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Based on document review and staff interview, the hospital failed to ensure that all outside companies were providing services under a current contractual arrangement in two of nine contracts. Such failure had the potential for outside companies not providing quality services as expected by the hospital.

Findings:

The written agreements for outside services used by the medical records department were reviewed on 7/24-25/12. The courier service agreement of 5/27/09 was not signed by a hospital representative and the full scope of services provided was not described. Also, the release of information copy service agreement was effective 11/12/07 for a term of one year. The wording was ambiguous regarding whether the term of the agreement would continue beyond that initial one-year term.

These findings were confirmed by the Health Information Manager 1 and the Chief Compliance Officer on the morning of 7/25/12.

Based on staff interview and administrative document review, the medical staff failed to have a process by which the competence of medical staff members would be assessed on a periodic basis. The medical staff failed to have a process for reappraising its members when 12 out of a total of 16 credential files examined (Medical Doctor [MD] 1, MD 5, DO 6, MD 7, MD 9, MD 10, MD 11, MD 12, MD 13, MD 14, MD 15, and Physician Assistant [PA] 16) revealed medical staff members had been reappointed with no evidence of periodic appraisals which considered practitioners competencies.

These failures placed patients at risk of receiving care from someone not qualified to provide those services.

Findings:

On 7/23/12 at 1 PM the facility staff Bylaws and Rules were reviewed. It states on page 5" ARTICLE 2 MEDICAL STAFF MEMBERSHIP 2.5 Qualifications for Membership 2.5.1 General Qualifications Membership on the Medical Staff and privileges shall be extended only to practitioners who are professionally competent and continuously meet the qualifications, standards, and requirements set forth in the Medical Staff Bylaws and Rules. 2.5.3 Additional Qualifications for Membership. In addition to meeting the basic standards, the practitioner must: a.) Document his or her: (1) adequate experience, education, and training in the requested privileges; (2) current professional competence; (3) good judgment; and (4) adequate physical and mental status (subject to any necessary reasonable accomodation) to demonstrate to the satisfaction of the Medical staff that he or she is professionally and ethically competent so that patients can reasonably expect to receive the generally recognized high professional level of quality of care for this community.

On 7/23/12 at 1 PM the facility Medical Staff Policy and Procedure for Peer Review (1-001) dated 11/19/2008 was reviewed. It indicated on page 1 " I. INTRODUCTION Medical members, departments and committees participate in peer review activities in accordance with this policy as well as the Medical Staff Bylaws, Medical staff Rules and regulations, Departmental Rules and Regulations, and as required by the licensure requirements, accreditation standards and conditions of participation in federally funded programs. Peer review review includes all evaluation activities involving members of the Medical Staff or other individuals holding privileges ("Practitioners"), including quality improvement, utilization review, monitoring, proctoring, focused review and evaluation, ongoing review and evaluation, and medical record review. The Medical Staff's peer review process also includes activities described in the Hospital's quality/performance improvement plan and utilization review plan. Results of the peer review activities are utilized to assess a Practitioner's professional practice and behavior as part of the credentialing, privileging and corrective action process. II. PEER REVIEW ACTIVITIES A. On-Going professional Practice Evaluation involves the Medical Staff's continuous monitoring practitioners' clinical practice behavior and compliance with expected bylaws, rules and policies; including data collection and evaluation activities which allows the organization to identify practice or behavior trends that impact on quality patient care and patient safety. 1. Data Collection shall be carried out on an on-going basis so as to preserve the protection from discovery of peer review information. Information received from the various sources shall be routed to the appropriate Medical staff Officer, Committee, or Department. As directed by the applicable officer, committee, or chief, support staff may (1) enter data into the quality database for tracking and trending purposes; (2) screen medical records against department-approved criteria; or refer those not meeting criteria to the applicable department or committee for initial medical record review. Note: Information received regarding practitioner behavior (e.g., disruptive, harassment, sexual harassment) shall be evaluated and processed in accordance with the Medical Staff's Policy and Procedure on disruptive Behavior when adopted, OR the Medical Staff Bylaws, Rules and Regulations. 2. Individual Case Review is initiated in the following circumstances: a. Routine medical record review based on approved screening criteria: Examples of criteria include operative/invasive procedure review, outcomes of operative/invasive procedures, blood usage, pharmaceutical usage, morbidity and mortality data. (Criteria shall be designed to collect information related to the six areas of general competency as described in Exhibit A to this policy). b. Medical record review in response to reported deviations from expected care; c. Statistical analysis showing: (i) important single events, levels of performance, or patterns or trends varying significantly from expected; (ii) performance varying significantly from other organizations; (iii) performance varying significantly from recognized standards; d. Variances fro recognized utilization practices (e.g., length of stay, use of consultants,appropriateness of admission); e. Risk management concerns involving quality of care; f. Complaints from patients, family of staff relating to quality of care; g. Notices from regulatory bodies, accreditation agencies or third party payors involving quality of care; h. An appropriate medical staff officer determines a need. 3. Initial medical record review will be performed by clinical departments in accordance with Departmental and Medical Staff indicators. Medical record review results will be rated according to the following system: Review Outcome 1: Practice acceptable, outcome expected, within standard of care. (Trend Only) 2: Practice not routine/unexpected outcome, but within standard of care. (Trend Only) 3: Practice unexpected, deviation from standard of care. (Practitioner required to provide written response or attend meeting) 4. Practice unacceptable/questioned, significant deviation from standard of care. (Automatic referral to Chair with specific issues/questions) Review Timelines. Peer review of a particular matter shall be conducted as soon as reasonably possible, based on when the matter is discovered and the complexity of the matter to be reviewed. In general, initial review of those circumstances identified herein should be carried out within thirty (30) days of discovery, unless unusual events intercede, including, but not limited to, focused review. Delays in review shall be reported to the Medical Executive Committee by the Department/ Committee Chair. Expedited reviews are appropriate in the event there may be an imminent threat to the health or safety of an individual. 5. Reporting Findings. The findings of peer review activities are reported through the Department/ Committee to the Medical Executive Committee within forty-five (45) days of review completion. 6. Action. Consistent with the provisions of the Medical Staff Bylaws, the Department/ Committee/Chair may take action or make recommendations for action, including implementation of monitoring, proctoring and focused evaluation activities. any recommendations for corrective action which may give rise to hearing rights shall be processed in accordance with the Medical Staff Bylaws."

Medical Staff credential files were reviewed on 7/23/12 at 1:30 PM with the Quality Analyst (QA) 3. Review of the credential files revealed 12 out of a total of 16 (MD 1, MD 5, MD 6, MD 7, MD 9, MD 10, MD 11, MD 12, MD 13, MD 14, MD 15, and MD 16) practitioner's credential files which showed no evidence of periodic appraisals which demonstrated the practitioner's competence. QA 3 stated there was a Medical staff policy and procedure which allowed for on-going professional practice evaluations of practitioners, however, the policy was not being followed in its entirety. She stated the information which was collected was not being used to appraise the practitioner's competence. She stated practitioners were routinely reappointed without appraisals/reappraisals of their competence.

The Vice President for Quality (VP) 2 was interviewed on 7/23/12 at 3:30 PM. VP 2 stated she was familiar with of the process by which practitioners of the hospital Medical Staff were reappointed. She stated there was a Medical Staff Policy and Procedure for Peer Review which allowed for the collection of data pertaining to on-going professional practice evaluations (competence appraisals) of practitioners. She stated on-going professional practice evaluations had been performed on individual practitioners, however, they were not used as a means of appraising individual practitioner's competence prior to reappointment. She stated practitioners were routinely reappointed without appraisals/reappraisals of their competence.

The interim Chief Executive Officer (CEO) 4 was interviewed on 7/23/12 at 4 PM. CEO 4 stated she understood she represented the Governing Body of the hospital. CEO 4 stated she was familiar with the process by which practitioners of the hospital Medical Staff were reappointed. She stated there was a Medical Staff Policy and Procedure for Peer Review which allowed for the collection of data pertaining to on-going professional practice evaluations (competence appraisals) of practitioners. She stated on-going professional practice evaluations had been performed on individual practitioners, however, they were not used as a means of appraising individual practitioner's competence prior to reappointment. She stated the data for the on-going professional practice evaluations (competence appraisals) of practitioners had been submitted to the hospital Medical Staff leadership for their review. She stated the Medical Staff leadership had reviewed the on-going professional practice evaluations data and had requested further clarification and explanation of the data. She stated the Medical Staff leadership had refused to allow the on-going professional practice evaluations data to be used for practitioner's appraisals of competence at the time of reappointment pending further clarification and explanation. She stated practitioners were routinely reappointed without appraisals/reappraisals of their competence as called for in the hospital's Medical Staff Policy and Procedure for Peer Review (1-001).

The Chief Medical Staff Officer (MD 1) was interviewed 7/23/12 at 4:30 PM. MD 1 stated he was the Chief of the Medical Staff for the hospital. MD 1 stated he was aware that staff practitioner's were routinely reappointed without being reappraised for competence as called for in the hospital's Medical Staff Policy and Procedure for Peer Review (1-001) dated 11/19/2008. He stated the Medical Staff leadership had reviewed the on-going professional practice evaluations data and had requested further clarification and explanation of the data. He stated the Medical Staff leadership had refused to allow the on-going professional practice evaluations data to be used for practitioner's appraisals of competence at the time of reappointment pending further clarification and explanation. MD 1 stated the hospital's Medical Staff leadership was aware practitioners were routinely reappointed without appraisals/reappraisals of their competence as called for in the hospital's Medical Staff Policy and Procedure for Peer Review (1-001).

Based on interview and record review, the hospital failed to evaluate nursing care provided.

1. For Patient 20, the hospital failed to evaluate the effectiveness of pain medications in a timely manner, which had the potential to result in ineffective pain management or overmedication causing harm.

2. For Patient 19, the hospital failed to complete time-outs prior to the procedure which had the potential to result in the wrong procedure performed on the patient.

Findings:

1. The clinical record for Patient 20 was reviewed on 7/23/12. The physician orders dated 7/16/12, indicated Patient 20 was receiving morphine through a patient controlled pump for pain management. The PCA (patient controlled analgesia) record, dated 7/16/12 through 7/20/12 at 9 AM, indicated assessment time intervals between 2 hours and 15 hours. There were seven assessment time periods that were more than four hours apart.

During an interview with Registered Nurse (RN) 3 on 7/23/12 at 11:45 AM, she reviewed the record and stated the PCA pump must be cleared every four hours and an assessment completed. She stated the assessment was not completed every four hours.

The hospital policy and procedure "Patient Controlled Analgesia (PCA)", dated 9/23/12, indicated "Assessment and Monitoring: 1. Obtain baseline vital signs followed by vital signs every one (1) hour x 2, then every 4 hours thereafter."

2. The clinical record for Patient 19 was reviewed on 7/23/12. Patient 19 had debridements (removal of dead or diseased tissue) of his left foot performed on 7/18/12 in the operating room and 7/20/12 at the bedside. The Universal Protocol and Fire Risk Assessment forms for both days were blank for the time-out procedure.

During an interview with RN 1 on 7/23/12 at 10:45 AM, she reviewed the records and stated the time-out should be performed prior to the start of the procedure and documented on the form.

The hospital policy and procedure titled "Universal Protocol and Fire Risk Assessment for Surgical and Non-Surgical Invasive Procedures" dated 4/26/12, indicated "Time out immediately prior to procedure: 1. During the time-out, other activities are suspended, so that all relevant members of the team are focused on the active confirmation of the correct patient, procedure, site, and other critical elements."

Based on interview and record review, the hospital failed to develop a care plan to address wound management for one of 48 sampled patient (23) which had the potential to result in inconsistent care delivered and prolonged wound healing.

Findings:

The clinical record for Patient 23 was reviewed on 7/23/12. The admission nursing assessment, dated 7/18/12, indicated Patient 23 was admitted with an open wound to his left ankle area related to chemotherapy treatments at another facility.

During an interview with Registered Nurse 4 on 7/23/12 at 2:30 PM, she reviewed the clinical record and was unable to find a care plan for wound care. She stated Patient 23 should have a wound care plan.

Based on interview and record review, the hospital failed to ensure medication policies and procedures were implemented and medications administered as ordered.

1. For Patient 21, the hospital failed to administer medications as ordered by the physician, which had the potential to result in an adverse drug reaction.

2. For Patient 20, the hospital failed to implement the policy and procedure to ensure medication orders were complete to ensure safe medication administration.

3. Failed to ensure medications were dispensed in accordance to valid physician orders for Patient 47 and Patient 48.

This failure had the potential to cause significant harm to patients receiving incorrect dose of medications.

Findings:

1. The clinical record for Patient 21 was reviewed on 7/23/12. The Emergency Department (ED) Physician Record, dated 7/22/12, indicated the physician prescribed hydroxyzine (a medication used to treat nausea) 25 milligrams (mg) to be administered intramuscularly (into the muscle). The medication administration record, dated 7/22/12 at 2:45 AM, indicated hydralazine (a medication used to lower blood pressure) 20 mg was administered.

During an interview with Registered Nurse (RN) 2, on 7/23/12 at 1:15 PM, she reviewed the clinical record and stated a medication error was made.

2. The clinical record for Patient 20 was reviewed on 7/23/12. The physician orders, dated 7/16/12 at 11:10 AM, indicated "Morphine [a medication used to control pain] PCA [patient controlled analgesia which is a machine that delivers pain medication controlled by the patient], 5 mg [milligrams] iv [into the veins] loading dose, and 1 mg q [every] 10 min [minutes] prn [as needed] with 1 mg/hr continuous, and 1 mg q 10 min prn bolus.

During an interview with RN 3, on 7/23/12 at 11:45, she stated the orders did not contain PCA lockout information.

The hospital policy and procedure titled "Patient Controlled Analgesia (PCA), dated 9/23/10, indicated the physician's orders must contain the following information: A. Name and strength of drug B. Bolus or loading dose C. Continuous rate D. Incremental dose E. Lockout/delay time in minutes F. Instructions (respiratory rate, sedation, pain intensity, etc.)".

3. A review of the Pyxis (an automatic Dispensing Cabinet) activity log of ED was conducted with Pharmacist (Pharm) 1 and Pharm 4 on 7/25/12 at 10:35 AM, which indicated that a tablet of Norco (pain medication) 10 mg was removed on 7/22/12 at 1:27 AM from the ED Pyxis.

The medication was then administered to Patient 47 according to the MAR (Medication Administration Record) while she was in the ED receiving treatment for pain.

Review of the original physician's order dated 7/22/12 for Patient 47 revealed that the medication order for Norco was written without a valid strength by her physician. The physician order for Norco did not provide clear dosage strength to the nursing staff and resulting in subjective interpretation of the medication strength by the individual administering the medication.

During the interview with Pharm 1 and Pharm 4, on 7/25/12 at 10:58 AM, regarding the discrepancy of the medication order, they both acknowledged the staff should clarify the Norco dosage strength with the prescribing physician prior to administering the medication to Patient 47.

Review of the hospital medication administration policy entitled "Medication Administration and Documentation", dated 2/23/12, read "Patients requiring medications at (name of hospital) and clinic facilities can expect to receive the correct dose of the appropriate drug ..."

4. Review of the clinical records with RN 5 and the Director of Intensive Care (DIR ICU) on 7/25/12 for patients who were receiving Propofol (medication for sedation) intravenous (IV) drips while in the ICU (Intensive Care Unit) showed that Patient 48 was admitted to the ICU on 7/18/12 and was ordered Propofol drip for sedation at 1:10 AM. Further review of clinical record did not identify a specific targeted sedation level assigned for Patient 48. There was no evidence that the titration was performed in accordance to the specific parameter (initiation for sedation at 5 mcg/kg/min; titration 5 mcg/kg/min after minimum of 5 minutes between adjustments) as outlined in the Propofol protocol/policy. The physician order of Propofol for Patient 48 did not provide clear instruction to the nursing staff and resulting in subjective interpretation by the individual administering the medication. Additionally, there was little documentation available which indicated regular evaluation of sedation on Patient 48 by nursing staff and assessment of central nervous system function to determine minimum dose of Propofol required for sedation.

During the interview with RN 5 and DIR ICU on 7/26/12 at 11:23 AM, they both acknowledged the titration of Propofol by nursing staff did not follow the hospital policy and guideline. Also they did not have an explanation as to why the Propofol order was allowed to proceed in spite of the missing targeted sedation level on the physician order.

Review of the hospital policy/protocol entitled "Propofol (Diprivan) Protocol" on page 1 under Procedure A, it read, "Diprivan may be used for sedation in the Emergency Room/ICU area for the mechanically ventilated patient only. Dosage for the mechanically ventilated patient will be ordered by the physician who is monitoring the mechanical ventilation. Registered nurses may medicate only the mechanically ventilated patients with this drug per the physician's order."

Based on medical record and document review and staff interview, the hospital failed to ensure that all medical record entries were accurately documented (with abbreviations defined), dated and timed in seven (25, 27, 28, 29, 30, 31, and 35) of 13 records. Such failure had the potential to affect safety and quality of services provided to its patients.

Findings:

1. On 7/24/12, the policy on approved abbreviations/symbols and prohibited abbreviations, effective 4/24/08, was reviewed. The policy referred to an approved abbreviation list, which was specific to the hospital, and to an additional approved abbreviation text (a published book). However, during the remainder of the survey, staff were unable to locate a copy of this book anywhere in the hospital. Abbreviations were used in entries in Records 25 and 27 that were not on the approved list.

2. On 7/24/12, the policy, "Medical Record Content," effective 1/27/11, states in Section I. B. that "All entries in the medical record shall be dated, timed and authenticated...." During review of medical records on 7/25/12, the following types of entries were not timed when written: progress record/notes (Records 27, 29, 30, and 35); pre-procedure patient evaluation (Records 27, 28); physician order (Record 27); and in Record 31, the authorization for and consent to surgery lacked both the date and time when the patient signed the form.

These findings was confirmed by Health Information Manager 1 on the afternoon of 7/25/12.

Based on medical record review and staff interview, the hospital failed to:

1. Ensure that the Conditions of Admission (COA) consents were documented in five of 13 records (25, 26, 30, 32, and 34). This failure had the potential to result in the hospital treating patients without documentation of the patient/responsible party's consent and to result in the lack of documentation of financial responsibility for payment of services rendered.

2. Ensure a consent for procedure was complete for one of 48 sampled patients (19), which had the potential to result in inadequate information provided to the patient to make an informed choice.

Findings:

1.a. Records for Patients 25, 26, and 30 were reviewed on 7/25/12 and they did not contain a COA form. After researching the missing consents, Health Information Manager (HIM) 1 reported that they could not be found and apparently were never signed during the patients' hospital stay. Two of the patients were first seen in the emergency department and then admitted (25 and 30). Patient 26 had a cardiac catheterization procedure done as an outpatient.

b. Also, records for Patients 32 and 34 were reviewed on 7/25/12 and they did not contain a copy of the mother's signed COA, which includes a clause for maternity patients stating that the conditions cover the infant born in the hospital. However, since the hospital's policy permits destruction of an adult patient's medical record before the infant's record, the evidence of the signed COA in the mother's record will be destroyed while the infant's record is still retained.

These findings were confirmed by HIM 1 on the afternoon of 7/25/12. And during an interview with Director of Patient Access on 7/26/12 at 10:50 AM, she stated the hospital did not have a policy and procedure on the process for ensuring a signed COA consent is obtained from every patient.



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2. The clinical record for Patient 19 was reviewed on 7/23/12. The "Authorization for and Consent to Surgery or Special Diagnostic or Therapeutic Procedures: Debridement [removal of dead or diseased tissue] and Revision of Amputation Left Foot First Metatarsal [toe]" was not dated, timed or witnessed by another person.

During an interview with Registered Nurse 1, on 7/23/12 at 10:45 AM, she reviewed the consent and stated should have been dated, timed, and witnessed when signed by the patient.

Based on interview and record review, the hospital failed to obtain competences for their pharmacist staff to ensure the safe administration of medications where pharmacists calculate and adjust doses, and provide safe and effective treatment.

Findings:

During an interview with Pharmacist (Pharm) 1 on 7/24/12 at 3:21 PM, he stated all pharmacists were competent to provide clinical services for the following medications: "warfarin (blood thinning medication), heparin (blood thinning medication), low molecular weight heparin (blooding thinning medication), and renal dosing (adjust doses to reduce potential for toxicity for patients that have poor kidney function). The pharmacists were currently providing these clinical services which involve calculating, adjusting doses, and providing safe and effective treatment. When Pharm 1 was asked to provide documentation to demonstrate staff pharmacists were competent to provide these clinical services, he provided a copy of the competencies completed by Pharm 2 and Pharm 3 on 7/25/12.

Review of the competency files completed by Pharm 2 did not show competency assessment in the area of anticoagulation (the use of drugs such as warfarin and heparin etc. to prevent clotting of blood) and also there was no other examination found in Pharm 3's employee record that showed competencies in the areas of anticoagulation, and renal dosing.

ASHP (American Society of Health-System Pharmacists) has published, "Guidelines on Preventing Medication Errors in Hospitals", approved June 23, 1993, which states, policies and procedures should be developed that ensure proper evaluation of competency and supervision. Review of the hospital policy entitled "Competency Assessment for Clinical Staff " on page 2 under "Unit Specific Orientation"; it read "D. Competency based and maintained if possible by National/State Standards of Practice and specific recommendations through national organization."

Based on observation, interview, and record review, the hospital failed to date intravenous fluid in a warmer in accordance to hospital policy and procedure to ensure potency of drug. This failure could result in the loss of integrity of the medication and potentially harm patients by not providing the expected therapeutic effect.

Findings:

On 7/26/12 at 10:05 AM, an inspection of the OR (Operating Room) with Pharmacist 1 (Pharm 1) and Registered Nurse (RN) 6 found a fluid warmer containing numerous bags of sodium chloride 0.9% intravenous (IV) fluid. Two bags of the 3000 ml 0.9 % sodium chloride IV fluid were found undated and there was no information on them to indicate how long they had been left inside the warmer.

In interview with RN 6 on 7/26/12 at 10:15 AM he acknowledged the two bags of sodium chloride 0.9 % IV fluid found in the warmer should have a 14 day expiration from the date that they were put inside according to the hospital policy on IV solution in warmer.

Review of the hospital policy and procedure entitled "Warming Recommendations for IV Contrast Media, Intravenous (IV) and Irrigation Solutions" dated 10/23/08 and under Procedure for IV and Irrigation Solutions, it read, "3 ...Solutions of volumes 150 ml or greater can be warmed in their plastic over wrap to temperatures not exceeding 40 C (104 F), and for a period no longer than 14 days..."

Based on observations, staff interviews, and document reviews, the infection control officer failed to develop effective systems for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel in accordance with hospital policy and nationally recognized infection control guidelines as evidenced by the failure to ensure:

1. Staff effectively cleaned and disinfected equipment between patient use when:
i. The crib used to photograph newborns was found in an unsanitary condition.
ii. Items that were present in the operating room(s) could not be effectively disinfected.

2. Separation of clean/sterile and soiled supplies when:
i. A cryostat machine, a machine used to freeze sterile human tissue specimen, was stored next to a hopper (a large toilet without a lid) in a dirty utility room.
ii. An automatic endoscope reprocessing machine was located immediately adjacent to a sink where endoscopes were cleaned and decontaminated.

3. An effective program to screen participating physicians for infectious diseases, including blood borne pathogens and tuberculosis.

4. Safe and sanitary medication practices in the perioperative area.

5. Infection control findings were fully integrated into the hospital's quality management program and processes.

Findings:

1.i. On 7/24 12 at 2:45 PM an infant crib was observed on the obstetrics floor in an area where soiled equipment, and cardboard boxes were stored. Numerous black particles were observed on the blanket located inside the crib. The interior crib surfaces also contained brown and orange colored particles. The screws visible inside the crib were rust colored. The outside surfaces of the crib had areas where the wood was scraped and had crevasses. A black fuzzy substance was noted on one side of the crib. During a concurrent interview with the Obstetrics Coordinator (OB COOR), she indicated the unsanitary crib was available for use to hold the newborns when they were photographed. OB COOR stated infant photography services were contracted out and hospital staff had not provided oversight of the cleaning/disinfection, or storage of this shared patient item.

According to the Centers for Disease Control and Prevention (CDC) 2008 Guidelines for Cleaning and Disinfection in Healthcare Facilities, "Ensure that, at a minimum, noncritical patient-care devices are disinfected when visibly soiled and on a regular basis such as after use on each patient. Inspect equipment surfaces for breaks in integrity that would impair either cleaning or disinfection/sterilization. Discard or repair equipment that no longer functions as intended or cannot be properly cleaned, and disinfected or sterilized."

1.ii. On 7/23/12 at 2:20 PM, a patient gurney, available for patient use, was observed located in the hallway of the operating suite. In operating room (OR) 4 tears and holes, ranging in size from pin-point to 1 by 1 inches were observed on the fabric surfaces of an arm restraint and a slider board. Additionally, a paper pamphlet for hospital service billing codes and a magazine on legal services was observed on the anesthesiology cart in OR 4. A leather satchel was situated nearby. In a concurrent interview with Housekeeper (HK) 1, she acknowledged the items with non-intact surfaces, leather satchel, and pamphlet and magazine could not be disinfected, and she stated "They (referring to the equipment with non-intact fabric surface, pamphlet, and magazine) need to be tossed." HK 1 indicated the leather satchel needed to be removed from the OR area.

According to the 2012 AORN (Association of Perioperative Registered Nurses), under the section titled Environmental Cleaning, Recommendation II, 11.b. stipulated "Mattresses and padded positioning devise surfaces (e.g. OR Beds, arm boards, patient transport carts) should be moisture-resistant and intact." Recommendation II,11 b.4. stipulated, "Damaged or worn covering should be replaced."

According to the 2008 CDC and Prevention Guidelines for Cleaning and Disinfection in Healthcare Facilities, "Inspect equipment surfaces for breaks in integrity that would impair either cleaning or disinfection/sterilization. Discard or repair equipment that no longer functions as intended or cannot be properly cleaned, and disinfected or sterilized."

2.i. A concurrent observation and interview was conducted with the Laboratory Director (LAB DIR) and Laboratory Supervisor (LAB SUP) on 7/26/12 at 8:20 AM in the dirty utility room located in the perioperative suite. A cryostat machine, a machine used to freeze sterile human tissue specimens, was observed immediately adjacent to a hopper, a large toilet without a cover, in the dirty utility room. A mop in a bucket of grey colored water was propped against the cryostat machine. In a concurrent interview, LAB SUP stated "This is horrible, specimens (referring to the tissue specimens) could be contaminated with bacteria. I am surprised the pathologists have not complained about this. This (referring to the cryostat machine) should not be here."

During an interview with HK 1 on 7/25/12 at 11:15 AM, she clarified that the hopper in the dirty utility room located next to the cryostat machine was used to dispose of human waste and used environmental cleaning products, i.e. mop bucket waste.

During an interview with Infection Control Nurse (ICN) 1, on 7/25/12 at 10:50 AM he stated clean and dirty processes and equipment should be kept exclusive from each other. When asked for the hospital policy on this, ICN 1 indicated the hospital did not have a policy or procedure on this topic.

During an interview with ICN 1 on 7/26/12 at 11:15 AM, he clarified he had identified the location of the cryostat machine as an infection control problem. ICN 1 produced the notification e-mail sent to OR leadership on 4/23/12. ICN 1 indicated there had been no response from OR leadership and no further follow-up from hospital infection control.

The 2003 Centers for Disease Control and Prevention (CDC's) " Guidelines for Environmental Control in Healthcare Facilities Setting " indicated, " The most common point-of-use fixtures for water in patient-care areas are sinks, faucets, aerators, showers, and toilets ... The potential for these fixtures to serve as a reservoir for pathogenic microorganisms has long been recognized. Wet surfaces and the production of aerosols facilitate the multiplication and dispersion of microbes. "

2. ii. On 7/24/12 at 10:15 a.m. the automatic endoscopy reprocessing (AER) machine (a machine that performs functions to remove germs from endoscopes) was observed located immediately adjacent to a sink. The door of the AER was completely open.

During an interview with Endoscopy Technician (ENDO Tech) on 7/24/12 at 10:20 a.m., she indicated the sink, situated next to the AER was used to clean and remove gross debris from the dirty endoscopes prior to placing them into the AER. When asked if there was a problem with the scope disinfection process being performed immediately next to cleaning the dirty endoscopes, ENDO Tech stated, " No, the scopes are removed immediately when they are reprocessed (high level disinfected) and the AER door is never left open. "

During an interview with ICN 1, on 7/25/12 at 10:50 a.m. he stated clean and dirty processes and equipment should be kept exclusive from each other. Sean acknowledged there was a potential of cross contamination with the dirty scopes being cleaned immediately next to where the endoscopes were being disinfected.

The hospital ' s policy titled High Level Disinfection, Sterilization, and Storage of Sterile Supplies, dated 2/23/12 and presented as current, was reviewed. Under the section titled High Level Disinfection there was no information related to requirement to establish separate areas for disinfecting and cleaning/decontaminating endoscopes.

On 7/ 23/12 at 2 p.m., during an interview with Environmental Supervisor (ENV SUP), she stated the hospital followed the AORN (Association of Perioperative Registered Nurses) standards for equipment sterilization and disinfection standards.

According to the 2012 AORN Recommended Practices for Prevention of Transmissible Infections in the Perioperative Setting, under Cleaning and Processing Endoscopes, Recommendation XI, " Flexible endoscopes should be decontaminated in an area physically separate from locations where clean items are handled and patient care activities are performed. Cross contamination can result when soiled items are placed in close proximity to clean items or placed on surfaces upon which clean items are later placed. Aerosols created during cleaning can also cause cross contamination. The area should contain but not be limited to: hand-washing facilities, eyewash station, proper ventilation ...

The 2003 CDC's "Guidelines for Environmental Control in Healthcare Facilities Setting" indicated, "The most common point-of-use fixtures for water in patient-care areas are sinks, faucets, aerators, showers, and toilets ... The potential for these fixtures to serve as a reservoir for pathogenic microorganisms has long been recognized. Wet surfaces and the production of aerosols facilitate the multiplication and dispersion of microbes."

3. During an interview with Quality Analyst (QA) 3 on 7/25/12 at 8:40 AM, she indicated the hospital did not have a program to screen physicians for measles, mumps, rubella, varicella, tuberculosis or hepatitis B. When physician medical records were requested, QA 3 stated the hospital did not have any records with participating physician immunization information.

An interview was conducted with ICN 2 and ICN 1 on 7/25/12 at 1 PM. ICN 2 indicated the infection control staff had been working on getting a hospital program to screen physicians for vaccine preventable diseases for the past 12 years she had worked in infection control. ICN 1 and ICN 2 cited competing priorities, need for support from upper management, and participating physicians stating vaccination (for measles mump rubella and varicella) was taken care of as part of their training as barriers experienced in getting the physician vaccine program. ICN 2 stated the hospital followed the CDC vaccine preventable disease standards.

The CDC Guidelines for Preventing the Transmission of Tuberculosis in a Health-Care Setting, 2005, page 10, indicated "The classification of medium risk should be applied to settings in which the risk assessment has determined that health care workers (HCW) will or will possibly be exposed to persons with TB disease or to clinical specimens that might contain M. tuberculosis. The recommendations for medium risk included, "All HCWs should receive baseline TB screening (checked to identify presence of the disease) upon hire, using two-step TST (skin test) or a single BAMT (alternate test) to test for infection, and after baseline testing for infection, HCWs should receive TB screening annually."

The CDC Morbidity and Mortality Report (MMWR Volume 46, Number RR-18, December 26, 1997) documented on page 24: "Persons who work within medical facilities should be immune to measles and rubella. Immunity to mumps is highly desirable for all HCW. Because any HCW (i.e., medical or nonmedical, paid or volunteer, full time or part time, student or nonstudent, with or without patient-care responsibilities) who is susceptible can, if exposed, contract and transmit measles or rubella, all medical institutions (e.g., inpatient and outpatient, public and private) should ensure that those who work within their facilities are immune to measles and rubella. Likewise, HCWs have a responsibility to avoid causing harm to patients by preventing transmission of these diseases on page 25, the MMWR documented: "All HCWs should ensure that they are immune to varicella."

The Occupational Safety and Health Administration (OSHA) requires hepatitis B vaccine be offered to HCWs who have a reasonable expectation of being exposed to blood on the job.

4. An observation and concurrent interview was conducted on 7/24/12 at 11:30 AM in OR 4. An opened 250 milliliter bottle of Sevofluorane (a medication used to induce anesthesia) was observed in an anesthesia cart. There was approximately 2 inches of fluid remaining in the bottle. The bottle was not labeled with the date it was opened, it was not initialed, and it did not contain the use by expiration date after opened. A single use 15 milliliter syringe of Darvocet (a powerful pain medication) was also observed in the anesthesiology cart. The syringe had 7.5 milliliters of fluid remaining in the syringe and was also not labeled. In a concurrent interview with Registered Nurse (RN) 6, he stated "These (referring to the syringe and the bottle of Sevofluorane) should be tossed."

An observation and concurrent interview was conducted on 7/25/12 at 11:50 AM in the perioperative area. Four syringes were observed in the anesthesiology cart available for patient use located in OR 3. The syringes were labeled as containing: Propofol (also known as Diprivan, a powerful hypnotic drug) 20 milliliters, Fentanyl (a potent pain medication and an anesthetic medication), Lidocaine (a local anesthetic drug), and Epinephrine (a medication used for many purposes, including drying of bodily secretions for surgery). All syringes except the one containing the epinephrine were not labeled with the date, time, or the name of the individual(s) who had drawn the medication into the syringe(s). The syringe containing the epinephrine was labeled with only the date, 7/18/12. In a concurrent interview with RN 6, he stated "These (referring to the syringes) should be tossed, keeping anesthesiologists is a full time job, they do whatever they want." RN 6, acknowledged the medications were available for patient use and there was no way to determine, with the exception of the epinephrine, when the medications had been prepared.

The USP (797), "Pharmaceutical Compounding - Sterile Preparations (CSPs)," in the USP National Formulary, a regulation that governs a wide range of pharmacy policies and procedures was reviewed. The standards for single-dose vials opened in room air is the contents must be utilized within one hour. Intravenous medications prepared in worse (dirtier) than ISO Class 5 environments are subject to the standards for Immediate-Use CSPs. Immediate-Use CSPs cannot be stored.

The product insert on Propofol states: "Propofol Injectable Emulsion should be prepared for use just prior to initiation of each individual anesthetic/sedative procedure... The syringe(s) should be labeled with appropriate information including the date and time the vial was opened. Administration should commence promptly ..."

Review of the hospital's policy, dated 2/09, and titled "Use of Multi-Dose Vials" stipulated, "Labelling of vials with the date to expire and initials upon opening is necessary." According to the 2012 AORN Recommended Practices for Prevention of Transmissible Infections in the Perioperative Setting, under under Medication Safety, indicated "Medications labeled as single dose vials (SDVs) must not be used directly for multiple patients, due to the risk of spreading infections. Multidose medications used for more than one patient should not be stored in the immediate area where direct patient contact occurs and should be separate from single-dose vials in the storage area. Medication containers must be dated to indicate expiration within 28 days of opening and should be discarded immediately upon expiration. When a vial cap has been punctured or removed, the manufacturer's expiration date is no longer valid and should be replaced with a new date. There is increased risk for bacterial growth the longer the seal is broken and a container is open."

These failures potentially placed patients at risk for serious life-threatening infections.

5. During an interview with ICN 2 on 7/26/12 at 11:15 AM, when asked why many infection controls deficiencies were identified during the survey, described under section 749 of the survey findings report, either had been previously identified and reported but not followed to resolution or not identified. ICN 2 cited competing priorities, changing leadership staff, sometimes resistance by affected parties, and time constraints due to work load.

During an interview with Chief Medical Officer (MD 1) on 7/26/12 at 9 AM, he stated
"Things fell through the cracks because physicians were busy, follow-through on identified infection control issues were left to the staff, and a better system of reminders was needed."

This failure placed hospital patients, staff persons, and participating physicians at increased risk for transmission of and infection from serious infectious diseases.