HospitalInspections.org

A. Based on observation, staff interview and review of facility documents, it was determined that the facility failed to ensure that specific State Law requirements are met.

Findings include:

Reference #1: AAMI publication RD 52:2004 states, "E.3.5.3 Softeners: Unless otherwise specified by the manufacturer of the reverse osmosis system, water treatment systems presented with incoming water with a hardness of > 10GPG should have a softer of other means of preventing scale formation. At lower levels of hardness (<10 GPG) the user may forego the use of softer by increasing the frequency of membrane descaling or by periodically replacing the reverse osmosis membranes in accordance with the instructions of the manufacturer of the reverse osmosis system. The amount of hardness in the supply water will determine the frequency of membrane cleaning and/or membrane replacement."

Reference #2: AAMI publication RD 52:2004 states, "E.3.4 Carbon adsorption media: Where practical, portable water treatment systems should include two carbon adsorption beds in series, which together provide a minimum of 10 minute Empty Bed Contact Time. Initially, the requirement for two carbon beds in series was waived for portable dialysis systems because of the impracticality of providing these features while retaining the portability of the system. However, alternative technologies are not available that allow portability while retaining redundancy associated with two carbon beds in series."


1. On 3/1/11, Staff #18 was questioned why the portable (Reverse Osmosis) machines were not equipped with a softener component, he/she stated that portable RO has always been set up without a softener. Staff #18 stated that he/she routinely tests the incoming water's hardness which always comes back as 40GPG. On 3/1/11, Staff #18 tested the incoming city water for hardness, it was observed at 40GPG. There was no evidence that the facility maintained the water treatment system within acceptable levels of hardness as stated above in Reference #1.

2. On 3/1/11, based on observation and interview with Staff #18, it was determined that all portable dialysis units are not equipped with two carbon adsorption beds in series as stated above in Reference #2.

B. Based on staff interview, document review and review of facility policy and procedure, it was determined that the facility failed to ensure that the radiology service's policies and procedures are reviewed every three years, or in accordance with their own policy and procedure.

Findings include:

Reference: Facility Policy and Procedure ISSUE NO: 704100, SUBJECT: "POLICY & PROCEDURE MANUAL REVIEW & APPROVAL" states "POLICY: The Department of Radiology Policy and Procedure Manual shall be reviewed annually and updated as needed. PURPOSE: To maintain current policies and procedures that are aligned with hospital procedure and updated patient care methods. RESPONSIBILITY: The Vice President of Operations, Chairman of Radiology, and the Director of Radiology will ensure compliance with this policy. PROCEDURE: Each reviewer shall sign below to attest that he/she has reviewed this manual and approves of all policies contained therein."

1. On 3/1/11 review of the Policy and Procedure Manual for the Department of Radiology evidenced a signature area below the above referenced policy. The policy/signature page was last signed by the Vice President of Operations, the Chairman of Radiology, and the Director of Radiology, to attest that he/she has reviewed the manual and approves of all policies contained therein, in 2007.

a. The policy and procedure manual was not reviewed within the last three years. The manual was due for review in 2010. This was confirmed by Staff #1.

b. The policy and procedure manual was not reviewed annually per the above referenced policy and procedure. There was no evidence the the manual was reviewed annually in 2008, 2009, and 2010.

Based on document review, staff interview and observation, it was determined that the Governing Body failed to demonstrate it is effective in carrying out the responsibilities of 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:

Finding include:

1. The Condition of Participation for Radiological Services is not in compliance because the facility failed to maintain approved standards of safety for all radiological services and equipment. (Cross refer 482.26).

2. The Condition of Participation for Surgical Services is not in compliance because the facility failed to ensure that surgical services are provided in accordance with acceptable standards of practice (Cross refer 482.51).

3. The Condition of Participation for quality Assurance is not in compliance because the facility failed to ensure an effective, ongoing hospital-wide data driven quality assessment and performance improvement program.
(Cross refer 482.21 (a) (2).

4. The Condition of Participation for Food and Dietetic Services is not in compliance because the facility failed to maintain an organized dietary service in accordance with recognized dietary practice ans standards. (Cross refer 482.28).

Based on observation, document review, and staff interview, it was determined that the facility failed to maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program.

Findings include:


The hospital failed to demonstrate evidence of a QAPI program for Food and Nutrition Services, Housekeeping, Dialysis, diagnostic X-Ray equipment and the Contracted Radiological Physicist services.
Cross refer to 482.21(a)(2).

Based on document review and staff interview, it was determined that the facility failed to measure, analyze and track quality indicators related to hospital services and operations.

Findings include:

Reference 1: The "University Hospital Quality Improvement Plan" policy states, "University Hospital has adopted a planned, systematic, organization-wide approach to planning for quality improvement, which incorporates the strategic goals of University Hospital. This includes process design, performance measurement, performance assessment, data collection and management, performance improvement and data sharing."

1. On 2/28/11 at 10:00 AM, Staff #1 and Staff #2 were asked to provide for review, a copy of the written Hospital Wide Quality Improvement Plan that measures, analyzes and tracks quality issues related to Food and Nutrition Services, Housekeeping, Dialysis, diagnostic X-Ray equipment and the Contracted Radiological Physicist services.

a. On the day of survey exit, 3/3/11 at 10:30 AM, Staff #1, Staff #2 and Staff #62 were unable to provide for review, a specific Quality Improvement Plan that measures, analyzes and tracks quality issues related to Food and Nutrition Services Infection Control and Patient Satisfaction, Housekeeping, Dialysis, and the Contracted Radiological Physicist services.

b. On 2/28/11 at 2:10 PM, Staff #40 stated that the Food and Nutrition Department was told by the quality committee that they are not required to continue with PI activities. Staff #40 stated that the Food and Nutrition Department does not have a specific PI action plan that includes regularly collecting and analyzing data to help identify problems, and their extent, and recommending, implementing and monitoring corrective actions based on this data. Refer to Tag 620 and Tag 749.

c. On 3/3/11 at 2:00 PM, Staff #62 and Staff #63 were asked to provide for review, the Housekeeping Quality Improvement Plan. Staff #62 stated and confirmed that the facility does not have a specific Housekeeping Quality Improvement Plan to measure, analyze and track quality issues.

d. On 3/3/11 at 11:00 AM, Staff #2 and Staff #62 stated that a specific Quality Improvement Plan that measures, analyzes and tracks quality issues related to the Dialysis service and the Contracted Radiological Physicist service is not available.

e. On 3/1/11 at 2:50 Staff #1 was asked to provide for review, the "Quality Control Program Guide" for quality management of diagnostic X-Ray equipment and the specific Quality Improvement Plan that measures, analyzes and tracks quality issues related to the quality management of diagnostic X-Ray equipment. On 3/1/11, Staff #1 stated that there is no guide. Refer to Tag 537.

2. On 3/3/11 at 10:00 AM, Staff #1 provided for review, the Quality Improvement Committee 2010 Reporting Calendar.

a. Review of the Quality Improvement Committee 2010 Reporting Calendar indicated that Nutrition Services, Housekeeping, Dialysis, and the Contracted Radiological Physicist services were not scheduled for review.

b. On 3/3/11 at 10:00 AM, Staff #1 confirmed that the Nutrition Services, Housekeeping, Dialysis, and the Contracted Radiological Physicist services were not scheduled for a Quality reporting during the 2010 year.

3. On 3/3/11 at 3:30 PM, Staff #1 and Staff #2 confirmed all of the above.

A. Based on a review of the facility's policies and procedures, staff interview and a review of facility documents, it was determined that the facility failed to maintain approved standards of safety for all radiological services and equipment.

Findings include:

1. The facility failed to follow all State laws to maintain and review all policies and procedures every three years. Cross reference to 482.11 (a).

2. The facility failed to provide periodic inspections of all radiological equipment to identify and correct hazards promptly. Cross reference to 482.26 (b) (2).


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B. Based on staff interview and review of facility documentation, it was determined that the facility failed to evaluate their quality control (QC) process of X-ray and fluoroscopy radiology equipment on a continual basis, failed to identify a health service problem, and failed to recommend, implement, and monitor corrective actions on the basis of this data, or lack there of.

Findings include:

1. On 3/1/11 at 11:00 AM, a meeting was held with Staff #1, #11, #12, #14, #16, #27, and #28 to discuss the process and responsibility of QC testing of radiology equipment. Per Staff #12, some of the QC testing is done daily and some weekly.

a. Staff #12 indicated he/she became aware that QC testing for the X-ray and fluoroscopy equipment was not being done or was missing when Staff #11 apprised him/her of this in late August, 2010.

b. Per Staff #11 on 3/1/11 at 1:30 PM, he/she asked Staff #12 for the QC reports to review QC, as this would be part of the new role he/she assumed in May 2010 as the Education and Training Specialist for the Radiology Department. Staff #11 stated it was at this time, August 2010, that they discovered the QC testing records could not be found.

2. It was determined that there was no evidence of QC testing since August 2010. Staff #12 stated upon interview that he/she would be ultimately responsible for the QC being done.

a. Review of Staff #12's job description for Director of Radiology, signed by Staff #12 on 7/21/08, states, "ESSENTIAL DUTIES, RESPONSIBILITIES AND PERFORMANCE STANDARDS include the following ... 4. Ensures that the quality of patient care and operations are defined, monitored,evaluated, and communicated. [1st bullet] Collaborates with staff, medical directors, physicians and other administrative colleagues to evaluate delivery of care and establish key indicators. [2nd bullet] Enhance care and services by incorporating the principles of continuous quality improvement (CQI) into the department. [3rd bullet] ensures that clinical standards are established and maintained. [4th bullet] Evaluates the use of systems, resources, and equipment/technology and recommends changes to improve efficiency and quality."

b. Staff #12 stated during interview on 3/1/11 at 11:20 AM, that he/she did receive the QC reports and he would meet with the Quality Control Technologist, Staff #13 weekly. He/she stated he never looked at most of the documentation but assumed the testing was being done.

c. On 3/2/11, the Physicist's report dated 7/20/10, for his/her survey date of 7/15/10 was reviewed in the presence of Staff Members #12, #17, and #27. The report indicates in the 'Comments:' section on the first page, "QA/QC records are not available. Please establish a QC program that satisfies the NJ State requirements." Per Staff #12 and #17, the physicist's reports are sent to Staff #12 and #28.

3. There was no evidence of corrective actions taken by the facility at the time it was discovered that QC testing was not being done or could not be found in August 2010, or when the physicist identified this in his report dated 7/20/10.

a. Per Staff #11 on 3/1/11 at 11:00 AM, the Quality Control Technologist, Staff #13, was responsible for QC testing prior to August 2010, and then Staff #11 was to take on the responsibility of QC testing.

i. Review of the personnel file of Staff #13 indicated he/she was demoted from the role of Quality Control Technologist to Radiologic Technologist I in August of 2010.

b. Staff #11 stated upon interview on 3/1/11 at 11 AM, that he/she did not receive any training in his/her new role as the Education Training Specialist for the Radiology Department.

c. Staff #12 stated upon interview on 3/1/11 at 11 AM, that the plan was for Staff #13 to train Staff #11, but that Staff #13 refused to train Staff #11. The alternate plan was for the Physicist to train Staff #11. Staff #12 confirmed that the physicist is at the facility 2-3 times per month to examine radiology equipment.

i. The personnel file of Staff #13 lacked any evidence of remediation for refusal to train Staff #11.

ii. In a telephone interview with the physicist on 3/2/11 at 9:15 AM, in the presence of Staff
#12, #17, #27, and #28, the physicist reported that he/she was not aware of Staff #11's hire/role in the Radiology Department until October 2010 and he/she was asked to meet with Staff #11 in January of 2011 to establish a QA plan. He/she further reported that he/she does not review the facility's routine QC every time he/she is there; only on an annual basis for their annual report, or intermittently.

iii. Review of the physicist's 2009 annual report, dated 3/25/10, indicated the facility's QC tests of X-ray producing machines were available for review by the physicist.

d. Following the refusal of Staff #13 to train Staff #11, there was no evidence of an alternate plan of action to train Staff #11.

4. On 3/1/11 at 1:05 PM, the QA plan for the Radiology Department and the QC tests that were completed were requested for review by the surveyor.

a. Per Staff #12 at 1:20 PM, there was no QA plan available for review. He/she stated he/she had a QA plan but cannot find it. He/she stated that any documentation related to the QA plan/manual and the daily QC testing for the X-ray and Fluoroscopy equipment, cannot be found for any time period prior to August of 2010.

b. There was no evidence of QC testing or a new QA plan for the time period of August 2010 thru January 2011.

c. Review of a chart/list of 'PATIENT CARE RADIATION PRODUCING MACHINES,' in the presence of Staff #11, #12, #17, and #27 indicated that out of 59 pieces of equipment, evidence of QC testing could not be shown for 32 pieces of equipment. The 32 pieces are X-ray and fluoroscopy equipment.

5. On 3/1/11 at 2:50 PM, the Radiology Department QA Meeting minutes for 2010 were reviewed and there was no evidence of discussion or reporting of the missing QC checks for the radiology equipment.

6. On 3/3/11 at 1:30 PM, the Radiation Safety Committee meeting minutes for 2010 were reviewed and there was no evidence of discussion or reporting of the missing QC checks for the radiology equipment.

7. The facility staff was aware of the lack of QC monitoring of X-ray and fluoroscopy equipment, a missing QA plan and data as well as the recognition of untrained staff. There was no evidence of recommending, implementing, and monitoring corrective actions on the basis of this information and incorporating it into QA activities.

Based on policy and procedure review and staff interview, it was determined that the facility failed to implement policies and procedures for quality management of diagnostic X-Ray equipment and approval of the radiology manual.

Findings include:

Reference #1: Facility Policy and Procedure ISSUE NO: 704100-406.1, SUBJECT: "QUALITY MANAGEMENT OF DIAGNOSTIC X-RAY PRODUCING EQUIPMENT" states, "REFERENCE: Quality Control Manual PURPOSE: To establish and maintain a program that ensures adequate monitoring and testing of diagnostic X-Ray generating equipment so as to achieve optimal diagnostic capability, the safety of workers and patients, the reduction of unnecessary radiation exposure, increased uptime, and compliance with State/FDA regulatory requirements. RESPONSIBILITY: The Quality Control Technologist, Radiation Safety Officer, and Diagnostic X-Ray Physicist under the oversight of the Director are responsible for implementation of this program/policy. ... POLICY: the Department of Radiology will maintain an ongoing quality Control Program as mandated by the State of New Jersey. PROCEDURE: 1. The Department of Radiology
will follow all Procedures Contained in the Quality Control Program guide (under separate cover) ...".

Reference #2: Reference: Facility Policy and Procedure ISSUE NO: 704100, SUBJECT: "POLICY & PROCEDURE MANUAL REVIEW & APPROVAL" states, "POLICY: The Department of Radiology Policy and Procedure Manual shall be reviewed annually and updated as needed. PURPOSE: To maintain current policies and procedures that are aligned with hospital procedure and updated patient care methods. RESPONSIBILITY: The Vice President of Operations, Chairman of Radiology, and the Director of Radiology will ensure compliance with this policy. PROCEDURE: Each reviewer shall sign below to attest that he/she has reviewed this manual and approves of all policies contained therein."

1. On 3/1/11 at 11:00 AM, a meeting was held with Staff #1, #11, #12, #14, #16, #27, and #28 to discuss the process and responsibility of QC testing of radiology equipment. Per Staff #12, some of the QC testing is done daily and some is done weekly.

a. The above Reference #1, policy and procedure, refers to a "Quality Control Program guide" for procedures to follow. This program guide was not available for review. Per Staff #1 on 3/1/11 at 2:50 PM, there is no guide.

b. Staff #12 indicated he/she became aware that the QC testing for the X-ray and fluoroscopy equipment was not being done or was missing, when Staff #11 apprised him/her of this in late August of 2010.

2. It was determined that there was no evidence of QC testing of the X-ray and fluoroscopy equipment since August of 2010. Staff #12 stated he/she would be ultimately responsible for QC being done.

a. Review of Staff #12's job description for Director of Radiology, signed by Staff #12 on 7/21/08, states "ESSENTIAL DUTIES, RESPONSIBILITIES AND PERFORMANCE STANDARDS include the following. ... 4. Ensures that the quality of patient care and operations are defined, monitored,evaluated, and communicated. [1st bullet] Collaborates with staff, medical directors, physicians and other administrative colleagues to evaluate delivery of care and establish key indicators. [2nd bullet] Enhance care and services by incorporating the principles of continuous quality improvement (CQI) into the department. [3rd bullet] ensures that clinical standards are established and maintained. [4th bullet] Evaluates the use of systems, resources, and equipment/technology and recommends changes to improve efficiency and quality."

3. The facility did not implement the policy stated above in Reference #1, for QC testing of the X-ray and fluoroscopy radiology equipment.

4. Per Staff #11 on 3/1/11 at 1:30 PM, he/she spoke to the physicist and it was recommended that the facility utilize the NJ Department of Environmental Protections (DEP) manual as their policy and procedure for their quality assurance program, that outlines the frequency of testing and standards for radiology equipment. Staff #11 provided the facility's new manual that was signed by Staff #11 on 2/21/11. There was no evidence that this manual was approved by the Vice President of Operations, Chairman of Radiology, and the Director of Radiology as per the policy in Reference #2.

Based on observation, document review, and interview, it was determined that the facility failed to provide organized dietary services that maintain the minimum standards for compliance.

Findings include:


The Director of Food and Nutrition Services failed to ensure daily management of the dietary services.
Cross refer 482.28(a)(1).

Based on staff interview, document review, lunch meal observations and a tour of the kitchen, conducted in the presence of Staff #38 and Staff #40, it was determined that the facility failed to ensure that daily supervision of the the Food and Nutrition Services Department was provided.


Findings include:

Reference #1: The Director of Food and Nutrition Services job description states, "Plans and directs the activities of the department to assure quality service of food to patients, staff, and visitors...Maintains a sanitary, safe and efficient operation in accordance with federal, state, and local health regulations, and all standards as set forth, by The Joint Commission(TJC)...Reviews and revises departmental policies and procedures, and ensures compliance with established policies and procedures."

Reference #2: The Assistant Director - Clinical & Patient Services job description states, "Plans, directs the activities for menu processing, meal assembly, distribution and delivery to ensure quality service of food to all patients at all stages of the meal delivery process. Develops, coordinates and revises the nutritionally balanced patient menu cycle as necessary to enhance patient satisfaction...Plans, coordinates, implements and manages the delivery of Clinical Nutrition Services to all Inpatient Units,...Conducts regular open and closed medical chart reviews and observations of clinical staff practice to monitor and evaluate Core / ongoing competencies for multiple subspecialty practice units inclusive of all Inpatient Units,...reviews and revises policies and procedures and diet manuals, evaluates and improves nutritional services through continuous performance Improvement Programs and maintains a sanitary, safe and efficient operation of inpatient and ambulatory nutrition services in accordance with Federal, State, & Local health regulations...Plans and develops a comprehensive performance improvement program to evaluate organizational performance, to enhance patient satisfaction."

Reference #3 : NJAC 8:24-2.1(b) states, "The person in charge shall demonstrate to the health authority knowledge of food borne disease prevention, application of the hazard Analysis Critical control Point (HACCP) principles, and the requirements of this chapter."

Reference #4: NJAC 8:24-3.3(c) states, "Separation, packaging and segregation requirements for packaged and un packaged food include the following: Food shall be protected from cross contamination by Separating raw animal foods from any ready-to-eat foods during storage, preparation, holding..."

Reference #5: NJAC 8:24-3.3(d) states, "Working containers holding food or food ingredients that are removed from their original packages for use in the retail food establishment, such as cooking oils, flour, herbs...shall be identified with the common name of the food, except that containers holding food that can be readily and unmistakably recognized..."

Reference #6: NJAC 8:24-3.5(f) states, "Potentially hazardous food shall be maintained at refrigeration temperatures (at or below 41?F)."

Reference #7: NJAC 8:24-4.2 states, "Equipment and utensils shall be designed and constructed to be durable and to retain their characteristic qualities under normal use conditions."

Reference #8: NJAC 8:24-4.5(a) states, "Equipment and equipment components shall be maintained in a state of repair and condition that meets the requirements specified under NJAC 8:24-4.1 and 2."

Reference #9: NJAC 8:24-4.5(c) states, "Surfaces such as cutting blocks and boards that are subject to scratching and scoring shall be resurfaced if they can no longer be effectively cleaned and sanitized, or discarded if they are not capable of being resurfaced."

Reference #10: NJAC 8:24-4.6(c) states, "Non food-contact surfaces of equipment shall be kept free of an accumulation of dust , dirt, food residue and other debris."

Reference #11: NJAC 8:24-4.7 states, "After being cleaned, equipment food-contact surfaces and utensils shall be sanitized."

Reference #12: NJAC 8:24-6.2(a) states, "The floors, floor coverings, walls, wall coverings and ceilings shall be designed, constructed and installed so that they are smooth and easily cleanable..."

Reference #13: NJAC 8:24-6.5(a) states, "The physical facilities shall be maintained in good repair."

Reference #14: NJAC 8:24-6.5(b) states, "The physical facilities shall be cleaned as often as necessary to keep them clean."

Reference #15: NJAC 8:24-6.6(h) states, "Toilet facilities, including toilet rooms and fixtures, shall be kept clean and in good repair." I

Reference #16: NJAC 8:24-8.11(a) states, "Immediately upon completion of the inspection, the health authority shall issue an evaluation placard of the establishment and leave the original copy of the inspection report form with the person in charge...The evaluation placard shall identify that the establishment is one of the following: 1. "Satisfactory": The establishment is found to be operating in substantial compliance with this chapter and food service personnel have demonstrated that they are aware of and are practicing sanitation and food safety principles as outlined in this chapter; 2. "Conditional Satisfactory": At the time of the inspection the establishment was found not to be operating in substantial compliance with this chapter and was in violation of one or more provisions of this chapter..."

Reference #17: The Menu Modification policy and procedure states, "Procedure: Diet prescriptions are faxed down from each nursing unit to the diet Office. Faxed information is then transcribed into each patients electronic card file utilizing CBOARD's designated abbreviations. A menu will be printed for each patient (except for those on pediatric formula, liquid, mechanical soft, pureed, NPO and tube feeding/supplements only diets). Menus will be delivered during the breakfast meal service. Patients will make their menu selections for lunch and dinner for that day and breakfast for the following day. Menus will be retrieved by the assigned Nutrition Care Assistant, Diet Control Assistant and/or Food Service Worker and selections will then be entered into electronic card files as assigned.

Reference #18: The Nonspecific Diet Orders policy and procedure states, "Policy: Diet Orders containing relative or general descriptions of the diet will be interpreted and processed by the Food and Nutrition Services Department until more specific orders are written by the physician. The Registered Dietitian will contact the physician within 24 hours to write a specific Diet Order. Procedure: All orders for the following diets will be interpreted as designated for 24 hours. "Non-Specific Orders Low Sodium interpretation 2 gm.. Sodium...The dietitian will contact the physician within 24 hours to clarify the specific diet prescription for nonspecific order."

Reference #19: The Levels of Nutrition Care, Acuity Risk Level, and Corresponding Follow-up Intervention Time Frame policy and procedure states, "Follow-up interventions...Documentation Must Include...Date, time diet prescription, new diagnosis/problems/DNI's current appetite/intake, GI tolerance to diet. Determine adequacy of diet...Evaluate significant changes...state appropriate care plan."

Reference #20: The Performance Improvement (PI) Plan policy and procedure states, "It is the policy of the Food & Nutrition Services Department to have a planned and systematic means for monitoring and evaluating the quality and appropriateness of care and services provided...The overall responsibility for monitoring and evaluating activities within the Department is that the Food & Nutrition Services director...the departments Performance Improvement Plan falls under the auspices of University Hospital's Performance Improvement Plan...The PI Plan will be assessed on an annual basis to determine the process and outcomes improved, and to identify and prioritize further areas for improvement."

Reference #21: The Customer Satisfaction policy and procedure states, "The University Hospital participates in the Press Ganey survey process to measure inpatient satisfaction with quarterly report available for hospital department use...The meals section is thoroughly reviewed by the Food and Nutrition Department and discussed for appropriate action. A specific action plan is developed for implementation and further evaluation of services."

1. On 2/28/11 at 11:35 AM, during observations in the main food services kitchen with Staff #38 and Staff #40, it was determined that the Food Services Director failed to 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 stated in the Director of Food and Nutrition Services job description, Reference #1.

a. On 2/28/11 at 11:35 AM, during observations in the main food services kitchen mechanical ware washing room in the presence of Staff #38 and Staff #40, the floor appeared rough and in disrepair. Several sections of the floor throughout lacked tiles. The missing tiles created an uneven surface causing water to puddle. The floor was not maintained as required in Reference #12 and #13.

b. On 2/28/11 at 11:35 AM, during observations in the main food services kitchen mechanical ware washing room in the presence of Staff #38 and Staff #40, the dishwasher room ceiling tile grid appeared to have red and brown rust-like spots/speckles. The ceiling was not maintained as required in Reference #12 and #13.

c. On 2/28/11 at 11:15 AM, during observations in the main food services kitchen refrigerator, a carton of frozen fish was observed open and unprotected. The fish was not protected from cross contamination, as required in Reference #3.

d. On 2/28/11 at 11:20 AM, during observations in the main food services kitchen catering room near the sink, a fire extinguisher was observed with a last inspected date and new date as 8/1994. Staff #38 stated and confirmed that the fire extinguisher should be checked monthly and inspected annually.

2. On 2/28/11 at 10:30 AM, during interview with Staff #38 and #40 the most recent annual Chapter 24 inspection report was requested for review.

a. On 2/28/11 at 11:45 AM, Staff #38 showed two Satisfactory placards posted near the Food Services Director's office. One placard for a complete Sanitation inspection was dated 8/25/03 and the second for a summer lunch program was dated 7/25/07. Staff #38 stated at 11:45 AM, that he/she is new to the facility and he/she was surprised that the facility was not inspected annually by the local health department.

b. On 2/28/11, this surveyor requested that the NJDHSS (New Jersey Department of Health and Senior Services) Consumer and Environmental Health Services Division conduct a Chapter 24 inspection which was completed on 03/07/11.

c. On 3/8/11, the NJDHSS Consumer and Environmental Health Services Division provided for review the requested Sanitary Inspection report that was completed by the Department of Health & Human Services (Food & Drug Bureau) Newark, NJ" dated 03/07/11. The facility was issued a "Conditional Satisfactory" (Refer to Reference #15) evaluation with the following citations documented:

-8:24-2.1(b) "Person in charge failed to demonstrate knowledge of food safety principles." Refer to Reference #3.
"Risk factor observations observed"

-8:24-3.3(c) "Improper separation of raw eggs and raw meat inside the refrigerator. Raw eggs and raw meat were stored above cheese." Refer to Reference #4.

-8:24-3.3(d) "Food container not identified with common name." Refer to Reference #5.

-8:24-3.5(f) "Victory refrigerator no. 22 failed to keep Refrigerated Temperature of 41 degrees F. Milk was 53 degrees F." Refer to Reference #6.

-8:24-4.2 "Some shallow pans observed in very poor state of repair." Refer to Reference #7 and #8.

-8:24-4.5(c) "Cutting boards were observed in very poor state of repair." Refer to Reference #9.

-8:24-4.6(c) "Observed dust in the Fan Guard in the walk-in refrigerator." Refer to Reference #10.

-8:24-4.7(c) "Sanitizer solution concentration in the three compartment sink was too low, 100 ppm." Refer to Reference #11.

-8:24-6.2 "Observed dust on the ceiling in the dishwasher room." Refer to Reference #12.

-8:24-6.5(b) "Walls in the dishwasher area observed unclean." Refer to Reference #14.

-8:24-6.6(h) "Walls men's & ladies room must be painted." Refer to Reference
#15.

3. On 2/28/11 at 12:15 PM, during lunch meal observations with Staff #38 and Staff #40, Patient #9 stated that he/she did not like the meal that was provided. The patient meal ticket had written on it mechanical soft, honey thickened liquids diet. The Food and Nutrition "Diet Screen" sheet had written the date of the mechanical soft, honey thick order as 2/26/11. During interview, the patient stated that he/she did not receive a menu and was not offered an opportunity to choose his/her meals from a menu.

a. Staff #40 first stated that the patients' with mechanical soft diet orders do not have a choice. They are on a non select menu. Refer to Reference #17.

b. Staff #40 then stated that the facility has started a new process for meal ordering. He/She stated that all patients are visited by the Nutrition Care Assistant/Diet Control Assistant to take menu preferences and orders. Patient #9, stated and confirmed that he/she was not visited by a Nutrition Care Assistant/Diet Control Assistant and given the opportunity to choose his/her meal preference.

c. On 2/28/11 at 12:20 PM, Staff #40 was asked to provide for review a policy that defines the new meal ordering process. Staff #40 replied that since this is a new process, a policy has not been developed. Staff #38 and Staff #40 failed to develop and ensure that a new policy and procedure was developed and implemented for the new meal ordering process as stated in their respective job descriptions. Refer to Reference #1 and Reference #2.

d. On 2/28/11 at 2:30 PM, Staff #38 and Staff #40 confirmed all of the above.

4. On 2/28/11 at 12:25 PM, during lunch meal observations with Staff #38 and Staff #40, Patient #11 was observed to receive a low cholesterol, 1.8g Sodium diet.

a. On 3/1/11 at 10:30 AM, during a review of Medical Record #11 with Staff #38 and Staff #40, the Physician's Order Sheet was observed to contain the following diet orders:

i. "Diet: 2 gm. Sodium, Low Cholesterol," that was signed and dated 2/25/11 at 9:45 PM.

ii. "Diet: Low Sodium/ Low Cholesterol," that was signed and dated 2/25/11 at 10:20 PM.

iii. "Diet: Low Sodium/ Low Cholesterol," that was signed and dated 2/27/11 at 5:55 PM.

b. During review of Medical Record #11, in the presence of Staff #38 and Staff
#40, it was noted that the patient received a lunch meal on 2/28 that was not consistent with the patient diet orders above. The patient received a lunch meal with 1.8 gm. Sodium, not a 2 gm. Sodium diet or a non specific low Sodium diet, that is interpreted to be 2 gm. Sodium as ordered (see above). Refer to Reference #18.

c. During review of Medical Record #11, in the presence of Staff #38 and Staff
#40, it was noted that the dietician's "Initial Nutrition Assessment" dated 2/27/11, stated that the patient's diet ordered on 2/25 was a 2 gm. Sodium, low cholesterol diet. The dietician's note did not address the fact that the medical record contained a non- specific diet order "Low Na/ Low Cholesterol," that was signed and dated 2/25/11 at 10:20 PM. There was no evidence that the dietitician contacted the physician within 24 hours to clarify the diet order as stated in Reference #18.

d. During review of Medical Record #11, in the presence of Staff #38 and Staff
#40, it was noted that the dietitian's "Initial Nutrition Assessment" dated 2/27/11, stated that the patient diet ordered on 2/25 was a 2 gm.. Sodium, low cholesterol diet. The dietitian's note did not address the fact that the medical record contained a non- specific diet order "Low Na/ Low Cholesterol," that was signed and dated 2/25/11 at 10:20 PM, 35 minutes after the original 2 gm.. Sodium diet order was written. There was no evidence that the dietitian contacted the physician with in 24 hours to clarify the diet order as stated in Reference #18.

e. During review of Medical Record #11, with Staff #38 and Staff #40, it was noted that the dietitian's "Initial Nutrition Assessment" dated 2/27/11, stated that the patient diet ordered on 2/25 was a 2 gm.. Sodium, low cholesterol diet. The dietitian's note did not address the fact that the patient was receiving a low cholesterol, 1.8g Sodium diet as written on the Food and Nutrition "Diet Screen" sheet with the diet order dated 2/26/11. There was no evidence that the dietitian contacted the physician within 24 hours to clarify the diet order as stated in Reference #18.

f. On 3/1/11 at 10:30 AM, Staff #40 confirmed all of the above.

5. On 3/1/11 at 2:35 PM, during a review of Medical Record #15, in the presence of Staff #38 and Staff #40, the Physician's Order Sheet was observed to contain the following diet orders:

i. "Diet: 2 gm. Sodium, Low Cholesterol, 1800 ADA, 2 gm. Potassium diet" that was signed and dated 1/05/11 at 5:45 PM.

ii. "Diet: 2200 kcal ADA, 2 gm. Sodium, 3 gm. Potassium, 110 gm. Protein, low Phosphorous, soft diet" that was signed and dated 1/22/11 at 2:30 PM.

iii. "Diet: 2 gm. Sodium, 3 gm. Potassium, 110 gm. Protein, 2200 kcal ADA, low Phosphorous, soft" that was signed and dated 1/25/11 at 12:30 PM.

iv. "Diet Clarification: 2 gm. Sodium, 3 gm. Potassium, 110 gm. Protein, 2200 kcal ADA, low Phosphorous, soft" that was signed and dated 1/31/11 at 10:05 AM.

a. On 3/1/11 at 2:35 PM, during review of Medical Record #15, in the presence of Staff #38 and Staff #40, the Dietitian's "Nutrition Follow-up" note dated 2/21/11 had written the patient's "Diet RX: 2 gm. Sodium, 1800 ADA, 2 gm. Potassium diet, (1/05/11)...Recommend 2200 cal ADA, 110 gm. Protein, 2 gm. Sodium, 3 gm. Potassium, Low Phosphorous." The dietitian failed to accurately assess and document the patient's most recent diet order "2 gm. Sodium, 3 gm. Potassium, 110 gm. Protein, 2200 kcal ADA, low Phosphorous, soft" dated 1/31/11. Refer to Reference #19.

6. On 3/1/11 at 11:45 AM, during a review of Medical Record #13, in the presence of Staff #38 and Staff #40, the Physician's Order Sheet was observed to contain the following diet order:

i. "Diet: 2 gm. Sodium, Low Cholesterol" that was signed and dated 2/24/11 at 5:20 PM.

a. On 3/1/11 at 11:45 AM, during a review of Medical Record #13, in the presence of Staff #38 and Staff #40, the Dietitian's "Nutrition Follow-up" note dated 2/27/11 documented the patient's diet as "Diet RX: 2 gm. Sodium, 1800 ADA." The dietitian failed to accurately assess and document the patients most recent diet order "2 gm. Sodium, Low Cholesterol," that was dated 2/24/11. Refer to Reference #19.

7. On 2/28/11 at 2:00 PM, Staff #38 and Staff #40 were asked to provide for review, the Food and Nutrition Department PI Plan, including the specific action plan developed for implementation and further evaluation of services.

a. On 2/28/11 at 2:10 PM, Staff #40 stated that the Food and Nutrition Department was told by the quality committee that they are not required to continue with PI activities. Staff #40 stated that the Food and Nutrition Department does not have a specific PI action plan that includes regularly collecting and analyzing data to help identify problems and their extent, and recommending, implementing and monitoring corrective actions based on this data. Refer to Reference #20 and Reference #21.

b. On 3/2/11 at 1:15 PM, the Quality Improvement Committee 2010 Reporting Calendar was provided by Staff #1. During review of the 2010 Reporting Calendar, it was determined that the Food and Nutrition Department was not scheduled to report during the 2010 year.

c. On 2/28/11 at 2:10 PM, Staff #40 stated that the Food and Nutrition Department has not reported to the Quality Improvement Committee for more than 18 months.

d. On 2/28/11 at 3:00 PM, Staff #38 and Staff #40 confirmed all of the above.

Based on observation, it was determined that the facility failed to comply with NFPA 99, which is referenced in the Life Safety Code, concerning eye wash fluid regulations.

Findings include:

1. On 2/8/11 at 10:35 AM in the presence of Staff #27, the eye wash fluid in the maintenance shop had expired September of 2010.

A. Based on observations in the presence of Staff #57, it was determined that the facility failed to ensure that the floors, ceilings, and walls were free of cracks and holes, discoloration, residue build-up, water stains, and other signs of disrepair.

Findings include:

1. A tour of the University Hospital Orthopedic Clinic, on 3/3/11 at approximately 2:00 PM, revealed the following:

a. Room #17 had 5 ceiling tiles that were observed with water stains.

b. Room#16 had laminate molding that was missing from the entire edge of the sink and attached cabinetry.

c. Room #C-155 had approximately an 6 inch area of exposed sheet rock on the wall behind a mounted soap dispenser. The counter top of the sink area was missing pieces of formica.

d. Rooms #8, #9, #12 and #13 had laminate missing from the side of the computer desks.

e. All of the walls in the exam rooms and hallways were discolored with signs of disrepair.

2. A tour of the Pediatric Unit, on 2/28/11 at approximately 2:00 PM, revealed the following:

a. In Room #F212, the toilet paper dispenser was being held in place with surgical tape.

b. Rooms #201 and #210 each had chairs with torn and cracked cushions.

c. Room #202 had a broken metal draw that was hanging from the hinges.

d. The non-functioning water fountain in the hallway had dislocated metal framing hanging from the frame.

3. A tour of the Operating Room Suites was conducted at approximately 11:00 AM in the presence of Staff #30, revealed a housekeeping cart with the doors dislocated from the hinges and rust markings.

a. The molding along the base of the floor outside of Operating Room #11 was missing.


B. Based on observation, staff interview, review of facility documents, and review of equipment manufacturer's recommendations, it was determined that the facility failed to ensure all equipment are maintained to an acceptable level of safety and quality.

Findings include:

Reference #1: LaMotte, the manufacturer of DPD Chlorine Test Kit states, "Free Available Chlorine: 1. Fill a test tube to the 5mL line with the sample water .... Total chlorine: 5. Add one chlorine DPD #3 tablet to the test sample from Step 4 above"

Reference #2: Manufacturer of "Millennium RO System's routine maintenance" states,
"4.1.1 Daily/Per Treatment Maintenance: 1. Test and record the hardness level of the feed water in the pretreatment log. 4. If you are using cartridge pre-filters with your Millennium, observe and record the pre-filter inlet and outlet pressure gauges on the operation log. The difference in the pressure values will help measure the condition of the filter cartridge. When the pressure differential increases 8PSI above the clean, initial delta P, the cartridges need to be changed(or sooner if the pre-filter core appears soiled). Observe and record the percent rejection and TDS water quality readings in the operation log. 4.1.2 Weekly Maintenance: 1. Observe, or measure, and record the waste and product flow rates on the operation log. 2. Observe, or measure, and record the feed water temperature. The water temperature has a significant effect in the product flow rate of the RO membrane and on the evaluation of the membranes ' need to be cleaned. 4.1.4 Quarterly Maintenance: 3. Verify the TDS and percent rejection readings with an independent monitoring device every 3 months. 4. Check the quick-disconnect fittings and hoses. They should seat securely and fluid should shut off when they are disconnected. Inspect o-rings for any nicks or cuts. 4.1.6 Annual Maintenance 1. Test feed water(tap water). Test for: a. Iron presence(critical when Renalin is used). b. pH alternation c. Chlorine/chloramine's shifts d. Hardness fluctuations."

Reference #3: Manufacturer of "Cidex OPA" states, "If your Automatic Endoscope Reprocessors(AER) can not be set to a minimum of 25?C, please follow the time and temperature stated in indications for Use, Manual Processing. Manual Processing: High level disinfectant at a minimum of 20?C."

1. On 3/1/11 at 2PM, Staff #25 was observed testing for total chlorine with 10ml sample water instead of 5mL as required by the manufacturer. Staff #19 also stated that he/she utilizes 10mL when testing for total chlorine. There was no evidence that the facility followed the manufacturer instructions as stated in Reference #1.

2. On 3/1/11, Staff #18 stated during interview that he/she does not follow the manufacturer routine maintenance requirements on Millennium RO System.

3. Staff #18 also stated on 3/1/11 that, testing and recording feed water hardness, feed water temperature, filter pressures, TDS, and percent rejection is not part of his/her routine maintenance requirement.

4. Staff #18 indicated on 3/1/11 that, TDS and percent rejection readings are verified annually. Documentation was not available for review upon request. At 1200 PM, Staff #18 was requested to demonstrate percent rejection calculation, he/she was not able to calculate the percent rejection.

5. There was no evidence that the Pre filter was equipped with pre and post pressure gauges to monitor pressure drop across the filter.

6. There was no evidence that the facility followed the manufacturer instructions as stated above in Reference #2.

7. On 3/1/11, Staff # 64 and Staff #65 both stated during interview that the temperatures of the high level disinfectants in the three AERs are not being monitored. There was no evidence that the facility was monitoring temperatures as stated above in Reference #3.

A. Based on staff interview, document review, a tour of the kitchen, and lunch meal observations conducted in the presence of Staff #38 and Staff #40, it was determined that the facility Infection Control Committee failed to provide oversight of the Food and Nutrition Department.

Findings include:

Reference #1: The Infection Control Program policy and procedure states, "The Infection Control Committee (ICC) is a multidisciplinary committee that is made up of representatives from Infection Control, Occupational medicine Service, clinical Laboratories, Medical Staff, Nursing, Respiratory Care Services, Environmental Services, Pharmacy...consultation is requested from other departments including dietary Services...The Infection control program participates in the development and approves all hospital policies and procedures related to infection control...The Infection Control continuous quality improvement plan includes the regular collecting and analysis of data to help determine the effectiveness of infection control practices."

1. On 3/3/11 at 11:30 AM, Staff #30 was asked if the ICC reviews the Food and Nutrition Department Infection Control policies and procedures. Staff #30 stated that he/she does, but that there is no written documentation of this review.

2. On 3/3/11 at 11:30 AM, Staff #30 was asked if the ICC monitors the Food and Nutrition Department for compliance to Infection Control procedures. Staff #30 stated that the facility does environmental rounds that include the Food and Nutrition Department, but that there is no written documentation of these rounds.

3. On 3/3/11 at 11:30 AM, Staff #30 was asked to provide a copy of the ICC continuous quality improvement plan including the regular collecting and analysis of data to help determine the effectiveness of infection control practices in the Food and Nutrition Department. Staff #30 stated that a quality improvement plan to monitor the effectiveness of infection control practices in the Food and Nutrition Department is not available for review.

4. On 3/3/11 at 11:30 AM, Staff #30 confirmed all of the above.


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B. Based on observation and document review, it was determined that the facility failed to ensure that temperature parameters in the decontamination area of Central Sterile Processing were monitored and recorded.

Findings include:

Reference#1: "(AAMI) guideline, Comprehensive guide to steam sterilization and sterility assurance in health care facilities," AAMI ST79:2006 Section (3.3.6.5) states, "The decontamination area should have temperature controlled between (60 degrees F and 65 degrees F). Independent monitors should be located in each of the areas where temperature should be controlled; temperature should be recorded daily. Processing personnel in each work area are responsible for monitoring and recording the temperature to ensure that the correct temperature is being achieved."

1. On 3/1/11 at 11:40AM, the temperature on the clock in the decontamination area displayed 70 degrees F. This temperature is above the (AAMI) Guidelines. The central Sterile Processing Department was unable to provide documentation regarding monitoring and recording of temperatures in the decontamination area.

C. Based on document review, it was determined that the facility failed to ensure that the process for proper cleaning of loaner instrumentation as part of their policy was incorporated.

Findings include:

Reference #1: "(AAMI) guideline, Comprehensive guide to steam sterilization and sterility assurance in health care facilities," AAMI ST79:2006 section (5.2.1). Receiving of purchased or loaner items states, "Clean or sterile items to be transported to central processing and storage areas within the facility should be removed from their external shipping containers before they enter the storage areas of the department. Any instructions for use accompanying the items should be kept with the items. When loaner items are delivered to the receiving area, personnel should document that according to the packing slip, the correct number of packages has been received."

Under no circumstances should the packages be opened. The packaged items, along with any instructions for use, should be delivered to the Central Service processing/decontamination area as soon as possible.

1. On 3/1/11, a review of the loaner instrumentation policy failed to include proper cleaning requirements upon acceptance by the facility, and upon return to the vendor upon use.

D. Based on observation and document review, it was determined that the facility failed to ensure that a test method that verifies the functionality of the Ultrasonic Cleaner as part of their Quality Assurance program was used.

Findings include:

Reference #1: "(AAMI) guideline, Comprehensive guide to steam sterilization and sterility assurance in health care facilities," AAMI ST79:2006 section Annex D.1 states, "User verification of cleaning processes. (General Considerations) state, Cleaning efficacy tests that are performed following reprocessing are used to verify the ability of a cleaning process to remove or reduce to an acceptable level the organic soil and microbial contamination that occurs during the use of reusable devices."

1. On 3/1/11, the Central Sterile Processing Department failed to provide a log for monitoring and verifying the cavitation process for the Ultrasonic Cleaner.


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C. Based on observation, it was determined that the facility failed to separate clean supplies from those that are soiled.

Findings include:

1. On 3/3/11 11:00 AM during a tour of the Ambulatory HIV Clinic, on level D of the ACC building, in the presence of Staff #58, the following clean supplies were observed stored in the Soiled Utility Room:

a. A gray cabinet with double doors contained blood draw kits.

b. Shelves located on the right wall upon entry, contained Pulmonary Function Testing equipment.

2. On 3/3/11 12:25 PM during a tour of the Ambulatory Surgical Services Clinic, on level E of the ACC building, in the presence of Staff #58, the following clean supplies were observed stored in the Soiled Utility Room:

a. Policy and Procedure Manuals for the Urology Service.

b. Four boxes of nylon sutures.

c. A television on a portable table.

Based on observation, review of facility documents, and staff interview, it was determined that the facility failed to ensure that surgical services are provided in accordance with acceptable standards of practice, including compliance with applicable Federal and State laws.

Findings include:

1. The facility failed to provide surgical services in an appropriate scope of organization to ensure compliance with acceptable standards of practice (Cross Refer A-0941).

2. The facility failed to ensure the implementation of surgical equipment policies to ensure the use of instruments in the Main O.R. and in the D.O.C. Surgery Center are monitored for efficacy and processed according to manufacturer's recommendations and that sterilized items are stored in a manner that ensures sterility at the time of use (Cross Refer A-0941).

A. Based on observation, staff interview and review of facility documentation, it was determined that the facility failed to provide the surgical services with an appropriate scope of organization to ensure compliance with acceptable standards of practice.

Findings include:

1. Upon request, the facility failed to provide documentation of monitoring of the efficacy of any of the four (4) sterilizers used in the OR for flash sterilization of instruments, as per facility policy.

a. A review of the OR sterilizer records did not provide evidence of documented results of daily Biological Indicator tests, used to monitor sterilizer efficacy, from 2009 through the date of the survey, 3/1/11.

b. During the period between 2009 and the day of the survey, 3/1/11, only three instances of documented results for the OR sterilizer were available for review: 12/10/10 (sterilizer #3), 12/17/10 (sterilizer #3), and 12/28/2010 (no sterilizer number noted).

2. OR storage of sterile instruments observed on 3/1/11, did not provide conditions for maintaining the integrity of sterile packaging, therefore did not ensure the sterility of instruments used in surgery.

a. On 3/1/11, a tour of the sterile storage cabinets behind OR #6 revealed the following:

i. A crowded, haphazard storage of sterilized instruments packaged in paper wrappers and paper/plastic pouches.

ii. Heavy items were stored on top of sharp instruments, causing pinholes and split package seals observed in instrument packaging stored below.

iii. Holes and split package seals were observed in instrument packaging stored below heavier items. A hole was observed in the paper/plastic packaging of an external pin instrument stored under a heavy paper-wrapped orthopedic instrument labeled "mother-in-law."

iv. Folded and crumpled packaging was observed on instruments crowded into storage bins. Heavy items were stored on top of sharp instruments.

v. The storage shelves inside of the cabinet were observed soiled with dust accumulation.

vi. Two paper/plastic packages containing ligaclip instruments were observed with torn side seals and stacked on top of each other and a urology instrument with a hole in paper/plastic packaging.

3. The manufacturer's written instructions for the recommended procedures of specific instrument decontamination and sterilization cycles were not available for reference. In one instance, the manufacturer's instructions, obtained at the time of the survey for verification, were not followed for the sterilization cycle routinely used in the D.O.C. Surgery Center.

The above findings were discussed with Staff #31 and Staff #34 on the day of the survey.

B. Based on observation, staff interview, and review of facility documentation, it was determined that facility policies for the sterilization of surgical equipment were not implemented.

Findings include:

Reference #1: Facility Policy Issue No: 831-200-176 titled "Flash Sterilization in the Perioperative Practice Setting" states, "The Perioperative personnel are responsible in complying and implementing this Policy and Procedure." The policy lists sterilizer monitoring requirements in items 7, 8, & 9 as follows: "7. Biological and chemical indicators should be used to monitor sterilizer efficacy and assess compliance of monitoring standards. 8. The sterilizer operator should use the sterilizer printout to verify cycle parameters (time, temperature, pressure) for each load. A documentation log of sterilization process will be maintained for every load sterilized, to provide tracking of the flashed items to the individual patient. 9. Document the following in the sterilization log book: Patient label, sterilizer print out with user's initial, result of chemical indicator, item sterilized, reason for flash sterilization, and name of staff member flashing the item."

1. The facility failed to provide documentation of monitoring of the efficacy of any of the four (4) sterilizers used in the OR for flash sterilization of instruments, as per the facility policy referenced above.

a. Sterilizer Attest Biological Indicator (B.I.) log books were reviewed in the Steris System 1 processing room for dates up to 2009.

b. A log book titled "Attest B.I." and labeled "2010" was presented by Staff #31 for review. The "2010 Attest B. I." log book provided evidence of only three dates of documented results that included the following dates: 12/10/2010 for sterilizer
#3, 12/17/2010 for sterilizer #3, and 12/28/2010 with no sterilizer number noted.

c. Staff #31 stated during interview on 3/1/11, that the results of the B.I. tests conducted daily in each of the four (4) OR sterilizers are recorded in the OR sterilizer log books located next to each sterilizer. Staff #31 further explained on 3/1/11 at approximately 12:30 PM, that the B.I. test is conducted on the night shift each night by a Central Processing staff member and the results are called in to OR staff. The OR staff are expected to record the results of the tests in the OR sterilizer log books.

d. Staff #33 and Staff #34, were interviewed in the office of the OR Nurse Manager at approximately 2:00 PM on 3/1/11 and stated that a call from Central Processing Department with the results of the B.I. tests are considered informational only and it is expected that the results of the B. I. tests be recorded in the Central Processing Department.

e. Staff #31 stated at approximally 2:00 PM on 3/1/11, that the Central Processing records had been checked and confirmed that there are no results of B.I. monitoring of the OR sterilizers kept in the Central Processing Department.

f. On 3/1/11, OR sterilizer log books were reviewed with records from 4/1/10 to 3/1/11 for the following Sterilizers: Sterilizer #2 and #3; from 9/1/10 to 3/1/11, and Sterilizers #1 and #4 from 11/3/10 to 3/1/11. A result-recording card was observed in the log for each day of the above sterilizers' operation. However, none of the cards had recorded the results of the Biological Indicator test or Control test for any of the Sterilizers stated above.

g. Facility policy referenced above states that the "The Perioperative personnel are responsible in complying and implementing this Policy and Procedure."

h. Staff #29, Staff #33, and Staff #34 and Staff #31 all confirmed that the daily practice of Biological Monitoring is implemented by the Central Processing Department staff, not the Perioperative personnel as stated in Reference #1.

i. The facility could not produce a policy to include the responsibility for documentation by the Central Processing Department, of the results for the Biological Indicator tests as confirmed by Staff #29, Staff #31, Staff #33 and Staff #34.

2. Records of the D.O.C. Surgery Center document the results of a Biological Indicator test and a Control result for each sterilizer load. Staff #36 stated during interview at 3:00 PM on 3/1/11, that a Biological Indicator is only run in the first sterilizer cycle of the day and in loads with an implant. Staff #36 further stated that Biological Indicator and Control tests are not run for each sterilizer load and results documented.

3. The OR storage of sterile instruments in the D.O.C. surgery Center were observed on 3/1/11 and does not provide conditions for maintaining the integrity of sterile packaging and, therefore, does not ensure the sterility of instruments used in surgery.

a. The D.O. C. Surgical OR flash sterilization logs dated January and February 2011, were reviewed, and indicated that three instances were observed where surgical instruments were flashed sterilized during surgery with the reason for flash sterilization recorded as "hole in the wrapper."

b. The following surgical instruments were documented as flashed for reasons of "hole in the wrapper:" On 1/7/11, Sterilizer # 2, Irrigating bipolars; on 2/11/11, Sterilizer #4, Orthomelic tray; and on 2/8/11, Sterilizer #4, a set of drill bits from small fragment.

4. On 3/1/11, Staff #36 stated that manufacturer's written instructions for sterilizer cycles are not maintained in the D.O.C. Surgery Center and also stated that only instruments requiring a sterilizer cycle of 4 minutes at 275?F with 20 minute dry time are sterilized at D.O.C. Surgery Center.

b. On 3/1/11 at 3:10 PM, a plastic container labeled "Katina brand" containing fine vertical scissors, were observed in the preparation and packaging room in the D.O.C. Surgery Center. Staff #36 stated that the manufacturer's recommendations for sterilization of the item were not available for reference or review. Staff #36 also stated that the item was sterilized for a 4 minute sterilize/ 20 minute dry cycle at 275?F and this practice is used for all items sterilized in the D.O.C. Surgery Center.

c. The manufacturer's instructions were obtained electronically by D.O.C. staff during the survey on 3/1/11. The instructions state, "Steam sterilize at 270?F (132?C) for 5 minutes. Other time and steam temperature cycles may also be used. However, user must validate any deviation from the recommended time and temperature."

d. There was no evidence that the facility is following manufacturer's instructions for sterilization of surgical instruments in the D.O.C. Surgery Center.


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C. Based on observation, staff interview, and review of facility policy and procedure, it was determined that the facility failed to prevent all sterile supplies from exceeding the shelf life date as recommended by the manufacturer of the packaging.

Findings include:

Reference #1: Facility policy Issue No: 841-200-057, titled 'Infection control: General Policies: Steris System I Processor: Guidelines for Use, Maintenance and Testing' states," PROCEDURE: ... I. Quality Assurance, Diagnostic Testing, Biological and Chemical Testing, Equipment Maintenance ... B. Chemical Monitoring ... 1. Storage of chemical strips: a) Keep monitoring strip container tightly capped; ... keep away from heat, light, moisture and strong oxidizing agents to maintain manufacturer's shelf life of 2 years (unopened) and 6 months (after first opening)."

Reference #2: Facility policy Issue No: 841-200-035, titled 'Guidelines for High Level Disinfection of Instruments Using CIDEX-OPA' states "... PROCEDURE: ...15) Efficay (sic) Testing Test CIDEX OPA Solution with CIDEX OPA Solution Test Strip prior to use. Verify that the Minimum Effective Concentration (MEC) of orthophthaladehyde is present. a) Check the date on the test strip bottle prior to use. Do not use outdated test strips. b) Record on the container label the date that the bottle of test strips was opened. Do not use any remaining strips beyond 90 days after opening the bottle."

1. On 3/3/11 at 2:25 PM, during tour of the Ambulatory Surgical Services Clinic on level E of the ACC building, in the presence of Staff #58, in the sterile processing room, a bottle of Steris 'Chemical Indicator for SYSTEM 1 Sterile Processing Systems' test strips were observed to be opened and marked with the date 12/15/10.

a. It could not be determined if the date indicated (12/15/10) was the date of opening, or the date the test strips were due to expire. The date was not written in the areas provided for the opening date, or the expiration date.

b. The printed manufacturers guidelines on the bottle indicated "6 months, not greater than expiring date."

c. Staff #58 confirmed the above findings.

d. Without a indication of the actual date of opening, it could not be determined if the bottle of Steris 'Chemical Indicator for SYSTEM 1 Sterile Processing Systems' test strips were within the 6 month expiration timeframe per the manufacturer's recommendation, or per facility policy in Reference #1.

2. A bottle of 'Cidex OPA' test strips was also observed opened in the sterile processing room. There was no indication on the bottle of an opening or expiration date.

a. Staff #61 stated the test strips are good for 45 days, which is not in accordance with manufacturer's guidelines.

b. The printed manufacturer's guidelines on the bottle indicate "Storage ... Caution: Do not use after 90 days of opening the bottle."

c. Without a date of opening or an expiration date, it could not be determined if the bottle of 'Cidex OPA' test strips were within the 90 day timeframe per the manufacturer's recommendation, or as per facility policy in Reference #2.

d. Staff #58 confirmed the above findings.