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Based on medical record review, staff interview, and review of facility policy and procedure it was determined that the facility failed to implement its policy and procedure for oxytocin administration, and state regulation for administration of Oxytocin, in two of three obstetrical deliveries reviewed (Medical Records #24 and #28).

Reference #1: Facility policy and procedure # MCH 025, Subject: 'Oxytocin Administration' states "POLICY: ... Prior to the initiation of Pitocin, an evaluation must be done by the physician. The physician must be present on the unit initially and he must remain on the unit for one (1) hour."

Reference #2: N.J.A.C. Title 8 Chapter 43 G Hospital Licensing Standards states at 8:43 G-19.11 (d) "If oxytoxics are administered, the following shall occur within one hour prior to administration: the patient shall be examined vaginally by either a physician with obstetric privileges, a certified nurse midwife or an advanced practice nurse in accordance with hospital bylaws, and electronic fetal heart rate monitoring shall be initiated."

1. On 11/3/11 three medical records were reviewed for obstetrical deliveries, and two of the three were vaginal deliveries. It was observed in Medical Records #24 and #28 that oxytocin was administered to the patients' without evidence of a completed evaluation by the physician prior to oxytocin administration. The following was observed in each medical record:

a. In Medical Record #24 a nursing note dated and timed 5/2/11 1800 indicated the patient was admitted to Labor and Delivery for increased blood pressure and an eleven pound weight gain in one week.

i. A telephone physician order dated and timed 5/3/11 12:10 AM to '... start Pitocin 30 units in 500 ml NS @ 1 mu increase every 30 minutes until contractions are every 2-3 min." was evident.

ii. Per the 'Labor 24 Hour Plan of Care' form, the Pitocin was started at 12:50 AM on 5/3/11.

iii. There was no evidence of a completed evaluation by the physician prior to the initiation of the Pitocin in Medical Record #24.

b. In Medical Record #28 a telephone physician order dated and timed 10/1/11 8:30 AM to "Admit to L & D Start Pitocin 30 units wit 500 ml of NS at 1 mu/h" was evident.

i. Per the 'Medication Administration Record' the Pitocin was initiated on 11/1/11 at 9:50 AM.

ii. There was no evidence of a completed evaluation by the physician prior to the initiation of the Pitocin in Medical Record #28.

2. The above was reviewed with and confirmed by Staff #11.

Based on observation, staff interview, and review of facility documents, it was determined that the facility failed to ensure that services performed under the dialysis service contract are provided according to facility and contractor policies and procedures.

Findings include:

Reference #1:
FMCNA Hemodialysis Procedure manual - Clinical Services procedure number 132-020-120, dated 01/28/04 titled "Evaluating the Patient Pre-Dialysis" was observed in the Dialysis Contract policy and procedure book. The procedure states, " Purpose: To evaluate the patient prior to initiating the dialysis treatment based in data collected from pre-dialysis evaluation and nursing assessment when indicated. Performing a pre-dialysis evaluation will assist the caregiver in identifying potential problems that may arise during treatment." The procedure states, "The staff member who collects the information and evaluates the patient pre-treatment will document their findings on the hemodialysis treatment sheet. "

1. Pre-dialysis patient assessments were not documented prior to initiation of patient treatment. The Hemodialysis Nursing Record for Patient #12 was observed at 2:30 PM on 10/31/11. The Hemodialysis Nursing Record documented that treatment began at "13:30" (1:30 PM) and the "notes and comments" section was charted six times between 13:30 and 14:30 (1:30 PM and 2:30 PM). However, the Hemodialysis Nursing Record was observed at 2:30 PM with Page 1 completely blank. There was no documentation on the Hemodialysis Nursing Record of pre-treatment patient assessments, catheter access assessment, or confirmation of hemodialysis orders.

Reference #2a:
FMCNA Hemodialysis Procedure Manual - Clinical Services procedure number 132-020-235, dated 02/16/05 titled "Pre-Treatment Safety Checks" was observed in the Dialysis Contract policy and procedure book. The procedure states, "Purpose: To assure that the safety features of the dialysis machine are functioning properly. To decrease the chance of human error in initiation of dialysis treatment. These procedures must be performed prior to initiation of the dialysis treatment." The procedure states in Step 1, "Check that the dialyzer and dialysate concentrate are what was prescribed for this patient. Check the conductivity, pH, and temperature." The procedure states that the air detector, arterial and venous pressure alarms, and the blood leak detector have been checked and properly functioning. At each test procedure, the document states, "Document on the checklist on the Hemodialysis Treatment Sheet."

Reference #2b:
BMA Hemodialysis Procedure Manual - Clinical Services procedure number 132-110-115, dated 10/01/95 titled "Checking Conductivity of the Dialysate" was observed in the Dialysis Contract policy and procedure book. The procedure states, "Step 7. Chart the conductivity on the patient's Hemodialysis Treatment Sheet for individual patient machine. Rationale 7. Prompt documentation assures accuracy."

Reference # 2c:
BMA Hemodialysis Procedure Manual - Clinical Services procedure number 132-110-130, dated 10/01/95 titled "pH Testing of Final Dialysate" was observed in the Dialysis Contract policy and procedure book. The procedure states, "Purpose: To ensure that both acid and bicarbonate are being used and that the bicarbonate pump is working properly. pH must be tested prior to initiating each treatment. Step 6. Document number on the Hemodialysis Treatment Sheet. Rationale 6. Accurate documentation provides a record of continuity of care."

2. Pre-dialysis safety checks were not documented prior to initiation of patient treatment. The Hemodialysis Nursing Record for Patient #12 was observed at 2:30 PM on 10/31/11. The Hemodialysis Nursing Record documented that treatment began at "13:30" (1:30 PM) and the notes and comments section was charted six times between 13:30 and 14:30 (1:30 PM and 2:30 PM). However, the Hemodialysis Nursing Record was observed at 2:30 PM with Page 2 safety checks blank or incomplete.

a. There was no documentation of verification of the prescribed dialyzer and dialysate concentrate. "Auto Alarm Test" was not checked.

b. Staff #17 was observed entering the Independent Dialysate pH, temperature, and machine conductivity readings at 2:30 PM. The conductivity independent meter reading entry was incomplete when the Hemodialysis Nursing Record was reviewed at 2:30 PM.

c. Staff #17 was asked to provide a copy of the Hemodialysis Nursing Record for Patient #12 at 2:30 PM on 10/31/11. Staff #17 asked if he/she could complete the record before the document was reviewed. Staff #17 was asked how the dialysate pH, temperature and conductivity values that he/she was observed writing in at 2:30 PM were derived. Staff #17 responded that sometimes the readings that are taken prior to patient treatment are written on note paper or on his/her hand to be entered later. Staff #17 did not present any evidence that the readings were previously documented somewhere other than on the Hemodialysis Nursing Record.

Reference #3:
Fresenius Medical Care Mobile Acute Policy # 132-060-125 titled, "How to Complete the In-patient Hemodialysis Nursing Record" was observed in the Dialysis Contract Policy and Procedure manual. The policy lists 37 items that correspond to the documentation required on the Hemodialysis Nursing Record.

3. The Hemodialysis Nursing Record was not completed according to Policy # 132-060-125.

a. Required documentation of patient general assessment pre-treatment, verification of dialysis orders, pre-treatment safety checks for the dialysis machine and water treatment equipment were observed at 2:30 PM on 10/31/11 on the Hemodialysis Nursing Record for Patient #12 treatment that was initiated at 1:30 PM.

b. Policy # 132-060-125 states in item #4 "Pain Assessment: Time:
Document the actual time the Pain Assessment was completed by using military time. Pre Treatment/During Treatment/Post Treatment. Rating: Document the number from the numbered pain scale or the corresponding face as is indicated by the patient."
A pre-treatment Pain Assessment time or rating was not entered on the Hemodialysis Nursing Record observed at 2:30 PM on 10/31/11 for Patient #12, whose hemodialysis treatment was initiated at 1:30 PM.

Reference #4
FMS Clinical Services policy dated 9/4/2008 titled "Chlorine/Chloramine Testing of the Water Treatment System; Acute Program - NJ Specific" was observed in the Dialysis Contract policy and procedure book. The policy states, "Prior to initiation of [the] every treatment, the Acute nurse will perform and validate the water system to ensure it is free of chlorine and chloramines and document the testing results on the log."

4. The result of pre-treatment chlorine test was not documented in the log prior to initiation of the patient treatment, observed on 10/31/11.

a. On 10/31/11, at 2:10 PM, Staff #17 was asked how the chlorine/chloramine in water was tested and where the results were documented. Staff #17 described the test procedure he/she stated was done prior to initiating Patient #12 hemodialysis treatment at 1:30 PM. At 2:10 PM on 10/31/11, the Total Chlorine log was observed blank for 10/31/11. At 2:10 PM, staff # 17 was observed entering the results of a total chlorine test on the log for 10/31/11, documenting the time of test done at "13:10" (1:10 PM).

5. FMS Clinical Services Procedure # FMS-CS-IC-II-155-110C, dated 10-Oct-2008, titled, "Cleaning the Dialysis Station Between Patient Treatments" was observed in the Dialysis Policy and Procedure manual. The procedure states, " 3. Clean and disinfect the dialysis station or treatments area (chair, bed, table, machine, Television, I.V. Pole, B/P cuff, hand sanitizer dispenser and holder, etc.) after each patient treatment with 1:100 bleach solution."

6. A disinfectant other than the bleach solution specified in the contract service policy is used to clean and disinfect the dialysis equipment and surrounding areas after patient treatment.

7. On 10/31/11, Staff #17 stated that he/she uses Super Sani-Cloth (ammonium chloride) Germicidal Disposable wipes to wipe down equipment in the patient room after patient dialysis treatment.

Based on observation, document review and staff interview conducted on 11/16/11, it was determined that the facility failed to ensure that medications were administered in accordance with physician's orders.

Findings include:

1. An order was written in Medical Record #34 on 11/15/11 at 15:41 for "Levaquin 500 mg now and 10 PM." Only the administration of Levaquin at 10:00 PM was documented on the Medication Administration Record. There was no evidence of administration of Levaquin 500 mg prior to this.

2. Orders were written in Medical Record #35 on 11/14/11 for Levofloxacin 750 mg (one 500 mg and one 250 mg tablet) by mouth daily and Pantoprazole 40 mg 1 tablet by mouth daily. The medication orders had not been transcribed onto the Medication Administration Record. There was no evidence of administration of the medications on 11/15/11 and 11/16/11.

3. During a medication pass observation on 3 Central at 10:30 AM, Staff #27 was observed administering Glipizide 5 mg to Patient #34. The administration time for Glipizide on the Medication Administration Record was 7:30 AM. Upon questioning the nurse about the late administration he/she stated that he/she had been too busy to give the medication at 7:30 AM.

4. The following medications were not recorded as given on the Medication Administration Record on 11/16/11 at 10:30 AM:

a. Glipizide 5 mg at 7:30 AM on 11/15/11 in Medical Record #27.

b. Meclizine 12.5 mg, Paxil 10 mg, Prilosec 40 mg, Celebrex 200 mg, Synthroid 0.025 mg and Evista 60 mg at 10:00 AM on 11/16/11 in Medical Record #36. The medications were not found in the patient's medication cassette drawer. Upon interview, Staff #27 stated that he/she had administered all of the 10 AM medications but had not yet signed the Medication Administration Record. He/she then proceeded to sign the Medication Administration Records of several patients.

5. These findings were confirmed by Staff #26.

Based on observation and staff interview conducted on 11/16/11, it was determined that the facility failed to ensure that medications were stored in locked storage areas.

Findings include:

1. The medication cabinet and medication refrigerator were found unlocked on Unit 3 Central at 11:00 AM.

2. This finding was confirmed by Staff #26.

Based on observation and staff interview conducted on 11/16/11, it was determined that the facility failed to ensure that expired or unusable medications were not available for patient use.

Findings include:

1. One opened single dose vial of Lidocaine 1% was found in the medication cabinet on Unit 3 Central at 11:00 AM.

2. The following vials of insulin that were not dated when opened or had expired, were found in the medication refrigerator on Unit 3 Central at 11:00 AM:

a. One vial of Novolin R that was dated as opened 10/11/11 and had a 'do not use after' date of 11/17/11 (37 days later). Upon interview Staff #26 confirmed that insulin vials should be dated with 'do not use after date' when opened, which is 28 days from the date of opening.

b. One opened vial of Novolog that had a 'do not use' date of "11/10."

c. One opened vial of Novolog Mix 70/30 that did not have a 'do not use after' date written on it.

d. One vial of Novolin R with a 'do not use after' date of 11/14/11.

3. Upon review of the Nurses' Night Cabinet at 2:30 PM, it was noted that several medications were packaged in small plastic bags. Each bag contained approximately 5 tablets/capsules and the bag was labeled with the drug name, strength, manufacturer, lot number and expiration date. This is not approved USP packaging and cannot be used to package medications. Examples of drugs found in small plastic bags included Cogentin 1 mg tablets, Amoxil 250 mg capsules, Terbutaline 2.5 mg tablets, and Keflex 500 mg capsules. Upon interview, Staff #26 stated that the medication should not have been prepared in this manner. The medications in the Night Cabinet should all have been in individual unit dose packaging.

A. Based on observation and staff interview on 11/16/11, it was determined that the facility failed to ensure that the physical environment of the intravenous medication preparation room in the pharmacy is properly maintained.

Findings include:

1. There was exposed plaster on the walls of the room which could not be properly cleaned.

2. There were dark red stains on the floor located close to the laminar flow hood.

3. These findings were confirmed by Staff #26.


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B. Based on observation, it was determined that the facility failed to ensure that the condition of the environment was maintained in such a manner that the safety and well-being of patients is assured.

Findings include:

1. On 10/31/11 at 11:10 AM, in the presence of Staff #1, the wall was ripped exposing a non-cleanable surface in OR #4.

2. On 10/31/11 at 11:10 AM, in the presence of Staff #1, the Gaymar warming system hose in OR #4 had a delaminating surface.

3. On 10/31/11 at 12:25 PM, in the presence of Staff #1, there was evidence of a ceiling leak in C-section Room #2.

A. Based on observation, it was determined that sterilized materials are not monitored and stored in the OR Department in a manner that ensures sterility.

Findings include:

1. On 10/31/11, the sterile and clean items observed stored on an anesthesia supply cart stored in the rear OR storage room were not maintained in a clean environment.

a. Two crumpled paper face masks were observed on the anesthesia supply cart, between storage of sterile wrapped items.

b. Cloth tape was applied to the anesthesia supply cart posts above the top storage shelf in order to contain clean and sterile items piled up on the top shelf of the cart.

c. Approximately 10 loose, unwrapped plastic airways were observed stored haphazardly beneath a pile of sterile wrapped items on the top shelf of the anesthesia supply cart.

2. A blue OR stock cart, which contains clean and sterile wrapped items, was observed in the Anesthesiology Room in the OR. It contained an empty sterile wrapper label, from a trach blade, crumbled between supplies.


B. Based on observation and staff interview, it was determined that equipment used in Operating Rooms is not cleaned properly between surgical cases.

Findings include:

1. The equipment storage room in the OR was observed with six sets of "candy cane" stirrups in storage. The stirrup straps, that Staff #18 stated are disposable, were not removed after use in the OR and were left hanging on the "candy cane" stirrups in storage.

2. One set (2) of the disposable "candy cane" stirrup straps observed in storage in the OR were heavily stained with residue of a liquid tan substance.

C. Based on observation and staff interview, it was determined that facility staff do not dispose of disposable personal protective equipment (PPE) after use.

Findings include:

1. On 10/31/11 at 10:50 AM, a pharmacy technician leaving the OR was observed in the OR locker room rolling up shoe covers removed from his/her shoes. The technician stated that he/she will be coming back to the OR so he/she saves the shoe covers for another use. The technician also stated that hair covers are saved and used again when returning to the OR. A hair cover was observed in the pharmacy supply bin which contained clean supplies that the technologist was observed carrying out of the OR.

2. On 10/31/11, several pairs of shoes were observed on the floor of the ladies locker room in the OR. Two pairs were observed with disposable shoe covers still attached. The shoe covers were observed ripped and heavily soiled with dirt and lint.

Based on review of medical records for discharge planning compliance, it was determined that the facility failed to provide appropriate discharge planning evaluations in two of four medical records reviewed (Medical Records #20 and #21).

Findings include:

Reference 1: Facility policy # N137, Interdisciplinary Discharge Planning, states the following: "Procedure/Process, 3. Case Management Responsibility: C. Initial assessment shall be completed on all patients that meet social service high risk criteria and/ or patients referred to the Case Management staff for intervention. This assessment shall be completed within 48 hours of admission/ referral."

Reference 2: Reference: Facility Policy [no number], High Risk Criteria for Assessment, Developed by: Dept. of Case Management, states: "Procedure: Every inpatient admission is screened by a Case Manager using criteria to evaluate whether patients are at risk of needing psychosocial and/ or discharge planning interventions. A full psychological assessment is completed within 24 hours for patients admitted or referred during the stay with the listed criteria. [Criteria includes] Social: Age 80 and above, ...Homeless/ Shelter, /..."

1. On 11/1/11 at approximately 11:00 AM, on the 3W (Tele) Unit, in the presence of Staff #19, two of four medical records were found to be lacking discharge planning evaluations.

a. Medical Record #20: A 64 year old homeless man was admitted on 10/27/11. There was no evidence in the medical record that the discharge planning evaluation had been completed for this patient.

b. Medical Record #21: An 86 year old woman that lives alone was admitted on 10/28/11. There was no evidence in the medical record that the discharge planning evaluation had been completed for this patient.

c. These findings were confirmed by Staff #19.

Based on medical record review and staff interview conducted on 11/16/11, it was determined that the facility failed to ensure that respiratory therapy treatments are performed in accordance with physician's orders.

Findings include:

1. An order was written in Medical Record #35 on 11/14/11 for Xopenex inhalation therapy every 8 hours. This order was not transcribed onto the Respiratory Therapy Medication Administration Record and there was no evidence that treatments had been administered on 11/14/11, 11/15/11 and 11/16/11 up to 2:30 PM. This finding was confirmed by Staff #26.