HospitalInspections.org

Based on document review, interview and observation, it was determined that the Governing Body failed to demonstrate it is effective in carrying out the responsibilities for the operation and management of the hospital. The Governing Body failed to provide necessary oversight and leadership as evidenced by the lack of compliance with the following Conditions of Participation:

CFR 482.25 Pharmaceutical Services
CFR 482.41 Physical Environment
CFR 482.42 Infection Control

Based on observations made during a tour of the Psychiatric Unit conducted at approximately 11:00 AM on 11/13/13, in the presence of Staff #54, and staff interview, it was determined that the facility failed to ensure that the patients received care in a safe setting.

Findings include:

1. Non vandal-proof screws were noted in the patient rooms on the door hinges, walls, and other areas.

2. The ceiling mounted smoke detectors in the patient rooms and in some of the bathrooms were not a type designed to resist a suicide by ligature attempt.

3. The ceiling vents in the patient rooms were not a type designed to resist a suicide by ligature attempt.

4. These findings were confirmed by Staff #54.

Based on a review of medical records and staff interview it was determined that the facility failed to ensure that a physician or other licensed independent practitioner did a face to face examination of the patient within 1 hour of the patient being restrained (Medical Records #37 and #38).

Findings include:

1. Medical Record #37 showed that the patient was restrained at 02:43 and again at 14:45 on 11/2/13.

a. There was no evidence of a face to face examination of the patient within one hour by a physician.

2. Medical Record #38 showed that the patient was restrained at 14:51 on 11/9/13.

a. There was no evidence of a face to face examination of the patient within one hour by a physician.

3. These findings were confirmed by Staff #54.

A. Based on a review of medical records of patients referred to social services by nursing, it was determined that the facility failed to ensure that the Nursing Process Documentation: Guidelines for Completion policy was implemented in three of five records reviewed (Medical records #19, #27, and #24).

Findings include:

Reference: Facility policy titled, "Nursing Process Documentation: Guidelines for Completion" stated, "Procedure: Adult Patient Database: Nursing Assessment & Interdisciplinary Referrals 1. The Registered Nurse completes all section within 12 hours of admission ... Referrals identified during the assessment will be done utilizing the Fax Referral form which is part of the database packet."

1. The Discharge Planning Screen section of the Initial Patient Assessment/Interdisciplinary Referral form dated 11/7/13 in Medical Record # 19 indicated that the patient needed assistance upon discharge. The Referral form indicated that no referral was needed from social services even though the need for assistance upon discharge was identified.

2. The Discharge Planning Screen section of the Initial Patient Assessment/Interdisciplinary Referral form dated 11/11/13 in Medical Record #27 indicated that the patient was currently receiving supportive services from community agency/home care. The Referral form indicated that no referral was needed from social services even though the assessment identified the use of supportive services.

3. The Discharge Planning Screen section of the Initial Patient Assessment/Interdisciplinary Referral form dated 11/10/13 in Medical Record #24 was not complete.

4. The above was confirmed with Staff #68 in the morning of 11/13/13.



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B. Based on medical record review, staff interviews and review of facility documents, it was determined that the facility failed to ensure implementation of their policy and procedure for the assessment and reassessment of the newborn circumcision post-operative site in two of two records reviewed for post circumcision monitoring (Medical Records #30 and #31).

Findings include:

Reference #1: Facility policy: "Circumcision of Infants" Procedure: 8) Postoperatively b. Check for bleeding every hour for 2 hours.

1. Review of Medical Records #30 and #31 in the presence of Staff #14, Staff #15 and Staff #74 indicated the following:

a. Medical Record #30:

(i) Progress Note: Circumcision: 11/11/13 at 3:00 PM.

(ii) Patient Care Flow Sheet: 11/11/13 at 3:30 PM; Baby back from circumcision...

(iii) There was no documentation in the medical record that the circumcision site was assessed for bleeding every hour for 2 hours.

b. Medical Record #31:

(i) Progress Note: Circumcision: 11/11/13 at 12:00 PM.

(ii) Patient Care Flow Sheet: 11/11/13 at 1200, Circ [circumcision] ok ...

(iii) There was no documentation in the medical record that the circumcision site was assessed for bleeding every hour for 2 hours.

2. When interviewed about the post circumcision assessment and reassessment practice, Staff #76 stated, "I check the circumcision site every 15 minutes for the first hour, then every hour after that."

3. Staff #77 stated, "I check the circumcision site after the procedure then every four hours and during diaper changes."

4. Staff #14 and Staff #74 confirmed that the policy and procedure for post circumcision assessment and reassessment is not followed.

A. Based on medical record review, staff interviews, and review of facility policy and procedure, it was determined that the facility failed to ensure that all medications administered by nursing personnel are administered in accordance with prescriber orders and all Federal and State laws and regulations.

Findings include:

Reference #1: The Nursing Practice Act for the State of New Jersey states: "The practice of nursing as a registered professional nurse (RN) is defined as diagnosing and treating human responses to actual or potential physical and emotional health problems, through such services as casefinding, health teaching, health counseling, and provision of care supportive to or restorative of life and wellbeing, and executing medical regimens as prescribed by a licensed or otherwise legally authorized physician or dentist."

Reference #2: Facility Policy: 'Pain Assessment and Management' states "...7. Using a pain scale rating of 0 -10... a pain score of: a. 1 - 2 is mild pain, b. 4 - 6 is moderate pain, c. 7 - 10 is severe pain... 11. The nurse administers prescribed medication at the stated intervals ..."

1. Review of Medical Record #28 on 11/12/13 in the presence of Staff #14 and #15, indicated the following:

a. Physician's Order dated 11/11/13 at 6:48 PM indicated: Percocet 1 tab every 4 hours as needed. PRN reasons: Moderate Pain (4-6).

b. Physician's Order dated 11/11/13 at 6:48 PM indicated: Percocet 2 tabs every 4 hours as needed. PRN reasons: Severe Pain (7-10).

c. Pain Assessment on 11/12/13 at 10:00 AM indicated a pain score of 5 (moderate pain).

i. The Medication Administration Record (MAR) dated 11/12/13 at 10:00 AM indicated that 2 Percocet tablets were administered, rather than the one tablet as ordered.

ii. Staff #75 confirmed that he/she administered 2 Percocet tabs (severe pain) for a pain score of 5.

2. Review of Medical Record #29 on 11/12/13 in the presence of Staff #14 and #15, indicated the following:

a. Physician's Order dated 11/10/13 at 11:41 PM indicated: Percocet 1 tab every 4 hours as needed. PRN reasons: Moderate Pain (4-6).

b. Physician's Order dated 11/10/13 at 11:41 PM indicated: Percocet 2 tabs every 4 hours as needed. PRN reasons: Severe Pain (7-10).

c. Physician's Order dated 11/10/13 at 11:41 PM indicated: Motrin 600 mg tab every 6 hours as needed. PRN reasons: Pain (1-3).

d. Pain Assessment on 11/11/13 at 1:19 PM indicated a pain score of 8 (severe pain).

i. The MAR dated on 11/11/13 at 1:19 PM indicated that 1 Percocet tablet and 1 Motrin 600 mg tablet were administered.

ii. Staff #76 confirmed that he/she administered 1 Percocet tablet (moderate pain) and 1 Motrin 600 mg tablet (mild pain) for a pain score of 8 rather than the 2 Percocet tablets ordered.



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3. On 11/13/13 at 11:45 AM, a WOW (workstation on wheels) cart with a non-functioning computer was noted on the H-Green Ortho Unit. Upon interview, Staff #58 stated that he/she used the WOW cart to pass medications to patients. When asked how he/she accesses the facility's E-MAR (electronic medication administration record) with a non-functioning computer when passing medications, Staff #58 stated that he/she prints out paper copies of all patient MARs (medication administration record) at the beginning of the shift and uses them to prepare medications and document administration for each medication pass.

a. Staff #58 stated that he/she uses the printed MARs to pull medications from the Pyxis (automated dispensing machine) for each patient. Staff #58 stated that he/she uses the paper MARs to document administration during the medication pass and then later documents in the facility's E-MAR.

i. Upon interview, Staff #33 stated that new medication orders are entered directly into the computer system, verified by a pharmacist, and reflected in the facility's E-MAR. The facility did not have a procedure in place for new orders, discontinued orders, or dose changes to be reflected on the printed MARs used by Staff #58 to pass medications.

ii. The facility did not have a mechanism in place to ensure that the paper MARs printed in the morning and used throughout the shift to pull medications from the Pyxis machine were an accurate medication profile for each patient.

b. Upon request, the facility staff was unable to provide a policy and procedure to guide the practice of using pre-printed paper MARs to pass medications.

4. These findings were confirmed with Staff #33, #64, and #65.

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Based on observation and staff interview on 11/12/13-11/13/13, it was determined that the facility failed to ensure that pharmaceutical services are provided in a safe manner.

Findings include:

1. The facility failed to develop and implement policies and procedures to ensure that drugs in single dose containers are not available for use on multiple patients. (Refer to Tag A-0491)

The findings of opened single dose containers was cause for an Immediate Jeopardy to be identified on 11/12/13. The Immediate Jeopardy was abated on the afternoon of 11/12/13 after receiving an acceptable plan of correction.

2. The facility failed to develop and implement policies and procedures to ensure that outdated or otherwise unusable drugs were not available for patient use. (Refer to Tag A-0505)

Based on observation and staff interview, it was determined that the facility failed to develop and implement policies and procedures to ensure that drugs in single dose containers are not available for use in multiple patients.

Findings include:

1. On 11/12/13 at 10:45 AM, one opened 0.9% Sodium Chloride 10 ml single dose vial was found in the Anesthesia Pyxis (automated dispensing machine) in OR #3.

2. On 11/12/13 at 11:30 AM, one needle punctured 0.9% Sodium Chloride 250 ml IV bag labeled "Phenylephrine 0.08 mg/ml" was found in the Anesthesia Pyxis machine in OR #11.

a. Upon interview, Staff #35 stated he/she prepared the bag of IV solution containing Phenylephrine earlier that morning at 9 AM. Staff #35 stated, "The bag is prepared in the morning and used to draw up syringes throughout the day for cases."

b. The manufacturer's label on the 0.9% Sodium Chloride 250 ml IV bag states "single dose container".

3. On 11/12/13 at 11:45 AM, the following opened single dose vials were found in the Anesthesia Regional Cart available for use in multiple patients:

a. Two opened Lidocaine 2% 5 ml vials.

b. One opened Bupivacaine 0.25% 30 ml vial.

c. Two opened Bupivacaine 0.5% 30 ml vials.

d. One opened Xylocaine-MPF 2% 10 ml vial.

4. These findings were confirmed by Staff #31, #33, and #34.

Based on observation and staff interview, it was determined that the facility failed to develop and implement policies and procedures to ensure that outdated or otherwise unusable drugs were not available for patient use.

Findings include:

Reference: United States Pharmacopoeia Chapter 797 (USP 797) states, "Opened or needle-punctured single-dose containers, such as bags, bottles, syringes, and vials of sterile products and CSPs [compounded sterile products] shall be used within 1 hour if opened in worse than ISO [International Organization for Standardization] Class 5 air quality and any remaining contents must be discarded."

1. On 11/12/13 at 10:45 AM, the following pre-drawn syringes containing medication were found past the beyond-use time of 1 hour from the time of preparation (Reference) in OR #3:

a. One 10 ml pre-drawn syringe containing a clear liquid labeled "Phenylephrine 0.1 mg/ml...Date: 11/12...Time: 7a".

b. One 10 ml pre-drawn syringe containing a clear liquid labeled "Succinylcholine 20 mg/ml...Date: 11/12...Time: 9a".

c. One 5 ml pre-drawn syringe containing a clear liquid labeled "Lidocaine 20 mg/ml...Date: 11/12...Time: 9:30a".

2. On 11/12/13 at 10:45 AM, three pre-spiked Lactated Ringer's solution 1,000 ml IV bags labeled "11/12/13 7a" and one pre-spiked Plasma-Lyte A injection 1,000 ml IV bag labeled "11/12/13 8a" were found in OR #3.

a. Upon interview, Staff #34 stated the IV bags were prepared in the morning and discarded after 24 hours if not used. This practice is not in accordance with USP-797 standards. (Reference)

3. On 11/12/13 at 11:30 AM, the following pre-drawn syringes containing medication were found past the beyond-use time of 1 hour from the time of preparation (Reference) in OR #11:

a. One 10 ml pre-drawn syringe containing a clear liquid labeled "Succinylcholine 20 mg/ml...Date: 11/12/13...Time: 0900".

b. One 5 ml pre-drawn syringe containing a clear liquid labeled "Zemuron 10 mg/ml...Date: 11/12/13...Time: 0900".

c. One 5 ml pre-drawn syringe containing a clear liquid labeled "Nimbex 2 mg/ml...Date: 11/12/13...Time: 0900".

d. One 10 ml pre-drawn syringe containing a clear liquid labeled "Ephedrine 5 mg/ml...Date: 11/12/13...Time: 0900".

4. On 11/12/13 at 11:30 AM, one pre-spiked Lactated Ringer's solution 1,000 ml IV bag labeled "11/12/13 10:00" was found past the beyond-use time of 1 hour from the time of preparation (Reference) in OR #11.

5. These findings were confirmed by Staff #31, #33, and #34.

A. Based on document review, staff interview, and observations, it was determined that the facility failed to employ a food service director who was responsible for the daily management of the dietary services in accordance with the facility job description, "Director of Food and Nutrition Services."

Findings include:

Reference #1: Facility job description, "Director of Food and Nutrition Services" stipulates, "...1. Plans and directs the activities to assure quality service of food to patients, staff, faculty, students and visitors. 2. Ensures that the nutritional needs of patients are met through ... and appropriate nutrition care/education...4. Develops and manages ...performance improvement initiatives and automation processes. 5. Maintain a sanitary, safe, and efficient operation in accordance with federal, state and local health regulations, and all standards set forth, by the Joint Commission (TJC). ..."

Reference #2 : N.J.A.C. 8:24-3.5(f)2 states potentially hazardous food shall be maintained "... 2. At refrigeration temperatures." N.J.A.C. 8:24-1.5 Definitions, Refrigeration temperatures mean: 1. 41 º F. or less, ..."

Reference #3: N.J.A.C. 8:24-4.5(a) states "Equipment and equipment components shall be maintained in a state of repair and condition that meets the requirements specified under N.J.A.C. 8:24-4.1 and 8:24-4.2." Specifically, 8:24-4.2 (a) states "Equipment and utensils shall be designed and constructed to be durable and to retain their characteristic qualities under normal use conditions", and 8:24-4.2 (b) 2 states Multiuse food contact surfaces shall be free of breaks, open seams, cracks, chips, pits, and similar imperfections.

Reference #4: N.J.A.C. 8:24-4.6(c) states "Non food-contact surfaces of equipment shall be kept free of an accumulation of dust, dirt, food residue, and other debris."

Reference #5: N.J.A.C. 8:24-5.2(a) states "A plumbing system shall be : 1. Repaired in accordance with 8:24-5:23, New Jersey Uniform Construction Code; and 2. Maintained in good repair."

1. On 11/12/13 and 11/13/13, there failed to be a food service director to ensure that the facility's food and nutrition department and associated food pantries are maintained in accordance with State health regulations N.J.A.C. 8:24:

a. There were six 4 oz. containers of milk stored inside the "Pantry E Blue 241" refrigerator that registered 57 º F. The containers of milk product were not maintained at the refrigerator temperature of 41 º F or lower in accordance with Reference #2.

b. The one plastic scoop used at the food and nutrition department ice machine had a crack on the food contact surface area. The plastic scoop failed to be maintained in accordance with Reference #3.

c. The food and nutrition department main refrigerator (#14) had a loose door handle. Refrigerator #14 failed to be maintained in accordance with Reference #3.

d. The door gasket on the refrigerator in "Pantry E Blue 241" was loose/broken. The refrigerator in "Pantry E Blue 241" failed to be maintained in accordance with Reference #3.

e. The cabinet beneath the microwave oven in "Pantry E Blue 241" had dried food spillage residues. The "Pantry E Blue 241" cabinet was not maintained in accordance with Reference #4.

f. The employee handwashing sink adjacent to the patient tray line in the food and nutrition department had a large crack in its porcelain surface. The handwashing sink failed to be maintained in accordance with Reference #5.

g. There was a build-up of dried food residue and food spillage in the internal cavity of the microwave in the "Pantry H Yellow." The microwave in the "Pantry H Yellow" was not maintained in accordance with Reference #3.

h. The refrigerator in the "Pantry H Yellow" was not operational on 11/12/13 at 2:50 PM. The temperature sheet dated 11/2013, indicates on 11/9/13, that the refrigerator was "not working." The refrigerator is not being maintained in accordance with Reference #2.



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2. Upon review on 11/12/13, the organizational chart showed a vacancy for the position of food service director.

3. During an interview on 11/12/13 at 10:30 AM, Staff #105 stated that the interim director of food service is Staff #106. However, upon request, Staff #105 did not show evidence that Staff #106 had been appointed to the position of food service director. At 10:40 AM, Staff #106 stated that he/she was the assistant food service director and not the interim food service director. Staff #105 stated that the former food service director's last date of employment at the facility was July 2013.

4. During an interview on 11/13/13 at 1:50 PM, Staff #107 confirmed the above findings and that the position of food service director is vacant.

B. Based on document review and review of 3 of 3 Medical Records (#25, #40, #41), it was determined that there failed to be a food service director to ensure that high nutrition risk patients were re-assessed in accordance with facility policy, "Levels of Nutritional Care, Acuity Risk Level, and Corresponding Follow-up Intervention Time Frame."

Findings include:

Reference: #1: Facility job description, "Director of Food and Nutrition Services" stipulates, "...1. Plans and directs the activities to assure quality service of food to patients, staff, faculty, students and visitors.

Reference #2: Facility policy, "Levels of Nutritional Care, Acuity Risk Level, and Corresponding Follow-up Intervention Time Frame" states, "...High Nutritional Risk Level (Level III): Follow-up time frame: 3 days."

1. Upon review of Medical Record #25, in the presence of Staff #68 on 11/13/13, the initial nutrition assessment dated 10/25/13 assessed Patient #25 at high nutrition risk and the subsequent nutrition assessment was completed on 10/29/13, 4 days after the initial assessment.

2. Upon review of Medical Record #40, in the presence of Staff #107, the initial nutrition assessment dated 11/6/13 assessed Patient #40 at high nutrition risk and the subsequent nutrition assessment was completed on 11/10/13, 4 days after the initial assessment.

3. Upon review of Medical Record #41, in the presence of Staff #107, the follow-up nutrition assessment dated 11/7/13 assessed Patient #41 at high nutrition risk and the subsequent nutrition assessment was completed on 11/12/13, 5 days after the initial assessment.

A. Based on observation, staff interview and review of Medical Record #40, it was determined that the facility failed to ensure that Patient #40's nutritional needs for food, were met in accordance with physician orders.

Findings include:

1. Medical Record #40 evidenced a prescriber's order dated 11/7/13 that stipulated, "Pureed diet with nectar thick liquids, 1:1 assistance." On 11/13/13 at 12:10 PM in Room #320 in the presence of Staff #107, there was a container of unthickened water on the table adjacent to the bed and a cup that contained unthickened water and a straw. There was no thickening agent observed to be in the room.

a. Upon review on 11/13/13, Medical Record #40 evidenced an initial nutrition assessment dated 11/10/13 that stated, "...Dx: ...Aspiration precautions, ...Diet Order: Pureed, Recommendations included "Change diet to: Pureed, 2 gm Na." Though it was noted that Patient #40 is on aspiration precautions, the nutrition follow-up note dated 11/10/13 did not include Patient #40's nectar thick liquids dated 11/7/13. Also, the nutrition follow-up note did not assess Patient #40's compliance to consuming nectar thick liquids as prescribed.

B. Based on staff interview and review of Medical Record #39, it was determined that the facility failed to ensure that Patient #39 received diabetic diet education to meet Patient #39's nutritional needs.

Findings include:

1. There was no evidence in Medical Record #39 to indicate Patient #39 was educated on a diabetic diet when it was determined to be a nutrition problem.

a. Upon review on 11/13/13 at 2:10 PM, in the presence of Staff #107, Medical Record #39 contained an initial nutrition assessment dated 11/11/13. The assessment indicated Patient #39's diet at home was low sodium and that Patient #39 had a history of diabetes mellitus and was on Novolog Insulin. On the same initial nutrition assessment, it was indicated under Problem #2, that Patient #39 had altered nutrition related laboratory values that were related to uncontrolled diabetes mellitus as evidenced by an elevated Hemoglobin A1C and elevated fasting blood glucose levels. The recommended diet change was to "1.8 gram sodium, 200 mg cholesterol, 2200 Calorie ADA diet, NCS." However, Patient #39 was educated on a heart failure (i.e. 1.8 gram sodium, 200 mg cholesterol) diet that did not include diabetic diet instruction. Furthermore, there was no explanation as to why Patient #39 was not also educated on a diabetic diet. It should be noted that this initial nutrition assessment was completed by a dietetic intern and co-signed by a registered dietitian.

b. Staff #107 confirmed the above.

Based on observation it was determined that the facility is out of compliance with the Condition of Physical Environment.

Findings include:

1. The facility failed to provide a well maintained and clean environment, free of dust, debris, and rust. (Cross refer Tag 0701 and Tag 0724).

A. Based on observation and staff interview, it was determined that the facility failed to clean and maintain floors and equipment to ensure a clean, safe and sanitary environment for patient care services in the Operating Room (OR) area, and in the central sterile processing department.

Findings include:

1. On 11/13/13, the portable carts containing cauterizing the scalpel power supply in OR Suites #4 and #6 were visibly soiled and rusted.

a. The lower shelf of OR Suite #4 cart's was laden with dirt accumulations easily removed with an alcohol pad.

b. The lower shelf of OR #6 cart's was stained with splash.

2. On 11/13/13, the pediatric bronchoscopy cart in the OR substerile corridor, by sterilizer #1, was dust laden along the lower rail and wheel base.

3. The floor in the OR entrance corridor (across from OR Suite #9) was encrusted with black build-up and loose dirt accumulations around the wall base of the emergency case storage area.

4. Floor-wall corners in the OR ladies locker room were encrusted with blackened deposits.

5. Environment of Care Rounds for the OR, dated October 9, 2013, reported the entrance reception cove base as " filthy-needs to be replaced ".

6. OR Cleaning checklists reviewed for November 2013 report the section "Clean Floors" as being completed.


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7. On 11/13/13, sub-sterile rooms #1 and #3, located in the Doctors Office Complex were observed unclean.

a. Dust was observed throughout the floor perimeters.

b. Damaged, not easily cleanable floor surfaces were observed surrounding the sterilizers.

A. Based on a tour of the Outpatient Physical Medicine and Rehabilitation Department and the Ambulatory Care Center, it was determined that the facility failed to ensure that all facilities, supplies, and equipment were maintained at an acceptable level of safety and quality.

Findings include:

1. During a tour of the Outpatient Physical Medicine and Rehabilitation Department located in the DOC Building, in the presence of Staff #68 and Staff #72, the following was evident:

a. The carpet throughout the Department was heavily stained.

b. In the Occupational Therapy (OT) section:

i. The OT table padding had a tear which was covered with tape.

ii. The floor edges had accumulations of dirt.

iii. The front panel of the stove was stained.

iv. The Forma Splint equipment lacked a biomed inspection sticker. The lid of the equipment had white residue and the hinges had a brown accumulation.

v. The Ultrasound Electro Stim was covered with tape.

c. In the Physical Therapy section:

i. Throughout the 5 patient treatment rooms, the cabinets under the sink were stained and dusty and the floors had an accumulation of dust along the room edges.

ii. The wall paint in Room #1 was peeled.

iii. The ultra sound equipment had a biomed inspection sticker that indicated the biomed inspection was due in 10/13.

iv. In Room #2, the table and stool padding had tears.

v. In Room #3 the countertop formica was chipped.

vi. In Room #4 the cabinet had a missing handle.

vii. In Room #5 the walls had holes, and the ultrasound and gel warmer equipment had a biomed inspection sticker that indicated the biomed inspection was due in 10/13.

viii. The base of the parallel bars was stained.

ix. The exercise table padding was frayed and a stool padding had tears.

x. In Room #3316 the wall was heavily plastered.

2. During a tour of the Ambulatory Care Center-E level with Staff #68 and Staff #100 the following was noted:

a. One Glass Bead Mirrow Warmer was last inspected in November 2010.

b. One Glass Bead Mirrow Warmer was due to be inspected in November 2012.

c. A microscope was due to be inspected in November 2012.

d. In the Clean Utility Room, where the scopes are disinfected, the wall and floor under the sink were stained.

3. During a tour of the H - Yellow, H - Green and G - Blue units in the presence of Staff #68, the floor edges had accumulations of dirt.




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B. Based on observation, staff interview, review of facility documents, and review of equipment manufacturer's recommendations, it was determined that the facility failed to ensure all equipment is maintained to an acceptable level of safety and quality.

Findings include:

Reference # 1: Manufacturer of 'Millenium RO System's routine maintenance' states, "4.1.4 Quarterly Maintenance: 1. Clean the RO Membranes. Refer to the RO membrane cleaning procedure. 2. Disinfect the RO machine. The RO should be disinfected after cleaning. 3. Verify the TDS and percent rejection readings with an independent monitoring device every 3 months. 4. Check the quick-disconnect fittings and hoses. They should seat securely and fluid should shut off when they are disconnected. Inspect o-rings for any nicks or cuts."

1. On 11/12/13, Staff #30 stated that he/she does not follow manufacturer's maintenance schedule on the 'Millenium RO System'. Review of the 'Millenium Preventive Maintenance Checklist' documents from February to November 2013, revealed that the last documented quarterly maintenance on 7 out of 9 machines dates back to May 2013.




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C. Based on a tour of patient care units, it was determined that the facility failed to ensure that all facilities, supplies, and equipment were maintained at an acceptable level of safety and quality.

Findings include:

1. During tour of the Labor and Delivery (L&D) Unit the following was observed:

a. Paint scuffed, chipped and peeled on walls, doors, and door frames.

b. The floor was cracked and lifting in various areas.

c. There was dust, grit and other refuse on the floor, in the corners of the patient rooms, patient bathrooms, hallways, and ancillary areas.

d. Caulking in back of toilets and hand washing sinks in bathrooms was breaking off, causing the toilets and sinks to separate from the walls.

e. Mattresses throughout the unit were cracked and/or torn.

f. Baby warmers contained tape and tape residue.

g. Bassinets contained tape and tape residue.

h. Blood Pressure monitor was not inspected. Biomed sticker indicated it was due for inspection 5/13.

i. The following was observed in the Clean Utility Room:

(i) There was a significant amount of dust, debris, particles and a sticky brown residue on the floor, cabinets, counter top, and shelves.

(ii) There were no paper towels in the paper towel dispenser.

j. The following was observed in the Dirty Utility Room:

(i) There was a significant amount of dust, debris, particles and a sticky brown residue on the floor, cabinets, counter top, and shelves.

(ii) Straws, bottle caps and small unidentifiable particles were noted under the sink.

(iii) The physician's specimen refrigerator had a significant amount of dust, tape and tape residue.

2. In the Operating Room and Delivery Unit of the L&D, the following was observed:

a. There was paint scuffed, chipped, and peeled on walls, doors, door frames.

b. The floor was cracked and lifting in various areas.

c. Dust, grit and other refuse was observed on the floor, in the corners of the corridors, OR rooms, and recovery area.

d. In (OR) #3 the following was observed:

(i) The cabinet doors had a significant amount greenish brown residue, tape, and tape residue.

(ii) The second drawer of the anesthesia cart contained a closed package of suction tubing with a smear of a dried reddish substance.

(iii) The anesthesia cart drawers contained small particles of debris.

(iv) The Intravenous (IV) pole had a bag of 0.9% Sodium Chloride solution, spiked with tubing, and hanging.

(v) The Bovie machine contained a significant amount of rust.

(vi) The Fetal Heart monitor contained tape and tape residue.

(vii) The material on the OR mattress headboard and arm boards had cracks and/or tears.

(viii) The upholstery on the OR chair was torn exposing the material beneath.

(ix) The mattress on the baby warmer had brown stains.

e. In OR #2 the following was observed:

(i) The material on the OR mattress headboard and arm boards had cracks and/or tears.

(ii) The cabinet doors had a significant amount greenish brown residue, tape, and tape residue.

(iii) The anesthesia cart drawers contained small particles of debris.

(iv) The Bovie machine contained a significant amount of rust.

(v) The Fetal Heart monitor contained tape and tape residue.

(vi) The mattress on the baby warmer was cracked.

f. The Recovery Room lacked a regular waste receptacle.

3. During tour of the Mother Baby Unit the following was observed:

a. There was paint scuffed, chipped, and peeled on walls, doors, door frames.

b. The floor was cracked and lifting in various areas.

c. Dust, grit and other refuse was observed on the floor in the corners of the patient rooms, patient bathrooms, hallways, and ancillary areas.

d. Caulking in back of toilets and hand washing sinks in bathrooms was breaking off, causing the toilets and sinks to separate from the walls.

e. Mattresses throughout the unit were cracked and/or torn.

f. Baby warmers had tape and tape residue.

g. Bassinets had tape and tape residue.

h. In the Shower Room a black substance was noted around the pull cord.

i. In the Family Pantry the following was noted:

(i) The water/ice dispenser contained a brown residue on the spouts.

(ii) The water/ice dispenser tray contained a heavy build-up of brown residue.

j. The slop sink in the Soiled Utility room contained dirty water, 1/3 filled.

4. During a tour of the Pediatric Unit the following was observed:

a. There was paint scuffed, chipped and peeled on walls, doors, door frames.

b. The wall paper was peeling.

c. The floor was cracked and lifting in various areas.

d. Dust, grit and other refuse was observed on the floor in the corners of the patient rooms, patient bathrooms, hallways, and ancillary areas.

e. The caulking in back of the toilets and hand washing sinks in the bathrooms was breaking off, causing the toilets and sinks to separate from the walls.

f. The pull cords in the bathrooms were hanging 2 - 3 feet off the floor, preventing access to a patient that may have fallen.

g. Mattresses throughout the unit were cracked and/or torn.

h. The cribs contained tape and tape residue.

i. In the Parents Lounge, the following was observed:

(i) The windows were taped along the window frames, in an effort to keep the cold out.

(ii) The thermostat was set at 85 degrees, however, the room was cold.

(iii) A request was made to obtain a temperature reading of the room, however, it was not received.

j. Windows in various patient rooms were taped along the window frames, in an effort to keep the cold out.

5. In the New Born Nursery Unit, the following was observed:

a. The paint on the doors and door frames was scuffed and chipped.

b. There was dust, grit and other refuse on the floor.

c. The laminate on the divider wall is chipped and peeled, exposing the press board beneath.

d. The upholstery on various chairs was torn exposing the material beneath.

6. In the New Born Nursery Unit the following was observed:

a. The paint on the doors and door frames was chipped.

b. There was dust, grit and other refuse on the floor.

c. The laminate on bottom of the cabinet to the right if the sink is peeled, exposing the material beneath.

d. The caulking in back of the sink was breaking off, causing the sink to separate from the wall.

e. The scale had no evidence of current calibration. The inspection sticker indicated: Due 5/13.

f. All of the above was confirmed by Staff #14 and Staff #15.

7. In the Radiology Unit in the presence of Staff #81 and Staff #82, the following was observed:

a. The paint was scuffed, chipped and peeled on walls, doors, and door frames.

b. The floor is cracked and lifting in various areas.

c. Dust, grit and other refuse was observed in the corners of the floor.

d. A locked cabinet was overstuffed with sterile packaged supplies that had rubber bands around them, compromising the integrity of the package.

Based on observation, staff interview, and review of documentation, it was determined that the hospital failed to maintain an ongoing program designed to prevent, control, and investigate infections and communicable diseases. The infection control and prevention program has not adequately implemented the Association for the Advancement of Medical Instrumentation (AAMI) standards that was selected by the hospital.

The Condition of Participation for Infection Control is not met.

Findings include:

1. The hospital failed to provide and maintain a sanitary environment to avoid sources and transmission of infections and communicable diseases. (Cross refer to A0701).

2. The facility failed to implement nationally recognized infection control guidelines. (Cross refer to A0749).

3. On November 13, 2013, any procedures using an implantable device were curtailed due to the findings related to the lack of biological monitoring and the inability to trace reprocessed sterile implants to the patient if needed.

On November 14, 2013, the facility submitted an acceptable plan of correction and the curtailment of procedures requiring an implantable device was lifted and the Immediate Jeopardy (IJ) abated.

A. Based on observation, staff interview, and review of facility documents, it was determined that the facility failed to ensure facility policy, manufacturer's instructions and industry standards were not followed for the immediate-use sterilization of instruments used for surgical procedures in the Operating Room.

Findings include:

Reference #1: Facility policy titled 'Immediate Use Steam Sterilization (IUSS) /Flash Sterilization' states, "Verify the Sterilizer has been validated for use each day: a. Bowie Dick test for Pre Vac, b. a test for Gravity."

1. Records of the November Operating Room (OR) sterilization log (sterilizer #1) indicates inconsistent compliance with facility policy for the frequency and type of Biological Indicator (BI) testing.

a. Of a two week period of sterilization logs reviewed for OR Sterilizer #1, a gravity (flash) cycle (270 F at 3 minutes) was monitored on four days and not daily.

i. An express cycle (270 F at 4 minutes) defined as an abbreviated prevacuum "flash" cycle was monitored 8 days during this period. A prevacuum cycle is not a gravity cycle.

ii. The express cycle monitoring frequency was not stated in the policy and procedure.

b. The operator manual manufacturer's instruction for Amsco vacamatic sterilizer for OR Sterilizer #1, states that an Express cycle is an abbreviated prevacuum "flash" cycle. It is designed to provide flash sterilization using a single wrapper on the instrument tray, not an application used by the OR.

Reference #2: Manufacturer's instructions for Flash Pak sterilization container system by Riley Medical states "Valves located at the top and bottom of the container should be vented at least once a day, when the container is cool."

1. On 11/13/13 at 10:45 AM, Staff #43 stated that Flash Pak valves are checked first use of the day but are not recorded. Of fourteen (14) observed Flash paks in sub sterile corridor (behind OR #8) containing sterilizer # 4, no verification could be made to identify if valves are checked daily on each Flash Pak observed.

2. Of 34 OR staff competencies for Flash Pak use, 3 were incomplete. Items for competencies were not checked as met or not met.

Reference #3: Facility policy titled 'Flash Pak-Closed Container System' states: "Clean and visually inspect Flash Pak container daily and as needed: Wash container with surgical instrument cleaner, rinse with tap water, dry with soft absorbent cloth..."

1. An estimated 14 Flash Pak containers were observed commonly stored, soiled and clean, on a portable cart in the sub sterile corridor #1-8 (containing sterilizer #4).

a. Two large Flash Pak containers were visibly soiled. The interiors of containers were encrusted with yellow residue, easily removed with an alcohol pad.

b. One large Flash Pak was stored with residual water (1/4 cup) and yellow deposits.

B. Based on observation, it was determined that the facility failed to provide a sanitary environment to avoid sources and transmission of infections and communicable diseases where methods for processing reusable medical devices conform with Association for the Advancement of Medical Instrumentation(AAMI) ST79:2010 Comprehensive guide to Steam Sterilization and sterility assurance in health care facilities (ST 79 replaces and supersedes ST46 by consolidating ST 46 with 4 other AAMI standards [ST33, ST37, ST42, and ST35] approved 7/10/2009).

Findings include:

Reference #1: AAMI ST 79: 8.4.3 "Inspection" states instruments should be carefully inspected for cleanliness and flaws or damage and dried before packaging.

1. Color indicator tape was observed on sterile instruments which were observed to be brittle and discolored. Tape is not routinely removed to allow cleanability of instrument surfaces.

a. A tracheostomy tray (lot no. Nov 10 13) taken from the emergency cart in OR substerile hallway #1-8, contained a curved forceps with brittle (green and red stripe) indicator tape, which flaked off on touch.

b. A major basic set (lot no. Nov 9 13 15) contained an 8" round tip forceps (red and pink) with flaking and brittle tape.

c. On 11-14-13 at 11:30 AM, Staff #1 stated the OR staff said they have not done color coding in years and anything left on should have been removed.

Reference #2: AAMI ST 79:10.3.1 'Lot control numbers' states Ideally, every reprocessed medical device, especially an implant, should be fully traceable to the patient on whom it is used or in whom it is implanted; such traceability can be accomplished by recording the sterilizer load identifier on the patient chart or the patient name on the load record.

1. A record was not available to have the ability to trace the reprocessed sterile implants to the patients.

2. On 11/14/15, Staff #57 stated that the Implant Log books maintained by the OR, do not provide the sterilizer load identifier of implants, which were sterilized in-house, such as orthopedic screws.

3. On 11/15/13 at 10:30 AM, Staff #36 stated implants taken from the Central Sterile storage were not noted in the OR implant log to be traceable to the

Reference #3: AAMI ST 79:10.6.4 'Sterilization Process Failures' states A faulty sterilizer cannot be made operational without identifying and correcting the underlying problem; merely extending the cycle time or increasing the cycle temperature, for example, is not appropriate. After a major repair of any type of steam sterilizer or the utilities connected to the sterilizer, three consecutive test cycles with a PCD containing a BI should be run, one right after the other, in an otherwise empty chamber for sterilizers larger than 2 cubic feet and for flash sterilization cycles and in a fully loaded chamber for table-top sterilizers (see 10.8). After a major repair to a dynamic-air-removal sterilizer, three consecutive Bowie-Dick test cycles should then be run in an empty chamber, one right after the other, and the test sheets examined (see 10.7.6). The test results should be obtained (i.e., the BI should be incubated according to the BI manufacturer's written IFU) and be determined to be satisfactory before the sterilizer is returned to service.

1. A review of OR sterilizer records (3M Attest Rapid Readout Biological Indicator log) for September and October 2013 revealed sterilizers were repeatedly out of service without a subsequent series of three consecutive test cycles of bowie Dick or biological indicators.

a. Out of service dates:
i. Sterilizer #1: 9/7/13, 9/13/13-9/20/13, 10/9/13- 10/29/13
ii. Sterilizer #3: 9/18/13-9/20/13, 10/3/13, 10/14/13-10/29/13
iii. Sterilizer #2: 9/20/13, 10/14/13-10/15/13, 10/4/13

2. On 11/13/13, a list of work orders from the BioMed Dept. including sterilizer repairs were presented by Staff #1. Information provided was not explicit to identify sterilizers located in the OR. The sterilizer identification and type of repair could not be tracked.

3. Evidence was not provided on request regarding the type of repair required (major or minor) to determine if 3 consecutive biological tests or 3 consecutive Bowie Dick test cycles were conducted.

Reference #4: AAMI ST 79: 9.4 'Routine care' states Sterilizers should be inspected and cleaned daily according to the manufacturer's written IFU (see 9.2). Examples of items requiring daily care and/or cleaning are recording charts, printers, printer ribbons, marking pens and ink, door gaskets, the chamber drain screen, the internal chamber, and external surfaces. Weekly or other prescribed inspection and cleaning should be performed as specified in the manufacturer's written IFU.

1. OR Sterilizer #1 (in OR #2 substerile area) had dark stains on the interior chamber surfaces. The gasket appeared gouged and split, and covered with greenish mineral deposits.

2. OR Sterilizer #4 had a brittle interior door gasket.

C. Based on observation, staff interview, and review of facility documents, it was determined that the facility failed to ensure facility policy, manufacturer's instructions and industry standards were not implemented for instrument processing in the Ambulatory Care Center.

Findings include:

Reference #1: Facility policy 'Monitoring Minimum Effective Concentration-Cidex solution' was not implemented.

1. Policy 'Monitoring Minimum Effective Concentration-Cidex' solution states that when opening a new bottle of Cidex OPA, a QA must be performed and documented by the Endoscopy technician with the following information: The date the test strips were opened, and the date the test strip expires.

a. OPA hi-level disinfectant Test strips were observed not dated (exp 2014-02) when opened and in use in the Ambulatory Care OB/GYN area.

b. On 11/15/13 at 11:00 AM, Staff # 101 confirmed that OPA test strips were not dated when opened for use.

2. Facility policy 'Monitoring Minimum Effective Concentration-Cidex Solution' states, cover the solution tray securely and soak instruments for 12 minutes at 20 degrees C.

a. Improper soak time was stated by Staff # 10, who stated the ultrasound probe is soaked in OPA, a high level disinfectant for 20 minutes at the beginning of each day.

b. Improper soaking method was observed; the ultrasound probe was observed soaking in an opened gallon jug of OPA, high level disinfectant, on the floor next to the patient exam table in Room #C1753.

Reference #2: Steris System 1E manufacturer Sterilization Log sheet used in the Ambulatory Care Center urology area, requires the name of person releasing the load verifies and documents the proper color change of the chemical indicator required in each sterilization cycle run.

1. 100% of Steris System 1E Sterilization Log records reviewed from January 2013 to present do not report chemical indicator outcomes.

2. On 11/15/13 at 12:00 PM, Staff #102 could not provide documentation to confirm the pass/fail of the chemical test strip with each load run. Staff #102 , temporarily filling in for the full-time technician, in charge of the Steris System 1E, did not know if the chemical indicator test was documented.

3. On 11/15/13 at 12:30 PM, Staff #103 presented 12 Steris System 1E load tickets dated 11/13/13 and 11/6/13 which he/she ran. All 13 load tickets were not verified by the operator. Staff #103 stated he/she did not have the time to complete load information.

D. Based on staff interview and review of facility documents, it was determined that the facility failed to implement and evaluate the Infection Control program through collaboration with persons responsible for non-patient care support services, including the Central Sterile Processing Department.

1. Infection Prevention & Control Committee (ICC) Minutes, reviewed for 2013 for January (signed off by Staff # 4 on 2/26/13), reported that Central Service identified 115 sterile indicator issues resulting from a review of 97,757 total trays. No further documentation explaining issues identified was reported.

a. On 11/14/13 at 11:15 AM, Staff #4 stated that detailed information regarding the findings of 115 sterile indicator issues was requested from the prior Central Service Director, but was not received.

2. The Infection Prevention and Control Committee Reporting Schedule 2012/2013 requires the Central Sterile Processing Dept. to report to the committee four times per year. The Central Sterile Dept. did not report to the Infection Control Committee when assigned.

a. Infection Prevention & Control Committee Attendance 2013 sign-in sheet identifies Central Service was represented at the committee only on one date in January 2013. No other attendance from this department was recorded for the year.

b. On 11/14/13 at 2:10 PM, Staff # 1 stated that the previous Central Service Manager (who attended the meeting in January) is no longer on staff as of August 2013.

c. The ICC minutes dated 9/24/13 lists the Central Sterile Dept. discussion as "report deferred, Tabled for next ICC meeting". The ICC minutes on Oct 29, 2013 did contain a report or comment regarding the Central Sterile Dept.



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E. Based on observation on November 12th 2013, it was determined that the facility failed to follow methods for reprocessing reusable medical devices in conformance with the guidelines recommended by The Association for the Advancement of Medical Instrumentation (AMMI) requirements, "Comprehensive guide to steam sterilization and sterility assurance in health care facilities," AAMI ST79. (ST79 replaces and supersedes ST 46 with 4 other AMMI standards, ST33, ST42, and ST35).

Findings Include:

Reference: #1:
AMMI ST.79: 2010, section (8.3.4) "Paper-plastic pouches" states, the use of paper peel pouches with heavy metal instrumentation (e.g., orthopedic drills, weighted speculums, orthodontic pliers) could result in problems with sterility maintenance, such as inadequate drying of the package after sterilization. Proper sizing and application of pouches allows for adequate air removal steam penetration, and drying.

1. There were 3 peel packs that contained heavy metal instrumentation. They included 1 Mesha Rentch, 1 ENT Laryngoscope and 1 Dingman Retractor.

Reference: #2: AMMI ST.79 2010, Section (8.3.1) states, if "wet packs" are observed, they should not be released. They should be reprocessed in a manner that ensures that excess moisture/condensation does not occur.

1. There were 2 peel packs containing a retractor and an elevator that had moisture staining on the exterior of the packs indicating that the packs were not properly dried prior to storage.

Reference: #3: AMMI ST.79 2010, Section (8.4.4) states, "Instrument Placement" all jointed instruments should be in the open or unlocked position with ratchets not engaged. Racks, pins, stringers, or other specifically designed devices can be used to hold the instruments in the open position.

1. In the Central Service sterile storage area there were 4 clamps and scissors observed processed in the closed position in peel packs.

F. Based on observation and document review, on November 14th 2013, it was dtermined that the facility failed to conduct an annual competency evaluation for the Central Service Supervisor.

Findings Include:

Reference #1: AMMI ST.79 2010, Section (4.2.1) states, Supervisory Personnel should maintain competency throughout their tenure.

1. A review of documents indicated that Staff #5 did not have an annual competency evaluation available for review.

G. Based on observation and document review, on November 12, 2013, it was determined that the facility failed to have a loaner policy, which requires specific documentation for the reprocessing and return of borrowed equipment.

Findings Include:

Reference #1: AMMI ST.79 2010, Annex Section (G.4.1) "General" States, Users are responsible for verifying that appropriate written instructions are supplied with the device; if no instructions or incomplete instructions are provided, the user should attempt to contact the manufacturer for return authorization and further instructions. The user is also responsible for processing the device according to the manufacturer recommendation. All documentation requested by the manufacturer should be accurately completed including type of instrument set, procedure, time and date received and returned, tech and vendor initials for verification of the count sheet regarding a loaner set.

The facility failed to provide a loaner policy requiring manufacturer documentation for reprocessing. In addition there was no verification through log records of the types of instrument sets requested, procedure, time, dates received by the facility or returned to vendor, or initials from the vendor or technician concerning count sheets regarding a loaner set.


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H. Based on observation it was determined that the facility failed to provide a sanitary environment to avoid sources and transmission of infections and communicable diseases where methods for processing reusable medical devices conform with Association for the Advancement of Medical Instrumentation(AAMI) ST79:2006 Comprehensive guide to Steam Sterilization and sterility assurance in health care facilities (ST 79 replaces and supercedes ST46 by consolidating ST 46 with 4 other AAMI standards [ST33, ST37, ST42, and ST35] approved 7/10/2009) and ST41:2008 Ethylene Oxide Sterilization in Health care facilities: Safety and effectiveness.

Findings include:

Reference #1: AAMI ST 79 section 3.3.6.8 on 'Handwashing facilities' states, "Handwashing facilities should be located in or near all areas in which instruments and other devices are decontaminated and prepared for sterilization."

1. A designated handwashing sink is not available in the Doctors Office Complex (DOC) central processing department decontamination room. On 11/13/13 at 12:30 PM, Staff #104 stated that he/she routinely washes his/her hands at the double bay compartment sinks which are used as reprocessing sinks to preclean soiled instruments.

Reference #2: AAMI St 79 section 4.2.1 on 'Supervisory personnel' states, "All preparation and sterilization activities, including decontamination, inspection, preparation, packaging, sterilization, storage, and distribution, should be supervised by competent, qualified personnel. Personnel assigned to supervisory functions should be prepared for this responsibility by education, training, and experience. Minimum recommended qualification include a) successful completion of a central service management certification examination."

1. Staff #1 stated that the central sterile processing department supervisor left the facility in August 2013 and the facility has not filled the position as of the date of this survey.

Reference #3: AAMI ST 79 section 4.3.1 on 'Sterile Processing Personnel' states, "Personnel engaged in sterile processing should receive both an initial orientation and on-the-job training. A day to day orientation program is recommended and should be designed to lead to competency-based knowledge and skills in all tasks performed in the sterile processing department ..... There should be a training manual that documents all aspects of training related to the on-site approved protocols. This manual should include checklists to document that training was performed and when competency was achieved."

1. On 11/14/13, the '2012 Annual Competency Training' conducted for all central sterile processing department staff were reviewed. The training check sheets were observed with preprinted competency checklists, where all staff were pre-evaluated, as 'competent' before the actual training took place.

Reference #4: AAMI ST 79 section 6.3 on 'Care and handling of contaminated reusable items at point of use' states, "To prevent the formation of biofilm, definitive cleaning should occur as soon as possible."

Reference #5: AAMI ST 79 section 6.5.5 on 'Transport between buildings' states, "The transportation system must be enclosed and designed to minimize the risk of personnel exposure to blood borne and other disease producing organisms and the possibility of damage to the instruments and other items being transported."

1. On 11/13/13 at 12:00 PM, the washer disinfector was noted observed out of service in the DOC decontamination room. Piles of contaminated instruments and trays, accumulated since 8 AM, were observed stored on the decontamination room storage rack. Due to the limited number of staff available to manually clean all instrumentation, Staff # 66 stated that instruments will be transported to the main building to be decontaminated. Staff #66 stated that policies and procedures have not been developed on proper transportation and containment of contaminated items between buildings.

Reference #6: AAMI ST 79 section 7.2.2 on 'Manufacturer's instructions' state, "The written recommendations of the device manufacturer should always be followed."

Reference #7: Manufacturer of 'Attest 1292 Rapid Readout Biological Indicator(RRBI)' states, "Directions for Use: 1. Identify the Attest 1292 RRBI by writing the sterilizer and load number and processing date on the indicator label. Do not place another label or indicator tape on the vial or on the cap. 2. Place the Attest 1292 RRBI in an appropriate process control device according to recommended practices. 3. Place the test tray or package in the most challenging area for the sterilant. This is typically on the bottom shelf, near the door and over the drain. 4. Process the load according to recommended practices. 5. After completion of the cycle, fully open the sterilizer minimum of 5 minutes prior to removing the Attest 1292 RRBI .... 9. Press the cap down. Crush the glass ampule of the RRBI in the crusher well of the Attest 190/290 Auto reader ... then incubate the RRBI. 10. Each day, that a processed RRBI is incubated, crush, tap and incubate at least one non processed Attest 1292 RRBI to use as a positive control. The positive control should be from the same manufacturing date and lot number as the processed RRBI in the incubator. 11. Incubate the positive control and sterilized Attest 1292 RRBI for 3 hours in an Attest auto-reader. Positive results are available within 3 hours. The final negative RRBI reading is made at 3 hours. Interpretation of Results: The positive(unprocessed) control RRBI must provide a positive fluorescent result(red light or +). Processed RRBI results are not valid until the positive control reads fluorescent positive(red light or +). With the processed RRBI, a positive (red light or +) result means a sterilization process failure may have occurred. The final negative processed RRBI reading for a fluorescence change(green light or -) after 3 hours of incubation indicates an acceptable sterilization process. The positive control should read positive (red light or +) at three hours. If the positive control reads negative (green light or -) at three hours, check the Attest 199/290 Auto reader Operator's Manual Troubleshooting Guide. Retest the Attest 190/290 Auto-reader with a new positive control. The processed RRBI results are not valid until the positive control reads fluorescent positive (red light or +). Act immediately on any positive RRBI results. Determine the cause of the positive RRBI following current facility policies and procedures. Always retest the sterilizer and do not use sterilizer for processing loads until three consecutive RRBI results are negative."

Reference #8: AAMI ST 79 section 10.6.1 on 'Process monitoring devices' state, "Every sterilization load containing implants should be monitored with a Process challenge device (PCD) containing a BI (a BI challenge test pack).

1. On 11/13/13 at 1145 AM, during the tour of the DOC central sterile processing department, five (5) unlabeled and undated biological testing vials were observed being incubated in the 'Attest Auto Reader'. All 5 vials in the incubator were noted with 5 different lot numbers. Unprocessed control vials were observed with lot #2015-08DF and #2014- 07TA and the other three processed test vials were observed with lot #2015-05DE, #2014-02TI and #2014- 08 TC.

a. Staff #104 was not familiar with the purpose of having control vials from the same manufacturer lot as the test vials.

b. Staff #104 stated that he/she was not familiar with the correct procedures on biological monitoring testing.

2. On 11/13/13 at 1:00 PM, based on review of the DOC's central sterile processing department sterilization records from June 2013 to November 13, 2013, it was determined that the facility failed to ensure that the negative results of biological test vials were obtained at least 3 hours after incubation.

a. The final outcomes of biological tests were not documented on 41 out of 96 records.

b. Further review of these deficient records indicated that 21 out of 96 records involved implantable devices.

c. Implantable devices identified being sterilized at the DOC central sterile processing department included K wires, Cortical Cancellous bone screws, Cochlear Implant screw set, Integra Ascersion Rearfoot plating, smooth Stainmann pin, cannulated screws set, Syntheses headless screws.

3. On 11/14/13 and 11/15/13 further review of the DOC's central sterile processing department sterilization records revealed the following data:

a. For year 2012, out of 251 sterilization records reviewed, 125 were found deficient in biological monitoring records, of which 79 of the deficient records involved not monitoring the biological outcome of implantable devices.

b. For 2013, out of 209 sterilization records reviewed, 72 were found deficient in biological monitoring records of which 46 of the deficient records involved monitoring the biological outcome of implantable devices.

4. On 11/13/13 at 3:00 PM, the following facility policies and procedures were requested from Staff #1: biological monitoring; processing and releasing implantable devices. On 11/14/13, Staff #1 confirmed that facility policies and procedures for biological monitoring and processing/releasing implantable devices currently do not exist.

I. On November 13, 2013, any procedures using an implantable device were curtailed due to the findings related to the lack of biological monitoring and the inability to trace reprocessed sterile implants to the patient if needed.

On November 14, 2013, the facility submitted an acceptable plan of correction and the curtailment of procedures requiring an implantable device was lifted and the Immediate Jeopardy (IJ) abated.

Based on medical record review and staff interview it was determined that the facility failed to implement its policy for documentation of a potential donor's suitability for organ/tissue donation in two of four medical records reviewed (Medical Records #1 and #2).

Findings include:

Reference: Facility policy and procedure Issue No: 831-200-035, subject: 'Organ and Tissue Donation' states "... Procedure: ... II. Screening and Evaluation ... 3) --[name of organ procurement organization]-- / staff will document in the patient's medical record the potential donor's medical suitability as determined by--[name of organ procurement organization]-- . 4) If the patient is determined to be an unsuitable candidate for donation, an explanatory notation shall also be made part of the patient's medical record."

1. On 11/12/13 review of Medical Record #1 indicated per a house physician's progress note, dated and timed 11/9/13 at 4:30 PM, that Patient #1 was pronounced dead at 4:20 PM and the organ procurement organization was notified.

a. A stamped progress note for notification by the facility to the Organ Procurement Organization (OPO), dated and timed 11/9/13 at 440 [am/pm not indicated], was evident in Medical Record #1. The 'Outcome of Call:' section indicated the patient was "suitable for donation", and "yes" was checked off in the 'Accepted for donation (if known)' section. There was no other follow up documentation to indicate organs/tissues were procured from Patient #1, or if it was determined by the OPO that Patient #1 was an unsuitable candidate for organ/tissue donation.

2. On 11/12/13 review of Medical Record #2 indicated per a house physician's progress note, dated and timed 11/10/13 at 7:30 AM, that Patient #1 was pronounced dead at 6:53 AM and the organ procurement organization was notified.

a. A stamped progress note for notification by the facility to the Organ Procurement Organization (OPO), dated and timed 11/10/13 at 0705, was evident in Medical Record #2. The 'Outcome of Call:' section indicated the patient was "Not a Candidate" and "yes" was checked off in the 'Accepted for donation (if known)'. There was no other follow up documentation to indicate organs/tissues were procured from Patient #2, or if it was determined by the OPO that Patient #1 was an unsuitable candidate for organ/tissue donation.

3. In interview on 11/12/13 at 1:55 PM Staff #13 stated that the OPO determined that Patient #1 and Patient #2 were not suitable for donation and the facility's nursing office was notified of the OPO's decision.

4. The OPO and / facility did not implement the facility's policy and procedure for documenting an explanatory notation for the unsuitability for donation for Patient #1 and Patient #2 in each of their medical records. This was confirmed by Staff #1 and Staff #13.

Based on staff interview and a review of medical records of patients receiving rehabilitation services, it was determined that the facility failed to ensure that rehabilitation services were provided for all patients in accordance with the plan of care in three of five medical records reviewed (Medical Records #37, #22 and #38).
Findings include:
1. In Medical Record #37 the physician order dated 10/15/13 indicated, "PT [physical therapy] eval [evaluation] and treat [treatment], and "OT [occupational therapy] eval and treat." Patient #37's initial physical therapy evaluation completed on 10/16/13 revealed that that the patient was to be seen 3-7 times per week. The patient was seen 3 times the week of 10/16/13, 5 times the week of 10/20/13, once the week of 10/27/13 and once the week of 11/10/13.
a. There was no evidence that the patient was seen during the week of 11/3/13.
b. There was no evidence that the patient was seen at a minimum of 3 times during the week of 10/27 and 11/10/13.
c. There was no evidence that the patient refused treatment or was not available for treatment.
d. There was no evidence that the patient's plan of care had been updated.
e. There was no evidence that the physician discontinued therapy.
2. Patient #37's initial occupational therapy evaluation completed on 10/16/13, revealed that the patient was to be seen 3-4 times per week. The patient was seen 1 time the week of 10/27/13 and 2 times the week of 11/3/13.
a. There was no evidence that the patient was seen at a minimum of 3 times during the week of 10/17/13 and 11/3/13.
b. There was no evidence that the patient refused treatment, or was not available for treatment.
c. There was no evidence that the patient's plan of care had been updated.
3. The above was confirmed with Staff #68 and Staff #106.
4. In Medical Record #22 the physician order dated 10/30/13 and 11/6/13 indicated, "OT [occupational therapy] eval and treat." Patient #22's initial occupational therapy evaluation completed on 10/31/13 revealed that the patient was to be seen 3-5 times per week. There was no evidence of any subsequent visits by the occupational therapist until 11/11/13.
a. There was no evidence that the patient was not available or refused treatment.
b. The above was confirmed with Staff #68 and Staff #69.
5. In Medical Record #38 the physician order dated 10/4/13 stated, "PT eval and treat." Patient #38's initial physical therapy evaluation completed on 10/7/13 revealed that the patient was to be seen 3-5 times per week. The patient was subsequently seen on 10/15/13 and 10/16/13.
a. There was no evidence that the patient was seen at least 3 times during the week of 10/17/13. The patient was only seen twice the week of 10/13/13.
b. There was no evidence that the patient refused services or was not available for treatment.
c. The above was confirmed with Staff #68 and Staff #105.

A. Based on review of four (4) medical records of patients receiving mechanical ventilation, review of facility policy and procedure, and staff interview, it was determined that the facility failed to ensure that a physician's order was written for mechanical ventilation in 3 of 4 medical records (Medical Records #5, #6, #7).

Findings include:

Reference: Facility policy titled "Mechanical Ventilation" states under Policy, "1. A physician order must be written for mechanical ventilators and parameters... 2. The ventilator parameter changes must be made by the RCP based on written physician order..."

1. On 11/12/13 at 10:45 AM through 12:00 Noon, the Medical Intensive Care Unit (MICU) was toured in the presence of Staff #2 and Staff #3. Medical Record #5 was reviewed and indicated a physician order dated and timed 11/12/13 at 11:07 AM for the following:

a. "Mechanical ventilation mode: AC [Assist Control]; FiO2 [Fraction of Inspired Oxygen] 40%; PEEP [Positive End-Expiratory Pressure] 5.0 CM/H2O; Rate 12; Tidal Volume 450."

b. According to the medical record, Patient #5 was admitted to the facility on 11/9/13, intubated and placed on a mechanical ventilator at 1404 on the same day.

c. The "DRAGER/PB 7200 AE VENTILATOR CHART" revealed the following ventilator settings:

i. 11/9/13 at 1404- Mode: AC [Assist Control]; FiO2 100%; Volume Setting 500; PEEP +5; Rate Setting 12.

ii. 11/9/13 at 2030- Mode: Assist Control: FiO2 50%; Volume Setting 500; PEEP +5; Rate Setting 12.

iii. 11/10/13 at 0810- Mode CMV [Continuous Mandatory Ventilation]; FiO2 50%; Volume Setting 450: PEEP +5; Rate Setting 12.

iv. 11/11/13 at 1645- Mode CMV; FiO2 40%; Volume Setting 450; PEEP +5; Rate Setting 12.

d. There was no evidence in the medical record of a physician order for the mechanical ventilator changes made to the mode, volume, and FiO2, as indicated above. The only physician order for mechanical ventilation was written 11/12/13, this was three days after the patient was placed on the ventilator.

e. The above findings were confirmed by Staff #2 and Staff #3.

2. Medical Record #6 was reviewed and indicated a physician order dated and timed 11/9/13 at 10:00 PM for the following:

a. "Mechanical ventilation mode: SIMV [Synchronized Intermittent Mandatory Ventilation]; FiO2 50%; PEEP 5.0 CM/H2O; Rate 12; Tidal Volume 450; Pressure Support 5."

b. The "DRAGER/PB 7200 AE VENTILATOR CHART" revealed that on 11/11/13 (time illegible), the mode on the ventilator was changed from SIMV to CMV.

c. There was no evidence in the medical record of a physician order to change the mode on the ventilator.

d. This was confirmed by Staff #3.

3. Medical Record #7 was reviewed and indicated a physician order dated and timed 11/7/13 at 9:24 AM for the following:

a. "Mechanical ventilation mode: AC [Assist Control]; FiO2 100%; PEEP 5.0 CM/H2O; Rate 12; Tidal Volume 400."

b. The "DRAGER/PB 7200 AE VENTILATOR CHART" revealed the following ventilator settings:

i. 11/7/13 at 0915- Mode CMV; FiO2 100%; Volume Setting 400; PEEP +7; Rate Setting 12.

ii. 11/7/13 at 1200- Mode CMV; FiO2 80%; Volume Setting 420; PEEP 8; Rate Setting 12.

iii. 11/7/13 at 1600- Mode CMV; FiO2 60%; Volume Setting 400; PEEP +5; Rate Setting 12.

c. There was no evidence in the medical record of a physician order for the mechanical ventilator changes made to the mode, volume, and FiO2, as indicated above.

d. This was confirmed by Staff #3.

B. Based on review of one patient receiving chest physical therapy (Medical Record #8), review of facility policy and procedure, and staff interview, it was determined that the facility failed to ensure that the therapy was delivered in accordance with physician order and facility policy.

Findings include:

Reference: Facility policy titled "Chest Physical Therapy" states under Assessment of Outcomes/Documentation Resources, "1. The RCP providing CPT will document in the Summary Therapy notes.
2. The following standard information will be documented for each treatment:
2.1. Date
2.2. Time
2.3. Therapy
2.4. Frequency
2.5. Respiratory rate, before & after therapy
2.6. Heart rate
2.7. Breath sounds, before & after
2.8. Location
2.10. Areas on concentration
2.11. Position
2.12. Cough effect
2.13. Sputum results
2.14. Sputum consistency
2.15 Sputum color
2.16. Sputum production...
4. If the therapy is not given, the RCP will document the reason why in the Summary of Therapy notes..."

1. On 11/12/13 at 12:00 Noon, the Pediatric Intensive Care Unit (PICU) was toured in the presence of Staff #2 and Staff #3. Medical Record #8 was reviewed and indicated a physician order dated and timed 11/11/13 at 6:00 PM for "Chest physiotherapy 4 times daily for 3 days."

2. Staff #3 stated during an interview at 12:05 PM, when CPT is ordered 4 times daily, it is done at 10 AM, 2 PM, 6 PM, and 10 PM.

3. Review of the "Summary of Therapy" sheet for Patient #8 revealed that CPT was done at 1800 and 2200 on 11/11/13.

a. There was no evidence in the medical record that CPT was done at 10:00 AM on 11/12/13, in accordance with physician order.

i. Upon interview at 12:10 PM, Staff #22 stated that the patient was up walking around and did not need the CPT.

ii. There was no evidence on the "Summary of Therapy" sheet why the CPT was not given.

4. There was no evidence on the "Summary of Therapy" sheet that the information indicated in the above referenced policy, was documented for each treatment when the patient received CPT at 1800 and 2200 on 11/11/13.

5. This was confirmed by Staff #2 and Staff #3.