HospitalInspections.org

Based on staff interviews, review of personnel files, tour and observation of the facility, review of pertinent hospital wide policies and procedures, and review of medical records, it was determined that the Governing Body failed to demonstrate that it is effective in carrying out the operation and management of the hospital. The facility did not provide the necessary oversight and leadership as evidenced by the lack of compliance with:
42 CFR 482.25 Pharmaceutical Services
42 CFR 482.41 Physical Environment
42 CFR 482.42 Infection Control

A. Based on document review and staff interview, it was determined that the facility failed to ensure implementation of policies and procedures addressing the administration of medications from single dose vials and multi-dose vials.

Findings include:

Reference: Facility policy titled "Multi-Dose and Single-Dose Medication Vials/Container" states, "3. Vials designated as a single dose vial must be discarded after one use..."

1. Pyxis activity reports, reviewed 12/12/17, revealed that on 12/6/17 at 20:18, one (1) Hydromorphone 2mg (milligrams)/1ml (milliliter) was removed for Patient #31. No additional vials were removed during the night.

a. The administration of Hydromorphone 0.5mg on 12/6/17 at 20:24 and 12/7/17 at 03:17 was recorded on the medication administration record.

b. Wastage of 1 mg of Hydromorphone, on 12/7/17 at 06:17, was recorded on the Pyxis activity report.

2. Staff #37 confirmed that, based on this information, it appears that the nurse administered medication from the same single dose vial on 12/6/17 at 20:24 and 12/7/17 at 03:17, seven (7) hours later.





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B. Based on review of 2 medical records for the administration of pain medication and staff interview on 12/12/17, it was determined that the facility failed to ensure that medications are administered in accordance with physician orders.

Findings include:

1. Upon review, the medical record of Patient #38 contained Post Anesthesia Care Unit (PACU) Admission Orders, dated and signed by the physician on 11/17/17 at 1555, for Hydromorphone 0.5 mg (milligram) IV (intravenous) every 10 minutes PRN (as needed) to max (maximum) total dose of 2 mg for moderate pain (4-6 on pain scale of 1-10).

a. The electronic medication administration record dated 11/17/17 at 16:00, 16:18 and 16:55 indicated that Hydromorphone 0.5 mg. was administered for a pain level of 10 each time.

b. There was no evidence that the physician was contacted to obtain a medication order for the pain scale of 10.

2. Upon review, the medical record of Patient #16 contained PACU Admission Orders dated and signed by the physician on 12/11/17 for, Morphine 2 mg. IV every 5 minutes, as needed for moderate pain (4-6 on a pain scale of 1-10) to max total dose of 10 mg. and for Morphine 2 mg. IV every 5 minutes, as needed, for severe pain (7-10 on a pain scale of 1-10) to max dose of 20 mg.

a. The electronic medication administration record dated 12/11/17 at 13:11, indicated administration of Morphine 2 mg IV for a pain level of 10 under the section of Morphine 2 mg. for Moderate pain level instead of Morphine 2 mg. IV for a pain level of 10.

3. Pain medications were administered for a pain level not consistent with physician orders.

4. The above was confirmed by Staff #69.



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C. Based on observation, staff interview, and facility policy review, it was determined that the facility failed to ensure that staff prepare intravenous medications in accordance with facility policy and Centers for Disease Control's (CDC) recommendations.

Findings include:

Reference #1: Contractual agreement for dialysis services, effective date October 7, 2002, states, "... 4. Protocols. Hospital and Contractor will mutually develop written protocols governing the procedures to be used in rendering ARRT [acute renal replacement therapies] at Hospital ..."

Reference #2: DaVita Dialysis policy titled, "MEDICATION POLICY INCLUDING THE USE OF VOLUME REPLACEMENT AND/OR VOLUME EXPANDERS", states, "Purpose: To provide guidance for medication management in the acute setting and to provide guidance for the aseptic preparation of all medications. ... 10. It is preferred that when saline syringes are required for vascular access care or to flush medications, facility should use prefilled saline syringes. 11. When saline syringes must be prepared for administration, the following safe injection practices must be followed: [bullet] Fill syringes with sterile saline for an individual patient in a dedicated clean area removed from the patient station. ..."

Reference #3: CDC'S MMWR, April 27, 2001/ VOL. 50/ NO. RR-5, titled Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients states on page 19, "... Infection Control Precautions for All Patients ... Additional measures to prevent contamination of clean or sterile items include a) preparing medications in a room or area separated from the patient treatment area and designated only for medications; ..."

1. On 12/12/17 at 10:49 AM, in the presence of Staff #57 and Staff #59, Staff #58 was observed using a 10 cc syringe to aspirate saline from the extracorporeal circuit on Machine #K4 to flush the Patient #25's vascular access. This is not in accordance with the above Reference #2.

2. On 12/12/17 at 11:00 AM, Staff #59 stated that staff should not aspirate saline from the extracorporeal circuit. Staff #59 stated that staff should be using prefilled saline syringes to flush a patient's vascular access.

Based on observation, document review and staff interview, it was determined that the facility failed to ensure implementation of facility policy regarding medications that are brought in from home.

Findings include:

Reference: Facility policy "Medications Brought into The Medical Center by Patients" stated, " ... Procedure: ... 11. The administration of the "home medication" is only allowed after specific instructions to do so are documented in a prescriber order. A staff pharmacist must identify the medications to ensure their stated content.
a. Patients are permitted to use their own medications only by valid order from a prescriber ...
i. Before any of this medication is administered to the patient, it shall be given to the pharmacist for identification and verification of contents for use in the hospital. The pharmacist will initial and date the medication ..."

1. One 12/11/17, during a tour of the Telemetry Unit, Patient #8 was interviewed at the bedside. A bottle of Amoxicillin 500 mg. (milligrams) was noted on the patient's bedside stand. Patient #8 confirmed that he/she was taking the medication that he/she had brought from home. There was no evidence that the bottle of medication had the pharmacist initial and the date.

2. Staff #69 confirmed the above referenced policy was not followed.

Based on review of 3 medical records for post anesthesia evaluation, document review and staff interview on 12/12/17, it was determined that the facility failed to ensure that all entries in the medical record are complete, dated and timed in 2 medical records (Medical Record #16 and #38).

Findings include:

Reference: Facility Rules and Regulations state, "Medical Records ... 9. All clinical entries in the patient's medical record shall be accurately dated, timed and authenticated."

1. In Medical Record #16, the Post Anesthesia Recovery and Post Anesthetic Evaluation sections of the Preanesthetic Evaluation form were signed and dated by the physician on 12/11/17, however, these sections lacked evidence of the patient's readiness to be discharged and of any untoward symptoms related to anesthesia.

2. In Medical Record #38, the Post Anesthesia Recovery and Post Anesthetic Evaluation sections of the Preanesthetic Evaluation form were signed and dated by the physician on 11/17/17, however, they were untimed.

3. The above finding were confirmed by Staff #69.

Based on observation, document review, and staff interview, it was determined that the facility failed to ensure that the hospital has pharmaceutical services that meet the needs of the patients.

Findings include:

1. The pharmacy and drug storage areas were not administered in accordance with accepted professional principles. Refer to Tag A491.

2. Current and accurate records of the receipt and distribution of scheduled drugs were not maintained. Refer to Tag A494.

3. Drugs and biologicals were not distributed in accordance with applicable standards of practice, consistent with facility policies and procedures. Refer to Tag A500.

4. Outdated, mislabeled, or otherwise unusable drugs were available for patient use. Refer to Tag A505.

Based on observation and staff interview, it was determined that the facility failed to ensure that a pharmacist is responsible for labeling dispensed medications.

Findings include:

1. On 12/12/17, a 100 ml (milliliter) intravenous (IV) bag of Potassium Chloride 20 mEq (milliequivalents) and an IV bag of Heparin 25,000 units were found in the medication room in ICU (Intensive Care Unit). A pharmacy label, including all the pertinent information required on the label prior to dispensing by pharmacy, was partially affixed to the overwrap of each IV bag.

a. Upon interview, Staff #37 stated that, in order to decrease waste, the nurse would remove the label from the overwrap and affix it to the IV bag prior to patient administration.

(i) The label on the intravenous solutions would be affixed by the nurse on the unit and not under direct supervision of a pharmacist.

A. Based on observation, document review, and staff interview, it was determined that the facility failed to ensure the development and implementation of policies and procedures for the control and accountability of controlled dangerous substances (CDS).

Findings include:

Reference #1: Facility policy titled "Pyxis" states, "Procedure: 4. To Waste a Medication: A) If part of a controlled substance dose remains and cannot be returned to the Station for future use, it must be destroyed and documented on the system as a waste. Waste is not to be returned to the Pyxis Return Bin. ..."

Reference #2: Facility policy titled "Medication Disposal (Medication Inspections)" states: Policy: All expired, discontinued medications/solution, or partial vials of medication will be disposed in an appropriate manner in accordance with all applicable Federal and State laws, rules and regulations." and "Procedure: Outdated controlled substance will be disposed of in accordance with Federal and State laws, rules and regulations."

1. On 12/11/17 at 10:30 AM, an opened vial of Hydromorphone 2mg (milligrams)/2ml (milliliter), a Schedule II CDS, was found in the pharmacy return bin located in the medication room on Unit 2A.

a. The contents were withdrawn into a syringe and totaled 0.5 ml.

b. Staff #37 confirmed that he/she was unable to account for the opened, partially used vial of Hydromorphone.

2. On 12/11/17 at 10:45 AM, an opened vial of Hydromorphone 2mg/2ml, a Schedule II CDS, was found in a Work Station on Wheels (WOW) on Unit 2A.

a. The contents were withdrawn into a syringe and totaled 0.3 ml.

b. Staff #37 confirmed that he/she was unable to account for the opened, partially used vial of Hydromorphone.

3. There was no evidence of wastage of a Hydromorphone, a Schedule II CDS, in 2 of 5 medical records (Medical Records #33 and #35) reviewed for Hydromorphone administration from 12/9/17 through 12/10/17.

a. The removal of Hydromorphone 2mg/1ml on 12/10/17 at 10:29 by Staff #67, for Patient #33, was recorded on the Pyxis Activity report. The administration of Dilaudid (Hydromorphone) 0.5mg at 8:10 and at 8:30, for a total of 1 mg, by Staff #67 was recorded on the anesthesia record in Medical Record #33. There was no evidence of wastage of the remaining 1 mg of Hydromorphone.

b. Hydromorphone 2mg/1ml was removed from Pyxis for Patient #35 on 12/9/17 at 12:08. One (1) mg was administered. There was no evidence of wastage of the remaining 1 mg.

c. Hydromorphone 1mg/1ml was removed from Pyxis for Patient #33 on 12/10/17 at 10:10. At 10:13, 0.5 mg was administered. There was no evidence of wastage of the remaining 0.5 mg.

4. Pyxis activity reports for Hydromorphone, a Schedule II CDS, from 12/7/17 through 12/11/17, were compared with medication administration records in six (6) medical records. In 4 of 6 medical records reviewed (Medical Records #11, #12, #34, and #35), wastage of the controlled drug occurred hours after the medication had been administered.

a. The removal of Hydromorphone 2mg/1ml syringe on 12/7/17 at 08:42 for administration to Patient #34 was recorded on the Pyxis activity report for Unit 2A. The administration of Hydromorphone 0.5 mg on 12/7/17 at 08:45 was recorded in Medical Record #34. The wastage of Hydromorphone 1.5 mg on 12/7/17 at 16:11 for Patient #34 was recorded on the Pyxis activity report. The medication was wasted more than seven (7) hours after administration.

b. Hydromorphone 2mg/1ml was removed from Pyxis for Patient #11 on 12/9/17 at 08:53. The administration was recorded on 12/9/17 at 11:54, 3 hours later.

c. Hydromorphone 2mg/1ml was removed from Pyxis for Patient #11 on 12/10/17 at 12:15. Wastage of 1 mg was recorded on 12/10/17 at 18:05, 6 hours later.

d. Hydromorphone 2mg/1ml was removed from Pyxis for Patient #12 on 12/11/17 at 08:41. Wastage of 1 mg was recorded on 12/11/17 at 13:59, 5 hours later.

e. Hydromorphone 2mg/1ml was removed from Pyxis for Patient #35 on 12/10/17 at 09:35, 14:05 and 18:04. In each instance, one (1) mg was administered. Wastage of 1 mg of Hydromorphone for Patient #35 was recorded 3 separate times, all dated 12/10/17 at 18:06.

(i) Staff #37 confirmed that it appears that the 3 partial doses remaining were saved and discarded together on 12/10/17 at 18:06.

f. On 12/11/17 at 11:53, one (1) vial of Hydromorphone 2mg/1ml had been removed for administration to Patient #10 by Staff #22. The order was for Hydromorphone 1 mg. There was no evidence of wastage of the remaining 1 mg at the time of removal.

(i) Upon interview, on 12/11/17 at approximately 2:00 PM, Staff #22 stated that he/she had not yet wasted the medication. He/she removed the opened vial of Hydromorphone 2mg/ml from his/her pocket to show the surveyor.

(ii) The wastage of 1 mg of Hydromorphone for Patient #10 by Staff #22 and witnessed by Staff #23, on 12/11/17 at 15:04, was recorded on the Pyxis activity report.

(iii) Upon interview on 12/12/17, Staff #23 confirmed that he/she had witnessed Staff #22 place a partial vial of Hydromorphone 2mg/ml in the sharps container. He/she stated that he/she did not visually inspect or measure the contents in the vial.

5. Upon request, Staff #37 was unable to provide for review a policy (or policies) addressing the time frame for wasting of controlled drugs and where to store partial doses of controlled drugs until wasted (if the policy permits this). Reference #2 above was provided for the proper method of disposal for controlled drugs, which is vague and not specific.

Reference #3: Facility policy titled "Pyxis" states, "Procedure: 3. To Return a Medication to Stock: A. Most medications removed from the Station and not administered to the patient may be returned to the original stock pocket in the Station. ...9) If returning a controlled substance and prompted for a witness, acquire the help of another user to act as a witness. ..."

1. On 12/11/17 at 10:45 AM, one (1) unit dose package of Oxycodone/Acetaminophen 10/325 tablet was found in a WOW on Unit 2A.

a. Staff #22 stated that he/she had removed it from the Pyxis for a patient who had refused the medication. He/she confirmed that the medication was not immediately returned to Pyxis.

(i) Review of the Pyxis activity report revealed that Staff #22 had removed one (1) Oxycodone/Acetaminophen 10/325 tablet from Pyxis on 12/11/17 at 08:04 and returned the unused medication on 12/11/17 at 11:14, approximately 3 hours later.

2. Upon request, Staff #37 was unable to provide for review a policy (or policies) addressing the time frame for returning controlled drugs, if not administered, and where to store controlled drugs until returned (if the policy permits this).

A. Based on observation and staff interview, it was determined that the facility failed to ensure that emergency carts/kits are properly labeled, by pharmacy staff, with the first drug to expire from the cart/kit.

Findings include:

1. During a tour of the CCU, on 12/12/17, it was noted that the expiration date on the outside of a Rapid Response Box located in the medication room was "Lasix 3/10/18."

a. Upon interview, Staff #37 stated that the facility policy states that the pharmacy department labels the box with the first drug to expire.

2. Upon checking the contents of the box, it was noted that the first drug to expire was furosemide 20mg, expiration date 2/18. The box was not labeled correctly.

B. Based on document review and staff interview, it was determined that the facility failed to ensure the implementation of policies and procedures addressing quality assurance activities related to the Pyxis medication dispensing device.

Findings include:

Reference #1: Facility policy titled "Pyxis" states, "... Pyxis Quality Assurance ...3. Pyxis machines in the facility are audited and inspected every 2 months to ensure accuracy, for expiration or use by date, misbranding and physical integrity, and for security and accountability. The results of the inspections are recorded on the floor inspection document (O0420PHM Drug Storage Areas - Monthly Inspections, Appendix A).

Reference #2: The "Floor Inspection of Medication Areas" form states, "... 8. Randomly select 3 non-controlled meds and 2 controlled meds in Pyxis to check for outdates.

1. During interview on 12/12/17, Staff #37 stated that during unit inspections, pharmacy staff do a "spot check" of the drugs in the Pyxis, as indicated in Reference #2. The facility policy in Reference #1 requires a more detailed inspection.

2. Review of Floor Inspection of Medication Areas for CCU for 2017 revealed incomplete documentation of Pyxis inspections in 3 of 3 inspections performed.

a. The inspection form dated 6/10/17 has "N/A" for item #8.

b. The inspection form dated 7/19/17 lists 2 non-controlled medications and no controlled medications.

c. The inspection form dated 9/15/17 lists 3 non-controlled medications and no controlled medications.

C. Based on observation, document review, and staff interview, it was determined that the facility failed to ensure the implementation of a system of control for legend drug doses.

Findings include:

Reference: Facility policy titled "Medication Administration Check (MAK) states, "... 5. Medication Administration in MAK...C. Medications are retrieved fro the patient from Pyxis or the medication cart filled drawer based on the profile. The medications will be removed one patient at a time and administered prior to removing medication for another patient by the same nurse (with the exceptions for emergencies)." and "14. Returning medication A. When a medication is not used and needs to be returned, use the Return function in Pyxis to return items to the system and credit the patient's account. ... B. Alternately, the medication can be placed into the secured return bin located on the unit or returned to the Pharmacy directly. ..."

1. On 12/11/17 at 10:45 AM, the following medications were found stored in a drawer on a Workstation on Wheels (WOW) on Unit 2A:

a. One (1) Lovenox 40 mg (milligram)/0.4 ml (milliliter) syringe

b. One (1) Metoprolol Succinate 25 mg tablet

c. One (1) Lactinex tablet

d. One (1) Metoprolol tartrate 5 mg/5 ml

e. Three (3) Divalproex Sodium 500 mg tablets

f. One (1) bottle of 25 Nitrostat 0.4 mg tablets

g. One (1) vial of Humalog insulin

h. Three (3) Nystatin Suspension 500,000 U/5 ml

i. One (1) vial of Heparin 5,000 Units

j. One vial of Lantus insulin

k. One (1) Oxycodone/Acetaminophen 10/325 tablet, a Scheduled II CDS

l. One (1) opened vial of Hydromorphone 2 mg/ ml, a Scheduled II CDS

2. Upon interview, Staff #22, who was using the WOW that day, stated that with the exception of the Oxycodone/Acetaminophen 10/325 tablet that had been refused by a patient, he/she could not account for the medications.

3. Upon interview, Staff #1 stated that the pharmacy did not monitor for medications that had been removed from the Pyxis but not administered.

4. The facility policy referenced above does not address the time frame for returning medications that had not been administered. However, since medications are to be removed and administered one patient at a time, it would be reasonable to assume that medications removed but not administered would be returned prior to removing medications for another patient.

D. Based on document review and staff interview, it was determined that the facility failed to ensure the implementation of policies and procedures addressing the inspection of drug storage areas by pharmacy staff.

Findings include:

Reference: Facility policy titled "Drug Storage Areas - Monthly Inspections" states, "PROCEDURE: ... 3. The Pharmacy Department shall inspect at least once very two months all areas of the Medical Center where drugs intended for administration to patients are stored. The pharmacy department shall maintain an electronic record of the inspections."

1. Review of pharmacy unit inspections, conducted on 12/12/17, revealed that inspections had not been conducted at least once every two months in all patient care areas in the hospital. Examples include but are not limited to:

a. The Radiology Department had been inspected on 8/17/17 in 2017.

b. The Critical Care Unit (CCU) had been inspected on 6/10/17, 7/19/17 and 9/15/17 in 2017.

c. These findings were confirmed by Staff #37.

2. Pharmacy unit inspection forms for CCU, dated 6/10/17, 7/19/17 and 9/15/17, had "Y [yes]" circled for criteria #4 (Discharged/transferred patient medications returned to pharmacy).

a. On 12/12/17, Patient #37's own supply of Humalog R U-500 insulin was found in the medication refrigerator in the medication room on CCU.

(i) Upon interview, Staff #37 stated that Patient #37 had been discharged from the hospital on 3/13/17, 9 months ago.

b. Staff #37 confirmed that, during the unit inspections, pharmacy staff had failed to identify that a discharged patient's own supply of medication remained on the unit.

A. Based on observation and staff interview, it was determined that the facility failed to ensure that expired medications are returned to pharmacy for disposal.

Findings include:

1. Three (3) bags of Vancomycin 500mg in 100 ml of D5W for injection, beyond use date 11/23/17, were found in the Pyxis drug dispensing device in the Holding Area of the Operating Room (OR) suite.

a. Review of Pyxis reports revealed that a bag with the same beyond use date had been administered to Patient #32 on 12/6/17.

2. The following expired medications were found in the anesthesia workroom in the OR suite:

a. In the Invasive Monitoring Cart:

(i) One (1) vial of Dobutamine 500mg/250ml, expiration date 11/1/17

(ii) One (1) vial of Sodium Bicarbonate 8.4%, expiration date 6/1/17

3. Four (4) bags of 500 ml and four (4) bags of 1000 ml Lactated Ringers Solution, expiration date 5/16, were found in the medication room in the ICU (Intensive Care Unit).

4. Two (2) bags of 500 ml 0.45% Sodium Chloride for Injection, expiration dates 8/2016 and 9/2017 and one (1) bag of 500 ml 5% Dextrose for Injection, expiration date 9/2017, were found in the IV storage room on Unit 2A.

5. These findings were confirmed by Staff #37.

B. Based on observation and staff interview, it was determined that the facility failed to ensure that intravenous solutions that have the overwrap removed are not available for patient use.

Findings include:

1. Intravenous solution out of the protective overwrap were found in the following instances:

a. On Unit 2A:

(i) One (1) bag of 1000 ml Lactated Ringers Solution

(ii) One (1) bag of 250 ml 0.9% Sodium Chloride for Injection

b. In the Operating Room (OR) Suite:

(i) Six (6) bags of 100 ml 0.9% Sodium Chloride for Injection were found in OR #4.

(ii) Five (5) bags of 100 ml 0.9% Sodium Chloride for Injection were found in OR #3.

(iii) Three (3) bags of 50 ml 0.9% Sodium Chloride for Injection were found in OR #6.

2. The labeling on the bag states, "Use immediately once overwrap is removed."

3. Upon request, Staff #37 did not provide for review a policy and procedure addressing the beyond use date for intravenous solutions removed from the overwrap.

Based on observation, document review and staff interview conducted on 12/11/17, 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: The facility policy and procedure titled, "Floor Supplies - Food" states, "... 5. The Nutrition Care Assistant assigned to the pantry is responsible for removal of outdated items on a 24 hour basis. ... 6. Environmental Service is responsible for cleaning and sanitizing refrigeration areas, as well as the refrigerators on the Nursing units. ..."

Findings include:

1. During a tour of the facility at approximately 10:30 AM, in the presence of Staff #28, the following observations were made:

a. The Intensive Care Unit (ICU) pantry area contained the following:

(i) Unwrapped plastic in drawers.

(ii) The Pantry floor had visible dirt and debris.

(iii) The refrigerator door had visible orange/brownish discoloration. The gaskets had visible wear and tear with black/grey discoloration.

b. The Medical-Surgical Unit pantry area contained the following:

(i) The microwave had visible dirt, debris and dried/crusty particles.

(ii) The refrigerator freezer gasket had visible black/grey discoloration.

(ii) The freezer contained an unlabeled bag filled with what appeared to be frozen meat.

(iii) The cabinets in the pantry had a total of three (3) handles missing. The inside drawers of the cabinets had visible dirt and debris.

(iv) The cabinet area counter tops and pantry floor were visibly dirty with dirt and debris.

(v) The pantry contained two (2) sinks. The sink next to the door had no running water. The second sink had no soap.

c. The Cardiac/Orthopaedic and Bariatric Unit- Floor 2A pantry area contained the following:

(i) The pantry area contained a microwave, which could not open. There was visible thick crusted dirt and debris all around the outside of the microwave.

(ii) The pantry doors under the sink area could not open, as they were stuck.

(iii) A water fountain in the hallway had no running water.

d. Pantry are on Unit 3B contained the following:

(i) The freezer contained unlabeled food items and two (2) cans of soda with visible bulges in the cans.

(ii) The pantry drawers had visible dry coffee grounds with brown stains inside the drawers.

(Refer to References #1, #2 and #3)

2. The above findings were confirmed by Staff #28.

Based on observation and staff interview conducted between 12/11/17 and 12/13/17, it was determined that the facility failed to ensure the hospital is maintained for the safety of patients.

Findings include:

1. The hospital failed to ensure the condition of the physical plant and overall hospital environment was maintained in such a manner that the safety and well-being of patients are ensured. Refer to Tag A701.

2. The facility failed to comply with the 2012 edition of the National Fire Protection Association's Life Safety Code. Refer to Tag A709.

3. The hospital failed to ensure that supplies and equipment were maintained to ensure an acceptable level of safety and quality. Refer to Tag A724.






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A. Based on tours of the facility and staff interviews, it was determined that the facility failed to ensure the condition of the physical plant and overall hospital environment was maintained in such a manner that the safety and well-being of patients are ensured.

Findings include:

1. A tour of the Emergency Department on 12/11/17 revealed:

a. Hallways:

(i) An unlocked, and unattended, blue and white supply cart contained numerous types of needles and syringes.

b. Nurses Station:

(i) Beneath all of the bottom drawers in the metal cabinets, located under the counter top closest to the ambulance entrance, had accumulations of heavy clumps of dust, grit, pieces of a torn latex-free glove, a patient's medication sticker, paper scraps, vial caps, syringe caps, pretzel pieces, popcorn pieces, candy wrappers, and other refuse on the floor. The ledge above the counter top had clear tape and tape residue on it.

(ii) There was a heavy accumulation of dust, grit, pretzel pieces, needle caps, paper clips, an empty snack bag, paper scraps, and other refuse beneath the bottom drawer of a cabinet in front of the door to the Medication Room.

(iii) Main Counter: There was grit, dust, paper scraps, cookies, and other refuse beneath the bottom drawer of a cabinet on the far left. The bottom drawer had a partially filled cup of coffee in it. The middle cabinet had broken cracker pieces, dust, grit, a individually wrapped pill, beneath the bottom drawer. Beneath the bottom drawer of the cabinet on the far right under the counter was paper scraps, cellophane wrappers, and other refuse.

c. Medication Room:

(i) Beneath and behind the medication refrigerator was dust, grit, multiple vial caps, multiple syringe caps, an empty glass syringe, multiple needle caps, medication wrappers, scraps of paper, and other refuse.

(ii) A wall on the side of the refrigerator had a hole in it.

(iii) The drawers beneath the counter had dust, grit, and paper scraps in them.

(iv) Three wall cabinets had missing hardware exposing particle board.

d. Bay 3: There was dust in the wall vent.

e. Registration Area: There was heavy dust behind the printer.

2. A tour of the Psychiatric Unit on 12/11/17 revealed:

a. Nurses Station:

(i) A shelf had a Tupperware container on it containing dried food and a green substance.

(ii) On the floor near the window was dried pieces of macaroni with dried sauce on them, corn chip pieces, dust, grit, a heavily dust-encrusted single-serve peanut butter container, and paper bags that had a thick coat of dust on them.

(iii) A drawer next to the sink contained cellophane wrappers, pieces of plastic, dried spillage, stains, spilt salt and pepper, and other refuse.

(iv) The wall behind the door to the hallway had an unpainted area that had been repaired with joint compound. There was also a hole in the repaired area.

(v) The drawer beneath the counter near the opening to the hallway was missing the finish exposing an uncleanable wood surface.

(vi) The floor behind the water and ice machine had a puddle of water on it. A water-soaked white towel and other refuse was on the floor behind the machine.

b. Pantry: Water was leaking from a faucet handle on the sink.

c. Hallway:

(i) There were cracked and broken floor tiles outside of the Nurses Station.

(ii) 6 ceiling light covers had dead bugs atop them.

(iii) There were 2 stained ceiling tiles outside of the Quiet and Shower Rooms.

d. Quiet Room (Room #802):

(i) Ceiling tiles around the light had holes in them. There were dead insects atop the ceiling light cover.

(ii) A strand of organic matter was hanging from the ceiling.

e. Restraint Room (Room #801): The bathroom adjacent to the Room had unpainted plaster on the ceiling and dead insects atop the light cover.

3. A tour of the CARES Unit on 12/11/17 revealed:

a. Quiet Area:

(i) There were dead insects atop the light cover.

(ii) There was a heavy accumulation of dust on the front grille of the wall air conditioner unit.

b. Hallway: there was a broken wall tile.

c. Patient Bathroom #A-213:

(i) There was heavy dust in the ceiling vent.

(ii) There was a broken wall tile above the wall light fixture.

(iii) There were dead insects atop the ceiling light cover.

d. Room #A-203:

(i) There was broken and cracked caulking behind the bathroom sink.

(ii) There were sticky foam strips on the interior side of the bathroom door.

e. Play Room:

(i) There was a missing face plate on the wall exposing a hole.

(ii) A piece of Plexiglas near the window had a broken corner.

(iii) There was tape and tape residue on the wall.

f. Hallway:

(i) There were dead insects atop the ceiling light covers.

(ii) There were cracked floor tiles.

g. 3rd Floor Quiet Area: There was broken sheetrock and ripped carpet on the wall.

h. 3rd Floor Hallway: 2 of 8 ceiling light covers had dead insects atop them.

i. Medication Room:

(i) The refrigerator was set atop a piece of raw plywood.

(ii) A metal cabinet, in an alcove where the air conditioner was located, had grit, raised stains, dust, staples, and other refuse beneath it. Other areas of the floor were stained.

(iii) The window blinds were dusty.

(iv) The wall between two windows was water damaged, including crumbling plaster and peeling paint.

4. A tour of the Forensic Unit on 12/12/17 revealed:

a. Paper scraps, dust, grit, and needle caps were under the Medication Refrigerator set atop the Pyxis Machine in the hallway.

b. Room #A54: There was dust, grit, wrappers, and other refuse on a raised base beneath a metal rack of shelves.

c. Shower Room: The shower stall finish was separated from the wall exposing an area for water to seep through to the wall.

5. A Tour of the Histology Lab on 12/12/17 revealed:

a. A raw particle board base beneath a sink was water damaged. There was grit and spillage on the base.

b. A raw wood pallet holding boxes and equipment was beneath a counter.

c. The back sink had rotting particle board from water damage.

d. A pallet with a raw wood base was in the middle of the room.

e. A raw wood pallet was under the IntelliPATH Machine.

f. The Formica was separated from the splash guard behind the Microtome Machine. There was heavy staining on the Microtome Machine.

6. A tour of the Cutting Room in the Laboratory on 12/12/17 revealed:

a. Cabinets beneath two sinks had heavily rusted bases and heavy spillage.

b. A blue cabinet had exposed, unfinished particle board and peeling paint.

7. A tour of the Laboratory Waiting Room on 12/12/17 revealed that under the sink was a pile of unwrapped corn chips and a large dead insect.

8. A tour of the Receiving area of the Laboratory on 12/12/17 revealed exposed, unfinished particle board holding up a counter top. There were broken pieces of the laminate on the counter top.

9. A tour of the Blood Bank on 12/12/17 revealed:

a. A drawer containing rusted paper clips, dried rubber bands, plastic caps, grit, and raised stains.

b. A cabinet beneath a counter top had a piece of cellophane with a greasy yellow substance on it.










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B. Based on observation and staff interview, it was determined that the facility failed to ensure patients safety and well being by providing a way for patients to communicate their needs with staff.

Findings include:

Reference: Guidelines For Construction and Equipment of Hospital and Medical Facilities. 2010 Edition. number, 2.1-8.3.7 Call Systems, states, "Hospital signaling and nurse call equipment includes four types of call stations: patient stations, bath stations, staff emergency stations, and code call stations. ... 2.1-8.3.7.1 General, ... (2) Call stations shall report to an attended location with electronically supervised visual and audible annunciation ..."

1. On 12/12/17 at 10:00 AM, a tour of the Dialysis Area was conducted and the following was observed:

a. Staff #58, a registered nurse, stated that he/she is the only person in the Dialysis Area when patients are dialyzing.

b. Staff #8 and Staff #57 stated that there is no call bell system in the Dialysis Area available for patients use.

c. During an interview, Staff #8 and Staff #57 were questioned how a patient, who is dialyzing in the Dialysis Area, would communicate with staff or call for help if the dialysis nurse became incapacitated or unavailable.

(i) Staff #57 stated that patients could yell for help.

(ii) When questioned if patients would be heard by anyone with the door to the Dialysis Area being closed, Staff #57 stated "Probably not."

(iii) Staff #8 stated that the dialysis patients could use the phone to call someone. Staff #57 confirmed there are not phones available at the dialysis patent's bedside while on dialysis. Staff #57 stated that there is a phone at the nurse's desk.

(iv) When questioned what would a patient who was actively dialyzing and connected to the machine or a patient that was unable to walk do if assistance was needed, Staff #57 stated "I don't know."

2. Staff #8 and Staff #57 confirmed that there are no safety measures or a means for patients to call for assistance if the one nurse in the dialysis area became incapacitated or unavailable.

Based on observation and staff interview, it was determined that the facility failed to ensure compliance with the 2012 edition of the National Fire Protections Associations's Life Safety Code.

Findings include:

Reference #1: National Fire Protections Associations's Life Safety Code, "101:19.3.2.6(8) Dispensers shall not be installed in the following locations: (a) Above and ignition source ... 101:19.3.2.6(9) Dispensers installed directly over carpeted floors shall be permitted only in sprinklered smoke compartments."

Reference #2: National Fire Protections Associations's Life Safety Code, "101.19.3.1 Any vertical opening shall be protected ... 19.3.1.1 Where enclosure is provided, the construction shall have not less than a 1-hour fire resistance rating."

Reference #3: 2012 edition of the National Fire Protection Association's Life Safety Code, "101:2.1 ... General. The Documents referred in this chapter, or portions of such documents, are referenced within this code, shall be considered part of the requirements of this code, and the following shall also apply: ... 2.2 NFPA Publications ... NFPA 70, National Electric Code, 2011 edition ... NFPA 99, Health Facilities Code ..."

Reference #4: National Fire Protections Associations's National Electric Code, "70:517.18(C) Pediatric Locations. Receptacles located within the rooms, bathrooms, playrooms, activity rooms, and patient care areas of designated pediatric locations shall be listed tamper-resistant or shall employ a listed tamper-resistant cover."

Reference #5: National Fire Protections Associations's Life Safety Code, "101.19.3.7.8 Doors in smoke barriers shall comply with ... (1) The door shall be self-closing or automatic-closing ..."

Reference #6: National Fire Protections Associations's Health Care Facilities Code, "99.5.1.3.1.8 Locations containing positive pressure gasses other than oxygen and medical air shall have their door(s) labeled as follows: Positive Pressure Gasses, NO Smoking or Open Flame, Room May Have Insufficient Oxygen, Open Door And Allow Room To Ventilate Before Entering."

1. On 12/12/17 at 12:00 PM, in the presence of Staff #40 and Staff #41, an alcohol based hand rub dispenser was located over a light fixture in Room #263. Refer to Reference #1.

2. On 12/12/17 at 12:15 PM, in the presence of Staff #40 and Staff #41 in Room #C205, a gap existed between the floor and piping material providing an unprotected path for smoke and fire to travel between floors. Refer to Reference #2.

3. On 12/12/17 at 12:30 PM, in the presence of Staff #40 and Staff #41, an alcohol based hand rub dispenser was mounted in the Intensive Care Unit Waiting Room. This room has carpet installed on the floor and is located in an unsprinklered smoke compartment. Refer to Reference #1.

4. On 12/12/17, during a tour of the Cares Units, power receptacles throughout Floor 3 and Floor 7 were not listed tamper-resistant or utilizing a listed covers. Refer to Reference #3 and Reference #4.

a. Staff #40 and Staff #41 confirmed this finding.

5. On 12/13/17 at 10:05 AM, in the presence of Staff #40 and Staff #41, a 30-minute labeled fire door located between the Recovery Room and the ACC Area was held open with a wooden wedge. Refer to Reference #5.

6. On 12/13/17 at 9:40 AM, in the presence of Staff #40 and Staff #41, the Medical Gas Room located outside the Emergency Department was not labeled with the following, "Positive Pressure Gases, NO Smoking or Open Flame, Room May Have Insufficient Oxygen, Open Door and Allow Room to Ventilate Before Opening." Refer to Reference #3 and Reference #6.

A. Based on observation, it was determined that supplies and equipment are not maintained to ensure an acceptable level of safety and quality.

Findings include:

1. A tour of the Emergency Department on 12/11/17 revealed:

a. Ambulance Foyer:

(i) One stretcher had a black mattress cover that was cracked, had tape and tape residue on the metal frame, and there were areas of rust on the frame.

(ii) One stretcher had a black mattress cover that was cracked and had holes in it.

(iii) One stretcher with a blue mattress cover had rust on the frame.

b. Hallways:

(i) A plastic bin attached to the side of an emergency cart had dust, grit, unwrapped tubing, paper scraps, and empty supply wrappers.

(ii) An unlocked, and unattended, blue and white supply cart contained numerous types of needles and syringes.

c. Nurses Station:

(i) A cabinet containing culture vials had a missing handle exposing particle board.

(ii) Beneath the bottom drawer in a cabinet under a counter holding 2 computer monitors were 2 BBL Culture Swab Collection and Transport packages with expiration dates of 2014-06 (June 30, 2014).

(iii) The unlocked bottom drawer of a cabinet outside of the Medication Room contained a Blunt Fill Needle.

d. Medication Room:

(i) Beneath and behind the medication refrigerator were unopened individually packaged medication tablets/capsules, unopened vials of medication, and unwrapped pills.

(ii) The medication refrigerator had heavy stains, spillage, hair, grit, and dust on the interior.

2. A tour of the Psychiatric Unit on 12/11/17 revealed:

a. Nurses Station:

(i) A metal cabinet contained stained packages of copy paper.

(ii) The drawer beneath the counter near the opening to the hallway contained commingled containers of toothpaste, shampoo, bar soap, body lotion, and "Cleanser No-Rinse Foam."

(iii) The water and ice machine had heavy tape and tape residue on the top and the front. There was a pool of water, a soaked white towel, and other refuse on the floor behind the machine.

(iv) Two small plastic bags containing one tablet of medication for two different patients was found behind the Pyxis refrigerator. One bag contained a tablet of 2.5mg Fluphenazine which was documented on the bag to be administered between 8/15 and 8/16 of an undocumented year. The other bag contained a 50mg tab of Naltrexone which was documented on the bag to be administered between 8/14 and 8/15 of an undocumented year.

b. Pantry:

(i) A plastic bin containing mustard packets had raised red, tacky, stains on the interior and exterior. The bottom interior of the bin had spilled white crystals and spilt pepper.

(ii) A plastic bin containing saltine crackers had saltine pieces and crumbs inside the bin at the bottom. The shelf beneath the bin also has crumbs on it.

3. A tour of the CARES Unit on 12/11/17 and 12/12/17 indicated:

a. Medication Room:

(i) Plastic bins used to hold medications, in a wall cabinet, had a sticky substance, grit, and metal shavings in them.

(ii) An oxygen mask hanging from an oxygen canister had a hole in the plastic bag holding it.

(iii) The freezer section of the Patient Refrigerator had orange and brown spillage in recesses of the base. The moulding at the bottom of the refrigerator section was broken.

4. A tour of the Forensic Unit on 12/12/17 revealed an unopened vial of Famotidine under the Medication Refrigerator set atop the Pyxis Machine in the hallway.

5. A tour of the Cutting Room in the Laboratory on 12/12/17 revealed a Sterile Pack with and expiration date of 2/28/17.

6. A tour of the Receiving area of the Laboratory on 12/12/17 revealed a Coulter Cell Control Tube with an expiration date of 2/28/14.





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7. A tour on 12/12/17, in the presence of Staff #69 revealed:

a. Inpatient Rehab Gym Room:

(i) A Hydrocollater Unit had reddish/brown and a white substance within the top of the tub.

(ii) A stool pad had a tear.

(iii) A ceiling tile had a brown large stain.

(iv) A garbage can had stains and sticky substance on the outside.




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8. On 12/12/17 at 10:00 AM, during a tour of the Dialysis area the following was revealed:

a. There was multiple pieces of tape on the gray tubing coming from the portable Reverse Osmosis (RO) to the wall drain on Machine #K1, #K3, #K4, and #K5.

b. There was white precipitate and dust on the base of Machine #K1 and Machine #K5.

c. There was white and tan debris in the black box containing the Myron-L meter, test strip bottles, and a bag of "RPC" test strips on the top of the Machine RO #K4 and Machine RO #K5.

d. There was a white substance on the sharps container located on the floor next to the clean sink.

e. There was a large amount of visible black and brown dirt on the floor.

f. On 12/12/17 at 10:10 AM, Staff #57 and Staff #8 confirmed the above findings.





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9. A tour of the Medical - Surgical Unit on 12/11/17, in the presence of Staff # 7, revealed:

a. 2B Patient Pantry:

(i) Brown, rust-colored particles covered the top of the refrigerator.

(ii) Cupboard shelves with brown stains and peeling laminate.

(iii) A wire bin in the cupboard, containing multiple tube feeding "Epump Spike Set," had chipped paint exposing the surface.

(iv) Two small containers of maple syrup were stored in the wire bin with the tube feeding spike sets.

(v) The microwave's interior surface had brown stains and grime throughout.

10. A tour of the Surgical Services Department on 12/11/17, in the presence of Staff #4 revealed the following:

a. Pre-Operative Area:

(i) An unlocked drawer of a cabinet had a navy-blue plastic container with multiple Blunt Fill needles and syringes.

(ii) A blue plastic tray containing supplies for drawing blood specimens was stored unsecured on top of the counter.

b. Post Anesthesia Care Unit:

(i) The wall behind the sink had an area of peeling paint, exposing dry wall surface.

11. A tour of the Radiology Department on 12/12/17, in the presence of Staff #33 and Staff #34 revealed the following:

a. Ultrasound Room #CB60:

(i) The top surface of a gray cabinet storing linens and other supplies for patient use, had chipped paint, rusted surface and black colored tape residue.

b. Nuclear Medicine Gamma Camera Room #1:

(i) A blue pillow with a torn cover, exposing brown stained foam, was in the supply storage cabinet.

(ii) A Lead Radiation Cart with peeled sticker residue, dust, scratched surface with areas of peeling paint.

(iii) Two (2) unpainted, wood slabs were stored in the corner of the room along with equipment used for calibration.

c. Nuclear Medicine Gamma Camera Room #2:

(i) A blue pillow with a torn cover, exposing foam, was stored on the equipment, ready for patient use.


B. Based on observation and staff interview, it was determined that the facility failed to ensure that all medications, needles, and syringes are kept in a locked storage area to ensure patient safety.

Findings include:

1. On 12/12/17 at 10:07 AM, the Dialysis supply closet "B329," located in the main hospital hallway, was found unlocked.

a. There were multiple empty 10cc syringes, prefilled saline syringes, fistula needles, and vacutainer needles located in the dialysis supply closet.

b. On 10:10 AM, Staff #58 stated that the Dialysis supply closet "B329" does not always lock. Staff #58 confirmed that there are needles and syringes in the unlocked dialysis supply closet "B329."

c. On 12/12/17 at 11:36 AM, Staff #59 confirmed that the dialysis supply closet was unlocked and unsecured. Staff #57 and Staff #59 confirmed that the dialysis supply closet was in an area where unauthorized persons could gain access.

2. On 12/12/17 at 2:00 PM, there were multiple empty 10cc syringes, prefilled saline syringes, fistula needles, and vacutainer needles located on a mobile cart unattended on the treatment floor.

a. Staff #59 stated that there wasn't a designated area to lock the prefilled saline syringes and needles on the treatment floor and that they were kept on the cart during the day while patients were dialyzing.

Based on observation, staff interview, review of facility documents, manufacturer's Instructions For Use (IFU), and nationally recognized guidelines, it was determined that the facility failed to ensure the provision of a sanitary environment to avoid sources and transmission of infections and communicable diseases, and failed to ensure an adequate Infection Control Program that seeks to minimize infections and communicable diseases.

Findings include:

1. The facility failed to provide and maintain a sanitary environment to avoid sources and transmission of infections and communicable diseases, and failed to implement nationally recognized infection control guidelines. Refer to Tag A749.

A. Based on document review and staff interview, it was determined that the facility failed to ensure implementation of policies and procedures addressing the use of multi-dose vials.

Findings include:

Reference: Facility policy titled "Multi-Dose and Single-Dose Medication Vials/Container" states, "4. ...Multiple dose insulin vials will not enter the immediate patient care area."

1. Three of four nurses interviewed (Staff #22, Staff #38, Staff #39) stated that he/she would prepare syringes from insulin vials at the patients' bedside.

This finding resulted in an Immediate Jeopardy which immediately curtailed this practice. The Immediate Jeopardy was removed on 12/12/17, day of survey, upon receipt of an acceptable plan of correction.

B. Based on observation, staff interview, review of facility documents and nationally recognized guidelines, it was determined that the facility failed to maintain a sanitary hospital environment to control infections.

Findings include:

1. On 12/11/17 at 10:15 AM, Staff #2 confirmed that the facility's Infection Control program is based on Association of periOperative Registered Nurses (AORN), Center for Disease Control (CDC), Occupational Safety and Health Administration (OSHA), Association for the Advancement of Medical Instrumentation (AAMI), Association for Professionals in Infection Control (APIC), and Society of Gastroenterology Nurses and Associates (SGNA) guidelines and recommendations.

2. A tour of the Decontamination Room on the lower level, revealed the following clean and dirty supplies commingled:

a. Intravenous (IV) poles with pumps attached were stored up against a cart that contained clean boxes of gloves.

(i) Staff #3 confirmed that the IV poles were used for patients and had not yet been cleaned or disinfected prior to being stored near the clean boxes of gloves.

(ii) There was no separation of contaminated and clean supplies to ensure cross contamination would not occur.

(iii) The above finding was confirmed by Staff #2, Staff # 3 and Staff #4.

Reference #1: 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. ... The items should be positioned so that packaging is not crushed, bent, compressed, or punctured and so that their sterility is not otherwise compromised."

1. On 12/11/17 at 11:05 AM, in the Sterile Processing Department (SPD) staging area on the lower level, there was a cart of sterile supplies used to restock code carts.

a. Located next to the restocking cart, was a large red biohazard container with sterile supplies on top and multiple central line kits stored on the floor.

(i) Staff #3 confirmed the supplies on top of the biohazard container and the central line kits on the floor were outdated items.

(ii) The biohazard container stored next to the sterile supply cart increases the potential for contamination of the sterile supplies.

(iii) The above outdated items, located next to the cart of sterile supplies, had no indicator that the supplies were not available for patient use.

2. In the Operating Room (OR) Prep and Pack area, a portable AM/FM radio was observed in a cabinet.

a. The radio was stored on top of peel packs used for packaging instruments to be sterilized, compromising the integrity of the packs.

3. On 12/12/17 at approximately 11:30 AM, a total of six (6) syringes (two 20 ml syringes, two 10 ml syringes, and two 3 ml syringes) were found stored out of the sterile wrap in the anesthesia cart in OR #3.

Reference #2: AORN [Association of periOperative Registered Nurses] "Perioperative Standards and Recommended Practices; RP: Environmental Cleaning" 2013 edition states, "Recommendation I ... The patient should be provided a clean, safe environment. ... Recommendation II ... A safe, clean environment should be reestablished after each surgical procedure. ..."

1. On 12/11/17 at 12:20 PM, at the completion of a procedure, cleaning and disinfecting of OR#3 was conducted and revealed the following:

a. The housekeeping cart had a metal-like mopping bucket with a metal mop wringer, containing cleaning/disinfecting solution.

(i) The wringer was attached to the inside of the bucket and hung over the cleaning solution.

(ii) Staff #18 was observed dipping a cloth in the cleaning solution and proceeded to clean the OR.

(iii) The wringer contained a visible buildup of brown colored residue that can potentially contaminate the cleaning solution.

(iii) The above finding was confirmed by Staff #4 and Staff #18.

Reference #3: Association of periOperative Registered Nurses (AORN) 2017 Edition Guidelines For Perioperative Practice, Guideline For Environmental Cleaning Recommendation II.h. states, "Mattresses and padded positioning device surfaces ...should be moisture-resistant and intact. Absorbent or nonintact surfaces may become reservoirs for microorganisms and may harbor pathogens. II.h.1. Damaged or worn coverings should be replaced."

1. On 12/11/17 in OR #3 and OR #4, there were patient mattresses on the OR tables, that contained visible adhesive tape and tears in the vinyl-like material.

a. In OR #4, the OR table head cushion contained adhesive tape and tape residue. Two (2) padded arm boards attached to the OR table, contained visible tears in the vinyl-like material.

(i) The adhesive tape and tears in the vinyl-like material make it an uncleanable surface and can contain debris.

2. The above findings were confirmed by Staff #4 and Staff #17.

Reference #4: Association of periOperative Registered Nurses (AORN) 2017 Edition Guidelines For Perioperative Practice, Guideline For Environmental Cleaning Recommendation VI.b.1. states, "Cleaning should progress from clean to dirty areas. VI.b.2 Cleaning should progress from top to bottom areas. ...If bottom areas are cleaned first, these areas could potentially be recontaminated with debris from the top areas."

1. On 12/11/17 during cleaning and disinfecting of OR #3, Staff #18 was observed first cleaning/ disinfecting the OR table then proceeded to clean/disinfect the overhead lights.

(i) Cleaning the overhead lights last allows debris from the lights to potentially recontaminate the already cleaned OR table and surrounding areas.

Reference #5: Facility policy number 3003 titled, "Environmental Cleaning of Central Service (CSP)" states, "Purpose: To maintain a standard of cleanliness. Procedure: Wire racks and carts shall be cleaned on a weekly basis with an approved germicide. Table tops, counters, sinks and cupboard doors require daily cleaning."

1. On 12/11/17 in the OR decontamination area, there was a metal-like table with a top and bottom shelf. The bottom shelf contained the following:

a. A round basin with an instrument and a small amount of an unknown solution

b. A tray with brushes and various instruments

c. A robotic endowrist instrument

d. The instruments in the basin contained an unknown visible white gelatinous substance.

e. Staff #3 confirmed that the instruments on the bottom shelf are old and are no longer used.

f. There was no indicator identifying that the instruments were not to be used.

g. Staff #2 and Staff #3 confirmed the bottom shelf of the table was unclean and cluttered with old non-usable instruments.

2. At 2:35 PM in the OR decontamination area, there was a metal-like transport cart that contained the following items on the bottom of the cart:

a. A gallon size bottle of Prolystica Enzymatic, with a small amount of solution remaining, and no cap on the bottle.

b. A yellow bin, with a brownish liquid spilled in the bottom. The bin contained multiple bottles of Prepzyme Extreme Foam (used to spray instruments).

c. A washer log book.

d. Multiple mechanical indicator strips in disarray throughout the bottom of the cart.

(i) Staff #2 and Staff #3 confirmed that the mechanical indicator strips were from the 10/2017 and 11/2017 washer cycles.

(ii) Staff #3 confirmed when the staff have time, they break down the strips and put them in peel packs to be saved for record keeping.

e. Staff #2 and Staff #3 confirmed that the items found in the cart were not properly stored and the cart was unclean.

C. Based on observation, staff interview, and review of manufacturer's Instructions For Use (IFU), it was determined that the facility failed to ensure that the manufacturer's IFU for cleaning and disinfecting are followed.

Findings include:

Reference #1: PDI Super Sani-Cloth manufacturer's IFU states, "...To Dispense Wipes: ...When not in use keep center cap of lid closed to prevent moisture loss."

1. On 12/11/17 at 12:20 PM in Operating Room (OR) #3, there were two (2) PDI Super Sani-Cloth containers observed with the lids in the open position. This observation was prior to housekeeping staff entering the room to clean.

a. When the Sani-Cloth containers lid remains open when not in use, the wipes can become dry and ineffective.

Reference #2: Welch Allyn Fiber Optic Laryngoscope Blades and Handles manufacturer IFU states, "Fiber Optic Laryngoscope Blades Care and Maintenance ...To insure maximum life and performance the following instructions should be strictly adhered to. ...Cleaning Procedure ...All Welch Allyn blades are compatible with enzymatic cleaners. Refer to manufacturer's instructions for recommended exposure times and solution strengths."

Reference #3: Steris Revital-Ox Resert High Level Disinfectant manufacturer's IFU states, " ...High Level Disinfection ...Once the instrument has been immersed and all surfaces in contact with the disinfectant solution, soak the instrument for a minimum of eight (8) minutes... . Monitor the time the instrument is in contact with the solution using a timer."

1. On 12/11/17 at 2:15 PM surveyors and Staff #2, Staff #3 and Staff #17 entered the OR decontamination room and the following was observed:

a. A red bin labeled "Revital-X Resert High Level Disinfect" containing eleven (11) Fiber Optic Laryngoscope Blades were soaking in Revital-OX disinfectant.

(i) The "Revital-OX" log sheet documentation noted that the laryngoscope blades were placed in the bin of Revital-OX disinfectant on 12/11/17 at 11:00 AM.

(ii) A column on the log sheet titled "exposure time" indicated the laryngoscope blades were exposed for 8 minutes.

(iii) There was signage posted in the decontamination workroom that stated, "Process for Revital-X Resert High Level Disinfectant ...Soak Stage: ...Cover with lid and soak for 8 minutes only!!!!"

(v) From 11:00 AM to 2:30 PM, the laryngoscope blades were soaking in the Revital-OX disinfectant.

(vi) Staff #3 confirmed the laryngoscope blades should have been removed from the disinfectant after 8 minutes and confirmed that there was no timer in the room.























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D. Based on observation, staff interview, and facility policy review, it was determined that the facility failed to ensure the separation of clean and dirty equipment and supplies.

Findings include:

Reference #1: Contractual agreement for dialysis services, effective date October 7, 2002, states. "..4. Protocols. Hospital and Contractor will mutually develop written protocols governing the procedures to be used in rendering ARRT [acute renal replacement therapies] at Hospital ..."

Reference #2: DaVita Dialysis Policy titled, "Infection Control In The Hospital Dialysis Setting" states, "... 25. Clean areas should be clearly designated for the preparation, handling, and storage of unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. ..."

Reference #3: Centers For Disease Control MMWR April 27, 2001/Vol.50/No. RR-5 states, "... Clean areas should be clearly designated for the preparation, handling, and storage of unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. ..."

1. On 12/12/17 at 10:25 AM, in the Dialysis Area, there were clean clamps, two (2) clean prime buckets, and ten (10) bicarbonate (bicarb) wands and caps drying at the dirty sink.

a. Staff #58 confirmed the above finding.

2. On 12/12/17 at 10:50 AM, in the Dialysis Area, Staff #58 was observed wearing a white gown during the cannulation of Patient #25.

a. Staff #58 exited the station and hung his/her potentially contaminated white gown on a hook on the wall. The white gown was touching the opened glove box hanging on the wall, thus potentially contaminating the clean gloves.

E. Based on observation, staff interview, and facility policy review, it was determined that the facility failed to ensure that items used on patients are cleaned and disinfected after every hemodialysis treatment.

Findings include:

Reference #1: Facility document titled, "AGREEMENT FOR INPATIENT DIALYSIS SERVICES" states, "... 4. Protocols. Hospital and Contractor will mutually develop written protocols governing the procedures to be used in rendering ARRT [acute renal replacement therapies] at Hospital ..."

Reference #2: DaVita Dialysis policy titled, "Infection Control In The Hospital Dialysis Setting", states, "... 2. Teammates will thoroughly wipe down all non-disposable items and equipment such as the blood pressure cuff, ... with 1:100 bleach solution, or hospital approved disinfectant after every treatment. ... 28. The outside surface of all equipment will be wiped with a bleach solution of hospital approved disinfectant prior to removal from treatment area. ..."

Reference #3: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention (CDC). Recommendations for preventing transmission of infections among chronic hemodialysis patients. Morbidity and Mortality Weekly Report, April 27, 2001/Vol. 50/No. RR-5, states, "... Infection Control Precautions for All Patients ... Any item taken to a patient's dialysis station could become contaminated with blood and other body fluids and serve as a vehicle of transmission to other patients either directly or by contamination of the hands of personnel. Therefore, items taken to a patient's dialysis station, including those placed on top of dialysis machines, should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being returned to a common clean area or used for other patients. Unused medications or supplies (e.g., syringes, alcohol swabs) taken to the patient's station should not be returned to a common clean area or used on other patients. ..."

1. On 12/12/17 at 10:25 AM, in the Dialysis Area, Staff #58 removed a plastic cup from Machine #K1 and used it to obtain a water sample on Machine #K4. He/she then placed the cup on the back of the Reverse Osmosis (RO) machine #K4.

a. Staff #58 stated that the plastic cup is used on the machine to obtain a water sample to test the pH and conductivity.

(i) Staff #58 stated that the same cup is used for each machine and is not cleaned between uses.

2. On 12/12/17 at 11:15 AM, in the Dialysis Area, Staff #58 brought a white protective pad into the area that Patient #25 was dialyzing. The white protective pad touched Patient #25's bed.

(i) Staff #58 then exited the area and entered Patient #26's area. Staff #58 placed the white protective pad, that touched Patient #25's bed, under Patient #26's arm and used it to place fistula needles and supplies used during the cannulation of Patient #26's fistula.

F. Based on observation, staff interview, and a review of facility policy, it was determined that the facility failed to ensure that the policy for hand hygiene and personal protective equipment is implemented.

Findings include:

Reference #1: Contractual agreement for dialysis services, effective date October 7, 2002, states. "..4. Protocols. Hospital and Contractor will mutually develop written protocols governing the procedures to be used in rendering ARRT [acute renal replacement therapies] at Hospital ..."

Reference #2: DaVita Dialysis Policy titled, "Infection Control In The Hospital Dialysis Setting", states, "... 10. Gloves should be worn when: [bullet] Potential for exposure to blood, dialysate and other potentially infectious substances ... [bullet] Touching the blood lines, dialyzer or dialysis delivery system during or after a dialysis treatment ... 11. Gloves should be changed when: [bullet] Going from a "dirty" area or task to a "clean" area or task [bullet] Moving from a contaminated body site to a clean body site of the same patient [bullet] After touching one patient or their dialysis delivery system and before arriving to care for another patient or touch another patient's delivery system ..."

Reference #3: DaVita Dialysis Policy titled, "PERSONAL PROTECTIVE EQUIPMENT", states, "... 2. Hands will be washed after removing PPE [personal protective equipment]."

Reference #4: DaVita Dialysis Policy titled, "HAND HYGIENE", states, "... 1. Hands will be washed upon entering the hospital/facility, prior to gloving, after removal of gloves, between patients, after contamination with blood or other infectious material, after patient and contaminated machine contact, between patients, before touching clean areas such as counter tops, supply carts or medication carts, ..."

1. On 12/12/17 at 11:20 AM, in the Dialysis Area, Staff #58 held a disposable glove in his/her right hand and used it to touch Patient #25's Hemodialysis Machine #K4 during dialysis.

a. Staff #58 did not fully don the glove prior to touching Hemodialysis Machine #K4 while Patient #25 was dialyzing.

2. On 12/12/17 at 11:25 AM, in the Dialysis Area, there was a white protective pad under Patient #25's left arm. This white protective pad was used during the insertion of the fistula needles, thus potentially contaminated with Patient #25's blood.

a. Staff #58 picked up the white protective pad, with his/her bare hands, and disposed of it in the trash can.

(i) Staff #58 failed to wear gloves while touching the potentially contaminated white protective pad.

3. On 12/12/17, during an observation on the hemodialysis treatment floor the following was revealed:

a. At 10:44 AM, at the nursing station, Staff #58, while wearing gloves, picked up Patient #25's chart and touched papers within the chart.

(i) Staff #58 removed his/her gloves and without performing hand hygiene, entered the clean glove box and donned a pair of gloves.

(ii) Staff #58 failed to perform hand hygiene after the removal of his/her gloves and prior to entering the clean supply of gloves.

b. At 10:48 AM, Staff #58 cared for Patient #25, while wearing gloves, then exited the area and went to the clean sink.

(i) Staff #58, while wearing the potentially contaminated gloves, touched the sink handles to turn the water on.

G. Based on observation, staff interview, and facility document review, it was determined that the facility failed to develop a policy and procedure for the preparation of a Arteriovenous Fistula (AVF) for cannulation.

Findings include:

Reference #1: Contractual agreement for dialysis services, effective date October 7, 2002, states, "... 4. Protocols. Hospital and Contractor will mutually develop written protocols governing the procedures to be used in rendering ARRT [acute renal replacement therapies] at Hospital ..."

Reference #2: DaVita Dialysis Procedure titled, "CONSTANT-SITE (BUTTONHOLE) AV FISTULA CANNULATION", states, "... "... Skin Antiseptic ... Isopropyl Alcohol 70% ... Effective Contact Time ... 60 seconds ..."

Reference #3: National Kidney Foundation. KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for 2006 Update: Hemodialysis Adequacy, Peritoneal Dialysis Adequacy and Vascular Access. AJKD 48:S1-S322, 2006, http://kidneyfoundation.cachefly.net/professionals/KDOQI/guideline_upHD_PD_VA/va_guide3.htm, states, "... Alcohol has a short bacteriostatic action and should be applied in a rubbing motion for 1 minute immediately prior to cannulation. ..."

1. On 12/12/17 at 10:49 AM, in the Dialysis Area, Staff #58 was observed initiating dialysis on Patient #25.

a. Staff #58 cleaned fistula site #1 with an alcohol prep pad for seven (7) seconds and then inserted the fistula needle.

b. Staff #58 cleaned fistula site #2 with an alcohol prep pad for eight (8) seconds and then inserted the fistula needle.

2. On 12/13/17 at 11:10 AM, this surveyor requested the procedure for Arterial Vascular Fistula (AVF) vascular care.

a. Staff #59 stated that the dialysis staff would use the Constant-Site (Buttonhole) AV Fistula Cannulation procedure (Reference #2) when using an alcohol pad to clean an AVF site prior to cannulation.

(i) When questioned if Patient #25 had a button hole access, Staff #59 stated "No."

(ii) Staff #59 stated that the staff would use the "CONSTANT-SITE (BUTTONHOLE) AV FISTULA CANNULATION" procedure to determine the cleaning time for cleaning an AVF with alcohol.

(iii) Staff #59 stated that the staff would only use the section that refers to the contact time when using an alcohol prep pad to clean a AVF site without a button hole.

H. Based on observation, staff interview, and facility policy review, it was determined that the facility failed to ensure that dedicated hand washing sinks are readily available for use and dedicated for hand washing only.

Findings include:

Reference #1: Contractual agreement for dialysis services, effective date October 7, 2002, states. "..4. Protocols. Hospital and Contractor will mutually develop written protocols governing the procedures to be used in rendering ARRT [acute renal replacement therapies] at Hospital ..."

Reference #2: DaVita Policy titled, "INFECTION CONTROL IN THE HOSPITAL DIALYSIS SETTING", states, "... 21. Sinks should be easily accessible and readily available in the treatment area and in other appropriate areas. Dedicated hand washing sinks should be for hand washing purposes and remain clean. Avoid placing, cleaning or draining used items in dedicated hand washing sinks. ..."

1. On 12/12/17 at 10:00 AM, in the Dialysis Area, there was a clean sink which had a hemodialysis machine hose connected to the water spigot.

a. Staff #58 confirmed that the hemodialysis machine hoses were attached to the water spigot of a designated clean sink.

(i) Staff #58 did not know why the hemodialysis machine was connected to the water spigot.

b. Staff #58 confirmed that the sink was designated as a clean sink and was to be used for handwashing.

c. Staff #58 stated that the sink was not able to be used for handwashing while the hemodialysis machine tubing was connected to the water spigot.

I. Based on observation, staff interview, and facility policy review, it was determined that the facility failed to ensure that there is a sink available for hand washing when dialysis is being performed.

Findings include:

Reference #1: Contractual agreement for dialysis services, effective date October 7, 2002, states. "..4. Protocols. Hospital and Contractor will mutually develop written protocols governing the procedures to be used in rendering ARRT [acute renal replacement therapies] at Hospital ..."

Reference #2: DaVita Policy titled, "INFECTION CONTROL IN THE HOSPITAL DIALYSIS SETTING", states, "... 22. If only one sink is available in the treatment area, a Y-connector must be used to connect machine [sic] to water source and for hand washing. ..."

1. On 12/12/17 at 11:45 AM, a tour of the Critical Care Unit with Staff #8, Staff #57, and Staff #59 revealed the following:

a. Staff #57 stated that room #1, #4, #6, #8, #9, #10, #12, and #13 in the Critical Care Unit were able to be used to perform bedside dialysis to patients.

b. Rooms #1, #4, #6, #8, #9, #10, #12, and #13 contained only one sink, in the patient bathroom, that was available for use.

(i) Staff #57 and Staff #59 stated that the portable reverse osmosis (RO) machine needs to be connected to the bathroom sink to provide hemodialysis to the patient.

(ii) Staff #57 confirmed that when the hemodialysis machine is connected to the patient's bathroom sink, there is no sink available to staff for handwashing.

c. On 12/13/17 at 10:30 AM, Staff #56 was questioned if Y-connectors were available for use in the Critical Care Unit rooms when dialysis is being performed to allow staff the ability to wash his/her hands. Staff #56 stated, "No."

J. Based on observation in the Dialysis Area and facility procedure review, it was determined that the facility failed to ensure that staff adhere to hand hygiene procedure and the Center for Disease Control recommendations.

Findings include:

Reference #1: Contractual agreement for dialysis services, effective date October 7, 2002, states. "..4. Protocols. Hospital and Contractor will mutually develop written protocols governing the procedures to be used in rendering ARRT [acute renal replacement therapies] at Hospital ..."

Reference #2: DaVita Dialysis procedure titled, "HAND WASHING", states, "... 2. Wet hands and apply antibacterial liquid soap. 3. Cover hands (palms, back of hands, between fingers) and wrists with lather and wash vigorously for a minimum of 15 seconds. 4. Rinse well using running water flowing from wrists to fingertips. ..."

Reference #3: The CDC Guideline for Hand Hygiene in Healthcare Settings states, "... When cleaning your hands with soap and water, wet your hands first with water, apply the amount of product recommended by the manufacturer to your hands, and rub your hands together vigorously for at least 15 seconds, covering all surfaces of the hands and fingers. Rinse your hands with water and use disposable towels to dry. Use towel to turn off the faucet. ..."

1. On 12/12/17 at 10:34 AM, after caring for a patient, Staff #58 applied soap to his/her hands and scrubbed for 8 seconds then rinsed with water. This was not in accordance with facility procedure.



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K. Based on observation and review of the CDC-HICPAC [Center of Disease Control and Prevention-Healthcare Infection Control Practices Advisory Committee] guidelines, it was determined that the facility failed to ensure its Infection Control and Prevention program adheres to CDC-HICPAC recommendations on disinfection.

Findings include:

Reference: AORN, Perioperative Standards and Recommended Practices for Inpatient and Ambulatory Settings, 2013 edition, pg. 53 states, "... Stethoscopes should be clean and not worn around the neck ... Cleaning stethoscopes in combination with health care personnel washing their hands between caring for patients decreases the possibility of transmission of pathogens to patients and environmental surfaces. ... ."

1. On 12/11/17, during a tour of the ICU (Intensive Care Unit) in the presence of Staff #69, Staff #72 was observed administering nebulizer treatments to patients.

a. Staff #72 auscultated the patient's lungs in Room #C3 prior to administration of a respiratory treatment and placed the stethoscope on the Work Station on Wheels (WOW).

b. Staff #72 failed to clean the stethoscope upon placement on the WOW and prior to auscultating the next patient's lungs in Room #C2.


L. Based on observation, document review, and staff interview, it was determined that the facility failed to ensure that manufacturer's instructions for use are implemented for cleaning the glucose meter.

Findings include:

1. On 12/12/17 at approximately 11:45 AM, at the completion of glucose testing, Staff #71 was observed cleaning the glucose meter with a PDI Sani Cloth wipe.

2. Upon review, the StatStrip glucose meter instruction for use stated, "The StatStrip Glucose Hospital Meter should be cleaned and disinfected after each patient use to minimize the risk of transmission of blood-borne pathogens between patients and healthcare professionals ...
Acceptable Cleaning and Disinfecting Materials
Nova Biomedical recommends the use of Clorox Healthcare Bleach Germicidal Wipes, EPA Registration #67619-12, or any disinfectant product with EPA Registration #67619-12 may be used."

3. Upon review, the facility policy "Point of Care Testing-Glucometer Testing" states, "Cleaning of the StatStrip meter is to be done after each patient use following approved infection control policies. Thoroughly wipe the surface of the meter ... with locally approved germicidal wipe (i.e. PDI Sani-Cloth, Clorox wipe) ..."

4. Upon review, the PDI Sani Cloth that was used had an EPA Registration number different from the suggested glucose meter recommendation.

5. The above was confirmed by Staff #2 and Staff #70.

Based on review of 2 of 2 medical records (#6 and #39) and staff interview on 12/12/17, it was determined that the facility failed to ensure that respiratory orders are provided in accordance with physician order.

Findings include:

1. In Medical Record #6, a physician order dated 12/8/17 at 12:00 stated, "Chest Percussion Therapy RQ4H [every 4 hours]."

a. Upon review, the Respiratory Therapy Assessment documentation revealed that on the following dates, chest percussion was not provided:

(i) 12/8/17 at 16:55 and 21:33

(ii) 12/9/17 at 09:45, 13:33, 17:49 and 20:18

(iii) 12/10/17 at 12:24

2. In Medical Record #39, a physician order dated 11/3/17 at 12:00 stated, "Chest Percussion Therapy Hypoxia RQ4H."

a. Upon review, the Respiratory Therapy Assessment documentation revealed that on the following dates, chest percussions were not provided:

(i) 11/3/17 at 19:44 and 23:32

(ii) 11/4/17 at 03:30 and 17:32

(iii) 11/5/17 at 08:32, 12:22 and 15:29

3. The above findings were confirmed by Staff #69.