HospitalInspections.org

CONDITION NOT MET

Based on observation, interview, and review of hospital policies and procedures, the hospital failed to meet the requirements for the Condition of Participation for Governing Body.

Failure to ensure that anesthesia and pharmaceutical services were being delivered according to minimum regulatory standards and accepted standards of practice resulted in provision of unsafe healthcare.

Findings:

Due to the cummulative effect of deficiencies detailed under the Conditions of Participation at 42 CFR 482. 21 Quality Assessment and Performance Improvement Program; 42 CFR 482.25 Pharmaceutical Services; and 42 CFR 482.52 Anesthesia Services, the Condition of Participation for Governing Body was NOT MET.

Refer to Tags A0084, A0263, A0490, A1000, A1005

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Based on observation and interview, the hospital failed to provide supervision of and monitor quality of care for anesthesia services provided under contract to surgical patients.

Failure to report unsafe medication preparation, storage, and administration practices of contracted anesthesia providers to the QAPI committee resulted in endangerment of the health and safety of patients.

Failure to perform a comprehensive evaluation of patients recovering from anesthesia according to accepted standards of practice placed patients at risk of harm related to unrecognized complications of anesthesia and delays in necessary treatment.

Findings:

Refer to Tags A0263, A0490, A1000, A1005.

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1. Based on interview and review of patient rights information, the the hospital failed to develop a process for informing all patient's of their rights according to State hospital regulations (Patient #1).

Failure to inform all patients of their rights limits the patient's ability to exercise those rights

Findings:

a. On 12/13/2011 at 10:15 AM, an interview with a patient admissions clerk in the main hospital admissions area (Staff Member #M1) revealed that patients were given a handout to read when they were admitted to the hospital as an inpatient. The handout was entitled "As a Patient at Samaritan Hospital, You Have the Following Rights". Review of the contents of this form revealed it did not include all of the patient's rights identified in current hospital regulations.

The form did not inform patients that they had the right that they had the right for spiritual care and communication [WAC 246-320-141(1)(b)]; the right to be protected from neglect [WAC 246-320-141(1)(c)]; the right to access protective services WAC 246-320-141(1)(d)]; the right to be involved with all aspects of their care, including resolving problems with care decisions [WAC 246-320-141(1)(g)(ii)]; the right to be informed of unanticipated outcomes of care according to RCW 70.41.380 [WAC 246-320-141(1)(h)]; the right to end of life care [WAC 246-320-141(1)(m)]; and the right to donate organs and other tissues according to RCW 68.50.500 and 66.50.560, including medical staff input and direction by family or surrogate decision makers [WAC 246-320-141(1)(n)(i)(ii)].

b. On 12/13/2011 at 10:20 AM, an interview with a patient admissions clerk in the emergency department (Staff Member #M2) revealed that the patient rights brochure was not offered to patients admitted for care in the emergency department nor for patients admitted for outpatient surgery, laboratory tests, or radiological tests.

On 12/15/2011 at 9:00 AM, Patient #1 confirmed he had not been given a list of patient rights when admitted to the hospital for outpatient surgery.


2. Based on record review and interview, the hospital failed to develop a process to ensure that Medicare patients were notified within two calendar days of discharge of their right to appeal their discharge to a designated Quality Improvement Organization, as demonstrated by 1 of 1 patients reviewed (Patient #4)

Reference: 42 CFR 405.1205(b) - Hospitals must provide each Medicare beneficiary who is an inpatient a standardized notice, the "Important Message from Medicare", within two days of their admission and again within two calendar days before discharge.

Findings:

a. Patient #4 was an 82 year-old Medicare patient who had been admitted to the hospital on 12/10/2011. The patient's medical records included an "Important Message from Medicare" notice that had been signed on 12/10/2011 by one of the patient's family members

The patient was discharged to a skilled nursing facility on 12/13/2011. There was no evidence that the patient or the family member had been given a second notice within 48 hours of the patient's discharge.

b. An interview with the admissions supervisor (Staff Member #M3) on 12/13/2011 at 2:45 PM revealed that the hospital did not have a process for re-issuing the notice for Medicare patients who stayed longer than 48 hours.

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Based on record review, interview, and review of hospital policies and procedures, the hospital failed to ensure that patients who received blood transfusions were informed of the risk and benefits of transfusion therapy according to hospital policy and procedure, as demonstrated by 2 of 2 patients reviewed (Patients #5, #6).

Failure to inform patients of the risks and benefits of care and treatment impedes the patient's participation in the care planning process.

Findings:

1. The hospital's policy and procedure entitled, "Blood Administration" (Policy #8720-B-2; Revised 3/7/2008), read in part under the section entitled "General Information/Policy" as follows: "1. Obtain consent to transfuse prior to transfusion."

2. On 12/14/2011, review of the records of two patients (Patients #5, #6) who had been admitted to the Short Stay unit for blood transfusions revealed that the records had no blood transfusion consent form that demonstrated that the patients had been informed of the risks and benefits of transfusion therapy.

3. On 12/14/2011 at 11:20 AM, during an interview the RN in charge of the Short Stay Unit (RN #2), the RN stated that patients were not given a blood transfusion consent form to read and sign prior to transfusion therapy on the Short Stay Unit.

4. On 12/14/2011 at 11:30 AM, the hospital's CNO stated that consent should have been obtained and documented on the hospitals form entitled "Blood Transfusion Consent/Refusal" (Form 009469; Reviewed July 2006). The CNO confirmed that the hospital's policy and procedure for informed consent for transfusion had not been followed.

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Based on interview and review of the hospital's patient rights information and visitation policy, the hospital failed to incorporate patient visitation rights into its visitation policy and procedure and develop a process for informing patient's of their visitation rights when admitted to the hospital according to 42 CFR 485.635(f).

Failure to inform patients of their rights and to incorporate those rights into visitation policies and procedures limits the patient's ability to exercise those rights.

Findings:

1. On 12/13/2011 at 10:15 AM, an interview with a patient admissions clerk in the main hospital admissions area (Staff Member #M1) revealed that patients were given a handout to read when they were admitted to the hospital as an inpatient. The handout was entitled "As a Patient at Samaritan Hospital, You Have the Following Rights".

Review of the contents of this handout revealed it did not include the patient's visitation rights identified under 42 CFR 485.635(f)(1) and (2).

2. The hospital's policy and procedure entitled "Visitor Policy" (Policy #8610-V-3; Revised 3/5/2010) did not include the visitation rights of patients as identified in the regulation.

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Based on interview and review of the hospital's patient rights information and visitation policy, the hospital failed to incorporate patient visitation rights into its visitation policy and procedure and develop a process for informing patient's of their visitation rights when admitted to the hospital according to 42 CFR 485.635(f).

Failure to inform patients of their rights and to incorporate those rights into visitation policies and procedures limits the patient's ability to exercise those rights.

Findings:

1. On 12/13/2011 at 10:15 AM, an interview with a patient admissions clerk in the main hospital admissions area (Staff Member #M1) revealed that patients were given a handout to read when they were admitted to the hospital as an inpatient. The handout was entitled "As a Patient at Samaritan Hospital, You Have the Following Rights".

Review of the contents of this handout revealed it did not include the patient's visitation rights identified under 42 CFR 485.635(f)(3) and (4).

2. The hospital's policy and procedure entitled "Visitor Policy" (Policy #8610-V-3; Revised 3/5/2010) did not include the visitation rights of patients as identified in the regulation.

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CONDITION NOT MET

Based on observation, interview, and review of hospital policies and procedures, the hospital failed to meet the requirements for the Condition of Participation for Quality Assessment and Performance Improvement Program (QAPI).

Failure to report unsafe medication preparation, storage, and control practices of contracted anesthesia providers to the QAPI committee resulted in endangerment of the health and safety of patients.

Findings:

During an interview on 12/16/2011 at 8:25 AM, the hospital's CNO stated that she had been notified by the pharmacy director that CRNAs under contract with the hospital had demonstrated improper medication preparation, storage, and control practices. The CNO stated that she had tried to resolve these issues on an informal basis and had not reported this problem to the hospital's quality improvement committee.

Refer to Tags A0084, A0490, A1000

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Based on review of personnel training records and hospital policies and procedures, the hospital failed to assess the competence of nursing staff responsible for the administration of medications for procedural ("moderate") sedation according to hospital policy and procedure and accepted standards of practice for 4 of 5 RNs reviewed (RN #3, #4, #5, #6).

Failure to periodically assess the competence of nurses who perform this skill risks improper treatment and an adverse patient outcomes.

Reference: "Policy Statement for Registered Nurses Performing Procedural Sedation" (Washington State Nursing Commission, January 14, 2000) "To ensure that nurses assisting in procedural sedation receive appropriate and continuous training and support, the Nursing Care Quality Assurance Commission recommends that all providers and institutions using nurses in procedural sedation should have in place written policies and procedures that contain, at a minimum, the following elements:...4) Specific yearly evaluation and continuing competency requirements."

Findings:

1. The hospital's policy and procedure entitled "Moderate Sedation by Non-Anesthesia Provider" (Policy #7170-M-7; Effective 5/11/2011), read in part under the section "Training/Requirements" as follows: "Annual competency for nurses will be established and will include the ability of the nurse to discuss moderate sedation as well as to demonstrate the skills needed to care for a patient undergoing moderate sedation."

2. Review of the personnel training records for 5 nurses who had been trained to administer medications for procedural sedation revealed that 4 of 5 nurses had not been evaluated for competence in performing this skill since 2009.

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Based on review of a list of delinquent medical records, review of the hospital's medical staff rules and regulations, and interview, the hospital failed to ensure that healthcare providers authenticated orders for care and treatment of patients according to the hospital's medical staff rules and regulations.

Failure to write and authenticate orders for medications and treatment risks provision of incorrect and/or inadequate patient care.

REPEAT CITATION - Formerly cited January 2007

Findings:

1. The hospital's medical staff rules and regulations (Approved 12/2010) read in part as follows:

"3.6 Authentication (a) Authentication means to establish authorship by written signature or identifiable initials and may include written signatures, or computer entry using unique electronic signatures."

"3.8 Delinquent Medical Records (a) It is the responsibility of the physician to prepare and complete medical records in a timely fashion in accordance with the specific provisions of these Rules and Regulations and other relevant policies of the Hospital."... "(c) If the record remains incomplete 30 days following discharge, the physician will be notified in writing of the delinquency and that his or her elective clinical privileges have been automatically relinquished in accordance with the Credentials Policy. The relinquishment will remain in effect until all of the physician's records are no longer delinquent. The physician will still be responsible for emergency call and to provide care for emergency patients."

2. During an interview on 11/29/2011 at 2:45 PM, a hospital HIM Specialist (Staff Member #M4) stated that the hospital's medical records department tracked unsigned orders and entries in the hospital's electronic medical record system. The HIM specialist stated that the medical records department sent weekly letters to healthcare providers who had delinquent records.

3. Review of the report dated 12/12/2011 revealed that of 35 of 56 healthcare providers had delinquencies over 30 days. The report identified that 5 of the 56 healthcare providers had between 71 and 107 deficiencies. These 5 healthcare providers (Healthcare Providers #1, #2, #3, #4, #5) routinely cared for hospitalized patients.

4. Review of credentialing files for these 5 healthcare providers on 12/15/2011 revealed that they had not had their hospital privileges suspended in accordance with the medical staff rules and regulations.

5. An interview with the hospital CEO and CMO on 12/16/2011 confirmed that the hospital had not enforced the medical staff rules and regulations for delinquent medical records.
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CONDITION NOT MET

Based on observation, interview, and review of hospital policies and procedures, the hospital failed to ensure that anesthesia and pharmaceutical services were being delivered according to minimum regulatory standards and accepted standards of practice

Failure to ensure that anesthesia and pharmaceutical services were being delivered according to minimum regulatory standards and accepted standards of practice resulted in provision of unsafe healthcare.

References:

WAC 246-873-040 Personnel - (1) Director of pharmacy. The pharmacy, organized as a separate department or service, shall be directed by a licensed pharmacist appropriately qualified by education, training, and experience to manage a hospital pharmacy. The patient care and management responsibilities of the director of pharmacy shall be clearly delineated in writing and shall be in accordance with currently accepted principles of management, safety, adequate patient care and treatment. The responsibilities shall include the establishment and maintenance of policies and procedures, ongoing monitoring and evaluation of pharmaceutical service, use and control of drugs, and participation in relevant planning, policy and decision-making activities.

WAC 246-873-080 Drug procurement, distribution and control - (3) The director shall be responsible for establishing specifications for procurement, distribution and the maintenance of a system of accountability for drugs, IV solutions, chemicals, and biologicals related to the practice of pharmacy.

Findings:

1. The hospital's policy and procedure entitled "Drug Storage Areas and Surveys" (Policy #7170.D-5; Revised 1/18/2010), under "Purpose", read as follows: "The Pharmacy Department is responsible for all drugs in the hospital. Monthly surveys of drug storage are required of the Pharmacy Department to prevent proliferation of drug storage areas, wastage, and excessive inventory investments. Department Managers and the Pharmacy Director are responsible to ensure everyone complies with drug storage requirements."

Under "Drug Storage", the policy and procedure read in part as follows: "Medications will not be drawn prior to use unless they are properly labeled and withdrawn from the Pyxis units identifying a patient's name and proper billing."

Under "Action", the policy and procedure read in part as follows: "3. Monthly surveys of drug storage areas by the Pharmacy staff shall be aimed at monitoring storage conditions of drugs; removing out-dated drugs, excessive quantities of drugs, and drugs not approved for storage; and monitoring compliance with policies and procedures regarding drug storage and usage."

Under "Drug Storage Areas", the policy and procedure read in part as follows: "Anesthesia: Anesthesia Carts (4)".

2. The following occurred on 12/14/2011

a. At 10:35 AM, Surveyor #2 interviewed CRNA #2 in the surgery unit and observed the following medications in his anesthesia cart (Cart #14810): Dexamethasone, adrenalin, epinephrine, atropine, and ondansetron.

b. At 1:30 PM, Surveyor #2 interviewed the hospital's pharmacy director and CNO regarding medications stored in anesthesia carts. The pharmacy director state he had requested that the CRNAs not store medications in the anesthesia carts unless pre-approved by him.

c. At 2:00 PM, the pharmacy director, the CNO, and Surveyor #2 went to the OR to examine five anesthesia carts (Carts #14809, #14810, #14807, #14808). The CNO and the pharmacist stated that the carts were used by three CRNA's (CRNA #1, #2, #3) employed by contract and were supervised by the hospital's CEO.

Four carts of the five carts were unlocked and examined using keys that retained by the surgery supervisor. Cart #14811 was not examined. This cart was locked, and there was no key available to unlock it.

The pharmacy director stated he did not have access to keys for the carts. He stated pharmacy staff members had no means to examine and inventory the medications and to check for outdated drugs unless the carts were left unsecured by the anesthetists.

Cart #14810 contained the same medication identified at 10:35 AM. Carts #14809, #14807, and #14808 had large amounts medications in them. Unrefrigerated, undated vials of succinylcholine were found in carts #14807 and #14809. 100 ml, 50 ml, and 20 ml vials of propofol were found in cart #14807. Cart #14808 contained an open, undated vial of Ketamine plus two pre-drawn syringes labeled epinephrine and neosynephrine, and one pre-drawn syringe of fluid with no label.

Five syringes outside their protective wrapper were found on top of cart #14810. Nine pre-labeled empty syringes out of their protective wrapper were found inside cart #14808. Two syringes out of their protective wrapper were found inside cart #14809.

The pre-drawn and unwrapped syringes were discarded by the CNO.

3. The following occurred on 12/16/2011:

a. At 8:00 AM, Surveyor #2 interviewed Pharmacist #1 and Pharmacy Technician #1 in the hospital's obstetrical unit. The pharmacy technician stated the anesthesia carts in the OR are usually locked and that the pharmacy does not have keys. She stated pharmacy technicians are only able to check the carts for outdated medications when they are left unlocked. She stated she removes medications and syringes that are left on top of the carts. She stated that she could show us bags of these medications in the pharmacy.

b. At 8:20 AM, Pharmacist #M1, Pharmacy Technician #1, the CNO, and Surveyor #2 proceeded to the hospital pharmacy. The pharmacy technician showed Surveyor #2 twenty-three plastic bags of medications and syringes and several medication vials not in bags located on a shelf in the pharmacy director's office. The medications had removed by pharmacy staff members from anesthesia carts and retained by the pharmacy director.

The medications were inventoried by Surveyor #1 and Surveyor #2. Twelve of the twenty-three of the bags were dated. The earliest date on the bags was 1/13/2011.

There were 123 medication vials and syringes in the medication collection. The medications included undated partially full single-dose vials; undated multi-dose vials; empty vials that had not been discarded after use; pre-drawn undated syringes, some with contents incompletely labeled, some unlabeled; unlabeled syringes of opaque white fluid; and vials of propofol with vent spikes in their diaphragms. There were also unopened vials of paralytics that had been removed from the carts by pharmacy staff members because they had not been dated and timed when they were removed from refrigeration.

The medications also included 2 open, undated, partial vials of Ketamine, and one open, undated partial vial of hydromorphone. Both of these medications are Schedule II controlled substances.

4. The findings above demonstrated that the hospital's pharmacist did not maintain oversight and control of medications administered by contracted anesthesia providers.

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Based on interview and review of hospital policies and procedures and contracts, the hospital failed to assume responsibility for notification of patients in the event that contaminated blood had been administered.

Failure to assume responsibility for notification of patients in the event that contaminated blood is administered risks uncertainty regarding awareness of the patient and/or provider that further medical testing and treatment may be necessary.

Findings include:

During a tour of the hospital laboratory on 12/14/2011, the hospital contract with blood purveyor INBC and the laboratory policy regarding patient notification following administration of contaminated blood were reviewed. The policy ("Lookback Policy", origination date unstated, reviewed 02/14/2011, collected 12/14/2011 at 11:37 a.m.) stated, in part:

"INBC is responsible to notify the hospital and the recipients physician in the event of a significant biological recall or donor look-back investigation."

The hospital contract with blood purveyor INBC (collected 12/14/2011 at 11:37 a.m.) stated, in part:

"In the event of a Biological Recall, including Lookback, INBC is responsible for notifying the Hospital. ....If appropriate, INBC will initiate recipient notification through the recipient's physician if requested by Hospital to do so."

Based on observation and interview, the hospital failed to construct and maintain the physical environment in such a manner that the safety and well-being of patients are assured, by failing to prevent cross-connections in the potable water supply.

Failure to prevent cross-connections in the potable water supply risks chemical contamination of hospital potable water and sewage contamination of sanitary food preparation surfaces.

Findings include:

During a tour of the hospital on 12/13/2011 - 12/14/2011 it was observed that:

1. A chemical dispenser in the 4th floor housekeeping closet was plumbed to the hospital potable water system. When the cover was removed it was observed that the dispenser was not provided with approved air gaps to prevent back-siphonage of chemicals into the hospital potable water system, and

2. A multiple-compartment sink adjacent to the dishwasher in the hospital kitchen was not provided with air-breaks in the sewage drain lines. The hospital dietary manager stated that the sinks were used for ware washing.

The hospital facilities manager confirmed the observations.

Based on observation, record review and staff interview, the facility failed to meet the provisions of the 2000 edition of the Life Safety Code of the National Fire Protection Association (NFPA).

Findings:

Refer to deficiencies written on the report:

MEDICARE RECERTIFICATION
LIFE SAFETY CODE SURVEY, dated 12/16/2011.

Based on observation and interview, the hospital failed to ensure that all staff members performed patient care activities in accordance with hospital infection control policies and procedures and accepted standards of practice.

Cross-contamination of clean and dirty areas and items, improper hand hygiene, and improper masking during surgery risked transmission of communicable diseases to patients.

Findings:

1. On 12/13/2011 at 11:20 AM, Surveyor #2 observed RN #1 priming tubing for an intravenous (IV) infusion in the medication preparation area. The nurse hung the IV on a hook over the handwashing sink and allowed the IV tubing to rest in the bottom of the sink.

This risked transmission of pathogens from the sink to the patient via the contaminated tubing.

2. On 12/15/2011 at 10:56 AM, Surveyor #1 observed that the door to OR #4 was open to the corridor for approximately 3 minutes while sterile instruments were in the room.

This risked transmission of pathogens from the air in the corridor to the sterile instruments.

3. On 12/15/2011 at 11:00 AM in OR #4, Surveyor #2 observed that CRNA #1 did not tie the lower strings of his surgical mask during surgery. The hospital's CNO also observed this finding.

During an interview at the time of the observation, the CRNA stated that he had not tied his mask because "Masks are only good for 15 to 20 minutes anyway."

Not wearing a mask during surgery risked transmission of pathogens from the CRNA's respiratory track to the patient's incision.

4. On 12/15/2011 at 11:05 AM, Surveyor #2 observed CRNA #1 drop an item on the floor of OR #4 and replace it on a clean supply shelf.

This risked transmission of pathogens from the floor to the patient via the contaminated item.

5. On 12/15/2011 between a surgical procedure that lasted from 10:30 AM to 12:35 PM, Surveyor #2 observed that the CRNA #1 did not use alcohol swabs to disinfect the tops of medication vials after removing their protective caps and withdrawing the medication into syringes. At 12:15 PM, CRNA #1 did not use an alcohol swab to disinfect the medication port of the patient's intravenous (IV) line prior to injecting medication. The hospital's CNO also observed these findings.

This risked transmission of pathogens from the IV vial tops and tubing to the patient.

APIC's position paper entitled "Safe Injection Infusion, and Medication Vial Practices in Health Care" (2010) reads in part as follows: "Disinfect IV ports and vial stoppers by wiping and using friction with a sterile 70% isopropyl alcohol, ethyl/ethanol alcohol, iodophor, or other approved antiseptic wash."

6. On 12/15/2011 at 10:38 AM in OR #5, Surveyor #1 observed a surgical technician pick up an object from the floor and hand it to a scrub nurse (Staff Member #M5). The scrub nurse then discarded the item and proceeded to manipulate the surgery table without removing her gloves and performing hand hygiene.

This risked transmission of pathogens from the nurse's hands to the patient.

The hospital's policy and procedure entitled "Exposure Control Plan Overview" (Policy #8770.102; Reviewed 2/4/2011) stated that hospital staff members would wash their hands after touching contaminated items.

7. On 12/15/2011 between a surgical procedure that lasted from 10:30 AM to 12:35 PM, Surveyor #2 observed that CRNA #1 did not perform hand hygiene before preparing and injecting medications nor before and after donning gloves.

This risked transmission of pathogens from the CRNA's hands to the patient.

The hospital's policy and procedure entitled "Exposure Control Plan Overview" (Policy #8770.102; Reviewed 2/4/2011) stated that hospital staff members would wash their hands at these times.
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Based on observation, interview, and review of hospital policies and procedures, the hospital failed to implement its policy and procedure for verification of the patient's identity, the surgical procedure to be performed, and the surgical site prior to initiating surgery for 1 of 1 patients observed (Patient #1).

Failure to systematically verify a patient's identity, procedure, and surgical site risks medical errors and patient harm.

Findings:

1. On 12/1/2011 at 11:20 AM, Surveyor #2 and the CNO observed the surgical team perform a "time-out" pause before initiating surgery on Patient #1. During this "time-out", the circulating nurse stated the patient's name, the type of surgery to be performed, and the surgical site. The circulator recited this information from memory and did not refer to the patient's medical record.

During this "time-out " the surgeon and the surgical technologist confirmed that the information was correct. The CRNA for the case (CRNA #1) did not cease his activities and participate in the "time-out" process.

2. The hospital's policy and procedure entitled "Surgical & Procedural Site Identification Policy Universal Protocol" (Policy #8720-S-5; Revised 9/14/2011) under the "Procedure" section read in part as follows: "In the surgical/procedural room, prior to the start of any surgical or invasive procedure, each member of the surgical/procedural team shall (by means of checking the consent and H&P [history and physical]) conduct a final verification process such as a "time-out" to confirm the correct patient, correct procedure, correct site and side, correct patient position, and availability of communication techniques."

3. An interview with the CNO immediately following the "time-out" procedure confirmed that the surgical team had not conducted the surgical site identification process according to hospital policy and procedure.

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CONDITION NOT MET - IMMEDIATE JEOPARDY

Based on observation, interview, and review of hospital policies and procedures, the hospital failed to meet the requirements for the Condition of Participation for Anesthesia Services.

Failure to ensure that contracted anesthesia providers were supervised by a physician and provided medical care that met accepted standards of practice and regulatory requirements resulted in endangerment of the health and safety of patients.

References: "Safe Injection Practices to Prevent Transmission of Infections to Patients" (CDC; April 2011); "APIC Position Paper: Safe Injection, Infusion, and Medication Vial Practices in Health Care" (APIC; 2010)

Findings:

1. During an interview on 12/14/2011 at 2:30 pm , the hospital's CNO stated that CRNAs that provided anesthesia services to the hospital were supervised by the CEO. The anesthetists were not supervised by a physician.

On 12/15/2011 at 8:30 AM, an interview with the hospital's CEO revealed that a group of three CRNA's (CRNA #1, #2, #3) provided anesthesia services to the main hospital OR, and eight CRNA's not in a group (CRNA #M4, #M5, #M6, #M7, #M8, #M9, #M10, #M11) provided anesthesia services to the obstetrical unit. The CEO confirmed the anesthetists provided anesthesia services by contract and were not supervised by a physician.

2. During observation of a surgical procedure on 12/15/2011 between 10:30 AM and 12:35 PM, Surveyor #2 observed CRNA #1 perform the following unsafe medication administration practices in OR #4. The hospital's CNO was present when these observations were made.

a. At 10:30 AM, Surveyor #2 observed the following on top of the anesthesia cart:

Two syringes of fluid, one syringe labeled "Versed" and one syringe labeled "Fentanyl". The labels did not include the date and time they had been prepared or the concentration of the medication.

One vial of Ondansetron and one vial of Ketorolac, each with protective cap removed and an unlabeled syringe inserted into the vial's diaphragm.

One 60 ml. unlabeled syringe of white fluid

CRNA #1 had prepared these syringes for Patient #1 while the previous surgery patient (Patient #2) was still in the room.

At 10:30 AM, an interview with CRNA #1 revealed that these medications checked out to and prepared for Patient #3. Patient #1 was the next patient on the surgery schedule. The surgery schedule taped to the CRNA's anesthesia cart was not the most current schedule. The CRNA had obtained the medications from the automated drug dispensing machine in OR #4 and had prepared them for administration before confirming the identity and performing the pre-anesthesia assessment of the next patient.

When asked why he hadn't labeled the syringes of medication, CRNA #1 stated because the syringes were inserted into and left in the medication vials, he knew what they were. He stated that he didn't label the syringe of white fluid as " Propofol " because he knew it was propofol because no other medication is white.

b. At 10:40 AM, CRNA #1 left the medications unattended in OR #4 and went to pre-op to interview Patient #1. The CNO, two surgical staff members, and Surveyor #2 were in the room with the unattended medications.

Similar findings were observed by Surveyor #1 in OR #5 on 12/15/2011 at 10:38 AM.

c. At 10:55 AM, CRNA #1 returned to OR #4 bringing a vial of Versed. CRNA #1 stated that he had obtained the vial in the pre-op area after a nurse had given Patient #1 a pre-op dose of the medication. The vial had a medication spike in its diaphragm. CRNA #1 inverted the vial and pierced the vial's diaphragm with a blunt-needle syringe and withdrew medication into a syringe. Fluid dripped from the spike during this procedure. Surveyor #2 asked CRNA #1 if he felt this was good practice, if he thought the medication might be contaminated. CRNA #1 said, "I think it's ok." The CNO instructed CRNA #1 to discard the medication vial and syringe in the sharps container and obtain a new medication vial from the Pyxis.

CRNA #1 then stated that he would use the medications checked out for Patient #3 for Patient #1 and check out the drugs for Patient #3 under Patient #1's name. CRNA #1 stated, "They're the same drugs."

CRNA #1 then stated, "In case you're wondering, I don't time my propofol syringes. I go by the time I check it out of the Pyxis."

d. At 11:35 AM, Surveyor #2 asked CRNA #1 where the medication in his anesthesia cart came from. CRNA #1 stated that he removes medications from the Pyxis, then credits the patient and keeps the medications in his anesthesia cart. He stated that he keeps ampoules of Marcaine and epinephrine from spinal trays that are left over spinal anesthesia procedures and puts them in his anesthesia cart. Regarding the Marcaine, he stated, " I have no idea how many [ampoules] I have. I would not use them on a patient."

The cart contained (among other drugs)18 amps of epinephrine 1:1000, 14 vials of neostigmine, 1 vial dexamethasone, 2 vials Ketorolac, 1 vial ondansetron, and innumerable ampoules of Marcaine.

The cart contained one undated syringe of fluid labeled "Ephedrine 1 mg/ml ". CRNA #1 stated that he keeps it in his pocket in case of emergencies.

e. At 11:44 AM, CRNA #1 asked the CNO if he could pass unused Fentanyl from OR to PACU. The CNO said he could not. This demonstrated that the CRNA was unfamiliar with hospital policies regarding controlled substances and medication administration.

f. At 12:05 PM, CRNA #1 stated, "I'm going to start drawing up for the next guy." CRNA #1 drew up Fentanyl, Versed, ondansetron, and Toredol into four syringes. He did not swab the tops of the vials with alcohol after removing their protective caps. The syringes were left in the vials and were not labeled by CRNA #1.

CRNA #1 withdrew approximately 30 ml of propofol into a 60 ml syringe and then laid the syringe on top of the anesthesia cart, leaving the needle and syringe inserted through the diaphragm of the vial. At 12:06 PM, CRNA #1 completed withdrawing 50 ml of propofol into the syringe and removed the syringe from the vial at 12:06 PM. CRNA #1 did not label the propofol syringe.

CRNA #1 then placed all the syringes of medication on top of the anesthesia cart. A partial syringe of propofol used to administer medication to Patient #1 was also on the top of the anesthesia cart. Because the syringes were not labeled, this risked mixing the syringes and using Patient #1's syringe of propofol for Patient #3.

The CNO instructed CRNA #1 not to pre-draw medications for subsequent patients before the current surgical case has been completed. CRNA #1 then removed the syringes prepared for Patient #2 from the top of the cart and placed them into one of the anesthesia cart drawers.

g. At 12:15 PM, CRNA #1 injected Fentanyl and propofol into the med port of Patient #1's IV without first swabbing the port with alcohol. CRNA #1 stated that the OR was a controlled environment and that he had swabbed the port with alcohol earlier in the case.

CRNA #1 then performed hand hygiene for the first time since the beginning of surgery.

h. At 12:34 PM, Patient #1's surgery was completed. 10 ml of propofol remained in the syringe. CRNA #1 left the syringe of propofol on top of the cart and left OR #4 to take Patient #1 to the post-anesthesia recovery unit. The CNO placed the syringe of propofol in the sharps container at Surveyor #2's request.

3. Immediate Jeopardy of the health and safety of patients was present due to the following:

a. CRNA #1 prepared medications for Patient #2 prior to confirming the identity of the patient who was next on surgery schedule. Confirming the patient's identity at multiple stages of the pre-surgery admission process is an integral part of reducing the risk of wrong-site/wrong-patient surgeries.

b. CRNA #1 prepared medications for Patient #3 prior to completion of Patient #1's surgery and placed them on top of the anesthesia cart. Because the propofol syringes were unlabeled, there was a risk of mixing up the syringes and using Patient #1's syringe of propofol for Patient #3.

4. The following additional unsafe medication practices were demonstrated by CRNA #1:

a. Not labeling pre-drawn medication syringes with the medication name, strength, quantity, and its expiration date and/or time according to accepted standards of practice risked medication administration errors. According to the drug manufacturer, propofol must be used within six hours after removing it from its vial.

b. Leaving a controlled substance (Fentanyl) unattended risked drug diversion

c. Inserting and leaving medication spikes and syringes inserted in medication vials compromised the vial's integrity and risks contamination of the medication.

d. Withdrawing medication from a vial and injecting medication into an IV port without first disinfecting the entry site with alcohol risked transmission of pathogens to the patient.

e. Not performing hand hygiene before and after medication preparation risked transmission of pathogens to the patient.

f. Storing and using medications that are not accessible for review by the hospital pharmacist risked administration of outdated, ineffective drugs to patients and risks patient harm.

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Based on record review and review of medical staff rules and regulations, the hospital failed to develop and follow policies and procedures for post-anesthesia evaluation according to professional standards of anesthesia care (Patients #M4, #M7).

Failure to perform a comprehensive evaluation of patients recovering from anesthesia places patients at risk of harm related to unrecognized complications of anesthesia and delays in necessary treatment.

Reference: "Practice Guidelines for Postanesthetic Care" (American Society of Anesthesiologists, 2002)

Findings include:

1. On 12/13/2011, Surveyor #2 reviewed the medical records of two patients who had surgery under general anesthesia (Patients #4, 7). The records included forms entitled "Post-Anesthesia Evaluation" that included the headings "No Anesth [sic] Complication" , "Oral/Teeth", "Cardiac", "Respiratory ", "Neuromuscular", "Drug Interaction/Allergy", "Other", and "Comments".

The box "No Anesth Complication" had been checked on the Post-Anesthesia Evaluation forms in both patient records. No other assessment of the patient had been documented by the CRNA that completed the form.

2. The American Society of Anesthesiologists recommended in "Practice Guidelines for Postanesthetic Care" (2002) that routine post-anesthesia assessment and monitoring includes respiratory function, including respiratory rate, airway patency, and oxygen saturation; cardiovascular function, including pulse rate and blood pressure; neuromuscular function; mental status; temperature; pain; nausea and vomiting; and postoperative hydration. This assessment is performed by an individual qualified to administer anesthesia.

3. The hospital's medical staff rules and regulations (Approved December 2010), under Article VII Anesthesia/Sedation Services, 7.3 "Post Anesthesia Evaluations", stated that a post anesthesia/sedation evaluation note would be documented in the patient's medical record by an individual qualified to administer anesthesia within 48 hours after the procedures. The rules and regulations did not identify the required components of a post-anesthesia/sedation evaluation.
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