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A. Based on staff interview, document review and review of 4 of 4 Medical Records
(#18, #19, #20, #21), it was determined that the facility failed to ensure that the contracted services adhered to facility "Hypotension During Treatment" policy.

Findings include:

Reference: The facility contractual agreement with the acute dialysis services dated 3/6/07 stipulates, "...3. Provision of Services, ...3.5 Orders., ...The Staff will be responsible for provision of the ordered Services, ...10.14 ...While performing or providing Covered Services at Hospital, " contracted company "warrants that their representatives shall comply with all rules, regulations, and standards set forth by the Hospital, including, but not limited to: all safety related policies, procedures, ..."

1. Medical Record #19 evidenced that there was a prescriber's hemodialysis order dated 1/10/12 that stipulated, "Treat SBP [Systolic Blood Pressure] under 90 mmHg with (Select One): Mannitol 25% 6.25 gm IV push every 45 minutes for a total of 3 doses prn, Albumin 25% 100 ml IV Infusion rapidly every 45 minutes for a total of 3 doses prn," and "NSS 200 ml IV Bolus(es) PRN up to _______ml." No volume was written on the prescriber's order. Patient #19's prescriber's orders to treat SBP under 90 mmHg, included 3 options for the treatment of SBP under 90 mmHg when the requirement on the prescriber's order form stipulates that the prescriber choose "only one option." Therefore, the prescriber's order is unclear and the facility policy, "Hypotension During Treatment" that stipulates, "...3. Administer a saline bolus, hypertonic saline or volume expanders per physician order. ..."does not specify the sequence of administering saline bolus, hypertonic saline or volume expanders.

2. Patient #20 failed to receive hemodialysis services in accordance with facility policy, "Hypotension During Treatment" on 2/13/12.

a. Medical Record #20 evidenced that there was a prescriber's hemodialysis order dated 2/12/12 that stipulated, "Treat SBP under 90 mmHg with (Select One): Mannitol 25% 6.25 gm IV push every 45 minutes for a total of 3 doses prn, Albumin 25% 100 ml IV Infusion rapidly every 45 minutes for a total of 3 doses prn," and "NSS 200 ml IV Bolus(es) PRN up to _______ml." No volume was written on the prescriber's order. Patient #20's prescriber's orders to treat SBP under 90 mmHg, included 3 options for the treatment of SBP under 90 mmHg, however, the requirement that the prescriber choose "only one option" to treat SBP under 90 mmHg was not followed. Therefore, the prescriber's order is unclear. Also, facility policy, "Hypotension During Treatment" that stipulates, "...3. Administer a saline bolus, hypertonic saline or volume expanders per physician order. ..."does not specify the sequence of administering saline bolus, hypertonic saline or volume expanders.

b. On the hemodialysis flowsheet dated 2/13/12, Patient #20's systolic blood pressure was under 90 mmHg during his/her hemodialysis treatment (i.e. The systolic blood pressure was 89 at 11:00, 69 at 11:15, 88 at 11:29, 75 at 11:45, 84 at 12:00, 87 at 13:15). It was stated at 11:00 that the systolic blood pressure was 89 and that "B/p low awake, no c/o." At this time, there were no interventions for systolic blood pressure under 90 mmHg in accordance with prescriber's orders that stipulated, "Treat SBP under 90 mmHg with (Select One): ..." There was no explanation as to why contracted staff did not implement prescriber's orders to treat systolic blood pressure below 90 mmHg.

c. It was stated on the flowsheet that Patient #20 received "Albumin 25%, 100cc IV" at 11:15 when the systolic blood pressure was 89. When the systolic blood pressure was re-checked after the albumin was administered it was "71." The hemodialysis flowsheet had a written entry that stated the ICU nurse was notified to call the physician to evaluate if he/she could start by "IV pressors." Additional documentation on the flowsheet stated that Patient #20 received a "NEO BOLUS" at "11:29." Patient #20 received a second and third dose of Albumin 25%, 100cc IV at 12:15 when the systolic blood pressure was 90 and 13:00 when the systolic blood pressure was 91/42. Patient #20 received 25% Albumin 100 cc IV at 12:15 and 13:00 when the systolic blood pressure was at or above 90 which is not in accordance with prescriber's orders and facility policy, "Hypotension During Treatment" that stipulates, "...3. Administer a saline bolus, hypertonic saline or volume expanders per physician order. ...."

d. Patient #20 experienced systolic blood pressure below 90 mmHg (i.e. systolic blood pressure was 89 at 11:00, 69 at 11:15, 88 at 11:29, 75 at 11:45, 84 at 12:00, 87 at 13:15). There was no explanation as to why the patient was not placed in trendelenburg position or why NSS was not administered or why Mannitol was not administered in accordance with prescriber's orders and facility policy, "Hypotension During Treatment" that stipulates, "...2. Place patient in tendelenburg position with the lower extremities elevated and head lowered, if allowed. 3. Administer a saline bolus, hypertonic saline or volume expanders per physician order. ...."

e. During an interview on 3/14/12 at 2:05 PM, Staff #40 stated that Patient #20's prescriber's orders dated 2/12/12 were for his/her treatment provided on 2/13/12. Staff #40 confirmed that facility policy "Hypotension During Treatment" was not implemented for Patient #20 on 2/13/12. Staff #40 stated that NSS would be given first, Mannitol would be given second, and Albumin would be given third.

2. Upon review with Staff #40 on 3/14/12 from 2:00 PM to 2:30 PM, 3 of 3 Medical Records (#18, #20, #21) showed no evidence that patients were placed in trendelenburg position in accordance with facility policy, "Hypotension During Treatment" that stipulates, "...2. Place patient in trendelenburg position with the lower extremities elevated and head lowered, if allowed. ...."

a. In Medical Record #18, it was stated on the hemodialysis flowsheet, that the blood pressure was low (i.e. systolic blood pressure on 1/7/12 at 1030 was 86; on 1/10/12 at 1600 was 83, at 1632 was 86, at 1715 was 78; on 1/17/12 at 1845 was 52 ). The record showed no evidence that Patient #18 was placed in trendelenburg position in accordance with "Hypotension During Treatment" on 1/7/12, 1/10/12 and 1/17/12. Staff #40 confirmed this finding.

b. In Medical Record #20, it was stated on the hemodialysis flowsheet, that the blood pressure was low (i.e. systolic blood pressure on 2/13/12 was 89 at 1100, 69 at 1115, 75 at 1145, 84 at 1200, and 87 at 1315, and 84 on 2/15/12 at 1100). The record showed no evidence that Patient #20 was placed in trendelenburg position in accordance with facility policy, "Hypotension During Treatment" on 2/13/12 and 12/15/12." Staff #40 confirmed this finding.

c. In Medical Record #21, it was stated on the hemodialysis flowsheet, that the blood pressure was low (i.e. systolic blood pressure on 3/8/12 at 1120 was 89, at 1140 was 85). The record showed no evidence that Patient #21 was placed in trendelenburg position in accordance with "Hypotension During Treatment" on 3/8/12. Staff #40 confirmed this finding.

B. Based on staff interview, document review and review of 4 of 4 Medical Records (#18, #19, #20, #21), it was determined that the contracted staff failed to implement prescriber's orders, and therefore, the director of nursing services failed to provided adequate supervision of the contracted service.

Findings include:

1. Upon review with Staff #40 on 3/14/12 from 2:00 PM to 2:30 PM, 4 of 4 Medical Records (#18, #19, #20, #21) showed no evidence that prescriber's orders for Heparin free dialysis were implemented.

a. In Medical Record #18, the prescriber's orders dated 1/7/12, 1/10/12, 1/12/12, 1/14/12, 1/17/12 and 1/19/12 stipulated "Heparin free Flush dialyzer with 100 mL NS every 30 minutes." The hemodialysis flowsheets dated 1/7/12, 1/10/12, 1/12/12, 1/14/12, 1/17/12 and 1/19/12 showed no evidence that Patient #18 received 100 mL NS every 30 minutes. Staff
#40 confirmed the above findings.

b. In Medical Record #19, the prescriber's orders dated 1/10/12, 1/12/12, 1/14/12, 1/16/12, 1/20/12 stipulated "Heparin free Flush dialyzer with 100 mL NS every 30 minutes." The hemodialysis flowsheets dated 1/10/12, 1/12/12, 1/14/12, 1/16/12, 1/20/12 showed no evidence that Patient #19 received 100 mL NS every 30 minutes. Staff #40 confirmed the above findings.

c. In Medical Record #20, the prescriber's orders dated 2/12/12 and 2/15/12 stipulated "Heparin free Flush dialyzer with 100 mL NS every 30 minutes." The hemodialysis flowsheets dated 12/13/12 and 12/15/12 showed no evidence that Patient #20 received 100 mL NS every 30 minutes. Staff #40 confirmed the above findings.

d. In Medical Record #21 the prescriber's orders dated 3/6/12, 3/8/12, 3/10/12 and 3/13/12 stipulated "Heparin free Flush dialyzer with 100 mL NS every 30 minutes." The hemodialysis flowsheets dated 1/10/12, 1/12/12, 1/14/12, 1/16/12, 1/20/12 showed no evidence that Patient #21 received 100 mL NS every 30 minutes. Staff #40 confirmed the above findings.

i. Patient #21's hemodialysis flowsheet dated 3/10/12 evidenced that the contracted staff flush the dialyzer with 100 mL NS at 1730 and at the next 30 minute interval, 1800, there was no administration of NS. At 1815, 45 minutes since the previous NS administration, there was an entry that stated, "dialyzer getting clotted changed." At this point, the contracted staff administered 250 cc of NS.

C. Based on review of 2 of 4 Medical Records (#20, #21) on 3/14/12 from 2:00 PM to 12:30 PM with Staff #40, it was determined that the contracted staff failed to implement prescriber's orders for dialysis treatment time, and therefore, the director of nursing services failed to provided adequate supervision of the contracted service.

Findings include:

1. In Medical Record #20, the hemodialysis order dated 3/12/12 stipulated a hemodialysis treatment time of 4 hours. The hemodialysis flowsheet dated 3/12/12 evidenced that Patient #20 received a 4 hour and 15 minute treatment. There was no written entry to explain why the 4 hour treatment was not provided. Staff #40 confirmed this finding.

2. In Medical Record #21, the hemodialysis order dated 3/10/12 stipulated a hemodialysis treatment time of 3 and 3/4 hours. The hemodialysis flowsheet dated 3/6/12 evidenced that Patient #21 received a 4 hour treatment. There was no written entries to explain why the 3 and 3/4 hour treatment was not provided. Staff #40 confirmed this finding.

3. In Medical Record #21, the hemodialysis order dated 3/13/12 stipulated a hemodialysis treatment time of 3 and 3/4 hours. The hemodialysis flowsheet dated 3/13/12 evidenced that Patient #21 received a 4 hour and 5 minute treatment. There was no written entries to explain why the 3 and 3/4 hour treatment was not provided. Staff #40 confirmed this finding.

A. Based on a review of hospital policy and procedure, review of one of two medical records and interview with administrative staff, it was determined that a drug was not distributed in accordance with applicable standards of practice.

Findings include:

Reference: The PROCEDURE section of hospital policy and procedure titled "MEDICATION ORDERING AND VERBAL ORDERS" indicated:
"Required medication order information - A properly executed order will contain the following:
Patient name
Drug name
Drug dose Frequency of administration
Route of administration
Time and date
Licensed practitioner's name or, if written, signature.
The order must be recorded on the patient's record.
If the pharmacist receives an order that is missing required information, illegible or unclear, the order must be clarified with the prescriber or surrogate (on call physician, etc) prior to dispensing.
....."

1. A DOCTOR'S ORDER FORM in the Medical Record #19 contained the handwritten order dated 1/19/12 at 6:30 AM: "Percocet 5/325 (1-2) (tablets) PO (by mouth) Q (every) 4-6 (hours) prn (as needed for) pain." The order did not specify when one tablet was to be administered as opposed to two tablets or when the time between each dose was to be; four hours as opposed to six hours. The electronic MAR (medication administration record) had the order transcribed as two separate orders. One order was for "one Percocet tablet to be administered as needed for pain every 4 hours and the other order was for two Percocet tablets to be administered as needed for pain every four hours." The orders did not indicate when one tablet was to be administered for pain and when two tablets were to be administered for pain. The medical record did not contain any documentation that the order was clarified by the pharmacist with the prescriber or surrogate prior to dispensing.

2. Medical Record #18 contained two orders dated 1/11/12 at 6:45 PM. One order was for Morphine Sulfate 0.5 mg to be administered IV (intravenous) push over 5 minutes for pain (PRN) as needed. The other order was for Oxycodone/Acetaminophen 5mg to be administered for pain PRN with a maximum daily dosage of 12 tablets. The orders did not specify when one of the medications was to be administered in favor of the other. The medical record did not contain documentation that the two PRN orders for the same indication were clarified by the pharmacist with the prescriber or surrogate prior to dispensing.

3. Administrator #6, on the afternoon of March 16, 2012, stated that there was no evidence available that the above referenced orders were clarified by the pharmacist with the prescriber(s) or surrogate(s) prior to dispensing.


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B. Based on document review and staff interview conducted on 3/13/12, it was determined that the facility failed to ensure the accountability of controlled drug substances.

Findings include:

1. The administration of Versed 5 mg (milligrams) at 7:30AM, 2 mg at 8:30 AM and 2 mg at 9:45 AM, for a total of 9 mg is recorded on the anesthesia record, dated 3/12/12, in Medical Record #22. The total administration of 10 mg of Versed is recorded in the "Medications" section of the anesthesia record and the corresponding Narcotic and Sedative Record. The records for the administration of Versed to this patient do not reconcile.

2. The administration of Versed 5 mg at 7:15 AM and 2 mg at 8:15 AM, for a total of 7 mg, is recorded on the anesthesia record dated 3/7/12, in Medical Record #13. The total administration of 10 mg of Versed is recorded in the "Medications" section of the anesthesia record and the corresponding Narcotic and Sedative Record. The records for the administration of Versed to this patient do not reconcile.

3. These findings were confirmed by Staff #6.

Based on observation and document review in the presence of Staff #8 and Staff #9, on 3/13/12, it was determined that the director of food and dietetic services failed to ensure that the Food and Nutrition Department was maintained in accordance with his/her job description.

Findings include:

Reference #1: Facility Food Director job description stipulates, "...Job Specific Performance Standards, Plans, directs, organizes and coordinates a broad outline all activities of the department. Responsible for Development and fiscal management of department...Supervision Given Overall supervision of the department ...G. Effectively manages performance of departmental employees...1. Coordinator of Clinical and Food Services Operations, organizing the work divisions through staff. ..."
Reference #2: N.J.A.C. TITLE 8, CHAPTER 43G, HOSPITAL LICENSING STANDARDS, SUBCHAPTER 10. DIETARY, (q) The dietary service shall comply with the requirements of Chapter XII of the New Jersey State Sanitary Code, "Sanitation in Retail Food Establishments and Food and Beverage Vending Machines" (N.J.A.C. 8:24).

Reference #3: 8:24-6.1 Materials for construction and repair, 8:24-6.1 Materials for construction and repair (a) Indoor surface characteristics shall include the following: 1. Except as specified in (a) 2 below, materials for indoor floor, wall, and ceiling surfaces under conditions of normal use shall be: i. Smooth, durable, and easily cleanable for areas where retail food establishment operations are conducted; ..."

1. On 3/13/12 at 11:05 AM near the cold prep area, there were broken tiles around the floor drain.

2. On 3/13/12 at 10:45 AM, it was observed that there was brown residue on the floor in the ladies locker room up against locker numbers #21 through #24.

Reference #4: 8:24-6.5 Maintenance and operation (a) The physical facilities shall be maintained in good repair.

3. On 3/13/12 at 10:35 AM, it was observed in the back hall of the kitchen that there was a build-up of dust and debris on the side of the ice machine.

Reference #5: 8:24-6.5 Maintenance and operation (d) Intake and exhaust air ducts shall be cleaned and filters changed so that they are not a source of contamination by dust, dirt, and other materials. If vented to the outside, ventilation systems shall not create a public health hazard or nuisance or unlawful discharge.

4. On 3/13/12 at 10:35 AM and 10:40 AM, it was observed that there was orange/brown residue on the ceiling vent in the cold prep area and the dishwasher room.

Reference #6: 8:24-6.2 Design, construction, and installation (k) The presence of insects, rodents, and other pests shall be controlled to minimize their presence on the premises by: ..."

5. On 3/13/12 at 10:45 AM in the dry food storage area, there was a bait station with multiple lines of dried brown residue and an insect carcass hanging from the ceiling. Staff #8 stated that the bait trap had been in the room for approximately 2 months.

6. On 3/13/12 at 11:10 AM near the cold prep area of the kitchen, the Vector System contained a bait station that had numerous insect carcasses. It could not be determined when the bait station had been previously changed.

Based on observation, it was determined that the facility failed to comply with the Life Safety Code concerning sprinkler and electrical maintenance.

Findings include:

1. On 3/13/12 at 10:35 AM, in the presence of Staff #2, an escutcheon plate was missing from the sprinkler in the lab corridor.

2. On 3/13/12 at 2:00 PM, in the presence of Staff #2, an electrical outlet was loose in Cardiac Catheterization Lab #1.

A. Based on observations made during a tour of the facility, it was determined that the facility failed to ensure that all supplies and equipment were maintained to ensure an acceptable level of safety and quality.

Findings include:

1. During a tour of the 4 Lesser unit, conducted at 9:30 AM on 3/13/12 in the presence of Staff #5, the following was noted:

a. In patient room #73, the telemetry unit on the bedside table at Bed A was found with the battery cover missing and cloth tape in place to hold the batteries in the unit.

b. In patient room #73, the telemetry unit on the bedside table at Bed B was found with two large cracks in the housing of the unit.

c. These findings were confirmed by Staff # 5.

2. During a tour of the Ambulatory Care Area, conducted at approximately 10:15 AM on 3/13/12 in the presence of Staff #5, the following was noted:

a. In Exam Room #1 there were two patient gowns and a pillow case found stored under the handwash sink.

b. In Exam Room #3 there were two pillow cases and a patient gown found stored under the handwash sink.

c. In Area B, at the Nurses' Station, the icemaker was found with a mineral build-up in the delivery chute.

d. These findings were confirmed by Staff #5.

3. During a tour of the Physical Therapy Department conducted at approximately 10:20 AM on 3/14/12, in the presence of Staff #5, the following was noted:

a. In the main gym there were many items stored directly on the floor, preventing proper cleaning.

b. In the Clean Storage Room there were many items stored directly on the floor, preventing proper cleaning.

4. During a tour of the Laboratory Department conducted at approximately 10:45 AM on 3/14/12, in the presence of Staff #5, the following was noted:

a. In the Blood Bank there were many items (a hammer, several vases, a wisk broom, etcetera) found stored under a handwash sink.

b. In the Histology Lab, the flammable liquid cabinet at the staining work area and the wall mounted fire blanket box were found with thick coats of dust.

c. In the Microbiology Lab, the refrigerator and the Bactec 9240 unit were found with thick coats of dust.

5. During a tour of the Medical Intensive Care Unit on 3/14/12 at 10:15 AM, in the presence of Staff #14, Staff #15 and Staff #16, an open shelved rolling cart that contained many boxes of needles, syringes, and IV catheters was found to be unsecured in the Clean Supply room. The door to the Clean Supply room had the capability of being locked, but was not at the time of the tour.

6. During a tour of the Operating Rooms (OR) conducted at approximately 10:30 AM on 3/13/12, in the presence of Staff #10 and #11, the following was noted:

a. In OR #4, the surface material on 2 arm boards and a slider board were cracked, exposing the sponge material underneath. In addition, the OR table pad was noted to have tape and tape residue.

b. In OR #3, the surface material on 2 arm boards were cracked, exposing the sponge material underneath.

c. In OR #2, the surface material on 2 arm boards, a slider board and a perfusion chair were cracked, exposing the sponge material underneath.

d. In the Soiled Utility room, the surface material on 5 arm boards were cracked, exposing the sponge material underneath.

e. These findings were confirmed by Staff #10 and Staff #11.


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B. Based on observation, it was determined that the facility failed to ensure that all equipment, including ice/water dispensers, were maintained to ensure an acceptable level of safety.

Findings include:

1. On 3/13/12 at Noon in the 4 Lesser Unit food pantry, the Symphony Series water dispenser contained a build-up of black residue and the ice dispenser contained a build-up of orange residue.

2. On 3/13/12 at 1:45 PM in the Medical Intensive Care Unit, the Symphony Series water dispenser contained light brown residue.

A. Based on observation and staff interview, it was determined that the facility failed to mitigate risks contributing to healthcare-associated infections by developing and implementing infection control policies based on nationally recognized standards of practice for the reprocessing of gastrointestinal endoscopes.

Findings include:
Reference #1: Society of Gastroenterology Nurses and Associates, Inc., "Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes (2009)", states in Endoscope Reprocessing Protocol, E. Cleaning, #9: "Clean and high-level disinfect reusable brushes between cases. Note that reusable brushes should be inspected between uses and replaced when worn, frayed, bent, or otherwise damaged. Worn bristles are ineffective in cleaning, and damaged brushes may damage endoscope channels."
Reference #2: CDC's "Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008, states in C Recommendations, #7e, High-Level Disinfection of Endoscopes: "Use cleaning brushes appropriate for the size of the endoscope channel or port (e.g., bristles should contact surfaces). Cleaning items (e.g., brushes, cloth) should be disposable or, if they are not disposable, they should be thoroughly cleaned and either high-level disinfected or sterilized after each use."

1. On March 20, 2012 at approximately 11:30 AM in the central service department's decontamination area, reusable endoscopes channel cleaning brushes were observed hanging above and in use at the endoscope washing sink.

2. Staff #37 confirmed that reusable brushes were not high-level disinfected between uses.

B. Based on observation, it was determination that the facility failed to ensure that a sanitary physical environment was maintained.
1. On March 20, 2012 at approximately 11:30 AM, in the three-compartment sink room located in the central service department's decontamination area, the following was observed:
a. The floor covering was worn and not easily cleanable, particularly surrounding the floor drain.
b. The floor drain grate was heavily soiled and covered with a dark residue.
c. The metal piping along the wall was rusting.