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Based on observation, interview, and record review, the facility's Governing Body (GB) failed to ensure the hospital's operation was conducted in an effective, safe, and organized manner by failing:

1. To develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement (QAPI) program, in which the governing body (GB) ensured the program reflected the different department/services; and the program focused on indicators in improving health outcomes and the prevention of medical errors (Refer to A263, A273, A286, and A297);

2. To ensure the medical staff was accountable to the GB for the quality of patient care provided at the facility (Refer to A338, A340, and A347); and

3. To ensure nursing services and operations were provided in a safe and effective manner that would meet the patients' needs (Refer to A385, A394, A395, A397, A398, and A405).

The cumulative effect of these systemic problems resulted in failure of the Governing Body to ensure patients were receiving quality care in a safe and effective manner.

Based on observation, interview and record review, the facility failed to ensure the acute dialysis services provided by an outside contracted agency were provided in a safe and effective manner. The contracted dialysis agency failed to ensure staff performed pre-dialysis Hepatitis B testing on two patients (Patient 10 and 33) undergoing dialysis and failed to bleach one dialysis machine after it was used for patients with an unknown Hepatitis B status.

Findings:

The "Acute Dialysis Services Agreement," dated December 3, 2013, was reviewed. The policy indicated it's effective date was January 1, 2014, and, "Contractor will be responsible for and, shall furnish qualified nursing staff to perform dialysis care services necessary...All Services provided pursuant to this agreement shall be performed in compliance with all applicable standards set forth by law or ordinance or established by the rules and regulations of any federal, state, or local agency, department , commission, association or other pertinent governing accrediting, or advisory body, including the Joint Commission..."

The Centers for Disease Control (CDC) indicated chronic hemodialysis patients were at high risk for infection because the process of hemodialysis required vascular access for prolonged periods. In an environment where multiple patients received dialysis concurrently, repeated opportunities existed for person-to-person transmission of infectious agents, directly or indirectly via contaminated devices, equipment and supplies, environmental surfaces, or hands of personnel.

Hepatitis B is an infectious inflammatory illness of the liver caused by the Hepatitis B virus (HBV). According to the CDC, preventing the transmission of HBV depended on timely detection of a patient converting from HBV- (HbsAG-negative) to HBV + (HbsAG-positive) and rapid implementation of isolation procedures before cross-contamination occured.

1a. The record for Patient 10 was reviewed on February 25, 2014. Patient 10 was admitted to the facility on February 22, 2014, with diagnoses that included end-stage renal disease (loss of kidney function) on hemodialysis (removal of waste products and free water from the blood when the kidneys are not functioning). The record contained two documents completed by the contracted dialysis nurses, the following was noted:

-On February 22, 2014, Patient 10 underwent dialysis from 2:38 p.m., to 6:05 p.m., using one of the dialysis unit's dialysis machines. (The serial number or machine number could not be determined from the documentation on the form). In the section for "Predialysis Chemistries," the patient's Hepatitis B Surface Antigen (HbsAG) was unknown. (Hepatitis B is caused by the hepatitis B virus. It is spread through contact with the blood and body fluids of an infected person. A positive HbsAG would indicate the patient was positive for Hepatitis B).

-On February 25, 2014, Patient 10 underwent dialysis with machine "181207." Patient 10's HbsAG was listed as unknown.

During an interview with the Chief Nursing Officer (CNO) on February 25, 2014, at 4 p.m., the CNO stated the facility had recently contracted with a different acute dialysis company. The CNO stated the new company started at the end of 2013, as the last company left prior to the end of their contract.

During an interview with Hemodialysis Registered Nurse (HDRN) 1, on February 26, 2014, at 1:50 p.m., HDRN 1 stated, due to the potential for blood splatter, he wore personal protective equipment including a gown and gloves during each dialysis treatment. HDRN 1 stated, prior to starting dialysis, he evaluated each patients' Hepatitis status. If the status was unavailable in the record, the HDRN "could" contact the patients' outside unit or the patients' physician. The HDRN stated dialysis "could" be performed on a patient with an "unknown status," and it was up to the "nurse's discretion to ask for a physician's order for a Hepatitis panel (to determine a patient's hepatitis status)." HDRN 1 stated he had not obtained a Hepatitis status on Patient 10 prior to starting dialysis.

b. The record for Patient 33 was reviewed on February 26, 2014. Patient 33 was admitted to the facility on January 16, 2014, with diagnoses that included urospesis (a condition occurring after the microorganisms that cause a urinary tract infection spread to the bloodstream). According to documentation in the record, hemodialysis was started on Patient 33 on January 19, 2014. Patient 33's HbsAG status was listed as unknown on January 19, and 20, 2014. According to the documentation, two different dialysis machines were used for Patient 33 on these two days. On January 22, 2014, the patient's status was identified as "positive." On January 25, 2014, Patient 33 was identified as Hepatitis C positive.

During an interview with the Infection Preventionist (IP), on February 27, 2014, at 2 p.m., the IP stated most of the dialysis patients were chronic and had Hepatitis status available. The IP stated, if the status was unknown, the dialysis machine required cleaning similar to the cleaning used for Hepatitis B positive patients. The IP stated he was in the process of evaluating the care provided by this contracted service, but had not conducted a review yet.

A policy and procedure manual located in the dialysis supply room was reviewed. Included in the manual was a policy titled "Hepatitis Screening Policy," with a last reviewed/revised date of April 18, 2013. The policy indicated: "...all patients should have their Hepatitis status known before treatment is initiated." According to the procedures: "Nurses will have to call the nephrologists for the hepatitis information for the first time dialysis in the hospital. If it is not known, then the nurse should get an order for the following tests: HBSAG (Hepatitis B surface antigen)..." The policy also indicated: "In exceptional instances when the hepatitis status is not known, then the machine will have to be chemically disinfected after use. The RN will make sure to resolve the problem so that the results are known for the benefit of the succeeding treatments."

Patient 10 and Patient 33 underwent two days of dialysis without the contracted dialysis nurse knowing the patients' Hepatitis status. The evidence showed the patients' status was not known prior to succeeding treatments.

2. On February 26, 2014, the dialysis supply room was observed. Four Fresenius dialysis machines were stored in the room, along with other dialysis supplies. Each of the dialysis machines had an attached log titled "Hemodialysis Machine Operation and Disinfection Log."

The logs were machine specific and included areas to document the date, time, patient treatment, operator's names and other information about the machines' use and cleaning.

The log for machine "181033" was reviewed. The log included documentation that indicated the machine was used for a patient with an unknown Hepatitis status on January 31, February 2, 3, and 4, 2014. The documentation on the log indicated the machine was not treated with bleach on those days.

During an interview with Hemodialysis Registered Nurse (HDRN) 1, on February 26, 2014, at 1:50 p.m., HDRN 1 stated, due to the potential for blood splatter he wore personal protective equipment including a gown and gloves during each dialysis treatment. HDRN 1 stated, prior to starting dialysis, he evaluated the patients' Hepatitis status. The HDRN stated dialysis "could" be performed on a patient with an "unknown status," and it was up to the "nurse's discretion to ask for a physician's order for a Hepatitis panel [to determine a patient's hepatitis status]." HDRN 1 stated when the patients' Hepatitis status was unknown, the machine would be bleached, like a machine used on Hepatitis B positive patients.

During record review the following was noted:

-On February 25, 2014, Patient 10 underwent dialysis with machine "181207." Patient 10's HbsAG was listed as unknown.

-On Janaury 19, Patient 33 underwent dialysis with machine "181207." On January 20, 2014, Patient underwent dialysis with "181033." Patient 33's HbsAG status was listed as unknown on January 19, and 20, 2014.

A policy and procedure manual located in the dialysis supply room was reviewed. Included in the manual was a policy titled "Hemodialysis Infection Control Guidelines," with a last reviewed/revised date of April 18, 2013. This policy indicated: "...The dialysis machine will be cleaned with bleach after each use and vinegar rinsed....The same machine will be used on all known Hepatitis B Surface antigen (HBsAG) positive patients. All recommended control measures for Hepatitis B are followed and all disposable supplies and accessories are used for one patient only..."

A second policy titled "Hemodialysis Infection Control Guidelines," with a last reviewed/revised date of April 18, 2013, was reviewed. The policy indicated: "... Likewise, if the machine was used by a Hepatitis positive patient or unknown hepatitis status, chemical disinfection must be done at the end of treatment. The same machine must NOT be used for another patient. At the day of discharge, the machine will be chemically disinfected; externally disinfected, tagged and Biomed technician must be notified..."

Two machines used for patients with unknown Hepatitis B status were used for subsequent treatments without evidence that policies and procedures for bleaching or cleaning, were followed.

The facility's "Quality Manual 2014," was reviewed on February 27, 2014. The Manual indicated: "The Governing Board is responsible and accountable for ensuring that the organization implements and maintains an effective Quality Management System (QMS)." The Quality Manual 2014 indicated: "The organization has a systematic process in place to collect necessary data. Such data should be used to: Design and assess new processes."

During an interview with the Infection Preventionist (IP), on February 27, 2014, at 2 p.m., the IP stated most of the dialysis patients were chronic and had Hepatitis status available. The IP stated, if the status was unknown, the dialysis machine required cleaning similar to the cleaning used for Hepatitis B positive patients. The IP stated he was in the process of evaluating the care provided by this contracted service, but had not conducted a review yet.

Based on interview and record review, the facility failed to ensure the quality assessment and performance improvement program:

1. Was hospital wide, data driven, and reflected the complexity of the services offered at the facility (A273);

2. Was effective in identifying and reducing treatment complications and adverse events (A286); and,

3. Included performance improvement projects that were proportional to the scope and complexity of the hospital's services and operations, were evaluated annually for their effectiveness (A297).

The cumulative effect of this systemic problem resulted in failure of the Governing Body to ensure the presence of an effective quality program focused on improving the outcomes of patients.

2. The contracted dialysis agency staff performed dialysis on two patients on two separate occasions, without obtaining the required Hepatitis screening. The staff also failed to perform a bleach wash of machines used on patients with unknown Hepatitis (Refer to A084).

During an interview with the Chief Nursing Officer (CNO) on February 25, 2014, at 4 p.m., the CNO stated the facility had recently contracted with a different acute dialysis company. The CNO stated the new company started at the end of 2013, as the last company left prior to the end of their contract.

During an interview with the Infection Preventionist (IP), on February 27, 2014, at 2 p.m., the IP stated most of the dialysis patients were chronic and had Hepatitis status available. The IP stated if the status was unknown, the dialysis machine required cleaning similar to the cleaning used for Hepatitis B positive patients. The IP stated he was in the process of evaluating the care provided by this contracted service, but had not conducted a review yet.

The facility's "Quality Manual 2014," was reviewed on February 27, 2014. The Manual indicated: "The Governing Board is responsible and accountable for ensuring that the organization implements and maintains an effective Quality Management System (QMS)." Quality management essential included: "Quality planning: Whenever the organization is planning to improve an existing process or developing a new process or system, the design of such processes or systems will be based on...5 Analysis of data regarding the process elements and outcome measures contained in our internal database and information obtained from external comparative data bases."

The Quality Manual 2014 indicated: "The organization has a systematic process in place to collect necessary data. Such data should be used to: Design and assess new processes."



22764

Based on interview and record review, the facility failed to ensure data collected was used to monitor the safety and effectiveness of services and the quality of care rendered, when:

1. All facility departments failed to submit 2013 third quarter data as of December 31, 2013. This failed practice resulted in the potential for adverse data and opportunities for improvement to go unrecognized and unchanged, and the increased potential for harm to patients.

2. A new contracted service was not evaluated by Quality Assurance (QA) department or the Infection Control Professional. This failure resulted in hemodialysis patients going untested for Hepatitis B and the incorrect cleaning and disinfecting of dialysis machines on multiple occasions, with the potential to transmit Hepatitis B from one patient to another.

Findings:

1. A review of the document that identified the schedule for, and the timeliness of, departments submitting their QAPI (Quality Assurance Performance Improvement) data was conducted on February 27, 2014. The document included a statement typed across the column for December 31, 2013, that read, "U (You) have not turned in 3rd Q (quarter) 2013 data, reports or team minutes - they are due in January 2014." The document also included columns that identified when departments were due to report their fourth quarter 2013 data.

During an interview with the Assistant Director of Quality (ADQ) on February 27, 2014, at 10:10 a.m., the ADQ stated "some" of the information was submitted. The ADQ stated not all of the data submitted by the departments had been analyzed by the committee (only those departments who submitted data and reported in January 2014 were analyzed). The ADQ stated departments did not present their data until their assigned month (some in Janaury, some in February, and some in March 2014), and the committee would review and discuss the information at that time. He stated the departments due to report in January 2014, and highlighted in red, had not submitted their third or fourth quarter data for 2013.

Further review of the document indicated departments who had not submitted their third or fourth quarter 2013 data included:

a. Critical Care: Emergency;

b. EOC (Environment of Care): Emergency Management;

c. Materials Management;

d. Medical Surgical Nursing - second floor;

e. Medical Surgical Nursing - third floor;

f. Fall Team; and,

g. Hypoglycemia Project.

Based on interview and record review, the facility failed to ensure the QAPI (Quality Improvement Performance Improvement) program included methods to identify all procedural complications/adverse events when a PICC line that was inserted into an artery, instead of a vein, resulted in formation of a hematoma at the insertion site, development of an arterial clot in the extremity, and the need for the patient to take coumadin (a blood thinner) to prevent development of additional clots. There was no mechanism in place for the quality department to identify the complication/adverse event and follow up with the patient to determine the eventual outcome. This failed practice resulted in the potential for repeat of the complication/adverse event, and the potential for further complications from PICC line insertion to go unrecognized.

A PICC line is a form of IV (intravenous) access that can be used for a prolonged period of time. It is inserted into a vein (not an artery) in the arm, and then advanced through increasing larger veins (not arteries), toward the heart until the tip rests in the distal superior vena cava or cavoatrial joint (above the right atrium of the heart). According to the Cleveland Clinic, during insertion of a PICC, accidental puncture of an artery, nerve, or tendon, can occur near the insertion site. However this is a rare occurrence.

Findings:

During an interview with Patient 11 on December 18, 2013, at 3:30 p.m., Patient 11 stated he went to the facility on May 5, 2013, with abdominal pain, and was diagnosed with an infection. Patient 11 stated he had a PICC line inserted and, as the nurse attempted to insert it, his vein was, "broken," and he suffered an, "enormous," blood loss. Patient 11 stated he went to an Urgent Care on May 22, 2013, with weakness, dizziness, and shortness of breath, and a CT (computerized tomography - a type of x-ray test) scan found he had a blood clot in his right shoulder area due to the broken vein caused by the PICC line.

The record for Patient 11 was reviewed on December 19, 2013. Patient 11, a 73 year old male, was admitted to the facility on May 5, 2013.

A radiology order requisition, dated May 8, 2013, indicated the physician ordered a PICC line to be inserted so IV antibiotics could be given after discharge home.

The PICC documentation record, dated May 8, 2013, completed by RN 4, indicated, prior to the procedure, Patient 11 was educated regarding the potential for complications, including infection, deep vein thrombosis (a clot in the vein), and phlebitis (inflammation of the vein). The record indicated at 5:30 p.m., there was an "inadvertent" arterial (artery, not vein) puncture in the right arm. The record indicated the introducer ( sheath that the PICC line is inserted through) that was inserted into the artery was removed, pressure was applied, and the nurse noted a hematoma formation (a semisolid mass of blood in the tissues caused by injury to the vessel) on the right arm. The record indicated a second attempt was made, and a PICC line was inserted successfully into the left arm. There was no evidence the "inadvertent" arterial puncture with development of a hematoma was reported to the physician.

The medical record indicated Patient 11 was discharged home on May 8, 2013, with the left arm PICC line in place for long term antibiotic therapy.

During an interview with RN 4 (a special procedures nurse certified to insert PICC lines documented the events in the PICC documentation record) on December 19, 2013, at 10:30 a.m., the RN stated an order was received on May 8, 2013, to insert a PICC line in Patient 11, who was being discharged home, for home antibiotic therapy.

RN 4 stated prior to him inserting the PICC line in the left arm successfully, a different nurse (RN 1) attempted to insert the initial PICC line and ended up doing an arterial stick. RN 4 stated he was with RN 1 as the "backup" and was proctoring RN 1, as she had not yet inserted her required number of PICC lines (10) successfully to deem her competent. RN 4 stated RN 1 prepped the patient and selected a site for insertion. RN 4 stated he agreed with the selection of the site, then left to see another patient. RN 4 stated RN 1 realized she was in the artery when she placed the introducer sheath. He stated the patient developed a hematoma, and he assisted RN 1 in determining presence of circulation and sensation distal to (below) the puncture site.

RN 4 stated, "it was an inadvertent arterial stick," and he documented it in the record, but he did not report it to the physician. RN 4 stated he did not report it in writing to the quality/risk department because, "it was not reportable." RN 4 stated he did quality studies related to PICC line insertion, and he reviewed infections and DVT (deep vein thrombosis). He agreed both of these occur over time and patients with PICC lines often go home shortly after the line is inserted, so he cannot collect accurate data. RN 4 stated he did not follow up with patients after discharge.

Patient 11 was readmitted to the facility on June 17, 2013, with recurrent abdominal pain. A review of the current medication list on admission indicated the patient was taking Coumadin 2.5 mg every day (a blood thinner used to prevent new clots from forming).

During an interview with the ADQ (Assistant Director of Quality) on December 19, 2013, at 1:10 p.m., the ADQ stated he did not know about this patient or the PICC line occurrence. The ADQ stated, "It wasn't reported to us."

During a concurrent interview with the ADQ and the Risk Manager (RM) on February 27, 2014, at 1:50 p.m., the RM stated she knew about this patient and his complications, as he filed a grievance with her and she followed up with each department involved. The ADQ stated it wasn't reported to the quality department, so he did not have any information on it. He stated he had not looked into the possibility of developing quality indicators for PICC line complications.

Based on interview and record review, the facility failed to:

1. Ensure each department developed an annual evaluation of the previous year's performance, and a plan identifying the QAPI (Quality Assurance Performance Improvement) projects they would be participating in for the upcoming year.

This failure increased the potential for adverse trends and opportunities for improvement to go unrecognized and unchanged, and the potential for harm to patients; and,

2. Follow through with implementation of it's OPPE (Ongoing Professional Practice Evaluation) program for evaluating the quality of medical care provided to patients when a plan and policies were put into place, but implementation was not completed.

This failure increased the potential for substandard quality of medical care provided to patients, inappropriate appointment and reappraisal of members of the medical staff, lack of appropriate peer review, and harm and death in patients; and,

Findings:

1. A review of the document that identified the schedule for, and the timeliness of, departments submitting their QAPI (Quality Assurance Performance Improvement) annual evaluations and plans was conducted on February 27, 2014. The document indicated the following departments were highlighted red for submission of 2013 QAPI evaluation and 2014 QAPI plan:

1. EOC (Environment of Care): Emergency Management;

2. EOC: Hazardous Materials and Waste;

3. EOC: Life Safety;

4. EOC: Medical Equipment;

5. EOC: Safety and Security;

6. EOC: Utilities;

7. Health Information Management;

8. Human Resources;

9. Materials Management;

10. Outpatient Bariatric Services; and,

11. Special Procedures.

During an interview with the Assistant Director of Quality (ADQ) on February 27, 2014, at 10:10 a.m., the ADQ stated the departments highlighted in red had not submitted their evaluation of the effectiveness of their department QAPI for 2013, or their plan for QAPI projects and indicators for 2014.

2A. The Medical Staff General Policy titled, "Ongoing Practitioner Performance Evaluation," was reviewed on February 27, 2014. The policy indicated the following:

a. All hospital-based clinical activities related to practitioners that held privileges at the facility were to be reviewed as part of the OPPE and organizational performance improvement program;

b. The medical staff performance improvement program had multiple components including first level assessment and focused practitioner performance review, and may also include a formal medical staff investigation and/or initiation of disciplinary action;

c. A specific event or case may be identified as requiring first level assessment through one of the following means:

· Medical Staff peer review and performance improvement indicators;
· Hospital wide generic indicators;
· Organizational indicators related to clinical functions;
· Occurrence reports; and,
· Staff concerns; and,

d. If the event or issue which is the basis of the focused review involves a technical aspect of clinical performance or clinical judgement, then the review committee shall also include practitioners who possess such technical skills and knowledge. If such practitioners are not available on the medical staff, then outside peer review consultants may be retained by the medical staff to assist in peer review activities.

B. Patient 11 underwent a GI (gastrointestinal) procedure performed by MD 5 on June 19, 2013. Prior to the procedure, the patient's blood clotting times were increased (indicating it would take him longer to clot than normal if he started bleeding). The procedure was performed, and following the procedure, the patient had a GI hemorrhage and was admitted to the ICU (Intensive Care Unit) and placed on a ventilator (breathing machine).

During a concurrent interview with the (ADQ) Assistant Director of Quality and the Quality Analyst on February 27, 2014, at 10:10 a.m., the ADQ stated the Quality Department did not learn about this case through reporting of surgical complications (an indicator that was tracked by the organization), "because nobody reported it to us." The analyst stated she received the case for review as a code blue because a rapid response was called. The analyst stated she forwarded the case for peer review, and she typed up a summary of the patient's stay along with the request for review. The analyst stated she did not notice the abnormal lab values prior to the procedure, so she did not include that in the summary. She stated the request for review included the question, "Could complication have been prevented?" She stated the review came back with a decision of, "Care was found to be appropriate after chart review." The DQS stated the physician who did the review was MD 6 (an individual), a FP (family practice) physician. He stated the GI physicians were part of the department of medicine, and medicine and FP could, "cross review," each other's cases, so it was okay for a FP physician to review the record regarding a GI procedure.

The case was reviewed by an individual (not a committee), by a FP physician (not a physician with the same level of technical skills and knowledge), and not in accordance with the facility OPPE policy regarding peer review.

C. Review of Medical Staff Committee meeting minutes conducted February 27, 2014, indicated the following:

a. The OPPE for the Family Medicine Department would result in a practitioner being below the benchmark of acceptable practices due to the low denominator number (measured in discharges);

b. The June 2013 meeting of the Emergency Medicine Department had no OPPE indicators to present; and,

c. The first quarter 2014 Department of Anesthesia meeting OPPE indicators were presented for review and selection.

OPPE indicators, reports, and analysis were not available and/or effective for the medical staff departments.

During an interview with the Director of Medical Staff on February 26, 2014, at 9:30 a.m., the director stated there was no "good" system in place for OPPE (Ongoing Professional Practice Evaluation). She stated the medical staff office was unable to obtain aggregated information to present to the department chair and to the credentials committee to assist them in determining whether a physician was an acceptable candidate for recredentialing. The director stated the information collected in the peer review process could not be presented in an organized fashion for assistance in determining the performance of a physician over time.

During an interview with the (ADQ) Assistant Director of Quality on February 27, 2014, at 2:20 p.m., the ADQ stated the medical staff departments had been "working on" OPPE and deciding on indicators to be reviewed "for a long time." He stated there was not effective OPPE being performed at the facility.

Based on observation, interview, and record review, the Medical Staff failed to operate in a safe and organized fashion according to their bylaws, rules and regulations, and policies, by failing to ensure:

1. The reappointment process was conducted in accordance with the Medical Staff Bylaws when one of one surgeons reviewed (MD [medical doctor] 4) was granted privileges for reappointment with no minimum requirements (uniform criteria) for multiple advanced privileges, no supporting documentation or verification of procedures performed, and no proctoring requirements for newly granted privileges (A340);

2. Two of three surgeons (MD 1 and MD 2) were immediately available for patients when they were placed under general anesthesia, when the surgeons consistently called for patients to be taken into the OR (operating room) and placed under general anesthesia while they were still performing surgical procedures on different patients (A347);

3. Physicians Assistants (PAs) with clinical privileges at the facility:

a. Were supervised by a member of the medical staff who had applied for, qualified for, and been granted specific privileges in accordance with the Medical Staff Bylaws, to supervise and direct a PA;

b. Provided services consistent with the privileges granted when they routinely completed surgical procedures on patients requiring general anesthesia;

c. Had practice specific protocols, by which they could practice, written, prepared, and submitted to Medical Staff Services for review and approval by the IDPC (Interdisciplinary Practice Committee), MEC (Medical Executive Committee), and the Governing Board, as required by the facility AHP (Allied Health Practitioner) Rules and Regulations; and,

d. Had a Delegation of Services Agreement between the PA and the supervising physician to establish written guidelines for adequate supervision as required by CCR (California Code of Regulations) Title 16, Section 1399.540 and 1399.545 (A347);

4. Operative reports were dictated immediately after completion of the procedure, in accordance with the Surgery Department Rules and Regulations, for four of nine patients operated on by MD 1 (Patients 12, 35, 36, and 37) (A347);

5. A GI (gastrointestinal) procedure with bleeding complications, performed by one of one GI physicians with a patient who had complications (MD 5), was reviewed for appropriateness by the physician's peer, in accordance with the Medical Staff General Policies, when Patient 11 underwent an ERCP (endoscopic retrograde cholangiopancreatogram) and suffered hemorrhage and an admit to the ICU (Intensive Care Unit) following the procedure (A347); and,

6. One physician (MD 7) was available for the medical care and treatment of his patient (Patient 11) when he failed to respond to multiple calls by a nurse caring for his patient while the patient was suffering from a complication of a foley catheter (tube inserted into the bladder to drain urine) removal.

The cumulative effect of these systemic problems resulted in the Medical Staff's failure to ensure quality medical care was being provided to patients at the facility.

Based on interview and record review, the facility failed to ensure the reappointment process was conducted in accordance with the Medical Staff Bylaws when one of one surgeons reviewed (MD [medical doctor] 4) was granted privileges for reappointment with no minimum requirements (uniform criteria) for multiple advanced privileges, no supporting documentation or verification of procedures performed, and no proctoring requirements for newly granted privileges.

This failed practice resulted in the potential for:

1. MD 4 to perform procedures he had not been trained to perform;

2. MD 4 to perform procedures he did not have current competence in performing;

3. MD 4 to perform procedures without appropriate proctoring; and,

4. Harm and death to patients.

Findings:

The Medical Staff Bylaws were reviewed on February 26, 2014.

According to Section 5.2-1:

Each application for appointment and reappointment to the medical staff must contain a request for the specific clinical privileges desired by the applicant. A request by a member for a modification of clinical privileges may be made at any time, but such requests must be supported by documentation of training and/or experience supportive of the request.

According to Section 5.2-2:

The basis for granting clinical privileges shall be based on clinical criteria and uniformly and individually applied to all applicants. Requests for clinical privileges shall be evaluated on the basis of the member's....demonstrated professional current competence....and the documented results of patient care and other quality review and monitoring which the medical staff deems appropriate. Privilege determination may also be based on pertinent information concerning clinical performance obtained from other sources, especially other institutions and health care settings where a member exercises clinical privileges.

The Department of Surgery privilege request form was reviewed on February 26, 2014. The form indicated for advanced clinical privileges (delineated on the privilege request form), the applicant was to, "submit required documentation at the time of request." The document further indicated the numbers listed in the table (a table that included the list of privileges that could be requested/granted, required training, the number of procedures required, and the amount of proctoring required), represented the minimal criteria for appointment and reappointment. According to the document, advanced procedural privileges required documentation of training and current competence when requested by any surgeon.

The credential file for MD 4 was reviewed on February 26, 2014. The file indicated MD 4 completed his application for reappointment on October 25, 2013. The file further indicated MD 4 completed an addendum to the application (to clarify missing items on the initial application) and returned it to the Medical Staff office on November 6, 2013. The application included the following:

1. The criteria for advanced privileges included a minimum number of procedures to be performed under each procedure for initial appointment, but no minimum number for reappointment;

2. Under each advanced clinical privilege was a note that read, "To document recent clinical experience, enter number and location performed in the last two years where indicated;"

3. MD 4 requested the following advanced clinical privileges:

a. Radical neck dissection (to remove cancerous tissue in the head and neck), documenting he had performed > six at the facility and at a nearby facility combined;

b. Laparoscopic cholecystectomy (gallbladder removal), documenting he had performed > 10 at the facility and at a nearby facility combined;

c. CO2 laser procedures, documenting he had performed >10 at the facility and at a nearby facility combined;

d. Angiography with fluoroscopy (visualizing the vessels using x-ray), documenting he had performed nine at the facility and at a nearby facility combined;

e. Management of a critical care vascular patient, documenting he had performed > five at a nearby facility;

f. AV (arteriovenous graft) fistula or graft placement (dialysis shunt), documenting he had performed > three at a nearby facility;

g. Aortic aneurysm (weakened arterial wall) repair or aortobifemoral bypass (bypassing a blockage in the artery leading to the legs), documenting he had performed > five at a nearby facility;

h. Carotid endarterectomy (cleaning out blockages in neck arteries that lead to the brain), documenting he had performed > three at a nearby facility; and,

i. Abdominal aortic nonvascular repair (repairing a weakened artery wall from inside the vessel), documenting he had performed > five at a nearby facility.

4. MD 4 requested the following new clinical privileges:

a. Two types of laser surgeries (KTP/YAG and Holmium), documenting he had performed none, with no evidence of training in the procedures;

b. Anterior abdominal approach for spinal procedures, documenting he had performed 38 at the facility and at a nearby facility combined;

c. Anterior thoracic approach for spinal procedures, documenting he had performed five at the facility and at a nearby facility combined;

d. Bladder repair, documenting he had performed three at the facility and at a nearby facility combined;

e. Repair of ureter (tube leading from the kidney to the bladder), documenting he had performed one either at the facility or at a nearby facility combined; and,

f. Nephrectomy (removal of the kidney) for trauma, documenting he had performed one either at the facility or a nearby facility combined.

There was no evidence of documentation in the credential file to support the numbers of procedures MD 4 documented he had performed at the facility or at a nearby facility.

The file indicated all of the requested privileges were granted to MD 4, with no minimum requirements (uniform criteria) for multiple advanced privileges, no supporting documentation or verification of procedures performed, and no proctoring requirements for the anterior abdominal and thoracic abdominal approaches for spinal procedures (new privileges for MD 4). The file indicated the Department Chair recommended privileges, signing a statement that read, "All privilege delineations have been individually considered and have been recommended based on the applicant's specialty, licensure, specific training, health status, current competence, and peer recommendations. Applicant may perform privileges and procedures as indicated." A letter to MD 4 dated December 20, 2013, signed by the CEO (Chief Executive Officer), indicated the Board of Directors approved the Medical Staff's recommendation for reappointment. MD 4 was reappointed effective 12/31/13, for a period of two years.

During an interview with the Director of Medical Staff on February 26, 2014, at 9:30 a.m., the director stated when a surgeon requested reappointment and completed the application with documentation of the numbers of procedures performed, it was up to the Department Chair to decide if the number of procedures documented was acceptable. The director stated there were no minimum number of procedures required for reappointment to the surgery department. The director stated there was no requirement for the applicant to prove the number of procedures he/she documented were, in fact, performed at the facility or at another facility. The director stated there was no, "good," system in place for OPPE (Ongoing Professional Practice Evaluation). She stated the medical staff office was unable to obtain aggregated information to present to the department chair and to the credentials committee to assist them in determining whether a physician was an acceptable candidate for recredentialing. The director stated the information collected in the peer review process could not be presented in an organized fashion for assistance in determining the performance of a physician over time.

Based on observation, interview, and record review, the Medical Staff failed to ensure accountability to the Governing Body for the quality of care provided to patients, appropriate appointment and reappraisal of members of the medical staff, and appropriate peer review, by failing to ensure:

1. Two of three surgeons (MD [medical doctor] 1 and MD 2) were immediately available for patients when they were placed under general anesthesia, when the surgeons consistently called for patients to be taken into the OR and placed under general anesthesia while they were still performing surgical procedures on different patients;

2. Physicians Assistants (PAs) with clinical privileges at the facility:

a. Were supervised by a member of the medical staff who had applied for, qualified for, and been granted specific privileges in accordance with the Medical Staff Bylaws, to supervise and direct a PA;

b. Provided services consistent with the privileges granted when they routinely completed surgical procedures on patients requiring general anesthesia;

c. Had practice specific protocols, by which they could practice, written, prepared, and submitted to Medical Staff Services for review and approval by the IDPC (Interdisciplinary Practice Committee), MEC (Medical Executive Committee), and the Governing Board, as required by the facility AHP (Allied Health Practitioner) Rules and Regulations; and,

d. Had a Delegation of Services Agreement between the PA and the supervising physician to establish written guidelines for adequate supervision as required by CCR (California Code of Regulations) Title 16, Sections 1399.540 and 1399.545;

3. Operative reports were dictated immediately after completion of the procedure, in accordance with the Surgery Department Rules and Regulations, for four of nine patients operated on by MD 1 (Patients 12, 35, 36, and 37);

4. A GI (gastrointestinal) procedure with bleeding complications, performed by one of one GI physicians with a patient who had complications (MD 5), was reviewed for appropriateness by the physician's peer, in accordance with the Medical Staff General Policies, when Patient 11 underwent an ERCP (endoscopic retrograde cholangiopancreatogram - a 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). Patient 11 suffered hemorrhage and an admit to ICU (Intensive Care Unit) following the procedure; and,

5. One physician (MD 7) was available for the medical care and treatment of his patient (Patient 11) when he failed to respond to multiple calls by a nurse caring for his patient while the patient was suffering from a complication of a foley catheter (tube inserted into the bladder to drain urine) removal.

These failed practices resulted in the potential for:

1. Patients to suffer complications from surgery without the surgeon being available to respond;

2. Prolonged and unnecessary general anesthesia;

3. PAs to practice outside of expected standards and without the appropriate level of supervision;

4. Operative reports to be inaccurate and not reflect the details of the procedure performed;

5. The inability to identify an opportunity to improve the care of patients undergoing procedures by MD 5, and prevent further complications when he performed ERCPs;

6. Significant delays in patient care; and,

7. Harm or death to a patient.

Findings:

1. During a tour of the operating room (OR) on February 24, 2014, at 3:35 p.m., accompanied by the Director of Surgery, a surgical procedure was in progress in OR 4, and the room next door (OR 3) was being prepared for a surgical procedure to be performed (a staff member was donned in a gown, gloves, and a mask, and was opening a sterile pack of surgical items onto a table).

The director stated the surgeon in OR 4 (MD [Medical Doctor] 1) used both rooms on the days he performed surgeries. He stated MD 1 would be finishing one patient, and he would have his next patient taken into the other room and prepared for surgery. The director stated MD 1 would have his assistant (PA [Physician Assistant]) close, and he would move over to the next room and start the next surgery. The director stated this was done so MD 1 could get through his surgeries, "efficiently."

A. The following records were reviewed for patients who underwent surgical procedures performed by MD 1 (with PA 1 assisting) on November 6, 2013:

A1. Patient 28, a 48 year old female, was admitted to the facility with diagnoses that included hypertension (high blood pressure) and morbid obesity (weighing two or more times the ideal weight, so called because it is associated with many serious and life threatening disorders). She was admitted for gastric bypass surgery.

The Intraoperative Nursing Record indicated Patient 28 was taken into OR 3 and anesthesia was started at 10:51 a.m., the surgery was started at 11:42 a.m., and the surgery was completed at 1:12 p.m.

A2. Patient 27, a 49 year old female, was admitted with diagnoses that included hypertension, diabetes, and morbid obesity. She was admitted for gastric bypass surgery.

The Intraoperative Nursing Record indicated Patient 27 was taken into OR 4 and anesthesia was started at 12:46 p.m. (26 minutes before surgery was completed on Patient 28). The surgery was started at 1:39 p.m., and completed at 3:37 p.m.

B. The following records were reviewed for patients who underwent surgical procedures performed by MD 1 (with PA 1 assisting) on January 20, 2014:

B1. Patient 12, a 42 year old female, was admitted to the facility with diagnoses that included morbid obesity and fatty liver disease. She was admitted for gastric bypass surgery.

The Intraoperative Nursing Record indicated Patient 12 was taken into OR 3 and anesthesia was started at 8:36 a.m., the surgery was started at 9:19 a.m., and the surgery was completed at 11:18 a.m.

B2. Patient 13, a 43 year old female, was admitted to the facility with diagnoses that included morbid obesity. She was admitted for gastric bypass surgery.

The Intraoperative Nursing Record indicated Patient 13 was taken into OR 4 and anesthesia was started at 10:48 a.m. (41 minutes before surgery was completed on Patient 12). Surgery was started at 11:32 a.m. (four minutes after surgery was completed on Patient 12), and completed at 12:46 p.m.

B3. Patient 14, a 58 year old male, was admitted to the facility with diagnoses that included hypertension and morbid obesity. He was admitted for gastric bypass surgery.

The Intraoperative Nursing Record indicated Patient 14 was taken into OR 3 and anesthesia was started at 12:47 p.m. The surgery was started at 1:26 p.m., and completed at 3:10 p.m.

B4. Patient 15, a 60 year old female, was admitted to the facility with diagnoses that included diabetes, hypertension, and morbid obesity. She was admitted for gastric bypass surgery.

The Intraoperative Nursing Record indicated Patient 15 was taken into OR 4 and anesthesia was started at 2:45 p.m. (25 minutes before surgery was completed on Patient 14). Surgery was started at 3:27 p.m., and completed at 5:27 p.m.

C. The following records were reviewed for patients who underwent surgical procedures performed by MD 1 (with PA 1 assisting) on February 5, 2014:

C1. Patient 35, a 44 year old female, was admitted to the facility with diagnoses that included fatty liver disease, hypertension, diabetes, and morbid obesity. She was admitted for gastric bypass surgery.

The Intraoperative Nursing Record indicated Patient 35 was taken into OR 3 and anesthesia was started at 8:14 a.m. Surgery was started at 8:58 a.m., and completed at 10:15 a.m.

C2. Patient 36, a 42 year old female, was admitted to the facility with diagnoses that included morbid obesity. She was admitted for gastric bypass surgery.

The Intraoperative Nursing Record indicated Patient 36 was taken into OR 4 and anesthesia was started at 9:36 a.m. (39 minutes before surgery was completed on Patient 35). Surgery was started at 10:31 a.m., and completed at 12:23 a.m.

C3. Patient 37, a 35 year old female, was admitted to the facility with diagnoses that included a leaking gastric lap band. She was admitted for replacement of the lap band.

The Intraoperative Nursing Record indicated Patient 37 was taken into OR 3 and anesthesia was started at 11:46 a.m. (37 minutes before surgery was completed on Patient 36). Surgery was started at 12:22 p.m. (one minute before surgery was completed on Patient 36), and completed at 1:16 p.m.

C4. Patient 38, a 41 year old female, was admitted with diagnoses that included fatty liver disease, hypertension, and morbid obesity. She was admitted for gastric bypass surgery.

The Intraoperative Nursing Record indicated Patient 38 was taken into OR 4 and anesthesia was started at 1:36 p.m. Surgery was started at 2:18 p.m., and ended at 4:36 p.m.

C5. Patient 39, a 45 year old male, was admitted to the facility with diagnoses that included fatty liver disease, diabetes, cholelithiasis (gall stones), and morbid obesity. He was admitted for a cholecystectomy (gall bladder removal) and liver biopsy.

The Intraoperative Nursing Record indicated Patient 39 was taken into OR 3 and anesthesia was started at 4:03 p.m. (33 minutes before surgery was completed on Patient 38). The surgery was started at 4:55 p.m., and completed at 5:40 p.m.

D. The following records were reviewed for patients who underwent surgical procedures performed by MD 1 (with PA 1 assisting) on February 24, 2014:

D1. Patient 16, a 35 year old female, was admitted to the facility with diagnoses that included cholesterolosis (formation of crystals in the gallbladder). She was admitted for a cholecystectomy (removal of the gallbladder).

The Intraoperative Nursing Record indicated Patient 16 was taken into OR 3 and anesthesia was started at 8:07 a.m. The surgery was started at 8:33 a.m., and completed at 9:07 a.m.

D2. Patient 17, a 68 year old female, was admitted with diagnoses that included fatty liver and morbid obesity. She was admitted for gastric bypass surgery.

The Intraoperative Nursing Record indicated Patient 17 was taken into the OR and anesthesia was started at 8:32 a.m. (one minute before surgery started, and 35 minutes before surgery was completed on Patient 16). The surgery was started at 9:02 a.m. (five minutes before surgery was completed on Patient 16), and completed at 10:33 a.m.

D3. Patient 18, a 55 year old female, was admitted to the facility with diagnoses that included hypertension, diabetes, and morbid obesity. She was admitted for gastric bypass surgery.

The Intraoperative Nursing Record indicated Patient 18 was taken into OR 3 and anesthesia was started at 9:56 a.m. (37 minutes before surgery was completed on Patient 17). The surgery was started at 10:31 a.m. (two minutes before surgery was completed on Patient 17), and completed at 12:10 p.m.

D4. Patient 19, a 43 year old female, was admitted to the facility with diagnoses that included hypertension, MI (heart attack), and morbid obesity. She was admitted for gastric bypass surgery.

The Intraoperative Nursing Record indicated Patient 19 was taken into OR 4 and anesthesia was started at 11:50 a.m. (20 minutes before surgery was completed on Patient 18). The surgery was started at 12:22 p.m., and completed at 2:12 p.m.

During an interview with RN (Registered Nurse) 2 (an OR nurse) on February 27, 2014, at 9 a.m., the RN stated she usually circulated in orthopedic cases, and she did not take a patient into a room until the surgeon had finished his previous case. She stated it was OK to let the PA close and complete the case, but the surgeon should stay in the room. The RN stated the surgeon could use the time to dictate the operative report or complete another task, but he should stay in the room. The RN stated she did not take a patient into a room until she saw the surgeon was available.

During an interview with the Director of Surgery on February 27, 2014, at 9:30 a.m., the director stated before MD 1 finished a surgery, he would call out to the staff and tell them to take his next patient into the OR next door. The director stated, "We work on his call. He wants to scrub his hands and drop the knife." The director stated, "A happy Doctor (MD 1) is a happy OR." He stated MD 1 left the OR before the surgeries were completed, and he let the PA finish for him. The director stated if the patient he left the PA with had a problem, MD 1 would not be able to respond if he had already started another surgery. The director stated if the second patient was under anesthesia and MD 1 had a problem with the first patient he was working on, the second patient would have to be woken up and put under anesthesia at a later time, or the second patient would have to be left under anesthesia until MD 1 was available to start his/her surgery. The director stated there were two surgeons who worked this way (alternating rooms for efficiency and letting the PA finish the case). He stated the two surgeons were MD 1 and MD 2.

E. The following records were reviewed for patients who underwent surgical procedures performed by MD 2 (with PA 2 assisting) on January 23, 2014:

E1. Patient 40, an 83 year old female, was admitted to the facility with diagnoses that included hypertension and DJD (degenerative joint disease) in the left knee. She was admitted for a left knee arthroplasty (replacement).

The Intraoperative Nursing Record indicated Patient 40 was taken into OR 3 and anesthesia was started at 7:36 a.m. The surgery was started at 8:17 a.m., and completed at 9:14 a.m.

E2. Patient 41, a 76 year old female, was admitted to the facility with diagnoses that included severe DJD in her right knee. She was admitted for right knee arthroplasty.

The Intraoperative Nursing Record indicated Patient 41 was taken into OR 4 and anesthesia was started at 8:46 a.m. (28 minutes before surgery was completed on Patient 40). The surgery was started at 9:21 a.m. (seven minutes after surgery was completed on Patient 40), and completed at 10:31 a.m.

E3. Patient 42, a 74 year old female, was admitted to the facility with diagnoses that included hypertension, hypothyroid disease, and DJD in both knees. She was admitted for arthroplasty of her left knee.

The Intraoperative Nursing Record indicated Patient 42 was taken into OR 3 and anesthesia was started at 10:15 a.m. (16 minutes before surgery was completed on Patient 41). The surgery was started at 10:54 a.m., and completed at 12:05 p.m.

E4. Patient 43, a 74 year old male, was admitted to the facility with diagnoses that included severe DJD in his left knee. He was admitted for arthroplasty of his left knee.

The Intraoperative Nursing Record indicated Patient 43 was taken into OR 4 and anesthesia was started at 12:02 p.m. (3 minutes before surgery was completed on Patient 42). The surgery was started at 12:36 p.m., and completed at 2:03 p.m.

E5. Patient 44, a 62 year old male, was admitted to the facility with diagnoses that included DJD in his right knee. He was admitted for arthroplasty of his right knee.

The Intraoperative Nursing Record indicated Patient 44 was taken into OR 3 and anesthesia was started at 1:40 p.m. (23 minutes before surgery was completed on Patient 43). The surgery was started at 2:18 p.m., and completed at 3:45 p.m.

During an interview with the Surgery Department Chairman on February 27, 2014, at 2:40 p.m., the chairman stated if the practice of a patient being put to sleep under general anesthesia before a surgeon completed his previous case was going on in the OR, "That's a problem." The Chairman stated he had not been involved in this issue previously, but it needed to be addressed.

According to the Surgery Department Rules and Regulations, Section 9.3.1, The surgeon must be immediately available in the hospital prior to induction of anesthesia. Anesthesia will not be induced unless the surgeon's presence is confirmed.

MD 1 and MD 2 could not be immediately available and present for a patient about to undergo general anesthesia when they were performing surgery on another patient.

2. The credential file for PA 1 was reviewed on February 26, 2014. The file indicated PA 1 was granted privileges to perform medical services and procedures as a Surgical PA at the facility on May 30, 2012, under the supervision of a physician who was a member of the medical staff or pursuant to standardized procedures or protocols. The document indicated PA 1 would be responsible to the Surgical Specialties Section Chief, Department of Surgery Chair, and the President of the Medical Staff.

a. The credential file for PA 1 was reviewed on February 26, 2014. The file indicated MD 1 signed an agreement to supervise PA 1 in the performance of his AHP duties on February 6, 2012. (An AHP is a professional, other than a physician, who is educated, trained, and licensed/certified to provide services to patients).

The credential file for MD 1 was reviewed on February 26, 2014. The file indicated MD 1 did not have the option of requesting privileges to supervise a PA. There was no evidence MD 1 requested or was granted privileges to supervise PA 1.

The Medical Staff Bylaws were reviewed on February 26, 2014. According to the Bylaws, an AHP whose scope of practice does not allow independent practice must apply and qualify for a service authorization and must provide services under the supervision of an active medical staff member who has applied for, qualified for, and been granted specific privileges in accordance with the Medical Staff Bylaws, rules and regulations, to supervise and direct the exercise of service authorizations by the same category of AHP as that of the applicant.

During an interview with the Director of Medical Staff on February 26, 2014, at 9:30 a.m., the director stated MD 1 did not have privileges specific to supervision of a PA. The director stated they did not have the option of requesting or granting specific privileges for supervising a PA, "anymore."

b. The credential file for PA 1 was reviewed on February 26, 2014. The file indicated PA 1 was granted privileges for, "Surgical Assisting (first or second surgical assist under the supervision of the supervising physician)." There was no definition of the level of supervision required for the PA when he was acting as a first assistant.

During an interview with the Director of Medical Staff on February 26, 2014, at 9:30 a.m., the director stated, "under the supervision of the supervising physician," meant direct supervision was required. The director stated the surgeon must be present, and could not leave the room during a surgical procedure and let the PA finish or close the case.

During an interview with PA 1 on February 26, 2014, at 1:30 p.m., PA 1 stated he worked with two different surgeons who alternated back and forth between rooms, MD 1 and MD 3. The PA stated when he worked with MD 1, the MD routinely left before the case was completed, and PA 1 would close the skin, staple the skin, and apply bandages to the patient. PA 1 stated MD 1 did this so he could move to the next OR and start on the next case. PA 1 stated when he worked with MD 3, the surgeon did not leave him to close.

According to CCR 1399.541, the medical services that may be performed by a PA include the following:

(i) (1) Perform surgical procedures without the personal presence of the supervising physician which are customarily performed under local anesthesia. All other surgical procedures requiring other forms of anesthesia may be performed by a physician assistant only in the personal presence of an approved supervising physician; and,

(2) A physician assistant may also act as first or second assistant in surgery under the supervision of an approved supervising physician.

c. The facility AHP Rules and Regulations were reviewed on February 26, 2014. According to the Rules and Regulations, Section 8.6.7 - Supervision, the designated supervising physician must prepare and submit to the Medical Staff Services written, practice specific, formulary and practice protocols/standardized procedures (as appropriate) for review and approval by the IDPC, MEC, and Governing Board.

During an interview with the Director of Medical Staff on February 26, 2014, the director stated no protocols for the PA practice had been submitted for review. She stated, "they don't do that."

d. The credential file for PA 1 was reviewed on February 26, 2014. The file did not contain evidence of a Delegation of Services Agreement between himself and his supervising physician.

During an interview with the Director of Medical Staff on February 26, 2014, at 9:30 a.m., the director stated there was no requirement for a written delegation of services agreement for a PA to receive privileges to practice in the facility.

According to CCR Section 1399.545(e), A physician assistant and his or her supervising physician shall establish in writing guidelines for the adequate supervision of the physician assistant...

The request for privileges document completed by PA 1 on February 3, 2012, was reviewed on February 26, 2014. The document included a column for PA 1 to select those privileges he was requesting, and a column for identifying the privileges that were recommended to be granted. The document indicated all of the requested privileges had been granted, but there was no name or signature of the individual or committee that recommended granting the privileges.

PAs were granted privileges to perform medical services and procedures without meeting Medical Staff Bylaws, Rules and Regulations, and regulatory requirements.

3. The Surgery Department Rules and Regulations were reviewed on February 26, 2014. The rules and regulations indicated operative reports should be dictated immediately after completion of the procedure.

Intraoperative records and operative reports were reviewed on February 26 and 27, 2014, for patients who had procedures performed by MD 1. The records indicated the following:

a. Patient 12, a 42 year old female, underwent gastric bypass surgery on January 20, 2014. The record indicated the surgery was completed at 11:18 a.m., and the operative report was dictated by the surgeon at 12:57 p.m. (one hour and 39 minutes after the procedure was completed);

b. Patient 35, a 44 year old female, underwent gastric bypass surgery on February 5, 2014. The record indicated the surgery was completed at 10:15 a.m., and the operative report was dictated by the surgeon at 2:14 p.m. (three hours and 59 minutes after the procedure was completed);

c. Patient 36, a 42 year old female, underwent gastric bypass surgery on February 5, 2014. The record indicated the surgery was completed at 12:23 p.m., and the operative report was dictated by the surgeon at 6:18 p.m. (five hours and 55 minutes after the procedure was completed); and,

d. Patient 38, a 41 year old female, underwent gastric bypass surgery on February 5, 2014. The record indicated the surgery was completed at 4:36 p.m., and the operative report was dictated by the surgeon at 6:16 p.m. (1 hour and 40 minutes after the procedure was completed).

4. During an interview with Patient 11 on December 18, 2013, at 3:30 p.m., Patient 11 stated he was admitted to the facility on June 11, 2013, with complaints of recurrent abdominal pain. He stated he was taking Coumadin (a blood thinner) daily due to a previously diagnosed arterial clot. Patient 11 stated he was told he needed to have an ERCP, and he reminded the physician that he was on daily Coumadin and concerned about bleeding, but the physician chose to do the procedure anyway. Patient 11 stated he ended up hemorrhaging and went into a coma, and he was transferred to the ICU and placed on a ventilator (a machine used to assist in breathing adequately).

The record for Patient 11 was reviewed on December 19, 2013. Patient 11, a 73 year old male, was admitted to the facility on June 17, 2013, with recurrent abdominal pain. His diagnoses included elevated liver function tests and pancreatitis. His current medication list on admission indicated he was taking Coumadin daily.

A review of the physician's orders indicated the following:

a. On June 17, 2013, at 8:05 p.m., the nurse noted the INR (a laboratory value used to determine the clotting tendency of blood - normal value is 1.0) was 2.3 (meaning it would take Patient 11 almost two and a half times longer than normal to develop a clot if he was to start bleeding). The physician ordered the Coumadin to be continued and given daily.

b. On June 18, 2013, at 6:30 a.m., the physician ordered the nurses to keep giving the Coumadin;

c. On June 18, 2013, at 8 a.m., the physician ordered the nurses to stop giving the Coumadin;

d. On June 18, 2013, the physician ordered the nurses to obtain consent for an ERCP to be performed by the GI physician (MD 5); and,

e. On June 18, 2013, at 9:21 p.m. (the night before the ERCP was performed), the nurse noted the INR was 2.8 (higher than the previous one) and the PT (a second laboratory value used to determine the clotting tendency of the blood - normal value is 8.8 to 10.5) was 27.7 (two and a half times normal). The physician ordered the nurses to give two units of FFP (fresh frozen plasma - a product that contains clotting factors in an attempt to reverse the effects of Coumadin), then recheck the PT and INR in the morning.

A review of the Physician's Progress Notes indicated the following:

a. On June 18, 2013, the primary physician's plan was to have an ERCP performed, and then do surgery to remove the gall bladder;

b. On June 18, 2013, at 1 p.m. (the day before the ERCP was performed), the GI consult indicated the pancreatic enzymes were normal, there was no sign of infection, and the physician noted the elevated INR. The plan was to have an ERCP scheduled to be performed by a GI physician;

c. On June 19, 2013 (the day the ERCP was performed), the primary physician's plan was still to have an ERCP followed by removal of the gall bladder;

d. On June 19, 2013, at 9:20 a.m. (after performing the ERCP), the GI physician (MD 5) documented the ERCP was completed and a stone was removed. MD 5 indicated Patient 11 had diverticulitis, and during the procedure he enlarged the opening of the sphincter (opening of the gall bladder duct), with, "significant oozing (of blood) encountered." MD 5 had a plan to check laboratory values every six hours to determine the presence or absence of bleeding, as well as to continue monitoring the INR; and,

e. On June 19, 2013, at 3:15 p.m., Patient 11 suffered a GI bleed after the ERCP and had to be transferred to ICU and intubated (a breathing tube was inserted into his trachea to provide an airway and assist in breathing). The physician noted the INR was 2.5 (two and one half times normal).

A review of the Lab Summary indicated on June 19, 2013, at 5:33 a.m. (the morning the ERCP was scheduled to be performed), the PT was 14.8 and the INR was 1.5 (indicating it would take Patient one and one half times longer to develop a clot if he started to bleed).

A review of the Nursing Narrative Notes indicated the following:

a. The primary care physician was notified of the initial increased INR on June 18, 2013 (the night before the ERCP was performed);

b. Patient 11 had received two units of FFP by 2:30 a.m., on June 19, 2013 (the morning the ERCP was scheduled - and three hours before the [repeat] elevated PT/INR results were obtained);

c. On June 19, 2013, the nurse caring for the Patient 11 asked the unit secretary to call the GI lab in the morning to inquire about whether the procedure was going to be done as scheduled;

d. On June 19, 2013, at 7 a.m., the nurse caring for Patient 11 received confirmation that Patient 11 was going to have the ERCP performed. The nurse informed the oncoming nurse during report to, "watch the patient's INR," as the primary physician would like for it to be observed.

A review of the Procedure/Sedation Record indicated the GI lab nurse (RN 6) made the GI physician (MD 5) aware of Patient 11's PT/INR values prior to the procedure starting.

A review of the Procedure Note indicated there was, "active oozing," at the site where the opening to the common bile duct was made, and a large clot formed after failed attempts to prevent further bleeding. MD 5 noted, "the patient tolerated the procedure with complications of post sphincterotomy bleeding, resulting in a large clot formation."

Further review of the Narrative Nursing Notes dated June 19, 2013, indicated the following:

a. Patient 11 returned from the GI lab at 10:30 a.m.;

b. At 1 p.m., his BP (blood pressure) had dropped to 88/62 (normal value - 120/80);

c. At 1:25 p.m., a fluid bolus (rapid infusion of IV [intravenous] fluids) was being given, and the BP was not improving;

d. At 2:10 p.m., Patient 11 had blood on his pajamas and a watery, bloody bowel movement;

e. 2:18 p.m., a rapid response (emergency team) was called due to a large amount of bleeding from the rectum and the patient was vomiting blood;

f. At 3 p.m., Patient 11 was in the ICU, receiving rapid fluids, intubated (a tube was put into his trachea to assist in delivering oxygen to the lungs) and on a ventilator (a machine to assist in breathing); and,

g. Patient 11 remained in the ICU for several days requiring medications to support his BP and a ventilator to assist his breathing.

During an interview with RN 3 (a GI lab nurse) on February 24, 2014, at 3:40 p.m., the nurse stated they always checked lab values, and paid particular attention to the PT/INR because if they were elevated there was an increased risk of bleeding. RN 3 stated when the PT/INR were elevated, the nurses would notify the physician, and the physician, "very rarely, almost never," proceeded with the procedure unless it was an emergency with the patient actively bleeding. RN 3 stated an ERCP was, "the most invasive procedure we do," actually cutting the sphincter (opening of the common bile duct) with a wire-type cautery.

During a concurrent interview with the (ADQ) Assistant Director of Quality and the Quality Analyst on February 27, 2014, at 10:10 a.m., the ADQ stated the Quality Department did not learn about this case through reporting of surgical complications (an indicator that was tracked by the organization), "because nobody reported it to us." The analyst stated she received the case for review as a code blue because a rapid response was called. The analyst stated she forwarded the case for peer review, and she typed up a summary of the patient's stay along with the request for review. The analyst stated she did not notice the abnormal lab values prior to the procedure, so she did not include that in the summary. She stated the request for review included the question, "Could complication have been prevented?" She stated the review came back with a decision of, "Care was found to be appropriate after chart review." The DQS stated the physician who did the review was MD 6 (an individual), a FP (family practice) physician. He stated the GI physicians were part of the department of medicine, and medicine and FP could, "cross review," each other's cases, so it was OK for a FP physician to review the record regarding a GI procedure.

The Medical Staff General Policies were reviewed on February 27, 2014. The policy regarding OPPE (Ongoing Practitioner Performance Evaluation) indicated, "If the event or issue which is the basis of the focused review involves a technical aspect of clinical performance or clinical judgement, then the review committee shall also include practitioners who possess such technical skills and knowledge. If such practitioners are not available on the medical staff, then outside peer review consultants may be retained by the medical staff to assist in peer review activities." The policy indicated the medical staff committee reviewing the event would determine whether or not an opportunity to improve care existed, and determine the nature of the further evaluation.

The case was reviewed by an individual (not a committee), by a FP physician (not a physician with the same level of technical skills and knowledge), and not in accordance with the facility OPPE policy regarding peer review.

5. During an interview with Patient 11 on December 18, 2013, at 3:30 p.m., Patient 11 stated he was getting ready to be discharged from the hospital after staying in there for several days, and the nurse who discontinued his foley catheter did not remove the fluid from the ba

Based on observation, interview, and record review, the facility failed to ensure it provided an organized nursing service to all patients by failing:

1. To ensure delivery of safe care, in accordance with nursing standards of practice for removing a Foley catheter (tube inserted into the bladder to drain urine), by one RN (RN 5) when he inserted fluid into the balloon of the catheter (instead of removing fluid) while discontinuing the catheter on Patient 11. This failed practice resulted in bleeding from the urethra (tube that drains urine from the bladder so one can urinate), and the potential for increased bleeding, need for additional medical services, and prolonged hospital stay. (Refer to A385);

2. To ensure contracted Registered Nurses providing dialysis services through a contracted agency, had valid and current licenses, resulting in the potential for unlicensed persons providing nursing care to dialysis patients. (Refer to A394);

3. To ensure one sampled patient (Patient 31) was weighed according to physician's orders and abnormal laboratory results were reported to the physician performing invasive procedures for three patients (Patient 45, 48, and 51). These failures had the potential to delay treatment changes for Patient 31 and placed Patients 45, 48, and 51 at risk for surgical complications. (Refer to A395);

4. To ensure one of three special procedures nurses (RN1) demonstrated competence in PICC line (peripherally inserted central catheter) insertion prior to inserting a PICC line into Patient 11. This failure resulted in the insertion of a line into Patient 11's artery instead of a vein, formation of a hematoma at the insertion site, development of an arterial clot in the extremity, and the need to take coumadin (a blood thinner) to prevent development of additional clots. (Refer to A397);

5. To ensure contracted dialysis nurses followed policies and procedures for obtaining a Hepatitis B Surface Antigen status on two patients (Patient 10 and 33) prior to starting hemodialysis; and, cleaning and disinfecting one dialysis machine (181033) with bleach after the machine was used on patients with an unknown Hepatitis B status. These failures had the potential to result in the transmission of Hepatitis B from one patient to another. (Refer to A398); and

6. To ensure medications were given as ordered by the physician to one of one patient receiving sedation (Patient 20) when the ICU (Intensive Care Unit) nurses administered sedation to keep the patient at a Ramsay score of 4 or 5 for multiple hours and days. This failed practice resulted in the potential for over sedation of the patient which could result in patient harm or death.(Refer to A405).

The cumulative effects of these systemic problems resulted in the failure of the nursing department to ensure care was being provided in a safe and effective manner.





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Findings:

During an interview with Patient 11 on December 18, 2013, at 3:30 p.m., Patient 11 stated he was getting ready to be discharged from the hospital after staying in there for several days, and the nurse who discontinued his Foley catheter did not remove the fluid from the balloon (that was holding it in place) before pulling it out.

According to the Lippincott Manual of Nursing Practice, when removing a Foley catheter, the balloon attached to the catheter should be deflated using negative pressure as follows:

1. Exercise the plunger of a leur-tipped syringe by moving up and down within the syringe barrel;

2. Pull back 0.5 ml air in the syringe to prevent adherence of the plunger to the end of the syringe barrel, then insert the syringe into the balloon port. (This allows for automatic flow of instilled liquid and balloon deflation via negative pressure in the syringe);

3. Use gentle aspiration, only if needed, to encourage deflation; and

4. Allow the pressure within the balloon to push the plunger back and fill the syringe with water.

To remove the Foley catheter, the balloon must be deflated. To deflate the balloon, fluid must be removed from the balloon, not added to the balloon, as RN 5 did.

Increasing the fluid in the Foley catheter balloon increased the risk of injury for Patient 11 by increasing the probability of tearing the patient's urethra during the removal of the Foley. As a result, the patient did experience bleeding from the urethra, required additional medical services, and prolonged Patient 11's hospital stay.

Based on interview and record review, the nursing service failed to ensure each Registered Nurse (RN) providing dialysis services through a contracted agency had a valid and current license, resulting in the potential for unlicensed persons to provide nursing care to dialysis patients.

Findings:

The record for Patient 10 was reviewed on February 25, 2014. Patient 10 was admitted to the facility on February 22, 2014, with diagnoses that included end-stage renal disease (loss of kidney function) on hemodialysis (removal of waste products and free water from the blood when the kidneys are not functioning). The record contained two documents completed by the contracted dialysis nurses. Patient 10 underwent hemodialysis on February 22, and 25, 2014.

During an interview with the Director of the Medical Surgical Unit (DMS), on February 25, 2014, at 2:40 p.m., the DMS stated the dialysis nurses underwent license verification before they began working at the facility. The DMS stated the dialysis nurses did not have to sign in, they just obtained the key for the supply room and the medications needed for each patient.

During an interview with Staff Coordinator (SC) 1 on February 25, 2014, at 3:30 p.m., SC 1 stated the staffing office was open 24 hours per day. SC 1 stated the hemodialysis nurses signed-in on the form, but the SC does not check the name to ensure the staff member was pre-verified by the facility. SC 1 stated SC 1 reviewed the dialysis nurse sign-in sheet for the week begining February 23, 2014, and was unable to read the three names on the form. SC 1 stated the process for registry personnel (temporary nurses sent to a floor or unit) was different, "we check to see that everything is current, we don't let them work if their CPR (cardiopulmonary resuscitation) or license was not up to date."

During an interview with the Chief Nursing Officer (CNO), on February 25, 2014, at 4 p.m., the CNO stated the facility had a new contracted agency for dialysis.

On February 26, 2014, at 1:50 p.m., Hemodialysis Registered Nurse 1 (HDRN) was interviewed. HDRN 1 stated he signed-in in the staffing office prior to going to a patient room.

During an interview with Staffing Coordinator 2, on February 26, 2014, at 2 p.m., SC 2 stated the dialysis nurses signed in on the log, but no other verification was completed. SC 2 stated she made sure the dialysis nurse had a badge, but she did not verify any other information. SC 2 stted when a registry nurse came to the facility they could check the nurses' files, or review the computer for the nurses competencies, but they did not have any information related to HDRN's licensure or competencies, in the staffing office. SC 2 stated the sign-in sheets were used to track the HDRNs' time for billing.

During an interview with the CNO, on February 27, 2014, at 10:30 a.m., the CNO stated the contracted agency had submitted paperwork for the dialysis nurses, but the information was not kept in the staffing office. The CNO agreed a HDRN could enter the building and perform care without license verification and evidence of competencies.

The facility policy and procedure titled "Utilization of Outside Sources for Nursing Personnel," with a last revised date of May 2009, was reviewed. The policy indicated its purpose was to "Maintain quality and continuity of patient care and to provide guidelines for the utilization of temporary agency nursing personnel." The procedure indicated "the agency providing temporary personnel will be expected to provide evidence of current nursing clinical competence for each prospective temporary person. BLS [Basic Life Support -cardiopulmonary resuscitation] and RN [Registered Nurse] licensure will be verified before employment."

Based on observation, interview, and record review, the facility failed to ensure the registered nurse supervised and evaluated the nursing care for four of 67 sampled patients by failing to:

1. Ensure abnormal laboratory results were reported to the physician performing invasive procedures for three patients (Patient 48, 45, and 51), resulting in an increased risk of procedure complications due to bleeding.

2. Ensure physician's orders for a weekly weight was implemented as ordered for Patient 31. This failure had the potential to delay recognition of Patient 31's weight loss or gain and delay physician changes to the patient's treatment.

Findings:

1a. On February 26, 2014, at 2:30 p.m., a review was conducted of Patient 48's record. Patient 48, an inpatient at the facility, was a 19 year old with a medical history of thrombocytopenia (low platelet count) and duodenal atresia (the congenital absence or complete closure of a portion of the lumen of the duodenum). The record indicated Patient 48 presented to the emergency room with complaints of episodes of vomiting blood, on April 7, 2013.

A documented titled, "GI Procedure," indicated the patient had an esophagogastroduodenoscopy with biopsy (is known as an upper endoscopy that is performed to view the esophagus, stomach, and duodenum and biopsy-tissue sample taken to be viewed under the microscope) as in inpatient procedure, on April 14, 2013.

A document titled, "The Preoperative Surgical/Procedure Checklist," and subtitled, "Preoperative Workup," dated April 13, 2013, did not indicate on the document that the physician who performed the procedure was notified of abnormal lab results (platelet count) prior to the procedure.

A review of Patient 48's laboratory results indicated on April 14, 2013, she had the following abnormal laboratory results:

-platelet count 61 L Reference range 142-424 X10*3/UL.

A review of Patient 48's "Post Procedure Note," indicated the following diagnosis:

"Hematemesis (bloody emesis) likely related to erosive gastroduodenitis (stress ulcer in the duodenum), exacerbated by thrombocytopenia...changes related to gastroesophageal reflux disease. Possible Barrett esophagus (Barrett's esophagus is a disorder in which the lining of the esophagus is damaged by stomach acid. The lining becomes similar to that of the stomach), status post biopsy. Erosive gastroduodenities of unclear etiology, possibly related to nonsteroidal anti-inflammatory drugs, aspirin use versus Helicobacter pylori (a bacterium that causes chronic inflammation of the inner lining of the stomach).

The registered nurse's failure to follow up on abnormal labs, and record in the medical record as well as notifying the physician about the abnormal lab results, placed the patient at increased risk for blood loss.

1b. On February 26, 2014, a review was done of Patient 45's record. Patient 45 was a 53 year old,outpatient, with a history of esophageal stricture with recurrent dysphagia (difficulty swallowing).

The record indicated on a document titled, "GI Procedure," dated February 13, 2013, the Patient 45 had an esophagogastroduodenoscopy with biopsy and balloon dilation (to create a larger opening) due to the patient's history of esophageal stricture (narrowing) with recurrent dysphagia (difficulty swallowing).

A document titled, "The Preoperative Surgical/Procedure Checklist," and subtitled "Preoperative Workup," indicated the area on the form for lab results was marked as "none" and dated February 13, 2013.

Patient 45's record included a fax cover sheet, dated February 11, 2013, with the following comment, "labs faxed." No laboratory findings were seen in the record.

On a form titled, "Exam: GI Procedure Report," the patient's findings included; diffuse esophagitis, status post biopsy, distal esophageal stricture, unable to pass adult EGD scope, traversed after dilation up to 11 millimeters, and small hiatal hernia.

1c. On February 27, 2014, a review was done of Patient 51's record. Patient 51, initially an outpatient, was admitted as an inpatient post procedure due to intractable nausea and vomiting. Patient 51 was a 48 year old with a history of obstructive jaundice post cholecystectomy (gallbladder removal, with possible stones blocking the duct not allowing bile fluids to flow freely).

The record included a form titled, "GI Procedure," which indicated the patient had endoscopic retrograde cholangiopancreatography with precut sphincterotomy and stone extraction (laparoscopic surgery done to remove the obstructing stone in the duct and cutting into the sphincter muscle to relieve the stone).

A review of a document titled, "The Preoperative Surgical/Procedure Checklist," and subtitled "Preoperative Workup," indicated the area to document labs was unmarked. The form was dated April 13, 2013.

On February 27, 2014, a review of the laboratory values in Patient 51's record, dated February 13, 2013 indicated the following results:

"Hematology

Hgb (hemoglobin-the molecule in blood cells that carry oxygen)
Hgb 12.5 L - Reference range 14.1-18.1 G/DL

Protime( PT-test measures clotting of plasma/liquid in the blood)
PT 10.7 H - Reference range 8.8-10.5 seconds

INR-Formal name: Prothrombin Time and International Normalized Ratio
(are used to monitor the effectiveness of the anticoagulant warfarin)
INR Therapy 1.1 H - Reference range .9-1.0"

The Preoperative Surgical/Procedure Checklist, did not include documentation to indicate the physician who performed the procedure was notified of Patient 51's abnormal lab results ( Hgb, Protime, and INR therapy results), prior to the procedure.

In an interview with Registered Nurse 3, on February 24, 2014, at 3:43 p.m., she stated that if the patient had abnormal lab values the nurse should,"Notify the doctor."

A review of the facility document titled, "Preoperative Care", indicated the following;

"Responsibility: All Nursing
Purpose: To provide guideline for pre-operative care.
1. Policy
PRE-OP
1.3 Confirm that the results of all ordered lab, x-rays and EKG are on the chart. Notify physician of abnormalities or pending results."

The failed practice of the registered nurse to properly evaluate and supervise Patient 51 had the potential to place the patient at risk for cardiovascular compromise, missed lesions, bleeding, infection perforation and potential death.



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2. On February 25, 2014, at 2:45 p.m., Patient 31 was observed in a bed in the Definitive Observation Unit (DOU). Patient 31 was receiving enteral tube feedings (complete formula, containing protein, carbohydrate, fat, water, minerals and vitamins, infused directly into the stomach) via a pump.

The medical record for Patient 31 was reviewed on February 25, 2014. The patient was admitted to the hospital on February 10, 2014, with diagnoses including altered level of consciousness.

An "Adult Dietary Evaluation," dated February 21, 2014, indicated the patient weighed 159 pounds 13 ounces and was receiving enteral feeding at 75 ml (millimeter) per hour with minimal residuals (solution remaining in the stomach). The dietitian documented the patient was still experiencing watery stools, and was pending transfer to DOU. "No new pre-albumin lab. request was signed but not ordered, staff informed and will put in request." The dietitian indicated the patient was a "High Risk," and suggested tube feeding continue as tolerated, "ensure Pre-albumin lab is ordered...accurate weight."

An "Adult Dietary Evaluation," dated February 24, 2014, indicated the patient weighed 159 pounds 13 ounces. The nutrition diagnosis indicated Patient 31 had swallowing difficulties related to respiratory failure and dementia. Suggestions included: "Continue current feeding regimen and weigh the patient."

A "Nutrition Order," form dated February 21, 2014, indicated "Weekly Weights." The order was signed by Patient 31's physician on February 22, 2014, with a check mark in the box : "I concur with the above recommendations, initiate as my orders."

During an interview with the DOU Monitor Technician (MT), on February 25, 2014, at 3 p.m., the MT stated once the Nutrition Order form was signed it was considered a physician order and it should be followed.

During an interview with Charge Nurse 5, on February 25, 2014, at 3 p.m., the Charge Nurse was unable to find documentation of Patient 31's weight after the initial weight done on admission. The Charge Nurse stated the DOU beds did not have bed scales and the patient was transferred to DOU on February 21, 2014. The Charge Nurse stated the physician's order to weigh the patient should be followed.

The patient went unweighed since his initial admission weight. Patient 31 was not weighed on February 21, 22, 23, or 24, 2014, despite a physician order for weekly weights.

Based on interview and record review, the facility failed to ensure one of three special procedures nurses (RN1) demonstrated competence in PICC line (peripherally inserted central catheter) insertion prior to inserting a PICC line into Patient 11.

A PICC line is a form of IV (intravenous) access that can be used for a prolonged period of time. It is inserted into a vein (not an artery) in the arm, and then advanced through increasing larger veins (not arteries), toward the heart until the tip rests in the distal superior vena cava or cavoatrial joint (above the right atrium of the heart). According to the Cleveland Clinic, during insertion of a PICC, accidental puncture of an artery, nerve, or tendon, can occur near the insertion site. However this is a rare occurrence.

This failed practice resulted in insertion of the line into an artery instead of a vein, formation of a hematoma at the insertion site, development of an arterial clot in the extremity, and the need for Patient 11 to take coumadin (a blood thinner) to prevent the development of additional clots.

Findings:

During an interview with Patient 11 on December 18, 2013, at 3:30 p.m., Patient 11 stated he went to the facility on May 5, 2013, with abdominal pain, and was diagnosed with an infection. Patient 11 stated he had a PICC line inserted, and as the nurse attempted to insert it, his vein was, "broken," and he suffered an, "enormous," blood loss. Patient 11 stated he went to an Urgent Care on May 22, 2013, with weakness, dizziness, and shortness of breath, and a CT (computerized tomography - a type of x-ray test) scan found he had a blood clot in his right shoulder area due to the broken vein caused by the PICC line.

The record for Patient 11 was reviewed on December 19, 2013. Patient 11, a 73 year old male, was admitted to the facility on May 5, 2013, with complaints of recurrent abdominal pain. His diagnoses included diverticulitis (formation of pouches in the wall of the colon) and pancreatitis (inflammation of the pancreas).

A review of the laboratory values indicated Patient 11 had elevated pancreatic enzymes, elevated liver function tests, and normal blood clotting factors.

A review of the current list of medications indicated Patient 11 was not taking coumadin (a blood thinner).

A radiology order requisition, dated May 8, 2013, indicated the physician ordered a PICC line to be inserted so IV antibiotics could be given after discharge home.

The PICC documentation record, dated May 8, 2013, completed by RN 4, indicated prior to the procedure, Patient 11 was educated regarding the potential for complications, including infection, deep vein thrombosis (a clot in the vein), and phlebitis (inflammation of the vein). The record indicated at 5:30 p.m., there was an, "inadvertent," arterial (artery, not vein) puncture in the right arm. The record indicated the introducer (a sheath that the PICC line is inserted through) that was inserted into the artery was removed, pressure was applied, and the nurse noted a hematoma formation (a semisolid mass of blood in the tissues caused by injury to the vessel) on the right arm. The record indicated a second attempt was made, and a PICC line was inserted successfully into the left arm. There was no evidence the "inadvertent" arterial puncture with development of a hematoma was reported to the physician.

The medical record indicated Patient 11 was discharged home on May 8, 2013, with the left arm PICC line in place for long term antibiotic therapy.

During an interview with RN 4 (a special procedures nurse certified to insert PICC lines documented the events in the PICC documentation record) on December 19, 2013, at 10:30 a.m., the RN stated an order was received on May 8, 2013, to insert a PICC line in Patient 11, who was being discharged home, for home antibiotic therapy. RN 4 stated prior to him inserting the PICC line in the left arm successfully, a different nurse (RN 1) had attempted to insert the initial PICC line and ended up doing an arterial stick. RN 4 stated he was with RN 1 as the, "backup," and was proctoring RN 1, as she had not yet inserted her required number of PICC lines (10) successfully to deem her competent. RN 4 stated RN 1 prepped the patient and selected a site for insertion. RN 4 stated he agreed with the selection of the site, then left to see another patient. RN 4 stated RN 1 realized she was in the artery when she placed the introducer sheath. He stated the patient developed a hematoma, and he assisted RN 1 in determining presence of circulation and sensation distal to (below) the puncture site. RN 4 stated, "It was an inadvertent arterial stick," and he documented it in the record. RN 4 stated he did not report the incident to the physician.

Patient 11 was readmitted to the facility on June 17, 2013, with recurrent abdominal pain. A review of the current medication list on admission indicated the patient was now taking Coumadin 2.5 mg every day (a blood thinner used to prevent new clots from forming).

The Qualification Skills Checklist (for documenting proctoring to determine competency) for RN 1 was reviewed on December 20, 2013. The document indicated RN 1 was proctored inserting PICC lines one time on May 1, 2013, and two times on May 8, 2013 (prior to attempting the insertion on Patient 11). RN 1 inserted three PICC lines successfully (instead of the required 10) before she was left to insert the PICC line on Patient 11 by herself, and a complication resulted.

Based on observation, interview, and record review, the facility failed to ensure contracted dialysis nurses followed policies and procedures for:

1. Obtaining the Hepatitis B Surface Antigen status on two patients (Patient 10 and 33) prior to starting hemodialysis; and,

2. Cleaning and disinfecting one dialysis machine (181033) with bleach after the machine was used on patients with an unknown Hepatitis B status.

These failures had the potential to result in the transmission of Hepatitis B from one patient to another.

Findings:

The "Acute Dialysis Services Agreement," dated December 3, 2013, was reviewed. The policy indicated it's effective date was January 1, 2014, and, "Contractor will be responsible for and, shall furnish qualified nursing staff to perform dialysis care services necessary...All Services provided pursuant to this agreement shall be performed in compliance with all applicable standards set forth by law or ordinance or established by the rules and regulations of any federal, state, or local agency, department, commission, association or other pertinent governing accrediting, or advisory body, including the Joint Commission..."

The Centers for Disease Control (CDC) indicated chronic hemodialysis patients are at high risk for infection because the process of hemodialysis required vascular access for prolonged periods. In an environment where multiple patients received dialysis concurrently, repeated opportunities existed for person-to-person transmission of infectious agents, directly or indirectly via contaminated devices, equipment and supplies, environmental surfaces, or hands of personnel.

Hepatitis B is an infectious inflammatory illness of the liver caused by the hepatitis B virus (HBV). According to the CDC, preventing the transmission of HBV depended on timely detection of a patient converting from HBV- (HbsAG-negative) to HBV + (HbsAG-positive) and rapid implementation of isolation procedures before cross-contamination occured.

1a. The record for Patient 10 was reviewed on February 25, 2014. Patient 10 was admitted to the facility on February 22, 2014, with diagnoses that included end-stage renal disease (loss of kidney function) on hemodialysis (removal of waste products and free water from the blood when the kidneys are not functioning). The record contained two documents completed by the contracted dialysis nurses. The following was noted:

-On February 22, 2014, Patient 10 underwent dialysis from 2:38 p.m., to 6:05 p.m., using one of the dialysis unit's dialysis machines. (The serial number or machine number could not be determined from the documentation on the form). In the section for "Predialysis Chemistries," the patient's Hepatitis B Surface Antigen (HbsAG) was documented as unknown. (Hepatitis B is caused by the hepatitis B virus. It is spread through contact with the blood and body fluids of an infected person. A positive HbsAG would indicate the patient was positive for Hepatitis B).

-On February 25, 2014, Patient 10 underwent dialysis with machine "181207." Patient 10's HbsAG status was listed as unknown.

During an interview with Hemodialysis Registered Nurse (HDRN) 1, on February 26, 2014, at 1:50 p.m., HDRN 1 stated, due to the potential for blood splatter, he wore personal protective equipment including a gown and gloves during each dialysis treatment. HDRN 1 stated, prior to starting dialysis, he evaluated each patients' Hepatitis status. If the status was unavailable in the record, the HDRN "could" contact the patients' outside unit or the patients' physician. The HDRN stated dialysis "could" be performed on a patient with an "unknown status," and it was up to the "nurse's discretion to ask for a physician's order for a Hepatitis panel (to determine a patient's hepatitis status)." HDRN 1 stated he had not obtained a Hepatitis status on Patient 10 prior to starting dialysis.

b. The record for Patient 33 was reviewed on February 26, 2014. Patient 33 was admitted to the facility on January 16, 2014, with diagnoses that included urospesis (a condition occurring after the microorganisms that cause a urinary tract infection spread to the bloodstream). Hemodialysis was started on Patient 33 on January 19, 2014. Patient 33's HbsAG status was listed as unknown on January 19, and 20, 2014. On January 22, 2014, the patient's status was identified as "positive." On January 25, 2014, Patient 33 was identified as Hepatitis C positive.

During an interview with the Infection Preventionist (IP), on February 27, 2014, at 2 p.m., the IP stated most of the dialysis patients were chronic and had Hepatitis status available. The IP stated, if the status was unknown, the dialysis machine required cleaning similar to the cleaning used for Hepatitis B positive patients. The IP stated he was in the process of evaluating the care provided by this contracted service, but had not conducted a review yet.

A policy and procedure manual located in the dialysis supply room was reviewed. Included in the manual was a policy titled "Hepatitis Screening Policy," with a last reviewed/revised date of April 18, 2013. The policy indicated: "...all patients should have their Hepatitis status known before treatment is initiated." According to the procedures: "Nurses will have to call the nephrologists for the hepatitis information for the first time dialysis in the hospital. If it is not known, then the nurse should get an order for the following tests: HBSAG (Hepatitis B surface antigen)..." The policy also indicated: "In exceptional instances when the hepatitis status is not known, then the machine will have to be chemically disinfected after use. The RN will make sure to resolve the problem so that the results are known for the benefit of the succeeding treatments."

The contracted dialysis nurse failed to follow policy and procedures to evaluate their patients' Hepatitis status prior to initiating dialysis for two patients, and failed to have the status available for the succeeding treatment nurse.

2. On February 26, 2014, the dialysis supply room was observed. Four Fresenius dialysis machines were stored in the room, along with other dialysis supplies. Each of the dialysis machines had an attached log titled "Hemodialysis Machine Operation and Disinfection Log."

The logs were machine specific and included areas to document the date, time, patient treatment, operator's names and other information about the machines' use and cleaning.

The log for machine 181033 was reviewed. The log included documentation that indicated the machine was used for a patient with an unknown Hepatitis status on January 31, February 2, 3, and 4, 2014. The documentation on the log indicated the machine was not treated with bleach on those days.

During an interview with Hemodialysis Registered Nurse (HDRN) 1, on February 26, 2014, at 1:50 p.m., HDRN 1 stated, when the patients' Hepatitis status was unknown, the machine would be bleached, like a machine used on Hepatitis B positive patients.

A policy and procedure manual located in the dialysis supply room was reviewed. Included in the manual was a policy titled "Hemodialysis Infection Control Guidelines," with a last reviewed/revised date of April 18, 2013. This policy indicated: "...The dialysis machine will be cleaned with bleach after each use and vinegar rinsed....The same machine will be used on all known Hepatitis B Surface antigen (HBsAG) positive patients. All recommended control measures for Hepatitis B are followed and all disposable supplies and accessories are used for one patient only..."

A second policy titled "Hemodialysis Infection Control Guidelines," with a last reviewed/revised date of April 18, 2013, was reviewed. The policy indicated: "... Likewise, if the machine was used by a Hepatitis positive patient or unknown hepatitis status, chemical disinfection must be done at the end of treatment. The same machine must NOT be used for another patient. At the day of discharge, the machine will be chemically disinfected; externally disinfected, tagged and Biomed technician must be notified..."

During an interview with the Infection Preventionist (IP), on February 27, 2014, at 2 p.m., the IP stated the HDRN must use bleach in the dialysis machine after use for a Hepatitis B positive or unknown status patient. The IP reviewed the log for machine 181033 and verified there were days when the patients' status was unknown and the machine was not bleached. The IP stated he was developing a checklist to evaluate the care provided by the agency, but had not instituted it yet.

Based on observation, interview and record review, the facility failed to ensure medications were given as ordered by the physician to one of one patient receiving sedation (Patient 20) when the ICU (Intensive Care Unit) nurses administered sedation to keep the patient at a Ramsay score of 4 or 5 for multiple hours and days. This failed practice resulted in the potential for over sedation of the patient resulting in patient harm or death.

Findings:

The RSS (Ramsay Sedation Scale) is used to assess and monitor the level of sedation in a patient to ensure appropriate management of the patient on a ventilator.

The RSS measures sedation as follows:

1 - Patient is anxious and
agitated or restless, or both;

2 - Patient is co-operative, oriented, and tranquil;

3 - Patient is asleep, and responds to commands only;

4 - Paient is asleep, and exhibits brisk response to light glabellar tap or loud auditory stimulus;

5 - Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus; and,

6 - Patient exhibits no response to stimulus.

The goal is to keep the patient at a level of sedation that allows him/her to tolerate the physical environment, and the unpleasant procedures and therapies that are necessary in the ICU, decreasing oxygen requirements, avoiding self-extubation (pulling out the breathing tube), and inadvertent removal of catheters and other life dependency equipment.

Oversedation results in the prolonged need for ventilatory assistance, a more difficult weaning process (getting the patient off of the ventilator, the potential for ventilator associated pneumonia and an increase in morbidity and mortality.

During a tour of the ICU on February 25, 2014, at 10:20 a.m., Patient 20 was observed lying quietly in bed, on a ventilator, with IV (intravenous) Versed (medication used for continuous sedation) infusing.

The record for Patient 20 was reviewed on February 25, 2014. Patient 20, a 55 year old female, was admitted to the facility on January 13, 2014, with diagnoses that included respiratory insufficiency.

The record indicated on January 18, 2014, the patient was intubated (a breathing tube inserted into the trachea), and put on a ventilator (a breathing machine). The physician ordered Versed IV infusion, to be titrated (increased and decreased) to achieve a RSS of three (asleep, but responding to commands).

The ICU Flowsheet indicated from January 19, 2014, through February 20, 2014 (for 33 days), Patient 20 was kept sedated at a RSS of four to six, with the majority of the time at a RSS of five or six.

The ICU flowsheet indicated from February 21, 2014, until the time of survey (February 25, 2014 ]for five days]), Patient 20 was kept at a RSS of four.

During an interview with ICU RN 1, the RN stated when she documented the level of sedation Patient 20 was under, she selected the option (in the computer) that best described the patient. She stated she did not know what number on the RSS the description correlated with. She stated the old (paper) ICU flowsheet had the RSS number next to the descriptor, but the new (electronic form) did not.

ICU RN 1 was not aware Patient 20 was being over sedated.

Based on observation, interview, and record review, the facility failed to:

1. a. Maintain a system for controlling sources of infection in accordance with internal policies and procedures, nationally recognized infection control practices and guidelines, and applicable regulations, when the facility's contracted dialysis nurses failed to follow their policies and procedures titled "Hepatitis Screening Policy," and "Hemodialysis Infection Control Guidelines;"

1. b. Ensure contracted dialysis staff obtained Hepatitis B status for two patients (Patient 10 and 33) undergoing dialysis; and,

2. Clean one dialysis machine (181033) with bleach following use on a patient with an unknown Hepatitis status.

These failures had the potential to result in the transmission of Hepatitis B from one patient to another.

Findings:

The "Acute Dialysis Services Agreement," dated December 3, 2013, was reviewed. The policy indicated its effective date was January 1, 2014, and "Contractor will be responsible for and, shall furnish qualified nursing staff to perform dialysis care services necessary...All Services provided pursuant to this agreement shall be performed in compliance with all applicable standards set forth by law or ordinance or established by the rules and regulations of any federal, state, or local agency, department , commission, association or other pertinent governing accrediting, or advisory body, including the Joint Commission..."

The Centers for Disease Control (CDC) indicated chronic hemodialysis patients were at high risk for infection because the process of hemodialysis required vascular access for prolonged periods. In an environment where multiple patients received dialysis concurrently, repeated opportunities existed for person-to-person transmission of infectious agents, directly or indirectly via contaminated devices, equipment and supplies, environmental surfaces, or hands of personnel.

Hepatitis B is an infectious inflammatory illness of the liver caused by the hepatitis B virus (HBV). According to the CDC, preventing the transmission of HBV depended on timely detection of patient converting from HBV- (HbsAG-negative) to HBV + (HbsAG-positive) and rapid implementation of isolation procedures before cross-contamination occurred.

1 a. The record for Patient 10 was reviewed on February 25, 2014. Patient 10 was admitted to the facility on February 22, 2014, with diagnoses that included end-stage renal disease (loss of kidney function) on hemodialysis (removal of waste products and free water from the blood when the kidneys are not functioning). The record contained two documents completed by the contracted dialysis nurses, the following was noted:

-On February 22, 2014, Patient 10 underwent dialysis from 2:38 p.m., to 6:05 p.m., using one of the dialysis unit's dialysis machines. (The serial number or machine number could not be determined from the documentation on the form). In the section for "Predialysis Chemistries," the patient's Hepatitis B Surface Antigen (HbsAG) was unknown. (Hepatitis B is caused by the hepatitis B virus. It is spread through contact with the blood and body fluids of an infected person. A positive HbsAG would indicate the patient was positive for Hepatitis B).

-On February 25, 2014, Patient 10 underwent dialysis with machine "181207." Patient 10's HbsAG was listed as unknown.

During an interview with Hemodialysis Registered Nurse (HDRN) 1, on February 26, 2014, at 1:50 p.m., HDRN 1 stated, due to the potential for blood splatter he wore personal protective equipment including a gown and gloves during each dialysis treatment. HDRN 1 stated, prior to starting dialysis, he evaluated each patient's Hepatitis status. If the status was unavailable in the record, the HDRN "could" contact the patients' outside unit or the patients' physician. The HDRN stated dialysis "could" be performed on a patient with an "unknown status," and it was up to the "nurse's discretion to ask for a physician's order for a Hepatitis panel (to determine a patient's hepatitis status)." HDRN 1 stated he had not obtained a Hepatitis status on Patient 10 prior to starting dialysis.

b. The record for Patient 33 was reviewed on February 26, 2014. Patient 33 was admitted to the facility on January 16, 2014, with diagnoses that included urospesis (a condition occurring after the microorganisms that cause a urinary tract infection spread to the bloodstream). According to documentation in the record, hemodialysis was started on Patient 33 on January 19, 2014. Patient 33's HbsAG status was listed as unknown on January 19, and 20, 2014. On January 22, 2014, the patient's status was identified as "positive." On January 25, 2014, Patient 33 was identified as Hepatitis C positive.

During an interview with the Infection Preventionist (IP), on February 27, 2014, at 2 p.m., the IP stated most of the dialysis patients were chronic and had Hepatitis status available. The IP stated if the status was unknown, the dialysis machine required cleaning similar to the cleaning used for Hepatitis B positive patients. The IP stated he was in the process of evaluating the care provided by this contracted service, but had not conducted a review yet.

A policy and procedure manual located in the dialysis supply room was reviewed. Included in the manual was a policy titled "Hepatitis Screening Policy," with a last reviewed/revised date of April 18, 2013. The policy indicated: "...all patients should have their Hepatitis status known before treatment is initiated." According to the procedures: "Nurses will have to call the nephrologists for the hepatitis information for the first time dialysis in the hospital. If it is not known, then the nurse should get an order for the following tests: HBSAG (Hepatitis B surface antigen)..." The policy also indicated: "In exceptional instances when the hepatitis status is not known, then the machine will have to be chemically disinfected after use. The RN will make sure to resolve the problem so that the results are known for the benefit of the succeeding treatments."

Patient 10 and Patient 33 underwent two days of dialysis without the contracted dialysis nurse knowing the patients' Hepatitis status. The evidence showed the patients' status was not known prior to succeeding treatments.

2. On February 26, 2014, the dialysis supply room was observed. Four Fresenius dialysis machines were stored in the room, along with other dialysis supplies. Each of the dialysis machines had an attached log titled "Hemodialysis Machine Operation and Disinfection Log."

The logs were machine specific and included areas to document the date, time, patient treatment, operator's names and other information about the machines' use and cleaning.

The log for machine 181033 was reviewed. The log included documentation that indicated the machine was used for a patient with an unknown Hepatitis status on January 31, February 2, 3, and 4, 2014. The documentation on the log indicated the machine was not treated with bleach on those days.

During an interview with Hemodialysis Registered Nurse (HDRN) 1, on February 26, 2014, at 1:50 p.m., HDRN 1 stated, when the patients' Hepatitis status was unknown, the machine would be bleached, like a machine used on Hepatitis B positive patients.

A policy and procedure manual located in the dialysis supply room was reviewed. Included in the manual was a policy titled "Hemodialysis Infection Control Guidelines," with a last reviewed/revised date of April 18, 2013. This policy indicated: "...The dialysis machine will be cleaned with bleach after each use and vinegar rinsed....The same machine will be used on all known Hepatitis B Surface antigen (HBsAG) positive patients. All recommended control measures for Hepatitis B are followed and all disposable supplies and accessories are used for one patient only..."

A second policy titled "Hemodialysis Infection Control Guidelines," with a last reviewed/revised date of April 18, 2013, was reviewed. The policy indicated: "... Likewise, if the machine was used by a Hepatitis positive patient or unknown hepatitis status, chemical disinfection must be done at the end of treatment. The same machine must NOT be used for another patient. At the day of discharge, the machine will be chemically disinfected; externally disinfected, tagged and Biomed technician must be notified..."

A review of HDRN 1's "Job Description," indicated,"...the Staff RN is responsible and accountable for the hemodialysis of acute patients...Demonstrates competency in the following areas...Follows infection control policy and procedures."

During an interview with the Infection Preventionist (IP), on February 27, 2014, at 2 p.m., the IP stated the HDRN must use bleach in the dialysis machine after use for a Hepatitis B positive or unknown status patient. The IP reviewed the log for machine 181033 and verified there were days when the patients' Hepatitis status was unknown; and the machine was not bleached. The IP stated he was developing a checklist to evaluate the care provided by the agency, but had not instituted it yet.

A dialysis machine, used on patients with unknown Hepatitis status, was not bleached according to policy and procedure.