HospitalInspections.org

Based on interviews with administrative and direct care staff; tours of the facility; and review of related documentation, it was determined that the governing body failed to demonstrate that it is effective in carrying out its' responsibility for the operation and management of the hospital. It did not provide the necessary oversight and leadership as evidenced by the facility's lack of compliance with the Medicare Condition of Participation for hospitals, specifically:

42 CFR 482.41- Physical Environment and
42 CFR 482.13- Patients' Rights.

Based on review of the facility's policies and procedures, staff interview, reviews of medical records, and other facility documents, 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 all patients are provided the the right to formulate an advance directive. (Cross refer Tag 0132).

2. The facility failed to ensure all patients receive care in an emotionally safe environment, specifically, failed to secure and return patient valuables. (Cross refer Tag 0144).

Based on a review of a facility policy and procedure for the formulation of advance directives and the medical records of four patients it was determined that the facility failed to ensure that all patients the right to formulate an advance directive.

Findings include:

Reference: The PROCEDURE section of facility policy and procedure titled Advance Directives indicated:
"A. REGISTRATION- HEALTH CARE ACCESS REPRESENTATIVE RESPONSIBILITIES The Health Care Access Representative (Registrar) will, during the registration process, ask the patient and/or the patient's family regarding the existence of an Advance Directive. ....C. PHYSICIAN RESPONSIBILITIES 1. On admission, the attending physician asks the patient and/or family about existence of an Advance Directive.
2. The Physician Inquiry section (D) of the Advance Directive Documentation Form must be signed by the attending physician at the time of the inquiry....."

1. Review of an ADVANCE DIRECTIVE DOCUMENTATION FORM in the medical record of Patient #4 indicated that he/she did not have an advance directive on 12/19/09. The patient was admitted to the hospital on 12/19/09. There was no entry or signature made on the PHYSICIAN INQUIRY section of the form indicating that the physician inquired about the existence of an advance directive during the patient's hospitalization.

2. Review of an ADVANCE DIRECTIVE DOCUMENTATION FORM in the medical record of Patient #6 indicated that he/she did not have an advance directive on 12/20/09. The patient was admitted to the hospital on 12/20/09. There was no entry or signature made on the PHYSICIAN INQUIRY section of the form indicating that the physician inquired about the existence of an advance directive during the patient's hospitalization.

3. Review of an ADVANCE DIRECTIVE DOCUMENTATION FORM in the medical record of Patient #20 indicated that he/she did not have an advance directive on 3/22/10. The patient was admitted to the hospital on 3/22/10. There was no entry or signature made on the PHYSICIAN INQUIRY section of the form indicating that the physician inquired about the existence of an advance directive during the patient's hospitalization.

4. Review of an ADVANCE DIRECTIVE DOCUMENTATION FORM in the medical record of Patient #24 indicated that he/she did not have an advance directive on 3/29/10. The patient was admitted to the hospital on 3/29/10. There was no entry or signature made on the PHYSICIAN INQUIRY section of the form indicating that the physician inquired about the existence of an advance directive during the patient's hospitalization.

Based on a tour of a patient care unit, review of the medical record of one patient, a review of facility policy and procedure, and an interview with an administrator it was determined that the facility failed to ensure all patients receive care in an emotionally safe environment.

Findings include:

Reference: The PROCEDURE section of facility policy and procedure titled 'Patient Valuables' indicated: "Upon admission to the facility, or pre-admission testing, the patient will be encouraged to send valuables home. 1. All patient valuables should be sent home with patient's family whenever possible. Patient's family member must sign for whatever is taken home on the Patient personal Belonging List (Attachment 1). 2. In the event that valuables cannot be sent home, such valuables are to be sent to the hospital safe. 3. the patient's clothes and valuables list must be filled out on admission (in ED if that is the point of admission). Each time the patient is transferred to another nursing unit or discharged the original form is to be completed and signed. a. The completed list is to be signed by the patient whenever possible. b. If the patient is unable to sign, a family member must sign it.
c. If no family member is present, make a note that "patient is unable to sign". [sic] A second signature is required. d. In all cases the responsible nursing employee filling out the list must sign and date it. ....7. In the event that valuables and excess money cannot be sent home, such valuables must be sent to the hospital safe. ....h. The Patient Belongings List should be signed by the patient and nursing staff person when the patient is discharged.....
NOTE: .... Valuables will not remain at the nurses station or in the Emergency Department for any period of time longer than absolutely necessary. The longer valuables are left lying around and not secure in the safe, the greater the risk of loss or theft. Time must be taken to protect the patient's valuables. ...."

1. A tour of the Unit 3A Medication Room on 4/6/10 at 10:35 AM indicated the presence of a ladies purse in a cabinet above the countertop. The purse contained cash, a Social Security ID card, a Medicaid ID card, a New Jersey driver's license, a key ring with keys attached, a vial of medication, and other personal property of Patient #21.

2. A review of the Medical Record of Patient #21 indicated that she was admitted to the Psychiatric Unit via the emergency department on 12/31/08. While being treated on the psychiatric unit she developed medical problems and was transferred to Unit 3A, a medical/surgical unit. There was no evidence in the medical record of a Patient Belongings List or a Patient personal Belonging List. A FOCUS NOTE on a 24 (hour) PSYCHIATRIC FLOW SHEET dated 10:00 AM on 1/10/09 indicated: "Pt. remains delusional - ... states someone came in her room and took 'my money' - pt reminded she had no money in room. ...." There was no evidence in the medical record that staff attempted to address the patient's complaint of her missing property. As of the last date of the survey it had been almost 15 months since the patient was discharged without her valuables. There was no evidence that any attempt was made to return the patient's valuables, even though her discharge address and the contact information of her next of kin were in the medical record.

3. An interview with Administrator #7 on the afternoon of April 9, 2010 indicated that an incident report regarding the patient's allegation of having had her money taken from her was not available. She further indicated that the facility did not have a formal lost and found policy.

A. Based on medical record review and review of facility policy and procedure, it was determined that the facility failed to implement its policies and procedures for consents for blood products in 3 of 4 medical records reviewed for the administration of blood transfusions (Medical Records #9, #11, and #12).

Findings include:

Reference #1: Facility policy number 068614:011, titled 'Consent Policy', states "...Procedure: ...Informed consent shall be obtained by the physician from all patients requiring certain types of procedures, including but not limited to: ...[5th bullet]...and administration of blood products."

Reference #2: Facility policy Number: B-1.51, Subject: 'Blood and Blood Products' states "...Procedure:...C. Preparing for the Administering of a blood Product 1. Person transfusing blood product (Transfusionist) must be an RN or MD. ...3. Transfusionist is responsible for the following: a. Assure that the "Consent for Transfusion of Human Blood or Human Blood Products" has been signed and witnessed."

1. On 4/8/10 review of Medical Records #9, #11, and #12 indicated each pt. received a blood transfusion without indication that the patient signed his/her consent for transfusion after the physician signed the consent area that states "EXPLANATION BY PHYSICIAN: I hereby certify that I have adequately explained the possible need for blood transfusions and options for donation to the patient or authorized patient representative and he/she has consented to such treatments." Without the physician signature prior to the patient signing the blood consent, it could not be determined if the patient was able to give full informed consent to the procedure. The following was evident in the medical records:

a. Medical Record #9 contained a 'Transfusion of Blood and Blood Products Disclosure and Consent' form that was signed by the patient, dated and timed 2/4/10 1625, and witnessed. There was no practitioner's signature in the 'Explanation by Physician' area. Per the 'Transfusion Report' forms, the patient received a unit of packed red blood cells on 2/4/10 at 1625 and a second unit at 1835.

b. Medical Record #11 contained a 'Transfusion of Blood and Blood Products Disclosure and Consent' form that was signed by the patient, dated 2/9/10 [not timed], and witnessed. The practitioner's signature in the 'Explanation by Physician' area did not indicate a date and time of signature by the practitioner. Per the 'Transfusion Report' forms, the patient received a unit of packed red blood cells on 2/9/10 at 1405 and a second unit at 1600.

c. Medical Record #12 contained a 'Transfusion of Blood and Blood Products Disclosure and Consent' form that was signed by the patient, dated 5/17/09 [not timed], and witnessed. The Advanced Practice Nurse signature in the 'Explanation by Physician' area was dated [not timed] the next day, 5/18/09. Per the 'Transfusion Report' forms, the patient received a unit of packed red blood cells on 5/17/09 at 1315.

i. Medical Record #12 contained a 'Transfusion of Blood and Blood Products Disclosure and Consent' form that was signed by the patient, dated and timed 12/4/09 0900, and witnessed. The practitioner's signature in the 'Explanation by Physician' area was not dated or timed. Per the 'Transfusion Report form, the patient received a unit of packed red blood cells 12/4/09 at 1055.

ii. Medical Record #12 contained a 'Transfusion of Blood and Blood Products Disclosure and Consent' form that was signed by the patient's daughter, dated and timed 2/16/10 12 PM, and witnessed. The practitioner signature in the 'Explanation by Physician' area was not dated or timed. Per the 'Transfusion Report' form, the patient received a unit of packed red blood cells 2/16/10 at 1125, and a second unit at 1315. The patient's daughter signed the consent after the blood transfusion started.

B. Based on observation, medical record review, and staff interview it was determined that the facility failed to have a policy and procedure in place to guide nursing care of all patients, in two of two medical records reviewed for patients receiving hyperbaric therapy, and failed to follow their own practice. (Medical Records #22 and #23).

Findings include:

1. On 4/8/10 12:15 PM the Wound Care Center was toured in the presence of Staff #1 and Staff #48. Patient #22 and Patient #23 were observed in the hyperbaric chambers receiving therapy. Review of Medical Record #22 and Medical Record #23 indicated on each 'Daily Patient Hyperbaric Pre-Treatment Checklist' that the pre-treatment checks were not signed off as being completed prior to Patient #22's and Patient #23's treatments.

a. Review of the 'Daily Patient Hyperbaric Pre-Treatment Checklist' indicates assessments for, (but not all inclusive), clothing or gown that is 80% cotton, removal of jewelry, hearing aids, and contact lenses or prosthesis. Also has assessments to ensure the patient does not have hairspray, hair oils, or make up on, that the patient has a ground bracelet on his/her wrist, and that pre-treatment vital signs are taken.

b. In interview Staff #49 stated that the patients are checked prior to entering the hyperbaric chamber and initiation of treatment and the 'Daily Patient Hyperbaric Pre-Treatment Checklist' is completed. He/she further stated that he/she did perform the pre treatment checks, but did not document the checks performed. Per the 'Vital Signs Daily Report' form for the Hyperbaric Department, Patient #22's treatment started at 11:20 AM and Patient
#23's treatment started 11:10 AM.

c. Per Staff #1 on 4/8/10 at 3:13 PM, the facility and/or Staff #48 does not have a policy and procedure for the 'Daily Patient Hyperbaric Pre-Treatment Checklist' for the hyperbaric treatments, that guides the practice of checking patients prior to entering the chambers.

C. Based on medical record review, and review of facility policy and procedure it was determined that the facility failed to implement its policy and procedure for tube feeding in 2 of 3 records reviewed for patients receiving tube feedings.(Medical Records #26 and 28).

Reference: Facility Policy Number: T2.0, titled 'Tube Feedings' states "...Procedures: ...II. Administration Guidelines ... 5. Assess and document patency and placement of tube every 8 hours and prn [as needed]. ...6. Assess and document residual feeding every 8 hours. ...7. To keep tubes patent and provide free water to the patient, they should be flushed with 50 ml warm water every 4 hours or per MD order. ..."

1. On 4/9/10 at 11:00 AM during tour of Unit 2A in the presence of Staff #9, Medical Record #26 and Medical Record #28 were reviewed for administration of tube feedings/enteral nutrition. The nurses are not assessing residual feeding checks every 8 hours as per policy and are not flushing the tubes every 4 hours to keep patent as per policy. The following was noted in the medical records:

a. Medical Record #26 indicated per the nursing flowsheet dated 4/8/10 that the patient was receiving a tube feeding of Osmolite at 60 cc/ hour from 4/8/10 1400 thru 4/9/10 0900 when it was stopped for a procedure off the unit.

i. The patient's residual was checked on 4/8/10 at 2000; there was no evidence of further residual checks of the patient's feeding from 4/8/10 at 2000 to 4/9/10 0600, a 10 hour time period.

ii. There was no evidence that the patient's tube was flushed at all between 4/8/10 1400 thru 4/9/10 0600, a 16 hour time period.

b. Medical Record #28 indicated per the nursing flowsheet dated 4/7/10 that the patient was receiving a tube feeding of Osmolite at 60 cc/ hour from 4/7/10 2400 thru 4/8/10 2300, a 23 hour period.

i. The patient's residual was checked on 4/8/10 between 1700 and 1800 per the nursing flowsheet. There was no evidence of a residual check from 4/7/10 2400 thru 4/8/10 1700, a 17 hour time period.

ii. The patient's tube was flushed on 4/7/10 initially at 0600, a 6 hour time period from 2400-0600. On 4/7/10 the patient's tube was not flushed between 1000-1800, an 8 hour time period; and there was no evidence the patient's tube was flushed between 1800-2300, a five hour period.

Based on a review of one of four medical records and interview with administrative staff it was determined that the facility failed to ensure all orders for medication were in accordance with acceptable standards of practice.

Findings include:

1. A review of an order sheet in the medical record of Patient #20 indicated orders dated 3/23/10 at 11:03 AM for 'morphine 4 mg every 15 minutes as needed up to 10 mg total' for pain and 'Zofran 4 mg IV x (times) 1 (dose).' The orders were entered and authenticated by an RN. There was no evidence of authorized medical staff involvement in the ordering of the medications.

2. Interview with Staff #11 on the afternoon of April 9, 2010 indicated that the nurse who ordered the medications was not an advanced practice nurse, but a registered nurse.

Based on observation it was determined that the facility failed to discard biologicals in accordance with manufacturer recommendations.

Findings include:

1. On 4/8/10 during tour of the Wound Care Center in the presence of Staff #1 a 500 cc [cubic centimeter] bottle of 0.9% Sodium Chloride for irrigation was found in a drawer of a small cart that contained wound care supplies. The bottle of saline contained printed manufacturer instructions on it that stated "Single-dose container. Contains no bacteriostatic. Discard unused portion." The bottle was marked with a date of opening as 3/18/10 1400. The single-dose bottle was available for multiple use.

2. On 4/7/10 2:30 PM the Same Day Surgery unit was toured in the presence of Staff #9 and Staff #5. The glucometer kit contained a Hi and a Lo Accu-Chek Comfort Curve control solution bottle. Each bottle was marked with a date of opening of 10/16/10 and expiration date of 1/16/10. Each bottle had printed manufacturer's instructions on it that stated "Discard 3 months after opening." The bottles of Hi and Lo control solutions were 80 days past their expiration timeframe and remained available for use.

Based on a tour of five patient care units and interview with administrative staff it was determined that the hospital did not have a procedure to ensure the confidentiality of patient records.

Findings include:

1. A tour of the Resident's Charting Room in the Emergency Department on the morning of April 6, 2010, accompanied by Administrator #2 indicated the presence of two DOCTOR'S CONTINUATION SHEETS, one of which was dated 4/6/10, in the regular waste paper basket. The sheets contained the name and some demographic information on Patient #5. The medical information on the first of the sheets indicated the patient's chief complaint, medical history information. The other sheet indicated physician orders for medication.

2. Interview with Staff #2 at the time of the tour indicated that the confidential documents should have been placed in the shredder bin outside of the Charting Room.

3. A tour of the 5ASU Unit (Forensic) on the afternoon of April 9, 2010, accompanied by Staff #11 indicated the following:

a. An unlocked cabinet above the counter, nearest the window, in the Nurses Station contained confidential information on multiple patients, some of the documents were dated more than six years ago. There were also confidential documents atop the cabinet. Also, in the blue recycling bin, used for non-confidential paper recycling, copies of medical record pages of Patients #32, #33, #34, #35, #36, and #37 were found. Confidential information on an additional 24 patients was also in the recycling bin.

b. Interview with Staff #11 at the time of the tour indicated that the confidential documents should have been placed in the shredder bin.

A. Based on medical record review it was determined that the facility failed to ensure all entries in the medical record are legible.

Findings include:

1. On 4/6/10 review of Medical Record #1 evidenced respiratory notes dated and timed 4/5/10 2130, 4/6/10 130, and 4/6/10 500 that were illegible.

B. Based on medical record review it was determined that the facility failed to ensure all entries in the medical records are dated and timed, in 3 of 3 medical records reviewed on 4/6/10 in ICU/CTCU (Medical Records #1, #2, and #3).

Findings include:

1. Medical Record #1 evidenced respiratory notes timed 0745 and 0930 on an 'Assessment/ Intervention' continuation sheet, that were not dated.

2. Medical Record #2 evidenced respiratory notes timed 0800 and 1100 on an 'Assessment/ Intervention' continuation sheet, that were not dated.

3. Medical Record #3 evidenced an 'Adult Ventilator Flowsheet' that was not dated, and listed the following times for assessments/notes: 1100, 1115, 1145, 1520, 1915, 2010.

C. Based on observation, medical record review, staff interview, and review of facility policy and procedure, it was determined that the facility failed to complete progress notes in the medical records by the person responsible for providing the service, at the time the service was provided in two of two hyperbaric patient medical records reviewed (Medical Records #22 and #23).

Findings include:

Reference: Facility policy titled 'Guidelines for EMR HBO Documentation/Data Entry' states "...6. Technicians enter events of the dive in their respective portions of the EMR [electronic medical record]. A patient specific worksheet with patient name and DOS for documentation is used to report information such as dive time, vital signs, blood glucose levels, any interventions, etc. These are kept on the unit in the event they need to be referenced. Under no circumstances should information be kept on miscellaneous papers. ..."

1. On 4/8/10 12:15 PM the Wound Care Center was toured in the presence of Staff #1 and Staff #48. Patient #22 and Patient #23 were observed in the hyperbaric chambers receiving therapy.

a. Staff #49 stated in interview that these patients are seen daily in the wound care center for hyperbaric therapy.

b. Medical Record #22 and Medical Record #23 lacked evidence of treatment notes for 4/7/09. This was confirmed by Staff #49. Staff #49 stated he has not completed his EMR documentation for yesterday, 4/7/09; He/she further stated he/she was not allowed to stay at the facility to complete the progress notes at the end of the day because he/she was not allowed to receive overtime.

c. Staff #49 reviewed the 'Vital Signs Daily Report' with the surveyor, for the hyperbaric department that contained information for Patient #22's and Patient #23's treatments for 4/7/10 and 4/8/10. The 'Vital Signs Daily Report' contains four boxes/ areas to document four treatments; each box contained a different patient name and their information. Patient #22's and Patient #23's treatments were documented on the same 'Vital Signs Daily Report' form for 4/7/10, along with two other patients, and on the same form for 4/8/10 along with one other patient. With the documentation of more that one patient on the 'Vital Signs Daily Report' form, the form is not "patient specific" as per policy.

2. The continuity of care by care providers can be broken when the course and results of care, treatment, and services is not documented at the time the care is provided.

Based on a review of medical staff rules and regulations and the medical records of four of eight patients it was determined that the facility failed to ensure all orders were timed.

Findings include:

Reference: The MEDICAL RECORDS section of MEDICAL STAFF RULES AND REGULATIONS ST. FRANCIS MEDICAL CENTER indicated: "...14. All clinical entries in the patient's medical record shall be accurately dated, timed, and authenticated....."

1. Medical Record #4: The MEDICATIONS ONLY section of an order sheet indicated two separate untimed orders dated '12 2009.' The PHYSICIAN'S ORDERS section of the same sheet indicated a set of untimed orders and a single untimed telephone order dated '12 2009.'

2. Medical Record #20: The MEDICATIONS ONLY section of an order sheet indicated an untimed order dated 3/24/10. The PHYSICIAN'S ORDERS section of the same sheet indicated an untimed order dated 3/24/10.

3. Medical Record #21: The PHYSICIAN'S ORDERS section of an order sheet indicated an untimed order dated 2/4/09.

4. Medical Record #30: The MEDICATIONS ONLY section of an order sheet indicated an untimed order dated 7/29/09. The PHYSICIAN'S ORDERS section of the same sheet indicated a set of eight untimed orders dated 7/29/09.

Based on review medical records it was determined that the facility failed to ensure all physician orders were complete, in one of four records reviewed.

Findings include:

Reference: The GENERAL CONDUCT OF CARE section of MEDICAL STAFF RULES AND REGULATIONS ST. FRANCIS MEDICAL CENTER indicated: "... 5. The practitioner's notes and orders must be contemporaneously written clearly, legibly, and completely..."

1. The MEDICATIONS ORDERS ONLY section of an order sheet indicated the following order dated 12/27/09 at 1500 (3:00 PM): "Robitussin 2 teaspoon Q4h (every 4 hours) prn (as needed)." The order did not identify the indication or indications for use.

A. Based on observation of medications in the Heart Surgery Operating Room in the presence of Staff #39 and Staff #40, and documentation available for review, it was determined that the facility failed to ensure that all drugs are stored under proper conditions, as indicated by the United States Pharmacopoeia (USP 797) and manufacturers' specifications.

Findings include:

Reference: United States Pharmacopeia (USP) Chapter 797 when addressing immediate-use CSP's (Compounded Sterile Products) states that they are "exempt from the requirements described for Low -Risk Lever CSP's only when all of the following are met...4. Administration begins not later than 1 hour following the start of the Preparation of the CSP."

USP Chapter 797, when addressing Single- Dose and Multiple-Dose Containers states: Opened or needle-punctured, single-dose containers such as bags, bottles, syringes and vials of sterile products and CSP's shall be used within 1 hour if opened in worse than ISO Class 5 air quality and any remaining contents must be discarded. The BUD (beyond use date) after initially entering or opening (e.g. needle punctured) multiple dose containers is 28 days unless otherwise stated by the manufacturer."

1. On 4/6/10 at 11:45 AM, intravenous (IV) bags containing, respectively, propofol, nitroglycerine, lactated ringers solution, and 0.9% sodium chloride were observed in the Heart Surgery operating room, spiked and ready to be infused. The time that each IV bag was spiked was not labeled on the bag. The facility was unable to provide a policy/procedure regarding the labeling of the time of spiking to ensure that administration begins within 1 hour of spiking, however, the facility's policy # 22-02, "Sterile Products: Aseptic Technique, Purpose" states, "To ensure all products are prepared in conditions, which will maintain product's sterility, in accordance with USP Chapter 797, Guidelines for Compounding Sterile Preparations."

2. On 4/6/10 at 11:45 AM, the following pre-filled syringes were observed in the Heart Surgery Operating Room:

-1x syringe, labeled "Heparin," (no date and/or time)

-1x syringe labeled "Esmolol," dated and timed as 4/5/10, 15:00

-1x syringe labeled "Protamine," dated and timed as 4/5/10, 15:00

-1x syringe labeled "Calcium Chloride," dated omitted, 10:00 AM

-1x syringe labeled "Fentanyl" dated and timed as 4/5/10, 15:00

-1x syringe labeled "Diprivan" (no date and/or time)

-1x syringe labeled "Succinylcholine" dated and timed as 4/5/10, 15:00

-1x syringe labeled "Nitroglycerine" (no date and/or time)

-1x syringe labeled "Decadron" dated as 4/5/10, time omitted

-1x syringe labeled "Phenylephrine" dated 4/5/10, time omitted

-1x syringe labeled "Versed" (no date and or time)

-1 x syringe labeled "Rocuronium" dated 4/5/10, time omitted

-1x syringe labeled "Epinephrine" dated and timed as 4/5/10, 15:00

a. Staff #43 informed the surveyor that the syringes for a surgical patient are usually drawn the day of surgery. The surveyor then asked staff in the Operating Room, "what is today's date?" A nurse answered "4/6/10."

b. The facility was unable to provide a policy/procedure regarding the preparation and length of time the pre-filled syringes may be stored prior to administration, if the syringes are prepared in worse than ISO Class 5 air quality.

B. Based on observation of medication storage areas in the presence of Staff #39 and Staff
#40, and documentation available for review, it was determined that the facility failed to ensure that out-dated/misbranded medications and supplies in the Emergency Carts, and Anesthesia Intubation Boxes are removed from active stock inventory.

Findings include:

1. On 4/6/10 at approximately 11:00 AM, the orange Anesthesia Intubation Box #1, located in the anesthesia workroom, contained the following outdated/misbranded medications:

-1x Atropine sulfate, lot # AS006J8, expired 3/31/10

-1x Epinephrine, lot # 4-1-67-407-DK, expired 4/1/10

-1x Succinylcholine, lot # 83-414EV, dated 2/11/10

-1x Succinylcholine, lot # 83-537-EV, dated 2/28/10

-1x Succinylcholine, lot # 83-537-EV, dated 3/1/10

-1x Zemuron, lot # 646628, dated 2/15/10

-1x Zemuron, opened vial, lot # 666190, dated 2/24/10.

a. According to the manufacturers' package inserts, Succinylcholine and Zemuron should be stored in a refrigerator between 2'C (degrees Centigrade) and 8'C. The multi-dose vials of Succinylcholine are stable for up to 14 days at room temperature. Zemuron, unopened, should be used within 60 days after removal from the refrigerator and opened Zemuron vials should be used within 30 days after removal from refrigeration.

b. Staff #42 was unable to tell the surveyor if the dates on the Succinylcholine and Zemuron vials represented the date they were removed from refrigeration or the date the vials should be discarded.

2. On 4/6/10 at approximately 11:10 AM, the orange Anesthesia Intubation Box #2 contained the following outdated/misbranded medications:

-1x Epinephrine, lot # 4-1-67-407-DK, expired 4/1/10

-1x Zemuron, unopened, lot # 646628, undated

3. On 4/6/10 at approximately 11:15 AM, the Malignant Hyperthermia Cart, located in the Operating Suite contained the following out-dated/misbranded items:
9x blue topped lab tubes, expired 2/1/10

4. On 4/6/10 at approximately 11:17 AM, the Emergency Cart located in the Operating Suite contained the following out-dated/misbranded items:

-2x Dextrose 50%, expired 2/1/10

-4x Procainamide, expired 3/1/10

-According to documentation provided, the Emergency Cart was checked on 4/1/10. According to Staff #39, "nurses check this cart."

5. On 4/8/10 at 10:35 AM, in the presence of Staff #9, the Intubation Box contained the following out-dated items:

-5x Bacitracin Packs, lot # U53, expired 2/28/09

-1x Compound Benzoin Swabs, expired 12/31/08

-4x Compound Benzoin Swabs, expired 1/31/08

C. Based on observation of medications in the Post-anesthesia Care Unit in the presence of Staff #39 and Staff #40, and documentation available for review, the facility failed to ensure that any remainder of a single dose medication is discarded, and witnessed, if the drug is subject to the Comprehensive Drug Abuse Prevention and Control Act of 1970 and its amendments.

Findings include:

1. On 4/6/10 at 11:30 AM, review of Patient #13's medical record revealed that anesthesia used 450 mcg (micrograms) out of 500 mcg Fentanyl for this patient during surgery. Thus, 50 mcg of Fentanyl which is packaged as a single patient use vial should be wasted, witnessed, and documented. The medical record did not contain any documentation of the wastage. Staff #40 informed the surveyor that sometimes any remaining narcotic is sent with the patient to the Post Anesthesia Care Unit or saved for use on another patient in the Operating Room. According to Staff #44, the 50 mcg of Fentanyl for Patient #13 was wasted. However, he/she did not document the wastage.

2. On 4/6/10 at 2 PM, the surveyor returned to the Post Anesthesia Care Unit and observed 2 syringes on Patient #13's bedside table, labeled "Compazine 10 milligrams (mg)" and "Dilaudid 2 mg." According to the patient's medical record, 5 mg of Compazine was administered to the patient at 12:55 PM, and Dilaudid 0.5 mg was administered at 12:20 PM. The remaining medication in each syringe should have been discarded after the initial use. After the surveyor questioned the nurse about the syringes, in the presence of Staff #39 and Staff #40, the syringes were discarded and the wastage of 1.5 mg Dilaudid was witnessed and documented in Patient #13's chart.

a. According to the facility's approved policy #21-05, "Single-use sterile drugs and devices should not be reused. Unused portions of single-use sterile drugs shall not be saved for later use."

A. Based on document review, a tour of the kitchen and lunch meal observations conducted in the presence of Staff #20 and Staff #21, it was determined that the food service director failed to provide daily supervision of the food services department and ensure compliance with the New Jersey State Sanitation Code: "Sanitation in Retail Food Establishments and Food and Beverage Vending Machines (Chapter 24)" of the NJ State Sanitary Code NJAC 8:24, as required by the written Food Services "Agreement" dated March 26, 2008.

Findings include:

Reference 1: Chapter 24, 8:24-4.6(c) states: "Non-contact surfaces of equipment shall be kept free of an accumulation of dust, dirt, food residue and other debris."

Reference 2: Chapter 24, 8:24-4.6(j) states: "Non-contact surfaces of equipment shall be cleaned at a frequency necessary to preclude accumulation of residues."

Reference 3: Chapter 24, 8:24-6.5(a) states: "The physical facilities shall be maintained in good repair.

Reference 4: Chapter 24, 8:24-6.5(b) states: "The physical facilities shall be cleaned as often as necessary to keep them clean."

Reference 5: Chapter 24, 8:24-6.5(j) states: "The premises shall be free of items that are unnecessary to the operation, or maintenance of the establishment such as equipment that is non-functional or no longer used, and litter.

Reference 6: Chapter 24, 8:24-6.7(j) states: "Each handwashing sink or group of adjacent sinks shall be provided with the following: Individual disposable towels."


1. On 04/23/10 at 11:00 AM, in the presence of Staff #1, #20, #21, and #35 the food services area was observed with the following non-functional and/or no longer used equipment. The Food Services area was not free of items that are not necessary to the operation, or maintenance of the establishment as per Reference #5.

a. A "Traulsen #5" and "#1" refrigerators were observed stored in the kitchen area with tacky interior and exterior surfaces. Staff #35 confirmed that these units are non-functional or no longer used.

b. The food services hallway was obstructed by two food carts. Staff #35 confirmed that the food carts are non-functional or no longer used.

2. On 04/23/10 at 11:00 AM, in the presence of Staff #1, #20, #21, and #35, the walk in Traulsen #6 refrigerator, the dry store room, freezers #1 and #2, bread walk-in, dairy walk-in and cafeteria were observed with food particles and litter on the floor under the work tables and shelving. The floors were not maintained clean as required per Reference #4.

3. On 04/23/10 at 11:00 AM, in the presence of Staff #1, #20, #21, and #35 heavily stained ceiling tiles were observed through out in areas such as the dry storage room, and main kitchen. The ceiling tiles were not maintained in good repair as required per Reference #3.

4. On 04/23/10 at 11:00 AM, in the presence of Staff #1, #20, #21, and #35 a hand washing sink located across from the pot wash sink area was observed to lack individual hand drying towels. The hand washing sink was not maintained with acceptable hand drying methods, such as individual disposable towels as required per Reference #6.

5. On 04/23/10 at 11:00 AM, in the presence of Staff #1, #20, #21, and #35 the drinking water fountain observed in the food service area was stained, tacky to touch and had a wire bulb cover placed over the drinking spout. The was not maintained in good repair as required per Reference #3 and clean as required per Reference #4.

6. On 04/23/10 at 11:00 AM, in the presence of Staff #1, #20, #21, and #35 the walk in Traulsen #6 refrigerator, drinking water fountain, two not in use food carts, freezers #1 and #2, bread walk-in, and dairy walk-in were observed with an accumulation of dust, dirt, food residue and not maintained clean as required per Reference #1 and #2.


B. Based on interview and document review, it was determined that the Food Service Director failed to ensure that all policies are implemented.

Findings include:

Reference 1: The facility Food & Nutrition Services policy "LD-101 Annual Review Signature Page" policy states "To ensure that the policies and procedures in the manual are up to date and in compliance with all appropriate regulations. Each Manager/Dietitian will review the manual each year and sign and date the review sheet."

Reference 2: The facility Food & Nutrition Services policy "PI-204 Tray Assessments" Policy states "Tray assessments will be randomly completed by management personnel, including the Food Service Director, Food Service Managers, Dietitians and other personnel as assigned. Weekly tray assessments conducted per schedule."

1. On 04/23/10 at 2:30 PM, Staff #1 and #21 confirmed that the facility policy and procedure manual is not reviewed annually as required in Reference #1.

a. The requested "Food and Nutrition Department Policy and Procedure Manual" review sheet was reviewed, signed and dated September 2008, 18 months ago.

2. On 04/23/10 at 2:45 PM, Staff #1 and #20 confirmed that weekly tray assessments are not completed as required in Reference #2.

a. Upon review of the data collected for weekly test trays, Staff #20 confirmed that the test trays are not completed on a weekly basis.

i. The facility provided for review documentation for test trays completed once a month on 6/9/09, 7/7/09, 8/6/09, 9/24/09, 10/27/09, 1/28/10 and 4/5/10.

ii. The facility provided for review documentation for test trays completed twice during the month of March on 3/2/10 and 3/9/10.

iii. During the review of the data provided, Staff #20 confirmed that the test trays were not completed during the months of November to December, 2009 and during the month of February 2010.

Based on observation of the facility's environment, and the lack of quality assurance and performance improvement (QAPI) activities for the environmental service, specifically housekeeping, it was determined that the facility is out of compliance with the Condition of Physical Environment.

Findings include:

1. The facility failed to maintain a clean environment, free of dust, debris, rust, foul odors and vermin; and failed to perform QAPI activities for the housekeeping service. (Cross refer Tag 0701 and Tag 0724).

A. Based on document review, and lunch meal observations conducted in the presence of Staff #20 and #21, it was determined that the facility failed to maintain patient unit pantries clean and in good repair.

Findings include:

1. On 04/23/10 at 11:00 AM, with Staff #1, #20, #21, and #37 the patient unit 2B pantry was observed with cabinets, shelves and counters that are delaminating and have particle board exposed. The 2B unit microwave had a heavy accumulation of food spatter on the interior walls and ceiling. Staff #37 confirmed that the pantry was not maintained clean and in good repair.



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B. Based on tours of the facility in the presence of administrative staff and interview with administrative staff it was determined that the hospital failed to ensure the condition of the physcial plant and overall hospital environment is maintained.

Findings include:

1. A tour of the 5ASU Unit (Forensic) on the morning of April 9, 2010, accompanied by Administrator #11 indicated the following:

a. Nurses Station: The handle on a light green cabinet above a computer counter was missing a screw and it was dangling.

b. Charting Area next to Nurses Station: There was exposed raw wood under the counter and abutting the counter beneath the window to the hallway. The unpainted/unfinished 2X4s and 4X8s are not cleanable surfaces.

c. Physician Charting Alcove:

i. Heavy dust atop a metal cabinet beneath the left side of the counter as one enters the alcove. The cabinet was stuck to the floor by an accumulation of dried spillage, grit, dust, rust, pieces of paper, paper clips, etc. beneath and behind it.

ii. Three corrugated boxes were observed on the floor beneath the counter.

d. Utility Area:

i. The middle drawer of a set of drawers abutting the wall across from the HVAC unit was broken and would not close properly.

ii. The front piece of the HVAC unit was not completely attached to the body of the unit and was hanging.

e. Hallway: A microwave oven with a sticker attached indicating it was last checked by 'Facilities Management' in an undocumented month in 2007 was found to have chipped paint and rusted metal on the interior bottom of the oven. Beneath the microwave on the wooden cart was an SCD Express Unit. The Biomedical Equipment sticker on the equipment indicated that it was due for reinspection by 1/2010 (1/31/10). There was no indication that it had been re-inspected as of the last date of the survey. The wooden cart was warped with exposed raw wood and had dust, grit, grime, and raised stains on it.

f. Shower Room:

i. There was black mold on walls and ceiling throughout the room.

ii. There was wet Chux and towels on the floor with a piece of bloody gauze atop a wet blood stained towel.

iii. There was paint peeling on tiles.

d. The ceiling was crumbling above the door inside of the room.

iv. The metal moulding at the entrance to the shower stall was heavily rusted and the remaining paint was peeling.

v. A slat from the vent was missing.

vi. The metal light cover was heavily rusted.

2. A tour of Patient Care Unit 3A at 10:45 AM on April 6, 2010 accompanied by administrative staff indicated:

a. Nurses Station: Dust atop windows.

b. Pantry:

i. A black metal grille and a white plastic refrigerator shelf were laying on the floor next to the ice machine. Both were stained and dusty.

ii. A cabinet above the counter had spilt sugar in it. The corners of the shelves had crumbs and grit.

iii. A cabinet above the sink had brownish, raised, tacky stains from the top shelf down the wall of the cabinet to the bottom shelf. A smeared red substance was on the inside of the cabinet and grit and crumbs were in the corners.

iv. There was a coat of dust atop the ice machine.

v. One of the two overhead lights did not work.

c. Shower Room: dead bugs were observed inside of the light cover globe.

d. Handwashing Station:

i. The formica was separated from the particle board, and rotting in sections around the sink.

ii. A shelf holding a microwave oven had heavy, raised, tacky, brown stains and grit on it.

e. Hallway Workstation: exposed cut wires protruding from the wall.

f. Room A335:

i. There were dusty windows.

ii. There was dust atop the light over the bed and inside the fluorescent light cover.

g. 3rd Floor Elevator Bank: 6 fuse boxes were found unlocked across from the entrance to the elevators.

h. Hallway alcove:

i. A floor tile section of approximately 2 inches by 10 inches was missing.

ii. Under a linen cart was found heavy dust, grease, grit, and paper scraps.

3. A tour of the Psychiatric Unit (8th Floor) at 2:00 PM on April 6, 2010 accompanied by Administrator #11 indicated:

a. Day Room:

i. The vinyl chair covers had a heavy accumulation of grit, paper, candy wrappers, hair, chewed gum, candy pieces, dust, etc was observed on the sides of the cushions.

ii. The HVAC unit in front of the window has broken and stained pieces of sheet rock behind it. The top of the unit was heavily rusted. An empty juice cup with a thick brown accumulation at the bottom of the cup was found with another empty cup under the unit.

b. Patient Kitchen:

i. The top left drawer of a freestanding cabinet contained sticky brown stains, candy wrappers, and a thick, black, tar-like substance in the corners. Sticky straw wrappers were also observed in the drawer. The drawer beneath the top drawer was in much the same condition.

ii. Behind and beneath the refrigerator was found heavy accumulations of dust, grit, paper, condiment packets, straws, popcorn, apple jelly, candy wrappers, raised stains, food pieces, etc.

iii. Inside of the refrigerator was found spillage on the shelves and interior walls. There was no thermometer in the refrigerator which contained undated cups of food and drink.

iv. Drawers under the countertop to the left of the sink contained a blackish, sticky substance, cereal pieces, grit, and raised stains.

v. A metal cabinet above the sink to the right was stained throughout the interior.

vi. Behind and beneath a freestanding cabinet was found cereal pieces, stains, cracker pieces, wrappers, grit, etc.

c. Clean Linen Room: There was a cracked plastic light cover globe.

d. Hallway Water Fountain:

i. The water fountain was leaking from the rear.

ii. A crushed water bottle, candy wrappers, individual creamer, wet paper, leaves, etc was pulled from behind the fountain.

iii. When the soaking trash was observed after being removed from behind the fountain, small bugs were observed running from the pile.

e. Charting Room:

i. Under the counter next to the shredder box was found a piece of cracker, a cookie, a cigarette lighter, and a container of a patient's medication from home.

ii. The ceiling had an approximately 4 foot x 4 foot section with peeling paint and powdery plaster. There were stains on the light cover from the deteriorating ceiling above it.

4. A tour of Patient Care Unit #B at 3:35 PM on April 8, 2010 accompanied by Administrator #37 indicated:

a. Hallway Handwashing Station:

i. The Formica countertop behind the sink to the right when pressed down forced cloudy water with pieces of particle board from the seams.

ii. A microwave stand had thick, tacky stains atop it. The microwave was missing the carousel plate. A burnt piece of paper was found under the microwave which had scorch marks on the bottom of it.

b. Ante Room for B301 and B303: The counter with the sink had broken formica exposing particle board.

c. Conference Room:

i. A wheelchair scale had a biomedical engineering sticker on it indicating: 'Biomedical Equipment Inspected 2/06 by __ (initials of writer) Due: 2/07.' There was no evidence that the scale was ever re-inspected subsequent to February 2006.

ii. The walls behind and above the door inside the room had a black, mold-like substance on the wall covering.

d. Pantry:

i. There were stains inside of the drawers.

ii. Formica was coming off of the cabinet doors beneath the water/ice machine.

iii. The handles on drawers below the water/ice machine were broken.

e. Room B327: There was ripped sheet rock beneath and around the soap dispenser in the bathroom.

f. Old Satellite Pharmacy:

i. There were two missing drop ceiling tiles and multiple tiles falling from ceiling.

ii. Floor was littered with trash, dust, grit, razor blades, etc.


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5. On 4/8/10 during tour of the Nuclear Medicine Department in the presence of Staff #1 and #47, the following was observed:

a. The alcove where the 'Curix Compact Plus' Processor for films is stored, was noted to have dust and debris on the floor [i.e. old plastic flexible tubes] surrounding the machine.

b. The last date of a preventative maintenance inspection was noted to be 4/2/07 per a maintenance sticker affixed to the machine. Per Staff #47, the Processor has not been utilized for about 6 months.

c. The Nuclear Medicine Preparation Room was observed to have dust on the floor and the sink and the countertop had dry liquid stains and markings. On 4/8/10 at 2:35 PM Staff #51 stated in interview that he/she does not have any liquid materials and the liquid stains are from general handwashing in the room. Staff #51 stated that the housekeeper is responsible for cleaning the Nuclear Medicine Preparation Room, but that he/she has to be present for the housekeeper to do this because the room is secured due to the need to safeguard the radioactive materials, and safeguard people from the radioactive materials. He/she could not say when the room was last cleaned. He/she stated it is not cleaned on a daily basis, maybe weekly.

6. On 4/8/10 during tour of the Wound Care Center in the presence of Staff #1 and #48 the following was observed:

a. The bathroom located in the patient changing area was observed to have a large amount of peeling paint from the ceiling above the sink, and from the wall above and below the light fixture hanging above the sink. Per Staff #48, there was a leak in the ceiling awhile ago and it was scraped down and repaired, but needs to be repaired again.

b. The metal cabinet used to store patient gowns was observed to be rusting on the shelves within. The patient gowns were stored on the floor of the cabinet.

7. On 4/7/10 at 2:00 PM the laboratory was toured in the presence of Staff #9. The corridor that the pharmacy and laboratory is located, on the first floor, was observed to have a foul odor. On 4/8/10 at 3:41 PM this was reported to Staff #33 during interview/discussion with him/her. Staff #33 stated that the foul odor observed yesterday on the first floor corridor was a dead mouse that was found and discarded.

8. On 4/9/10 the Rehabilitation Department was toured in the presence of Staff #9 and #53, and the following was observed:

a. The Hydrocollator had rust on the interior of its surface.

b. The freezer for the cold packs was observed to have excess frost on the sides of the interior; one of the frozen gel packs within the freezer was leaking and the blue gel of the ice pack froze to the side of the interior.

i. A sticker on the freezer indicated it was defrosted and cleaned 12/08. Per Staff #53, he/she cleaned the the freezer two and a half months ago, but did not keep a record/log.

c. The Paraffin Wax unit was off, plugged in, and a thermometer was standing straight up inside of the solidified wax. There was paper tape adhered to the side of the unit indicating it was "Cleaned 8/7/06." There also was a post-it sticker taped to another side of the unit that stated it was "Cleaned 5/1/07." There was solidified wax remnants on top of the exterior of the lid to the unit.

i. Per Staff #53 the unit is no longer used in the department.

9. On 4/8/10 2:40 PM the hospital wide QAPI was reviewed with Staff #17. Staff #17 stated that the Housekeeping Department does quality control in their department, but it is not reported to the QA Council. He/she further stated that Patient Satisfaction Surveys for housekeeping are used to evaluate the housekeeping service.

i. The Patient Satisfaction Survey results from April 1, 2008 thru March 31, 2009 were reviewed and there was one result/indicator for housekeeping that evaluated the "Percent of patients who reported their room and bathroom were always clean."

10. On 4/8/10 at 3:41 PM Staff #33 was interviewed and he/she stated the housekeeping department/environmental department does not do QA; they do inspections once a week in different areas of the hospital, but there is no tracking or trending of these inspections, and there is no data to report to the QA council.

Based on a tour of the facility and interview with facility Staff #1 and #21, it was determined that the facility failed to ensure compliance with all applicable provisions of the "NFPA 101, 2000 edition of the Life Safety Code and all codes incorporated by reference."

Findings include:

1. On 04/23/10 at 11:30 AM, Staff #1, #20, #21, and #35 confirmed that the fire extinguisher opposite the food services tray line was observed on the floor and was not wall mounted as required by NFPA 110.

2. On 04/23/10 at 11:30 AM, Staff #1, #20, #21, and #35 confirmed that the following CO2 cylinders were observed standing on the floor and were not secured to the wall by a chain or other approved method as required by NFPA 110.

a. Two CO2 cylinders were observed standing in the kitchen area unsecured.

b. Three CO2 cylinders were observed standing in the kitchen compressor room unsecured.

A. Based on tours of the facility it was determined that the facility failed to ensure all supplies were maintained within an acceptable level of safety and quality.

Findings include:

1. A tour of the ED beginning at 10:15 am on April 6, 2010 accompanied by Staff #2 indicated the following:

a. Decontamination Room: One package of 100 BD Vacutainer K2 EDTA (K2E) 7.2 mg Plus Blood Collection Tubes with expiration dates of 2008-11 (11/30/2008) and one package of 100 BD Vacutainer Serum Blood Collection Tubes with expiration dates of 2008-10 (10/31/2008) were observed available for patient use.

b. Medication Room: A cabinet above the sink was found to contain:

i. Three BD Spinal Needles 18G x 3-1/2 packages with expiration dates of 2009-05 (May 31, 2009).

ii. Two 16G x 1-1/4 Protect IV Needles with expiration dates of 2008-08 (August 31, 2008).

iii. Two 14G x 1-1/4 Protect IV Needles with expiration dates of 2008-05 (May 31, 2008).

2. A tour of Patient Care Unit 3B beginning at 3:35 PM on 4/7/10 accompanied by Administrator #11 indicated the following:

a. Nurses Station: A drawer under a computer at the counter was found to contain one blue cap Vacutainer with an expiration date of 2010-02 (2/28/2010).

b. In the Medication Room, the blood tubes cabinet was found to contain:

i. Two gray top Vacutainers with expiration dates of 2009-07 (7/31/09).

ii. Two gray top Vacutainers with expiration dates of 2010-01 (1/31/10).

iii. Two blue cap Vacutainers with expiration dates of 2009-11 (11/31/09).

iv. One red cap Vacutainer with an expiration date of 2009-01 (1/31/09).

v. One yellow cap Vacutainer with an expiration date of 2010-01 (1/31/10).

c. A cabinet beneath the counter underneath the needle collection box contained:

i. Four red cap Vacutainers with expiration dates of 2005-12 (12/31/05).

ii. One red cap Vacutainer with an expiration date of 2009-08 (8/31/09).

iii. One blue cap Vacutainer with an expiration dates of 2005-02 (2/28/05).

iv. Two blue cap Vacutainers with expiration dates of 2005-07 (7/31/05).

v. Two blue cap Vacutainers with expiration dates of 2005-11 (11/31/05).

vi. One green cap Vacutainers with an expiration date of 2005-10 (10/31/05).

vii. Two green cap Vacutainers with expiration dates of 2006-04 (4/30/06).

viii. Two lavender cap Vacutainers with expiration dates of 2006-06 (6/30/06).

ix. One lavender cap Vacutainer with an expiration dates of 2006-08 (8/31/06).

3. A tour of the Prison Unit beginning at 11:15 am on 4/9/10 accompanied by Staff #11 indicated the following:

a. Nurses Station: A drawer under a cabinet next to the window was found to contain:

i. One yellow top Vacutainer with an expiration date of 2009-11 (11/31/09).

ii. One Baxter Mini Cap with Povidone Iodine Solution package with an expiration date of Dec '08.

iii. One Post Op Sponges package with numerical calculations made in pen on the exterior package.

b. Utility Area: Drawers against the wall and across from an HVAC unit were found to contain:

i. One red cap Vacutainer with an expiration date of 2009-09 (9/31/09).

ii. One yellow cap Vacutainer with an expiration date of 2009-08 (8/31/09).

iii. One 22G x 1 Protect IV Needle with an expiration date of 2008-08 (8/31/08).

iv. Two Kendall Curity Cover Sponges with expiration dates of 2009-01 (1/31/09).

v. One Anaerobic Pulsator Arterial Blood Sampling Kit with an expiration date of 2001-06 (6/30/06).

vi. One Ross Enteral feeding Tube with an expiration date of 8/09 (8/31/09).

vii. One In-Line Filter for Protonix I.V. with an expiration date of 2005-03 (3/31/05).

B. Based on tours of the facility it was determined that not all facilities were maintained to ensure an acceptable level of safety and quality.

Findings include:

1. A tour of the ED beginning at 10:15 AM on April 6, 2010 accompanied by Staff #2 indicated the following:

a. Decontamination Room:

i. The vent on the ceiling above a stretcher had a heavy accumulation of dust.

b. Sub Zero Room:

i. Plastic bags, a plastic fork, dust, old tape, paper scraps, surgical gloves, popcorn, grit, a broken piece of concrete, candy wrappers, chewed gum, plastic needle covers, etc were observed on the unwaxed floor.

ii. There were cobwebs in the corners of the room and along the floor moulding.

iii. The interior ledge of the window to the ED entrance had desiccated moths, a fly, and other smaller winged insects.

c. Ambulance Entrance:

i. Just inside of the entrance (between both sets of double doors) a ceiling light cover was observed to have heavy yellow stains.

ii. Ceiling light covers contained dead bugs inside of them.

d. Waiting Room:

i. The floorboard heating unit was pulled away from the wall approximately 3-4 inches.
There was a heavy accumulation of dust, paper, ripped sheet rock, and other trash. The wall screws were completely exposed in some areas.

ii. There was a stained ceiling tile.

e. Medication Room:

i. The medication refrigerator was heavily frosted on the back wall and top shelf. Heavy dust was observed beneath a plastic drawer inside the bottom of the refrigerator. A corner of a glass shelf in the refrigerator was broken off and there was spillage on the interior shelves of the door.

ii. A dead mosquito was found on the wall next to the paper towel dispenser, as well as tacky, orange-colored splash stains.

f. Nurses Station:

i. The top drawer at the end of the counter closest to the ambulance entrance contained corn chip pieces, broken pretzel pieces, candy wrappers, plastic knives, piles of salt and /or sugar, bobby pins, a package of raspberry drink mix, and other refuse. The drawer beneath it contained magazines which were covered with salt and/or sugar spilt from the drawer above it. There was also an accumulation of the crystals at the bottom of the drawer.

ii. A power cord was sticking out of a cabinet door beneath the counter top. The cord was heavily covered with dust, cellophane, paper scraps, etc.

iii. A top drawer under a counter across from Bay 10 contained an opened overturned salt shaker. The bottom of the drawer beneath the top drawer contained salt and/or sugar crystals.

iv. A countertop across from Bay 3 had heavy dust, paper clips, paper scraps, grit, and coins behind racks of medical records.

v. Beneath the counter across from Bay 11, a rolling cabinet was found to have dust, grit, and dried spillage atop it. Beneath the cabinet was found heavy dust, pieces of cookie, a cheese puff, grit, and raised dried spillage covered with dust.

vi. There were thick clumps of dust, raised stains, and grit behind and under the copy machine.

vii. There was a blue cloth covered rolling chair with a rip to the seat cover of approximately 8 inches by three inches.

viii. A rolling cabinet beneath the countertop across from Bay 3 was found to have heavy raised stains covered with dust, grit, candy wrappers, used rubber gloves, bent paper clips under it. There was dust atop the cabinet and the wheels were encrusted with dust.

ix. A blue cabinet beneath the countertop to the left of the above referenced rolling cabinet was observed to have a coat of dust atop it. Beneath the cabinet was found dried heavy spillage, dust, grit, paper clips, and paper scraps.

g. Residents Charting Room:

i. There was chewed gum on the wall under a cabinet.

ii. There was a blue cloth chair with surgical gauze and tape attached on arm rest to cover disrepair.

iii. Beneath the countertop was observed an uncovered electrical outlet.

h. Soiled Utility Room: There was a small hole in the wall behind the door leading to the hallway.

i. Patient Room 12:

i. Approximately 1/4 of a drop ceiling tile was cracked.

ii. A metal cabinet beneath the sink was rusted thoroughly from the interior to the face of the cabinet doors. The interior of the cabinet contained moist, rusted, and unfolded towels and bed sheets. There were detached flakes of rusted metal in the cabinet. There was a black mold-like substance and paint chips in the cabinet.

iii. The call bell in the bathroom, when activated, didn't turn on the light outside of the patient room.

j. Patient Room 13: Two walls were observed to have grooves. The gypsum was exposed.

Based on observation and interview with staff on April 6 and 7, 2010, it was determined
that the facility failed to follow nationally recognized infection control guidelines from a
nationally recognized organization.

Findings include:

Reference: The Association for the Advancement of Medical Instrumentation (AAMI) requirements, " Good Hospital Practice: Steam Sterilization and Sterility Assurance,"
ST 79, Section 3.3.7.1 Decontamination area indicates, the area in which instruments and other devices are decontaminated should be physically separate from all other processing areas and from areas in which clean or sterile patient care procedures are carried out.

1. On April 7, 2010 at 11:15 AM, Staff # 34 was questioned on the cleaning procedure for the heart and lung equipment. Staff # 34 indicated that the machine is cleaned in the sterile corridor outside of Operating Room #8, providing a potential source of contamination.

Reference: The Association for the Advancement of Medical Instrumentation (AAMI) requirements, "Good Hospital Practice: Steam Sterilization and Sterility Assurance," ST 79, Section 8.3.7 Surgical supplies indicates that surgical supplies should be individually packaged to ensure sterility and prevent a source of contamination.

1. On April 7, 2010 at 11:30 AM, a tray of approximately 8 rolls of cotton padding was observed open on top of the anesthesia machine in Operating room 3. Staff #5 indicated that the padding is used on patients as a cushion below the blood pressure cuff. This may provide a source of contamination to patients.

Reference: The Association for the Advancement of Medical Instrumentation (AAMI) requirements, "Good Hospital Practice: Steam Sterilization and Sterility Assurance,"
ST 79, Section 8.9.2 Storage facilities indicates sterile items should be stored in a manner that reduces the potential for contamination.

1. On April 7, 2010 at 11:45 AM, clean and sterile oxygen masks, plastic respiratory tubing, and plastic airways were observed open and uncovered on the anesthesia carts in Operating Rooms #1, #3, and #5, providing a potential for contamination to patients.

Reference: The Society of Gastroenterology Nurses and Associates, Inc., (SGNA)
The Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes.
Page 3 of 12 indicates the reprocessing of contaminated patient equipment should be done in an area designated and dedicated for this function, and should separate soiled and clean processes. Considerations include space for reprocessing activities, work flow, work surfaces and storage.

1. There is no separation of soiled and clean processes by design or work flow. On April 6, 2010 at 2 PM, Staff #15 was observed to leak test and clean an endoscope in a gray bin placed on top of the hopper sink where soiled suction fluids are emptied. Staff #15 then discarded her gloves and removed a clean endoscope from the Steris equipment directly across from the sinks, providing a potential for cross contamination.

Reference: The Society of Gastroenterology Nurses and Associates, Inc., (SGNA) page 9 of 12, J. Storage, indicates that the scope should be hung vertically with the distal tip hanging freely in a well ventilated, and dust free area to prevent moisture buildup and potential microbial contamination.

1. On April 6, 2010 at 2:15 PM, endoscopes stored in the cabinet in Procedure Rooms #2 and #3 were hung too low in the cabinet, allowing the scopes to hang down onto the cabinet shelf without draining freely.

2. The bronchoscopes stored in the wall cabinet in the X-Ray Fluoroscopy room were stored in a coiled condition, which allows moisture buildup and potential microbial contamination.

3. The bottom shelves of the scope storage cabinet in Procedure Room #2 and #3 contained a metal plate which was soiled and dusty.

Reference: The Society for Gastroenterology Nurses and Associates, Inc., (SGNA)
Page 4 of 13, Final Rinse/Alcohol Purge indicates the entire endoscope must be dried, and the internal channels flushed with 70% alcohol, followed by forced air drying, before patient procedures and prior to storage.

1. On April 6, 2010 at 2:30 PM, 2 endoscopes processed in the Steris equipment were observed stored in two drawers in a portable plastic cabinet outside the decontamination room. Staff #15 indicated that the scopes are stored there until she is able to process them with the alcohol and air in Procedure Room #1. The delay in processing may provide a source of contamination.

2. Procedure Room #1 is not a designated clean room and was observed to be soiled and cluttered; providing a potential for contamination.

Reference: Centers for Disease Control and Prevention, (CDC), Guideline for Hand Hygiene in Health-Care Settings.

1. On April 6, 2010 at 2 PM, Staff #15 was observed to remove her gloves after the decontamination process of an endoscope and then putting on a new pair of gloves prior to removing a clean endoscope from the Steris equipment. Staff #15 did not wash her hands prior to putting on the new gloves.

2. A hand wash sink or surgical scrub product was not available for use.

A. Based on observation on April 6 and 7, 2010, it was determined that the facility failed to ensure a sanitary environment.

Findings include:

1. The lower cabinets below the Steris equipment in the Endoscopy decontamination room were soiled and dusty.

2. The patient table mat in the X-Ray Fluoroscopy room were torn in several sections; exposing a porous mat below, making cleaning difficult.

3. A suction canister filled with fluid from a procedure on April 5, 2010 was observed attached to the wall suction port in the X-Ray Fluoroscopy room. The canister was not removed after the patient procedure as per hospital policy.

4. On April 6, 2010 at 3 PM a bottle of open sterile water dated 4-5-10, 7:30 AM was observed on a storage cart in the X-Ray Fluoroscopy room. The sterile water was not discarded after 24 hours as per hospital policy.

5. The over bed trays in the Endoscopy Post Operative area were covered with contact paper which were torn and peeling, providing a potential source of contamination.

6. There was dust, soil, and/or rust accumulation in the following areas:

a. The plastic storage bins and storage carts for clean and sterile supplies throughout the Endoscopy unit.

b. The IV pole in Operating Room #1.

c. The anesthesia cart in Operating Room #4.

d. The storage cabinets in Operating Room #4.

e. The shelves and storage racks within the OR Light/Dark room.

f. The floor in the OR perfusion room. There were also boxes of syringes, and clean & sterile supplies stored on the floor, that prevents proper cleaning of the floors.

g. The storage cabinets alongside the sinks in the Sterile Processing Department decontamination room contain heavy rust.

h. The floor behind the Pasteurmatic equipment in the decontamination room of the Sterile Processing department.

i. The ventilation slats in the doors to the back of the sterilizers in the decontamination room of the Sterile Processing department.

7. The following areas had surfaces that are not cleanable and show signs of disrepair:

a. The storage closet in the sub sterile room between Operating room 5 and 6 contains shelving with porous wood surfaces.

b. Several ceiling tiles in the bulk linen room adjacent to the Sterile Processing department are water damaged and contain mold growth.

c. Two tables used for the packaging of sterile supplies in the Sterile Processing department linen folding room contain porous wooden surfaces and peeling laminate material.


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B. Based on observation it was determined that the facility failed to implement its policy and procedure for the dress code in the post anesthesia recovery unit (PACU).

Findings include:

Reference: Facility Policy Number: D-3.0, Subject: 'Dress Code," states "Policy: Scrub attire, made of material which meets N.F.P.A. standards, will be worn at all times within the restricted and semi-restricted areas of the surgical suite; scrub attire will be supplied and laundered by the Medical Center. ...Purpose: To prevent microbial contamination of the OR environment. Procedure: 1. Scrub attire will be provided to all OR personnel."

1. On 4/7/10 2:30 PM the Same Day Surgery unit and Recovery Room were toured in the presence of Staff #9 and #5. The three Recovery Room nurses each were wearing scrub attire that was not supplied and laundered by the Medical Center.

i. One nurse had full scrub navy blue scrub attire, a scrub top and scrub pants, that were her own.

ii. A second nurse was wearing her own printed scrub top.

iii. A third nurse was wearing her own printed scrub jacket.

2. Staff #5 confirmed that the nurses should be wearing hospital issued scrub attire.

Based on observation, patient interview, and review of facility documents it was determined that the facility failed to ensure all patients give informed consent to surgery.

Findings include:

Reference: Medical Staff Rules and Regulations states "...D. General Conduct of Care...3. ...In addition to obtaining the patient's general consent to treatment, a specific consent that informs the patient of the nature of a procedure, the risks and benefits and alternatives available in any surgical or invasive procedure should be obtained."

1. On 4/9/10 at 10:40 AM the Holding Room of the Surgical area was toured in the presence of Staff #9. Patient #25 was lying on a stretcher, in a gown with his IV infusing, awaiting his surgery. Review of Patient #25's medical record evidenced a 'Consent for Surgical Procedure,' for a repair of an umbilical hernia with mesh, that was signed by the patient on 4/9/10 [no time indicated] and witnessed. The area that states "Explanation by Physician: I certify I have explained the surgery or procedure as designated above to the patient or authorized patient representative and he/she has consented to surgery on: [physician signature area and date]" was blank.

2. In interview on 4/9/10 at 10:54 AM, Patient #25 stated he saw his surgeon last week, but has not seen him/her yet today. He further stated he has some questions for the surgeon prior to surgery.

3. With the facility's practice to obtain the patient's signature for surgical consent prior to the surgeon signing the consent attesting to explaining the surgical procedure to the patient, and Patient #25 stating he still had questions regarding the procedure, it could not be determined if the patient was able to give informed consent for surgery.

Based on observation it was determined that the facility failed to implement its policy and procedure for the dress code in the post anesthesia recovery unit (PACU).

Findings include:

Reference: Facility Policy Number: D-3.0, Subject: 'Dress Code', states "Policy: Scrub attire, made of material which meets N.F.P.A. standards, will be worn at all times within the restricted and semi-restricted areas of the surgical suite; scrub attire will be supplied and laundered by the Medical Center. ...Purpose: To prevent microbial contamination of the OR environment. Procedure: 1. Scrub attire will be provided to all OR personnel."

1. On 4/7/10 2:30 PM the Same Day Surgery unit and Recovery Room were toured in the presence of Staff #9 and Staff #5. The three Recovery Room nurses each were wearing scrub attire that was not supplied and laundered by the Medical Center.

i. One nurse had full scrub navy blue scrub attire, a scrub top and scrub pants, that were her own.

ii. A second nurse was wearing her own printed scrub top.

iii. A third nurse was wearing her own printed scrub jacket.

2. Staff #5 confirmed that the nurses should be wearing hospital issued scrub attire.

A. Based on observation, staff interview, and review of facility policies and procedures it was determined that the facility failed to implement its policies and procedures for hot packs and cold packs.

Findings include:

Reference #1: Facility Department of Physical Medicine and Rehabilitation Policy titled 'VII. Hot Packs or Hydrocollator Packs' states "...Water temperature shall be maintained between 160-165 degrees F [Fahrenheit]. Daily temperature log is kept."

Reference #2: Facility Department of Physical Therapy Policy Subject: 'Cold Packs' states "...Cold packs are maintained in a semi-solid form between 32-41 degrees F. Daily temperature log is kept."

1. On 4/9/10 the rehabilitation department was toured in the presence of Staff #9 and #53 and the following was observed:

a. The Hydrocollator had rust on the interior and there was not a temperature log located within the department to indicate the temperature of the Hydrocollator was checked today. This was confirmed by Staff #53. Staff #53 stated the temperature is supposed to be checked daily. There were no temperature logs for the Hydrocollator available for review.

b. The freezer for the cold packs was observed to have excess frost on the sides of the interior; one of the frozen gel packs within the freezer was leaking and the blue gel of the ice pack froze to the side of the interior. There was no temperature log located within the department to indicate the temperature of the freezer was checked today, as per policy in reference #2. This was confirmed by Staff #53. There were no temperature logs for the freezer available for review.

2. Without a daily temperature log for the Hydrocollator and the freezer, it could not be determined when the temperatures were checked last, and if the temperatures were in a safe range for application of the hot packs and ice packs to the patients.

Based on medical record review, staff interview and review of facility policy and procedure, it was determined that the respiratory therapists failed to assess patients pre and post aerosol treatment in 2 of 3 medical records reviewed for respiratory treatments (Medical Records #1 and #2).

Findings include:

Reference #1: Facility Policy Number RC3, Subject 'Assessment', states "...PROCEDURE: ...Assessment is performed by RCP [respiratory care therapist]. This will include the following. ...RESPIRATORY RESPONSE TO THERAPY: -Changes in respiratory rate and /or rhythm -Patient color -Breath sounds before and after therapy -Cough effectiveness -Sputum production, quantity, consistency and color...-results of any non-invasive respiratory monitoring in use during therapy. ...CARDIOVASCULAR RESPONSE TO THERAPY: -Heart rate, pre and post therapy."

Reference #2: Facility Policy Number RC35, Subject 'SMALL VOLUME NEBULIZER', states "PROCEDURE: ... 6. Patient assessment check HR [heart rate], BS [breath sounds] and RR [respiratory rate]. ...9. At the end of treatment encourage patient to cough and expectorate. 10. Reassess heart rate and breath sounds."

1. On 4/6/10 in the presence of Staff #1 and #11 the Intensive Care Unit and Cardio Thoracic Unit was toured. Review of Medical Records #1 and #2, in the presence of Staff
#1, #11, and #12 evidenced respiratory treatments that were administered by the respiratory therapists without a pre and post assessment as directed by facility policy. The following was noted:

a. Review of Medical Record #1 indicated per the physicians' orders that the patient was receiving Albuterol [Proventil] and Ipratropium Bromide [Atrovent] treatments every 4 hours. Review of the Medication Administration Records also indicated the patient was receiving Albuterol and Atrovent treatments every 4 hours. The respiratory care notes were reviewed for 4/2/10-4/5/10. The following was noted:

i. There was no evidence in Medical Record #1 of an assessment of the patient's breath sounds on the 7 PM-7 AM shift's single entry note for 4/2/10.

ii. There was no evidence in Medical Record #1 of any respiratory therapy notes/assessments for the day shift, 7 AM-7 PM, on 4/3/10.

iii. There was no evidence in Medical Record #1 of an assessment of the patient's breath sounds on the 7 PM-7 AM shift's single entry note at 2030 for 4/3/10.

iv. There was no evidence in Medical Record #1 of an assessment of the patient's breath sounds on the 7 PM-7 AM shift's notes at 1900, or on the referred Ventilator flowsheet for 4/4/10.

c. Review of the medication Administration Records for Patient #1 for 4/5/10 indicated the patient received Atrovent and Albuterol treatments at 0121, 0508, 1100, 1412, 1803, and 2116. There was no evidence in medical record #1 that the respiratory therapists assessed patient #1's lung sounds, respiratory rate, heart rate, and pulse ox if in use during therapy, pre and post treatment at these times.

d. Review of Medical Record #2 indicated per the physician orders that the patient was receiving Pulmicort every 12 hours and Albuterol and Atrovent every 6 hours. Review of the Medication Administration Records also indicated the patient was receiving Albuterol and Atrovent treatments every 6 hours and Pulmicort every 12 hours. The respiratory care notes were reviewed for 4/2/10-4/5/10. The following was noted:

i. There was no evidence in Medical Record #2 of any respiratory therapy notes/assessments for the day shift, 7 AM-7 PM, on 4/2/10.

ii. There was no evidence in Medical Record #2 of an assessment of the patient's breath sounds and heart rate on the 7 PM-7 AM shift's single entry note for 4/2/10.

iii. There was no evidence in Medical Record #2 of any respiratory therapy notes/assessments for the day shift, 7 AM-7 PM, on 4/3/10.

iv. There was no evidence in Medical Record #2 of an assessment of Patient #2's heart rate in the note completed on 4/3/10 at 1950; There was no evidence of an assessment of Patient #2's respiratory rate, heart rate, or lung sounds in the note completed 4/3/10 at 2325 as a late entry.

v. There was no evidence of an assessment of the patient's respiratory rate or heart rate in the single entry note for 7 AM-7 PM on 4/4/10.

vi. There was no evidence of an assessment of heart rate, breath sounds, or respiratory rate in the note for 4/4/10 2325.

vii. There was no evidence of an assessment of heart rate, respiratory rate, or lung sounds in the 7 AM-7 PM shift's single entry note for 4/5/10.

e. Review of the Medication Administration Records for Patient #2 for 4/5/10 indicated the patient received Atrovent and Albuterol treatments at 2400, 0600, 1200, 1800, and received Pulmicort treatment at 2200. There was no evidence in Medical Record #2 that the respiratory therapists assessed Patient #2's lung sounds, respiratory rate, and heart rate pre and post treatments.

2. The respiratory therapists are not implementing the facility's policies in references #1 and #2 for assessing patients pre and post treatment for breath sounds, respiratory rate, heart rate, pulse oximetry if using during treatment or as per Staff #12's interview. The documented assessments that were evident do not specify if the assessments were pre or post respiratory treatment.

Based on medical record review, staff interview, and review of facility policy and procedure, it was determined that the respiratory therapists failed to administer all medications in accordance with physician orders in 1 of 3 medical records reviewed for respiratory treatments (Medical Record #2).

Findings include:

Note:
mg=milligrams
ml=milliliters

Reference #1: Policy No. R.T. 1.5, Subject: 'Documentation in the MAK (Medication Administration Check) System', states "...PROCEDURE: ...[2nd bullet] Once the medication is profiled the nurse will verify and accept the order as it appears in the MAK System with the original physician order. Once verified the medication may then be administered at the specific times. [3rd bullet] All recurring aerosol orders are recognized as 5-day orders."

1. On 4/6/10 on the Intensive Care Unit, Medical Record #2 was reviewed in the presence of Staff #1, #11, and #13. The following physician orders for respiratory treatments were noted:

i. A physician order dated and timed 3/30/10 8:45 AM to renew Pulmicort respules every 12 hours.

ii. A physician order dated and timed 4/2/10 9:00 AM to renew Pulmicort respules every 12 hours.

2. Review of the Medication Administration Record [from the MAK system] for the date of 4/5/10 indicated the ordered Pulmicort Respules 0.5 mg/2 ml every 12 hours was due at 1000, and the 1000 signature area for administration was blank/ lacked evidence of a computerized signature to indicate the medication was administered.

a. This was confirmed by Staff #13 on 4/6/10 at 11:45 AM.

b. The Pulmicort order was current and within the 5 day order timeframe per policy.

c. There was no indication in Medical Record #2 as to why the medication was not administered on 4/5/10 at 1000. This was confirmed by Staff #13.