HospitalInspections.org

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

CFR 482.42 Infection Control

Based on document review and staff interview, it was determined that the governing body failed to ensure that the contracted Food Service company provides services in a safe and effective manner.

Findings include:

1. On 6/8/10 at 2:00 PM during interview, Staff #1, Staff #5 and Staff #12 stated that the Governing Body did not have an established system to evaluate the contracted Food Service company.

a. Staff #1, Staff #5 and Staff #12 confirmed that the Governing Body was not informed that the facility kitchen was evaluated as conditional by the local "Retail Food Inspector" during an inspection conducted on 12/11/09.

b. Staff #1, Staff #5 and Staff #12 confirmed that the requested Governing Body meeting minutes, for the year 2009 and first quarter of 2010, do not reference and/or evaluate the Contracted Food Service provider, including the local "Retail Food Inspection Reports."

2. On 6/7/10 at 10:30 AM, Staff #20 and Staff #22 provided for review, the requested local "Retail Food Inspection Report" dated 12/11/09 and the local "Reinspection Retail Food Inspection Report" dated 12/21/09.

a. On 6/7/10 at 10:30 AM, Staff #20 and Staff #22 confirmed that the local "Retail Food Inspection Report," dated 12/11/09 had written "Conditional" in the "Evaluation" section of the report.

b. On 6/7/10 at 10:30 AM, Staff #20 and Staff #22 confirmed that the local "Reinspection Retail Food Inspection Report" dated 12/21/09 had written "Satisfactory" in the "Evaluation" section of the report.

c. During interview on 6/7/10 at 10:30 AM, Staff #20 and Staff #22 stated that the local "Retail Food Inspection Reports" are not shared with the Infection Control Committee, Quality Assurance Committee and/or the Governing Body.

d. Staff #1, Staff #5 and Staff #12 confirmed on 6/8/10, that there was no communication regarding the "Conditional" status of the kitchen. Staff #1, Staff
#5, and Staff #12 confirmed that there is no process in place to evaluate the contracted Food Service Company's services.

Based on medical record review, it was determined that the physicians failed to implement the facility policy and procedure for DNR (Do Not Resuscitate) in three of four medical records reviewed (Medical Record's #8, #10 and #28).

Findings include:

Reference #1: Facility policy and procedure Code Number: 2.4, Subject: 'Non-Resuscitation/ DNR Policy', states "... VII. DNR ORDER A. The DNR order must be written, dated, timed and signed by the Attending Physician on the Do Not Resuscitate Order Sheet. B. The decision-making process, including the clinical facts and circumstances, and all discussions with the patient, health-care representatives, or other surrogate decision-makers, shall be documented in detail in the patient's medical record in the Physician Progress Notes. At a minimum, the documented information shall include: ... d) Documentation that discussion of DNR status has occurred and with whom. If not discussed with a competent patient, documentation of the reason."

Reference #2: RWJUHR Medical/Dental Staff Bylaws Rules and Regulations, Revised 5/10, states, "All orders for treatment shall be in writing. A verbal order shall be considered to be in writing if dictated to a duly authorized person functioning within his or her sphere of competence, and signed by the responsible practitioner or another practitioner who is responsible for the care of the patient...The responsible practitioner for the care of the patient must authenticate such order within 48 hours... All orders dictated over the telephone shall be signed by the appropriately authorized person to whom dictated with the name of the practitioner per his or her own name...Authentication of such orders shall include the date, time and signature of the responsible practitioner."

1. On 6/7/10 at 2:15 PM, in the presence of Staff #10 and Staff #13, medical records were reviewed for DNR orders and implementation. Medical Record #8 indicated the following:

a. Per the Patient Admission Assessment dated 6/3/10, the patient did not have an advance directive.

b. A 'Do Not Resuscitate Order Sheet' dated 6/4/10 and signed by the physician. "No" was circled next to "chest compressions and mask and bag ventilation," "Defibrillation," and "Intubation, mechanical ventilation." "Yes" was circled next to "Vasopressors or antiarrhythmics" and "Critical care Transfer."

c. There was no evidence in the Physician Progress Notes in Medical Record #8 to indicate that the physician had a discussion with the patient, health-care representatives, or other surrogate decision-maker(s), as per facility policy, prior to ordering the DNR status for Patient #8.

2. Medical Record #10 contained a 'Do Not Resuscitate Order Sheet' dated 2/26/10. "No" was circled next to "Chest compression and mask and bag ventilation," "Defibrillation," and "Vasopressors or antiarrhythmics." "Yes" was circled next to "Intubation, mechanical ventilation" and "Critical Care Transfer."

a. The order was taken as a telephone order on 2/26/10 at 2:55 AM and was co-signed by the physician, but the order was not dated or timed.

b. There was no evidence in the Physician Progress Notes in Medical Record #10 to indicate that the physician had a discussion with the patient, health-care representatives, or other surrogate decision-maker(s), as per facility policy, prior to ordering the DNR status for Patient #10.

3. Medical Record #28 contained a 'Do Not Resuscitate Order Sheet' dated 3/28/10. "No" was circled next to "chest compressions and mask and bag ventilation," "Defibrillation," and "Intubation, mechanical ventilation." "Yes" was circled next to "Vasopressors or antiarrhythmics" and "Critical care Transfer."

a. The order was taken as a telephone order on 3/28/10 at 6:00 PM and was not co-signed by the physician until 4/3/10; six days later.

b. There was no evidence in the Physician Progress Notes in Medical Record #28 to indicate that the physician had a discussion with the patient, health-care representatives, or other surrogate decision-maker(s), as per facility policy, prior to ordering the DNR status for Patient #28.

A. Based on observation, it was determined that the facility failed to apply patient allergy stickers to the front of patient medical records as per facility policy and procedure.

Findings include:

Reference: Facility policy and procedure Code Number: 4.10, Subject: 'Medication or Food Allergies' states "POLICY History of allergies, as well as types of responses, and adverse drug reactions will be documented by the Registered Nurse at the time of admission. PROCEDURE ... 2.0 Write allergies and/or adverse reactions on the red allergy label and attach to the outside of the chart holder."

1. On 6/7/10 10:30 AM, review of 2 of 3 medical records in the ED Holding area indicated that Patients #1, #2, and #3 each had allergies. Patient #2's and #3's allergies were not documented on a red allergy label and applied to the outside of the chart.

a. Per the Nursing Admission Assessment dated and timed 6/4/10 5:45 PM, Patient #2 has an allergy to Iodine and Vitamin K.

b. Per the Nursing Admission Assessment dated and timed 6/5/10 2 PM, Patient #3 has an allergy to Cipro.

2. On 6/7/10 11:28 AM, review of 1 of 2 medical records on 3 East indicated, per the Nursing Admission Assessment dated and timed 6/6/10 10 PM, Patient #6 has an allergy to Sulfa, PCN [Penicillin], and Mycins. Patient #6's allergies were not documented on a red allergy label and applied to the outside of his/her chart.

3. On 6/8/10 10:54 AM, review of 1 of 2 medical records on 2 East indicated, per the Nursing Admission Assessment dated and timed 5/26/10 7 PM, Patient #12 has an allergy to Paxil, Cipro, Keflex, and Cy-pohe--ptane [illegible]. Patient #12's allergies were not documented on a red allergy label and applied to the outside of his/her chart.


B. Based on observation, it was determined that the facility failed to sign off physician orders as per facility policy and procedure in 2 of 3 medical records reviewed in the ED holding area.

Findings include:

Reference: Facility policy and procedure Code Number: 7.5, Subject: 'Receiving and Transcribing Physicians' Orders' states "PROCEDURE: ...2.0 TRANSCRIPTION ... 2.4 The RN places his/her full signature beneath the physician's signature including the date and time of verification."

1. On 6/7/10 10:30 AM, during a tour of the ED Holding area, in the presence of Staff #11, three medical records were reviewed. The following physician orders, in Medical Records
#1, and #3 lacked evidence of the RN's full signature beneath the physician's signature; including the date and time to indicate that the RN had verified/acknowledged the physicians's order:

a. Medical Record #1:

i. An order dated and timed 6/6/10 at 9:40 AM for two physician consults, a CAT Scan of the abdomen, Lasix 40 mg IV BID, IV D5 1/2 NS at 50 cc/h, Accucheck BID, and an Insulin Sliding Scale. [Note: this order also lacks a physician signature, thus making it difficult to determined if the order is a telephone order, or if it was actually written by a physician].

ii. An order dated and timed 6/6/10 1:00 PM for a CAT Scan of the Abdomen and pelvis with oral contrast as soon as possible.

iii. An order dated ant timed 6/6/10 3:25 PM for a CBC, CMP, Mag, and PO4 in the AM [blood tests/ lab work].

b. Medical Record #3:

i. An order dated 6/5/10 for an SMA12, direct and indirect bilirubin, S. Haptoglobin, and a Coomb's test [blood tests/ lab work].

ii. An order dated and timed 6/4/10 0800 AM for Vacholine 10 mg PO tid.

iii. An order dated 6/6/10 for a neuro consult.

iv. An order dated 6/6/10 to "transfer medical service to Dr.---."

C. Based on medical record review, it was determined that the nursing staff failed to implement the facility's policy and procedure for DNR (Do Not Resuscitate) in two of three medical records reviewed (Medical Records #7 and #8).

Findings include:

Reference #1: Facility policy and procedure Code Number: 2.4, Subject: 'Non-Resuscitation/ DNR Policy', states "... VII. USE OF THE DO NOT RESUSCITATE ORDER SHEET ... D. All forms are to be initialed, dated, timed and signed appropriately as indicated on the form."

Reference #2: Facility policy and procedure Code Number: 7.5, Subject: 'Receiving and Transcribing Physicians' Orders' states "PROCEDURE: ...2.0 TRANSCRIPTION ... 2.4 The RN places his/her full signature beneath the physician's signature including the date and time of verification."

1. On 6/7/10 at 2:15 PM, in the presence of Staff #10 and Staff #13, medical records were reviewed for DNR orders and implementation. Review of Medical Records #7 and #8 revealed that each lacked evidence of the Registered Nurse's signature in the designated area of the form, acknowledging the Physician's order for the DNR.

Based on observation and staff interview conducted on 6/8/10, it was determined that the facility failed to ensure that intravenous medications were prepared using a laminar airflow hood that had been inspected and certified.

Findings include:

1. During a tour of the pharmacy at approximately 2:00 PM, it was noted that the certification inspection of 2 laminar airflow hoods was due May 2010.

2. Upon interview, Staff #23 confirmed that the hoods had not been certified but were being used to compound sterile products.

A. Based on observation, it was determined that the facility failed to ensure that supplies and equipment are maintained at an acceptable level of safety and quality.

Findings include:

Reference: AAMI ST 79:2006, "Comprehensive Guide to Steam, Sterilization and Sterility Assurance in Health Care Facilities" states, "8.4.3 Instruments should be carefully inspected for cleanliness and flaws or damage and dried before packaging."

1. In the sterile supply storage rooms throughout the Operating Room and Central Supply, surgical steel instruments with steam permeable tape affixed to their handles were noted. The steam permeable tape was no longer affixed and/or stained on a large number of the instruments.


18165

B. Based on observation, a review of facility policies and procedures and review of equipment manufacturer's recommendations, it was determined that the facility failed to ensure that all equipment is maintained at an acceptable level of safety and quality.

Findings Include:

Reference #1: Manufacturer of Millenium RO System states, "Quarterly Maintenance: 3. Verify the TDS and percent rejection readings with an independent monitoring device every three months..."

Reference #2: Facility policy and procedure titled, 'Equipment Repair Records' states, "1. The Acute Program will maintain records of repair and preventative maintenance made to all equipment. 2. Records will be maintained on equipment repair record form ER-1."

1. On 6/9/10 at 12:00 PM, Staff #32 stated that preventative maintenance records, which included the quarterly maintenance requirements for the Millenium RO System, were not available for review.

A. Based on document review, staff interview, and observation, it was determined that the facility failed to ensure a sanitary environment to avoid sources and transmission of infections and communicable diseases.

Findings include:

Reference #1: CDC Hospital Infection Program, "Guideline for Prevention of Surgical Site Infection" states in Sterilization of surgical instruments (Section II C. 2-d-1), "Sterilize all Surgical instruments according to published guidelines."

Reference #2: Facility Policy and Procedure, "Central Service / Linen Room Purpose and Function" states under Procedure 1.0, "Sterilization of Equipment 1.1 All instruments, packs, procedural trays and patient equipment will be accurately processed and monitored according to policies and procedures."

1. Review of the Sterile Processing Biological Implant Records and the sterilizer load record tapes from January 1, 2010 to June 6, 2010, revealed that 3 brands of orthopedic implants were not processed according to manufacturer guidelines.

a. Stated in the 'Instructions for Use' for the Tornier ® Volar plates and screws, "This device is supplied NONSTERILE and must be cleaned and sterilized prior to use. Steam sterilization 132 F (270 F) prevacuum, with 3 pulses for 10 minutes is recommended."

b. The following was stated in the 'Instructions for Use' for the Pioneer Surgical Technology ® anterior cervical plate systems: "These devices are supplied NONSTERILE. Sterilization is recommended as follows: Method Steam Cycle Pre-vacuum (wrapped) Temperature 270 - 272 F Exposure Time 12 minutes."

c. Under 'Instructions for Use' for the Tirad ® Nuvasive screws, it states that implants are processed as follows; "Method; Steam Cycle: Pre-vacuum Temperature: 260 F Exposure time: 6 minutes."

d. A review of the sterilizer load record tapes for the 2 autoclaves used in Central Sterile Processing showed that sterilization cycles were only being run with a 4 minute sterilization cycle.

e. Staff #14 stated that at the present time, staff was only running a 4 minute sterilization cycle.

f. A review of the Biological Implant Record log showed that on the following dates, implants (# of implant and/or tray), were sterilized with exposure times not consistent with manufacturer instructions. They are as follows:
2/4/10 @ 630pm Pioneer Surgical (1)
2/4/10 @ 630pm 3- Nuvasive (13)
2/10/10 @ 1240PM Nuvasive (5)
2/10/10 @ 1245pm Nuvasive (1)
2/26/10 @ 905pm Tornier (2)
3/18/10 @ 1PM Tornier (1)
3/22/10 @ 750pm Tornier (1)
4/7/10 @ 955 pm Tornier (1)
4/24/10 @ 530pm Tornier (1)
4/30/10 @ 4pm Pioneer Surgical (1)
5/3/10 @ 1040am Pioneer Surgical (1)
5/18/10 @ 230pm Tornier (1)

g. A review of the OR flash sterilization logs showed that Staff #15's instrumentation was being processed for 10 minutes at 270 F with no dry time.

h. Staff #14 and Staff #2 were asked during interview on 6/8/10, for the manufacturer's instructions for the sterilization of these instruments. Neither Staff #14 or Staff #2 were able to produce the instructions by the completion of the survey.

Reference #3: Facility Policy and Procedure, "Monitoring Flash Sterilization" states under, Procedure 2.0, "Sterilization of Items 2.1, Flash sterilize for only emergency situations."

Reference #4: CDC's Hospital Infections Program, "Guideline for Prevention of Surgical Site Infection" states in the Sterilization of surgical instruments (Section II C. 2-d-2), "Perform flash sterilization only for patient care items that will be used immediately (e.g., to reprocess an inadvertently dropped instrument). Do not use flash sterilization for reasons of convenience, as an alternative to purchasing additional instrument sets, or to save time."

2. A review of the OR's flash sterilization logs from April 1 to June 6, 2010 showed that instruments were being flashed with no documentation that it was due to an emergency situation.

a. Sterilizer #1's flash log showed approximately 19 flash cycles run on April 1, 5, 7, 8, 14, 22, 26, 30 and May 5,14,16, 28 and 26.

b. Sterilizer #2's flash log showed approximately 6 flash cycles (April 6, May 5, 7, 10 and June 1).

c. Sterilizer #4's flash log showed approximately 13 flash cycles (April 27, May 14, 7,18, 13, 24,19 and June 1).

d. Staff #14 and Staff #2 stated that many of the OR nurses will flash instruments just in case the physician may need them.


18165


B. Based on observation, staff interview and review of facility documents, it was determined that the facility failed to ensure a sanitary environment during hemodialysis treatments.

Findings include:

Reference #1: Fresenius' policy #FMS-CS-IS-I520-005A on 'Cannulation Site Selection and Skin Preparation' states, "Follow the steps below to select site for cannulation: 1. Wash hands and don PPE to remove bacteria and provide protection."

Reference #2: Facility policy #4.8.1 on 'Handcleansing' states, "When healthcare personnel's hands are visibly soiled, they should wash with soap and water ... Hands must be washed with soap and water after 10 to 15 uses of alcohol rub according to the manufacturer."

1. On 6/9/10 at 10:30 AM, during a tour of the temporary dialysis room #329, it was observed that a handwashing sink was not available to be utilized by dialysis nursing staff during patient treatment. The only available handwashing sink located in the bathroom was hooked up to the Reverse Osmosis machine to supply treated water to the dialysis machine.

2. On 6/9/10 at 10:45 AM, Staff #34 stated that alcohol sanitizer is readily available to be utilized in between patient treatment. When Staff #34 was questioned as to where the nearest handwashing sink was located, Staff #34 stated that he/she only utilizes alcohol sanitizer in the temporary dialysis room
#329, due to the inaccessibility of the handwashing sink in the bathroom. Staff
#34 was not familiar with maximum number of uses of alcohol sanitizer as stated in Facility Policy #4.8.1.

Based on observation, it was determined that the facility failed to implement its policy and procedure for Hydrocollator (Hot) Packs.

Findings include:

Reference: Facility policy and procedure Code Number: 706, Subject: Hydrocollator (Hot) Packs, states "Procedure: ...1.3 Water Temperature Control 1.3.1 Water temperature should be approximately 170 degrees Fahrenheit. ... 1.3.2.3 Water temperature will be tested on the quarterly cleaning schedule (Code 602) or as needed. 1.3.2.4 If water temperature cannot be maintained between 165 degrees Fahrenheit and 175 degrees Fahrenheit, the unit will be taken out of service and the Biomedical Department will be called for repair. Temperature will be measured with a hand held thermometer."

1. On 6/8/10 at 2:36 PM, the Rehabilitation Department was toured in the presence of Staff #13 and Staff #26. Staff #26 confirmed during interview, that there was no daily temperature recording or quarterly temperature recording of the Hydrocollator's water temperature available for review. Without a temperature reading of the Hydrocollator's water, it could not be determined if the temperature was within 165 degrees Fahrenheit and 175 degrees Fahrenheit as per facility policy.