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Based on observation, document review and staff interview, it was determined the governing body failed to ensure hospital operations were conducted in a manner to ensure safety and quality of care and failed to prevent patient exposure to Immediate Jeopardy which could lead to harm or potential for harm, serious injury or death.

These failed practices had the potential to affect all patients admitted to the hospital.

Findings:

1. At the time of survey, surgical services were not provided in accordance with accepted standards of practice and as required by the Condition of Participation for Surgical Services. Refer to citations at A-0940, A-0941, A-0942, A-0945, A-0951 and A-0957.

2. Anesthesia services were not provided in accordance with accepted standards of practice and as required by the Condition of Participation for Anesthesia Services. Refer to citations at A-1000, A-1002, A-1003, A-1004 and A-1005.

3. The hospital did not provide a sanitary environment to avoid sources and transmission of infection and communicable diseases and as required by the Condition of Participation for Infection Control. Refer to citations at A-0747, A-0748, and A-0749.

4. The hospital did not ensure outpatient services were provided according to accepted standards of practice and consistent with services provided to inpatients according to the Condition of Participation for Outpatient Services. Refer to citation A-1076.

5. The hospital was no longer constructed, arranged and maintained in a manner to ensure the safety of the patient as required by the Condition of Participation for Physical Environment. Refer to citations at A-0700, A-0702, A-0714, A-0722, A-0724, A-0725, A-0726.

6. The hospital did not effectively develop, implement and maintain an effective, hospital-wide quality assessment and performance improvement program as required by the Condition of Participation for Quality Assessment and Performance Improvement (QAPI). Refer to citation at 0263.

Based on observation, document review, clinical record review and staff interview, it was determined the hospital failed to develop, implement and maintain an effective, ongoing, hospital-wide quality assessment and performance improvement (QAPI)program.

The QAPI program failed to:

1. ensure all members of the medical staff had current licensure and narcotic permits and were granted privileges by the governing body. See Tag A-0046.

2. evaluate for quality of care, all services provided by contract or agreement. See Tag A-0083.

3. effectively apply the QAPI process to facility maintenance and all other departments responsible for buildings and equipment. See Tag A-0700.

4. expand the QAPI process to include all aspects of the infection control program. See Tag A-0747.

5. apply the QAPI process to all aspects of surgical services, including inpatient and outpatient surgical services. See Tag A-0940.

6. include evaluation of anesthesia services and failed to identify, review and address adverse events related to the administration of anesthesia and analgesia. See Tag A-1000.

7. evaluate all aspects of outpatient services. See Tag A-1076.

8. review all aspects of patients' rights, including informed consent and seclusion and restraint. See Tags A-0168, A-0175 and A-0466.

9. evaluate contracted nursing services. See Tags A-0084 and A-0395.

10. ensure nursing personnel were sufficiently qualified to meet the needs of the patients within their care. See Tag A-0392.

11. ensure an RN evaluated the care for all patients. See Tag A-0395.

12. ensure the quality, content and completion of medical records. See Tags A-0454 and A-0466.

13. evaluate all services provided by the pharmacist and the pharmacy department. See Tags A-0500 and A-0502.

14. ensure a licensed respiratory therapist supervised respiratory services. See Tag A-1154.

Based on observation, record review and staff interview, it was determined the hospital failed to:

a. provide emergency power and lighting in the operating room. See Tag A-0702 and Life Safety Code Survey Tag K-0147;

b. ensure operating room staff were knowledgeable about their responsibilities during an emergency. See Tag A-0714 and Life Safety Code Survey Tag K-0078;

c. utilize and maintain facilities as originally designed. See Tag A-0722 and Life Safety Code Survey Tag K-0130;

d. ensure the physical facilities were appropriately designed and equipped for the services provided in the surgery department. See Tag A-0725;

e. store equipment and supplies in a manner to ensure safety and quality. See Tag A-0724; and

f. the hospital failed to ensure proper ventilation, lighting, temperature and humidity control. See Tag A-0726 and Life Safety Code Survey Tag K-0067 and K-0078.

The hospital did not effectively utilize a quality assessment and performance improvement process to evaluate buildings and equipment.

These failed practices posed Immediate Jeopardy to the health and safety of patients which could lead to harm or potential for harm, serious injury or death. These failed practices had the potential to affect all patients admitted to the hospital.

Based on observation, staff interviews and review of hospital documentation, the hospital failed to maintain:
a. A sanitary environment.
b. An active ongoing hospital-wide program to prevent, control and investigate infections and communicable diseases.

Findings:

1. The hospital failed to provide a safe and sanitary environment for surgical services, including central sterile. Refer to Tag A-940.

2. The hospital failed to develop and monitor compliance with infection control policies and procedures throughout the hospital. Refer to Tags A-748 and A-749.

3. Disinfectants commonly used throughout the hospital, especially the ones used in endoscopic surgery, is not effective again Clostridium difficile. Refer to Tag A-749.

4. The infection control program did not develop measures to evaluate staff and volunteers exposed to patients with infections and communicable diseases.

Based on observation, document review and staff interview, it was determined the hospital failed to:

a. limit access to the operative and recovery areas and ensure traffic patterns adhered to accepted standards of practice;

b. ensure staff adhered to aseptic and sterile technique;

c. ensure regular terminal cleaning of the surgery department;

d. ensure sterilized materials were packaged, labeled and stored in a manner that ensured sterility;

e. ensure high level disinfection was performed properly;

f. maintain acceptable levels of temperature and humidity in the ORs and other areas within the surgery department;

g. maintain adequate airflow and pressure as required in all areas of the surgery department;

h. provide outpatient surgery services consistent with inpatient surgery; and

i. failed to integrate inpatient and outpatient surgical services into the hospital's QAPI program and failed to evaluate all surgery department activities.

The hospital also failed to:

j. provide adequate equipment for the surgery department, failed to provide an organizational chart for surgery that indicated lines of authority and delegation of responsibility and failed to have a written scope of surgical services approved by the medical staff. See Tag A-0941;

k. ensure all surgical services were adequately supervised by an qualified RN. See Tag A-0942;

l. maintain a current roster of practitioners with surgical privileges. See Tag A-0945;

m. ensure current policies, based on nationally recognized standards, were available to the surgical services department. See Tag A-0951; and

n. the hospital failed to provide post-operative care in accordance with acceptable standards of practice. See Tag A-0957.

Findings:

1. During observations of the surgery department, staff members and physicians were seen entering the restricted areas of the surgery department without proper surgery attire. OR staff also left the surgery department without covering their surgical attire and did not don shoe covers when returning to the OR. At the time of survey, a CRNA in street clothes walked past a surveyor and into the restricted OR corridor.

2. The surgery department did not adhere to appropriate traffic patterns. Because the surgery department had been modified from its original design, the OR staff were required to either travel through the recovery room to deliver dirty instruments to the decontamination area, or leave the department to travel through a public hallway to deliver dirty surgical instruments. Staff also had to leave the restricted corridor of the surgery department to travel through the emergency department to discard waste materials. The OR no longer had a soiled utility room to handle the storage of waste and biohazardous materials.

OR equipment was moved in and out of the department without appropriate cleaning and disinfection.

3. Anesthesia staff collected contaminated laryngoscope blades in a plastic receptacle on top of the anesthesia cart between cases. The anesthesia staff stated at the end of the day, the blades were sent for cleaning. "Clean" laryngoscope blades were not stored in an aseptic manner inside the anesthesia carts.

4. A piece of endoscopy equipment in the OR had a used water reservoir (still filled with water) and used suction tubing attached to it that had not been changed between patients.

5. The anesthesia staff used bottles of isopropyl alcohol to "disinfect" the anesthesia cart and "other things" as needed. The anesthesia staff did not use hospital approved disinfectants. There were indications in other areas of the surgery department that bottles of alcohol were used to "disinfect" surfaces. The disinfectant agent used in some areas of the surgery department was not effective against C. difficile. In addition, there was no documentation to show the agent was effective against hepatitis viruses.

6. The surgery staff did not have access to hand sanitizer in all locations were it was necessary.

7. Items that should be stored in the sub-sterile area, such as hair clippers and large gallon bottles of surgical prep solution, were stored in the operating rooms.

8. When staff demonstrated how they poured large bottles of prep solution onto the sterile prep field, the staff stood too close to the sterile field, and risked contaminating the field. There was also a risk of drips from the lip of the bottle onto the sterile field. In addition, the staff were not sure if a large bottle of prep solution that had been open for several days/weeks was still aseptic and appropriate for use as a surgical prep solution.

9. Cardboard shipping boxes were found throughout the surgery department, including the operating rooms.

10. During a tour of the surgery department, it was evident there was no regular terminal cleaning and no periodic deep cleaning. Floors, shelves and other surfaces had dust and debris. Air vents were dusty and rusted. The anesthesia carts were rusted, had old medical tape on them and were dirty inside and out. Metal cabinetry was rusted and chipped. OR walls, doors, door frames and baseboards were marred, chipped, scratched and no longer intact. These areas could not be cleaned or disinfected.

Surgical equipment was not thoroughly wiped clean after each case and again at the end of the day. Various pieces of equipment and other department surfaces had old adhesive tape that could not be cleaned or disinfected.

The instrument decontamination room and the sterile processing room were not terminally cleaned and did not have regular repairs to walls and surfaces to allow for adequate disinfection. Sinks in all areas had a build up of mineral deposits that prevented adequate cleaning and disinfection.

The staff changing areas were dirty. Sinks and floors were dirty and there was no hand sanitizer available in this area. The staff stated they had little or no housekeeping support for the surgery department. There was no documentation the OR staff had adequate training on all departmental cleaning requirements.

11. Multiple packages of hospital-processed sterilized materials were found throughout the department. Deficient practices included related to sterilization included:

a. Peel packages were not sealed correctly to prevent contamination after sterilization.
b. Some items were packed with too many items for adequate sterilization.
c. Clamped instruments were sterilized in the closed position, preventing steam from penetrating all the grooved surfaces.
d. Items were wrapped for sterilization in cloth wrappers that had not been inspected for holes. The cloth-wrapped items were not tightly wrapped and allowed for air contamination and contact contamination.
e. Some sterile packages had evidence of liquid stains and possible contamination.
f. Many of the sterilized items were stored incorrectly. There were too many items stored in bins and on cabinet shelves. This allowed for potential crushing, tearing and damaging of the sterile packaging.
g. Non-sterile items were stored with sterile items.
h. Liquids were stored with sterile packages.
i. Some sterile packages were stored on the floor of the sterile supply room.
j. The staff did not follow the most basic rules about instrument decontamination. The decontamination room was not kept clean. Used blankets and towels were found on counter tops. The room did not have a magnifying glass that should be used to inspect grooved instruments for remaining bio-contaminants after washing and rinsing.
k. The staff did not adhere to accepted standards of practice to verify adequate sterilization. Steam indicators were placed on top of multiple items wrapped together, rather than in the middle of the materials.
l. The hospital failed to maintain adequate records of sterilization processes as required by accepted standards of practice. Some of the missing documentation included no autoclave number, no detail of what was contained in each load, no documentation of pass/fail, no documentation of the cycle parameters and no staff name, date and time of loads that were processed.
m. Flash sterilization records were not documented adequately. The staff wrote over the sterilizer tapes so that the time and temperature of sterilization could not be seen. There was no documented reason for the flash cycle. The staff did not document the patient's name, the medical record number, the doctor's name and the procedure performed when flash sterilization was used.
n. Staff were inadequately trained or had no documentation of training to perform decontamination and sterilization processes.
o. The hospital had inadequate policies to govern these practices.
p. There were no reports to the infection control committee or the quality committee on sterilization practices.

12. The hospital failed to perform high-level disinfection appropriately:

a. The agent used for high-level disinfection of endoscopes was not maintained at a temperature recommended by the manufacturer to ensure adequate disinfection.
b. Appropriate and complete records of high-level disinfection were not maintained to verify adequate processing.
c. The staff did not record the number of the scope used on each patient.
d. The sinks used to wash/rinse endoscopes were not large enough or deep enough to allow for adequate cleaning.
e. The area where high-level disinfection was performed was dirty and was set up to allow for cross contamination between dirty and clean processed in the room.
f. Staff were inadequately trained or had no documentation of training to perform high-level disinfection.
g. The hospital had inadequate policies to govern these practices.

13. Records indicated temperature and humidity levels in the surgery department and operating rooms were frequently too high in the summer and too low in the winter. There was no documentation actions were taken to correct these conditions. The decontamination room was excessively warm, excessively humid and did not have adequate air exchanges.

14. The OR where bronchoscopy was performed did not have negative airflow and did not maintain adequate air exchanges.

15. Inpatient and outpatient surgical services were not consistently provided to all patients. Pre-operative preparation was different for all types of inpatient and outpatients. Some surgery outpatients had abbreviated intraoperative care and/or extremely shortened or no recovery period, based on the type of procedure performed. None of the processes related to pre, intra and post-operative care were consistently provided in a uniform manner for all surgery patients.

These failed practices posed Immediate Jeopardy to the health and safety of patients which could lead to harm or potential for harm, serious injury or death. These failed practices had the potential to affect all patients admitted to the hospital.

Based on interview, clinical record review and hospital document review, it was determined the hospital failed to:

a. provide anesthesia services under the direction of a qualified physician;

b. identify all the locations in the hospital where anesthesia / analgesia may be administered;

c. define the qualifications for each clinical practitioner who may administer anesthesia, moderate sedation or other forms of analgesia;

d. review adverse events related to the administration of anesthesia and analgesia, including moderate sedation;

e. develop, approve and implement policies and procedures for the delivery of anesthesia services consistent with nationally recognized standards of practice. See Tag A-1002;

f. ensure an appropriate pre-anesthesia evaluation was provided for each surgical patient according to nationally recognized standards of practice. See Tag A-1003;

g. ensure the intraoperative record documented sufficient information to demonstrate appropriate anesthesia care was provided to the patient during surgery. See Tag A-1004; and

h. the hospital failed to ensure the post-anesthesia evaluation was not performed at the time of admission to the recovery area and failed to ensure the post-anesthesia evaluation conformed to current standards of practice. See Tag A-1105.

The hospital failed to include anesthesia services and anesthesia-related adverse events in the QAPI program.

Findings:

1. On 02/12/14, the hospital provided anesthesia services policies and procedures. There was no documentation of an organizational chart for anesthesia services.

On 02/13/14, two contracted certified registered nurse anesthetists were asked who had been appointed as the chief of anesthesia. They stated they were unsure.

The surgery manager stated no physician had been designated as the chief of anesthesia.

A review of medical staff appointments had no documentation a physician had been appointed to the position of chief of anesthesia. The medical staff bylaws did not document criteria for determining appointment to this position.

In addition, the two CRNAs did not have current privileges granted by the medical staff and the governing body.

2. The anesthesia policies and procedures did not address all hospital locations where anesthesia may be provided.

3. The policies did not define the qualifications for each clinical practitioner who may administer anesthesia, moderate sedation or other forms of analgesia.

4. The policies had no documentation they were based on national guidelines and did not delineate who could administer moderate sedation.

5. The hospital had no system to review adverse events related to the administration of anesthesia and analgesia, including moderate sedation.

6. OR and recovery room staff stated the CRNAs who provided anesthesia services failed to utilize patient warming devices in the OR and in recovery resulting in abnormally low temperature readings during the post-operative period. Clinical record review verified that patient temperatures were sometimes below 97 degrees Fahrenheit at the time of admission to the recovery room.

These failed practices posed Immediate Jeopardy to the health and safety of patients which could lead to harm or potential for harm, serious injury or death. These failed practices had the potential to affect all patients admitted to the hospital.

Based on observation, document review and staff interview, it was determined the hospital failed to provide outpatient services consistent with acceptable standards of practice. The hospital did not include outpatient services in the QAPI program.

Findings:

1. On 02/13/14 and 02/13/14, observations were made of the the pre-op/outpatient unit. The physical facility for this unit was not consistent with other patient care areas in the hospital.

The area where patients were prepared for surgery (the pre-op/outpatient unit) was remotely located from the operating room. The area was not configured to be a pre-op unit. Patient bays could not be visualized by the nurse working at the nurse's station.

The nurse's station was too small to function as a nurse's station. Confident information could not be secured in this area. The nurse's station was not manned at all times and was vulnerable to access by unauthorized persons.

The unit was isolated from other areas by heavy double doors. A geriatric psychiatric unit was adjacent to the outpatient unit, but it was separated by locked double doors. A nurse who needed help in pre-op could not get assistance from that unit. There were no other nursing units nearby for immediate assistance.

The unit did not have all the features of other patient care areas. There was no family or visitor waiting area. The unit did not have a supply room, linen room, clean and soiled utility rooms, or nourishment station. There was no functioning medication room or IV preparation station.

The nurse working on the unit was asked how she obtained medications. She stated she called the OR to bring them to her or she called pharmacy as needed.

She was asked if there was anyone else assigned to the unit when it was open. She stated she was the only person assigned to that unit. She was asked if she ever had to leave the unit for any reason. She stated sometimes had to transport patients to the OR. She stated during those times when she left the unit, the area was left unattended until she returned.

2. During interviews with staff, it was evident there were inconsistencies in the way patients received pre-op care. The staff stated some outpatients received pre-op care in the outpatient department. Some patients received pre-op care in the recovery room. The recovery room was not designed an equipped as a pre-op area. Decisions about where patients received pre-op care were based on staffing availability and anesthesia personnel preferences.

Clinical records documented different care for patients who received pre-op care in the outpatient area versus in the recovery area or on the inpatient unit. Different documents were used to record pre-op care in different areas. Standardized pre-op checklists and pre-op procedures were not used for all patients who received pre-op care.

3. Intra-operative care provided to outpatients differed from inpatients. Some outpatients had modified or hybrid records for the intra-operative period. When the standard intra-operative record was used, all required parts of the form were not completed. It was not evident all outpatients received the same standard of care during the intra-operative period.

4. Post-anesthesia and post-sedation care was not provided for all patients consistently. Endoscopy patient records had no documentation of post-procedure care and assessment. Staff stated the patients were either taken directly from the OR back to the outpatient department for discharge, or were placed in wheelchairs in the OR corridor until they were "awake enough" to go home. Some patients received recovery care in the pre-op unit rather than in the recovery room. There was no consistent recovery care provided for all surgery patients.

Based on record review and interviews with hospital staff, the governing body does not ensure that all members of the medical staff providing patient care have current appointments to the medical staff with proof of current licensure, narcotic permits and privileges.

Findings:

1. Three (#'s YY, ZZ & c) of three physicians, two (#'s UU & VV) of two Certified Registered Nurse Anesthetists (CRNA), one (# a) of one Certified Nurse Practitioner (CNP), one (# TT) of one Radiology Practice Assistant (RPA), and one (# b) of one podiatrist did not have evidence of current appointment to the medical staff as required.

2. Three (#'s YY, ZZ & c) of three physicians, two (#'s UU & VV) of two CRNAs, and one (# TT) of one RPA did not have current privileges delineated.

3. Two ( #'s ZZ and c) of three physicians and one (# UU) of two CRNAs did not have evidence of current licensure.

4. Three (#'s YY, ZZ & c) of three physicians and one (# a) of one CNP with prescriptive authority did not have evidence of current federal and state narcotic permits as required.

5. Staff T stated on 02/ 13/14 that the person previously doing credentialing no longer worked at the hospital and no one was presently performing that task.

Based on record review and interviews with staff, the governing body did not ensure all services provided by contract or agreement were evaluated, and in compliance with all applicable Medicare Conditions of Participation. Contracted services were not assessed through the hospital's Quality Assessment Performance Improvement (QAPI) program.

There was no evidence in governing body, medical staff or QAPI meeting minutes for 2013 that services provided by contract or agreement were evaluated for quality of care and for actions taken if needed.

Hospital staff verified that contracted services were not evaluated by the QAPI program.

Based on record review and interviews with hospital staff, the governing body failed to ensure personnel providing services by contract were oriented, trained and evaluated to ensure competence and were required to meet the same requirements as employees of the hospital.

Findings:

During the tour of the hospital on 02/11/14, Staff P stated the hospital utilized agency nurses.

Review of Staff N's, an agency nurse, personnel file had no documentation of hospital orientation, competencies or skills checklist.

On 02/13/14 in the afternoon, Staff U was asked for evidence of hospital training and orientation for Staff N. None was provided.

Based on review of hospital documents and interviews with hospital staff, the hospital failed to maintain a complete list of all services provided by contract or agreement which includes the scope and nature of the services provided.

Findings:
On 02/11/14, the hospital were asked to provide a list of contracted services.

On 02/12/14 Staff SS, provided the surveyors with a list of contracted services. Staff SS stated the dates on the contract list were inaccurate and the person who was responsible for the contract list is no longer employed at the hospital.

The list of contracted services provided for review did not contain a description of the services provided by contract or agreement. This was confirmed by Staff SS on 02/13/14.

Based on medical record review, policy and procedure review and interview, it was determined the hospital failed to provide the patient or his/her representative with informed consent prior to treatment/procedure.
This occurred in 5 of 5 newborn records reviewed (#1, 2, 4, 5, & #10).
Findings:
1. On the morning of 02/12/2014, surveyors reviewed policies and procedures for the Obstetrical unit. A policy titled, " Hepatitis B Vaccination of Newborns", documented, "...obtain consent for the administration of Hepatitis B vaccine for all newborns ..."
2. Five of Five newborn records reviewed documented the Hepatitis B vaccination was given. All five newborn records reviewed contained no documented and signed informed consent.
3. On the morning of 02/13/2014, surveyors asked Staff B if informed consents were initiated prior to administering the Hepatitis B vaccine to newborns. Staff B stated that no informed consents are done prior to administering the Hepatitis B vaccine to newborns.

Based on review of hospital documents and medical records, the hospital failed to ensure restraints were used in accordance with physician's orders. Three of three patients (Patients #16, 17 and 18) restrained and whose medical records were reviewed, were not restrained according to physician's orders.

Findings:

Patient #16 - Review of the medical record documented Patient #16 had been placed in soft wrist restraints on 01/14/13 and 01/15/13. The medical record did not contain a physician order on 01/14/13 for restraints.

Patient #17 -Review of the medical record documented the patient was restrained from 01/09/13 through 01/12/13. There was no physician order for restraints for 01/10/13. The restraint order for 01/12/13 was not complete. The order did not contain the time the physician wrote the order.

Patient #18 - According to the restraint flowsheet, was restrained on 11/10/13, 11/17 through 11/19/13, 11/21/13 and 11/22/13. The restraint orders for the following dates were incomplete, 11/18, 11/21 and 11/22/13. The order dated 11/18/13 did not contain a patient label or any other patient identifier. The order also did not contain the time and date the physician wrote the order. The restraint order dated 11/21/13 did not contain the date the order was written by the physician. The restraint order dated 11/22/13 did not contain the date or time the order was written by the physician. The medical record did not contain a physician order for restraints for the 11/19/13.

Based on policy and procedure review, medical record review and staff interview the hospital failed to ensure restrained patients were monitored and assessed according to the hospital policy. This occurred in three of three patients (Patient # 16, 17 and 18) restrained and whose medical records were reviewed.

Findings:
The hospital nursing Policy and procedures for restraints, documents..."After the original order expires, a physician or licensed independent practitioner...must see and assess the patient before issuing a new order..." and "...The condition of the restrained patient will be continually assessed, monitored, and reevaluated at observed at (sic) intervals not greater than 15 minutes. This will be documented on the restraint flowsheet..."

Review of the medical record for Patient #17 did not contain a physician face-to-face assessment on the following dates 01/09/13 and 01/12/13.

The restraint flowsheets for Patient's #16, 17 and 18 did not contain documentation of every 15 minute assessments per hospital policy. This was confirmed by Staff I, on 02/13/14 at 0815.

Based on personnel record review, policy and procedure review, and staff interview, it was determined the hospital failed to ensure qualifications of nursing personnel was sufficient to meet the needs of the patients. This occurred in 5 of 5 maternal/newborn nursing personnel records (A, B, C, D, & E) and 4 of 4 operating room personnel records (Y, QQ, RR, & PP).
Findings:
1. A policy titled, "Orientation to Childbirth Center", documented " ...All employees working in Labor and Delivery must attend Fetal Monitoring Classes and take a test ..." The policy further documented, "... In-services will be offered ... concerning Labor/Delivery, Postpartum, and Nursery ... "
2. A policy titled, "newborn hearing screening", documented "...on-going staff education will be provided by the Program Coordinator to screening personnel..."
3. On the morning of 02/13/2014 the OB manager was asked who performed the newborn hearing screening tests. She stated that the nurses on the OB unit performed the hearing screening tests.
4. On the morning of 02/13/2014 the OB manager was asked if all OB personnel were adequately trained in OB specific competencies:
· Fetal heart rate monitoring
· Care of the antepartum patient
· Care of the postpartum patient
· Newborn hearing screens
· Newborn care and assessment
· Post-operative cesarean deliveries
· Administration of blood products
· Discontinuing of epidural catheters
· Newborn heel sticks for drawing of blood
· Use of bili-lights and bili-blankets
The OB manager stated that all staff on the OB unit was trained in OB specific competencies and the competencies would be found in the personnel records. Five of Five OB staff personnel files reviewed did not contain OB unit specific competencies.
5. On the morning of 01/13/2014, surveyors asked the OB manager what nursing personnel recovered a patient that delivered by cesarean delivery. The OB manager stated that during the initial recovery phase the patient is taken care of by the Operating Room circulating nurse or the Operating Room recovery nurse. Four of Four operating room personnel files reviewed did not contain competencies for post-operative care of the cesarean delivered patient.

Based on record review and staff interview it was determined the hospital failed to ensure a Registered Nurse (RN) evaluated the care of each patient on an ongoing basis. This occurred in 13 (#1 through 10, #12, #14 and #15) of 32 records reviewed.
Findings:
1. On the afternoon of 02/13/2014 Staff U stated that an RN assessment is to be done on all patients at least once every 24 hours.
2. Five of Five newborn records reviewed did not contain an RN assessment every 24 hours.
3. Five of Five maternal records reviewed did not contain an RN assessment every 24 hours.
4. Review of the medical records for pediatric Patients # 12, 14, and 15 did not contain
any initial or on-going assessment of the vital signs to include blood pressure. This was
confirmed by Staff U on the afternoon of 2/13/14. On the afternoon on 02/13/14, Staff U
was asked if the hospital had a policy regarding the vital sign assessments for pediatric
patients. None was provided.

5. An LPN was regularly assigned to provide care in the recovery room. The LPN assessed patients upon admission to recovery and at the time of discharge from recovery. The OR manager stated an RN was not provided to oversee and verify the LPN's assessments.

Based on record review and staff interview, the hospital failed to ensure non-employee nursing personnel were oriented to hospital policies and procedures and their clinical activities were evaluated.

Findings:

During the tour of the hospital on 02/11/14, Staff P stated the hospital employees agency nurses.

Review of Staff N's, an agency nurse, personnel file did not have any documentation of competencies or skill checklist in the education file.

On 02/13/14 in the afternoon, Staff U was asked for evidence of hospital training and orientation for Staff N. None was provided.

Based on medical record review and staff interview, the hospital did not ensure that all entries in the medical record:

a. Contain date and time when they were signed by the physician. This occurred in 32 of 32 (#1 through #32) medical records reviewed.

b. Contains complete entries. This occurred for two of thirty-two medical records (#20 and #26) reviewed.

Findings:

1. On the afternoon of 02/12/14, Staff T verified that the medical records (#1 through #32) reviewed were incomplete, missing date and time that physicians issued orders.

2. Clinical records #20 and #26 did not contain a physician signature for verbal orders. Medical records greater than 30 days following discharge did not contain physician signatures for verbal orders.
3. On the afternoon of 02/12/14, Staff T verified that medical records (#20 and #26) reviewed did not contain a physician signature for verbal orders.

Restraints

4. Patient #16 - Review of the medical record documented Patient #16 had been placed in soft wrist restraints on 01/14/13 and 01/15/13. The medical record did not contain a physician order on 01/14/13 for restraints.

5. Patient #17 -Review of the medical record documented the patient was restrained from physicia01/09/13 through 01/12/13. There was no physician order for restraints for 01/10/13. The restraint order for 01/12/13 was not complete. The order did not contain the time the physician wrote the order. The restraint orders for 01/09/13 and 01/12/13 did not contain the date/time the face-to-face assessment was completed by then.

6. Patient #18 - According to the restraint flowsheet, was restrained on 11/10/13, 11/17 through 11/19/13, 11/21/13 and 11/22/13. The restraint orders for the following dates 11/18/13 and 11/22/13 did not contain the time and date the restraint order was written by the physician. The restraint order for 11/21/13, did not contain the date the restraint order was written by the physician.

Based on medical record review, policy and procedure review and interview, it was determined the hospital failed to provide the patient or his/her representative with informed consent prior to treatment/procedure.
This occurred in 5 of 5 newborn records reviewed (#1, 2, 4, 5, & #10).
Findings:
1. On the morning of 02/12/2014, surveyors reviewed policies and procedures for the Obstetrical unit. A policy titled, "Hepatitis B Vaccination of Newborns", documented, "...obtain consent for the administration of Hepatitis B vaccine for all newborns..."
2. Five of Five newborn records reviewed documented the Hepatitis B vaccination was given. All five newborn records reviewed contained no documented and signed informed consent.
3. On the morning of 02/13/2014, surveyors asked Staff B if informed consents were initiated prior to administering the Hepatitis B vaccine to newborns. Staff B stated that no informed consents are done prior to administering the Hepatitis B vaccine to newborns.

Based on clinical record review and staff interview, it was determined the hospital failed to ensure:

a. medication orders were reviewed for appropriateness by a pharmacist;

b. medications were properly stored; and

c. the hospital failed to show evidence a pharmacist monitored and evaluated a patient's frequent need for an antihistamine medication for one (#36) of one patient identified with a potential drug reaction.

Findings:

On 02/12/14 and 02/13/14, clinical records were reviewed for medication orders.

1. The records for some surgery patients included a set of pre-printed standing orders for the recovery room. The orders for pain medication, nausea medication and IV fluids left the following to the discretion of the nurses:

~ the route the medications could be administered
~ the intervals at which the medications could be administered

None of the recovery nurses had questioned or requested clarification of the orders from the physicians.

There was no documentation as to when the standing orders were originated and no documentation the pharmacist and the medical staff approved these standing orders or other standing orders used in the hospital.

2. Medications were observed stored with food and with chemicals in the surgery department and recovery area. Medications were not stored in a sanitary manner in the anesthesia carts.

3. Medications in the OR and in recovery were not secured when not in use. Medications were left on desks, on countertops and in drawers in all areas.

4. Open, undated medications were found in the OR, in the recovery room and in anesthesia carts.

5. Topical, injectable and oral medications were found stored together in bins in the anesthesia workroom.

6. Expired medications were found throughout the ORs, the anesthesia workroom and the recovery room.

7. A tray of emergency medications for the nuclear medicine department was found unsecured in the recovery room. The tray was dirty and some of the items in it were expired.

8. OR staff stated the pharmacy department did not survey for storage of medications or for expired medications in the OR or recovery room.

9. The clinical record for patient #36 documented eight doses of intramuscular antihistamine were administered to the patient over a period of approximately 48 hours. The clinical record documented the patient complained of intolerable itching and a rash. There was no documentation a pharmacist reviewed this patient's case as a possible adverse drug reaction.

Based on observation and staff interview, it was determined the hospital failed to secure medications in the OR and in the recovery room when the department was closed.

Finding:

On 02/13/14, the OR staff was asked if all doors accessing the OR and the recovery room could be locked. They said they could not.

Medications were stored in these areas in unlocked cabinets and drawers. The anesthesia carts could be easily rolled out of the department.

The hospital could not ensure the medications were safe from tampering or misappropriation.

Based on observation and interview, it was determined the hospital failed to provide the operating room suites with two sources of power. The operating rooms had only one source of power.

The hospital did not provide battery back-up lighting for the operating rooms.

On 02/13/14, the plant operations manager confirmed these findings.

Based on observation and staff interview, it was determined the hospital failed to ensure operating room staff were knowledgeable about their responsibilities during an emergency.

Findings:

On 02/13/14, staff member C was asked by the surveyor the purpose of the Line Isolation Monitor Remote Alarm located on the wall in the operating room. She did not know the purpose of the equipment. She stated she thought it was a medical gas alarm.

A review of training files for the operating room staff had no documentation of training on all aspects of fire safety preparedness including:

~ the location of zone valves of nonflammable medical gas systems and the station outlets controlled by each valve
~ the location of electrical service boxes and the areas they served
~the location and proper use of fire extinguishers
~the designated methods and routes for evacuating patients from the OR
~the location of fire alarm boxes, or knowledge of other methods for summoning the fire department

There was no documentation the OR staff had conducted a fire drill within the department to evaluate and train for the fire hazards that could be encountered during surgical procedures.

Based on observation and staff interview, it was determined the hospital failed to utilize and maintain the areas within the surgery department as they were originally designed.

Findings:

On 02/12/14 and 02/13/14, observations were made of the surgery department.

During tours of the department, it was determined rooms and spaces within various areas of the surgery department had been modified or eliminated from the original design.

Because of the design changes and alterations made to the purposes of certain rooms, the rooms no longer met the requirements as required by State regulation. These changes also caused significant problems with adherence to infection control guidelines.

Examples of the changes included:

1. The surgery pre-operative holding area was changed to a nuclear medicine location.

2. The semi-restricted corridor adjacent to the former pre-op holding area was made into an unrestricted corridor.

3. The change to the corridor required the OR staff to leave the restricted areas of the surgery department and travel through a public corridor to deliver dirty surgical instruments to the decontamination area.

4. The change to the corridor then placed the OR manager's office outside the surgery department.

5. The original recovery room was being used inappropriately as a combination pre-operative and post-operative care area.

6. A utility room had been changed into a decontamination room that did not meet the requirements.

7. The soiled utility room was eliminated from the OR. Staff now had to leave the department to discard trash, used linens and biohazard material.

8. Another room, possibly a clean utility room, was made into the staff breakroom. This placed a break area inappropriately in the middle of the restricted space in the OR.

9. The OR no longer had a clean utility room.

10. There was no designated room for biohazard material.

11. The two CRNAs made the anesthesia workroom, located within the surgery suite, into their personal living space. The room contained a household bed with personal linens, upholstered furniture, curtains, a rug, personal grooming items and food. This area was supposed to be used exclusively for anesthesia supplies (sterile and non-sterile) and medications. Instead, the CRNAs mingled their personal items and food with sterile supplies and medications.

12. One of the three operating rooms designed with positive airflow was used to perform bronchoscopy procedures. Bronchoscopy must be done in a room with negative airflow.

13. The OR had no areas to clearly separate clean and dirty equipment.

14. The sub-sterile room between two operating rooms was not used appropriately and no longer had all the required features.

15. The surgery department no longer had a medication station or medication room with all the required features.

16. Large and small cylinders of medical gases were stored with surgical equipment.

17. A former obstetrical unit was used as a pre-op area and as a recovery area. The space did not meet the requirements for pre-op and recovery and was located far from the surgery department.

18. The surgery department did not have storage for clean linens.

On 02/13/14, the staff confirmed these findings.

Based on observation and staff interview, it was determined the hospital failed store surgical equipment and other supplies in a manner to ensure quality and safety.

Findings:

On 02/12/14 and 02/13/14, tours were conducted throughout the surgery department. The following observations were made:

1. Sterile supplies were stored in various places within the OR in a manner that subjected the items to contamination through punctures or tears through the packaging.

2. Sterile supplies were subjected to excessive heat and humidity levels as observed during the survey and as documented on hospital records of temperature and humidity in the sterile supply storage areas.

3. Sterile supplies were stored on dusty and dirty shelves.

4. Vents in the OR and in other areas of the surgery department were not cleaned and allowed for air contamination of surgery equipment and supplies.

The findings were verified by the staff.

Based on observation and staff interview, it was determined the hospital failed to ensure the physical facilities were appropriately designed and equipped for the services provided in the surgery department.

Findings:

1. During observations of the surgery department on 02/12/14 and 02/13/14, it was determined the surgery department was no longer equipped to provide services as required.

2. The following areas were not properly equipped:

recovery room
pre-op
endoscopy procedure room
anesthesia workroom

Staff confirmed this finding at the time of survey.

Based on observation, record review and staff interview, it was determined the hospital failed to ensure proper ventilation, light, temperature and humidity control in the surgery department.

Findings:

1. On 02/13/14, the surveyors noted excessive room temperatures and humidity in the decontamination room. The room also did not provide adequate air exchanges and negative airflow.

2. Records indicated the staff noted frequent excessive temperature and humidity over a period of time in various areas operating rooms. At other times the records indicated excessively low humidity. Actions had not been taken to correct this.

3. All areas where sterile supplies were stored did not have positive air flow as required.

4. Soiled work areas and decontamination rooms did not have negative airflow pressure with 10 air exchanges per hour as required. The air was not ventilated directly outdoors as required.

5. The hospital did not ensure clean work areas and clean storage areas maintained positive airflow.

Based on surveyors' observations, hospital document review and interviews with staff, the hospital's infection control preventionist (ICP) failed to ensure hospital wide infection control policies were implemented and monitored.

Findings:

1. The hospital provides its own laundry services. Although the laundry services department had policies and procedures for washing, they did not have policies and procedures for drying the laundry. The infection control manual did not contain policies and procedures for the laundry services.

2. Although the infection control manual contained infection control policies and procedures for each department/area of the hospital except for laundry services, meeting minutes and surveillance activities provided to the surveyors did not reflect the ICP had tracked to ensure the policies had been implemented or followed. Staff Y, A and AA told the surveyors that the ICP had not monitored activities in their departments.

3. The policies and procedures manual and meeting minutes did not contain evidence the hospital's infection control policies and procedures had been reviewed annually as required by the Infection Control Plan (Plan) provided to the surveyors and identified as the current Plan.

4. The hospital did not have a current Infection Control Plan. The Plan, provide to the surveyors and identified as the current one, documented the ICP and committee would review the Plan annually. The revision date recorded at the top was 3/12. Meeting minutes from October 2012 to October 2013 did not demonstrate the ICP and committee had revised or reviewed the Plan since that time.

Based on observation, review of infection control data, surveillance activities, personal files, meeting minutes, and hospital documents, and interviews with hospital staff, the hospital failed to ensure the infection control practitioner (ICP) developed and maintained an ongoing comprehensive system for reporting, analyzing and controlling infections and communicable diseases among patients and staff and ensuring a sanitary environment.

The hospital does not have an ongoing infection control/prevention (IC) program that reviews hospital practices and infections/communicable diseases, analyzes data on these practices and infections, develops qualitative plans of actions to and provides follow-up to ensure corrective actions are appropriate, working and sustained.

Findings:

Program:
1. The hospital IC program had not performed a hospital risk assessment to determine what organisms are most likely to occur in the hospital and what organisms are most likely to be present in the community.

2. The hospital IC program had not performed an annual tuberculosis (TB) risk assessment. Staff U stated they had been having trouble obtaining testing supplies for annual TB testing.

3. The hospital IC program had not reviewed and revised its current infection control plan with details for active surveillance/monitoring to ensure the hospital wide infection control procedures were followed in each department of the hospital.

4. The IC program did not develop measures to evaluate staff and volunteers exposed to patients with infections and communicable diseases.


Disinfectant:
1. On 02/11/2014, surveyors observed the following products in use throughout the hospital: CDC-10 and GS Neutral disinfectant cleansers. Neither of these products is effective against Clostridium difficile (C-diff of C-difficile) or tuberculosis. Staff U told the surveyors that bleach should be used for C-diff. One of two housekeeping employees did not know that a one part bleach to ten parts water, made fresh daily, was the appropriate disinfectant for C-diff.

2. The hospital's surgical services included endoscopy procedures. The most prevalent organism for colonoscopies is Clostridium difficile (C-diff). Staff Y stated they used PD-129 throughout the surgery area. This produce is not effective against C-diff.

3. Meeting minutes did not reflect the ICP and infection control committee had reviewed and approved the disinfectants.


Surveillance/Monitoring:

At the time of entrance to the hospital, the surveyors requested infection control documentation, including "all surveillance/monitoring activities" for the past 12 months. The surveyor reviewed all data presented.

Review of infection control surveillance/monitoring data and meeting minutes did not show the infection control monitored all departments and units to ensure compliance with established hospital policies and procedure and standards of practice to maintain a safe and sanitary environment, including, but not limited to:

1. Surgical Services:
a. There was no oversight and monitoring of flash sterilization practices. The surveyor reviewed the autoclave envelopes. Flash sterilization loads did not document a patient name associated with the flashed item and there was no documentation of the reason for flashing. There was no documentation if the flashed items were processed wrapped or unwrapped.

b. Routine sterilization was not reviewed or monitored for adequate cycles. On 02/13/2014, one surveyor observed surgical packs that were wrapped incorrectly.

c. Routine endoscope processing was not reviewed for adequate cycles.

d. There was no system in place to monitor and identify when a scope had been stored for five or more days without reprocessing. The staff stated they did not know this was a requirement.

e. Refer to Surgery tags A-940, A-942, A-951, and A-957 for detailed examples.

f. Staff Y told the surveyors on 02/12/2014 that she nor the ICP had monitored surgical services. This was confirmed with Staff X on 02/12/2014.

2. Isolation is not monitored to ensure:
a. Patient are placed in appropriate isolation according to current CDC guidelines,
b. Isolation carts are stocked appropriately,
c. Staff, physicians, volunteers, and visitor follow appropriate isolation requirements,
d. Appropriate disinfection of the room occurs.

3. There is no monitoring of disinfectant applications throughout the hospital departments and locations to ensure:
a. Appropriate disinfectants are selected and used; and
b. The disinfectants are mixed/diluted, applied and remain "wet" contact time according to the manufacturers guidelines.
c. This finding was confirmed with Staff X on 02/12/2014.

4. The ICP did not monitor and track staff illness to ensure infections and communicable diseases were not transmitted between staff and between patients and staff.

5. Laundry services are not monitored to ensure washing and drying of hospital linens is completed according to appropriate standards of practice and infection control. Staff Z and AA told the surveyors on the morning of 02/13/2014 that no one monitored laundry practices.

6. On 02/12/2014, the surveyors observed two obstetrical nursing staff in the cafeteria without covers over their scrub uniforms. The unit has a policy that requires staff to wear cover-ups when leaving the unit.

Based on observation, document review and staff interview, it was determined the hospital failed to:

a. provide adequate equipment for the surgery department;

b. develop and implement an organizational chart for the surgery department that indicated lines of authority and delegation of responsibility; and

c. the hospital failed to have a written scope of surgical services.

Findings:

1. During a tour of the surgery department on 02/12/14 and 02/13/14, the surveyors observed the recovery room. This room was also used to prepare patients pre-operatively. The staff stated that potentially two recovery patients and two pre-op patients could be cared for in this area at the same time.

At the time of the survey, there was not enough of the required equipment, such as blood pressure, pulse, temperature, EKG, and oxygen saturation monitoring equipment available for four patients.

The room was not set up with other supplies and equipment to care for four patients. The staff stated they sometimes borrowed equipment and supplies from the operating room.

2. The hospital did not have an organizational chart for surgical services.

3. The hospital did not have a scope of surgical services defined in writing and approved by the medical staff.

Based on observation, document review and staff interview, it was determined the hospital failed to ensure all surgical services were adequately supervised by an qualified RN.

Findings:

1. Observations were made of the surgery department and related areas. The department had the appearance of neglect and poor maintenance. Staff was observed violating requirements for surgical attire and traffic flow in the restricted areas. Anesthesia staff and physicians were not required to adhere to strict operating room guidelines for infection control.

2. Inadequate oversight was provided over critical processes such as sterilization, high-level disinfection, aseptic and sterile technique and other infection control requirements for surgical instrument processing.

3. Staff who performed circulating duties, scrub tech duties and pre- and post-operative care were not adequately supervised.

4. Surgery department policies and procedures had not been reviewed and were no longer current.

5. Through record review and interview, it was verified the OR manager was required to routinely provide direct patient care in a number of areas within the surgery department. Many clinical records documented the OR manager was the circulator and recovery nurse for patients.

6. The OR manager was also tasked with training and direct supervision of all new OR staff, many with no prior surgery, pre-op or recovery experience.

7. Although the OR manager had the training and experience for this position, she was prevented from performing these management duties because she was required to provide direct patient care and direct staff supervision whenever the surgery department was open.

Based on document review and staff interview, it was determined the hospital failed to maintain a current roster of practitioners with surgical privileges.

Findings:

On 02/12/14, this finding was confirmed by the OR staff. The surgery department did not have access to this information.

Based on document review and staff interview, it was determined the hospital failed to ensure surgery department policies were current and were based on nationally recognized standards.

Findings:

On 02/12/14 and 02/13/14, the policies and procedures for surgical services were reviewed. The policies were not current and lacked documentation they were based on nationally recognized standards. There was no documentation the policies were reviewed and approved by the medical staff and the governing body.

The surgical services department did not develop, approve and implement and keep current all the policies required by regulation such as:

infected versus non-infected cases
department-specific housekeeping requirements
pre-operative and post-operative care
procedure-specific policies and procedures and procedure protocols
duties for all personnel in the surgical areas
surgical counts
surgery scheduling
DNR status
handling of specimens
sterilization and disinfection practices
outpatient requirements
alcohol skin preps and prevention of surgical fires
patient position and padding

The OR Manager stated work needed to be done on the policies.

Based on observation, record review and staff interview, it was determined the hospital failed to provide post-operative care in accordance with acceptable standards of practice.

Findings:

1. The medical staff had not defined admission and discharge criteria for the recovery room.

2. Clinical records for four out of five patients who received general anesthesia had documentation the patients were intubated at the time of admission to the recovery room. The recovery records did not document who extubated the patient and what time the patient was extubated. There was no documentation of an assessment of the patient's respiratory status after extubation.

The hospital did not have a policy that specified who was qualified to extubate patients and no policy to define how long an extubated patient must be observed prior to discharge from recovery.

3. Clinical records for five surgery patients documented that regardless of the type of surgery, the type of anesthesia or the condition of the patient, no one was recovered for more than 30-40 minutes after surgery.

Patient #36 received naloxone (a potent narcotic antagonist) immediately prior to leaving the OR. The patient remained in recovery for 40 minutes before he/she was transferred to an inpatient room. Current literature documents naloxone remains active between 30-90 minutes after administration. After this time, the patient has the potential to slip back into an over-sedated state and potentially stop breathing. The hospital did not have a policy to address the special recovery needs of a patient who has received this type of medication. There was no documentation recovery room nurses were trained on the use and effects of naloxone.

4. The clinical record for patient #36 documented the patient was admitted to recovery at 11:20 a.m. and was extubated shortly after arrival. The patient then received a narcotic pain medication at 11:23 a.m., 11:30 a.m., 11:40 a.m., and 11:45 a.m. without relief. At 11:50 a.m., the record documented the patient was still in pain and the medication was not working. The record did not describe the patient's pain or it's location. At 11:55 a.m., the patient was transferred to the inpatient unit. At the time of transfer, the record documented the patient's pain was not controlled and the patient was crying.

5. The clinical records for some surgery patients included a set of pre-printed standing orders for the recovery room. The orders for pain medication, nausea medication, oxygen administration and IV fluids left the following to the discretion of the nurses:

~ the route the medications could be administered
~ the intervals at which the medications could be administered
~ the level of pain to be treated
~ how oxygen could be delivered (nasal cannual, mask, etc.)
~ the rate oxygen could be delivered

None of the recovery nurses had questioned or requested clarification of the orders from the physicians. There was no documentation as to when the standing orders were originated and no documentation the medical staff approved these standing orders.

6. The OR manager stated an LPN usually recovered patients. She was asked if the LPN was directly supervised by an RN. She stated,"Rarely." There was no documentation the LPN had specific training and competency evaluation for recovery room nursing. The medical staff had not determined the role of an LPN in the recovery area.

7. None of the clinical records had documentation of a "hand-off" report given from the circulating nurse to the recovery nurse, or from the recovery nurse to the floor nurse/discharge nurse.

8. Endoscopy patients had no documentation of recovery care and assessment before discharge from the hospital. Staff stated that in the interest of time, and at the direction of the CRNAs, endoscopy patients were sometimes placed wheelchairs in the OR corridor until they were "awake enough" to go back to the outpatient department for discharge.

9. The recovery room was not adequately equipped to provide care to more than one recovery patient, even though the staff stated there could be more than one patient in recovery at any given time. Staff stated vital sign monitoring equipment was borrowed from the OR when there was a second patient in recovery. Equipment that was found in the recovery room was old and outdated.

10. Supplies were not stored appropriately. For example, an ambu bag without the plastic protective covering was hanging on a wall and exposed to dust and other contaminants. Opened, undated and expired medications were found in the recovery room. Medications were not secured in the recovery room.

11. The staff stated the recovery room was also used as for pre-operative patients. They stated both pre-op and recovering patients may be in the room at the same time.

12. The pre-op/outpatient department, a former obstetrical unit located remotely from the OR, was also being used to recover patients. This area was not designed, equipped or designated as a recovery room. Among other issues, recovering patients were not visible at all times from the nurses' station. There were no emergency call lights in this area.

On 02/13/14, a surgery patient was being recovered in this area from approximately 8:30 a.m. to at least 3:00 p.m. The nurse working in this area stated that while the patient had a relatively simple surgical procedure, her recovery was "not going that well." The nurse working in this area had no documentation of training, experience and competency evaluation for recovery room nursing.

Based on clinical record review, policy and procedure review and staff interview, it was determined the hospital failed to develop, approve and implement policies and procedures for the delivery of anesthesia services consistent with nationally recognized standards of practice.

Findings:

1. On 02/12/14, anesthesia policies and procedures were reviewed. The policy manual was signed as approved by one of the contracted CRNAs. There was no documentation the medical staff and governing body approved the anesthesia policies.

2. The policies were missing or failed to adequately address:

how the hospital's anesthesia services would be met
patient consents for anesthesia / analgesia
infection control measures specific to the provision of anesthesia
safety practices in anesthetizing locations
protocols for cardiovascular and respiratory emergencies
anesthesia reporting requirements
documentation requirements
equipment requirements
biomedical equipment program for the monitoring, inspection, testing and maintenance of anesthesia equipment
delineation of pre- and post-anesthesia staff responsibilities
moderate sedation

The surgery manager confirmed there were no other anesthesia policies available for review.

3. None of the policies referenced nationally recognized sources.

Based on interview and clinical record review, it was determined the hospital failed to ensure an appropriate pre-anesthesia evaluation was provided for each surgical patient according to nationally recognized standards of practice.

Findings:

1. Clinical records were reviewed for five (#36, 37, 38, 39 and #41) surgery patients. The pre-anesthesia evaluations did not document a plan for anesthesia care. The evaluations did not document potential anesthesia problems such as difficult airway, ongoing infection and others.

2. The clinical record for patient #38 had documentation from the surgeon's office that noted the patient "has laryngospasm upon extubation." This information was not noted on the pre-anesthesia evaluation record, although the form had a section for notations of the patient's previous anesthesia history.

3. Patient #36 was admitted to an inpatient bed prior to surgery. There was no nursing documentation in the clinical record that indicated the patient had a pre-anesthesia evaluation conducted on the unit at the bedside. The pre-anesthesia evaluation included in the clinical record had no documentation of the time or place where it was conducted.

4. On 02/12/14 and 02/13/14, interviews were conducted with the contracted CRNAs and the surgery manager regarding pre-anesthesia evaluations.

The surgery manager stated the CRNAs often conducted the pre-anesthesia evaluation in the surgery restricted corridor on the way to the operating room. She stated the evaluations took less than five minutes and were conducted in the presence of any personnel who may be standing in the corridor.

The CRNAs confirmed they conducted pre-anesthesia evaluations in this manner because "the pre-operative area was too far from the OR" and "going there took too much time."

The pre-operative nurse confirmed the CRNAs rarely came to the pre-operative area. The surgery manager was asked what would happen if a problem was discovered during the pre-anesthesia evaluation in the OR. She stated, "We would have to send the patient back to the pre-op area or put them in the recovery room until the issue was taken care of."

5. The hospital had no policy that detailed the requirements for the pre-anesthesia evaluation.

Based on clinical record review and staff interview, it was determined the hospital failed to ensure the intraoperative record documented sufficient information to demonstrate appropriate care of the patient during surgery.

Findings:

1. Five clinical records (#36, 37, 38, 39 and #41) were reviewed for patients who had anesthesia services. The anesthesia records had no documentation of the following:

the time the patient arrived in the OR
the time the patient left the OR
procedure start time
procedure stop time
laryngoscope blade type and size
the size and type of endotracheal tube used
cuff absent or present, how inflated, amounts/pressure
intubation performed awake or asleep
technique used: direct vision, blind, fiberoptic
difficulties with intubation
assessment of tube placement
how tube was secured
time of intubation and extubation
artificial airway (oral/nasal)
maintenance of general anesthetics (circle system, non-rebreathing)
patients positioning during surgery and all the protective devices used to support the patient
patient eye protection used
warming devices used

2. The hospital had no policy that addressed the requirements for intraoperative documentation by the anesthesia practitioners.

Based on clinical record review, document review and staff interview, it was determined the hospital failed to ensure the post-anesthesia evaluation was not performed at the time of admission to the recovery area and failed to ensure the post-anesthesia evaluation conformed to current standards of practice.

Findings:

1. Five clinical records (#36, 37, 38, 39 and #41) documented the post-anesthesia evaluations were done at the time of admission to the recovery area. There was no documentation the evaluations were done when the patient was able to participate in the evaluation.

The CRNAs were asked when they performed the post-anesthesia evaluations. They stated they performed this at the time of admission to recovery.

2. The post-anesthesia evaluations did not address mental status, temperature, pain, nausea and vomiting, and hydration. The post-anesthesia evaluation did not document when the patient was extubated, the patient's response to it and the airway patency post-extubation.

The hospital's post-anesthesia evaluation section of the medical record requested documentation of the patient's level of consciousness, if the patient had stable/non-stable vital signs, and whether or not there were complications from anesthesia. The CRNAs did not document the patient's status in these areas.

3. The hospital did not have a policy and procedure that detailed all the requirements for a post-anesthesia evaluation.

Based on review of hospital documents and personnel files and interviews with hospital staff, the hospital failed to ensure respiratory services were supervised by qualified staff, consistent with State law.

Findings:

State Licensure Hospital Standards, Subchapter 23-6(a) requires that "respiratory therapy services, including equipment, shall be supervised by a licensed respiratory therapist".

During the hospital tour on 02/11/14, Staff P, a registered nurse, informed the surveyors she was the manager for the intensive care unit (ICU), medical-surgical unit and the respiratory department.