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65 JAMES STREET

EDISON, NJ 08820

PATIENT CARE ASSIGNMENTS

Tag No.: A0397

Based on review of the nurse staffing for 4/4/10 thru 4/17/10, review of the recommended staffing plans for the in patient units and emergency department, review of facility policy and procedure, and staff interview it was determined that the facility failed to implement its staffing plan, and failed to have a patient acuity system in place to ensure the assignment of nursing care is in accordance with the patients' needs.

Findings include:

Reference: Facility Policy and Procedure titled 'Nurse Staffing and Delivery of Care' states "...III. PROCEDURE: ...2. The Nursing Directors/Nurse Mangers oversee the daily staffing requirements for their particular area(s). This oversight includes: ...e. Managing of the unit on a twenty-four basis and making adjustments as needed to ensure appropriate staffing. Staffing is flexed to meet the needs of the unit as indicated by the staffing grids. ...4. All nursing care is provided utilizing established staffing guidelines, which are based on Nursing Hours Per Patient Day (NHPPD). Budgeted nursing care hours (NHPPD) are reviewed annually for each service based on the needs of the patients. 5. Adherence to the staffing plan and monitoring of staffing effectiveness is performed each shift comparing actual census, unit activity and patients' needs. Adjustments in staffing are made based on fluctuations of census, unit activity and/or patient needs and on staff competencies. ..."

1. On 4/21/09 10:30 AM the nurse staffing was reviewed with Staff #27. The staffing policy and staffing plans are based on hours per patient per day. The nurses generally work 12 hour shifts and the Patient Care Technicians (PCTs) work 8 hour shifts. The following nursing and/or PCTs shortages were noted as compared to the 'Recommended Staffing Plans':

a. Unit 4 North Telemetry: Please refer to Attachment A.

i. Review of the 'Scope of Services' for 4 North indicates in section II. that "Staffing is reviewed every 8 hours and as needed, based on volume and acuity."

ii. In interview on 4/21/10 Staff #27 stated the facility does not have a patient acuity system.

b. Unit 4 West Telemetry/Intermediate Care Unit: Please Refer to Attachment B.

2. Without an acuity system it cannot be determined if the facility's Recommended Staffing Plans are in accordance with the patients' needs.

No Description Available

Tag No.: A0404

Based on document review and staff interview, it was determined that the facility failed to ensure that medications were administered in accordance with the physicians orders.

Findings include:

1. The following medications were ordered on the "Anesthesia Protocol" form in Medical Record #7 on 4/19/10:

a. "Pain Management: If ineffective after 30 minutes; may move on to next checked medication."

b. The first checked medication was "Morphine sulfate 2 mg IVP prn pain q5 minutes, maximum dose 10 mg [2 milligrams intravenous push as needed for pain every 5 minutes, maximum dose 10 milligrams]."

c. The second checked medication was "Hydromorphone (Dilaudid) 1 mg IVP prn pain q 5 minutes, maximum dose 4 mg."

2. The administration of Dilaudid 1 mg at 22:45, 22:50 and 23:15 was recorded on the Post Anesthesia Nursing Record. There was no evidence that Morphine sulfate had been administered first as ordered by the physician.


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3. On 4/20/10 Medical Record #14 indicated a hemodialysis physician order dated 4/12/10 for "Venofer 100 mg [milligram] IV [intravenous] 3 times per week on dialysis X [times] 5 doses."

a. Review of the hemodialysis flowsheet revealed that Venofer was administered on 4/12/10 and on 4/16/10. Hemodialysis treatment was also done on 4/14/10. Venofer was not administered during the 4/14/10 hemodialysis treatment, and there was no evidence as to why the medication was not administered.

b. This was confirmed by Staff #17.

DELIVERY OF DRUGS

Tag No.: A0500

Based on document review and staff interview conducted on 4/20/10, it was determined that the facility failed to ensure accountability of controlled dangerous substances (CDS).

Findings include:

1. An order for Patient Controlled Analgesia (PCA) with Morphine Sulfate, a Schedule II CDS, was written in Medical Record #4 on 4/17/10. The patient was in the Post Anesthesia Care Unit (PACU). The initiation of Morphine Sulfate was recorded on the "PCA Monitoring" form with a start time of 11:50.

2. The medication was discontinued on 4/17/10 at 16:15, after the patient had been transferred to Unit 3N. The amount of medication received by the patient and the disposition of any remaining Morphine was not recorded on the PCA Monitoring form or in any other part of the medical record. There was no evidence of destruction of any remaining Morphine Sulfate.

3. These findings were confirmed by Staff #2.

CONTROLLED DRUGS KEPT LOCKED

Tag No.: A0503

Based on observation, staff interview, and document review conducted on 4/20/10, it was determined that the facility failed to ensure implementation of policies and procedures addressing the security of controlled drugs.

Findings include:

Reference: Facility policy titled "Narcotics, Barbiturates and Controlled Substances, Control Of" states "Procedure...7...Throughout the shift, the keys are to be kept on the licensed nurse while on the unit at all times..."

1. At 10:30 AM the keys to the controlled drug cabinet were found in a drawer in the medication room. This was confirmed by Staff #2.

MAINTENANCE OF PHYSICAL PLANT

Tag No.: A0701

Based on observation it was determined that the facility failed to maintain the overall condition of the hospital environment in a manner to assure the safety and well being of patients.

Findings include:

1. On 4/20/10 during tour of the Emergency Department (ED), in the presence of Staff #8 and #9 the following was observed:

a. The ladies bathroom in the waiting room had a leaky sink faucet with wet and stained floor tiles underneath the sink, and brown staining/ dirt around the sink faucet and water control knobs.

b. A chair [seats two] in the waiting room contained a 1-1/2 inch and a 2 inch tear in the seat surface, exposing the foam cushion underneath; with a tear in its surface exposing the cushion within. The chair cannot be cleaned adequately.

c. In Triage Room 2, the Dash 4000 blood pressure machine had a coating of dust on its top surface.

d. In the third triage room, the wall mounted Welch Allyn Ophthalmoscope and otoscope had a coating of dust on its surface, and the wall plaster was chipping along the area of where the chairs in the room would back into the wall.

e. In the Clean Utility Room of the Red Zone area, there was a hole in the wall, to the right of the sink, that exposed tearing plaster and two screws where the soap dispenser used to be.

f. The Soiled Utility Room of the Red Zone area contained a cabinet that stored a large plastic bag containing hand tissue rolls, and a large plastic bag containing toilet paper rolls. These clean items were stored in a soiled area.

g. In Bay 2 of the Red Zone a large hole, about 10 inches, was observed above the electrical outlet.

h. In the Pediatric ED, the ice machine was observed to have a moderate amount of dust underneath it and an empty ice tea container was observed on the floor in back of the ice machine.

i. In Pediatric bay #46, #47, and #49, the wall plaster was chipped along the area of where the chairs in the room would back into the wall.

j. There was dust/debris on the floor behind the entry doors to the Pediatric ED leading from the Adult side of the ED.

2. In interview on 4/21/10 4:10 PM, Staff #1 stated that the contracted housekeeping service does not report to the QA Committee.

FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE

Tag No.: A0724

A. Based on document review, interview, and observation, facility failed to maintain supplies and equipment to ensure an acceptable level of safety and quality in the ambulatory operating room and the endoscopy unit.

Findings include:

Reference #1: CDC's Hospital Infections Program, 'Guideline for Prevention of Surgical Site Infection' states in Sterilization of surgical instruments (Section II C. 2-d-2), "Perform flash sterilization only for patient care items that will be used immediately (e.g., to reprocess an inadvertently dropped instrument). Do not use flash sterilization for reasons of convenience, as an alternative to purchasing additional instrument sets, or to save time."

1. A review on 4/22/10 of the Mediplex Surgery Center OR's flash log from January 2010 to present showed that various instruments as listed on the flash log were flashed for reasons other than an emergency.

a. On 3/5/10 at 8:20, 9:50 and 11:50 AM SNR and sinus tray instruments used for surgeries of Staff #51 were flashed in a gravity cycle at 270F for 10 minutes.

b. On 3/17/10 a weighted speculum, belonging to Staff #52, per Staff #53, was flashed in a gravity cycle at 8:04 and 9:29 AM.

c. Eye instruments used in surgeries of Staff #54 were flashed in a gravity cycle on 1/15/10 at 9:30 and 10:00, 10:45, 11:00 AM and at 12:00 PM., 1/25/10 at 9:50 and 11:32 AM, 3/5/10 at 10:00 and 10:55 AM and 3/19/10 at 8:59 and 9:43 AM.

Reference #2: Facility Policy and Procedure titled 'Care of Endoscopes and Cystocopes' states under Procedures "Endoscopic equipment should be handled with care to prevent damage to lenses, fiberoptic components and delicate instruments."... under 'IN CLEAN PROCESSING ROOM' ...#9 "Place in clean basin and cover for transport to Endo Suite."

1. During the tour of the facility on 4/20/10, it was observed that small bowl scope # E110614 was stored inside the clean storage cabinet in Room A coiled and wrapped around the upper support.

2. Two cleaned endoscopes were observed lying in a towel on a cart outside of the clean processing room. Staff # 55 stated during interview that the scopes were going to be transported to the storage closets located inside the procedure rooms.


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B. Based on observation, a review of facility's policies and procedures, a review of equipment manufacturer's recommendations, the facility failed to ensure all equipment are maintained to an acceptable level of safety and quality for dialysis.

Findings Include:

Reference #1: Manufacturer of Myron L Meter states, "USING YOUR METER: 7. When you are finished with the meter, RINSE THE CELL CUP with clean water, preferably R.O., distilled, or deionized." Facility's policy & procedure #7-12-33B titled 'Operation of Myron L Meter' also states to rinse cell cup with dialysis quality water.

1. On 4/22/10 at 1030 AM, RO water was not available at the Myron L Meter station. Staff #40 and #42 were not familiar with manufacturer's rinsing requirement after each use and stated that RO water is not being used to rinse out the meter after use.

Reference #2: Manufacturer of Mediport PB Portable RO Unit states to "CALIBRATE THE PORTABLE R.O. WATER QUALITY MONITOR: 1. You must have a handheld TDS meter that reads in PPM. 2. Calibrate TDS meter with standard NaCl solutions per TDS meter manual .... 9. At the product sample port on side of R.O. unit below incoming water, collect a sample in the hand-held meter (rinse meter cup 2-3 times first). 10. Push mode button until product TDS light illuminates. Compare value from hand-held meter to mediport control/display. If values differ, adjust the board with the CAL-UP or CAL-DOWN buttons on the back of the board to match value on hand held meter. Push mode button % rejection light illuminates and "CAL" is displayed .....13. Water quality monitor is now calibrated."

1. On 4/22/10 at 11 AM, Staff #40 was asked if independent TDS reading is obtained from the Mediport PB Portable RO Unit. Staff #40 stated that although a handheld TDS meter is available onsite, it is not being utilized by dialysis staff.

2. On 4/22/10 at 11:30 AM, Staff #40 stated that the Mediport PB Portable RO Water quality monitor is not being calibrated using an independent handheld TDS meter as required by the manufacturer.

Reference #3: Manufacturer of "Serim Hisense Ultra 1" and facility's policy and procedure #7-12-30J titled, 'Serim Hisense Ultra .1 a Test for Total Chlorine in Feed or Rinse Water' states "Immerse indicator pad in sample solution and swish test strip back and forth vigorously for 30 seconds. Remove the test strip and shake to remove excess sample. Compare color of the indicator pad to the color chart immediately."

1. On 4/22/10, at 1045 AM, when staff #42 was asked to demonstrate the total chlorine test utilizing the Serim Hisense Ultra .1 test strip, staff was observed immersing the indicator pad in sample solution for 5 seconds and immediately reading the result against the color chart.

2. Staff #41 and #42 both stated that the total chlorine result is read immediately after 5 seconds of immersing the test strip in the sample solution, not at 30 seconds as per manufacturer guidelines.

Reference #4: Better Water's Mediport portable RO System states, "The micron sediment filter should be changed when there is a 15 PSI pressure differential between the filter in and filter out pressure gauges, or if it appears dirty, or a minimum of every 3 months, whichever comes first."

1. Based on review of "Portable RO Log Sheet" from October 2009 to February 2010, filter changes have not been documented on following RO's: Gambro's WRO 95 #s 3218, 4630, 2920 and Better Water's RO #2 and #66.

2. Gambro's WRO95 portable RO System states, "Changing the pre-filter cartridge frequency is monthly or according to local standards."

a. Staff # 40 stated that it is the facility's policy to change the filters monthly during the disinfection process.

b. Although a space is allotted for documenting filter change on the form 'Portable RO Log Sheet', results were not documented.


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C. Based on observation it was determined that the facility failed to maintain all supplies and equipment within an acceptable level of safety and quality in the ED.

Findings include:

1. On 4/20/10 during tour of the ED in the presence of Staff #8 and #9, the Blanket Warmer, that was located in the Clean Utility room in the 'Red Zone' section of the ED, had a 'Blanket/Fluid Warmer' log mounted on the front door of its surface. The log indicated that the temperature range is 105 'F [degrees Fahrenheit] to 115 'F.

a. Review of the log indicated the temperature of the Blanket Warmer was 120 'F for the dates of 4/1/10 thru 4/10/10, 118 'F on 4/11/10, and 120 'F for 4/12/10 thru 4/20/10. There was no indication in the 'Corrective Action Taken' section of the form for any of these dates that exceeded the temperature range up to 115 'F for the Blanket Warmer.

2. On 4/20/10 2:40 PM during tour of the ED in the presence of Staff #8 and #9, telemetry lead placement pads were observed out of their original packaging in Bay 2 of the Red Zone. Without the package labeling that bears the expiration date of the lead placement pads, it could not be determined if the pads were within the expiration timeframe as recommended by the manufacturer.

INFECTION CONTROL PROGRAM

Tag No.: A0749

Based on observation, it was determined that the facility failed to ensure that the Standard Precautions and Transmission Based Precautions policy was implemented.

Findings include:

MRSA
C. Dif=Clostridium Difficile
VRE=

Reference #1: The facility's policy titled, "Standard Precautions and Transmission Based Precautions," stated, "VII. Contact Precautions-...B. Gloves and Handwashing - In addition to wearing gloves as outlined under Standard Precautions...Remove gloves before leaving the patient's environment and wash hands immediately with an antimicrobial agent or decontaminate hands using alcohol based rub. C. Gown - In addition to wearing a gown as outlines under Standard Precautions, wear a gown ... when entering the room if you anticipate that your clothing will have substantial contact with the patient, environmental surfaces, or items in the patient's room..."

Reference #2: The CDC document titled "Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Health Care Settings 2007" states "...Standard Precautions...Hand Hygiene...Wash hands with non-antimicrobial soap and water or with antimicrobial soap and water if contact with spores (e.g., C. difficile...) is likely to have occurred. The physical action of washing and rinsing hands under such circumstances is recommended because alcohols, chlorhexidine, iodophors, and other antiseptic agents have poor activity against spores..."

1. On 4/21/10 during a tour of 4 West at approximately 10:30 AM with Staff #26, it was observed that Staff #30 was in Patient #43's room performing an x-ray. Patient #43 was on contact isolation for MRSA, C. Dif and VRE. Following the procedure Staff #30 removed the gown and gloves, wheeled the x-ray machine out of the room, proceeded to go into another patient room (not on isolation), completed an x-ray, then went to the nurses station and picked up a chart. Staff #30 did not wash his/her hands after leaving Patient #43's room or after visiting the second patient room. This was not in accordance with the above references.

2. On 4/20/10 while on 3 West at approximately 2:00 PM, it was observed that Staff #29 was in Patient #15's room. Patient #15 was on contact isolation for MRSA. Staff #29 was noted to be by the patient bed and touching/moving the bedside table. Staff #29 was not wearing a gown and gloves. This was not in accordance with the above references.

ORDERS FOR RESPIRATORY SERVICES

Tag No.: A1163

Based on document review, it was determined that the facility failed to ensure that respiratory treatments were administered in accordance with physician's order and with the respiratory policy in 1 of 3 medical records reviewed (Medical Record #29).

Findings include:

Reference: The facility's policy titled, "Aerosol Therapy," stated,
"E. Documenting aerosol therapies-- ...2. Documents "med given", "not available" or "refused on the EMar on non-Admin Rx units by the end of the shift, by initialing next to time. Documents 'med given", "not available" or "refused" in the computer on Admin Rx units by the end of the shift 3. Documents patient assessment in computer on all units after each aerosol therapy...Respiratory--Scheduling aerosol therapies--...Aerosol Therapy orders are valid for 5 days."

1. On 4/21/10 review of Medical Record #29 revealed the following physician orders:

a. 4/9/10 "Albuterol 2.5 mg [milligram]/3ns [normal saline] nebulizer q [every] 6 (circle drawn) [hour]."

b. 4/9/10 "Change Aerosol to Albuterol 1.25 mg. with Atrovent 0.5 mg. via nebulizer q 6 h."

c. 4/12/10 "Continue therapy-1.25 mg. Proventil + 0.5 mg. Atrovent q 6."

d. 4/14/10 "Pulmicort 0.5 mg. via neb [nebulizer] q [every] 12 h [hour]."

e. 4/15/10 "Continue therapy-1.25 mg. Proventil + 0.5 mg. Atrovent q 6."

f. 4/19/10 "Renew Budesonide NBSP [Pulmicort] BID [twice daily] Resp [respiratory] Therapy 0.5 mg/2 ml [milliliter]."

2. The EMar [electronic medical administration record] dated 4/17/10 at 2:00 AM, 4/18/10 at 20:00, and 4/20/10 at 20:00 lacked evidence that Albuterol/Atrovent respiratory treatments were administered, as ordered. There was no documentation of a patient assessment in the computer nor were there initials in the EMar, as required by the above policy.

3. The EMar dated 4/15/10, 4/16/10, 4/17/10 and 4/20/10 lacked evidence that Pulmicort respiratory treatments were administered at 8:00 AM, as ordered. There were no initials in the EMar next to the due time, as required by the above policy.

4. The EMar dated 4/16/10, 4/17/10, 4/19/10 and 4/20/10 lacked evidence that Pulmicort respiratory treatments were administered at 8:00 PM, as ordered. There were no initials in the EMar next to the due time, as required by the above policy.