DEPARTMENT OF HEALTH PO BOX 367 TRENTON, N.J July 31, 2013

Transcription

1 DEPARTMENT OF HEALTH PO BOX 367 TRENTON, N.J CHRIS CHRISTIE Governor KIM GUADAGNO Lt. Governor July 31, 2013 MARY E. O'DOWD, M.P.H. Commissioner Arlene Maravilla Administrator Pavonia Surgery Center 600 Pavonia Avenue, Fourth Floor Jersey City, NJ Dear Ms. Maravilla: Thank you for the courtesy and cooperation extended during the Medicare Recertification Survey of your facility on June 12, 13, and 20, 2013 by surveyors from the New Jersey Department of Health. As a result of observation and evaluation certain Federal deficiencies were evident. The deficiencies identified during this visit have resulted in the determination that your facility is not in compliance with the following Medicare Conditions for Coverage: 42 CFR Governing Body and Management 42 CFR Surgical Services 42 CFR Pharmaceutical Services 42 CFR Infection Control A complete listing of the specific deficiencies identified by the surveyors is enclosed. These Federal deficiencies were discussed with you and/or your staff during the visit and are listed on the left side of the enclosed CMS-2567 form. Please reply to each deficiency, on an item by item basis, with your Plan of Correction (PoC) and the date you expect the correction to be completed. You may write your PoC on the deficiency report in the space provided, or it can be written on a separate document and submitted along with the signature page (page 1 of the deficiency report). Please number your response to correspond to the number of each deficiency statement.

2 Pavonia Surgery Center July 31, 2013 Page 2 The PoC for each deficiency must contain the following elements: 1. How the specific findings cited for each deficiency will be corrected. 2. The systemic changes put into place for each deficiency. 3. The measures that will be put into place to monitor each corrective action to ensure that the plan of correction is effective and that compliance is maintained. 4. The title of the person responsible for implementing the plan of correction. 5. The date on which each item addressed on the PoC will be corrected. 6. Do not reference and/or include attachments with your PoC. 7. Do not include names of individuals in the PoC. Use of titles is acceptable, such as, Administrator, Director of Nursing, Infection Control Practitioner, etc. Please be advised that the PoC will not be accepted for review by this office and will be returned to you if it contains reference to and/or attachments and/or names of individuals. Sign and date the first page of the CMS-2567 form and return the form with your PoC. Please retain a copy of each page for your records. All responses must be returned within 10 calendar days of receipt of this letter to Edward Harbet, SHCE, New Jersey Department of Health, Health Facilities Evaluation and Licensing, PO Box 367, Trenton, NJ It is important to return the completed forms promptly. Any delay or lack of response may jeopardize the certification status of your facility. If you have any questions concerning this report, please contact Eileen Kreiling, Coordinator of Inspections, at (609) Sincerely, Encl./EH Edward Harbet, RN, BSN, BA Supervising Health Care Evaluator Assessment and Survey

3 PRINTED: 05/07/2014 Statement of Deficiencies Citation Summary Sheet For: PAVONIA SURGERY CENTER ( 31C / NJ31C ) Survey Event: FTT811, Exit Date 06/20/2013 Citations Cited This Visit Regulation Type Regulation ID Regulation Version Building Number Tag Number Tag Title Scope/ Severity Federal FQ INITIAL COMMENTS Federal FQ GOVERNING BODY AND MANAGEMENT Federal FQ SURGICAL SERVICES Federal FQ ORGANIZATION AND STAFFING Federal FQ FORM AND CONTENT OF RECORD Federal FQ PHARMACEUTICAL SERVICES Federal FQ ADMINISTRATION OF DRUGS Federal FQ INFECTION CONTROL Federal FQ SANITARY ENVIRONMENT Federal FQ INFECTION CONTROL PROGRAM Federal FQ INFECTION CONTROL PROGRAM - RESPONSIBILITIES Federal FQ ADMISSION ASSESSMENT Federal FQ DISCHARGE WITH RESPONSIBLE ADULT

4 DEPARTMENT OF HEALTH AND HUMAN SERVICES PRINTED: 05/07/2014 FORM APPROVED CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: (X2) MULTIPLE CONSTRUCTION A. BUILDING (X3) DATE SURVEY COMPLETED 31C B. WING 06/20/2013 NAME OF PROVIDER OR SUPPLIER PAVONIA SURGERY CENTER STREET ADDRESS, CITY, STATE, ZIP CODE 600 PAVONIA AVENUE, FOURTH FLOOR JERSEY CITY, NJ (X4) ID SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) ID PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (X5) COMPLETION DATE Q 000 INITIAL COMMENTS Q 000 Medicare Recertification Survey Medical Records Reviewed: 20 Q 040 The survey resulted in 4 Condition level deficienciies GOVERNING BODY AND MANAGEMENT The ASC must have a governing body that assumes full legal responsibility for determining, implementing,and monitoring policies governing the ASC's total operation. The governing body has oversight and accountability for the quality assessment and performance improvement program, ensures that facility policies and programs are administered so as to provide quality health care in a safe environment, and develops and maintains a disaster preparedness plan. Q 040 Q 060 This CONDITION is not met as evidenced by: Based on review of policies and procedures, review of physician credential files, and staff interview, it was determined that the governing body failed to demonstrate that it is effective in carrying out the operation and management of the facility. The necessary oversight and leadership was not provided as evidenced by the lack of compliance with: 42 CFR Surgical Services; 42 CFR Pharmaceutical Services; and CFR Infection Control SURGICAL SERVICES Surgical procedures must be performed in a safe manner by qualified physicians who have been Q 060 LABORATORY DIRECTOR'S OR PROVIDER/SUPPLIER REPRESENTATIVE'S SIGNATURE TITLE (X6) DATE Any deficiency statement ending with an asterisk (*) denotes a deficiency which the institution may be excused from correcting providing it is determined that other safeguards provide sufficient protection to the patients. (See instructions.) Except for nursing homes, the findings stated above are disclosable 90 days following the date of survey whether or not a plan of correction is provided. For nursing homes, the above findings and plans of correction are disclosable 14 days following the date these documents are made available to the facility. If deficiencies are cited, an approved plan of correction is requisite to continued program participation. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: FTT811 Facility ID: NJ31C If continuation sheet Page 1 of 27

5 DEPARTMENT OF HEALTH AND HUMAN SERVICES PRINTED: 05/07/2014 FORM APPROVED CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: (X2) MULTIPLE CONSTRUCTION A. BUILDING (X3) DATE SURVEY COMPLETED 31C B. WING 06/20/2013 NAME OF PROVIDER OR SUPPLIER PAVONIA SURGERY CENTER STREET ADDRESS, CITY, STATE, ZIP CODE 600 PAVONIA AVENUE, FOURTH FLOOR JERSEY CITY, NJ (X4) ID SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) ID PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (X5) COMPLETION DATE Q 060 Continued From page 1 Q 060 granted clinical privileges by the governing body of the ASC in accordance with approved policies and procedures of the ASC This CONDITION is not met as evidenced by: A. Based on a review of facility bylaws, observation, and the credential files of two of two physicians and interview with administrative staff it was determined that members of the medical staff did not have delineation of privileges. Findings include: Reference #1: The PURPOSES section of MEDICAL STAFF BYLAWS stated: "The primary purpose of the Medical Staff of the Ambulatory Surgical Center is to provide for the collegial organization of physicians, and thereby to: Permit a high level of professional performance of all physicians authorized to practice in the ASC through the appropriate delineation of the clinical privileges which each practitioner may exercise in the ASC and through a continuing review and evaluation of each practitioner ' s performance in the ASC.... " The CONDITIONS AND DURATION OF APPOINTMENT section of the BYLAWS stated: "1. Both initial appointment and reappointments to the Medical Staff shall be made by the Director (who functions as a single member of the credentials committee). 2. Initial appointments and reappointments shall be for a period of three (3) years...." FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: FTT811 Facility ID: NJ31C If continuation sheet Page 2 of 27

6 DEPARTMENT OF HEALTH AND HUMAN SERVICES PRINTED: 05/07/2014 FORM APPROVED CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: (X2) MULTIPLE CONSTRUCTION A. BUILDING (X3) DATE SURVEY COMPLETED 31C B. WING 06/20/2013 NAME OF PROVIDER OR SUPPLIER PAVONIA SURGERY CENTER STREET ADDRESS, CITY, STATE, ZIP CODE 600 PAVONIA AVENUE, FOURTH FLOOR JERSEY CITY, NJ (X4) ID SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) ID PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (X5) COMPLETION DATE Q 060 Continued From page 2 Q Review of the personnel file of Physician #2 did not indicate evidence of a delineation of privileges which the practitoner may exercise in the facility. 2. Review of the personnel file of Physician #3 did not indicate evidence of a privilege request or a delineation of privileges which the practitoner may exercise in the facility. 3. On the morning of June 12, 2013, a patient was observed being examined by a resident physician. 4. Administrator #1 stated that there was no evidence that the two physicians had delineation of privilleges. He/she further stated that there was no documentation available regarding privileging of residents or a credential file for the resident. B. Based on a review of facility medical staff bylaws it was determined that the facility failed to ensure that all members of the ASC's medical staff and all clinicians granted medical staff privileges must be appointed to their positions within the ASC by the ASC's governing body. Findings include: Reference: The TEMPORARY PRIVILEGES section of MEDICAL BYLAWS stated: "The Director may grant temporary privilleges to a physician who is not on the medical staff after reviewing available information on the applicant's qualifications and who is able to attest to the applicant's ability to perform the privileges requested. Temporary privileges may be granted FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: FTT811 Facility ID: NJ31C If continuation sheet Page 3 of 27

7 DEPARTMENT OF HEALTH AND HUMAN SERVICES PRINTED: 05/07/2014 FORM APPROVED CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: (X2) MULTIPLE CONSTRUCTION A. BUILDING (X3) DATE SURVEY COMPLETED 31C B. WING 06/20/2013 NAME OF PROVIDER OR SUPPLIER PAVONIA SURGERY CENTER STREET ADDRESS, CITY, STATE, ZIP CODE 600 PAVONIA AVENUE, FOURTH FLOOR JERSEY CITY, NJ (X4) ID SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) ID PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (X5) COMPLETION DATE Q 060 Continued From page 3 Q 060 only when the information available supports a favorable determination regarding the applicant's qualifications, licensure, malpractice insurance coverage, and ability to exercise the privileges requested. Temporary privileges may be granted in the following circumstances. a. An applicant is going to assist an attendee in the ASC on a single day. Q Medical staff privileges may only be granted by the governing body. The Medical Director may not, without consent of the governing body, grant privileges to a practitioner (a) ORGANIZATION AND STAFFING Patient care responsibilities must be delineated for all nursing service personnel. Nursing services must be provided in accordance with recognized standards of practice. There must be a registered nurse available for emergency treatment whenever there is a patient in the ASC. Q 141 This STANDARD is not met as evidenced by: Based on document review, it was determined that the facility failed to ensure that nursing services were provided in accordance with recognized standards of practice. Findings include: Reference # 2: The New Jersey Board of Nursing Statutes 45:11-23 states "... Definitions... The practice of nursing as a registered professional nurse is defined as diagnosing and treating human responses to actual or potential physical and emotional health problems, through such services as casefinding, health teaching, FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: FTT811 Facility ID: NJ31C If continuation sheet Page 4 of 27

8 DEPARTMENT OF HEALTH AND HUMAN SERVICES PRINTED: 05/07/2014 FORM APPROVED CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: (X2) MULTIPLE CONSTRUCTION A. BUILDING (X3) DATE SURVEY COMPLETED 31C B. WING 06/20/2013 NAME OF PROVIDER OR SUPPLIER PAVONIA SURGERY CENTER STREET ADDRESS, CITY, STATE, ZIP CODE 600 PAVONIA AVENUE, FOURTH FLOOR JERSEY CITY, NJ (X4) ID SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) ID PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (X5) COMPLETION DATE Q 141 Continued From page 4 Q 141 health counseling, and provision of care supportive to or restorative of life and wellbeing, and executing medical regimens as prescribed by a licensed or otherwise legally authorized physician..." Q On 6/12/13, during Patient #16's admission process, at approximately 11:00 AM, Staff #6 was observed administering antibiotic eye drop to the right eye and subsequently placing a Hep-lock. Review of the physician orders revealed that the orders were dated, untimed and not signed by the physician, yet the pre-during-post op orders were taken off by the nurse on 6/12/13 at 11:05. Physician orders were being carried out without a valid order (b) FORM AND CONTENT OF RECORD The ASC must maintain a medical record for each patient. Every record must be accurate, legible, and promptly completed. Medical records must include at least the following: (1) Patient identification. (2) Significant medical history and results of physical examination. (3) Pre-operative diagnostic studies (entered before surgery), if performed. (4) Findings and techniques of the operation, including a pathologist's report on all tissues removed during surgery, except those exempted by the governing body. (5) Any allergies and abnormal drug reactions. (6) Entries related to anesthesia administration. (7) Documentation of properly executed informed patient consent. (8) Discharge diagnosis. Q 162 FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: FTT811 Facility ID: NJ31C If continuation sheet Page 5 of 27

9 DEPARTMENT OF HEALTH AND HUMAN SERVICES PRINTED: 05/07/2014 FORM APPROVED CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: (X2) MULTIPLE CONSTRUCTION A. BUILDING (X3) DATE SURVEY COMPLETED 31C B. WING 06/20/2013 NAME OF PROVIDER OR SUPPLIER PAVONIA SURGERY CENTER STREET ADDRESS, CITY, STATE, ZIP CODE 600 PAVONIA AVENUE, FOURTH FLOOR JERSEY CITY, NJ (X4) ID SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) ID PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (X5) COMPLETION DATE Q 162 Continued From page 5 Q 162 This STANDARD is not met as evidenced by: Based on review of the medical records of 5 patients who received anesthesia and interview with administrative staff it was determined that the facility failed to ensure that the anesthesia consent form, signed by the patient, included the type of anesthesia for all 5 patients. Findings include: 1. Review of CONSENT FOR SURGERY AND SPECIAL PROCEDURES forms in the medical records of Patient #2, #4, #7, #11 and #13 did not indicate the type of anesthesia to be administered. Based on document review, it was determined that the facility failed to ensure that the medical record was promptly completed. Findings include: 1. Medical Record #2 indicated that the patient underwent a procedure on 5/16/13. There was no evidence of findings and techniques of the operation, as of 6/12/13, date of review. 2. Medical Record #9 indicated that the patient underwent a procedure on 1/17/13. There was no evidence of findings and techniques of the operation, as of 6/12/13, date of review. 3. Medical Record #4, #5, #12, and #15 indicated that the patients underwent a procedure on 4/4/13, 3/25/13, 12/27/12, and 3/18/13, respectively. The procedure notes were signed but not dated, therefore it could not be determined how promptly the notes were recorded. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: FTT811 Facility ID: NJ31C If continuation sheet Page 6 of 27

10 DEPARTMENT OF HEALTH AND HUMAN SERVICES PRINTED: 05/07/2014 FORM APPROVED CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: (X2) MULTIPLE CONSTRUCTION A. BUILDING (X3) DATE SURVEY COMPLETED 31C B. WING 06/20/2013 NAME OF PROVIDER OR SUPPLIER PAVONIA SURGERY CENTER STREET ADDRESS, CITY, STATE, ZIP CODE 600 PAVONIA AVENUE, FOURTH FLOOR JERSEY CITY, NJ (X4) ID SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) ID PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (X5) COMPLETION DATE Q PHARMACEUTICAL SERVICES Q 180 The ASC must provide drugs and biologicals in a safe and effective manner, in accordance with accepted professional practice, and under the direction of an individual designated responsible for pharmaceutical services. This CONDITION is not met as evidenced by: Based on document review, observation, and staff interview conducted on 6/12/13, it was determined that the facility failed to ensure that medications are administered in a safe and effective manner in accordance with acceptable standards of practice. Findings include: 1. The facility failed to ensure that multi-dose vials used in an immediate patient care area are used for just one patient. (Refer to Tag 0181) 2. The facility failed to ensure that single dose containers of medications are used for just one patient. (Refer to Tag 0181) 3. The facility failed to ensure that medications are not used in the eye whenever the manufacturer states that the medication is not for ophthalmic use. (Refer to Tag 0181) 4. The facility failed to ensure that expired medications are not available for use. (Refer to Tag 0181) 5. The facility failed to ensure that medications are administered in accordance with physician's orders. (Refer to Tag 0181) FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: FTT811 Facility ID: NJ31C If continuation sheet Page 7 of 27

11 DEPARTMENT OF HEALTH AND HUMAN SERVICES PRINTED: 05/07/2014 FORM APPROVED CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: (X2) MULTIPLE CONSTRUCTION A. BUILDING (X3) DATE SURVEY COMPLETED 31C B. WING 06/20/2013 NAME OF PROVIDER OR SUPPLIER PAVONIA SURGERY CENTER STREET ADDRESS, CITY, STATE, ZIP CODE 600 PAVONIA AVENUE, FOURTH FLOOR JERSEY CITY, NJ (X4) ID SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) ID PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (X5) COMPLETION DATE Q 180 Continued From page 7 Q 180 Q The facility failed to ensure the development and implementation of policies and procedures that reflect the practice at the facility. (Refer to Tag 0181) (a) ADMINISTRATION OF DRUGS Drugs must be prepared and administered according to established policies and acceptable standards of practice. Q 181 This STANDARD is not met as evidenced by: A. Based on observation and staff interview conducted on 6/12/13, it was determined that the facility failed to ensure that multi-dose vials are used for a single patient when used in an immediate patient care area and that eye drops labeled as single dose are used once and discarded. Findings include: Reference: Center for Disease Control website< nt/checklist/outpatient-care-checklist-observation s.html>, titled "Infection Prevention Checklist for Outpatient Settings: Minimum Expectations for Safe Care" states, "Multi-dose vials to be used for more than one patient are kept in a centralized medication area and do not enter the immediate patient treatment area (e.g,. operating room, patient room/cubicle) (Note: If multi-dose vials enter the immediate patient treatment area they should be dedicated for single-patient use and discarded immediately after use.)" FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: FTT811 Facility ID: NJ31C If continuation sheet Page 8 of 27

12 DEPARTMENT OF HEALTH AND HUMAN SERVICES PRINTED: 05/07/2014 FORM APPROVED CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: (X2) MULTIPLE CONSTRUCTION A. BUILDING (X3) DATE SURVEY COMPLETED 31C B. WING 06/20/2013 NAME OF PROVIDER OR SUPPLIER PAVONIA SURGERY CENTER STREET ADDRESS, CITY, STATE, ZIP CODE 600 PAVONIA AVENUE, FOURTH FLOOR JERSEY CITY, NJ (X4) ID SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) ID PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (X5) COMPLETION DATE Q 181 Continued From page 8 Q The following opened multi-dose vials were found in the supply cart located inside the operating room at 11:30 AM: a. One (1) vial of 30ml Xylocaine 2%, dated with a use by date of 7/2/13. b. Two (2) vials of Gentamycin 80mg/2ml, dated with a use by date of 7/4/13. These findings resulted in an Immediate Jeopardy which immediately curtailed this practice. The Immediate Jeopardy was abated on 6/12/13, day of survey, upon receipt of an acceptable plan of correction. 2. Two (2) opened single dose containers of Tetracaine 0.5% ophthalmic drops, dated with a use by date of 6/21/13, were found in the supply cart located inside the operating room at 11:30 AM. 3. Three (3) 120ml opened single dose bottles of Purified water 98.3% ophthalmic solution were found in the exam room. 4. These findings were confirmed by Staff #1. B. Based on document review and staff interview conducted on 6/12/13, it was determined that the facility failed to ensure that drugs were administered in accordance with manufacturer's recommendations. Findings include: 1. Upon interview at approximately 11:30 AM, Staff #1 stated that the facility adds 10% povidone-iodine topical solution to 15 ml BBS FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: FTT811 Facility ID: NJ31C If continuation sheet Page 9 of 27

13 DEPARTMENT OF HEALTH AND HUMAN SERVICES PRINTED: 05/07/2014 FORM APPROVED CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: (X2) MULTIPLE CONSTRUCTION A. BUILDING (X3) DATE SURVEY COMPLETED 31C B. WING 06/20/2013 NAME OF PROVIDER OR SUPPLIER PAVONIA SURGERY CENTER STREET ADDRESS, CITY, STATE, ZIP CODE 600 PAVONIA AVENUE, FOURTH FLOOR JERSEY CITY, NJ (X4) ID SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) ID PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (X5) COMPLETION DATE Q 181 Continued From page 9 Q 181 (balanced salt solution) droptainer bottles. He/she stated that the mixture is administered into the eye prior to surgery. a. The manufacturer's label on the bottle of povidone-iodine provided by Staff #4 states, "Warnings... For external use only..." This product is not sterile. b. The label on the BSS bottle states, "The use of additives with this solution may cause corneal decompensation." c. Upon request, Staff #1 was unable to provide evidence that the addition of 10% povidone-iodine topical solution to BBS for application to the eye was an acceptable practice based on manufacturer's recommendations and warnings. These findings resulted in an Immediate Jeopardy which immediately curtailed this practice. The Immediate Jeopardy was abated on 6/12/13, day of survey, upon receipt of an acceptable plan of correction. C. Based on observation and staff interview conducted on 6/12/13 it was determined that the facility failed to ensure that expired medications are not available for patient use. Findings include: 1. Five vials of 50ml Mannitol 25%, expiration date 5/1/13, were found in the medication cabinet. 2. Twenty-five vials of 50ml Mannitol 25%, expiration date 5/1/13, were found in the storage room. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: FTT811 Facility ID: NJ31C If continuation sheet Page 10 of 27

14 DEPARTMENT OF HEALTH AND HUMAN SERVICES PRINTED: 05/07/2014 FORM APPROVED CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: (X2) MULTIPLE CONSTRUCTION A. BUILDING (X3) DATE SURVEY COMPLETED 31C B. WING 06/20/2013 NAME OF PROVIDER OR SUPPLIER PAVONIA SURGERY CENTER STREET ADDRESS, CITY, STATE, ZIP CODE 600 PAVONIA AVENUE, FOURTH FLOOR JERSEY CITY, NJ (X4) ID SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) ID PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (X5) COMPLETION DATE Q 181 Continued From page 10 Q Five vials of 50ml Mannitol 25%, expiration date 5/1/13, were found in the malignant hyperthermia cart. 4. The following expired medications were found in the medication room located in the operating room (OR) suite: a. One (1) Lidocaine 2% 100mg/5ml Abboject syringe, expiration date 1/6/13 b. Three (3) Epinephrine 1:10,000 1mg Abboject syringes, expiration date 4/1/13 c. One vial of amiodarone 50mg/3ml, expiration date 5/13 d. Four (4) Atropine 1mg Abboject syringes, expiration date 2/1/ Four (4) Sodium Chloride 0.9% 3ml syringes, expiration date 11/12, were found in the Malignant Hyperthermia Cart. 6. These findings were confirmed by Staff #1. D. Based on medical record review and staff interview conducted on 5/12/13, it was determined that the facility failed to ensure that medication orders are clear and that medications are administered in accordance with physician's orders. Findings include: 1. Medical Record #11 contained the following entry on the PACU Record, "Medications Motrin 400mg po [by mouth] 11:35." There is no FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: FTT811 Facility ID: NJ31C If continuation sheet Page 11 of 27

15 DEPARTMENT OF HEALTH AND HUMAN SERVICES PRINTED: 05/07/2014 FORM APPROVED CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: (X2) MULTIPLE CONSTRUCTION A. BUILDING (X3) DATE SURVEY COMPLETED 31C B. WING 06/20/2013 NAME OF PROVIDER OR SUPPLIER PAVONIA SURGERY CENTER STREET ADDRESS, CITY, STATE, ZIP CODE 600 PAVONIA AVENUE, FOURTH FLOOR JERSEY CITY, NJ (X4) ID SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) ID PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (X5) COMPLETION DATE Q 181 Continued From page 11 Q 181 evidence of a physician's order for Motrin 400mg in the medical record. 2. Medical Record #11 contained an order, which was not dated or timed by the physician, for "Tylenol 500mg x 2 tabs po stat [2 tablets by mouth now]." There was no evidence of administration of Tylenol in the medical record. 3. Medical Record #11 contained an order, which was not dated or timed by the physician, for "NSAID [non-steroidal anti-inflammatory drug] eye drop 1 gtt x 2 in OS [one drop 2 times in left eye]." The medication order lacks the name of the medication [NSAID is a class of drugs, not one particular drug] and frequency. 4. Medical Record #11 contained an order, which was not dated or timed by the physician, for "Antibiotic eye drop 1 gtt x 2 in OS [one drop 2 times in left eye]." The medication order lacks the name of the medication and frequency. 5. Medical Record #11 contained an order, which was not dated or timed by the physician, for "Tetracaine 0.5% 1 gtt x 2 in OS [one drop 2 times in left eye]." The medication order lacks frequency. 6. Medical Record #6 contained an order, dated 3/21/13, for "NSAID [non-steroidal anti-inflammatory drug] eye drop 1 gtt x 2 in OD [one drop 2 times in right eye]." The medication order lacks the name of the medication and frequency. The administration of "NSAID eye drop" is recorded at 7:20. There is no evidence of a second administration. 7. Medical Record #6 contained an order, dated FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: FTT811 Facility ID: NJ31C If continuation sheet Page 12 of 27

16 DEPARTMENT OF HEALTH AND HUMAN SERVICES PRINTED: 05/07/2014 FORM APPROVED CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: (X2) MULTIPLE CONSTRUCTION A. BUILDING (X3) DATE SURVEY COMPLETED 31C B. WING 06/20/2013 NAME OF PROVIDER OR SUPPLIER PAVONIA SURGERY CENTER STREET ADDRESS, CITY, STATE, ZIP CODE 600 PAVONIA AVENUE, FOURTH FLOOR JERSEY CITY, NJ (X4) ID SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) ID PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (X5) COMPLETION DATE Q 181 Continued From page 12 Q 181 3/21/13, for "Antibiotic eye drop 1 gtt x 2 in OD [one drop 2 times in right eye]." The medication order lacks the name of the medication and frequency. The administration of Antibiotic Eye drop is recorded at 7:20. There is no evidence of a second administration. 8. Medical Record #6 contained an order, dated 3/21/13, for "Tetracaine 0.5% 1 gtt x 2 in OD [one drop 2 times in right eye]." The medication order lacks frequency. The administration of Tetracaine 0.5% is recorded at 7:20. There is no evidence of a second administration. 9. Medical Record #14 contained an order, dated 3/14/13, for "NSAID [non-steroidal anti-inflammatory drug] eye drop 1 gtt x 2 in OS [one drop 2 times in left eye]." The medication order lacks the name of the medication and frequency. The administration of "NSAID eye drop" is recorded at 8:00. There is no evidence of a second administration. 10. Medical Record #14 contained an order, dated 3/14/13, for "Antibiotic eye drop 1 gtt x 2 in OS [one drop 2 times in left eye]." The medication order lacks the name of the medication and frequency. The administration of Antibiotic Eye drop is recorded at 8:00. There is no evidence of a second administration. 11. Medical Record #14 contained an order, dated 3/14/13, for "Tetracaine 0.5% 1 gtt x 2 in OS [one drop 2 times in left eye]." The medication order lacks frequency. The administration of Tetracaine 0.5% is recorded at 8:00. There is no evidence of a second administration. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: FTT811 Facility ID: NJ31C If continuation sheet Page 13 of 27

17 DEPARTMENT OF HEALTH AND HUMAN SERVICES PRINTED: 05/07/2014 FORM APPROVED CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: (X2) MULTIPLE CONSTRUCTION A. BUILDING (X3) DATE SURVEY COMPLETED 31C B. WING 06/20/2013 NAME OF PROVIDER OR SUPPLIER PAVONIA SURGERY CENTER STREET ADDRESS, CITY, STATE, ZIP CODE 600 PAVONIA AVENUE, FOURTH FLOOR JERSEY CITY, NJ (X4) ID SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) ID PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (X5) COMPLETION DATE Q 181 Continued From page 13 Q These findings were confirmed by Staff #1. E. Based on observation, document review and staff interview conducted on 6/12/13, it was determined that the facility failed to ensure the development of policies and procedures that reflected the practices of the facility. 1. Upon interview, Staff #1 stated that the facility did not have a pharmacy. 2. Review of the facility's policy and procedure manual identified the following policies and procedures that were specific to a facility that had a pharmacy: a. Drug Recalls, Reference #1227. The policy has several references to the Pharmacy. For example, the policy states, "Within 24 hours after the receipt of recall notice by the Pharmacy from a manufacturer withdrawing or recalling its medication, the Pharmacy shall observe the following procedure:..." b. Adverse Drug Reactions Definition and Process, Reference#1230. This policy has several references to the Pharmacy. For example, the policy states, "The Pharmacy will review drugs commonly known to treat ADRs [Adverse Drug Reactions]...supported by the Information Systems department." and "Each ADR is reviewed by a pharmacist and the QA Committee..." Staff #1 confirmed that the facility does not have a pharmacist on site or a contract with a consultant pharmacist. c. Emergency Crash Carts, Reference #1224, stated the following: FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: FTT811 Facility ID: NJ31C If continuation sheet Page 14 of 27

18 DEPARTMENT OF HEALTH AND HUMAN SERVICES PRINTED: 05/07/2014 FORM APPROVED CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: (X2) MULTIPLE CONSTRUCTION A. BUILDING (X3) DATE SURVEY COMPLETED 31C B. WING 06/20/2013 NAME OF PROVIDER OR SUPPLIER PAVONIA SURGERY CENTER STREET ADDRESS, CITY, STATE, ZIP CODE 600 PAVONIA AVENUE, FOURTH FLOOR JERSEY CITY, NJ (X4) ID SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) ID PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (X5) COMPLETION DATE Q 181 Continued From page 14 Q 181 i. The policy makes several references to the pharmacy and also "auxiliary Emergency Medication Boxes" in each patient care area. There were not emergency medication boxes in each patient care area, only a code cart in the Post Anesthesia Care Unit. ii. The policy states that "emergency drug supply shall be stored in a tray in each crash cart." The tray is to be sealed. The policy also states, "A label showing the earliest medication to expire and the name of the last person inspecting/sealing the medication tray from Pharmacy shall be placed on the outside of the sealed tray. An emergency cart was observed in the Post Anesthesia Care Unit. The medications were not in a sealed tray. Staff #1 confirmed that the facility does not have a Pharmacy. d. Medication Administration, Reference #1215 addresses practices that are not appropriate for this facility. Examples include but are not limited to the following: i. "Medications will be administered only on the order of a physician, dentist or podiatrist, who is a member of the medical staff and is an authorized member of the house staff... The orders are written under the guidelines of their respective scopes of practice by a physician, registered nurse, licensed vocational/practical nurse, respiratory therapist, rehabilitation therapist and/or their respective students." This facility only performs eye surgery. ii. "No medications will be left at the patient's bedside except for the following, as ordered: nitroglycerin SL tablets, respiratory inhalers, patient controlled analgesia (PCA), antacids, eye FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: FTT811 Facility ID: NJ31C If continuation sheet Page 15 of 27

19 DEPARTMENT OF HEALTH AND HUMAN SERVICES PRINTED: 05/07/2014 FORM APPROVED CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: (X2) MULTIPLE CONSTRUCTION A. BUILDING (X3) DATE SURVEY COMPLETED 31C B. WING 06/20/2013 NAME OF PROVIDER OR SUPPLIER PAVONIA SURGERY CENTER STREET ADDRESS, CITY, STATE, ZIP CODE 600 PAVONIA AVENUE, FOURTH FLOOR JERSEY CITY, NJ (X4) ID SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) ID PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (X5) COMPLETION DATE Q 181 Continued From page 15 Q 181 drops, throat lozenges and external preparations for topical application." Many of these medications are not appropriate for this facility. iii. "Medications will be prepared immediately prior to administration...(except when unit dose system is used and the intravenous admixtures are prepared by the Pharmacy)." iv. "Medications from home, which the patient brings to the Facility, will be disposed of in one of two ways:...sent to the Pharmacy to be stored until the patient is discharged..." v. "The charge nurse will send copies of the physician orders sheets to the pharmacy as soon as possible after a medication order or discharge order is written." B. Based on document review, it was determined that the facility failed to ensure that physician orders were carried out, as ordered. Findings: 1. Medical Record #15: The physician Medication and IV (intravenous) Orders dated 3/18/13, untimed, stated, "Tetracaine 0.5% 1 gtt [drop], Lidocaine Jelly 2%- apply a small amount to the conjunctival sac of operative eye, BBS 15 mg. [milliliter] w/ [with] 0.2 ml Betadine solution 1 gtt." a. Staff #1 indicated that the above drops are administered during the procedure by the nurse. There was no evidence in the intra-operative record of the administration of these medication by the nurse. b. The physician Non-Medication Orders dated 3/18/13, untimed, stated, "Place Honan balloon on surgical mmhg. [millimeter of FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: FTT811 Facility ID: NJ31C If continuation sheet Page 16 of 27

20 DEPARTMENT OF HEALTH AND HUMAN SERVICES PRINTED: 05/07/2014 FORM APPROVED CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: (X2) MULTIPLE CONSTRUCTION A. BUILDING (X3) DATE SURVEY COMPLETED 31C B. WING 06/20/2013 NAME OF PROVIDER OR SUPPLIER PAVONIA SURGERY CENTER STREET ADDRESS, CITY, STATE, ZIP CODE 600 PAVONIA AVENUE, FOURTH FLOOR JERSEY CITY, NJ (X4) ID SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) ID PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (X5) COMPLETION DATE Q 181 Continued From page 16 Q 181 mercury]." The Pre-Op Meds (medications) section of the admitting form, dated 3/18/13, lacked evidence that the above order was carried out. 2. Medical Record #12: Patient underwent a procedure on 12/27/12. The physician Medication and IV (intravenous) Orders, not dated or timed, stated, "Post -op [operative] Orders Tylenol 500 mg. [milligram] x2 tabs [tablets] po [by mouth] stat [immediately]." The PACU (Post Anesthesia Care Unit) Record lacked evidence of the administration of Tylenol. a. The physician Non-Medication Orders not dated or timed, stated, "Place Honan balloon on surgical mmhg. [millimeter of mercury]. " The Pre-Op Meds (medications) section of the admitting form, dated 12/27/12, lacked evidence that the above order was carried out. 3. Medical Record #2: The physician Non-Medication Orders dated 5/16/13, untimed, stated, "Place Honan balloon on surgical mmhg." The Pre-Op Meds section of the admitting form, dated 5/16/13, lacked evidence that the above order was carried out. Q 240 a. The physician Medication and IV (intravenous) Orders, dated 5/16/13, timed, stated, "Post -op Orders Tylenol 500 mg. x2 tabs po stat." The PACU Record lacked evidence of the administration of Tylenol INFECTION CONTROL The ASC must maintain an infection control program that seeks to minimize infections and communicable diseases. Q 240 FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: FTT811 Facility ID: NJ31C If continuation sheet Page 17 of 27

21 DEPARTMENT OF HEALTH AND HUMAN SERVICES PRINTED: 05/07/2014 FORM APPROVED CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: (X2) MULTIPLE CONSTRUCTION A. BUILDING (X3) DATE SURVEY COMPLETED 31C B. WING 06/20/2013 NAME OF PROVIDER OR SUPPLIER PAVONIA SURGERY CENTER STREET ADDRESS, CITY, STATE, ZIP CODE 600 PAVONIA AVENUE, FOURTH FLOOR JERSEY CITY, NJ (X4) ID SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) ID PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (X5) COMPLETION DATE Q 240 Continued From page 17 Q 240 This CONDITION is not met as evidenced by: Based on document review, observation, and staff interview, it was determined that the facility failed to maintain an infection control program that sought to minimize infections and communicable diseases. Findings include: 1. The facility failed to provide a sanitary environment for the provision of surgical services. (Refer to Tag 0241) 2. The facility failed to implement a policy designed to prevent infections and communicable diseases. (Refer to Tag 0242) Q The facility failed to provide a plan of action for preventing, identifying, and managing communicable diseases. (Refer to Tag 0242) (a) SANITARY ENVIRONMENT The ASC must provide a functional and sanitary environment for the provision of surgical services by adhering to professionally acceptable standards of practice. Q 241 This STANDARD is not met as evidenced by: Based on observation, it was determined the facility failed to provide a sanitary environment for the provision of surgical services. Findings include: 1. On 6/12/13 at 1:25 PM, in the presence of Staff #1, the lower vents were dusty in the OR. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: FTT811 Facility ID: NJ31C If continuation sheet Page 18 of 27

22 DEPARTMENT OF HEALTH AND HUMAN SERVICES PRINTED: 05/07/2014 FORM APPROVED CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: (X2) MULTIPLE CONSTRUCTION A. BUILDING (X3) DATE SURVEY COMPLETED 31C B. WING 06/20/2013 NAME OF PROVIDER OR SUPPLIER PAVONIA SURGERY CENTER STREET ADDRESS, CITY, STATE, ZIP CODE 600 PAVONIA AVENUE, FOURTH FLOOR JERSEY CITY, NJ (X4) ID SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) ID PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (X5) COMPLETION DATE Q 241 Continued From page 18 Q 241 Q On 6/12/13 at 2:20 PM, in the presence of Staff #1, the left side sink in the corridor mens room did not have a water supply and did not have a soap supply (b) INFECTION CONTROL PROGRAM The ASC must maintain an ongoing program designed to prevent, control, and investigate infections and communicable diseases. In addition, the infection control and prevent program must include documentation that the ASC has considered, selected, and implemented nationally recognized infection control guidelines. Q 242 This STANDARD is not met as evidenced by: Based on observation, staff interview and document review on June 12, 2013, it was determined that the ASC facility failed to implement the nationally recognized infection control guidelines they selected. The Association for the Advancement of Medical Instrumentation (AAMI) requirements, Comprehensive guide to Steam Sterilization and sterility assurance in health care facilities (ST 79 replaces and super cedes ST 46 by consolidating ST 46 with 4 other AAMI standards [ST33, ST37, ST42, and ST35] approved 7/10/2009. Findings include: Reference # 1: AAMI document ST 79, section states, " The Bowie-Dick test should be carried out each day the sterilizer is used, before the first processed load. " 1. Upon questioning, Staff #4 stated that the FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: FTT811 Facility ID: NJ31C If continuation sheet Page 19 of 27

23 DEPARTMENT OF HEALTH AND HUMAN SERVICES PRINTED: 05/07/2014 FORM APPROVED CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: (X2) MULTIPLE CONSTRUCTION A. BUILDING (X3) DATE SURVEY COMPLETED 31C B. WING 06/20/2013 NAME OF PROVIDER OR SUPPLIER PAVONIA SURGERY CENTER STREET ADDRESS, CITY, STATE, ZIP CODE 600 PAVONIA AVENUE, FOURTH FLOOR JERSEY CITY, NJ (X4) ID SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) ID PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (X5) COMPLETION DATE Q 242 Continued From page 19 Q 242 Bowie Dick test is performed once per week, not daily. The manufacturer instructions are not followed. 2. Upon questioning Staff #4 stated that the Bowie Dick test is performed in the same load as the Biological monitoring device. The manufacturer instructions are not followed. Reference # 2: AAMI document ST 79, section states, " Biological monitors are the only sterilization process monitoring devices that provide a direct measure of the lethality of the process. Various types of BI ' s are available, each with different response characteristics and incubation requirements. The appropriate BI must be chosen for the steam sterilization cycle being run and the BI must be used correctly in accordance with the manufacturer ' s written instructions ". 1. The biological monitoring device used in this Ambulatory Care facility is the 3M Attest 1261/1261 P (blue cap). The manufacturer instructions indicate this is the device used for Gravity sterilization cycles at 270F only. It is not for use in Pre-vacuum sterilization cycles at 270F, or steam gravity cycles at 250F. 2. The ASC performs both a Pre-vacuum cycle at 270F, and a steam gravity cycle at 250F. The manufacturer instructions are not followed. Reference # 3: AAMI document ST 79, section (k) states, " If a rigid container sterilization container system is used, the manufacturer's written instructions regarding set preparation and assembly should be followed. Whenever items FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: FTT811 Facility ID: NJ31C If continuation sheet Page 20 of 27

24 DEPARTMENT OF HEALTH AND HUMAN SERVICES PRINTED: 05/07/2014 FORM APPROVED CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: (X2) MULTIPLE CONSTRUCTION A. BUILDING (X3) DATE SURVEY COMPLETED 31C B. WING 06/20/2013 NAME OF PROVIDER OR SUPPLIER PAVONIA SURGERY CENTER STREET ADDRESS, CITY, STATE, ZIP CODE 600 PAVONIA AVENUE, FOURTH FLOOR JERSEY CITY, NJ (X4) ID SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) ID PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (X5) COMPLETION DATE Q 242 Continued From page 20 Q 242 are prepared for sterilization, the user should verify that the container system and the medical device to be sterilized have been tested and validated for the preset standard steam sterilization cycle to be used ". 1. Staff #5 stated that the Genesis container systems have not been validated for the multiple sterilization cycles used in this Ambulatory surgical center. Reference # 4: AAMI document ST 79, section states, "The written instructions of the device manufacturer should always be followed. The manufacturer's written instructions should be kept on file and periodically reviewed for any updates. If there are no specific instructions in the labeling, then the manufacturer should be contacted directly to provide a documented method." 1. The device manufacturer written instructions for Alcon, Acutome, Wolcott, and Katena eye instruments are incomplete and/or not up to date in the facility. 2. Staff #5 stated that the sterilization cycles for the eye instruments in use is based on the Genesis sterilization container parameters and not the individual eye instrument manufacturers ' instructions. 3. The Diamond knives written manufacturer instructions indicate a 5 minute pre-vacuum sterilization cycle at a maximum temperature of 275F. The manufacturer written instructions are not followed. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: FTT811 Facility ID: NJ31C If continuation sheet Page 21 of 27