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Based on medical record review and nursing staff interview the hospital failed to ensure accurate admission screening for nutritional risk for one of 37 sampled patients (Patient 15). Failure to identify nutritional risk in an accurate and timely manner may result in delayed nutritional assessment and interventions.

Findings:

Patient 15 was admitted with diagnosis including dizziness. An admission history and physical dated 6/30/11 noted that patient had a poor appetite and weight loss. A nursing admission assessment dated 7/1/11 noted that the assessment was limited to the preadmission diet, last bowel movement, ability to feed self and oral appliances. There was no indication that nursing staff assessed patient's nutritional status prior to admission. Review of dietary intake from 7/1-7/5/11 noted an average intake of 15% for 15 meals. It was also noted that nursing staff recorded dietary intake for 5 of 15 meals. There was no indication that nursing staff assessed or notified the Registered Dietitian (RD) of the poor dietary intake.

In an interview on 7/19/11 at 10:30 am, with Registered Nurse (RN) P she acknowledged that the nursing screen did not accurately reflect the patient's nutritional status.

Based on observations, staff interviews, policy and procedure (P & P) and document review, the facility failed to ensure that drugs and biologicals were stored in accordance with manufacturer's directions as evidenced by: Fifteen (15) of fifteen (15) vials of medication were not stored in accordance with the manufacturer's instructions. This failure had the potential for putting the patient(s) at risk due to unsafe administration of medication(s).

Findings:

During an observation and a concurrent interview in the Center Core of the perioperative area on 7/18/11 at 11:15 a.m., nine vials of Lidocaine HCl 2% and Epinephrine 1:100,000 injection (a medication for production of local or regional anesthesia), 30 ml (milliliter)/vial, were stored in a tray with no lid/cover on the bottom shelf (labeled as drawer 23) of the Pyxis machine (an automated medication system - the unit is the size of a refrigerator outfitted with well-lit shelves and drawers that close and lock for security). Light source was observed on the left side interiorly of the pyxis machine. Additionally, light from the ceiling of the room passed through the door of the pyxis machine. Reviewed the printed label on the Lidocaine HCl 2% and Epinephrine vial with the NMOR (Nurse Manager of Operating Room) indicated "Protect from light." When asked if the Lidocaine HCl 2% and Epinephrine vials could be protected from light in the presence of the aforesaid light sources, the NMOR stated he needed to check with the pharmacist.

On 7/18/11 at 1 p.m., the manufacturer (Hospira)'s insert of Lidocaine HCl and Epinephrine injection was reviewed, which indicated "Protect from light."

During an observation and a concurrent interview in the Intensive Care Unit (ICU) on 7/18/11 at 2:25 p.m., six vials of Labetalol Hydrochloride (HCl) Injection (a medication for control of blood pressure in severe hypertension), 100 mg (milligram)/20 ml (milliliter)/vial, were stored in a tray with no lid/cover on the shelf (labeled as drawer 8) of the Pyxis machine. Light source was observed on the left side interiorly of the pyxis machine. Additionally, light from the ceiling of the room passed through the door of the pyxis machine. Reviewed the printed label on the Labetalol HCl vial with the Nurse Manager Intensive Care Unit (NMICU) indicated "Protect from light, retain in carton until time of use." When asked if the Labetalol HCl vials which were out of the carton could be protected from light in the presence of the aforesaid light sources, the NMICU stated she needed to check with the pharmacist.

On 7/18/11 at 3:30 p.m., a review of the manufacturer (Hospira)'s insert of Labetalol HCl Injection indicated "Protect from freezing and light."

During an interview with Pharmacist 1 (Pharm1) on 7/21/11 at 10 a.m., Pharm1 stated the light on the Lidocaine HCl 2% and Epinephrine vials and the Labetalol Hydrochloride vials was at very low ambient level. Pharm1 confirmed the Lidocaine HCl 2% and Epinephrine vials and the Labetalol Hydrochloride vials, which were out of carton before time of use, were safe to be used on patients.

During an interview with Pharmacist 2 (Pharm 2) on 7/21/11 at 1:45 p.m., the Pharm 2 stated the light had no significant effect on the Lidocaine HCl 2% and Epinephrine vials; the Labetalol Hydrochloride vials were photo-stable due to the acidic status. When asked why the manufacturer's specification did not support the Pharm2's explanation, the Pharm 2 stated the manufacturer could not contradict its label.

On 7/21/11 at 2 p.m., a review of the facility's P & P titled "Storage and Disposition of Medications," dated 10/12/08, indicated "Medications are stored under necessary conditions to ensure stability, i.e., under proper conditions of sanitation, temperature, light, moisture, ventilation, segregation, and security as specified by the manufacturer..."

On 7/21/11 at 2:05 p.m., a review of the document titled "APIC (Association for Professionals in Infection Control and Epidemiology) position paper: Safe injection, infusion, and medication vial practices in health care" dated 2010 indicated "Always follow the manufacturer's instructions for storage and use."

Based on observation interview and document review, the hospital failed to ensure timely nutrition assessment of patient risk based on weight loss and poor meal intake for one of 37 sampled patients (Patient 15). Failure to assess timely may result in delayed nutrition assessment and untimely nutrition interventions in patient care.

Findings:

Patient 15 was admitted with diagnosis including dizziness. An admission history and physical dated 6/30/11 noted that patient had a poor appetite and weight loss. A nursing admission assessment dated 7/1/11 noted that the assessment was limited to the preadmission diet, last bowel movement, ability to feed self and oral appliances. There was no indication that nursing staff assessed patients ' nutritional status prior to admission. Review of dietary intake from 7/1-7/5/11 noted an average intake of 15% for 15 meals. It was also noted that nursing staff recorded dietary intake for 5 of 15 meals.

On 7/3/11(3 days after admission) the RD (Registered Dietitian) completed a patient education session for an 1800 calorie diabetic diet. There was no indication that the RD acknowledged or assessed the patient's poor dietary intake despite a documented history of poor appetite and weight loss. On 7/6/11 (6 days after admission) the RD completed a follow up assessment noting Patient 15's estimated nutritional needs, the history of weight loss. The RD also noted that the patient was at high nutritional risk. There was no documentation that the hospital identified Patient 15's nutritional risk despite documented poor dietary intake and weight loss.

In an interview on 7/19/11 beginning at 11 am, RD Q acknowledged that the hospital failed to identify Patient 15's nutritional risk in a timely manner.

Based on observation, interview and document review, the hospital failed to ensure adequate food supplies to fully implement the planned disaster menu were on hand at all times. This put patients at nutrition risk in the event of a disaster that required the hospital to shelter in place with no outside resources available.

Findings:

During review on 8/18/11 at 1:10 p.m., of the hospital disaster feeding menu, and observation of the associated foods that would be provided to patients and staff in the event of a disaster that required the hospital to "shelter in place with no additional resources" it was revealed that not all needed foods were in the hospital. The inventory indicated the following:
1) five cases of rice drink were needed, and 1 case was available,
2) 3 1/8 cases of muffins needed and 2 cases available
3) 28 cases of Healthy Choice Entrees were needed and 23 cases were available.

Further concurrent interview with DMS (Dietary Management Staff) A revealed staff feeding would come from foods in the cafe, but there was no menu planned and no method to determine if there was adequate foods in the cafe to provide the meals for staff. DMS A acknowledged the available foods did not meet the requirements of the menu plan and that there was no detailed menu plan for staff meals.

Based on observations, staff interviews, and document review, the facility failed to remove the expired laboratory items from the storage cabinet and the dialysis carts in the dialysis area, which allowed the expired items be ready for use when: Two (2) of two (2) packets of blood collection tubes (103 blood collection tubes) were observed expired in the storage cabinet; five (5) blood collection tubes were observed expired in two (2) of two (2) dialysis carts; and two (2) of two (2) blood culture bottles were observed expired in one (1) of two (2) dialysis carts. These failures had the potential for putting the patient(s) at risk due to storage of expired and unsafe items which were ready for use.

Findings:

During an observation and a concurrent interview in the Dialysis room on 7/19/11 at 1:40 p.m., 53 BD (Becton-Dickinson) vacutainer - red top serum plus blood collection tubes (REF 367820 [catalog number]) dated 2011-02 and 50 BD vacutainer - green top Gel Separation tubes with Gel and Lithium Heparin (REF 367964 [catalog number]) dated 2010-12 were observed in the storage cabinet. There was an hour-glass symbol close to the aforesaid dates on the blood collection tubes. When asked the meaning of the hour-glass symbol, the ICN (Infection Control Nurse) stated she did not know and she would find it out.

During an observation and a concurrent interview in the Dialysis room on 7/19/11 at 1:52 p.m., 3 red top blood collection tubes (BD vacutainer - REF 367820 [catalog number]) dated 2011-02 were observed in the dialysis cart. The RN3 stated he did not know what 2011-02 stood for.

During an observation and a concurrent interview in the Dialysis room on 7/19/11 at 1:55 p.m., a pair of blood culture bottles with specific media for aerobic and anaerobic organisms (an aerobic organism is an organism that can survive and grow in an oxygenated environment; an anaerobic organism is any organism that does not require oxygen for growth) were observed in the dialysis cart. The anaerobic bottle with burgundy top (Lot number: 1025933) was dated 2011-05-31; the aerobic bottle with blue top (Lot number: 259789) was dated 2011-04-30. The RN3 confirmed that those blood culture bottles were expired.

During an observation and a concurrent interview in the hallway outside the Dialysis room on 7/19/11 at 2 p.m., 2 red top blood collection tubes (BD vacutainer - REF 367820 [catalog number]) dated 2011-02 were observed in the second dialysis cart (the RN3's cart). The NM 1 (Nurse Manager) confirmed that those red top tubes belonged to the same log of blood collection tubes stored in the storage cabinet.

During an interview in the Intensive Care Unit (ICU) on 7/19/11 at 3:50 p.m., The ICN (Infection Control Nurse) confirmed that the hour-glass symbol on the blood collection tube signified the expiration date.

On 7/20/11 at 10 a.m., a review of the document titled "BD Vacutainer Evacuated Blood Collection System" dated 11/2010 indicated "Do not use tubes after their expiration date. Tubes expire on the last day of the month and year indicated." On page 9, the Symbol Key indicated the hour-glass symbol date was the "use by" date.

On 7/21/11 at 1 p.m., a review of the document provided by the facility titled "FMS (Fresenius Medical Care) Clinical Services: Storage of Supplies for Inpatient Services dated 5/18/2011 indicated "Stock will be rotated on a regular basis according to expiration dates."

Based on observations, staff interviews, and document review, the facility failed to maintain the temperature and humidity in multiple peri-operative locations within acceptable standards in accordance with the facility's policy and procedure (P & P) when:

1. The recorded temperatures for the decontamination room; the sterile processing room; Operating Room (OR) 1; OR2; OR3; OR4; OR5; Cystoscopy (Cysto) Room; and Procedure Room were out of normal range on multiple occasions with no documented evidence of notification or correction for the variances in accordance with the facility's P & P;

2. The recorded humidity levels for OR 1; OR 2; OR3; OR 4; OR 5; Cysto Room; Procedure Room; Mauve Room (the sterile storage room); and Brown Room (the sterile storage room) were out of normal range on multiple occasions with no documented evidence of notification or correction for the variances in accordance with the facility's P & P;

These failures had the potential for putting the patient(s) at risk due to posing a fire hazard in an oxygen-enriched environment or conducing bacterial growth which would compromise the integrity of wrapped sterile items and cause infection.

Findings:

1. During the observations in the decontamination room on 7/18/11 at 10:10 a.m. and 12:34 p.m., the temperature gauge displayed on the wall was 65.3 degrees Fahrenheit.

On 7/18/11 at 12:40 p.m., the document titled "Sterile Processing Dept (Department) Temperature/Humidity Log - Decontamination Room" dated July 2011 was reviewed with the NMOR (Nurse manager Operating Room) and a concurrent interview was conducted. The aforesaid document indicated "Temperature Range: 60 - 65 degrees Fahrenheit" and "Notify Engineering immediately if Temperature or Humidity reading is out of range." The NMOR stated the current temperature (65.3 degrees Fahrenheit) was out of range and engineering should have been notified. The aforesaid document also indicated the temperature was 65.3 degrees Fahrenheit on 7/13/11 at 8:30 a.m. and 7/15/11 at 8:40 a.m.; the columns of "Engineer Call Time", "Engineer Action and Time", and Adjust Temperature" were left blank. The NMOR confirmed the engineering had not been called on those days.

On 7/20/11 at 9:15 a.m., the document titled "Operating Room Daily Temperature Log" dated 1/2011 through 7/2011 was reviewed with the NMOR. The aforesaid document indicated the normal temperature range was 68 degrees Fahrenheit to 73 degrees Fahrenheit. The recorded temperatures were out of normal range on multiple occasions with no documented evidence of notification or correction for the variances in accordance with the facility's P & P, and they were listed as follows:

a. On 3/14/11, the temperature of OR 1 was 67 degrees F; OR 2 was 66.2 degrees F; OR 4 was 66.8 degrees F; OR 5 was 66.6 degrees F; Cysto Room was 67.6 degrees F;

b. On 3/15/11, the temperature of OR 1 was 67 degrees F; OR 2 was 66.1 degrees F; OR 4 was 67 degrees F; OR 5 was 66.8 degrees F;

c. On 3/16/11, the temperature of OR 1 was 67.1 degrees F; OR 2 was 67.1 degrees F; OR 4 was 67.1 degrees F; OR 5 was 66.8 degrees F; Cysto Room was 67.6 degrees F;

d. On 3/28/11, the temperature of OR 2 was 67 degrees F;

e. On 4/25/11, the temperature of OR 2 was 66.2 degrees F; OR 3 was 67.7 degrees F; Cysto Room was 66.9 degrees F;

f. On 4/26/11, the temperature of Procedure Room was 67.2 degrees F;

g. On 4/27/11, the temperature of OR 3 was 67.3 degrees F; Cysto Room was 65.8 degrees; Procedure Room was 67.5 degrees F;

h. On 4/28/11, the temperature of OR 5 was 67.3 degrees F; Cysto Room was 65.4 degrees; Procedure Room was 67 degrees F;

i. On 4/29/11, the temperature of OR 1 was 66.4 degrees F; OR 2 was 67.9 degrees F; OR 3 was 67.7 degrees F; Cysto Room was 65.8 degrees F; Procedure Room was 66.6 degrees F.

On 7/20/11 at 9:20 a.m., the document titled "Sterile Processing Dept. Temperature/Humidity Log - Assembly" dated 7/2011 was reviewed with the NMOR. The aforesaid document indicated the normal temperature range was 68 degrees Fahrenheit to 73 degrees Fahrenheit and the engineering to be notified immediately if temperature or humidity reading was out of range. The recorded temperatures were out of normal range on multiple occasions with no documented evidence of notification or correction for the variances in accordance with the facility's P & P, and they were listed as follows:

a. On 7/2/11, the temperature was 66.9 degrees F;

b. On 7/3/11, the temperature was 67.2 degrees F;

c. On 7/4/11, the temperature was 66.4 degrees F;

d. On 7/5/11, the temperature was 66.3 degrees F;

e. On 7/6/11, the temperature was 67.2 degrees F;

f. On 7/8/11, the temperature was 67.7 degrees F;

g. On 7/9/11, the temperature was 63.2 degrees F;

h. On 7/10/11, the temperature was 65.3 degrees F;

i. On 7/11/11, the temperature was 67.6 degrees F;

j. On 7/12/11, the temperature was 67.6 degrees F;

k. On 7/15/11, the temperature was 67.8 degrees F;

During an interview with the NMOR on 7/20/11 at 9:23 a.m., the NMOR stated the staff should have notified the engineering immediately if temperature or humidity reading was out of range. The NMOR further confirmed that the documentation did not show the engineering had been notified.

On 7/21/11 at 11:30 a.m., a review of the facility's P & P titled "Perioperative Services Policy/Procedure: Environmental Control Parameters" dated 12/31/09 indicated the recommended temperature parameters: "Operating Rooms: 68 degrees F to 73 degrees F...Clean/Sterile Storage Areas: < (less than) 75 degrees F... Decontamination: 60 degrees F to 65 degrees F... Assembly /Prep and Pack: 68 degrees F to 73 degrees F...In the event that the temperature or relative humidity is not within the parameters listed above, staff will notify Engineering Department and the Sterile Processing Manager."

On 7/21/11 at 1 p.m., the 2011 Perioperative Standards and Recommended Practices, published by AORN (Association of periOperative Registered Nurses), was reviewed. On page 219, under Recommendation V.c.1., direction was given that, "Temperature should be maintained between 68 degrees Fahrenheit to 73 degrees Fahrenheit within the operating room suite and general work areas in sterile processing." Under Recommendation V.c.2., direction was given that, "The decontamination area temperature should be maintained between 60 degrees Fahrenheit to 65 degrees Fahrenheit."

2. During the observation and a concurrent interview in the sterile processing room on 7/18/11 at 12:25 p.m., the humidity gauge displayed on the wall was 62% (percent). The NMOR stated the normal range of the humidity in the sterile processing room was 30% to 60%. The NMOR also stated the engineering should have been notified for humidity out of normal range.

On 7/20/11 at 9:15 a.m., the document titled "Operating Room Daily Temperature Log" dated 1/2011 through 7/2011 was reviewed with the NMOR. The aforesaid document indicated the normal humidity range was 30% to 60%. The recorded humidity levels were out of normal range on multiple occasions with no documented evidence of notification or correction for the variances in accordance with the facility's P & P, and they were listed as follows:

a. On 1/20/11, the humidity of Mauve Room was 25%;

b. On 2/2/11, the humidity of OR1 was 23%; OR 2 was 23%; OR 3 was 23%; OR 4 was 24%; OR 5 was 23%; Cysto Room was 26%; Procedure Room was 28%; Mauve Room was 20%; and Brown Room was 23%;

c. On 2/8/11, the humidity of OR1 was 23%; OR 2 was 23%; OR 3 was 23%; OR 4 was 25%; OR 5 was 25%; Cysto Room was 22%; Procedure Room was 29%; Mauve Room was 22%; and Brown Room was 23%;

d. On 2/9/11, the humidity of OR 1 was 26%; OR2 was 24%; OR 3 was 25%; OR 4 was 26%; OR 5 was 28%; Cysto Room was 25%; Procedure Room was 29%; Mauve Room was 20%; and Brown Room was 24%;

e. On 2/10/11, the humidity of OR 2 was 28%; OR 3 was 27%; OR 4 was 28%; OR 5 was 20%; Cysto Room was 24%; Procedure Room was 29%; Mauve Room was 20%; and Brown Room was 28%;

f. On 2/11/11, the humidity of Mauve Room was 28%;

g. On 2/23/11, the humidity of Mauve Room was 28%;

h. On 3/18/11, the humidity of Mauve Room was 29%;

i. On 4/7/11, the humidity of Mauve Room was 24%;

j. On 4/14/11, the humidity of Mauve Room was 25%;

k. On 4/29/11, the humidity of Mauve Room was 23% (Engineering call time was at 7:40 a.m. and no response time had been documented).

During an interview with NMOR on 7/20/11 at 9:23 a.m., the NMOR stated the staff should have notified the engineering immediately if temperature or humidity reading was out of range. The NMOR further confirmed that the documentation did not show the engineering had been notified.

On 7/21/11 at 11:30 a.m., a review of the facility's P & P titled "Perioperative Services Policy/Procedure: Environmental Control Parameters" dated 12/31/09 indicated the recommended humidity parameters: "Operating Rooms: 30% to 60%; Clean/Sterile Storage Areas: < 70%; Decontamination: 30% to 60%; Assembly/Prep and Pack: 30% to 60%...In the event that the temperature or relative humidity is not within the parameters listed above, staff will notify Engineering Department and the Sterile Processing Manager."

On 7/21/11 at 1 p.m., the 2011 Perioperative Standards and Recommended Practices, published by AORN, was reviewed. On page 218, under Recommendation V.b., direction was given that, "Relative humidity should be maintained between 30% and 60% within the perioperative suite, including operating rooms... instrument processing areas, and sterilizing areas and should be maintained below 70% in sterile storage areas."

Based on observations, staff interviews, and document review, the facility failed to maintain an ongoing program to prevent, control, as well as investigate infections and communicable diseases that put the patient(s) at risk for possible exposure to blood-borne pathogen(s) and/or transmission of communicable diseases as evidenced by:

1. The facility did not maintain a sanitary physical environment when the housekeeping staff returned the used mop to the cleaning solution during the operating room cleaning between surgical cases;

2. The facility did not implement nationally recognized infection control guidelines when no hand-washing facility was available in the decontamination area;

3. The facility did not monitor staff compliance with the facility's policies and procedures when:
a. One (1) of one (1) staff member did not cover his personal clothing by the scrub suit before entering the semi-restricted or restricted areas of the OR (operating room)/procedure suite;
b. The facility did not process the surgical scissors of various types in the open position when seven (7) of fourteen (14) pairs of scissors inspected were processed with the blades closed;
c. The facility had a tote bag in the operating room;

4. The facility did not mitigate risks contributing to healthcare-associated infections when signs restricting entry to authorized personnel and designating appropriate attire was not posted near the entrance of the endoscopy room.

5. The facility failed to maintain safe food handling practices that could potentially put patients at risk of food-borne illness, which can cause nausea, vomiting, and diarrhea when:

a. Undated opened foods were available for use;

b.Time-temperature monitoring requirements for cool down of food were not followed;

c. Ice machine in the cafe was very dirty, and one ice machine at a patient care area did not have an air gap with adequate clearance to prevent contamination.

Findings:

1. During an observation of the environmental cleaning between surgical cases in the Operating Room 2 (OR 2) on 7/18/11 at 11:50 a.m., a female housekeeping staff mopped the floor; she returned the used mop to the cleaning solution; and she re-mopped the floor with the used mop head after squeezing excessive cleaning solution in the bucket.

During an interview with the NMOR in the decontamination room on 7/18/11 at 12:30 p.m., the NMOR stated the female housekeeping staff should have used a new mop head when she re-mopped the floor in OR 2.

On 7/19/11 at 9 a.m., a review of the document titled "OR suite between surgical cases" dated 3/27/09 indicated "Mop head and solution must be changed after each use."

2. During an observation and a concurrent interview with the NMOR in the decontamination room on 7/18/11 at 12:30 p.m., there was no hand-washing facility available for hand-washing purposes. The NMOR confirmed that there was no hand-washing facility in the decontamination room.

On 7/19/11 at 9 a.m., the 2011 Perioperative Standards and Recommended Practices, published by Association of periOperative Registered Nurses (AORN), was reviewed. On page 433, under Recommendation VII.b., direction was given that, "The decontamination area should...contain...hand-washing facilities..."

3.a. During a tour of the perioperative areas accompanied by the NMOR on 7/18/11 from 10:10 a.m. through 12:40 p.m., the NMOR was observed wearing a white clothing under the scrub suit. About 2 to 3 inches of the white clothing was not covered by the scrub suit at the V-neck area. The NMOR accompanied the surveyors walking through the operating rooms, decontamination room, sterile processing room, sterile storage areas, center core, and the scrub sink area.

On 7/19/11 at 11 a.m., a review of the facility's document titled "Surgical Attire" dated 8/28/09 indicated "All persons who enter the semi-restricted or restricted area of the surgical suite must wear hospital provided and laundered surgical attire. Restricted areas include: OR's and procedure rooms, clean core areas, sterile storage areas, and Sterile Processing Departments. Semi-restricted area includes peripheral support areas of the surgical or procedural suite (hallways, supply and equipment storage areas within the suite, utility rooms)...Garments worn under the scrub suit for purpose of warmth should fit snugly against the body and be covered by the scrub suit before entering the semi-restricted or restricted areas of the OR/Procedure Suite."

During an interview with the NMOR in the hallway on 7/19/11 at 2:45 p.m., when asked if the white clothing was part of the surgical attire, the NMOR stated "No, it's my attire." When the NMOR was told the facility's Policy and Procedure specified that the garments worn under the scrub suit should be covered by the scrub suit before entering the semi-restricted or restricted areas of the OR/Procedure Suite, the NMOR stated he was aware of the facility's policy; there was no problem with the white clothing under the scrub.

3.b. During a tour of the perioperative area on 7/18/11 at 10:35 a.m., seven pairs of scissors were in the closed position in sealed peel pouches (self-sealable pouches that contain surgical instruments during the sterilization process).

During an interview with the NMOR on 7/18/11 at 10:35 a.m., he was shown the scissors with blades closed in the peel pouches. When asked if that was the ASC's usual practice of sterilizing the scissors (with the blades closed), NMOR said, "No". The NMOR indicated the scissors would need to be reprocessed before use.

Review of the hospital policy titled "Reusable Supplies and Equipment: Cleaning of", dated 4/3/2000, included information that, "All instruments in washer baskets must be opened and as neat as possible. Make sure that all clamps and scissors are in the open position."

On 7/18/11 at 4 p.m., the 2010 Perioperative Standards and Recommended Practices, published by AORN, was reviewed. On page 430, direction was given that, "Cleaned surgical instruments should be organized for packaging in a manner to allow the sterilant to contact all exposed surfaces." and "Instruments with hinges should be opened..." On page 431, direction was given that, "Instruments should be kept in the open and unlocked position using instrument stringers, racks, or instrument pegs designed to contain instruments."

3.c. On 7/18/11 at 12:05 p.m. a tote bag was observed hanging from the anesthesiology cart in OR2.

During an interview with the NMOR on 7/18/11 at 12:07 p.m., he acknowledged the cloth tote bag could not be effectively cleaned between surgical cases and it should be removed or exchanged for a material that could be cleaned.

On 7/18/11 at 4:30 p.m., the 2011 Perioperative Standards and Recommended Practices, published by AORN, was reviewed. On page 61, direction was given that, "Fanny pack, backpacks, and briefcases, and other personal items that are constructed of porous materials, may be difficult to clean or disinfect adequately and may harbor pathogens, dust, and bacteria. Pathogens have been shown to survive on fabrics and plastics. Dust is made up of skin particles, hair, fabric fibers, pollens, mold, fungi, insect parts, glove powder, and paper fibers, among other things. Bacteria may be transported from one location to another by carriers such as dust or liquids, and may contaminate fanny packs, backpacks, and briefcases."

4. During an interview with the NMOR on 7/20/11 at 9:35 a.m., he indicated the endoscopy (A type of medical examination in which an instrument called an endoscope is passed into an area of the body for the purpose of examining visually the interior of a bodily canal or a hollow organ such as the esophagus, colon, bladder, or stomach or intestine, for example) procedure room was located between the perioperative areas and the intensive care unit and was designated as a semi-restricted area. The NMOR stated "people could come and go in the GI procedure room (meaning from the ICU entrance) and we would not know it." The NMOR acknowledged there were no signs near the intensive care entry into the Gastrointestinal (GI) (The large, muscular tube that extends from the mouth to the anus, where the movement of muscles and release of hormones and enzymes digest food also referred to as the digestive tract) procedure room to alert individuals they were entering an area that the hospital had designated for authorized personnel only and required appropriate hospital attire.

Review of the hospital policy entitled "Traffic Patterns in Surgical Suite" indicated in the procedure section that "Only authorized personnel may enter the semi-restricted and restricted areas of the surgical suite. The areas is limited to the medical staff, nursing staff, support services personnel working in the area, and upon authorization, other persons not directly involved in operational functions. Prior to entering the semi-restricted and restricted areas of the surgical suite, personnel shall change into appropriate hospital provided operating room attire in the locker rooms, located in the unrestricted area. Traffic in the restricted areas shall be limited to properly attired authorized personnel.




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5a.On 7/18/11 between 10:15 a.m.-11:50 a.m. during initial observations with Dietary Management Staff A (DMS) and Cafe Management Staff (CMS) B, in the reach-in freezer there were 7 bags of undated, opened onion rings, out of the original packing box, and in the walk-in refrigerator there was a covered pan of cut sweet potatoes dated 7/5, a container of garbanzo beans dated 7/14, and an undated 10 pounds of smoked salmon, thawed. On 7/19/11 DMS A provided the 8/5/10 Fresh and Natural Policy for perishable foods shelf life that specified food items should be dated with the " pull " date (the date to discard the food.) During a concurrent interview, CMS B acknowledged the frozen onion rings and salmon should have been dated, and the observed dated foods should have been discarded.

5b.On 7/18/11 at 11:00 a.m. a six-inch deep pan of warm rice was observed in the walk-in refrigerator. During a concurrent interview, Cafe Staff (CS) D stated he had cooked the rice earlier at 7:45 a.m. and then put it in the refrigerator at 9:30 a.m. because it was the wrong kind of rice for the menu. CS D stated he had not recorded the temperature of the rice at any point. The hospital provided the Fresh and Natural Cooling Chart that specified temperatures should be taken hourly when cooling potentially hazardous foods. CMS B acknowledged the rice should have been monitored for time/temperature, but had not.

5c.On 7/18/11 at 11:30 a.m. the cafe ice machine was observed to have a coating of black and pink debris coating over half of the visible section of the plastic ice deflector that directed new ice from the ice maker to the back of the ice bin. The debris was easily removed when wiped with a clean paper towel. DMS A acknowledged the machine was dirty and stated facility engineering was responsible for cleaning the inside.

At 12:00 p.m. on 7/18/11 during an interview, Facility Engineer E stated he was responsible for cleaning the interior of the machine by wiping it with the product IMS II Sanitizer but did not remove any of the interior parts. Review of the manufacturer ' s cleaning/sanitizing directions provided by the hospital revealed the machine was to be cleaned (descaled) and sanitized using only Manitowoc Ice Machine Cleaner and Sanitizer (two separate products). Review of the cleaning and sanitizing process revealed the cleaner and sanitizer to circulate through the ice maker for a time period, and also removable parts of the ice maker and bin were to be removed and soaked in the solutions.

On 7/18/11 at 12:00 p.m. during observation of the ice machine at Northeast Station, it was observed the no air gap where the ice machine drained into the plumbing. The exit drain of the ice machine was submerged beneath the top of the drain pipe. Facility Engineer E acknowledged the air gap did not have the correct clearance to prevent contamination of the ice machine in the event of a sewer back-up.