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

CFR 482.13 Patient's Rights
CFR 482.25 Pharmaceutical Services

Based on medical record review, review of facility policy and staff interview, it was determined that the facility failed to protect and promote the rights of each patient.

Findings include:

1. The facility failed to ensure that the use of restraints was in accordance with a written modification to the patients' plans of care. (Refer to Tag 166).

2. The facility failed to ensure that the use use of restraints was not on a PRN basis. (Refer to Tag A-0169).

3. The facility failed to ensure that restraint orders for adult patients who were physically restrained for the management of violent or self-destructive behavior that jeopardized the immediate physical safety of the patient or a staff member, were limited to four hours. (Refer to Tag A-0171).

4. The facility failed to ensure that restraints were discontinued at the earliest possible time. (Refer to Tag A-0174).

Based on review of facility policy, review of medical records of patients who were physically restrained, and interview with administrative staff, it was determined that the use of restraints was not in accordance with a written modification to the patient's plan of care in five of five medical records reviewed (Medical Records #2, #4, #5, #36, and
#38).

Findings include:

Reference: Facility policy and procedure titled "Restraints" states under the DOCUMENTATION section, d: "... An Interdisciplinary Plan of Care specific to restraints will be initiated on application of restraints. The plan of care will be reviewed and updated daily. ..."

1. A review of Medical Records #2, #4, #5, #36, and #38 indicated each patient was placed in physical restraint during their hospitalization. There was no evidence in any of the medical records that a written modification to any of their plans of care was made.

2. Staff #63 confirmed the above.

Based on medical record review of adult patients who were physically restrained for the management of violent or self-destructive behavior that jeopardized the immediate physical safety of the patient, a staff member, or others, it was determined that each order for restraint was not limited to four hours, in two of five medical records reviewed (Medical Records #4 and #5).

Findings include:

1. Review of Medical Record #4 indicated the following:

a. A 'NOTES Continued' form dated 4/29/13, contained the following entries:

i. 8:50 am - ... hands flailing, combative. ... Md (medical doctor)--- @ (at) bedside, (with) order to adm. (administer) 5 mg IV (intravenous) lorazepam. ...

ii. 0925 - pt. (patient) wild, sitting up in bed...

iii. 935 (9:35 AM) - ... pt. combative - 2 mg. ativan IV given as ordered. ...

iv. 11 am - agitated - combative - Haldol 2 mg IV given as ordered

v. 1115 - pt. again combative, Haldol (without) any effect on pt. Md --- made aware - order for 4 mg Ativan IV rec'd (received) [and] given

vi. 12 pm - pt once again combative - speech incoherent, except for word 'pain.' Pulling at foley catheter and attempting to get hands out of wrist restraints. Kicking in bed. Md --- notified. 5 mg. morphine IV given as ordered. Ativan 8 mg IV given as ordered

vii. 3:30 pm - pt (increased) combative - Md --- (at) bedside. Order for 10 mg ativan bolus + (and) to increase ativan gtt (drip) to 20 mg/hour rec'd and carried out

viii. 815 (8:15 PM) Received in bed sitting up snoring in 2pt (2 point) soft wrist restraints ... restraints removed. ..."

b. A RESTRAINT ASSESSMENT FLOW SHEET, dated 4/29/13, indicated the patient was "combative" at 10:00 AM, 12:00 PM, and 2:00 PM. The REASON FOR RESTRAINT USAGE section of the form included the entry: "PHYSICALLY ABUSIVE TO SELF/OTHERS."

c. A RESTRAINTS ORDERS sheet dated 4/29/13 at 9:00 AM indicated the patient's behavior was harmful to "self" and "other," and that it [his/her behavior] "creates a disruption of treatment." The patient was ordered to be placed in a vest restraint and two point soft restraints. Four side rails were also indicated in the order. The order was time limited to 24 hours.

d. A 'NOTES Continued' form dated 4/30/13, contained the following entries:

i. 0730 - pt. rec'd in bed -wide awake - flailing arms - swinging legs over rails - kicking - swinging arms at RN (registered nurse) ..... ativan gtt infusing @ 20 mg/hour.

ii. 0745 - pt. remains extremely combative -... Md--- @ bedside - ativan gtt (increased) to 25 mg/hour. [sic] bilat (bilateral) wrist (restraints) applied - vest (restraint) applied.

iii. 5 pm - pt. combative in bed - dangling - wife states pt is 'going wild'

iv. 630 (6:30 PM) - pt. increasingly combative - attempting to dangle - yelling @ RNs (and) family - ativan gtt (increased) to 25 mg/hr ....

v. 7:30 pm - ... Pt. is very agitated (with) bil. soft wrist restraints + vest restrain [sic] ... Pt. is doesn't [sic] accept any explanations, verbally aggressive (and) violent.

e. A RESTRAINT ASSESSMENT FLOW SHEET dated 4/30/13 indicated the patient was "combative" at 8:00 AM; "combative/calm @times" at 10:00 AM; "agitated" at 5:00 PM, 6:00 PM, and 7:00 PM; and "agitated (and) verbally violent" at 8:00 PM. The REASON FOR RESTRAINT USAGE section of the form included the entry: "PHYSICALLY ABUSIVE TO SELF/OTHERS."

f. A RESTRAINTS ORDERS sheet, dated 4/30/13 at 7:45 AM, indicated the patient's behavior was harmful to "self" and "other," and that it "creates a disruption of treatment." The patient was ordered to be placed in a vest restraint and two point soft restraints. Four side rails were also indicated in the order. The order was time limited to 24 hours.

g. A 'NOTES Continued' form dated 5/1/13 contained the following entries:

i. 7:30 am - Pt. received in bed, on vest + wrist restraints appears very anxious, agitated, attempting to get OOB (out of bed), safety measures in place ativan drip @ 25 mg/hr ...

ii. 10A - ... Pt very agitated + restless yelling foul / language, disoriented to time + place. Dr. --- at bedside. ...

iii. 1 p - Pt. still very anxious and getting combative Ativan (increased) to 30 mg/hr, safety measures in place.

iv. 8:30 pm Pt is awake + trying to get OOB, restless and verbally abusive. Ativan gtt (increased) to 30 mg/hr. Dr. --- called and made aware. Ativan 15 mg IV order received.

v. 10:30 pm Pt is still very agitated + broke bed siderail, security called code gray (assaultive patient code), MD called + and order for Haldol 5 mg IV obtained.

vi. 11:30 pm Pt is on Ativan gtt @30 mg/hr, looks comfortable now, four point restraints applied by security at 10:30PM, Pt placed on 1:1 (level of observation) for safety.

vii. 0130 Pt intermittently wakes up and screams, restless agitated and verbally abusive. Ativan gtt (increased to) 40 mg/hr.

viii. 0530 Pt agitated again, screaming and cursing. Haldol 5 mg IV given. Ativan gtt @ 25 mg/hr. ..."

h. A RESTRAINT ASSESSMENT FLOW SHEET, dated 5/1/13, indicated the patient was "agitated/anx (anxious)" at 8:00 PM; "verbally abusive" at 9:00 PM; "agitated + combative" at 10:00 PM; and "combative" at 11:00 PM.

i. A RESTRAINTS ORDERS sheet, dated 5/1/13 at 8:00 AM, indicated the patient's behavior was harmful to "self" and that it "creates a disruption of treatment." The patient was ordered to be placed in a vest restraint and two point soft restraints. Four side rails were also indicated in the order. The order was time limited to 24 hours.

j. Another RESTRAINTS ORDERS sheet, dated 5/1/13 at 10:30 PM, indicated the patient's behavior was harmful to "self," "other," and "property" and that it "creates a disruption of treatment." The patient was ordered to be placed in a vest restraint and four point soft restraints. Four side rails were also indicated in the order. The order was time limited to 24 hours.

k. A 'NOTES Continued' form dated 5/2/13, contained the following entries:

i. 3A patient awake, restless, agitated. ...

ii. 4A awake, restless and still agitated. ... ativan (increased) to 40 mg/hr ...

iii. 5A patient agitated attempting to get out of bed. cursing. security called. patient calmed down - restraints applied to LE (lower extremities) as well.

iv. 6A assessment unchanged. still agitated. given Haldol 5 mg / IV at 630 am.

v. A RESTRAINT ASSESSMENT FLOW SHEET, dated 5/2/13, indicated the patient was "agitated" at 4:00 AM and 5:00 AM; "aggitated [sic]" at 7:00 AM and 10:00 AM; and "aggitated [sic] (at) times" at 8:00 AM.

vi. A RESTRAINTS ORDERS sheet, dated 5/2/13 at 7:00 AM, indicated the patient's behavior was harmful to "self," and "other," and that it "creates a disruption of treatment." The patient was ordered to be placed in a vest restraint and four point soft restraints. Four side rails were also indicated in the order. The order was time limited to 24 hours.

2. In Medical Record #5, review of RESTRAINT ORDERS sheets, dated 10/16/13, 10/17/13, 10/19/13, and 10/20/13, indicated Patient #5's behavior was harmful to "self" and "other."

a. A RESTRAINT ORDERS sheet, dated 10/18/13, indicated Patient #5's behavior was harmful to "other."

b. The REASON FOR RESTRAINT USAGE section of a RESTRAINT ASSESSMENT FLOW SHEET, dated 10/16/13, contained the entry: "PHYSICALLY ABUSIVE TO SELF/OTHERS."

c. All of the orders for physical restraint, a vest restraint, were time limited to 24 hours.

Based on review of medical records of patients who were physically restrained, it was determined that restraint was not discontinued at the earliest possible time in one of four medical records reviewed (Medical Record #4).

Findings include:

1. Review of Medical Record #4 indicated:

a. A RESTRAINT ASSESSMENT FLOW SHEET dated 5/1/13 indicated that Patient #4 was "sedated" and "lethargic" at 12:00 AM on 5/2/13 and "Sedated" between 1:00 AM and 3:00 AM on 5/2/13. During these time periods the patient was in 2 point soft wrist restraints and a vest restraint. There was no evidence that the restraints were discontinued at any time during the three hours the patient was sedated and lethargic.

b. A RESTRAINT ASSESSMENT FLOW SHEET, dated 5/2/13, indicated Patient #4 was "sedated" and "calm" between 7:00 PM and 12:00 AM. During that time, the patient was in 2 point soft wrist restraints and a vest restraint. There was no evidence that the restraints were discontinued at any time during the five hours the patient was sedated and calm.

c. A RESTRAINT ASSESSMENT FLOW SHEET, dated 5/3/13, indicated Patient #4 was "sedated" between 7:00 PM on 5/3/13 and 2:00 PM on 5/4/13. During that time, the patient was in 4 point soft wrist restraints and a vest restraint. There was no evidence that the restraints were discontinued at any time during the seven hours the patient was sedated.

Based on staff interview and document review, it was determined that the Registered Nurse did not refer two of two patients, identified with nutritional problems, to the Registered Dietitian. This is not in compliance with the facility's policy referenced below.

Findings include:

Reference #1: Policy states "Patients will be screened as part of the initial patient assessment and will be referred to the Registered Dietitian ... Registered Nurse completes the patient admission profile which includes the following information pertinent to nutrition: Anorexia, weight loss, weight gain. Based on this information, the registered nurse identifies patients with nutritional problems and refers them to the registered dietitian."

1. On 1/23/14 at 2:40 PM, review of Medical Record #43 was conducted in the presence of Staff #65 and Staff #70. The "Patient Admission Profile," dated 1/16/14, indicated in the "Nutritional Status" section, that a check was marked next to "Decreased appetite...Longer than 4 days...If yes to any of the above, refer to registered dietitian via order entry."

2. On 1/24/14 at 11:20 AM, review of Medical Record #47 was conducted in the presence of Staff #65 and Staff #71. The "Patient Admission Profile," dated 1/16/14, indicated in the "Nutritional Status" section, that a check was marked next to "Decreased appetite...Longer than 4 days...If yes to any of the above, refer to registered dietitian via order entry."

3. The "Patient Admission Profile" Nursing Referral sections were not checked for Dietitian Referrals in Medical Records #43 and #47.

4. The above findings were confirmed by Staff #65 on 1/24/14 at 12:30 PM.

Based on medical record review of patient's having had a Caesarean Section (C-Section), staff interviews, and review of pertinent facility documentation, it was determined that the facility failed to ensure that all medications administered by nursing personnel are administered in accordance with prescriber orders and all Federal and State laws and regulations, in 2 of 3 medical records reviewed (Medical Records #23 and #24).

Findings include:

Reference #1: The Nursing Practice Act for the State of New Jersey states: "The practice of nursing as a registered professional nurse (RN) is defined as diagnosing and treating human responses to actual or potential physical and emotional health problems, through such services as casefinding, health teaching, health counseling, and provision of care supportive to or restorative of life and wellbeing, and executing medical regimens as prescribed by a licensed or otherwise legally authorized physician or dentist."
Reference #2: Facility Policy: 'Pain Management' ... Pain assessment and reassessment is documented using a standard 0 -10 numeric pain distress scale, quality of indicators and location. 0 = No Pain, 1 - 3 = Mild pain, 4 - 6 = Moderate Pain, 7 = 10 is Severe Pain.
1. A review of Medical Record #23 was conducted on 1/23/14 in the presence of Staff #9 and Staff #56, and revealed the following:

a. A Physician's Order, dated 1/20/14 at 5:30 AM, for Percocet 2 tabs every 4 hours prn (as needed) for moderate pain.

b. A Physician's Order, dated 1/20/14 at 5:30 AM, for Ibuprofen 600 mg 1 tab every 6 hours prn (as needed) for moderate pain.

i. Two pain medications were ordered for the same indications (moderate pain). There were no clear instructions as to which medication is to be given first, or if they can be given together.

c. A pain assessment on 1/21/14 at 5:36 AM, indicated a pain score of 7 (severe pain).

i. There was no pain medication ordered for severe pain.

d. The Medication Administration Record (MAR), dated 1/21/14 at 5:35 AM, indicated that 2 Percocet tablets and 1 Ibuprofen were administered.

2. A review of Medical Record #24 was conducted on 1/24/14, in the presence of Staff #9 and Staff #57, and revealed the following:

a. A Physician's Order, dated 1/21/14 at 10:30 AM, for Percocet 2 tabs every 4 hours prn (as needed) for moderate pain.

b. A Physician's Order, dated 1/21/14 at 10:30 AM, for Ibuprofen 600 mg 1 tab every 6 hours prn (as needed) for moderate pain.

i. Two pain medications were ordered for the same indication (moderate pain) and there were no clear instructions as to which medication is to be given first, or if they can be given together.

c. A pain assessment on 1/22/14 at 5:21 PM indicated a pain score of 3 (mild pain). Review of the MAR dated 1/22/14 at 5:51 PM, indicated that 2 Percocet tablets were administered. Medication ordered for moderate pain was administered to Patient #24 to treat his/her mild pain.

d. A pain assessment on 1/23/14 at 5:36 AM indicated a pain score of 1 (mild pain). Review of the MAR dated 1/23/14 at 5:36 AM, indicated that 2 Percocet tablets were administered. Medication ordered for moderate pain was administered to Patient #24 to treat his/her mild pain.

e. Pain Assessment on 1/23/14 at 10:03 AM indicated a pain score of 2 (mild pain). Review of the MAR dated 1/23/14 at 10:03 AM, indicated that 2 Percocet tablets were administered. Medication ordered for moderate pain was administered to Patient #24 to treat his/her mild pain.

Based on medical record review, it was determined that not all physician orders were complete and/or accurately written in two of five medical records reviewed (Medical Records #4 and #22).

Findings include:

Reference: Facility policy and procedure number 8.5, 'Standard Medication Order' states "... Procedure ... all properly written Medication Orders must contain: ... frequency of dosing (SIQ), ... PRN orders must also contain or state the indication, when there is more than one routine indication."

1. Medical Record #4 contained the following physician orders:

a. A telephone physician order on a 'BLANK PHYSICIAN ORDER' sheet, dated 4/30/13 at 11:15 PM for "PRN Ativan 10 mg IV (intravenous) for agitation." The order did not include a frequency of administration.

b. A 'BLANK PHYSICIAN ORDER' sheet contained an order dated 5/9/13 at 11:00 AM to "Start Ativan 2 mg Po Q4H (every four hours) PRN." The order did not include an indication for use.

2. A 'BLANK PHYSICIAN ORDER' form in Medical Record #22 contained the following order: "Start Benadryl 50 mg PO Q 6H PRN." The order did not include an indication for use.

Based on observation, policy review, and staff interview on 1/21/14 and 1/23/14, it was determined that the facility failed to ensure that pharmaceutical services are provided in a safe manner.

Findings include:

1. The facility failed to develop and implement policies and procedures addressing the use of multiple dose medication vials in immediate patient treatment areas. (Refer to Tag A-0491)

The findings of opened multiple dose vials used in immediate patient treatment areas was cause for an Immediate Jeopardy to be identified on 1/23/14. The Immediate Jeopardy was abated on the afternoon of 1/23/14 after receiving an acceptable plan of correction.

2. The facility failed to implement policies and procedures addressing the control and accountability of controlled dangerous substances (CDS). (Refer to Tag A-0494)

3. The facility failed to implement policies and procedures to ensure that controlled dangerous substances (CDS) were kept locked and secure. (Refer to Tag A-0503)

Based on observation and staff interview, it was determined that the facility failed to develop and implement policies and procedures addressing the use and storage of multiple dose medication vials in immediate patient treatment areas.

Findings include:

Reference: Centers for Disease Control and Prevention (CDC) FAQ [frequently asked questions] regarding Safe Practices for Medical Injections states, "...Questions about Multi-dose vials...2. Can multi-dose vials be used for more than one patient? How?...Multi-dose vials should be dedicated to a single patient whenever possible. If multi-dose vials must be used for more than one patient, they should not be kept or accessed in the immediate patient treatment area. This is to prevent inadvertent contamination of the vial through direct or indirect contact with potentially contaminated surfaces or equipment that could then lead to infections in subsequent patients. If a multi-dose vial enters the immediate patient treatment area, it should be dedicated to that patient only and discarded after use ... 3. What are examples of the "immediate patient treatment area?" ... Examples of the immediate patient treatment area include patient rooms or bays, and operating rooms."

1. On 1/21/14 at 11:45 AM, one opened Atropine injection 20 ml multiple dose vial was found in a medication tray in the Pharmacy.

a. Upon interview, Staff #45 stated that the medication tray was an exchange tray used in an OR (operating room) anesthesia cart. These medication trays are exchanged out of the anesthesia carts in the ORs and brought to the pharmacy to be refilled.

b. Staff #45 stated that the practice of the facility is to discard a multiple dose vial after use on a single patient with the exception of medications in short supply such as Atropine. Medications in multiple dose vials affected by drug shortages were permitted by the Pharmacy to be stored and used for multiple patients.

c. Upon request, the facility was unable to provide an approved facility policy addressing the use of multiple dose vials in immediate patient treatment areas.

2. On 1/23/14 at 12 PM, one opened Heparin injection 30 ml multiple dose vial dated "1/13/14" was found in a cart located in the OR corridor labeled "Dr. [Staff #49]'s Cart."

a. Upon interview, Staff #47 stated this cart traveled into the operating rooms depending on which room Staff #49 performed cases in.

3. These findings were confirmed by Staff #2, #46, #47, and #48.

Based on observation, staff interview, and policy review, it was determined that the facility failed to implement policies and procedures addressing the control and accountability of controlled dangerous substances (CDS).

Findings include:

Reference: Facility policy titled "Non-Automated Dispensing Machine Controlled Substances Administration Record" states, "... Purpose: ... To maintain accountability of controlled dangerous substances (CDS) medications dispensed from Pharmacy to a Patient Care Unit which must be stored outside of the an [sic] automated dispensing machines (i.e. AcuDose)...Medication will be kept in a designated, locked cabinet in the Nursing Unit Medication Room or in another double locked location ... Every shift, nurses must record inventory on the CSAR [Controlled Substance Administration Record sheet] and Non-ADM [Automated Dispensing Machine] Med. Count sticker ... Counts must [sic] done at end of every shift with two RNs."

1. On 1/23/14 at 11 AM, a wall mounted controlled drug cabinet containing Midazolam 2 mg (milligram)/2 ml (milliliter) vials, Morphine 10 mg/1 ml vials, and Demerol 25 mg/1 ml carpujects was found in the Bronchoscopy Room of the OR (operating room) Suite.

a. Upon interview, Staff #48 stated that facility practice is to inventory the controlled drugs stored in the cabinet only on surgery days in the Bronchoscopy Room when the cabinet is accessed. Staff #48 confirmed that the last inventory was performed on 1/13/14. This is not in compliance with the facility's policy referenced above which states that inventory counts must be done at the end of every shift.

b. Review of the Bronchoscopy Room Controlled Drug Administration Record dated "1/13/14" revealed that it lacked the signatures of two RNs (registered nurses) performing the counts along with evidence that counts were completed at the end of every shift in accordance with facility policy. (Reference)

c. These findings were confirmed with Staff #2, #46, #47, and #48.

Based on observation, staff interview and policy review, it was determined that the facility failed to ensure that controlled dangerous substances (CDS) were kept locked and secure.

Findings include:

Reference: Facility policy titled "Non-Automated Dispensing Machine Controlled Substances Administration Record" states, "...Purpose:...To maintain accountability of controlled dangerous substances (CDS) medications dispensed from Pharmacy to a Patient Care Unit which must be stored outside of the an [sic] automated dispensing machines (i.e. AcuDose)...Medication will be kept in a designated, locked cabinet in the Nursing Unit Medication Room or in another double locked location."

1. On 1/23/14 at 11:15 AM, CDS Box #18A containing Midazolam 2 mg (milligram)/2 ml (milliliter) vials and Fentanyl 50 mcg (microgram)/ml ampules were found in OR (operating room) #5 on top of the anesthesia cart not locked and unsecure. Facility staff were in the process of cleaning the room in preparation for the next case and the anesthesiologist who was responsible for the controlled drugs stored in Box #18A was not present in the room.

a. These findings were confirmed with Staff #2, #46, #47, and #48.

Based on review of 1 of 1 medical record with a documented adverse drug reaction, document review, and staff interview conducted on 1/23/14, it was determined that the facility failed to ensure implementation of policies and procedures addressing the reporting of adverse drug reactions.

Findings include:

Reference: Facility policy titled "Adverse Drug Reactions & Medication Incidents" states, "DEFINITIONS - Adverse Drug Reaction - An undesirable and usually unanticipated response independent of the intended therapeutic or diagnostic purpose of the drug, which includes, but is not limited to the following:...skin rash/hives or itching (allergic reaction) ... " and "PROCEDURE for ADVERSE DRUG REACTION 7 MEDICATION RELATED SAFETY REPORTS - 1. Adverse Drug Reactions and Medication related Safety Reports are reported immediately to the Nurse Manager or Charge Nurse and the prescribing physician when necessary. 2. By the end of the shift, an entry into the patient's medical record and either an Adverse Reaction Form or on-line Patient Safety Report must be completed ..."

1. Review of Medical Record #33 revealed that on 1/21/14 the following was recorded on the anesthesia record: "Skin rash after sux [succinylcholine] and Ancef, hydrocortisone given ...". The Post Anesthesia Care (PACU) nurse's note at 10:30, states, "Dr. XXX notified of possible reaction to Ancef per anesthesia."

a. The anesthesia note indicated that both succinylcholine and Ancef were administered prior to the patient developing a skin rash. The attending physician was only notified of a possible adverse drug reaction to Ancef.

b. Upon interview, Staff #45 stated that neither an Adverse Reaction Form or on-line Patient Safety Report was completed by the end of the shift on 1/21/14.

Based on observation, policy review and staff interview, it was determined that the facility failed to clean and maintain walls, floors and equipment to ensure a clean, safe and sanitary environment for patient care services in surgical suites and sterile processing rooms.

Findings include:

1. The floor in the OR soiled work room was soiled, encrusted and discolored along the floor/wall juncture and under the processing sink. Wall areas around the regulated medical waste (RMW) trash chute were broken, with exposed sheet rock, and are not cleanable.

Reference: Environmental cleaning Facility Policy "Surgical/Invasive Areas and Delivery rooms-Between cases" states Procedure - Mandatory Attire: "Gloves are to be worn only when working with chemicals, soiled items or handling trash."

2. On 01/24/14 at 12:30 PM, the housekeeper was observed mopping the floor in OR #3, after a case. Staff #72 did not wear gloves during mopping and was observed moving two portable regulated medical waste containers and a ring stand with his/her bare hands. His/her hands contacted top surfaces of RMW containers, before moving to the ring stand.

D. Based on a tour of one patient care unit and interview with administrative staff, it was determined that the facility failed to ensure that sterile supplies are maintained at an acceptable level of safety and quality.

Findings include:

1. A tour of the psychiatric unit on the morning of January 23, 2014, accompanied by administrative staff indicated:

a. Medication Room: A metal wall cabinet above the sink, with a sign on it reading: "RESPIRATORY ONE TOUCH" contained nine 'PORTEX PULSATOR Arterial Blood Sampling Kit with liquid sodium heparin' packages. The expiration dates on the packages indicated that two expired on July 31, 2011; four expired on January 31, 2011; two expired on September 30, 2011; and one expired on June 30, 2012.

b. Nurses' Station Unit Clerk Area: A drawer under the counter contained a plastic biohazard bag containing one yellow and red capped Vacutainer with an expiration date of October 31, 2013 and one gray capped Vacutainer with an expiration date of September 30, 2013.

c. The Clean Utility Room: A wall cabinet contained four 'PORTEX PULSATOR Arterial Blood Sampling Kits with liquid sodium heparin' packages with an expiration date of July 31, 2012 and one 'Non Conductive Connecting Tubing' package with an expiration date of October 31, 2013.

2. Staff #38 confirmed the above findings.

E. Based on a tour of the psychiatric unit on the morning of 1/23/14, in the presence of Staff #38, it was determined that all equipment and environmental surfaces were not kept clean to sight and touch.

Findings include:

1. The following was observed on the psychiatric unit in the presence of Staff #38:

a. The Nurse's Station:

i. A counter at the Nurse's Station had heavy accumulation of dust behind the mail rack and book rack, paper scraps, small brown coffee-like granules and dust atop the rack, and grit behind the binders, addressograph machine, and other equipment.

ii. A drawer under the counter contained a broken tubular lamp bulb at the bottom of the drawer.

b. The Clean Utility Room:

i. A bottom cabinet next to the window had a thick green, raised, sticky substance on the top shelf. The bottom shelf was rusty and had dust accumulation.

ii. The water machine contained a dust accumulation.

c. Kitchen:

i. The refrigerator had heavy stains throughout the interior. The bottom crisper drawer contained hair, raised red stains, crumbs, and food particles. There was dried spillage on the shelves. There were stains and grit on the refrigerator door gasket. The freezer section of the refrigerator had brown and red, raised, sticky stains on the interior surface. There were pieces of hair on the interior of the door and raised, sticky yellow and cream colored stains on the freezer door gasket.

d. Medication Room:

i. The food refrigerator contained stains and grit, white and orange raised stains on the interior of the door, and the door gasket was torn.

ii. The counter under and behind, the Pyxis machine had a heavy accumulation of dust and three individual medication wrappers.

iii. The faucets and spout of the stainless steel sink had a heavy accumulation of scale.


18165

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

Findings include:

Reference #1: AAMI RD52:2004 section 8 on 'Environment' states. "Water systems should include schematic diagram that identify components, valves, sample ports, and flow direction. Additionally, piping should be labeled to indicate the contents of the pipe and direction of flow."

On 1/24/14, based on discussion with Staff #73 and Staff #74, it was determined that the schematic diagram is not available for the water, acid and bicarbonate loops within the hospital's inpatient dialysis.

Reference #2: Facility's 'Acute Dialysis Services Agreement' states, "1.04: PROVIDER and HOSPITAL shall jointly and mutually develop a written protocol governing specific responsibilities and procedures to be used by Provider Staff in rendering Services to Patients."

On 1/23/14, based on interview with Staff #6, it was determined that the facility has an acute dialysis contract service agreement with Fresenius Medical Care (FMC). On 1/24/14, specific policies outlining responsibilities of FMC acute care staff in water treatment and equipment monitoring were not available when requested from Staff #73 and Staff #74.


26599

C. Based on observation, it was determined that the facility failed to ensure that all equipment and environmental surfaces were kept clean to sight.

Findings include:

1. On 1/24/14 at 12:10 PM, in the presence of Staff #9 and Staff #60, brown residue was observed on the water spigot of the water/ice machine in the Pediatric food pantry.







20148

B. Based on staff interview, document review, and review of facility policy and procedure, it was determined that the facility failed to ensure that defibrillators and code carts in the Emergency Department (ED) are checked in accordance with facility policy.

Findings include:

Reference: Facility policy titled "Code Cart" states under Procedure, "2. ... Nursing is responsible for daily defibrillator and pacer testing, if unit has pacing capabilities... 3. Code cart check to be done every shift and document on checklist..."

On 1/21/14 at 11:30 AM, the ED was toured in the presence of Staff #7 and Staff #8. The "Code Cart Daily Checklist" for the Pediatric Code Cart in the Resuscitation Room and the Adult Code Cart in the Resuscitation Room and POD #3 were reviewed for the months of December 2013 and January 2014.

1. The defibrillator on the Pediatric Code Cart was not checked on the following dates:

a. December 14, 15, 18, 19, 22, 23, 24, 28, and 29, 2013; and January 4, 5, 6, and 13, 2014.

2. The Pediatric Code Cart was not checked on the following dates/shifts:

a. Day shift on December 18, 19, 20, 22, 23, 24, 26, 28, and 29, 2013; January 4, 5, and 6, 13, 2014.

b. Evening shift on December 19, 22, 23, 28, 30, and 31, 2013; January 5, 8, 12, 13, 15, 16, 17, 19, and 20, 2014.

c. Night shift on December 22, 23, 31, 2013; January 5, 12, 13, 15, 16, 17, 18, and 19, 2014.

3. The defibrillator on the Adult Code Cart in the Resuscitation Room was not checked on the following dates:

a. December 19, 20, 22, 24, and 26, 2013; and January 4, 5, 12, and 17, 2014.

4. The Adult Code Cart in the Resuscitation Room was not checked on the following dates/shifts:

a. Day shift on December 19, 20, 22, 24, and 26, 2013; and January 4, 5, 12, 16, and 17, 2014.

b. Evening shift on December 19, 22, 28, 30, and 31, 2013; and January 15, 16, 17, and 19, 2014.

c. Night shift on December 19, 21, 22, and 31, 2013; and January 15, 16, and 19, 2014.

5. The defibrillator on the Adult Code Cart in POD #3 was not checked on the following dates:

a. December 27, 2013; and January 18, 2014.

6. The Adult Code Cart in POD #3 was not checked on the following dates/shifts:

a. Day shift on December 26 and 27, 2013; and January 18, 2014.

b. Evening shift on December 17, 19, 22, 23, 25, 27, 29, and 31, 2013; and January 17 and 20, 2014.

c. Night shift on December 18, 21, 22, 23, 25, 27, 29, 30, and 31, 2013; and January 20, 2014.

A. Based on observation, staff interview, and review of facility documents, it was determined that the facility failed to ensure that facility policy, manufacturer's instructions and industry standards are followed for the immediate-use sterilization of instruments used for surgical procedures in the Operating Room.

Findings include:

Reference # 1: Facility policy titled 'Sterilization in the Preoperative Practice Setting', states:
Procedure #3. IUSS (Immediate Use Steam Sterilization) parameters are followed in accordance with AAMI standards and the instrument manufacturer's instructions for use. Procedure #8. Key Points: A closed sterilization container is used whenever possible (Flashpak)."

Reference # 2: Symmetry Surgical manufacturer of FlashPak Sterilization Container System Instructions For Use states "Intended Use: It is intended to enable flash sterilization of the enclosed devices and prevent recontamination during immediate transport to the point of use."

Reference #3: AORN p. 520 Sterilization Section VII e. States "Rigid sterilization containers designed and intended for IUSS cycles should be used."

1. The use of a FlashPak (a reusable rigid container system to be used during flash sterilization) in accordance to facility policy could not be determined. Documentation provided did not record when a FlashPak (a reusable rigid container system to be used during flash sterilization) or open pan method was used during IUSS.

2. Immediate Use Steam Sterilization logs reviewed for January 2014 do not identify when an "open pan" or (FlashPak) rigid container is used during IUSS.

3. On 1/21/14 at 12:10 PM, Staff #15 and Staff #16 stated that the Flash Pak (a reusable rigid container system to be used during flash sterilization) is used when instrument(s) requiring IUSS need to be transported outside of the substerile area across the hall into another OR room. An open container is routinely used with immediate use steam sterilization (IUSS), and is aseptically handled and transferred within the OR areas, when the sterilizer is in a connecting substerile room to the OR.

a. Three substerile areas with sterilizers have two connecting ORs. One OR room does not connect to a substerile area.

4. On 01/21/14 the sterilizer D in the sub sterile room between OR 5 & 6 was requested to be opened and contained a wire basket with 3 instruments. Instruments were identified in the IUSS log (Immediate Use Steam Sterilization) as "trocar inst". Later, Staff #15 identified the instruments as trocars or cannulas for the DaVinci robotic unit.

5. On 1/24/14 at 10:30 AM, Staff #15 stated AORN guidelines are used, and provided AORN p. 520 Sterilization Section VII e., that states "Rigid sterilization containers designed and intended for IUSS cycles should be used."

B. Based on observation, it was determined that the facility failed to ensure that
sterilized materials are monitored and stored in the OR in accordance with industry standards, "The Association for the Advancement of Medical Instrumentation, AAMI ST 79:2010, Comprehensive guide to steam sterilization and sterility assurance in health care facilities". Note: ST 79 replaces and supercedes ST46 by consolidating ST 46 with 4 other AAMI standards [ST33, ST37, ST42, and ST35] approved 7/10/2009.

Reference #1: AAMI ST79:2010 section 4.2.2 Sterile processing personnel 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. Qualifications include b) Demonstrated knowledge of and documented competence in the operation of the specific steam sterilizing system used by the health care facility."

1. Immediate Use competency was not documented for those OR individuals who perform IUSS.

a. On 1/24/14, at 12:15 PM, Staff #17 stated that the OR personnel are not trained or evaluated by Central Services for Immediate Use Steam sterilization.

b. On 1/24/14, upon request, Staff #15 could not provide competency for OR staff using IUSS.

Reference #2: AAMI ST79:2010 section 7.5.9 states in Rigid Sterilization container systems, "Rigid sterilization container systems should be cleaned carefully before sterilization even if they are to be returned immediately to use."

1. Aesculap rigid container system used for sterile instrument sets were observed in the OR instrument storeroom. Approximately 20+ containers appeared unclean on the exterior, stained with ink from count sheets, and contained several layers of identification stick-on labels.

2. On 1/21/14 at 11:45 AM, Staff #15 stated that purchase of new rigid instrument cases have been looked at as a part of the capital budget process.

Reference # 3: AAMI ST 79-8.4.3 Inspection states, Instruments should be carefully inspected for cleanliness and flaws or damage and dried before packaging.

1. Color indicator tape used on instruments appeared loose and brittle, and were easily removed. A Lami Bone tray (load No. Nov 16 13 2 5) contained osteotome with brown friable tape, which chipped off on contact.

2. Dr. ---'s tray (load no. Sep 10 13 7 9) contained color indicator tape on instruments, which appeared friable.

3. Ortho Minor set (load no Jan 20 14 1 6) contained 12 hinged instruments with stain/residues that were easily removed with an alcohol pad.

Reference # 4: AAMI ST 79- 10.7.4.1 Composition of the PCD (Biological Indicator (BI) challenge test tray) states "A representative of the same type of tray to be routinely processed through the flash sterilizer should be selected to serve as the PCD (BI challenge test tray). Each type of tray configuration in routine use for flash sterilization should be tested separately. One or more BIs and one or more CIs should be placed in the empty tray configuration to be tested: a perforated, mesh-bottomed, open surgical tray; a rigid sterilization container system; a protective organizing case; or a single-wrapped surgical tray. Rationale: Each type of tray configuration used should be tested because it poses a barrier to air removal and sterilant penetration during the sterilization process. It is possible for the cycle to pass the open-tray test indicating that the cycle parameters are adequate for microbial kill, yet fail when other configurations are used in the same sterilizer on the same day."

Reference # 5: Facility Policy "Central Sterile Supply Policy, Biological Testing of Sterilizers" states "biological testing shall be performed as follows; In the Operating Room; a) PreVac - weekly, using a biological test pack. To be performed the same day of the week using a representative load of items usually sterilized. B) Gravity Displacement - weekly, using a rapid readout indicator. To be performed the same day of the week using a representative load of items usually sterilized."

1. On 1/24/14 at 10:45 AM, Staff # 63 stated that he/she conducts the BI test in an open test tray for routine testing of the IUSS cycles in the OR. Each type of tray configuration, in routine use for flash sterilization (including the FlashPak), was not tested separately.

2. No record of routine BI monitoring of the FlashPak container system was provided. Review of Attest Rapid Readout Biological Indicator records from the OR, dated January 5, 12, and 19, report routine Prevac (270°F for 5 mins) Biological indicator (BI) tests for sterilizers C,D & F; and routine BI tests for Gravity Flash cycle (270°F for 5 mins) on Sterilizer E.

3. On 1/24/14 at 10:45 AM, Staff #63 stated as a part of routine BI testing procedure, a BI is not run inside of the Flash Pak sterilization container system. Staff #63 stated a BI in the Flash pak is being done by OR staff.

4. At 12:15 PM, Staff #17 stated that the Flash Pak has not been validated and is not routinely checked with a BI.

Reference #6: AAMI ST 79-Immediate-Use Steam Sterilization Position Statement states that Sterilization cycles with little or no dry time are efficacious when used in compliance with validated written instructions provided by the device manufacturers, sterilization equipment manufacturers, and (if applicable) container manufacturers and when done in accordance with professional guidelines.

1. The facility did not follow manufacturer's guidelines when using immediate use sterilization (IUSS) in the OR.

a. On 1/24/14, Staff #15 provided Instructions for use for the cannula (trocar) instrument observed in a wire basket inside of sterilizer D, in the substerile room between/shared by ORs 5 & 6, on 1/21/14. Intuitive Surgical Manufacturer's Instructions for Cleaning and Sterilization state, "Autoclave: Cycle: Pre-vacuum, Temperature: 270-272° F, Minimum Exposure: 4 minutes, Dry Time: 20 Minutes. Warning: The use of flash sterilization is not recommended."

b. The OR Immediate Use Steam Sterilization log dated 1/21/14 for Room #5, recorded that the trocar instrument was run on a "Flash" cycle for 10 minutes and a 5 minute dry time.


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C. Based on observation and document review, it was determined that the facility failed to follow AMMI ST. 79 Guidelines for the early release of implants.

Findings Include:

Reference: #1: AMMI ST.79: 2010, section (10.6.3) "Release criteria for implants" states, Emergency situations should be defined in written guidance developed in consultation with infection prevention and control, the surgeon and risk management. Steps should be taken to reduce the frequency of emergency release of implantable items. For example, ongoing periodic reviews of the exception forms and implant logs could reveal consistence patterns of events that are causing emergency release and that could be corrected.

Reference: #2: The facility policy titled "Implantable Medical Devices-Biological Testing" states, the implantable device will be held until the incubation period is complete as per biological test manufacturer's recommendations. The implant can be released in an emergency if the class 5 integrator shows an accept result.

1. On 1/21/14 at 11:30 AM, a review of BI Implantable early release records from 2012 to 2013, revealed the following five instances where devices were released prior to a negative BI for non-emergency criteria:

a. On 2/9/12, Vue Point Case Trays were delivered late by the vendor for back to back procedures.

b. On 3/30/12, the doctor insisted on starting the case by a certain time period.

c. On 4/21/12, the case had been moved up on the schedule to an earlier time.

d. On 5/29/13 and 6/4/13, the OR did not have another Neuro Fixation Modular Tray or A&OS Screw Tray.

D. Based on observation and document review, it was determined that the facility failed to follow AMMI ST. 79 Guidelines for Processing Policies and procedures.

Findings include:

Reference: #1: AMMI ST. 79 Section (7.2) titled "Policies and procedures" which states, Policies and procedures should be developed for all methods of decontamination of reusable items. Process audits to monitor compliance with the various policies and procedures should be performed on a scheduled basis, with appropriate follow-up addressing problems.

1. On 1/24/14 at 11:45 AM, a review of facility documents revealed there is no written policy for cleaning and testing of the Ultrasonic cleaner.

E. Based on observation and document review, it was determined that the facility failed to ensure there was a written policy for monitoring of temperature and humidity requirements in Central Sterile Supply.

Findings include:

Reference: #1: AMMI ST. 79 Section (8.3.1) "General Considerations" states, Adherence to established policies and procedures is important in ensuring proper sterilization and drying. Temperature and humidity equilibration of packaging material and product is needed to permit adequate steam penetration and to avoid superheating. Temperature affects relative humidity, so a preconditioning temperature range is also recommended. Humidity and Temperature ranges were chosen for consistency with conditions for general environmental control work areas.

Findings Include:

1. On 1/24/14 at 12:00 PM, a review of facility documents revealed there is no written policy regarding the monitoring of temperature and humidity.

F. Based on observation and document review, it was determined that the facility failed to follow AMMI ST.79 Guidelines concerning "User Responsibilities" for loaner instrument documentation.

Findings Include:

Reference: #1: (AAMI) guideline, "Comprehensive guide to steam sterilization and sterility assurance in Health Care Facilities", AAMI ST79:2009. (ST79 replaces and supersedes ST42-R with four other AAMI standards [ST33, ST37, ST35 and ST46] approved July 10, 2009.) Section Annex (G.4.1) Users are responsible for verifying that appropriate written instructions/inventory sheets are supplied. The user is also responsible for processing the device according to manufacturer's recommendation and that all documentation requested by the manufacturer is completed.

1. On 1/24/14 at 12:15 PM, loaner request forms reviewed for January 2014, indicated that no inventory sheets accompanied the loaner trays to ensure accuracy of loaner instrumentation.

G. Based on observation, it was determined that the facility failed to follow ST. 79 Guidelines for "Immediate Use-Steam Sterilization."

Findings Include:

Reference: #1: AMMI ST.79 "Guidelines for Immediate Use-Steam Sterilization" states, Instrument inventories should be sufficient to meet anticipated surgical volume and permit the time to complete all critical elements of reprocessing.

1. On 1/24/14 at 12:30 PM, a review of log records for January 2014 indicated that a thyroid tray and an I&D neck abscess tray were flashed on a routine basis. This was due to the vendor trays arriving late for the procedure.

Based on medical record review of patients requiring post hospital care, and staff interview, it was determined that the facility failed to ensure that all patients are provided with a list of post acute care providers to choose from, in two of four medical records reviewed (Medical Records #13 and #14).

Findings include:

1. Review of Medical Record #14 indicated a case management assessment dated 1/14/14 at 16:05. The anticipated discharge planning needs for the patient were for the patient to return home. The patient had home health aide services privately provided prior to his/her admission. The social worker note dated 1/21/14 at 09:15 indicated the patient was being discharged home and that a referral was sent to --(name of facility)-- visiting nurse agency. A Post Acute Service Referral Form indicated that the type of referral was of "Resumption of Care."

a. There was no evidence in the medical record that a list of choices of home health agencies was provided to the patient.

b. There was no evidence in the medical record to indicate the patient was in agreement to receive care from the agency the facility was referring the patient back to for post acute services.

2. Review of Medical Record #13 indicated a social work assessment dated 1/20/14 at 15:44 by the social worker. The anticipated discharge planning needs were for post acute services. The assessment indicated that a list and explanation of available resources was provided to the patient/family member/significant other.

a. A social worker note dated 1/20/14 at 15:50 indicated that a referral was made to --(name of facility)-- visiting nurse agency.

b. On 1/24/14 an interview with Patient #13 and his/her spouse revealed that Patient #13 had not received a list of home health agencies for post hospital care.

c. Interview with Staff #21 confirmed that a list had not been provided to the patient.