one we have until new one arrives" that was dated 7/9/2010.

The expiration dates were confirmed with the Emergency Department Director. S/he stated that currently there was not a mechanism in place to routinely track expiration dates of supplies. Prior to exiting the facility the surveyor was provided a document titled "Emergency Department Action Plan" that indicated staff were to be assigned to check for and document expiration dates monthly. The plan also indicated that the plastic containers maintained in the trauma rooms would indicate an expiration date of the supplies contained within to aid staff in tracking the expiration dates monthly.

A tour of the GI-Lab was conducted with the Perioperative Services Director on 10/26/2010 at approximately 11:30 a.m. It was discovered that in one of the procedure rooms, a tray contained two angiocatheters with expiration dates of February 2008.

A tour of the perioperative services area of the hospital was conducted with the Perioperative Services Director on 10/26/2010 at approximately 11:45 a.m.

A tour of the Pre-operative area revealed the following expired supplies:
Four 18 gauge angiocatheters with an expiration date of March 2010
One 18 gauge angiocatheter with an expiration date of May 2010
Two 18 gauge angiocatheters with an expiration date of July 2010

A clean supply room located in the preoperative area contained the following expired supplies:
Two boxes of 24 gauge 3/4 inch needles for injections with an expiration date of June 2009
Four boxes of 22 gauge 1 inch needles for injections with an expiration date of August 2009
Four boxes of 20 gauge 1 1/4 inch needles for injections with an expiration date of August 2009
A Ziploc bag that contained assorted needles with expiration dates of October 2007 and December 2008
13 packages of sterile gloves with expiration dates of 6/30/2005 and 6/30/2009
A cart for pre-operative hair removal contained the following expired supplies:
Two boxes of remover lotion with an expiration date of July 2010
Three boxes of remover lotion with an expiration date of October 2008

The post-anesthesia care area storage room contained the following expired supplies:
Two needles for injection with expiration dates of July 2010 and August 2010
Two angiocatheters with an expiration date of August 2010

The expiration dates in the Perioperative areas and GI lab were confirmed with the Perioperative Services Director at the time of the tour and the supplies were removed from the areas they were contained to prevent their use in patient care.

Cross reference tag A0582 for findings related to failure to ensure laboratory services provided at the point-of-care were provided in a safe manner, specifically the hospital failed to ensure quality control checks were completed daily as expected and that supplies were maintained per manufacturer's instructions. Additionally, the hospital failed to ensure laboratory supplies maintained in departments other than the laboratory were discarded to prevent use when expired.

Cross reference tag A0505 for findings related to failure to ensure outdated and unusable drugs were not available for patient use.

Based on staff interview, review of facility policies/procedures and review of facility reports, the hospital failed to ensure security personnel's use of weapons was being monitored and integrated into the hospital's quality program.

The findings were:

An interview with the Director of Telemetry & Intensive Care on 10/25/2010 at approximately 2:30 p.m. revealed the employed security personnel for the hospital carried "pepper spray" (Oleo-resin Capsicum spray, or OC spray). When asked if it had ever been used or removed from the holster to use, s/he called security personnel. S/he reported s/he was told that although it had never been used, it had to be "pulled out several times". S/he was asked if reports were to filed with quality or another department in the hospital when the OC spray was removed from the holster, s/he stated s/he was unsure if such a report was required or done.

An interview with the Director of Quality on 10/26/2010 at approximately 4:30 p.m. revealed the Quality department did not receive reports if security personnel pulled their OC spray out of their holsters. S/he stated s/he would ask about the process of reporting such incidents as well as how often OC spray had been pulled out of the holster.

An interview with the Director of Quality on 10/27/2010 at approximately 10:30 a.m. revealed the facility had a system policy that addressed the use of OC spray. S/he stated s/he was given a security report that outlined an instance when a security officer responded to assist on a nursing unit. S/he stated s/he was unable to find any other reports regarding the use or removal OC spray.

A system policy and procedure was reviewed on 10/27/2010 that was untitled. The policy stated, in pertinent parts:
"...III. Policy:
A. It is the policy of Banner Health Security that Security Officers will use only the degree of force that appears reasonably necessary to bring an incident under control. A security officer will exhaust every other reasonable means of force (see Force Continuum) before resorting to the use of OC spray or physical force...
IV. Procedure/Interventions:...
...B. Whenever a Security Officer uses force in any form, other than the application of patient restraints under medical/nursing supervision, the shift supervisor will be immediately notified. Dispatch will notify the Security Director/Manager. Every Security Officer involved with the incident will complete a detailed, written Incident Report, prior to the end of his/her shift, which will be forwarded to the Security Director/Manager..."
A Security Department report dated 2/19/2010 contained a description of an event where a security officer reported to an inpatient unit to aid in the application of restraints. The report indicated, "once we got him situated I asked the nurse to remove the O.C. spray from my holster and put it somewhere safe so the patient would not be able to grab it."

An interview with the Director of Quality on 10/27/2010 at approximately 1:00 p.m. revealed there was no documentation of any other incidents where OC spray was removed from a holster and that further questioning by him/her into the statements of the OC spray being removed from a holster "several times" could not be clarified.

Based on facility tour and staff interview the facility failed to monitor the effectiveness and safety of services provided to patients, specifically those of the laboratory and point-of-care testing. This failure had the potential of negative patient outcome due to decreased efficacy of laboratory testing.


The findings were:


Cross Reference to A 0582 - Adequacy of Laboratory Services - for findings related to the hospital's failure to ensure laboratory services provided at the point-of-care were provided in a safe manner, specifically the hospital failed to ensure quality control checks were completed daily as expected and supplies were maintained per manufacturers' instructions. Additionally, the hospital failed to ensure laboratory supplies maintained in departments other than the laboratory were discarded to prevent use when expired.

Based on tour observation and staff interviews, the facility failed to ensure all hard-copy portions of the patients' medical records were stored in a secure location until they could be scanned and entered into the electronic medical record. The failure to adequately secure the portions of the medical record created the potential for unauthorized individuals to gain access or alter patient records.

The findings were:

On 10/26/10 at approximately 1:15 p.m., a tour and observations of the medical records department were conducted with the quality specialist for the facility and the director of the medical records department. During the tour it was observed that despite the fact most of the medical records are electronic, hard-copies of documents that had been scanned or were awaiting scanning/confirmation were stored in stacks in open floor-to-ceiling shelves in the main medical records area. There were no doors or other mechanism to secure the records when the department was closed. In addition, a room adjoining the main medical record contained numerous open floor-to-ceiling rolling shelves that also had no mechanism for locking. Additional medical records were stored on those shelves. The only mechanism for securing the records was the locked doors (2) that secured the entire department and the door that could lock the adjoining record room containing the rolling shelves. When asked about hours of operation, control of keys and control of access to the area by other staff, such as housekeeping, security and maintenance, the director of the department stated that staff are in the department to supervise records and cleaning/maintenance activities, except on the night shift (12 midnight to 6 a.m.) on the weekends. In addition, the director was unable to say how many keys to the department were out and who had them. During the survey, the director began the process of reviewing the number and types of people having access to the department, particularly when closed/unattended by medical records staff. S/he also began the process of changing locks and limiting access to keys to a smaller group of staff.

Based on medical record reviews and staff interviews, the facility failed to ensure an updated History and Physical (H & P) was present in the medical record within 24 hours after admission for sample patient #21. In addition, the facility failed to ensure the H & P's were reviewed/updated just prior to surgery if they were completed within 30-day window prior to the surgery. The failure created the potential for a negative patient outcome.

The findings were:

Sample patient #21 was an adult admitted to the hospital on 10/23/2010 at approximately 9:08 p.m. A review of sample patient #21's record on 10/26/2010 at approximately 12:14 p.m. revealed the admitting physician had not documented a History and Physical. An entry titled "History and Physical" contained documentation that it was an "Anticipated document". The Director of Telemetry and Intensive Care was asked if there was a dictated report or copy maintained elsewhere. S/he stated, after contacting the medical record department, there was not a dictated history and physical examination or a report available elsewhere.

On 10/27/2010 at approximately 4:30 p.m., the surveyor was provided with a documented history and physical exam for sample patient #21 that was dated as being performed by the admitting physician on 10/26/2010 at approximately 2:08 p.m.

Reference Tag A 0952 for findings related to failure to ensure history and physical examinations in the medical record were reviewed/updated just prior to surgery if they were completed within 30 days prior to the surgery.

Based on medical record and policy/procedure review and staff interviews, the facility failed to ensure there was a properly executed informed consent for the surgical procedures, as well as for possible administration of blood and blood products, prior to surgery for sample patients #25, #26, #27, #28, #29 and #30, as required by facility policy/procedures and medical staff rules and regulations. The failure created the potential for negative patient outcomes.

The findings were:

Reference Tag A 0955 for findings related to failure to ensure properly executed informed consents were obtained and documented for surgical procedures and possible administration of blood and blood products prior to surgery.

Based upon observation and staff interview, the hospital failed to ensure that outdated and unusable drugs were not available for patient use.

The findings were:

A tour of the hospital's emergency department was conducted in the presence of the Director of Emergency Services as well as the Emergency Department's Clinical Nurse Specialist on 10/26/2010 at approximately 9:30 a.m.

A storage room contained procedure carts that were used in patient rooms for suturing wounds. Within a cart identified as the "hand cart" there were five multidose vials of local anesthetic that had been opened. There were no dates or times written on the bottles to indicate when the vials had been opened or when the vials were to be discarded. Within a cart identified as the "suture cart" there were two multidose vials of local anesthetic that had been opened. There were no dates or times written on the bottles to indicate when the vials had been opened or when the vials were to be discarded.

A patient room utilized for caring for trauma patients contained a aerosol can of Ethyl-chloride spray that is utilized for external use prior to venipuncture for pediatric patients. The can had a manufacturer's expiration date of April 2010. The room also contained a plastic container that contained a 250 milliliter bag of normal saline solution with a manufacturer's expiration date of June 2010.

A warming cabinet that was utilized to warm bags of intravenous fluids contained a one liter bag of normal saline solution that had a date of 10/10/2010 written on it and a one liter bag of normal saline solution that had a date of 10/16/2010 written on it. The remaining bags of intravenous fluid were dated 11/14/2010 or 11/15/2010.

An interview with the Director of Emergency Services at the time of the observations revealed the date written on the bags of intravenous fluid indicated when the bags should be removed from the warmer so the bags would not be utilized for patient care. S/he stated that on the outside of the warmer it is stated that fluid can only remain in the cabinet for 14 days, after which it must be removed so it may not be used for patient care. S/he stated when inquiring with personnel who had labeled the bags of fluid dated 11/14/2010 and 11/15/2010, s/he had discovered the staff member had incorrectly labeled the bags of fluid.

A position paper from the Association for Professionals in Infection Control and Epidemiology (APIC) dated July 30, 2009, stated in pertinent parts:
"...Vials...
...Dispose of opened multidose medication vials 28 days after opening, unless specified otherwise by the manufacturer, or sooner if sterility is questioned or compromised..."

Based on facility tour and staff interview the hospital failed to ensure that supplies were maintained to ensure an acceptable level of safety and quality, specifically the hospital failed to ensure that laboratory testing supplies, medications, and patient care supplies were not expired. This failure had the potential to negatively affect patient care through the use of potentially expired supplies in the care of patients.


The findings were:

Cross Reference to A 0144 - Patient Rights: Care In a Safe Setting - for findings related to the hospital's failure to ensure that patients receiving care included the use of non-expired supplies.

Cross Reference to A 0505 - Unusable Drugs Not Used - for findings related to the hospital's failure to ensure that outdated and unusable drugs were not available for patient use.

I. Quality control checks
A tour of the hospital's emergency department was conducted in the presence of the Director of Emergency Services as well as the Emergency Department's Clinical Nurse Specialist on 10/26/2010 at approximately 9:30 a.m. A tour of the point-of-care laboratory area in the Emergency Department that is utilized by nursing staff for the performance of point-of-care testing revealed a log was maintained that indicated when quality control testing was conducted by nursing staff to ensure accurate results for point-of-care testing. A log of quality control testing for the urinalysis machine had no documentation of quality control testing on 10/4/10, 10/5/10, 10/6/10, or 10/7/10.

An interview with the Point-of-Care laboratory coordinator was conducted in the presence of the Director of Emergency Services on 10/26/2010 at approximately 10:00 a.m. S/he stated it was expected that nursing staff would conduct and document a quality control test for the urinalysis machine daily. S/he confirmed that no documentation existed of such testing on 10/4/10, 10/5/10, 10/6/10, or 10/7/10.

II. Point-of-care testing supplies
A tour of the Emergency Department on 10/26/2010 at approximately 9:30 a.m. revealed that in the case that contained a glucometer for blood glucose point-of-care testing contained two opened bottles of testing strips. The area on the bottles allocated for writing the date when the bottles were opened were blank on both bottles. The bottles contained instructions from the manufacturer to discard any unused testing strips three months after the bottles were opened.

A tour of the Pre-operative area on 10/26/2010 at approximately 2:00 p.m. revealed one case that contained a glucometer for blood glucose point-of-care testing contained two opened bottles of testing strips. The area on the bottles allocated for writing the date when the bottles were opened were blank on both bottles. The bottles contained instructions from the manufacturer to discard any unused testing strips three months after the bottles were opened. It was also revealed that another case that contained a glucometer for blood glucose point-of-care testing contained one opened bottle of testing strips. The area on the bottle allocated for writing the date when the bottle was opened was blank. The bottle contained instructions from the manufacturer to discard any unused testing strips three months after the bottle was opened.

III. Expired laboratory supplies
A tour of the hospital's emergency department was conducted in the presence of the Director of Emergency Services as well as the Emergency Department's Clinical Nurse Specialist on 10/26/2010 at approximately 9:30 a.m.

A tour of the point-of-care laboratory area in the Emergency Department that is utilized by nursing staff for the performance of point-of-care testing revealed the following expired laboratory supplies:

Pediatric blood culture bottles with a manufacturer's expiration date of 12/31/2009.
A box of iStat PT/INR testing cartridges with a manufacturer's expiration date of 10/14/2010

A tour of a patient room revealed the following expired laboratory supplies:
A light blue laboratory tube for blood collection with a manufacturer's expiration date of September 2010
A culture swab with a manufacturer's expiration date of September 2010.

A tour of a patient room utilized for trauma patients revealed a light blue laboratory tube for blood collection with a manufacturer's expiration date of August 2010.

A tour of supply storage area revealed that a cart utilized for obstetric/gynecology/urologic examinations contained male urethra culture swabs with a manufacturer's expiration date of 8/30/2010.

A tour of the hospital's gastrointestinal laboratory conducted on 10/26/2010 at approximately 1:25 p.m. in the presence of the Perioperative Services Director revealed the following expired laboratory supplies:
Three green laboratory tubes for blood collection with a manufacturer's expiration date of July 2010
Two blue laboratory tubes for blood collection with a manufacturer's expiration date of August 2010
One blue laboratory tube for blood collection with a manufacturer's expiration date of December 2006.

A tour of the hospital's pre-operative storage area conducted on 10/26/2010 at approximately 2:00 p.m. in the presence of the Perioperative Services Director revealed the following expired laboratory supplies:

Culture swabs with a manufacturer's expiration date of August 2009
Yellow laboratory tubes for blood collection with a manufacturer's expiration date of September 2010.

Based on review of facility policies/procedures and staff interviews, the facility failed to ensure discharge planning case managers did not steer patients/families to entities in which the facility or the facility's parent corporation had a financial interest, as required.

The findings were:

1. On 9/27/10, the system (Banner Health) policy/procedure "Patient Referral Services for Home-based Services," was reviewed and revealed the following, in pertinent parts:

"...III. Policy:
A. Banner Health ('BH') will carry out the patient's choice of Home-based services provider. If the patient does not express a choice and has not consented to the Home-based services provider, if any, specified by the patient's physician, then BH personnel will refer that patient to the BH-affiliated provider of Home-based services at that location. BH personnel will not recommend to patients any non-BH-affiliated provider of Home-based services.

IV. Procedure/Interventions:
A. Referrals for Home-based services. After a patient has been identified (via screening, assessment, discharge planning, staff, family, physician, or other means) as being in need of home-based services, and, as necessary, a physician's order has been obtained, the following procedures will be used when connecting patients to the appropriate home-based services...
3. Give the patient a printed list of available home-based service providers in the market (see guidelines below) together with the attached Home-Based Services Provider Choice Form ( the provider list to be delivered with the form will be updated under the guidelines below). If BH (Banner Health)-affiliated home-based services of the type ordered are provided in the location of the facility, inform the patient that BH (Banner Health) has home-based services available to the patient.
4. Give the patient any available brochures or other marketing material that describes BH (Banner Health) home-based services. Inform the patient that brochures for some of the other home-based services providers are available upon request. The patient shall then be given brochures or other marketing material of any other home-based services provider specifically requested by the patient (if such providers have supplied those materials).
5. Inform the patient that BH (Banner Health) cannot recommend a provider other than the BH providers. If a patient asks about specifics of any of these other providers, inform the patient that the patient may call that provider, but that BH is not in a position to provide specifics itself. Inform the patient that representatives from these providers are available upon request to assist the patient in the selection of needed equipment or services...
6. Ask if the patient has a preference for a home-based service provider...
c. If the patient does not express a preference or choice, ask the patient if he/she consents to provision of the home-based service by the BH provider. If the patient consents, the patient is referred to the BH Home-based service.

B. Guidelines for Home-Based Service Provider Lists:
1. Prepare home-based services lists and provide them to local BH facilities...
2. Include in Provider lists
a. Names addresses, and telephone numbers.
b. The BH (Banner Health)-affiliated home-based services provider is listed first, then alphabetize by provider thereafter.
c. A statement indicating the list does not necessarily contain all home-based service providers in the area. If a patient asks about specifics of any of these other providers, the patient is informed that the patient may call that provider, but that BH is not in a position to provide those specifics itself.
d. A statement that BH has done no independent evaluation of the other home-based services providers included on the list, and thus cannot provide any information as to their services, availability or quality..."

Review of the attached "[Name of BH Facility (in this case McKee Medical Center)] Home-Based Services Provider Choice Form," revealed the following, in pertinent parts:

"You may have the need for certain home health, hospice, home medical equipment or home infusion services and products following your discharge. McKee Medical Center provides comprehensive home-based services through its affiliated providers [Insert Name(s) of Local BH-Affiliated Home-Based Services Providers]...
We are providing you with other choices that are currently available in our community. If you choose one of these providers, we will call to advise them of your choice. We cannot recommend a provider other than [Insert Name(s) of Local BH-Affiliated Home-Based Service Providers], as we have done no independent review or evaluation of these other providers. However, you should be assured that your selection of a provider other than that [Insert Name(s) of Local BH-Affiliated Home-Based Service Providers] will in no way affect your care at our facility or prevent you from receiving future care from us.
Please indicate your choice below:

__[Insert Name(s) of Local BH-Affiliated Home-Based Service Providers. Use more than one line if more than one BH-Affiliated Provider]:
__Other (Please Specify): _____
________
Patient: _____
Patient Signature: _____ Date: ___ "

2. On 10/27/10 at approximately 2:30 p.m., a case manager was interviewed and revealed that the facility offers patients/families a choice of home-based services, but referred to the policy/procedure and to the language that stated they recommended Banner Health home-based services. Finally, the case manager stated "since they are part of us, they are the only ones that we can recommend."

Based on medical record reviews and staff interviews, the facility failed to ensure an updated history and physical examination (H & P) was present in the medical record prior to surgery for sample patients #25, #26 and #28, as required.

The failure created the potential for a negative patient outcome.

The findings were:

1. Medical record reviews on 10/26/10:

Review of sample record #25 revealed the patient was admitted to the facility on the morning of 10/25/10 for right total hip replacement that was performed on 10/25/10. Review of the electronic medical record with the assistance of a nurse on the orthopedic unit reveal the patient had an H & P conducted by a physician assistant (PA) on 10/8/10. The record revealed the PA electronically signed and verified the H& P on 10/22/10, which was three days prior to the surgery, rather than the required 24-hour window prior to the surgery, as required.

Review of sample record #26 revealed the patient was admitted to the facility on the morning of 10/25/10 for a right total hip replacement that was performed on 10/25/10. Review of the electronic medical record with the assistance of a nurse on the orthopedic unit reveal the patient had an H & P conducted by a physician assistant (PA) on 10/8/10. The record revealed the PA electronically signed and verified the H& P on 10/22/10, which was three days prior to the surgery, rather than the required 24-hour window prior to the surgery, as required.

Review of sample record #28 revealed the patient was admitted to the facility on the morning of 10/25/10 for a left total knee replacement revision that was performed on 10/25/10. Review of the electronic medical record with the assistance of a nurse on the orthopedic unit revealed the patient had an H & P conducted by a physician assistant (PA) on 10/15/10. The record revealed the PA electronically signed and verified the H& P on 10/22/10, which was three days prior to the surgery, rather than the required 24-hour window prior to the surgery, as required.

2. Staff Interviews:

On 10/26/10 at approximately 10:30 a.m., the orthopedic unit nurse assisting with the electronic audit and the quality specialist present confirmed the expectation was for review and re-confirmation of the findings on the H&P just prior to surgery. They were unable to provide evidence of more timely review of the H & P findings at the time of surgery or in the 24-hour window prior to the surgery for sample patients #25, #26 and #28.

Based on medical record and policy/procedure review and staff interviews, the facility failed to ensure that there was a properly executed informed consent for the surgical procedures, as well as for possible administration of blood and blood products, prior to surgery for sample patients #25, #26, #27, #28, #29 and #30, as required by facility policy/procedures and medical staff rules and regulations. The failure created the potential for negative patient outcomes.

The findings were:

1. Review of the "Medical Staff Rules and Regulation" on 10/26/10 revealed the following, in pertinent parts:

"...Part 8: Consents
8.2 INFORMED CONSENT
The surgeon is responsible for obtaining informed consent for surgery. The surgeon is responsible for discussing the planned procedure, the risks, the benefits, the potential complications and the alternatives, including the need to administer blood and blood components, with patient and family prior to anesthesia or sedation. The surgeon is responsible for providing the documented and authenticated informed consent to the appropriate surgical area at McKee Medical Center prior to the surgery..."

2. Review of the system policy/procedure "Informed Consent" on 10/26/10 revealed the following, in pertinent parts:
"I. Purpose/Expected Outcome:
A. Patients have the right to participate in all decisions involving their care or treatment. Patients or their legal representative must be given sufficient information to allow them to make informed choices from among the alternative courses of available treatment along with any risks and benefits from the proposed treatment for their specific medical condition or ailment.
...III. Policy:
A. Surgical-Procedural Informed Consent:
1. Informed Consent is required for any surgical or invasive procedure (other than drawing blood or vena-puncture) or other treatment or procedure not considered part of routine hospital care or exceeds a minimal material risk to the patient. Informed Consent is base upon a clear, concise explanation of the patient's condition and must provide enough information about the procedure, including but not limited to the following:
a. Name of the hospital where the procedure or other type of medical treatment is to take place;
b. An explanation of the recommended treatment or procedure in layman's terms and in a form of communication understood by the patient, or the patient's legal representative;
c. Name of the responsible practitioner who is performing the procedure or administering the medical treatment;
d. An explanation of the risks and anticipated benefits of a treatment or procedure; the probability of success, mortality risks, and serious side effects;
e. An explanation of the alternatives with the risks and benefits of these alternatives;
f. An explanation of the consequences if no treatment is pursued;
g. An explanation and discussion of anticipated problems and the anticipated length of recuperative period; and
h. An explanation that the patient, or the patient's legal representative, is free to withdraw his or her consent and to discontinue participation in the treatment regimen.
i. Additional, a statement, if applicable, that physicians other than the operating practitioner, including but not limited to residents, will be performing important tasks related to the surgery, in accordance with the hospital's policies and, in the case of residents, based on their skill set and under the supervision of the responsible practitioner.
j. A statement, if applicable, that qualified medical practitioners who are not physicians who will perform important parts of th surgery or administration of anesthesia will be performing only tasks which are within their scope of practice, as determined under state law and regulations, and for which they have been granted privileges by the hospital.
2. It is the responsibility of the primary provider performing the procedure/surgery or treatment to provide the patient or authorized representative the details listed in II. A. 1. in order to obtain their informed consent.
3. A properly executed informed consent is one which is signed by the physician, the patient or his/her legal representative and a witness. The witness is not responsible for informing the patient of any aspect of the informed consent or responding to the patient's questions regarding the treatment/procedure as this remains the responsibility of the physician..."

3. Review of the system policy/procedure "Consent for Transfusion of Blood or Blood Components" on 10/26/10 revealed the following, in pertinent parts:
"...I. Purpose/Expected Outcome:
A. To provide guidelines for obtaining consent for transfusion of blood or blood components...
III. Policy:
A. The relationship between McKee Medical Center and a patient is contractual. A conscious patient has the right to consent to or deny transfusion of blood or blood components for situation which are non-emergency or non-life-threatening. When transfusion of blood or blood components may be required for an elective procedure and sufficient time is available, the patient must consent to transfusion of blood or blood components. The written consent is obtained prior to the procedure...
IV. Procedure/Interventions:
A. The consent is available to the physicians and a supply will be kept in their office. The consent will be explained to the patient by their physician when any blood bank work is ordered at the time the surgical consent is obtained..."

4. Medical records reviewed on 10/26/10:

Review of sample record #25 revealed the patient was admitted to the facility on the morning of 10/25/10 for right total hip replacement that was performed on 10/25/10. Review of the electronic medical record with the assistance of a nurse on the orthopedic unit revealed that the record contained a "Consent for Operation or Procedure" that was signed by the patient on 10/8/10 (but not timed) and witnessed by the PA that completed the H & P. The area for the physician signature attesting s/he had "discussed the procedure, risks, complications, consequences, and alternatives with the patient or patient's representative, and to the best of my knowledge, the patient or representative understand such and consent to the proposed procedure" was unsigned by the physician. A second page of the consent form "Consent For Transfusion Of Blood Or Blood Components" was signed by the patient, but not dated, timed, witnessed or signed by the physician below the following section " Physician Declaration: I have discussed the procedure, risks, complications, consequences, and alternatives with the patient or patient's representative, and to the best of my knowledge, the patient or representative understand such and consent to the proposed procedure."

Review of sample record #26 revealed the patient was admitted to the facility on the morning of 10/25/10 for a right total hip replacement that was performed on 10/25/10. Review of the electronic medical record with the assistance of a nurse on the orthopedic unit revealed the record contained a "Consent for Operation or Procedure" that was signed by the patient, but not timed or dated, and witnessed by the PA that completed the H & P. The Physician Declaration was signed, timed and dated by the physician on the date of the procedure (10/25/10 at 11:30 a.m.). The consent form "Consent For Transfusion Of Blood Or Blood Components" was signed by the patient on 10/25/10 at 9:38 a.m. and witnessed by a facility nurse (per information provided by the nurse assisting with the record review) at 10/25/10 at 9:38 a.m. The consent was not signed by the physician, as required.

Review of sample record #27 revealed the patient was admitted to the facility on 10/25/10 for a revision of a previous left total hip replacement that was performed on 10/25/10. Review of the electronic medical record with the assistance of a nurse on the orthopedic unit revealed that the record contained a "Consent for Operation or Procedure" that was signed by the patient, but not timed or dated, and witnessed by a person whose title/role was not specified. The Physician Declaration was signed and dated by the physician on the date 10/20/10, but not timed. The consent form "Consent For Transfusion Of Blood Or Blood Components" was signed by the patient on 10/20/10 at 1 p.m. and witnessed by a person whose title/role was not specified on 10/20/10 at 1 p.m. The consent was not signed by the physician, as required.

Review of sample record #28 revealed the patient was admitted to the facility on the morning of 10/25/10 for a left total knee replacement revision that was performed on 10/25/10. Review of the electronic medical record with the assistance of a nurse on the orthopedic unit revealed the record contained a "Consent for Operation or Procedure" that was signed by the patient, dated 10/15/10, but not timed or witnessed. The Physician Declaration was not signed by the physician. The consent form "Consent For Transfusion Of Blood Or Blood Components" was signed by the patient on 10/15/10, but not timed. The witness was the PA conducted the H & P. The consent was not signed by the physician, as required.

Review of sample record #29 revealed the patient was admitted to the facility on 10/25/10 for a left total knee replacement that was performed on 10/25/10. Review of the electronic medical record with the assistance of a nurse on the orthopedic unit revealed the record contained a consent form "Consent For Transfusion Of Blood Or Blood Components" that was signed by the patient on 10/19/10 at 11:20 a.m. and witnessed by a person whose title/role was not specified. The consent was signed by the physician, but not dated or timed. The consent form had a letterhead for another system facility, as did the surgical consent and anesthesia consent forms.

Review of sample record #30 revealed the patient was admitted to the facility on 10/25/10 for a left ankle fusion that was performed on 10/25/10. Review of the electronic medical record with the assistance of a nurse on the orthopedic unit revealed the record contained a "Consent for Operation or Procedure" that was signed by the patient on 10/14/10 at 3 p.m., and witnessed by a person identified as a medical assistant (MA). The Physician Declaration was signed by the physician, but not dated or timed.