HospitalInspections.org

Based on observation, interview, and document review, the hospital failed to ensure that all operating(OR)/procedure rooms, where surgical procedures were performed, were monitored for temperature, humidity, and total number of air exchanges (the number of times the ventilation system replaces the air within a room with fresh air) for 2 of 2 rooms. This failure could lead to ineffective ventilation and the spread of infection.

Findings:

On 4/9/12 at 10:30 am, the OR and recovery room was observed with the Infection Control Nurse (ICN). She confirmed that the recovery room was also utilized as a procedural room where endoscopy (a tube inserted through the throat to visualize the digestive tract) procedures were performed.

During an interview with the Director of Plant Operations (DPO) on 4/11/12 at 7:40 am, he stated that the operating room staff monitors the temperature and humidity levels in the OR and procedure rooms themselves. The DPO had no knowledge of the air exchange rates.

During an interview and concurrent document review with the ICN on 4/11/12 at 9:50 am, she stated that she did not have any knowledge of the positive air pressure system, or air exchange rates and just assumed that the maintenance department monitored that. The Operating Duty List, which documents the daily/weekly tasks that are preformed in the operating and recovery/procedures rooms, which included documented temperatures and humidity levels was reviewed from January through March of 2012. The ICN acknowledged that the temperature and humidity levels were not recorded every day. She further explained that those figures are only documented on days that a surgery or procedure is done. She also confirmed that according to the documentation that the temperature in the recovery room is almost always above 70 degrees.

The facility's policy and procedure, titled, "Temperature and Humidity, Operating Room/Recovery Room" dated 1/11, read, "The operating room and recovery room temperatures and humidity will be recorded daily. Once every 24-hours, preferably in the morning, record the temperature and humidity in the surgery room and recovery room. The operating room should have a temperature of about 64-68 degrees Fahrenheit and humidity of about 60%."

The facility's documented temperature and humidity, in the operating room/recovery room, was reviewed with the ICN. She confirmed that the facility was not following their policy and procedure.

According to The Perioperative Standards and Recommended Practices, published by Association of periOperative Registered Nurses (AORN) in 2012. AORN recommended that, "Air in the perioperative environment contains microbial-laden dust, lint, skin squames, and respiratory droplets. The number of microorganisms in the air in an operating room is directly proportional to the number of personnel moving in and around the room. Outbreaks of surgical-site infections have been traced to airborne contamination from colonized health care workers. Heating, ventilation, and air conditioning systems dilute and remove contaminants from the air and control airflow patterns.... AORN recommended that, the minimum rate of total air exchanges per hour should be maintained at a constant level as follows. Operating room: minimum of 15 air exchanges per hour with a recommended range of 20 to 25 air exchanges...."

Based on interview and document review, the facility failed to properly prepare and train staff in the event of a fire. This failure could result in staff being unprepared in the event of a fire and potentially put patient lives in danger.

Findings:

During a concurrent interview and document review with the Safety Officer (SO), documentation of facility's fire drills were reviewed. The SO confirmed that there had been no fire drills for the following dates; 2011 third quarter (July-September) during the swing shift (2:30 pm to 11 pm), 2011 fourth quarter (October-December) during the night (NOC)shift (11 pm to 6 am), and 2012 first quarter (January-March) during the NOC shift.

The facility's policy and procedure, titled, "Fire Plan" dated 7/12, read, "All employees must be familiar with the current written fire plan that outlines procedures to be followed in the event of a fire in order to act in an organized and efficient manner. Fire drills will be conducted quarterly for each shift.

The SO acknowledged that the facility had not followed their policy and procedures in regards to the fire plan.

Based on observation, interview, and document review, the facility failed to ensure the provision of services were in accordance with appropriate written policy and procedures and standards of practice as evidence by:

* Failure to implement written policies for conscious sedation management (Refer to C 271)

* Failure to administer medications in accordance with accepted professional principles (Refer to C 276)

* Failure to ensure a system for identifying, reporting, investigating and controlling infections and communicable diseases (Refer to C 278)

* Failure to ensure that the nutritional needs of inpatients were met in accordance with recognized dietary practices (Refer to C 279)

* Failure to have written policies and procedures regarding the visitation rights of patients (Refer to C 1000)

* Failure to utilize the Interdisciplinary Practices Committee or another team of professionals that included multiple disciplines with at least one physician assistant or nurse practitioner and a non-staff member in reviewing and developing the hospital's policies (Refer to C 272).

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of quality health care in a safe environment, and ensure provision of services were in compliance with the statutorily-mandated Condition of Coverage: Provision of Services.

Based on interview and documentation, the facility failed to implement written policies for conscious sedation (lighter level of sedation than general anesthesia where the patient maintains a good airway and responds to stimuli) management for 2 of 2 sampled patients (Patients 22 and 23) The outcome resulted in no documentation of the patient's condition or response to medications and surgical intervention to identify current or potential problems.

Findings:

1. On 4/9/12, Patient 22's record was reviewed. On 4/5/12, Patient 22 was an inpatient and had an upper endoscopy (scope visualization of the throat, stomach, and entrance of the small intestine) procedure. The procedure was documented beginning at 6:47 am and ending at 7:03 am. The following were identified in the record:
a. The consent for the procedure and conscious sedation was obtained and documented after the procedure was completed at 8:30 am.
b. The height and weight in the assessment section of the endoscopy nurses notes were blank.
c. Present history in the assessment section was blank when the patient required three units of pack cells (condensed red blood cells), the evening prior to the procedure.
d. There was no documented pulse rate/rhythm, respiration, temperature, skin sensation, or cardiac (heart) monitor rhythm assessment immediately prior to administering conscious sedation.
e. There was no documentation that pre procedural instructions were given.
f. There were no assessments documented following sedation that included blood pressure (BP), pulse rate/rhythm, respirations, oxygen saturation (SaO2, percent of oxygen in blood) , skin color, level of consciousness, and pain level.
g. There was no post-procedure care assessment. The documented post procedure vital signs were initiated 24 minutes after administering conscious sedation medication.
h. There was no documentation when oxygen was initiated and discontinued.
i. Cetacaine (local anesthesia of throat) was not documented in the endoscopy nurses notes.
j. There were no signed orders for the post procedure by the physician.

The facility policy, titled, "Conscious Sedation Management Protocol," dated 3/12, read, "8. Obtain a written informed consent for IV (Intravenous) conscious sedation from the patient or responsible family member if patient is a minor or unable to give consent. 9. Obtain the following: a. Height b. Weight... 10. Assess the patient's readiness for conscious sedation using the following criteria prior to initiation sedation. c. Patient has recent physical assessment and brief history... 15. Perform the following assessment immediately prior to any medication administration: a. Vital signs (BP, Pulse rate/rhythm, respiration, temperature) b. Skin color, warmth and sensation c. Oxygen Saturation level via Pulse Oximeter (machine used to calculate percent of oxygen in blood) and d. Cardiac monitor rhythm assessment with documentation strip... 16. Attach nasal cannula (tubing that fits into the nostrils of the nose for delivery of oxygen therapy) and initiate O2 (oxygen) at 2 Liters per minute. 17. Instruct the patient in the following related to IV Conscious Sedation...19. Assess the following every 5 minutes during sedation: a. BP, pulse rate/rhythm, respiratory rate/depth b. SaO2 level c. Patient responsiveness to verbal/tactile stimulus d. Color of nail beds, mucosa e. Skin and IV sight for rash, edema (localized accumulation of excess fluid), induration (an abnormally hard area)...23. For endoscopy patients, record assessment data, total procedural documentation, medications and IV fluids administered and post-procedural charting on the Endoscopy charting form...25. Post-Procedure Care a. Assess the patient every 15 minutes four times, then every 30 minutes twice, then every one hour until discharge following the invasive or diagnostic procedure for: 1. BP, pulse, respiratory rate/depth 2. SaO2 level 3. Level of consciousness, orientation, sensation 4. Ability to articulate/follow instructions 5. Mobility, coordination...31. For in-patients, record as follows: a. Assessment, procedure documentation in the nurses notes of the patient's medical record. b. Frequent vital signs may be noted on the frequent vital sign flow sheet."

In an interview on 4/10/12 at 9 am, Infection Control Nurse (ICN) verified the above findings in Patient 22's record. There was no additional documentation of the procedure in the nurses notes and no "frequent vital sign flow sheet" in the record to reflect assessment during the procedure. The anesthetist (a person trained in administering anesthetics) was responsible for reviewing the conscious sedation documentation for completeness.

2. On 4/9/12, Patient 23's record was reviewed. On 3/23/12, Patient 23 was an outpatient and had a lower endoscopy (scope visualization of the colon and large intestines) procedure. The procedure was documented beginning at 9:48 am and ending at 9:58 am. The following were identified in the record:
a. There was no documented skin sensation or cardiac monitor rhythm assessment prior to administering conscious sedation.
b. There was no documentation that pre procedural instructions were given.
c. There were no assessments documented following sedation that included BP, pulse rate/rhythm, respirations, oxygen saturation, skin color, level of consciousness, and pain level.
d. The documented post procedure vital signs were initiated 28 minutes after administering conscious sedation medication.
e. There was no documentation when oxygen was initiated and discontinued.
f. There was no documentation that Patient 23 was discharged with an adult.
g. There was no documentation of discharge criteria: mental status and ability to verbalize discharge instructions.

According to the policy, "Conscious Sedation Management Protocol," dated 3/12, read, "15. Perform the following assessment immediately prior to any medication administration: a. Vital signs (BP, Pulse rate/rhythm, respiration, temperature) b. Skin color, warmth and sensation c. Oxygen Saturation level via Pulse Oximeter and d. Cardiac monitor rhythm assessment with documentation strip... 16. Attach nasal cannula and initiate O2 at 2 Liters per minute. 17. Instruct the patient in the following related to IV Conscious Sedation...19. Assess the following every 5 minutes during sedation: a. BP, pulse rate/rhythm, respiratory rate/depth b. SaO2 (oxygen saturation) level c. Patient responsiveness to verbal/tactile stimulus d. Color of nail beds, mucosa e. Skin and IV sight for rash, edema, induration...23. For endoscopy patients, record assessment data, total procedural documentation, medications and IV fluids administered and post-procedural charting on the Endoscopy charting form...25. Post-Procedure Care a. Assess the patient every 15 minutes four times, then every 30 minutes twice, then every one hour until discharge following the invasive or diagnostic procedure for: 1. BP, pulse, respiratory rate/depth 2. SaO2 level 3. Level of consciousness, orientation, sensation 4. Ability to articulate (speak)/follow instructions 5. Mobility, coordination...26. The patient may be discharged when the following criteria are met: ...b. Patient is alert, oriented to time, place, person and able to converse with clear articulation or at pre sedation level...e. Patient can verbalize post sedation/discharge instructions...27. The patient must have a designated driver for transportation home. a. No patient will operate a motor vehicle after receiving conscious sedation...31. For in-patients, record as follows: a. Assessment, procedure documentation in the nurses notes of the patient's medical record. b. Frequent vital signs may be noted on the frequent vital sign flow sheet."

In an interview on 4/10/12 at 9 am, INC verified the above findings in Patient 23's record. There was no additional documentation of the procedure in the nurses notes and no "frequent vital sign flow sheet" in the record to reflect assessment during the procedure. The anesthetist was responsible for reviewing the conscious sedation documentation for completeness.

Based on staff interview and document review, the facility failed to utilize a team of professionals that included physicians, plus at least one or more physician assistants, nurse practitioners, or clinical nurse specialists, and at least one non-staff member in reviewing and developing the hospital's policies.

Findings:

On 4/9/12 and 4/10/12 the minutes of the hospital's Interdisciplinary Practices Committee (IPC, a committee comprised of physicians and multiple other types of health care providers, that is required by California Code of Regulations for all hospitals utilizing physician assistants, nurse practitioners, or other non-physician health care practitioners) meetings for the past year were requested. On 4/9/12 and 4/10/12 the minutes of the Medical Executive Committee (MEC) for the past year were reviewed, and it was noted that there were no IPC reports. On 4/11/12 the binder containing IPC minutes was provided. On the cover of this three large ring binder was written "2007, 2008, 2009." It contained a number of sets of minutes, the last three entries were labeled "Agenda for 1/19/10" and "Minutes for 1/18/10" and "Minutes for 2/23/10". From these minutes, the last time the IPC met was greater than 2 years ago. According the the Medical Staff Rules and Regulations, page 31, Appendix 4B, "3. Meetings - The IPC shall meet as often as needed, but at least quarterly." None of the minutes in the binder referenced an attendee that was not on the hospital staff; and the Medical Staff Rules and Regulations do not specify that that the committee should have a member that is not a member of the hospital staff.

On 4/11/10 at 5:35 pm, Physician Assistant M (PA-M) and his Clinic Manager (Staff N) were interviewed and PA-M stated the following: He could not recall if the committee meeting he use to attend was called the IPC, but it did fit the description of the IPC. There was a physician, several nurses and himself on the committee. Minutes for those meetings had been taken by the prior medical staff coordinator, who is not longer employed at the hospital. The last time PA-M had attended a meeting was at least one or more years ago. He thinks that was the last meeting that had occurred. During those meeting the committee had been reviewing various hospital P/P (policies and procedures), but he could not recall which P/P or how they were chosen.

On 4/12/10 beginning at 9:05 a.m., the current medical staff coordinator (Staff O) was interviewed. She had started work at the hospital in October or November of 2010. She commonly took minutes for various staff meeting, but she had never been assigned to the IPC and she didn't know the hospital still had an IPC.

Based on observation, interview, and document review, the hospital failed to administer medications in accordance with accepted professional principles as evidence by:
* The hospital failed to account for missing and extra medications that could indicate that a patient received too much, missed a dose, or were given the wrong medication when a 7 day audit revealed 6 of 8 missing and extra medications were unaccounted for by the Pharmacy.
* The hospital failed to ensure emergency medications were competently administered when one nurse did not demonstrate an accurate administration of Epinephrine (a medicine used in emergencies to treat respiratory and heart conditions, and allergic reactions) during a mock pediatric code (simulation of an emergency).
* The hospital failed to ensure safe use of medication syringes when bulk (multiple) amounts of syringes were stored outside of their overwrap.
* The hospital failed to ensure that an outdated medication in the anesthesia cart (a cart containing medications used in surgery) was not available for patient use.

Findings:

1. A review of the American Society of Health-System Pharmacists (a nationally recognized professional organization) in the entitled document Minimum Standard for Pharmacies in Hospitals indicated "The pharmacy shall be responsible for the procurement, distribution, and control of all drug products used in the hospital ..."

A review of the hospital policy entitled Responsibilities of the Director (dated last reviewed on 05/10) indicated "The Director of Pharmaceutical Services (DOP) is responsible for ...Maintaining adequate control over the requisitioning and dispensing of all drugs and pharmaceutical supplies."

An automated dispensing cabinet (ADC) is a computerized medication dispensing machine. The ADC is similar to a vending machine in that the user enters what they want and the machine dispenses medication. The ADC is where the nurses obtain medications to administer to patients.

During an interview on 04/10/12 at 9:30 am, the Pharmacist stated the Pharmacy did not review all the missing or extra medications (aka discrepancies) found in the ADC. She stated that misuse was primarily the cause of the discrepancies. She acknowledged that administering too much, missing a dose, or giving the wrong medication could be a cause of the discrepancies.

ADC medication discrepancies are when the count of the medication is different from what is expected. This occurs from misuse of the ADC when medications are not correctly placed, taken, or entered into the computer. Discrepancies also occur when there are medication errors. For example a patient could receive an extra dose and the ADC would show a missing dose. A patient could miss a dose and the ADC would indicate an extra dose. If a patient received a wrong medication then one of the ADC pockets would have an extra dose and another pocket would have a missing dose.

During an interview on 04/10/12 at 9:30 am, the Pharmacist stated that the discrepancies could be medication errors. The DOP then stated she could not account for all the discrepancies. She also said that she could generate a discrepancy report. Some of these discrepancies were not reviewed for medication errors by the pharmacy.

A review of the ADC generated discrepancy report listed discrepancies (excluding narcotics) over the period from 04/03/12 to 04/10/12. This report indicated there were 8 discrepancies. Each discrepancy had one or more extra doses; or one or more missing doses. The hospital did not provide evidence that the Pharmacy could account for 6 out of 8 discrepancies.

2. According to the hospital policy entitled Medication Regulations (reviewed date of 04/09) indicated, "The medication administration competencies of RN's ...are validated during orientation ...The medication competency exam will be completed by all new licensed staff. Annual competency will be completed by all licensed staff and recorded in the competency file. "

During an interview on 04/10/12 at 2:00 pm, the Risk Management Coordinator stated that Charge Nurse P did not have an initial and annual competency demonstrating accurate administration of pediatric emergency medications.

A review of the Broselow medication tape, a guide used for emergency response, indicated calculated doses for emergency medications which included Epinephrine (concentration 0.1 mg, milligram/ml, milliliter). The tape indicated the initial intravenous (IV) dose of Epinephrine for a 3 kg child was 0.3 ml.

During an observation and interview on 04/10/12 at 10:10 am, Charge Nurse P, emergency department nurse, was asked to demonstrate the administration of an initial IV dose of Epinephrine (concentration 0.1 mg/ml) for a 3 kg child. Charge Nurse P demonstrated that she would draw 3 ml of Epinephrine. Instead of drawing up 0.3 ml as indicated by the Broselow tape she drew up 3 ml of Epinephrine.

Epinephrine is an emergency medication that maybe needed immediately in an emergency response situation. Charge Nurse P would have drawn up 10 times the recommended dose of Epinephrine.

3. A review of the hospital policy entitled, Responsibilities of the Director (dated last reviewed on 05/10), indicated "The Director of Pharmaceutical Services is responsible for ...Maintaining adequate control over the requisitioning and dispensing of all drugs and pharmaceutical supplies."

On 04/10/12 at 11:00 am it was observed in the anesthesia cart in the operating room, 10, 5, 3, and 1cc syringes that were not in their overwrap. The overwrap is used to ensure sterility of the syringes. There were approximately 50 syringes without the overwrap.

During an interview on 04/10/12 at 11:00 am, the Infection Control Nurse stated that the syringes should be in their overwrap until they are ready for use. She also stated that she did not know how long the syringes were outside of their overwrap.

According to APIC (Association for Professionals in Infection Control and Epidemiology) Position Paper: Safe Injection, Infusion and Medication Vial Practices in Healthcare, American Journal of Infection Control, April 2010, under Aseptic (absence of pathogens) Technique, reads, "Never store needles and syringes unwrapped because sterility cannot be ensured."


22456


4. On 4/11/12 at 10:20 am, the anesthesia cart in the only operating room was observed to have a 60 ml syringe containing a container of Pro Air (bronchodilator) set up to attach to a breathing circuit to administer to patients during surgery. The Pro Air had an expiration date of 1/12.

In a concurrent interview, Infection Control Nurse stated that the Pro Air was outdated and should not be available for patient use.

Based on interview and document review, the facility failed to implement the policy for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel hospital-wide. The outcome could result in not identifying, reporting, investigating, and controlling infections and communicable diseases for surgical patients.

Findings:

On 4/12/12 at 8:30 am, Infection Control Nurse stated that she does not observe practices or receive monitoring data from surgical services, such as washing hands, surgical antiseptic scrub (preparation of hands and forearms prior to surgery to remove pathogens), cleaning the operating room, and competency of cleaning endoscopes (fiber optic scope to visualize the various tracts of the throat, stomach, lungs, large intestines, and colon).

On 4/12/12 at 10 am, Risk Manager Coordinator and Director of Nurses stated that there had been no recent monitoring of infection control practices within the surgical services department. The only information reported was the required data to the National Healthcare Safety Network associated with Centers of Disease Control and Prevention.

The policy titled, "Infection Control Program," dated 10/11, under program standards list "C. Provisions for review and evaluation of all aseptic, isolation and sanitary technique, and Universal/Standard Precautions employed in the Facility. D. Monitoring procedures relating to the inanimate facility environment including sterilization and disinfection procedures..." The responsibilities of the Infection Control Nurse included, "ii. Performs administrative functions such as evaluating epidemiology activities, facility-wide patient/resident care from an infection control standpoint...v. Coordinates infection control surveillance activities facility-wide..."

Based on observation, staff interview, and document review the hospital failed to ensure the in-patient dietary services were in accordance with recognized dietary practices and the orders of the practitioner responsible for the care of patients, when the food and dietetic services was not organized, directed, and staffed in such a manner to ensure that the nutritional needs of the patient are met as evidenced by:

Food Service Operation:
* lack of safe food handling practices as evidenced by deficient practices in cool down and handwashing,
* lack of infection control oversight in food service operation,
* Emergency meal plan did not address all diets required,
* Food service and nutrition was not addressed in the quality appraisal and performance improvement program.

Recognized Dietary Practice:
* No menu analysis to meet menu requirements for 2 gram sodium and other therapeutic diets and no menu analysis to ensure diets met the recommended dietary allowances,
* Incomplete nutritional assessment and screening of two patients (Patients 9 and 17),
* Therapeutic diets not prescribed by the practitioner responsible for the care of the patient.

These failures placed patients at risk of developing food borne illness not meeting their nutritional needs.

Findings:

Food Service Operation:

1. Safe food handling practice:
a. On 4/11/12 at 8:30 a.m., Cook B was asked about the practice of cooking meat ahead of service. She stated that the meat was cooked and then placed on ice bath and the temperatures recorded on the log.

Review of the cool down temperature record on 4/11/12 at 8:30 am, showed the entry for roast pork cooked on 3/3/12 was 164 degrees Fahrenheit (F) at 9:30 am, the second temperature was recorded as 120 degrees F at 1300 hours (1:00 pm). The entry for the temperature of the turkey roast cooked on 3/12/12 was 168 degrees F at 8:00 am, and at 10:00 am the temperature was recorded as 98 degrees F. The first temperature entry for corn beef cooked on 3/14/12 at 12:00 pm was 170 degrees F, and the second temperature recorded at 2:00 pm was 100 degrees F. The Dietary Manager stated on 3/11/12 at 8:30 am, these temperatures were appropriate.

In a review of the cool down temperature form, the temperatures were recorded on the form as Step 1: to "cool product from 135 degrees F to 70 degrees F within 2 hours." The policy titled, Food Preparation, stated the "cooked meat is placed in a double plastic bag and temperature must be cooled to 41 degrees F in 6 hours."

The FDA Food Code 2009, the standard in the industry, requires potentially hazardous food, like cooked meat, be cooled requiring a two-step cooling process. The first step is from 135 degrees F to 70 degrees F within 2 hours and then from 70 degrees to 41 degrees F in 4 additional hours. There is serious potential for food borne illness when cooked foods are held in the danger zone (135 degrees F to 41 degrees F) when pathogenic microorganisms can grow. The FDA cool down program is intended to prevent potential for food borne illness.

b. On 4/11/12 at 12:00 pm, Cook B was observed washing her hands. She applied soap and immediately rinsed the soap from her hands. Cook B was asked to demonstrate the hand washing and she again used the soap and rinsing practice. The Dietary Manager was asked on 4/11/12 at 12:00 pm, if this was the correct practice for handwashing. She acknowledged the cook did not properly wash for the 20 seconds to ensure clean hands before rinsing.

Review of the policy titled, "handwashing," indicated handwashing was the single most effective technique to prevent the spread of infection. The directions required staff to "apply soap and use a firm rubbing circular movement to wash the palm, back and wrist of each hand. Interlace the fingers and thumbs and move the hands back and forth. Continue for 10 to 15 seconds. Rinse hands."

c. On 4/11/12 at 8:15 am, Cook B was observed washing dishware. She was asked how she knew the dish machine was working properly. She stated that she checked the wash and rinse temperature and washed her dishware. The Dietary Manager stated on 4/11/12 at 8:15 am, the dish machine was a low temperature sanitizing machine and required the sanitizer concentration to be measured. She stated the dietary aide checked the sanitizer concentration before they started the morning dishes and acknowledged the cook should have checked the sanitizer concentration before running her dishware.

The policy titled, "Equipment", indicated the dishwasher will maintain a final rinse of a least 180 degrees F. The policy did not address the procedure for measuring the sanitizer concentration required of a low temperature dish machine.

d. On 4/11/12 at 12:00 pm, Dietary Staff D was observed with bangs uncovered by the hairnet when serving the lunch meal. The Dietary Manager was asked 4/11/12 at 12:00 pm, if this was appropriate for hair net placement and she acknowledged that all of the hair should be covered by the hairnet.

Review of the policy titled, "infection control", indicated that "hair must be covered with a hairnet when preparing and serving food and when working a food area."

e. The Infection Control Preventionist was interviewed 4/12/12 at 8:15 am, regarding the infection control oversite of the dietary department. She stated that she did walk through the kitchen 2 times per week and did an annual full inspection. She stated there was no documentation of the weekly or the annual rounds. She stated that she did not review the dietary department policies or was not aware of the FDA Food Code standards that included the HACCP (Hazard Analysis Critical Control Point Program) an FDA program to prevent food borne illness.

Review of the policy titled, "Dietary Infection Prevention", under environmental controls, showed no reference to the cool down standard. There was no integrated infection control program to include the scope of the dietary Department in the hospital infection control program.

f. On 4/11/21 at 3:00 pm, Cook C was observed handling dirty dishware and loading the dish machine. She was then observed to directly handle clean and sanitized dishware. There was no handwashing observed before she handles clean dishware after handling dirty dishware.

The Dietary Manager stated at 3:10 pm, that the cook should have washed her hands before handling clean and sanitized dishware.

Review of the policy titled, "Equipment", indicated "one person available, he or she must wash hands thoroughly and don a clean apron before handling clean dishes."

2. Emergency Food Supplies:
On 4/11/12 at 10:00 am, the emergency food plan was reviewed. The menu and food supplies addressed the regular diet. The Dietary Manager was asked on 4/11/12 at 10:00 am, how the therapeutic diet restrictions or modified texture consistency diets were planned. She stated they had canned puree food but there was no menu or directions to serve a puree or other texture modified diet. She acknowledged that there was no menu or directions for therapeutic diet restrictions like a renal diet, diabetic diet, or sodium restricted diet.

3. Dietary Service Quality Program:
On 4/12/12 at 10:00 am, the quality appraisal and performance approval program for the Dietary Department was discussed with the Risk Management Coordinator. She stated that the Dietary Department collected temperature data and during the 4th quarter did some chart reviews. She acknowledged the quality program was directed at the long term care program and there was no quality appraisal or performance improvement program developed for the hospital.

Review of the continuous quality Improvement Plan stated the purpose of planned systemic and interdisciplinary approach to improving the care and services for the hospital. There was no detailed, documented, quality appraisal and performance improvement program.

Recognized Dietary Practice:

1. On 4/11/12 at the hospital menus were reviewed and the Dietary Manger asked for the nutrition analysis of the menus. The menus were for Liberal Renal (kidney), Regular, 2 gram sodium (salt), reduced cholesterol and fat, consistent carbohydrate diet, cardiac (heart) diet. The Dietary Manager provided nutrient analysis for the regular menus -week 1 to 4. There was no nutrient analysis for the therapeutic diets. Review of the menu showed that all of the therapeutic diets received the same food, except for carbohydrate control diets. The Dietary Manager was asked if there were recipes for the low sodium, renal, low cholesterol and cardiac diets. She stated that there was one recipe for all the diets. Review of the nutrition analysis showed that the week average sodium content was between 3,090 milligrams to 3,784 milligrams. She stated that the menus were bought from a company and they did not review the nutrition content to the diets to ensure the sodium, potassium, fiber, or other nutrients met the diet requirement including 2000 milligrams for the 2 gram sodium diet. In addition, the 4 week menus cycles were not reviewed to ensure they met the current Recommended Dietary Daily Allowances (RDA) or the Dietary Recommended Intakes (DRI).

In an interview with the consultant dietitian by telephone on 4/12/12 at 9:00 am, she stated that she did not review the menu analysis to ensure the menus provide the nutrients to meet the therapeutic diet restrictions like the 2 gram sodium diet or the RDA's or DRI's.

2. Patient nutrition assessment:
a. Patient 17 was admitted 3/23/12 with diagnosis of status post-acute myocardial infraction (heart attack) and chronic heart failure. Weight on admission was 174 pounds and he was 6 feet tall. Meal intake documented on the nursing flow sheets dated 3/27/12 to 4/11/12, stated 25 to 50 percent intake.

In an interview with the patient's daughter on 4/11/12 at 10:00 am, she stated that her father had been weak and not eating well.

Diet order on 3/25/12 was 2 gram sodium low fat. On 4/3/12 a calorie shake supplement was added three times a day.

Review of the nutrition screening form dated 3/23/12 showed his albumin level (measurement of visceral protein and nutritional status) was 2.8 g/dl and he was determined to have a low risk and was not referred to the consultant dietitian. The nutrition screening form stated the low risk would be reevaluated in one week. There were no reevaluations for nutrition risk on 3/30 or 4/6.

Review of the dates the consultant dietitian visits showed she was in the hospital 3/15/12 and 3/22/12. The staff stated she came every other Friday. She had not made another visit in three weeks. Consultant dietitian stated in interview on 4/12/12 at 9:00 am that she was due to visit.

Charge Nurse A was interviewed on 4/11/12 at 9:43 am, and stated the patients were weighted on admission and then only if the physician writes an order.

Patient 17 had nutritional deficiencies with compromised albumin. The patient had compromised intake and no regular weight monitoring. Patient 17 was not assessed and reassessed for nutritional status.

Review of the policy titled, "Swing bed nutrition", stated the dietary department will perform a nutritional assessment and work with the member of the team to provide an appropriate diet for the patient.

b. Patient 9 was admitted 4/8/12 with diagnoses of recurring anemia and past history of Diabetes Mellitus, hypertension (high blood pressure), senile dementia and chronic renal kidney) failure.

Admission weight was 150 pounds and his height was 5 feet 9 inches.

The physician diet order, dated 4/8/12, was "as tolerates."

The nutrition screen identified moderate risk and referral for the consultant dietitian was faxed 4/8/12. The consultant dietitian assessment was faxed back and stated "history: not available." The consultant dietitian recommended to change diet to nectar thick liquid, swallow evaluation, and diet listed a clear liquid.

Review of the Patient 9's history and physical (H&P), dated 4/8/12, showed a 90 year old male with severe anemia, dehydration, chronic renal failure, and hyperkalemia (elevated sodium level). In addition, the H&P stated diabetes, hypertension, and chronic renal failure.

Lab dated 4/8/12 BUN (blood urea nitrogen- a test that measures kidney function and hydration) was 100 mg/dl (normal 9.0 to 20 mg/dl). The reference stated "critical results repeated."

In an interview with the consultant dietitian on 4/12/12 at 9:00 am she was asked about the patient information she received faxed from the hospital. She stated that she did not get the labs of the patient history.

Patient 9 was not assessed for the low albumin and renal insufficiency that were on the nutrition risk form. The patient was not assesses for the history of Diabetes Mellitus, hypertension, elevated BUN.

In an interview on 4/12/12 at 9:00 am, the consultant dietitian was asked about the Nutrition Risk Screening form that the nurses filled out and faxed to her. She stated the screening criteria had not been evaluated in a long time, and was not evaluated in the quality program to ensure the patient requiring nutrition assessments were adequately referred to the dietitian.

3. Patient 9 was admitted 4/8/12 with diagnoses of recurring anemia and past history of Diabetes Mellitus, hypertension, senile dementia and chronic renal failure.

Admission weight was 150 pounds and height 5 feet 9 inches.

The physician diet order dated 4/8/12 was "as tolerates."

Review of the Nutrition Progress notes and the nursing daily assessment sheets showed diet as clear liquid on 4/9/12.

Interview with RN E on 4/12/12 at 10 am, she stated that when the physician ordered a diet as tolerated the nurses decide what the patient will tolerate and this is clear liquid or regular diet and this is the order that is provided to the dietary department.

The facility failed to have therapeutic diets prescribed by the practitioner responsible for the care of the patient.

Based on interview and document review, the facility failed to ensure that medical records were complete and accurately recorded for 6 of 17 sampled patients. This failure could result in inaccurate record keeping or the incorrect treatment being received. (Patients 16, 17, 22, 23, 24, and 27).

Findings:

1. During the review of Patient 16's medical record a physician's order, dated 4/9/11 at 11:10 am, read, "Zofran (anti-nausea medication) 4 mg (milligram) PO (by mouth) one time." A review of Patient 16's medication administration record (MAR) revealed that Registered Nurse (RN) R recorded the Zofran as being administered on 4/8/12 at 11:15 am.

During an interview and concurrent document review, with RN R at 4/9/12 at 2:40 pm, she acknowledged that the physician's order was missing an indication and that she had recorded the medication administered on the wrong date on the MAR.

2. During a review of Patient 17's medical record a physician's order, dated 3/24/12, read, "Mylanta (30 ml (milliliters) PO every two hours PRN (as needed) and Tramadol (pain medication) 50 mg PO every 3-hours PRN."

During an interview with the pharmacist on 4/10/12 at 5 pm, she confirmed that PRN (as needed) medication needed to have an indication stating as to what they are needed for. She reported that medications which need further clarification and specification of indications has been an ongoing problem.

The facility's policy and procedure, titled, "Medication Regulation", dated 4/09, read, "Physician's order must be complete, if there are any questions about the order, it must be verified with the physician and clarified in the chart... Medications are documented on the MAR as being administered; document time, route and dose administered in the appropriate place on the MAR, initial and sign the MAR in the appropriate areas...


22456


3. On 4/10/12, Patients 22, 23, and 24's records were reviewed. The three operative reports did not document the correct anesthesia that was administered to these patients.
a. Patient 22's operative report documented that her anesthesia included Versed (sedative), fentanyl (narcotic), cetacaine (topical numbness), and lidocaine (topical numbness). The documentation for the anesthesia did not include fentanyl.
b. Patient 23's operative report documented that her anesthesia included Versed, fentanyl, and Diprivan (general anesthesia). The documentation for the anesthesia did not include fentanyl.
c. Patient 24's operative report documented that her anesthesia was only a bier block (local anesthetic into the venous circulation of a surgical extremity, usually the arm). The documentation for the anesthesia also included Versed, fentanyl, and Diprivan.

On 4/10/12 at 1:50 pm, the Risk Manager Coordinator (RMC) stated that the three operative reports did not document the correct anesthesia that was administered to these patients.

4. On 4/10/12, Patient 22's record did not have signed post procedure orders for an upper endoscopy (visualization of the throat, stomach, and entrance of the small intestine) procedure on 4/5/12.

On 4/10/12 at 1:50 pm, RMC stated that Physician I did not sign post procedure orders for Patient 22 on 4/5/12.

5. On 4/11/12, Patient 27's record was reviewed. On 2/8/12, Patient 27 had the procedure, "Laparoscopic Cholecystectomy," removal of the gallbladder through a scope. There was a form in the record titled, "Consent to Observe Surgery," that indicated Observer J had permission to watch the procedure. The form was signed by Patient 27's parent, Physician I, and RN F. Anesthetist K did not sign the form. The operating room record had Observer J listed, but there was no affiliated agency listed.

In an interview on 4/11/12 at 12:30 pm, the RMC stated that Observer J was not affiliated with any medical or nursing program.

In an interview on 4/11/12 at 3:10 pm, Scrub Tech G, who was in the operating room during Patient 27's procedure, stated that she was told that Observer J was interested in the medical field. Scrub Tech G stated that she was aware that Observer J was not in an affiliated medical or nursing program.

According to the policy, "Access to Operating Room/Recovery Room - Visitors, Vendors and Observers," dated 1/10, under Standard, "A. Visitors in surgery must: 1. Have a legitimate medical, scientific, educational purpose for requesting visitor privileges. 2. Have written consent of the patient, surgeon, anesthetist and circulator..." Under Observers, "8. Document in intraoperative nurse's notes who is present and the name of the affiliated agency."



16614


6. a. Patient 17 was admitted 3/23/12 with diagnoses of status post-acute myocardial infraction (heart attach) and chronic heart failure. Weight on admission was 174 pounds and he was 6 feet tall. Meal intake was recorded on nursing flow sheets dated 3/27/12 to 4/11/12, of 25 to 50 percent intake.

Physician diet order on 3/25/12 was 2 gram sodium low fat. Review of the physician order, dated 3/25/12, showed the diet order written with other medical orders on a ? order sheet.

Review of the Acute Dietary Roster breakfast, dated 4/11/12, stated Patient 17's diet was 2 gram sodium.

On 4/12/12 at 11:00 am, the diet order was reviewed with the Charge Nurse A . She acknowledged the diet order read 2 gram sodium low fat diet. She acknowledged the diet order was crowded with other medical orders and was not easily read. She acknowledged the diet order had not been transferred to the dietary department as written by the physician.

On 4/12/12 at 12:00 pm, the Acute Dietary Roster for lunch, dated 4/11/12, still listed the diet for Patient 17 as 2 gram sodium.

b. Patient 17's medical record showed no weights were obtained since the admission weight even though the patient was admitted for 19 days.

In an interview with Charge Nurse A she stated that a patient was weighed only if the physician wrote an order.

There was no policy to weigh a patient on a regular basis when they are admitted for more than an average stay of 3 to 4 days.

Based on observation, interview, and document review, the facility failed to protect medical records from damage. This failure allowed twenty-three medical records to be damaged due to a water leak in the facility's outside storage unit.

Findings:

During an interview with the Health Information Manager (HIM) on 4/11/12 at 2:40 pm, she reported that on 3/23/12, she had been alerted to a water leak in their outside storage unit where purged medical records (records that are older than 18-months) were stored. She reported that twenty-three medical records had been affected, dried out and were still readable. The HIM reported that this was the second time that this particular area of the outside storage unit had leaked resulting in medical record damage from water.

On 4/11/12 at 3:10 pm, the outside storage unit was observed with Health Information Staff (HIS) Q. The twenty-three medical records that were previously damaged by water were examined. HIS Q explained that these records are segregated and now stored in a separate plastic tote and require special handling procedures due to the possible presence of mold. The records were noted to be wrinkled and had obviously been previously exposed to water, but the pages were still readable. HIS Q reported that the trailer is accessed only when needed and no one regularly checks for leaks.

The facility's policy and procedure, titled, "Retention of Records" dated 1/09, read, "Patient records including x-ray films or reproduction thereof shall be preserved safely, for a minimum of seven years following discharge of the patient..."

Based on observation, interview, and document review, the facility failed to provide surgical procedures in a safe manner as evidence by:

* Failure to administer general anesthesia (propofol) by an unqualified practitioner. (Refer to C 323, item 1)

* Failure to verify registered nurse (RN) competency to administer moderate conscious sedation. (Refer to C 323, item 2)

* Failure to evaluate each patient for proper anesthesia recovery by a qualified practitioner. (Refer to C 322)

* Failure to monitor and document patients receiving conscious sedation according to AORN (Association of periOpertative Registered Nurses) standards of practice. (Refer to C 271)

* Failure to perform "Time Out" prior to endoscopy (scope visualization of throat, lungs, stomach, and colon) procedures for 2 of 2 sampled patients. (Patients 22 and 23) (Refer to item 1)

* Failure to store and process flexible endoscopes according to AORN standards of practice. (Refer to items 2 and 3)

* Failure to develop recommended traffic patterns to include the procedure room in the restricted area (surgical attire and hair coverings required and masks required when there was open sterile supplies in the room) and clean procedure room according to national standards. (Refer to item 4)

* Failure to provide maintenance services in the surgical services area in accordance with approved policies and procedures and national standards of practice. (Refer to C 226)

* Failure to process sterile instruments according to CDC (Centers for Disease Control and Epidemiology) recommendations. (Refer to item 5)

* Failure to store syringes and needles according to standards of practice. (Refer to C 276, item 3)

* Failure to launder all surgical attire at a health care-accredited laundry facility within the perioperative setting. (Refer to item 6)

* Failure to implement the policy to prevent injuries from needle sticks. (Refer to item 7)

* Failure to develop and implement policy and procedures for transferring a patient directly from the operating room to post anesthesia care unit phase II. (Refer to item 8 )

* Failure to have a non medical observer in surgery. (Refer to C 302, item 5)

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of quality health care in a safe environment, and ensure surgical services were in compliance with the statutorily-mandated Condition of Coverage: Surgical Services.

Findings:

1. On 4/10/11 Patients 22 and 23's records were reviewed. On 4/5/12, Patient 22 had an upper endoscopy performed. On 3/23/12, Patient 23 had a lower endoscopy performed. There was no documented evidence that a "time out" was conducted prior to the procedure.

In an interview on 4/10/11 at 11:40 am, Risk Manager Coordinator (RMC) stated that a "time out" was not documented in Patients 22 and 23's records. RMC stated that the practice was to have a "time out" prior to every procedure done in the facility and documented.

According to the policy, "Preoperative Management," dated 1/11, Addendum - 1, "Timeout" The circulator RN will lead the entire surgical team in the OR room, after the patient is prepped and draped. All team members must verbally verify their agreement...Documentation of "Timeout" should indicate the following was verified: Correct patient. Correct site and side. Agreement to procedure. Correct patient position. Implants and/or special equipment or special requirements available.

2. On 4/11/12 at 11 am, two of five flexible endoscopes were observed to be lying on a blanket on the bottom shelf of the storage cabinet. In a concurrent interview, Scrub Tech H stated that two flexible endoscopes were not stored vertically.

According to AORN Perioperative Standards and Recommended Practices, 2012 Edition, Recommended Practices for Cleaning and Processing Endoscopes and Endoscope Accessories, Recommendation IX.a. "Flexible endoscopes should be stored in a closed cabinet...hanging in a secure vertical position;...When flexible endoscopes are hung in the vertical position, coiling or kinking is prevented, allowing any remaining moisture to drain out of the endoscope and decreasing the potential development of an environment conducive to microbial growth in the endoscope...The scope protector may create an environment favorable for microbial growth if the flexible endoscope is not dry and cannot hang straight."

3. In an interview on 4/11/12 at 11 am, Scrub Tech H stated that the flexible endoscopes were reprocessed prior to use. He further stated the endoscopes were not tracked if they were unused for more than five days.

According to AORN Perioperative Standards and Recommended Practices, 2012 Edition, Recommended Practices for Cleaning and Processing Endoscopes and Endoscope Accessories, Recommendation IX.b. Flexible endoscopes should be reprocessed before use if unused for more than five days.

4. On 4/11/12 at 10:05 am, Scrub Tech G was observed entering the procedure room without a hair covering. The red line on the floor did not designate that the procedure room was considered a restricted area. There were items in the procedure room observed to be covered with linen sheets.

In a concurrent interview, Scrub Tech H stated that the procedure room was used for recovering patients after surgery and for endoscopy procedures, so it was considered an unrestricted area allowing for street clothes and did not require the covering of the hair.

On 4/12/12 at 8:30 am, the Infection Control Nurse stated that the procedure room, used for recovering patients after surgery and endoscopy procedures, was considered unrestricted and therefore the room was not terminally cleaned (a routine thorough cleaning at the end of the day).

According to AORN (Association of periOperative Nurses) Perioperative Standards and Recommended Practices, 2012 Edition, Recommended Practices for Traffic Patterns in the Perioperative Practice Setting, Recommendation I, "Traffic patterns should be designed to facilitate movement of patients and personnel into, through, and out of defined areas within the surgical suite. Signs should clearly indicate the appropriate environmental controls and surgical attire required. 1. Surgical suite should be divided into three designated areas...
The unrestricted area includes a central control point that is established to monitor the entrance of patients, personnel, and materials. Street clothes are permitted in this area, and traffic is not limited. The entrance to the surgical suite should be restricted to authorized personnel based on organizational policies.
The semirestricted area includes the peripheral support areas of the surgical suite. It has storage areas for clean and sterile supplies, work areas for storage and processing of instruments, scrub sink areas, and corridors leading to the restricted areas of the surgical suite...Personnel are required to wear surgical attire and cover all head and facial hair.
The restricted area includes ORs (operating rooms), and the clean core area. Surgical attire and hair coverings are required. Masks are required where open sterile supplies or scrubbed persons are located. All persons entering the restricted area should follow the AORN Recommended practices for surgical attire."

According to AORN (Association of periOperative Nurses) Perioperative Standards and Recommended Practices, 2012 Edition, Recommended Practices for Environmental Cleaning in the Perioperative Setting, Recommendation IV "Surgical and invasive procedure rooms and scrub/utility areas should be terminally cleaned daily...IV.a. Terminal cleaning and disinfection of operating and invasive procedure rooms should be done - when the scheduled procedures are completed for the day, and - each 24-hour period during the regular work week. IV.a.1. Unused rooms should be cleaned once during each 24-hour period during the regularly scheduled work week."

5. On 4/11/12 at 10:45 am, ten packages of scissors, ten packages of needle holders with the hinges closed, and five clamps packaged together, were observed in the operating room cabinets. In a concurrent interview, INC stated that the hinges of the sterile instruments should be opened and the package of clamps were too full to sterile properly.

According to CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008, under Sterilizing Practices, read "Packaging. Once items are cleaned, dried, and inspected, those requiring sterilization must be wrapped or placed in rigid containers and should be arranged in instrument trays/baskets according to the guidelines provided by the AAMI and other professional organizations. These guidelines state that hinged instruments should be opened; items with removable parts should be disassembled unless the device manufacturer or researchers provide specific instructions or test data to the contrary...The packaging material must allow penetration of the sterilant, provide protection against contact contamination during handling, provide an effective barrier to microbial penetration, and maintain the sterility of the processed item after sterilization."

6. On 4/12/12 at 8 am, the Infection Control Nurse (ICN) was asked if any surgical staff laundered their surgical scrubs at home. ICN stated that there was a member of the surgical staff that laundered their scrubs at home.

According to the policy, "Uniform Policy," dated 1/10, "Scrub uniforms will be available for Operating Room (OR) personnel...2. The uniform will be returned when employee work shift is completed. EXCEPTION: Unless deemed necessary to wear scrub uniform (body fluid spills) home. This would need approval by OR, ER (Emergency Room) or RR (Recovery Room) RN. If this occurs, it is mandatory the scrubs be returned the following day. NO EXCEPTIONS!

According to AORN Perioperative Standards and Recommended Practices, 2012 Edition, Recommended Practices for Surgical Attire, Recommendation III, "All individuals who enter the semirestricted and restricted areas of the surgical suite should wear freshly laundered surgical attire that is laundered at a health care-accredited laundry facility or disposable surgical attire provided by the facility and intended for use within the perioperative setting."

7. On 4/11/12 at 10:30, six Jelco IV (Intravenous) catheters without the use of engineered sharps injury protection were observed in a drawer of the anesthesia cart in the operating room. There were boxes of various sizes of Jelco without the use of engineered sharps injury protection observed in the Procedure Room/Post Anesthesia Care Unit. In a concurrent interview, ICN stated that the Jelco used in the surgery department did not have injury protection to prevent a sharps injury.

According to the policy, "Sharps Injury Prevention Program," dated 10/11, under "Medical procedures requiring the use of engineered sharps injury protection: a. Accessing a vein or artery b. Withdrawal of body fluids c. Administration of medications or fluids; and d. Any other procedure involving the potential for an exposure incident for which a needle device with engineered sharps injury protection is available."

According to Centers for Disease Control and Prevention (CDC) on Preventing Needlesticks and Sharps Injury had an article titled, "Occupational Safety: Selected Cost and Benefit Implications of Needlestick Prevention Devices for Hospitals," referred to the Health Care Worker Needlestick Prevention Act (HR 1899), which would require the use of needles with safety features...On November 6, 2000, the President signed the Needlestick Safety and Prevention Act (P.L. 106-430), which mandates changes in the bloodborne pathogens standard in effect under the Occupational Safety and Health Act of 1970. The Act requires employers to document the consideration and implementation of safer medical devices, including safe needle devices, in their facilities."
8. On 4/10/12 Patient 24's record was reviewed. On 3/28/12 Patient 24 had surgery on the right hand. Patient 24 received propofol (anesthesia), versed (sedation), and alfentanil (narcotic). After the surgery was completed Patient 24 was transferred directly to the medical/surgical (Med/Surg) floor to recover. There was no documentation that post procedure monitoring occurred. There was no policy or procedure for bypassing PACU (Post Anesthesia Care Unit) Phase I according to AORN standards.

According to the policy, "Discharge Criteria," dated 1/10, the anesthetist may discharge the patient from the Recovery Room (PACU) at his or her discretion...Transfer to Med/Surg after minimum of one half hour and when patient meets discharge criteria (or return to pre op state)."

According to AORN Perioperative Standards and Recommended Practices, 2012 Edition, under Postoperative Patient Care in the Ambulatory Surgery Setting, reads "Fast tracking is defined as transferring a patient directly from the OR to PACU phase II (focuses on preparing the patient for self-care, care by family members, or care in an extended care environment) bypassing PACU phase I (focuses on providing a transition from a totally anesthetized state to one requiring less acute interventions. The purpose is for patients to regain physiological homeostasis and received appropriate nursing intervention as needed). Policy and procedures should be developed before initiating a patient fast-tracking process. Patient education concerning fast tracking begins during the preoperative assessment. Wherever fast tracking is practiced, a collaborative plan of care should be developed by anesthesia care providers and perianesthesia nurses. The plan should include: written guidelines addressing patient selection, preoperative patient education, selection and management of anesthetic agents, assessment criteria, discharge criteria, and monitoring and reporting of patient outcomes."

Based on interview and record review, the facility failed to ensure that each patient was evaluated for proper anesthesia recovery by a qualified practitioner for 1 of 4 sampled patients who received anesthesia (Patient 24). The potential outcome could result in an unsafe discharge from anesthesia services.

Findings:

On 4/11/12 Patient 24's record was reviewed. On 3/28/12 Patient 24 had monitored anesthesia care with sedation and a bier block (local anesthetic injected intravenously in an extremity) for surgery on the right hand. There was no written evidence that Patient 24 was evaluated for proper anesthesia recovery.

In an interview on 4/11/12 at 12:30 pm, the Director of Nurses and the Risk Manager Coordinator reviewed Patient 24's record and stated that the section where the anesthetist would document their post anesthesia note was blank and there was no written evidence that Patient 24 was evaluated for proper anesthesia recovery.

Based on interview and document review, the facility failed to ensure that propofol (general anesthesia, deep conscious sedation) was administered according to manufacturer's recommendation and standard of practice for 1 of 2 sampled patients (Patient 23) who received moderate conscious sedation (lighter level of sedation than general anesthesia where the patient maintains a good airway and responds to stimuli) and verified competency to administer moderate conscious sedation for 1 of 1 conscious sedation registered nurses (RNs). The result was allowing an RN to practice outside their scope of practice and not verify RNs competency to administer moderate conscious sedation.

Findings:

1. On 4/9/12, Patient 23's record was reviewed. Patient 23 had a lower endoscopy (scope to visualize the colon and large intestine). During the procedure, RN F documented that Patient 23 was administered 23 milliliters of propofol, (dosage not provided in the documentation) while an anesthetist (someone specially trained and licensed to administered general anesthesia) was on "standby."

On 4/12/12, RN F's personnel file was reviewed. There was no written evidence that RN F was competent to administer general anesthesia.

According to AORN (Association of periOperative Registered Nurses) Perioperative Standards and Recommended Practices 2012 Edition, under Moderate Sedation/Analgesia, Recommendation V.e. "Only persons trained in administering general anesthesia should administer propofol for moderate sedation/analgesia. On April 14, 2004, the American Association of Nurse Anesthetists (AANA) and the ASA (American Society of Anesthesiologist) in a joint statement said: "Because sedation is a continuum, it is not always possible to predict how an individual patient will respond. Due to the potential for rapid, profound changes in sedative/analgesia depth and the lack of antagonistic medications, agents such as propofol require special attention. Whenever propofol is used for sedation/anesthesia, it should be administered only by persons trained in the administration of general anesthesia, who are not simultaneously involved in these surgical or diagnostic procedures. This restriction is concordant with specific language in the propofol insert, and failure to follow these recommendations could put patients at increased risk of significant injury or death... The AORN Board of Directors endorsed this statement on January 14, 2005."

2. On 4/12/12, RN F's personnel file was reviewed. There was no written evidence that RN F was competent to administer moderate conscious sedation .

In an interview on 4/12/12 at 10 am, Risk Manager Coordinator stated that there was no written evidence in RN F's personnel file that she was competent in administering moderate conscious sedation.

According to AORN Perioperative Standards and Recommended Practices 2012 Edition, under Moderate Sedation/Analgesia, Recommendation IX, "Competency. The perioperative RN should be clinically competent, possessing the skills necessary to manage the nursing care of the patient receiving moderate sedation/analgesia. Competency assurance verifies that personnel have an understanding of moderate sedation; the risks of unplanned, deeper sedation; and the safe use of monitoring equipment. This knowledge is essential to minimize the risks of moderate sedation and to provide safe care. IX.a. The competency of the perioperative RN to administer moderate sedation/analgesia should be assessed, demonstrated, documented, and maintained...IX.e. Administrators should ensure that perioperative RNs who administer moderate sedation/analgesia for procedures are competent to perform these skills. IX.f. Competencies should reflect current regulations, nurse practice acts, standards, recommended practices, and guidelines affecting the administration of moderate sedation analgesia."

Based on document review and interview the hospital failed to ensure patients are discharged with complete instructions for after care including diet order.

Findings:

On 4/11/12 at 7:30 am, the medical record of Patient 22 was reviewed. Patient 22 was admitted 4/5/12 on a clear non carbohydrate liquid diet. Patient 22 was discharged 4/6/12. Review of discharge forms, dated 4/6/12, showed medications. There was not a diet recorded. The form did not have a place to record the diet, only "other. In a concurrent Interview with Charge Nurse A she stated that information is not noted on the discharge form unless the physician orders on the discharge order.

Based on observation, staff interview and document review the hospital failed to ensure that requirements were met for the condition of participation: Periodic Evaluation and Quality Assurance Review as evidenced by:

* Failure to develop an effective, ongoing, data-driven, quality appraisal and performance program for the hospitals' total program (Refer to C 331, C 332, C 279, C 302 and C 325).

* Failure to ensure a system for identifying, reporting, investigating and controlling infections and communicable diseases (Refer to C 278 and C 336).

* Failure to evaluate the quality and appropriateness of the diagnosis and treatment furnished by doctors of medicine or osteopathy at the hospital by an appropriate and qualified Quality Improvement Organization (QIO) or network hospital (Refer to C 340).

The cumulative effect of these systemic problems resulted in the facility's inability to comply with the statutorily mandated Condition of Participation: Periodic Evaluation and Quality Assurance Review.

Based on observation, staff interview, and document review, the hospital failed to maintain an effective, ongoing, hospital wide data driven quality assessment program, which involved the dietary department, when there was no evidence of periodic evaluation of the total program.

Findings:
On 4/12/12 at 10:00 a.m., with the Risk Management Coordinator stated she was responsible for the quality program at the hospital. She stated they did not have a lot of quality program for the dietary department and clinical nutrition. She was not able to provide any documented quality program. She stated there was a 4th quarter chart review but there was no documentation provided.

Multiple findings for the survey were discussed regarding the infection control, safe food preparation, and nutrition screening and nutrition assessment of patients. The Risk Management Coordinator acknowledged that there were no quality programs addressing any of these areas including the food safety and handwashing deficiencies in the kitchen.

The Risk Management Coordinator was asked if the Agreement for Professional Services Dietary Consultant Services were reviewed or a quality program developed to ensure dietary consulting services were evaluated and met requirements of the hospital. The Risk Management Coordinator stated that there was no quality review of the contracted consultant dietitian services. She stated there was not quality evaluation of the nutrition screening process of patients or patient nutritional evaluations including the telecommunication of patients' nutrition evaluation.

The agreement for Professional Services Dietary Consultant Services, dated October 1, 2011, was reviewed. The contract did not have a quality statement requiring the provision of quality assessment.

Review of the Continuous Quality Improvement Plan showed the purpose is to establish a planned, systemic and interdisciplinary approach to improving the care and services provided by the hospital. The plan included scope of performance for infection control and care service provided to high risk population, There was no data driven analysis of the high risk patient or infection control, including dietary practices and hand washing. There were no data performance measures developed. There was no analysis of rick measures to identify opportunities for improvement. There were no benchmarks developed to evaluate quality of services.

In addition the agreement for the dietary consultant services from Mercy Hospital stated "Mercy shall provide professional ADA qualified dietitian services to patients and residents of facility only to the extent possible under Mercy's staffing levels at the time services are requested."

Based on staff interview and document review, the hospital failed to do or have done an annual evaluation of the utilization of services, volume of services and number of patients served, for the entire hospital program or for individual providers caring for patients in the hospital.

Findings:

On 4/9/12 and 4/10/12 the minutes of meetings conducted since 1/1/11 of the Board of Directors (Board), the MEC, and the Continuous Quality Improvement Committee (CQIC) were reviewed and these documents did not contain verification that the hospital had evaluated the utilization of services, the volume of services or the number of patients served.

On 4/11/12 contracts for outside services were requested and reviewed. The hospital did not have a written contract with a Quality Improvement Organization (QIO) to provide an annual evaluation of the hospital's services. However, two documents were offered as proof that the hospital did have an understanding with the QIO. One document was titled "Peer Review Network Reimbursement Policy" published by the QIO. The other document was titled "Critical Access Hospital: Periodic Evaluation and Quality Assurance Review" written by the hospital and last reviewed 10/10. This document read in part, "(Name of Hospital) carries out or arranges for a periodic evaluation of its program. The evaluations is done by (QIO) and includes* The utilization of (Name of Hospital)'s services, including the number of patients served and the volume of services;* A representative sample of both active and closed clinical records;* (Name of Hospital)'s health care policies."

On 4/11/12 the latest Periodic Evaluation and Quality Assurance Review report from the QIO was requested but not provided.

On 4/10/12 the hospital's "Continuous Quality Improvement Plan (CQI Plan)", last approved by the Board on 1/26/10, was reviewed. This document did not call for the QIO to be involved in any way. The plan did not specify how the evaluation of the utilization of hospital services, or how the evaluation of the quality and appropriateness of diagnoses and treatments were to be accomplished. It did state that "On an annual basis, this plan will be evaluated to determine if any changes to the scope or content must be made ..." There was no evidence provided that the CQI Plan had been evaluated in the twenty-six months since last approved by the Board.

On 4/10/12 at 2:50 p.m. the HIM (Health Information Manager) was interviewed. She provided information about a study that is ongoing to collect information about admissions for pneumonitis and/or heart failure. However to her knowledge, related data had not been shared with the CQIC, the MEC, or the Board. The hospital staff member responsible for UR (utilization review) was not available for interview.

On 4/11/12 beginning at 2:15 the Medical Staff Coordinator (MSC) and the HIM (former MSC) were interviewed and twelve medical staff credential files were reviewed. None of the reviewed credential files contained any information about the number of patients treated or the number of clinical procedures performed. The files also did not contain any proctor reports or peer review reports. There was nothing in the files to demonstrate that routine or for-cause professional proficiency evaluations had been done on any of the practitioners. As a result, when a medical staff member was up for re-appointment and renewal of clinical privileges, the credential file does not contain information to show the individual has provided sufficient services and demonstrated competence for the renewal of privileges being requested.

During that same interview, the staff members were asked how the hospital conducted periodic professional proficiency evaluations (PPPE) or ongoing professional proficiency evaluations (OPPE) for the hospital's one general surgeon. They explained that in the past, the QIO had assisted the hospital in finding a qualified consultant surgeon to do surgical proficiency evaluations of the surgeon. However that had not happened in the past several years. The surgeon's current term of appointment was expiring at the end of the current month and in preparation for his reappointment the credential file contained no objective data concerning his performance over the past two years of his current appointment.

Based on interview and document review, the facility failed to ensure that an evaluation of infection control measures in the surgical department were integrated into the quality assurance program. The failure to not evaluate the quality and effectiveness of surgical and infection control practice resulted in non compliance in these services.

Findings:

On 4/12/12 at 8:30 am, a review of the quality assurance program was conducted with the Infection Control Nurse (INC). In an concurrent interview, INC stated that there was no monitoring of policy and procedure compliance or standards of practice within the surgery department with the Director of Surgical Services. INC stated that the procedure room for endoscopies (visualization of either the throat, stomach, and small intestines or large intestines) and recovering patients immediately postoperatively was not cleaned as recommended by AORN (Association of periOperative Registered Nurses). INC stated that data collection and investigation focused on the formal system and reporting for identifying, reporting, investigating, and controlling infections and communicable diseases.

In an interview on 4/12/12 at 10 am, the Risk Manager Coordinator and the Director of Nurses stated that minimal observations for compliance of infection control practices were conducted in the surgical department.

According to AORN Perioperative Standards and Recommended Practices, 2008, under Quality and Performance Improvement Standards for Perioperative Nursing, Standard I, Assign responsibility for monitoring and evaluation activities. Interpretive statement 1: The director and/or the designee assume overall responsibility for the monitoring and evaluation processes within the department and in the department's participation in the organization-wide performance improvement plan...Standard III, Identify processes impacting the quality and safety of patient care. Interpretive statement: High-volume, high-risk, and/or problem-prone processes are identified...Standard VII. Evaluate care based on data collected. Standard VIII. Take actions to improve care and services. Standard IX. Assess the effectiveness of action(s) and document outcomes. Standard X. Communicate relevant information to the appropriate individuals, organization-wide, while maintaining confidentiality.

Based on staff interview and document review, the hospital failed to contract for and utilize a network hospital or other appropriate and qualified Quality Improvement Organization (QIO) to evaluate the quality and appropriateness of the diagnosis and treatment furnished by doctors of medicine or osteopathy at the hospital.

Findings:

On 4/9/12 and 4/10/12 the minutes of the Board of Directors (Board) and the Medical Executive Committee (MEC) from January 2011 to present were reviewed. The minutes of both did not contain information about efforts to evaluate the quality of the diagnosis or treatments furnished by the medical staff. Each month the MEC provides a report to the Board which most often contained a line item titled "Peer Review." This line item supplies the number of charts reviewed, but does not provide any information about what was reviewed or other information. In the report there are lists of medical staff members for appointment or reappointment, but no information about the dates of their membership, the privileges they are requesting, the volume of care they provided, or any information about the quality the care they provide. There are no statements of the recommendation being made by the medical staff. The appointments, reappointments, and privileges requests are considered in closed session where no minutes are taken.

The MEC reports do not provide information to the board about quality assessment or performance improvement efforts conducted in the hospital. The Board does quarterly receive a report from the Continuous Quality Improvement Committee (CQIC). However that report is not part of the minutes,and is heard in closed session where no minutes are kept.

On 4/10/12 the hospitals "Continuous Quality Improvement Plan" (CQI Plan) was reviewed along with the the five most recent quarterly minutes from the CQIC meetings. Neither the minutes nor any of the attached reports had information about the quality and appropriateness of the diagnosis and treatment furnished by medical staff or allied health practitioners. Nor were there any reports concerning peer review.

On 4/10/12 beginning at 11:05 am the RMC and chairperson of the CQIC was interviewed. She acknowledged that the committee had no official means of evaluating the health practitioners of the hospital and did not have any quality indicators designed to address the quality and appropriateness of the diagnosis and treatment furnished in the hospital, although one medical staff member sits on the committee. She also acknowledged that neither the Board nor the MEC provide any direction for the CQIC. Most departments select their own quality indicators, and most have only one active project at a time.

On 4/10/12 beginning at 2:50 pm the HIM (Health Information Manager) was again interviewed. When asked about quality evaluations related to diagnoses and treatment she told about efforts by the Utilization Review (UR) committee. The UR committee tracks the number and severity of admissions for pneumonitis and heart failure. However these statistics are not reported to the MEC or the CQIC or the Board. Currently the person in charge of UR is out on sick leave.

When asked about how the medical staff did peer review, she said that in the past the hospital had an arrangement with a general surgeon that did regular peer review of the single surgeon at this hospital. The consulting surgeon worked at another hospital in northern California, and had been referred to this hospital by a Quality Improvement Organization. However it had been a number of years since the hospital had used this peer review consultant. She had no peer review reports in any of the medical staff credential files.

Based on staff interview and document review, the hospital failed to ensure that requirements were met for the condition of participation: Organ, Tissue and Eye Procurement as evidenced by:

* Failure to develop and implement any written policies, procedures or protocols that would ensure, in collaboration with the designated OPO (Organ Procurement Organization) , that the family of each potential donor is informed of its option to either donate or not donate organs, tissues, or eyes. The hospital did not have a staff member designated and trained to initiate the request to the family (Refer to C 347).

* Failure to develop and implement any written policies, procedures or protocols that encouraged the hospital staff to use discretion and sensitivity with respect to the circumstances, views, and beliefs of the families of potential donors (Refer to C 348).

* Failure to develop and implement any written policies, procedures or protocols that would assure the hospital worked cooperatively with the designated OPO, tissue bank and eye bank in educating staff on donation issues (Refer to C 349).

The cumulative effect of these systemic problems resulted in the facility's inability to comply with the statutorily mandated Condition of Participation: Organ, Tissue, and Eye Procurement

Based on staff interview and the absence of documents to review, the hospital failed to develop and implement written policies, procedures, or protocols that ensured, in collaboration with the designated OPO (Organ Procurement Organization), that the family of each potential donor is informed of its option to either donate or not donate organs, tissues, or eyes. The hospital failed to designate and train a staff member to initiate the request to the family and coordinate with the OPO.

Findings:

On 4/9/12 the hospital was presented with a list of requested documents. The list included a request for any Policies and Procedures (P/P) pertaining to organ and/or tissue procurement. During the morning of 4/10/12 a second request was made for any P/P relating to organ and/or tissue procurement. On 4/10/12 at 1:15 p.m. the hospital's Risk Management Coordinator (RMC) and Health Information Manager (HIM) were interviewed and they acknowledged that the hospital had no written policies, procedures or protocols that:
1.) encouraged the hospital staff to collaborate with the OPO,
2.) instructed the hospital staff to inform the family of potential organ donors of their option to either donate or not donate organs, tissues, or eyes, or
3.) specified the hospital would have "designated requestor."
The RMC also acknowledged that the hospital had not selected and/or trained a staff member to be the designated requestor. The hospital did not provide any pertinent documents to review.

Based on staff interview and the absence of documents to review, the hospital failed to develop and implement any written policies, procedures (P/P), or protocols that encouraged the hospital staff to use discretion and sensitivity with respect to the circumstances, views, and beliefs of the families of potential donors.

Findings:

On 4/10/12 at 1:15 p.m. key hospital administrative staff, the Health Information Manager and Risk Management Coordinator, acknowledged that the hospital had no written P/P that encouraged the hospital staff to use discretion and sensitivity with respect to the circumstances, views, and beliefs of the families of potential donors. The hospital did not provide any pertinent documents to review.

Based on staff interview and the absence of any documents to review, the hospital failed to develop and implement any written policies, procedures (P/P), or protocols that would assure the hospital worked cooperatively with the designated OPO (Organ Procurement Organization), tissue bank and eye bank in educating staff on donation issues.

Findings:

On 4/10/12 at 1:15 p.m. key hospital administrative staff members, Risk Management Coordinator and Health Information Manager (RMC and HIM) acknowledged that the hospital had no written P/P that where designed to assure the hospital staff worked cooperatively with the designated OPO, tissue bank and eye bank in educating staff on donation issues. On 4/10/12 at 1:30 p.m. the RMC acknowledged that the hospital had no training logs to show that the hospital staff had been trained on donation issues. The hospital did not provide any pertinent documents to review.

Based on interview the facility failed to have written policies and procedures regarding the visitation rights of patients. This failure could result in the patient not being informed that they have the right to have visitors or a reasonable explanation for the clinical restriction or limitation.

Findings:

On 4/12/12, a review of patient care policies and procedures did not include patient visitation rights.

In an interview on 4/12/12 at 12:50 am, the Health Information Manager stated that there were no written policies and procedures regarding the visitation rights of patients.