HospitalInspections.org

Based on review of governing body bylaws, facility documents, medical records (MR), and interview with staff (EMP), it was determined the governing body was ineffective in carrying out their responsibilities to approve, implement and enforce standards of patient safety and quality management and improvement for the hospital by failing to ensure a safe setting for patients in the surgical area (0144), failing to follow infection control policies in the surgical area (0940), failing to investigate and take corrective action involving an unusual event in the surgical area (0049), failing to ensure the medical record was complete and accurate regarding an event in surgery (0438), and failing to properly verify licensure of medical staff (0023).

Findings include:

Review of the Bylaws of Bradford Regional Medical Center revised May 29, 2013, revealed, "Section 1.3 The Specific Purposes of the Corporation. The specific purposes of the corporation shall be: to establish, support, manage and furnish facilities, personnel and services ... medical, surgical and hospital care, ... to carry on such activities related to the promotion of health ... to engage in any and all activities consistent with or in furtherance of the above purposes, including demonstrating excellence in patient safety and service, quality of care, and performance improvement ... while promoting compliance with federal and state law... Article X Medical Staff ... 10.2.1 Purpose The medical staff organization shall propose and adopt by vote written bylaws, rules, and regulations for its internal governance, which shall be effective when approved by the Board. These bylaws shall create an effective administrative unit to discharge the functions and responsibilities assigned to the medical staff by the Board..."



Cross reference:
482.11(c) Licensure of Personnel
482.12(a)(5) Medical Staff Accountability
482.13(c)(2) Patient Rights-Care in Safe Setting
482.24(b) Form and Retention of Records
482.51 Surgical Services
482.51(b)(6) Operative Report

Based on review of facility documents and medical records (MR), and staff interviews (EMP), it was determined the facility failed to provide surgical services in accordance with acceptable standards of practice in one of ten medical records (MR1).

The Department received an allegation that during an endoscopic retrograde cholangiopancreatography (ERCP), a surgical procedure that combines the use of a flexible, lighted scope with x-ray pictures to examine the tubes that drain the liver gallbladder and pancreas) the stent fell to the floor. The surgeon ordered the stent to be rinsed off and used.

The Department received an allegation that surgeons were wearing visibly soiled scrubs and shoes in the Operating Rooms (ORs), wearing personal scrubs into the ORs, wearing their scrubs outside the facility and then going into the ORs without changing their scrubs or shoes.

Findings include:

Review of Policy No. 100.001 "Patient Rights and Responsibilities" reviewed July 8, 2014, revealed, "5. You have the right to good quality care and high professional standards that are continually maintained and reviewed..."

Review on August 6, 2014, of the Medical Staff Rules and Regulations Bradford Regional Medical Center dated August 31, 2011, revealed, "Article III Medical Records 3.1 General Requirements The medical record provides data and information to facilitate patient care ...guides professional and organizational performance improvement. The medical record must contain information to justify ... medical treatment, ... to validate and document the course and results of treatment... The attending physician is responsible for the preparation of the physician components to ensure a complete and legible medical record for each patient... Operative reports will include: ... b. the name of the procedure performed, c. a description of the procedure performed, d. findings of the procedure... 4.10 Infection Prevention All practitioners are responsible for complying with Infection Prevention policies and procedures in the performance of their duties... The hospital and medical staff code of conduct policies and procedures shall be followed..."
Review of Bradford Regional Medical Center Risk Management Policy 110.006 "Event Reporting" revised September 2013 revealed, "Policy: All events (resulting in harm or not) including near misses, involving patients and visitors will be reported to the Risk Management Department. Definitions: 1. Event: Any unusual occurrence involving patient or visitor that is not consistent with regular hospital routine regardless of whether there is an apparent injury or other damage. Events would include, but are not limited to, ... deviation from established policy, ... Procedure: ... 1. Upon recognition that an event or near miss has occurred, an event notification will be initiated. ... 4. The event should be documented in the medical record as a separate entry from the event notification to the best of the ability of the staff member who is reporting it. Information should include: date, time, specific injury (if any), actions taken, and notification of MD."

Review of Operating Room Policy No. 6600.004 "Infection Control guidelines" revised August 2012, revealed, "Attire 1. Surgical attire will be donned as directed by policy #6600.039, 'Surgical Attire' ..."

Review of Surgical Services Policy No. 6600.039 "Surgical Attire" revised November 2013, revealed, "1. All persons who enter the semi-restricted and restricted areas of the surgical suite should wear surgical attire intended for use within the surgical suite. a. Approved, clean, and freshly laundered attire made of multi-use fabric or limited-use non-woven fabric is worn within the semi-restricted areas of the surgical environment. b. After daily use, reusable surgical attire will be laundered in a laundry facility approved and monitored by BRMC and not laundered in home laundries. ..."

1. Review of a facility document revealed that an event, involving a break in sterile technique occurred on May 16, 2014, during an ERCP procedure (endoscopic retrograde cholangiopancreatography) on the patient of MR1.

2. Review of MR1 revealed the patient had an ERCP, with placement of a stent in the bile duct and one in the pancreatic duct. There was no documentation in the medical record that one of the stents that was utilized was dropped on the floor, rinsed off and then inserted. Review of a CT scan performed after the procedure revealed there was "Retroperitoneal air. Possible pancreatic necrosis as well." A physician progress note revealed, "CT done Shows free air Probable microperforation ..." The transfer form revealed the "Medical Condition Requiring Transfer" was "perforated bowel."

3. Interviews conducted from approximately 12:05 PM on August 6, 2014, continuing intermittently through approximately 10:30 AM on August 15, 2014, with EMP1, EMP2, EMP3, EMP4, EMP5, EMP7, EMP10, EMP14, EMP19, and EMP21 confirmed that the employees were aware of the use of the contaminated stent in surgery and also aware that surgeons sometimes do not wear appropriate surgical apparel in the OR suite.

Cross reference:
482.12(a)(5) Medical Staff-Accountability
482.13(c)(2) Patient Rights: Care in Safe Setting

Based on review of facility documents and credential files (CF), it was determined that the facility failed to verify current Commonwealth of Pennsylvania licensure and/or Drug Enforcement Agency (DEA) validation by a primary source for four of nine providers (CF3, CF5, CF6 and CF9).

Findings include:

Review of the Bradford Regional Medical Center Medical Staff Bylaws, dated October 27, 2010, revealed, "Part III: Credentials Procedures Manual ... Section 3.1.5 Upon receipt of a completed application, the medical staff office will verify current licensure, education, relevant training, and current competence from the primary source whenever feasible, or from a credentials verification organization (CVO)."

1. Review of CF3 revealed approval for Medical Staff privileges, including the prescribing of narcotics. Review of CF3 revealed no verification for current licensure in medicine through the Pennsylvania Department of State, or validation of DEA registration through the U.S. Department of Justice, DEA, or Office of Diversion Control.

2. Review of CF5 revealed approval for Medical Staff privileges, including the prescribing of narcotics. Review of CF5 revealed no verification for current licensure in medicine through the Pennsylvania Department of State.

3. Review of CF6 revealed approval for Medical Staff privileges, including the prescribing of narcotics. Review of CF6 revealed no validation of DEA registration through the U.S. Department of Justice, DEA, or Office of Diversion Control.

4. Review of CF9 revealed approval for Medical Staff privileges, including the prescribing of narcotics. Review of CF9 revealed no verification for current licensure in medicine through the Pennsylvania Department of State, or validation of DEA registration through the U.S. Department of Justice, DEA, or Office of Diversion Control.

5. On August 8, 2014, at approximately 1:55 PM, a request was made for documentation not found during the credential file review. Review of materials received in response to the request revealed no documentation of primary source verifications for items requested in the review of CF3, CF5, CF6 and CF9.

Based on review of facility documents and staff interviews (EMP), it was determined the governing body failed to ensure that medical staff was accountable to the governing body for the quality of care provided to patients, relative to a break in surgical technique and appropriate surgical attire.

Findings include:

Review of the Bylaws of Bradford Regional Medical Center revised May 29, 2013, revealed, "Section 1.3 The Specific Purposes of the Corporation. The specific purposes of the corporation shall be: to establish, support, manage and furnish facilities, personnel and services ...medical, surgical and hospital care, ... to carry on such activities related to the promotion of health ... to engage in any and all activities consistent with or in furtherance of the above purposes, including demonstrating excellence in patient safety and service, quality of care, and performance improvement ... while promoting compliance with federal and state law..."

Review on August 6, 2014, of the October 27, 2010, Medical Staff Bylaws Part III Credentials Procedures Manual ... Section 4. Professional Practice Evaluation revealed, "The credential committee, after receiving a recommendation from the Clinical service chair and with the approval of the MEC will define the circumstances which require monitoring and evaluation of the clinical performance of each practitioner following his or her initial grant of clinical privileges at the hospital... The medical staff will also engage in ongoing professional practice evaluation (OPPE) to identify professional practice trends that affect quality of care and patient safety. Information from this evaluation process will be factored into the decision to maintain existing privileges, to revise existing privileges, or to revoke an existing privilege prior to or at the time of reappointment. OPPE shall be undertaken as part of the medical staff's evaluation, measurement, and improvement of practitioner's current clinical competency. In addition, each practitioner may be subject to focused professional practice evaluation (FPPE) when issues affecting the provision of safe, high quality patient care are identified through the OPPE process... Part IV: Organization and Functions Manual ... 1.3 Governance, direction, coordination, and action a. Receive, coordinate and act upon, as necessary, the reports and recommendations from clinical services, committees, other groups, and officers concerning the functions assigned to them and the discharge of their delegated administrative responsibilities; b. Account to the Board and to the staff with written recommendations for the overall quality and efficiency of patient care at the hospital; c. Take reasonable steps to maintain profession and ethical conduct and initiate investigations, and pursue corrective action of medical staff business, and fulfill any state and federal reporting requirements; ..."

Review of the Medical Staff Rules and Regulations Bradford Regional Medical Center dated August 31, 2011, revealed, "All practitioners are responsible for complying with Infection Prevention policies and procedures in the performance of their duties..."

The Department received an allegation that during an endoscopic retrograde cholangiopancreatography (ERCP), a surgical procedure that combines the use of a flexible, lighted scope with x-ray pictures to examine the tubes that drain the liver gallbladder and pancreas) the stent fell to the floor. The surgeon ordered the stent to be rinsed off and used.

1. Review of an internal document revealed an event, "Break in sterile technique," occurring on May 16, 2014, at 3:30 PM. The document revealed, "9. Describe The Event. ... Doctor dropped a stent on the floor during an ERCP and picked it up, rinsed it off and used it again. Another stent was right next to him and available to be used."

2. Review of Upper Allegheny Health System Board of Director's Meeting Minutes from October 30, 2013-May 28, 2014, Bradford Regional Medical Center Board of Director's Meeting minutes from October 30, 2013- May 28, 2014, and Bradford Medical Staff Meeting minutes from March 11-June 10, 2014, failed to reveal documentation of any discussion of a break in technique during a surgical procedure.

3. Interviews on August 6, 2014, at approximately 12:30 PM continuing intermittently through August 15, 2014, with EMP1, EMP2, EMP3, EMP4, EMP5, EMP7, EMP14, EMP19, and EMP21 revealed:

EMP1 regarding the use of the contaminated stent- "[A nurse in the OR] did it [completed an event report]. It goes to Quality. They review it and ask questions."

EMP2 when asked about the contaminated stent- confirmed an awareness of the event and said there was internal documentation regarding the event.

EMP3 when asked about any followup with the physician involved in the use of the contaminated stent- "I don't think it went up through formal review. You don't do it, but this was a clean versus sterile procedure... If [the surgeon] was spoken to, it would have been by the Chair of Medicine. If submitted there should be some paper trail. ...It might be on a salmon sheet." When asked if there was a paper trail EMP3 indicated he/she would have to look. Surveyors requested to see a copy of a blank 'salmon sheet' and also asked for an explanation/definition of the use of the salmon sheet. No additional information was provided.

EMP4 when asked about use of contaminated items in the OR-"We are starting 'Stop the Line' in November..."

EMP5 when asked about the use of contaminated items in OR-"There was an implant. It was a biliary or pancreatic stent... [the physician] told them to pick it up and use it..."

EMP14 when asked about the use of the contaminated stent-"They acted like nobody in the room knew what was going on..." When asked if anyone ever notified administration EMP14 said, "I would think so... It's kind of like that's just what they do... It's horrifying. I can't believe it happened..."

EMP19 when asked about the use of the contaminated stent-"The stent was dropped on the floor. It was dropped, washed off, and used..." I hope this is anonymous. Administration does not back staff here..."

EMP21 when asked about the use of the contaminated stent-"[He\she] said, 'Pick it up, rinse it off... It was a tense situation..."

4. Review of CF1 failed to reveal any documentation regarding the break in technique, discussion with the involved physician, or action taken by the hospital to prevent future occurrences. Review of eight additional credential files failed to reveal any documentation of any actions related to breeches in techniques or infection control practices.

***************

Review of Operating Room Policy No. 6600.004 "Infection Control guidelines" revised August 2012, revealed, "Attire 1. Surgical attire will be donned as directed by policy #6600.039, 'Surgical Attire' ..."

Review of Surgical Services Policy No. 6600.039 "Surgical Attire" revised November 2013, revealed, "Policy: All personnel entering the semi-restricted and restricted areas of the surgical suite will wear the appropriate surgical attire (scrub suits, caps/hoods, shoe covers, masks, protective eyewear, gloves, and gowns)

The Department received an allegation that surgeons were wearing visibly soiled scrubs and shoes in the Operating Rooms (ORs), wearing personal scrubs into the ORs, wearing their scrubs outside the facility and then going into the ORs without changing their scrubs or shoes.

Interviews on August 6, 2014, at approximately 12:30 PM continuing intermittently through August 15, 2014, with EMP1, EMP2, EMP3, EMP4, EMP5, EMP7, EMP14, EMP19, and EMP21 revealed:

EMP1 regarding the inappropriate apparel in the OR confirmed physicians were told by staff when they wore apparel outside of hospital policy into the OR. "... we're told we can't do anything [about it]."

EMP2 when asked about breeches in infection control-"Multiple [occurrences] ... There was one particular person who made it [a common practice not follow infection control in the OR] ... Others wouldn't wear their hat ... [staff] filled out salmon sheets [facility failed to provide any salmon sheets when requested.] They went to Risk Management but nothing ever changed."

EMP4 when asked about inappropriate apparel in the OR-"We are reining in some inappropriate behaviors... We struggle with attire in the OR. Our employees follow our policy to a 'T', but one of our surgeons wears personal scrubs to the OR."

EMP5 when asked about inappropriate apparel-"Yes. It is one particular doctor... [His/her] argument is that his wearing [his/her] own leads to no surgical infections so he says he will continue to wear them. [He/she] wears [his/her] scrubs from [his/her] office and comes in without changing..."

EMP7 when asked about inappropriate apparel in the OR-"It's on the agenda [regarding what to do about it] ... We don't allow staff to wear them [scrubs] outside."

EMP14 when asked about inappropriate apparel in the OR-"Yes. I have seen that. Multiple times. It's a big no no..."

EMP19 when asked about inappropriate apparel in the OR-"... A lot of things like physicians wearing scrubs from outside the facility..." After identifying one physician, when asked if it had been brought to the physician's attention that it was outside of policy very many times, EMP19 replied, "Right."

EMP21 when asked about inappropriate apparel in OR identified three physicians that do not always wear appropriate apparel in the OR.










Cross reference:
482.13(c)(2) Patient Rights: Care in Safe Setting
482.51 Surgical Services

Based on review of facility documents and medical records (MR), and staff interviews (EMP), it was determined the facility failed to implement policies to ensure the patient received care in a safe setting in one of ten medical records (MR1).

The Department received an allegation that during an endoscopic retrograde cholangiopancreatography (ERCP), a surgical procedure that combines the use of a flexible, lighted scope with x-ray pictures to examine the tubes that drain the liver gallbladder and pancreas) the stent fell to the floor. The surgeon ordered the stent to be rinsed off and used.

The Department received an allegation that surgeons were wearing visibly soiled scrubs and shoes in the Operating Rooms (ORs), wearing personal scrubs into the ORs, wearing their scrubs outside the facility and then going into the ORs without changing their scrubs or shoes.

Findings include:

Review of the Bylaws of Bradford Regional Medical Center revised May 29, 2013, revealed, "Section 1.3 The Specific Purposes of the Corporation. The specific purposes of the corporation shall be: to establish, support, manage and furnish facilities, personnel and services ...medical, surgical and hospital care, ... to carry on such activities related to the promotion of health ... to engage in any and all activities consistent with or in furtherance of the above purposes, including demonstrating excellence in patient safety and service, quality of care, and performance improvement ... while promoting compliance with federal and state law..."

Review on August 6, 2014, of the October 27, 2010, Medical Staff Bylaws Part I Governance revealed, "Part III: Credentials Procedures Manual ... Section 4. Professional Practice Evaluation ... The credential committee, after receiving a recommendation from the Clinical service chair and with the approval of the MEC will define the circumstances which require monitoring and evaluation of the clinical performance of each practitioner following his or her initial grant of clinical privileges at the hospital... The medical staff will also engage in ongoing professional practice evaluation (OPPE) to identify professional practice trends that affect quality of care and patient safety. Information from this evaluation process will be factored into the decision to maintain existing privileges, to revise existing privileges, or to revoke an existing privilege prior to or at the time of reappointment. OPPE shall be undertaken as part of the medical staff's evaluation, measurement, and improvement of practitioner's current clinical competency. In addition, each practitioner may be subject to focused professional practice evaluation (FPPE) when issues affecting the provision of safe, high quality patient care are identified through the OPPE process... 10.1 Exclusivity policy Whenever hospital policy specifies that certain hospital facilities or services may be provided on an exclusive basis in accordance with contracts or letters of agreement between the hospital and qualified practitioners, then other practitioners must, except in an emergency or life threatening situation, adhere to the exclusivity policy in arranging for or providing care ... Practitioners who have previously been granted privileges, which then become covered by an exclusive contract, will not be able to exercise those privileges unless they become a party to the contract ... Part IV: Organization and Functions Manual ... 1.3 Description of Medical Staff Functions The medical staff, acting as a whole or through committee, is responsible for the following activities: 1.3.1 Governance, direction, coordination, and action a. Receive, coordinate and act upon, as necessary, the reports and recommendations from clinical services, committees, other groups, and officers concerning the functions assigned to them and the discharge of their delegated administrative responsibilities; b. Account to the Board and to the staff with written recommendations for the overall quality and efficiency of patient care at the hospital; c. Take reasonable steps to maintain professional and ethical conduct and initiate investigations, and pursue corrective action of medical staff members when warranted; ... f. Act on all matters of medical staff business, and fulfill any state and federal reporting requirements; ..." (ddb)
Review on August 6, 2014, of the Medical Staff Rules and Regulations Bradford Regional Medical Center dated August 31, 2011, revealed, "Article III Medical Records 3.1 General Requirements The medical record provides data and information to facilitate patient care ...guides professional and organizational performance improvement. The medical record must contain information to justify ... medical treatment, ... to validate and document the course and results of treatment... The attending physician is responsible for the preparation of the physician components to ensure a complete and legible medical record for each patient... 3.3 Clarity, Legibility, and Completeness ... The clarity, completeness, and legibility of medical record documentation may be considered in evaluating the practitioner at the time of reappointment. Practitioners whose medical record entries are habitually unclear, incomplete, or illegible may be subject to one or more of the following remedial actions as determined by the Medical Executive Committee: ... Operative reports will include: ... b. the name of the procedure performed, c. a description of the procedure performed, d. findings of the procedure... 4.10 Infection Prevention All practitioners are responsible for complying with Infection Prevention policies and procedures in the performance of their duties... The hospital and medical staff code of conduct policies and procedures shall be followed..."
Review on August 6, 2014, of Policy No. 100.001 "Patient Rights and Responsibilities" reviewed July 8, 2014, revealed, "5. You have the right to good quality care and high professional standards that are continually maintained and reviewed."
Review on August 11, 2014, of the Upper Allegheny Health System Bradford Regional Medical Center Quality Plan Overview 2014 revealed, "This mission is aligned with the Institute of Medicine's (IOM) six aims of patient care that include the following elements and definitions: -Safe: Care should be as safe for patients in health care facilities as in their own home -Effective: The science and evidence behind health care should be applied and serve as the standard in the delivery of care -Efficient: Care and service should be cost effective, and waste should be removed from the system... 2014 Quality Focus Areas ... -Audits for unreported adverse events ... Partnership for Patients ... The following are the initiatives (BRMC required to report on those with an asterisk): ... -Infection Prevention Initiatives ... -Surgical site infections [not marked with an asterisk] ... Audits for Unreported Adverse Events To be able to improve processes that result in errors, the first step is the identification of errors... -Monthly review of event reports for patterns or trends -Information will be reported to the Vice President of Quality, Chief Nursing Office, and Senior Vice President of Quality and Professional Affairs with data present at the Performance Improvement Committee for action plan development -Summary information being forwarded to the Board Quality Assurance Committee which will forward it to the Board of Directors ... Culture of Safety ... -May-Disclosure & Apology ... -Initiation of a "stop the line" program (early Quarter 2) ... Quality Improvement Plan Structure ... Issues that are deemed to be of specific physician nature are handled through the Medical Executive Committee and the established Physician Peer Review process under the Senior Vice President for Quality and Professional Affairs..."
Review on August 11, 2014, of Operating Room Policy 6600.003 Quality Assurance revised May 2012, revealed, "Policy: As part of the nursing division Quality Assessment program, the Surgical Services will monitor and evaluate the quality and appropriateness of the patient care services provided and resolves identified problems... Procedure: ... 2. The quality and appropriateness of surgical services are monitored and evaluated by the routine collection of data... 4. When problems in patient care are identified, actions are taken and the results of those actions are evaluated. Actions shall result in sustained alleviation or elimination of the problem. Any problem that cannot be resolved within the department shall be referred to the Division Head."
Review on August 6, 2014, of Policy No. 146.001 "The Infection Control Plan" reviewed January 2014, revealed "Infection Control Committee (ICC): ... 2. The ICC has the authority to institute any surveillance, risk reduction, prevention, and control measures or studies when there is reason to believe that any patient, visitor or staff may be at risk for infection. In order to assure continuity of the Infection Control Program,t he Chairperson of the ICC, his/her designee, or in their absence, the Infection Control Practitioner has the authority to institute the above stated control measures..."
Review on August 11, 2014, of Operating Room Policy No 6600.004 "Infection Control Guidelines" revised August 2012, revealed, "Purpose: ... 2. To provide supplies and equipment free of contamination. 3. To lessen the risk of workers serving as a potential source of infection... Attire 1. Surgical attire will be donned as directed by policy #6600.039, 'Surgical Attire' ..."
Review of Surgical Services Policy No. 6600.039 "Surgical Attire" revised November 2013, revealed, "Review of Surgical Services Policy 6600.039 "Surgical Attire" revised November 2013, revealed, "Policy: All personnel entering the semi-restricted and restricted areas of the surgical suite will wear the appropriate surgical attire (scrub suits, caps/hoods, shoe covers, masks, protective eyewear, gloves, and gowns)... Interpretive Statement: 1. All persons who enter the semi-restricted and restricted areas of the surgical suite should wear surgical attire intended for use within the surgical suite. a. Approved, clean, and freshly laundered attire made of multi-use fabric or limited-use nonwoven fabric is worn within the semi-restricted and restricted areas of the surgical environment. b. After daily use, reusable surgical attire will be laundered in a laundry facility approved and monitored by BRMC and not laundered in home laundries. c. Change scrub attire daily or whenever it becomes visibly soiled or wet with blood, body fluid, sweat, or food. Discard appropriately after use in a designated post-use container. d. A cover-up type jacket will be worn over scrub clothes when the employee leaves the surgical suite. e. Non-scrubbed personnel should wear long-sleeved jackets that are buttoned or snapped closed during use..."
1. Review of the Bradford Regional Medical Center Board of Directors' Meeting minutes from October 30, 2013, to May 28, 2014, revealed no documentation of peer related issues or physician behaviors being reported or reviewed.
2. Review on August 7, 2014, of the Board of Directors Meeting Minutes from the April 30, 2014, meeting noted the 2014 Quality Plan focused on areas including audits for unreported adverse events, nursing quality improvement, and creating a culture of safety.
3. Review of the Bradford Regional Medical Center Committee: Performance Improvement minutes from the February 24, 2014 to June 23, 2014 meetings revealed discussion regarding what is meant by a Culture of Safety and review the Performance Pyramid that outlines how to build that culture, managing poor performance and taking corrective action when necessary. There was no documentation of discussion regarding an implant that was dropped in surgery, rinsed off, and then used, there was no documentation of discussion about physicians wearing their own scrubs in the OR being against hospital policy, wearing scrubs in from another facility to the OR, or not wearing head covers in the OR suite.
4. Review on August 8, 2014, of the Bradford Regional Medical Center 2013 Infection Prevention & Control Plan Year End Review revealed that minutes from the Infection Prevention Committee are forwarded to the Med Exec Committee and information from the Infection Control Dashboard is forwarded to the Board. No documentation of what information from the Infection Control Dashboard was provided .
5. Review of facility documentation revealed that an event, involving a break in sterile technique occurred on May 16, 2014.
6. Interview on August 7, 2014, at 1:00 PM with EMP8 confirmed there was no information related to an investigation or follow-up of the event with the contaminated stent.
7. On August 7, 2014, at approximately 11:45 AM, EMP3 confirmed there was no documentation of Medical Staff intervention for EMP20 wearing surgical attire from outside the facility into the operative area. When asked if there had been any follow-up at all, EMP3 stated, "Nothing other than reminders."

8. Interviews on August 6, 2014 continuing intermittently through August 15, 2014 with EMP1, EMP2, EMP3, EMP4, EMP5, EMP7, EMP14, EMP19, and EMP21 revealed:

EMP1 regarding the use of the contaminated stent- "[A nurse in the OR] did it [completed an event report]. It goes to Quality. They review it and ask questions."

EMP1 regarding the inappropriate apparel in the OR confirmed physicians were told by staff when they wore apparel outside of hospital policy into the OR. "... we're told we can't do anything [about it]."

EMP2 when asked about the contaminated stent- confirmed an awareness of the event and said there was internal documentation regarding the event.

EMP2 when asked about breeches in infection control-"Multiple [occurrences] ... There was one particular person who made it [a common practice not follow infection control in the OR] ... Others wouldn't wear their hat ... [staff] filled out salmon sheets [facility failed to provide any salmon sheets when requested. They went to Risk Management but nothing ever changed..."

EMP3 when asked about any followup with the physician involved in the use of the contaminated stent- "I don't think it went up through formal review. You don't do it, but this was a clean versus sterile procedure..."

EMP4 when asked about use of contaminated items in the OR-"We are starting 'Stop the Line' in November..."

EMP4 when asked about inappropriate apparel in the OR-"We are reining in some inappropriate behaviors... We struggle with attire in the OR. Our employees follow our policy to a 'T', but one of our surgeons wears personal scrubs to the OR.

EMP5 when asked about the use of contaminated items in OR-"There was an implant. It was a biliary or pancreatic stent... [the physician] told them to pick it up and use it..."

EMP5 when asked about inappropriate apparel-"Yes. It is one particular doctor... [His/her] argument is that his wearing [his/her] own leads to no surgical infections so he says he will continue to wear them. [He/she] wears [his/her] scrubs from [his/her] office and comes in without changing..."

EMP7 when asked about inappropriate apparel in the OR-"It's on the agenda [regarding what to do about it] ... We don't allow staff to wear them [scrubs] outside."

EMP14 when asked about the use of the contaminated stent-"They acted like nobody in the room knew what was going on..." When asked if anyone ever notified administration EMP14 said, "I would think so... It's kind of like that's just what they do... It's horrifying. I can't believe it happened..."

EMP14 when asked about inappropriate apparel in the OR-"Yes. I have seen that. Multiple times. It's a big no no..."

EMP19 when asked about the use of the contaminated stent-"The stent was dropped on the floor. It was dropped, washed off, and used..." I hope this is anonymous. Administration does not back staff here..."

EMP19 when asked about inappropriate apparel in the OR-"... A lot of things like physicians wearing scrubs from outside the facility..." After identifying one physician, when asked if it had been brought to the physician's attention that it was outside of policy very many times, EMP19 replied, "Right."

EMP21 when asked about the use of the contaminated stent-"[He\she] said, 'Pick it up, rinse it off... It was a tense situation..."

EMP21 when asked about inappropriate apparel in OR identified three physicians that do not always wear appropriate apparel in the OR.

Cross reference:
482.12(a)(5) Medical Staff Accountability
482.51 Surgical Services

Based on review of facility documents and medical records (MR), and staff interview (EMP), it was determined the facility failed to ensure medical record information pertaining to a patient was accurately written in one of 10 medical records (MR1).

Findings include:

Review of the Medical Staff Rules and Regulations Bradford Regional Medical Center dated August 31, 2011, revealed, "Article III Medical Records 3.1 General Requirements The medical record provides data and information to facilitate patient care, ... and guides professional and organizational performance improvement. The medical record must contain information to justify ... medical treatment, ... to validate and document the course of treatment, and to facilitate continuity of care ... The attending physician is responsible for the preparation of the physician components to ensure a complete and legible medical record for each patient... 3.3 Clarity, ... and Completeness ... The clarity, completeness ...may be considered in evaluating the practitioner at the time of reappointment. Practitioners whose medical record entries are habitually unclear, incomplete, or illegible may be subject to one or more of the following remedial actions as determined by the Medical Executive Committee ... Operative reports will include: ... the name of the procedure performed, c. a description of the procedure performed ... 4.10 Infection Prevention All practitioners are responsible for complying with Infection Prevention policies and procedures in the performance of their duties... VII Rules of Conduct 7.1 Disruptive Behavior Members of the Medical Staff are expected to conduct themselves in a professional and cooperative manner in he Hospital. Disruptive behavior is behavior that is disruptive to the operations of the Hospital or could compromise the quality of patient care ... The hospital and medical staff code of conduct policies and procedures shall be followed."

Review of Bradford Regional Medical Center Risk Management Policy 110.006 "Event Reporting," revised September 2013 revealed, "Policy: All events (resulting in harm or not) including near misses, involving patients and visitors will be reported to the Risk Management Department. Definitions: 1. Event: Any unusual occurrence involving patient or visitor that is not consistent with regular hospital routine regardless of whether there is an apparent injury or other damage. Events would include, but are not limited to, ... deviation from established policy, ...Procedure: ... 1. Upon recognition that an event or near miss has occurred, an event notification will be initiated. ... 4. The event should be documented in the medical record as a separate entry from the event notification to the best of the ability of the staff member who is reporting it. Information should include: date, time, specific injury (if any), actions taken, and notification of MD."

1. Review of MR1 revealed the patient had an ERCP (endoscopic retrograde cholangiopancreatography) with placement of a stent in the bile duct and pancreatic duct. There was no documentation that one of the stents that were utilized was contaminated prior to insertion.

2. Review of an internal document revealed a break in sterile technique when a physician dropped a stent on the floor during an ERCP, rinsed it off and used it. Documentation revealed another stent was right next to him/her and available to be used.

3. Interviews on August 6, 2014, continuing intermittently through August 15, 2014, with EMP1, EMP2, EMP3, EMP4, EMP5, EMP7, EMP14, EMP19, and EMP21 revealed all were aware of the stent being dropped on the floor, rinsed, and then being used. When asked if there would be documentation in the medical record when an event occurred, EMP2 stated, "To the best of my knowledge with incident reports, nothing is ever put in the charts..."

4. Interview on August 7, 2014, at 12:00 PM with EMP8 revealed, "... There is nothing documented in the record [as far as the contaminated stent being used.] After reviewing the record again, at 1:00 PM EMP8 stated, "I looked at the record. There is nowhere in the medical record of the stent being on the floor, cleaned and used."

Cross reference:
482.51(b)(6) Operative Report

Based on review of facility documents and medical records (MR), and staff interviews (EMP), it was determined the surgeon failed to include in the operative report complete information describing the techniques used during surgery in one of 11 medical records (MR1).

Findings include:

Review on August 6, 2014, of the Medical Staff Rules and Regulations Bradford Regional Medical Center dated August 31, 2011, revealed, "Article III Medical Records 3.1 General Requirements The medical record provides data and information to facilitate patient care ... The medical record must contain information to justify ... medical treatment, ... to validate and document the course and results of treatment... The attending physician is responsible for the preparation of the physician components to ensure a complete and legible medical record for each patient. ... Operative reports will include: ... b. the name of the procedure performed, c. a description of the procedure performed, d. findings of the procedure... "
Review of Bradford Regional Medical Center Risk Management Policy 110.006 "Event Reporting" revised September 2013 revealed, "Policy: All events (resulting in harm or not) including near misses, involving patients and visitors will be reported to the Risk Management Department. Definitions: 1. Event: Any unusual occurrence involving patient or visitor that is not consistent with regular hospital routine regardless of whether there is an apparent injury or other damage. Events would include, but are not limited to, ... deviation from established policy, ... Procedure: ... 1. Upon recognition that an event or near miss has occurred, an event notification will be initiated. ... 4. The event should be documented in the medical record as a separate entry from the event notification to the best of the ability of the staff member who is reporting it. Information should include: date, time, specific injury (if any), actions taken, and notification of MD."

1. Review of an internal facility document revealed an event occurring on May 16, 2014, at 3:30 PM. The event was for a "Break in sterile technique." The documentation revealed, "9. Describe The Event. ... Doctor dropped a stent on the floor during an ERCP (endoscopic retrograde cholangiopancreatography), and picked it up, rinsed it off and used it again. Another stent was right next to him and available to be used."

2. Review of MR1 Operative Report, dictated on May 16, 2014, revealed a description of the procedure, that did not include documentation that a stent was dropped on the floor, rinsed off, and inserted in the patient. "Plan: Watch [him/her] for pancreatitis, which might be severe for the next few days..."

3. Interviews from August 6, 2014, beginning at approximately 12:05 PM intermittently through August 15, 2014, with EMP1, EMP2, EMP3, EMP4, EMP5, EMP7, EMP14, EMP19, and EMP21 revealed:

EMP1 regarding the use of the contaminated stent- "[A nurse in the OR] did it [completed an event report]. It goes to Quality. They review it and ask questions."

EMP2 when asked about the contaminated stent- confirmed an awareness of the event and said there was internal documentation regarding the event.

EMP3 when asked about any followup with the physician involved in the use of the contaminated stent- "I don't think it went up through formal review. You don't do it, but this was a clean versus sterile procedure..."

EMP4 when asked about use of contaminated items in the OR-"We are starting 'Stop the Line' in November..."

EMP5 when asked about the use of contaminated items in OR- "There was an implant. It was a biliary or pancreatic stent... [the physician] told them to pick it up and use it..."

EMP14 when asked about the use of the contaminated stent- "They acted like nobody in the room knew what was going on..." When asked if anyone ever notified administration, EMP14 responded, "I would think so... It's kind of like that's just what they do... It's horrifying. I can't believe it happened..."

EMP19 when asked about the use of the contaminated stent- "The stent was dropped on the floor. It was dropped, washed off, and used..." I hope this is anonymous. Administration does not back staff here..."

EMP21 when asked about the use of the contaminated stent-"[He\she] said, 'Pick it up, rinse it off... It was a tense situation..."

Cross reference:
482.24(b) Form and Retention of Records