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


482.42 Infection Control

Based on observation, facility documentation review, and staff interviews conducted between 3/13/17 and 3/15/17, it was determined that the facility failed to ensure a sanitary environment to avoid sources and transmission of infections and communicable diseases, is provided.

Findings include:

1. The facility failed to provide a functional and sanitary environment for the provision of dental and podiatry services by adhering to professionally acceptable standards of Asepsis and Sterilization. (Cross refer to Tag 0749)

2. The facility failed to ensure that an active Infection Control program for the prevention, control and investigation of infections and communicable diseases is implemented. (Cross refer to Tag 0749)

Based on review of facility documents, review of personnel files, and staff interviews, it was determined that the facility failed to ensure its director of nursing services (DON) determined the types of nursing personnel necessary to provide nursing care for all areas of the facility.

Findings include:

Reference: Facility job description for Manager of Medical and Dental Services states, "... Qualifications/Education... Bachelor's degree in a related field from an accredited college or university required. ... ."

1. On 3/15/17, review of the personnel file of Staff #11, lacked evidence of him/her having a Bachelor's Degree.

a. Upon interview, Staff #5 confirmed that Staff #11 does not have his/her Bachelor's Degree, as indicated in his/her job description.

b. Staff #11 failed to ensure the Manager of Medical and Dental Services had the proper credentials for the position.

2. Staff #2 and Staff #5 confirmed the above findings.

Based on review of the facility's staffing plan, review of staffing patterns, policy and procedure, and staff interviews, it was determined that the facility failed to implement its staffing plan.

Findings include:

Reference: Facility policy titled Staffing Policy - Determination states, "... 1. The CNO shall be responsible for the development, approval and implementation of a plan of organization that: A. assures all department functions are defined and grouped into the required number of positions. ... 2. Modifications to the staffing pattern are made by the CNO or her designees... ."

1. On 3/16/17, staffing for 2/26/17 until 3/11/17 for the Red Zone, Yellow Zone, and Green Zone, was reviewed. The Red Zone comprised of 30 adult beds, the Yellow Zone was comprised of 33 pediatric beds, and the Green Zone was comprised of 38 adult beds. The facility staffing plan incorporates the staff needed for all three units combined. The following staffing shortages were evident:

a. The day shift, 7 AM - 7 PM, was short staffed at the following times:

i. On 2/26/17, ten (10) RNs, one (1) LPN, and thirty-two (32) patient care aides (PCAs) staffed the units. The staffing plan called for fifty-two (52) PCAs. The units were short staffed twenty (20) PCAs.

ii. On 2/27/17, eleven (11) RNs and thirty-four (34) PCAs staffed the units. The staffing plan called for fifty-two (52) PCAs. The units were short staffed eighteen (18) PCAs.

iii. On 2/28/17, eleven (11) RNs and thirty-one (31) PCAs staffed the units. The staffing plan called for fifty-two (52) PCAs. The units were short staffed twenty-one (21) PCAs.

iv. On 3/1/17, eleven (11) RNs and thirty-three (33) PCAs staffed the units. The staffing plan called for fifty-two (52) PCAs. The units were short staffed nineteen (19) PCAs.

v. On 3/2/17, eleven (11) RNs and thirty-three (33) PCAs staffed the units. The staffing plan called for fifty-two (52) PCAs. The units were short staffed nineteen (19) PCAs.

vi. On 3/3/17, eleven (11) RNs and thirty-two (32) PCAs staffed the units. The staffing plan called for fifty-two (52) PCAs. The units were short staffed twenty (20) PCAs.

vii. On 3/4/17, eleven (11) RNs and thirty-two (32) PCAs staffed the units. The staffing plan called for fifty-two (52) PCAs. The units were short staffed twenty (20) PCAs.

viii. On 3/5/17, eleven (11) RNs and thirty (30) PCAs staffed the units. The staffing plan called for fifty-two (52) PCAs. The units were short staffed twenty-two (22) PCAs.

ix. On 3/6/17, eleven (11) RNs and twenty-eight (28) PCAs staffed the units. The staffing plan called for fifty-two (52) PCAs. The units were short staffed twenty-four (24) PCAs.

x. On 3/7/17, eleven (11) RNs and thirty-one (31) PCAs staffed the units. The staffing plan called for fifty-two (52) PCAs. The units were short staffed twenty-one (21) PCAs.

b. The night shift, 7 PM - 7 AM, was short staffed at the following times:

i. On 2/26/17, eleven (11) RNs and thirty-four (34) PCAs staffed the units. The staffing plan called for fifty-nine (59) PCAs. The units were short staffed twenty-five (25) PCAs.

ii. On 2/27/17, eleven (11) RNs and thirty-seven (37) PCAs staffed the units. The staffing plan called for fifty-nine (59) PCAs. The units were short staffed twenty-two (22) PCAs.

iii. On 2/28/17, eleven (11) RNs and thirty-nine (39) PCAs staffed the units. The staffing plan called for fifty-nine (59) PCAs. The units were short staffed twenty (20) PCAs.

iv. On 3/1/17, eleven (11) RNs and thirty-seven (37) PCAs staffed the units. The staffing plan called for fifty-nine (59) PCAs. The units were short staffed twenty-two (22) PCAs.

v. On 3/2/17, ten (10) RNs and thirty-seven (37) PCAs staffed the units. The staffing plan called for eleven (11) RNs and fifty-nine (59) PCAs. The units were short staffed one (1) RN and twenty-two (22) PCAs.

vi. On 3/3/17, eleven (11) RNs and thirty-five (35) PCAs staffed the units. The staffing plan called for fifty-nine (59) PCAs. The units were short staffed twenty-four (24) PCAs.

vii. On 3/4/17, eleven (11) RNs and thirty-four (34) PCAs staffed the units. The staffing plan called for fifty-nine (59) PCAs. The units were short staffed twenty-five (25) PCAs.

viii. On 3/5/17, eleven (11) RNs and thirty-four (34) PCAs staffed the units. The staffing plan called for fifty-nine (59) PCAs. The units were short staffed twenty-five (25) PCAs.

ix. On 3/6/17, eleven (11) RNs and thirty-seven (37) PCAs staffed the units. The staffing plan called for fifty-nine (59) PCAs. The units were short staffed twenty-two (22) PCAs.

x. On 3/7/17, eleven (11) RNs and forty-one (41) PCAs staffed the units. The staffing plan called for fifty-nine (59) PCAs. The units were short staffed eighteen (18) PCAs.

2. Staff #2 and Staff #5 confirmed the above findings.

Based on review of personnel files and staff interviews, it was determined that the facility failed to ensure a registered nurse supervised and evaluated the nursing care for each patient.

Findings include:

1. During an interview with Staff #5 on 3/16/17, he/she indicated that there is no full-time RN working in the outpatient clinic area.

a. Staff #5 indicated that Staff #11, is a nurse and will help out when needed.

b. Staff #5 indicated that the outpatient clinic occasionally utilizes a per-diem RN for coverage when Staff #11 is absent.

c. Review of Staff #11's personnel file on 3/15/17 revealed he/she is an LPN.

d. The facility failed to ensure that the nursing care of each patient was supervised and evaluated by an RN.

2. Staff #2 and Staff #5 confirmed the above findings.

Based on observation, staff interview and document review conducted on March 15, 2017, it was determined that the facility failed to ensure implementation of policies and procedures addressing discontinued medication orders.

Findings include:

Reference: Facility policy titled "Medication Return and Disposal" states, "Procedure: A. The nurse shall return medications which have been discontinued, found to be beyond the expiration date or considered otherwise unusable to the Pharmacy Department for disposition."

1. During an observation to the Red Zone Unit at 11:30 AM, the contents of medication for Patient #21 was compared with the Medication Administration Record. The following discrepancy was revealed:

a. One bottle of a compounded medication labeled "Desitin, Stomahesive, Nystatin" was found in a drawer. The medication was dispensed on 2/20/2017.

b. The Medication Administration Record revealed that the compounded medication ordered on 2/20/17, was to be applied three times daily for 14 days.

2. Upon interview, Staff #48 stated that "the medication should have been taken out on 3/6/17 and returned to pharmacy."

3. This finding was confirmed by Staff #48.

A. Based on observation, review of facility policy and procedure, and staff interviews, it was determined that the facility failed to ensure expired medications are not available for patient use.

Findings include:

Reference: Facility policy titled Medication Return and Disposal states, "... A. The nurse shall return medication which have been discontinued, found to be beyond the expiration date or considered otherwise unusable to the Pharmacy Department for disposition. B. Each month, pharmacy will assure removal of all medications which have expired. The pharmacy and all med areas and units will be included in this process. ... ."

1. During a tour of the Yellow Zone on 3/13/17, expired medications were found in the bottom drawer of the respiratory services cart.

a. The expired medications included:

i. One (1) box of Albuterol Sulfate nebulizer vials with an expiration date of 12/19/16.

ii. One (1) package of Ipratropium Bromide nebulizer vials with an expiration date of December, 2016.

iii. One (1) Flovent inhaler with an expiration date of 11/7/16.

iv. One (1) Flovent inhaler with an expiration date of 11/25/16.

b. Upon interview, Staff #22 indicated that he/she was responsible for checking the respiratory cart for expired medications.

c. The facility failed to follow its policy regarding the disposal of expired medications.

2. Staff #2, Staff #5, and Staff #21 confirmed the above findings.


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3. During a tour of the Yellow Zone on 3/15/17, expired medications were found in the first and second drawer of the patient's bedside respiratory cart.

a. The expired medications included:

(i) Airlife Sterile Water Inhalation solution, one liter, with an expiration date of 8/2013.

(ii) Addipak 0.9 sodium chloride inhalation solution with an expiration date of 06/16.

2. The above findings were confirmed with Staff #21 and Staff #20.

Based on observation, staff interview and facility document review, it was determined that the facility failed to develop a policy and procedure for quality management of diagnostic X-Ray equipment.

Findings include:

Reference: The American Dental Association 2012 titled, Dental Radiographic Examinations: Recommendations for Patient Selection and Limiting Radiation Exposure stated, "Quality assurance protocols for the x-ray unit ... and patient shielding should be developed and implemented for each dental healthcare setting. All quality assurance procedures, including date, procedure, results, and corrective action, should be logged for documentation purposes ..."

1. During a tour of the dental clinic conducted on 3/13/17 at approximately 11:40 AM, a Panoramic X-Ray machine, a wall-mounted X-Ray device and a portable X-Ray device (NOMAD) were observed in Dental Operatory Room #2.

a. Review of physicist's reports were reviewed as follows:

i. Dental Diagnostic X-Ray Machine (In-wall): 4/17/03

ii. Panoramic X-Ray unit: 8/13/2014

iii.Portable X-Ray unit: 6/26/12

2. On an interview with Staff #5, it was determined that there is no written policy and procedure regarding periodic inspections and maintenance for all x-ray equipment.

Based on observation, facility document review and staff interview conducted on 3/13/2017, it was determined that the dietary service failed to comply with the New Jersey State Sanitation Code: "Sanitation in Retail Food Establishments and Food and Beverage Vending Machines (Chapter 24)" of the NJ State Sanitary Code NJAC 8:24.

Findings include:

Reference #1: N.J.A.C. 8:24-6.5(a) states, "The physical facilities shall be maintained in good repair."

Reference #2: N.J.A.C. 8:24-6.5(b) states, "The physical facilities shall be cleaned as often as necessary to keep them clean."

Reference #3: N.J.A.C. 8:24-6.5(i) states, "Maintenance tools such as brooms, mops, vacuum cleaners, and similar items shall be stored: 1. So that they do not contaminate food, equipment, utensils, linens, and single-service and single-use articles."

References #4: N.J.A.C. 8:24-2.4(c) states, "The following requirements shall apply to hair restraints: 1...employees shall wear hair restraints such as hats, hair coverings or nets, beard restraints, and clothing that covers body hair, that are designed and worn to effectively keep their hair from contacting exposed food, clean equipment, utensils, linens; and unwrapped single-service and single-use articles. ..."

References #5: The facility policy titled, "Personal Hygiene" states, "...13. Wear suitable and effective hair restraints while in the kitchen. ..."

1. On 3/13/2017, in the presence of Staff #7, the following deficient practices were observed:

a. The microwave placed on top of the cabinets in the patient dining area, was visibly dirty. There was visible food residue on the inside of the microwave.

b. Patient adaptive meal time equipment was placed in a four (4) section utensil holder. All four (4) sections of the utensil holder were filled with adaptive meal time equipment for different patients'. The utensil holder had visible debris and food particles in it. The patient adaptive meal time equipment was wet and appeared unclean with a red colored residue on it.

(i) During interview, Staff #7 stated that the meal time adaptive equipment was cleaned and made available for the next meal.

2. During a tour of the kitchen tray line and food preparation area, two (2) staff members failed to wear hair restraints for their facial hair.

3. The kitchen dry storage area contained approximately three (3) cases of diet coke which had expired on 8/28/2016.

4. During a tour of the Yellow Zone Unit, in the presence of Staff #20, the refrigerator in the medicine room contained a carton of lactaid milk which had expired 1/2017. A large blue colored cup, without a label was found in the freezer section and contained a frozen substance.

(i) Staff #20 stated that he/she had no idea what was in the blue colored cup.

5. The above findings were confirmed with Staff #13 and Staff #14.

A. Based on observation, it was determined that the facility failed to ensure environmental surfaces are kept clean to sight and touch.

Findings include:

1. On 3/13 and 3/15/17, in the presence of Staff #46, the following was observed:

a. In Room #339:

i. The bathroom sink had tape covering the cracked formica.

ii. The shower supplies holder had stains and some of the pockets were torn.

b. In Room #336:

i. The armrest of a black chair was torn, the corner wall by the closet was chipped, and the bathroom sink had tape covering the cracked formica.

c. In Room #347:

i. The wall shower was stained, and the shower supplies holder had stains and pockets were torn.

d. In Room #345:

i. The shower curtain was torn, the bathroom sink had tape covering the cracked formica, and the intravenous pole was stained.

e. In the hallway, across from Room #341, the upholstered chair pad was heavily stained, and two chairs had torn seat covers.

f. In Room #333: The walls were scuffed, and cups and gloves were on the floor.

g. The outer doors of Room #262, Room #624, Room #267, and Room #269 were gauged.

h. The inner door of Room #252 had holes in it.

i. In Room #260, a rust colored substance was noted at the bathroom door and under the sink, dirt accumulation was noted at the floor corner edges, and the wall was gauged.

j. In Room #267, the shower floor was stained.

k. In Room #256, in the bathroom, the plywood covering the wall was cracked.

l. In Room #504 and #345, a strong musty odor was present in the shower room.

m. In Room #504, the baseboard had a rust colored substance, and the ceiling grid was stained.


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B. Based on observation, it was determined that the facility failed to ensure facilities are maintained to an acceptable level of safety and quality.

Findings include:

1. On 3/13/17 at 11:35 AM in the presence of Staff #6, the following areas in Room #544 were chipped, pealed and cracked, exposing a porous surface that can not be properly cleaned:

a. The door to the room

b. The closet door

c. The bathroom floor

2. On 3/13/17 at 11:40 AM in the presence of Staff #6, the floor in Room #550 was chipped, pealed and cracked. exposing a porous surface that can not be properly cleaned.



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C. Based on observation, staff interview and review of The Association for the Advancement of Medical Instrumentation (AAMI) guidelines, it was determined that the facility failed to ensure that supplies and equipment are maintained at an acceptable level of safety and quality.

Findings include:

Reference #1: The Association for the Advancement of Medical Instrumentation (AAMI) Standard 79 section 8.9.2 on Storage Facilities states, "The (sterile) items should be positioned so that packaging is not crushed, bent, compressed or punctured and so that their sterility is not otherwise compromised."

Reference #2: The Association for Advancement of Medical Instrumentation (AAMI) Standard 79 section 5.3 on Disposition of sterile items (Issued but not used) states, "Unused disposable items that previously have been packaged, sterilized, and issued to patient care units or other uncontrolled areas should be discarded unless the packaging is intact, impervious, and the previous storage conditions are known and acceptable ... Unused reusable items not meeting the above criteria should be unwrapped and reprocessed through the decontamination area."

1. A tour of Medical Exam Room #2 conducted on 3/13/17 at approximately 11:50 AM revealed a clear plastic container containing sterile instruments with crushed, bent and wrinkled packaging. Instruments found are as follows:

a. Two (2) speculums dated 9/6/16.

b. Three (3) speculums dated 12/28/16.

c. One (1) speculum dated 12/26/16.

d. Six (6) speculums dated 1/30/17.

e. One (1) Long forceps dated 3/10/09.

f. One (1) Long forceps dated 6/13/03.

g. One (1) Long forceps dated 5/26/05.

2. At approximately 12 noon, twenty-one plus (21+) speculums, wrapped in disposable plastic zip bags, were found in a clear plastic bin in the bottom cabinet.

3. During interview, Staff #11 stated that they have stopped using reusable speculums and have switched to disposable speculums.

a. Facility staff was unable to provide the time of the switch to disposable speculums.

4. These findings were confirmed with Staff #5 and Staff #11.

A. Based on observation, review of nationally recognized guidelines and staff interview conducted on 3/13/17, it was determined that the facility failed to ensure its sterile processing is assigned to qualified personnel.

Findings include:

Reference: AAMI (Association for the Advancement of Medical Instrumentation) Sterilization in Health Care Facilities, 2015 edition ST 79 section 4.2.2 states, "The responsibility for sterile processing should be assigned to qualified individuals who have demonstrated competence in all aspects of sterile processing: decontamination, preparation, packaging, sterilization, sterile storage, and distribution of sterile medical devices. ... It is recommended that all personnel performing sterile processing be certified as a condition of employment. At a minimum, all such personnel should successfully complete a central service certification examination within two years of employment and should maintain that certification throughout their employment."

1. During a tour of the Dental Department at 12:00 PM on 3/13/17, Staff #12 stated that he/she functions as the SPD technician.

2. Staff #12 was asked the type of steam sterilizer he/she was using. Staff #12 stated, " I don't know."

a. Later, Staff #12 stated, "It is a prevac sterilizer."

3. Staff #12 was asked for evidence of Bowie-Dick testing. He/she did not know what a Bowie-Dick is and what it is for.

a. Staff #12 presented a BI (biological indicator) test strip as a Bowie-Dick.

4. Staff #11, Staff #12's supervisor, was asked regarding the use of CIs (chemical indicator/ integrator). He/she stated, "What is a CI?"

5. The facility failed to ensure its sterile processing is assigned to qualified personnel.`

These findings resulted in an Immediate Jeopardy which immediately curtailed this practice. The Immediate Jeopardy was removed upon receipt of an acceptable plan of correction.

B. Based on observation, review of disinfectant label instructions, AAMI and CDC Guidelines and staff interview conducted on 3/13/17, it was determined that the facility failed to ensure a safe and sanitary environment for the provision of dental services by implementing its disinfectants' use directions.

Findings include:

Reference #1: CDC [Centers for Disease Control and Prevention] Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 page 84 states, "Disinfect noncritical medical devices (e.g., blood pressure cuff) with an EPA-registered hospital disinfectant using the label's safety precautions and use directions. ... By law, all applicable label instructions on EPA-registered products must be followed. If the user selects exposure conditions that differ from those on the EPA-registered product label, the user assumes liability from any injuries resulting from the off-label use and is potentially subject to enforcement action under FIFRA."

Reference #2: AAMI (Association for the Advancement of Medical Instrumentation) Sterilization in Health Care Facilities, 2014 edition, ST 79 section 7.5.2 states, " ... The cleaning agent manufacturer's written IFU should be followed."

1. During turnover cleaning of the Dental Operatory #2 at 11:30 AM, Staff #12 was observed cleaning the room using PDI disinfectant wipes.

2. Staff #12 was asked about the use of the disinfectant wipes.

3. Staff #12 stated, "Is it 5 or 10?"

4. There were three disinfectant wipes observed in the facility: PDI Super Sani, Clorox Bleach Germicidal, and Clorox Hydrogen Peroxide wipes. All have different and specific contact times.

5. The facility failed to ensure its personnel are knowledgeable of the correct use of its disinfectant wipes.

6. The facility failed to ensure the disinfectant's label instructions are followed.

These findings resulted in an Immediate Jeopardy which immediately curtailed this practice. The Immediate Jeopardy was removed upon receipt of an acceptable plan of correction.

C. Based on observation, lack of facility documentation and staff interview conducted on 3/13/17, it was determined that the facility failed to ensure that manufacturer's instructions for use (IFU), for reprocessing equipment, are available and followed.

Findings include:

Reference: AAMI (Association for the Advancement of Medical Instrumentation) Sterilization in Health Care Facilities, 2014 edition states in ST 79 section 7.2.2 Manufacturers' written IFU [Instructions for Use], "The written IFU of the device manufacturer should always be followed."

1. During a tour of the Dental Department at 11:10 AM on 3/13/17, in the presence of Staff #12, a Benco Dental Opti Sonic ultrasonic cleaning equipment and a M-9 Ultraclave autoclave were observed in the Reprocessing Room.

2. The manufacturer's instructions for use (IFU) for the Benco Dental Opti Sonic ultrasonic and the M-9 Ultraclave autoclave were requested and not received.

a. The facility failed to ensure that device IFUs are available at the point of use.

3. Staff #12 confirmed that the IFUs were not available.

4. The facility failed to ensure that its reprocessing device manufacturer's IFUs are available and followed.

These findings resulted in an Immediate Jeopardy which immediately curtailed this practice. The Immediate Jeopardy was removed upon receipt of an acceptable plan of correction.

D. Based on observation, review of nationally recognized guidelines and staff interview conducted on 3/13/17, it was determined that the facility failed to ensure its instrument reprocessing adheres to AAMI guidelines.

Findings include:

Reference #1: AAMI (Association for the Advancement of Medical Instrumentation) Sterilization in Health Care Facilities, 2015 edition, ST 79 section 6.3 states, " ...To prevent the formation of biofilm, definitive cleaning should occur as soon as possible. ... If processing is delayed, attention should be given to minimizing bacterial proliferation, including the use of precleaning disinfectants."

1. During observation of the transport of soiled instruments into the Soiled Utility Room between 11:15 AM to 12:00 PM, Staff #12 was observed to not use an enzymatic precleaning solution on the instruments. The instruments were observed dry.

2. Staff #12 was asked by this surveyor, "When are the instruments cleaned?" He/she stated that the soiled instruments are cleaned, usually at the end of the day, or when he/she can get to it.

a. Without immediate cleaning of soiled instruments, and pre-treatment with enzymatic precleaning disinfectants, biofilm formation can occur.

3. The facility failed to ensure its soiled dental instruments are cleaned immediately or pre-treated to minimize bacterial proliferation and biofilm formation.

These findings resulted in an Immediate Jeopardy which immediately curtailed this practice. The Immediate Jeopardy was removed, upon receipt of an acceptable plan of correction.

Reference #2: AAMI Sterilization in Health Care Facilities, 2015 edition, ST 79 section 10.5.2.2.2 Internal chemical indicators states, "An internal CI should be used within each package, tray, or rigid sterilization container system to be sterilized."

1. During observation in the Dental Operatory #2, in the presence of Staff #8 and Staff #11, 12 of 15 sterile instruments wrapped in paper-plastic pouches were observed to lack CIs (chemical indicator/integrator).

2. This finding was confirmed with Staff #8 and Staff #11 at 12:20 PM.

This finding resulted in an Immediate Jeopardy which immediately curtailed this practice. The Immediate Jeopardy was removed upon receipt of an acceptable plan of correction.

Reference #3: AAMI (Association for the Advancement of Medical Instrumentation) Sterilization in Health Care Facilities, 2015 edition ST 79 section 8.9.2 states, "Sterile items should be stored in a manner that reduces the potential for contamination."

1. During observation in the Dental Operatory #2, in the presence of Staff #8, Staff #11 and Staff #12, sterile items were observed to be stored together with non-sterile items.

a. Dental instruments stored in opened paper-plastic pouches were observed to be co-mingled with sterile dental instrument pouches.

2. This finding was confirmed with Staff #8 and Staff #11 at 12:20 PM.

3. At 12:22 PM, a dental instrument pouch, stored with other sterile instruments, was observed to be labeled, "11/18/14."

a. Staff #12 was asked what the date meant. He/she stated, "It's the expiration date."

4. The facility failed to ensure expired items are not available for patient use.

5. The facility failed to ensure its sterile dental instruments are stored in a manner that adheres to AAMI guidelines.

Reference #4: AAMI (Association for the Advancement of Medical Instrumentation) Sterilization in Health Care Facilities, 2015 edition states in ST 79 section 7.5.3.3, "Ultrasonic cleaning should be used only after gross soil has been removed from items. The cleaning solution should be changed before it becomes heavily soiled so that effective ultrasonic cleaning is not inhibited by soil and so that the risk of cross-contamination is minimized. ... ultrasonic cleaning should be followed by thorough rinsing to remove dislodged particles. ... the ultrasonic cleaner manufacturer's written IFU should be followed. ... It is imperative that all traces of blood, body fluids, and debris be removed during the wash phase of a mechanical cleaning equipment cycle. Failure to do so could result in undetected bioburden that could pose a risk to employee health or result in a patient infection."

1. During observation in the Soiled Utility Room at 11:10 AM, Staff #12 was observed to place soiled dental instruments into the Benco Dental OptiSonic ultrasonic cleaner without first rinsing and removing the gross soil from the instruments.

2. This finding was confirmed with Staff #12.

This finding resulted in an Immediate Jeopardy which immediately curtailed this practice. The Immediate Jeopardy was removed upon receipt of an acceptable plan of correction.

Reference #5: AAMI Sterilization in Health Care Facilities, 2015 edition, ST 79 section 10.5.3.2 Using biological indicators states, " ... The use of Bis provides evidence of efficacy by challenging the sterilizer with a large number of highly resistant bacterial spores. Biological monitoring provides the only direct measure of the lethality of a sterilization cycle. Sterilizer manufacturers validate their sterilization cycles using BIs; therefore, routine sterilizer efficacy monitoring in health care facilities should also be conducted using BIs."

1. During an interview with Staff #12 regarding procedures in Sterile Processing, Staff #12 stated, "The BIs are done weekly. They are sent out to Facility X."

2. Staff #11 and Staff #12 were asked how the BI results are reviewed.

3. Staff #12 stated, "I don't know who reviews them."

4. Staff #11 stated, "The BI results from January 2017 were just received. There is no oversight of the BI process."

5. The facility failed to ensure its Sterile Processing adherence to AAMI ST 79 guidelines.

This finding resulted in an Immediate Jeopardy which immediately curtailed this practice. The Immediate Jeopardy was removed upon receipt of an acceptable plan of correction.



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E. Based on observation, staff interview and document review conducted on March 15, 2017, it was determined that the facility failed to ensure the implementation of policies and procedures addressing the proper cleaning and disinfecting of the blood glucose meter.

Reference #1: Center for Disease Control (CDC) website: , titled "Infection Prevention during Blood Glucose Monitoring and Insulin Administration," states, "...Whenever possible, blood glucose meters should not be shared. If they must be shared, the device should be cleaned and disinfected after every use, per manufacturer's instructions. If the manufacturer does not specify how the device should be cleaned and disinfected, then it should not be shared."

Reference #2: The manufacturer's instruction for EvenCare G3 Glucose Meter titled "Cleaning and Disinfecting Procedures for the Meter" states, "The Evencare G3 Meter should be cleaned and disinfected between each patient. The meter is validated to withstand a cleaning and disinfection cycle of ten times per day for an average period of three years. The following products have been approved for cleaning and disinfecting the EvenCare G3 Meter: Dispatch Hospital Cleaner Disinfectant Towels with Bleach, Medline Micro-Kill Disinfecting, Deodorizing, Cleaning wipes with Alcohol, Clorox Healthcare Bleach Germicidal and Disinfectant Wipes... ."

1. During an observation in the Green Zone Medication Storage Room, an EvenCare G3 Blood Glucose Meter was found.

a. Upon interview, when asked how the glucometer is cleaned and disinfected after patient use, Staff #26 stated that he/she would wipe the meter with alcohol wipes.

2. Using alcohol wipes is not in accordance with the manufacturer's recommendation for the EvenCare G3 Glucose Meter (Reference #2).

3. This finding was confirmed with Staff #46 and Staff #26.


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F. Based on observation, review of facility policies and procedures, review of nationally recognized guidelines, and staff interviews, it was determined that the facility failed to implement and evaluate infection control measures within the hospital.

Findings include:

Reference #1: AAMI, Sterilization in Health Care Facilities, 2014 edition, pg. 37-38 states, " ... 4.2.2 Sterile processing personnel ... The responsibility for sterile processing should be assigned to qualified individuals who have demonstrated competence in all aspects of sterile processing. ... It is recommended that all personnel performing sterile processing activities be certified as a condition of employment. ... Personnel engaged in sterile processing should receive both an initial orientation and on-the-job training. ... All orientation, on-the-job, and in-service training should be documented. ... ."

1. During an interview on 3/13/17, Staff #11 and Staff #12 identified Staff #17 as the alternate SPD technician.

a. Staff #17's personnel file on 3/16/17, lacked evidence of orientation training, on-the-job training, annual competencies, or a certification in sterile processing.

b. On 3/16/17, upon interview, Staff #17 indicated that he/she is not certified in sterile processing.

i. Staff #17 indicated that he/she was trained by an RN who no longer works at the facility. When asked why there was no documented training or competencies in his/her personnel file, Staff #17 did not respond.

ii. Staff #17 indicated that he/she continues to work in the clinic area "maybe once a month if they need me."

iii. Staff #17 indicated that he/she takes the dirty instruments into the decontamination room, sprays them, then soaks them in a solution. He/she states, "I don't run the machines."

c. The facility failed to ensure that the staff responsible for sterile processing and decontamination procedures are certified and received proper training and evaluation.

Reference #2: Facility policy titled Respiratory Therapy Services Equipment Sanitation & Storage states, "... All reusable respiratory equipment must be sanitized and or [sic] disinfected using a germicidal/disinfecting product. ... A log book will be kept indicating the location of each piece of respiratory medical equipment which will include the history of its use including the name of the patient the item was used on and the dates the item was used for that patient."

1. A request was made to Staff #21 on 3/16/17 for the log book used to document the location of respiratory medical equipment.

a. Staff #21 indicated that the facility did not keep a log book indicating the location of each piece of respiratory medical equipment.

2. The facility failed to follow its policy on the storage and sanitation of equipment.

Reference #3: Facility policy titled Handwashing and Hand Decontamination states, "... Procedure: ... Decontaminate Hands with Alcohol Handrubs: ... 2. Before direct patient care... 3. After contact with patients intact skin... 7. After contact with objects (including equipment) located in the patients environment... ."

1. During a tour of the physical therapy unit on 3/15/17, Staff #31, Staff #35, Staff #36, and Staff #37 were observed transferring Patient #17 from his/her wheelchair to another wheelchair.

2. Staff #31, Staff #35, and Staff #37 did not sanitize his/her hands prior to patient contact.

3. Staff #2, Staff #5, Staff #8 and Staff #15 confirmed the above findings.


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G. Based on observation, facility documentation review and staff interview, it was determined that the facility failed to ensure implementation of hand hygiene in accordance with nationally recognized guidelines and facility policy and procedure.

Findings include:

Reference #1: CDC Guideline for Hand Hygiene in Health Care Settings Recommendations of the Healthcare Infection Control Practices Advisory Committee and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force (2002) states on page 32, "Recommendations: 1. Indications for hand washing and hand antisepsis ... (I) Decontaminate hands after contact with inanimate objects (including medical equipment) in the immediate vicinity of patient (J) Decontaminate hands after removing gloves ..."

Reference #2: Facility Policy & Procedures: Standard Precautions: Policy Code: Prev-SP states, " ... 1. HAND WASHING: a. Wash hands after touching ... contaminated items, whether or not gloves are worn. Wash hands immediately before gloves are donned and after gloves are removed ... to avoid transfer or microorganisms to other patients or environments ..."

1. During an interview on 3/13/17, Staff #11 stated that "the facility follows AAMI [Association for the Advancement of Medical Instrumentation], APIC [Association of Professionals in Infection Control and Epidemiology], CDC [Centers for Disease Control and Prevention], and OSHA [Occupational Safety and Health Standards] guidelines."

2. At 11:25 AM, Staff #12 was observed donning gloves without washing his/her hands and proceeded to clean multiple areas in Dental Operatory #2.

3. After cleaning multiple areas in Dental Operatory #2, Staff #12 failed to sanitize his/her hands after glove removal.

4. The above findings were confirmed with Staff #5.

H. Based on observation, staff interview and facility document review, it was determined that the facility failed to ensure that a sanitary environment, to prevent and control infectious and communicable diseases, is provided.

Findings include:

Reference #1: 29 CFR 1910.1030(d)(3)(vii), OSHA (Occupational Safety and Health Administration) Blood Borne Pathogens Regulation states, "All personal protective equipment shall be removed prior to leaving the work area."

Reference #2: Facility Policy titled: Standard Precautions, Policy Code: Prev-SP states, " ... 4. GOWN: a ... Remove a soiled gown as promptly as possible and wash hands."

1. A tour of the Dental Clinic conducted on 3/13/17 revealed the following:

a. Staff #16 was observed walking out of Dental Operatory #2 in to Dental Operatory #1, wearing a blue lab coat and face mask dangling on his/her neck.

i. This mask was worn for the previous patient's procedure.

b. In Dental Operatory #2, one (1) blue lab coat was observed hanging behind the door.

i. Another blue lab coat was observed hanging behind the Panorex X-Ray Machine.

2. At 11:35 AM in the presence of Staff #5, when asked if lab coats are changed between each patient, Staff #12 stated that:

a. Lab coats are not changed after each patient.

b. Lab coats are disposed of at the end of the day.

c. "We don't usually walk out of the room with them."

3. The above findings were confirmed with Staff #5.

Based on observation, document review and staff interview conducted on 3/15/2017, it was determined that the facility failed to ensure policies and procedures for the therapy services involving interdisciplinary communication, are implemented.


Findings Include:

Reference #1: The facility policy and procedure titles, "Feeding Orders" states, "...4. The SLP will change the mealtime card and inservice appropriate staff. .."

Reference #2: The facility policy titled, "Mealtime Techniques" states, "... Any updates/changes to Mealtime Cards: ST/OT will notify PCA Supervisor of Zone, they will then notify appropriative PCA staff. ... Routine review of mealtime changes should be discussed at Unit meetings to assure that all Zone staff has been notified. ..."

1. During lunch time, in the presence of Staff #29, it was observed that Patient #2 failed to have a chest Strap applied during meal time as indicated on his/her mealtime card.

2. During interview, the PCA assigned to the patient stated that the patient did not have an order for a chest strap anymore. The PCA stated that the mealtime cards are not always up to date.

3. During interview, Staff#29 stated that the meal cards are updated by the Speech Therapy Department.

4. During interview with Staff #29, Staff #30 and Staff #31, the process by which the meal time cards are changed was reviewed. The communication process of changes to the mealtime cards and inservice of the PCA staff of changes made to the mealtime cards, was unclear.

5. Review of Medical Record #2 failed to contain evidence of communication between the therapies regarding changes made to adaptive meal time equipment.

6. The above findings were confirmed with Staff #29.

A. Based on observation, review of nationally recognized guidelines, and staff interview conducted on 3/13/17 and 3/15/17, it was determined that the facility failed to ensure its sterile processing is assigned to qualified personnel.

Findings include:

Reference: AAMI (Association for the Advancement of Medical Instrumentation) Sterilization in Health Care Facilities, 2015 edition ST 79 section 4.2.2 states, "The responsibility for sterile processing should be assigned to qualified individuals who have demonstrated competence in all aspects of sterile processing: decontamination, preparation, packaging, sterilization, sterile storage, and distribution of sterile medical devices. ... It is recommended that all personnel performing sterile processing be certified as a condition of employment. At a minimum, all such personnel should successfully complete a central service certification examination within two years of employment and should maintain that certification throughout their employment."

1. During a tour of the Dental Department at 12:00 PM on 3/13/17, Staff #12 stated that he/she functions as the SPD technician.

2. Staff #12 was asked what type of steam sterilizer he/she was using. Staff #12 stated, "I don't know."

a. Later, Staff #12 stated, "It is a prevac sterilizer.

3. Staff #12 was asked for evidence of the Bowie-Dick testing. He/she stated he/she did not know what a Bowie-Dick is and what it is for.

a. Staff #12 presented a BI (biological indicator) test strip as a Bowie-Dick.

4. Staff #11, Staff #12's supervisor, was asked regarding the use of CIs (chemical indicator/ integrator). He/she stated, "What is a CI?"

5. Staff #5 stated on 3/15/17 that the facility has consulted with an SPD consultant, who recommended some changes, however the facility has not yet implemented the changes in SPD.

a. The contract with the SPD consultant was requested and not received.

6. The facility failed to ensure the necessary oversight in SPD.

7. The facility failed to ensure its sterile processing is assigned to qualified personnel.

These findings resulted in an Immediate Jeopardy which immediately curtailed this practice. The Immediate Jeopardy was removed upon receipt of an acceptable plan of correction.

B. Based on lack of facility documentation and staff interview conducted on 3/13/17, it was determined that the facility failed to ensure the Chief Executive Officer, Medical Staff and Director of Nursing provided the necessary oversight to implement a safe and sanitary environment for the provison of podiatric services.

Findings include:

1. During an interview with Staff #8 and Staff #11 at 11:50 AM, Staff #11 stated, "The podiatrist brings in his/her own instruments and sprays to disinfect them in between patients."

2. This surveyor asked Staff #8 if the "disinfectant spray" was approved through the Infection Control Committee.

a. Staff #8 stated, "No".

3. Staff #8 and Staff #11 were asked by this surveyor how the facility ensures the podiatry instruments are sterile and safe for patient use.

a. Staff #8 and Staff #11 did not respond.

These findings resulted in an Immediate Jeopardy which immediately curtailed this practice. The Immediate Jeopardy was removed upon receipt of an acceptable plan of correction.