ICPD_2006

The Abortion Industry

The following list of violations resulted in the closure of the Alternatives Abortion Clinic,
in Atlantic City, New Jersey, in 2007:

State Requirements	Violations
Organizational chart	Facility failed to establish an org chart
Medical director must develop, implement and review written medical policies	Facility failed to ensure the implementation of approved policies and procedures
Peripheral nerve simulator will be available to each anesthetizing location	Peripheral nerve stimulators not functional
Physician undergoes surgical scrub, gowning, gloving and remains sterile while performing procedure	No clock available for timing scrubs Physicians do not scrub for procedures Staff #1 said: “Abortions aren't really surgery, they aren't sterile procedures.”
All drugs shall be stored under proper conditions and labeled	Seven predrawn syringes containing liquid were found in “local box” in Procedure Room #1 with no indication of the drug name, strength or date it was drawn up Seven more predrawn syringes were found in a supply cart in Procedure Room #1, each containing clear liquid with drug name documented but no drug strength or date drawn up indicated In Procedure Room #2, 17 predrawn syringes found in “local box” with no indication of drug name, strength or date drawn up Additional five predrawn syringes found in supply cart in Procedure Room #2, each containing clear liquid with drug name documented but no strength or date it was predrawn

Drugs with open or broken seals shall be returned to institutional pharmacy for disposal, or brought to specified location in the family, specified by facility policies and procedures for disposal	Facility failed to ensure that all expired medications were disposed of in accordance with facility policy; Containers and fluids found in facility in violation
Complete medical record shall include documentation of the medical history and physical examination if performed, signed and dated by the examiner	Facility failed to ensure that all medical records contain documentation of the medical history and physical signed/dated by examiner; 3 of 6 medical records reviewed were incomplete; 2 of 6 records examined lacked examiner's signature
The complete medical record shall include patient assessments developed by each service providing care to the patient	Facility failed to ensure that all medical records contain documentation of the patient assessments developed by each service providing care to the patient 3 of 6 medical records reviewed had Operative Sheets that were not signed by the anesthesiologist and had a blank in the space for discharge time 3 of 6 medical records reviewed had Preanesthesia assessments left blank 3 of 6 medical records reviewed has social services notes, postoperative counseling sections that were unsigned by patient 6 of 6 medical records reviewed had social service notes, postoperative counseling sections unsigned by patient
All entries in medical record shall be typewritten or written legibly in ink, dated and signed by the person entering them, or authentication of computerized records	Facility failed to ensure that all entries in the medical records are signed by the person entering them fetal ultrasonography report and the emergency contact sheet (in Spanish) not signed by physician in Medical Record #4 fetal ultrasonography report and the emergency contact sheet (in Spanish) not signed by physician in Medical Record #5 fetal ultrasonography report and the emergency contact sheet (in Spanish) not signed by physician in Medical Record #6
Facility shall be able to respond to medical emergencies occurring on the premises during its hours of operation	Facility failed to ensure ability to respond to medical emergencies There was only East Cap II C)2 detector available in Procedure Room 1; it expired March 6 th There was only one Easy Cap II CO2 detector available in Procedure Room 2 There were no other CO2 detectors available As a result, physicians could not monitor the patients' endtidal CO2 should an emergency necessitate intubation of the patient Emergency cart in Room 1 had only two endotracheal tubes; both had the sterile packaging opened; both expired In Room 2, 3 of 6 endotracheal tubes had sterile packaging opened; one was in an unlabeled and open plastic bag; four bags had expired dates; remaining tube very old and discolored The lack of endotracheal tubes leaves facility unable to intubate a patient in even of emergency
Written policies and procedures regarding emergency kits and, if required, emergency carts which are appropriate to the patient population served by facility, shall include policies that ensure that emergency kits are secure but are not kept under lock and key	Facility failed to ensure that all emergency carts were secured
All areas, including areas with limited access such as cabinet, drawers, locked medication rooms and storage areas, shall be kept clean to sight and touch and free of condensation, mold growth and noxious odors	Facility failed to ensure proper storage patient care items Blood draw room contained numerous patient care items stored under the handwash sink
Environmental requirements: all furnishings shall be clean and in good repair; mechanical equipment shall be kept covered to protect from contamination and accessible for cleaning and inspection; broken or worn items shall be repaired, replaced or removed promptly	Facility failed to ensure that all furnishings were kept clean and in good repair Anesthesia machines not kept covered to protect from contamination IV poles in both procedure rooms found with accumulations of rust, dirt and debris on their bases Procedure tables found with: soiled and/or stained table pads; torn armboard pads, rust and dirt accumulation on moving parts, what appeared to be dried blood under the leg pads Lab equipment not kept covered to protect from contamination Baseboard heater in bathroom of room 2 was covered with rust and dust Wall mounted datascope in room 2 had a thick coating of dust present
Hot running water between 105-120 degrees and cold running water shall be provided in patient care areas	Review of water temperature logs and facility policies and procedures showed facility failed to ensure proper hot water temperatures were maintained Facility policy required water temps of 95-120 2003 Review of hot water temps were below standard on 48 of 54 checks 2004 Review of hot water temps were below standard on 55 of 55 checks 2005 Review of hot water temps were below standard on 12 of 12 checks 2006 Review of hot water temps were below standard on 34 of 49 checks 2073 Review of hot water temps were below standard on 25 of 25 checks
Administrator shall have a baccalaureate degree and 2 years of FT or FTE administrative or supervisory experience in a healthcare facility. Each additional year of FT or FTE administrative or supervisory experience and/or training in a health care facility may be substituted for each year of the four-year degree requirement. Four years of such experience and/or training may be used to satisfy the degree requirement	Requirement not met; facility did not ensure the administrator(s) were experienced, trained and satisfied the degree requirement for this position Employees #2 and #4 said employee #1 asked them to be the administrator and co-administrator since March 2007 Employees 2 and 4 said that prior to March 2007, they were the lab technician and ultrasound technician for the facility and they continue to serve these roles Employees 2 and 4 do not meet baccalaureate degree, experience or administrative/supervisory requirements
Facility shall develop written job descriptions and ensure that personnel are assigned duties based upon their education, training and competencies and in accordance with their job descriptions	Facility could not provide any evidence of written job descriptions to ensure that personnel are assigned duties based upon their education, training and competencies. Findings confirmed by employee #1
All personnel who require licensure, certification or authorization to provide patient care shall be currently licensed, certified or authorized under the appropriate laws or rules of the State of New Jersey or under the applicable standards of the appropriate body	Facility did not ensure all personnel who require licensure, certification or authorization to provide patient care were currently licensed or certified RN license for employee #10 expired 7/31/06 RN license for employee #11 expired 5/31/07
Staffing schedules shall be implemented to ensure continuity of care to patients. Provision shall be made for substitute staff with equivalent qualifications to replace absent staff members	Facility did not implement staffing schedules to ensure continuity of care to patients Facility could not provide any documented evidence of a staffing schedule Employee #4 said “the clinic is opened on Thursdays and Saturdays and we are all here on those days and whenever we are needed”
Facility shall have a governing authority which shall assume legal responsibility for the management, operation and financial viability of the facility	Facility failed to provide any evidence of a governing authority which assumed legal responsibility for the management, operation and financial viability of the facility
Governing authority shall be responsible for but not limited to the services provided and the quality of care rendered to patients	Facility could not provide any documented evidence that the governing authority ensured the services provided and the quality of care rendered to patients, including but not limited to the lack of: 1.an infection prevention and control services 2. surgical and anesthesia services 3.a quality assurance program 4. pharmaceutical services 5. medical services 6. nursing services 7. physical plant and functional requirement 8. emergency services and disaster plans 9. housekeeping, sanitation and safety
The governing authority shall be responsible for but not limited to the provision of a safe physical plant equipped and staffed to maintain the facility and services	This requirement is not met as evidenced by: Facility could not provide any documented evidence that the governing authority ensured a safe physical plant, equipped and staffed to maintain the facility and services Not provided: Emergency services and disaster plans including drills, evacuation procedures, instruction in fire fighting, testing of the fire extinguishers Physical plant and functional requirements that include: recovery room, with the lack of privacy curtains at each recovery station does not provide patient privacy and dignity as required facility has no nurses station as required facility has no drug distribution station equipped with a work counter, sink, refrigerator and locked storage for biologicals as required facility does not have a soiled holding room or closet for collection of, storage and disposal of soiled materials no parking for patients not equipped with a covered entrance for the pick up of patients waiting room does not have wheelchair storage, public telephone and a water fountain no interview space for private interviews with patients no multipurpose or consultation room no special storage for staffs' personal effects soiled utility room is not equipped with a worktable, a flush type device and washer/sterilizer clean utility room has no hand washing sink, worktables, counters, ultrasonic storage facilities for backup supplies and instrumentation and a drying cabinet or drying equipment and is not large enough to accommodate sterilizer carts facility stores sterilized packs with no provision for ventilation, humidity and temperature controls two operating rooms less than 360 square feet, are not equipped with an emergency communication system connected to a surgical suite control station and do not have a minimum of one x-ray illuminator in each post-anesthesia recovery room is approximately 12-17 and does not provide a minimum of 3 feet at each side of each recovery bed to a wall or curtain, recovery beds not visible from a nurses' station and does not have bed pan cleaning facilities nearby patient recovery lounge is not supervised, does not contain a control station and does not have convenient access to toilet facilities there is no control station to provide visible surveillance of all traffic entering the operating suite soiled utility room is not equipped with a clinical equivalent flushing type fixture, work counter, handwashing sink and waste receptacle; lefthand bay of the existing three bay stainless steel sink, in the soiled utility room equipped with a garbage disposal used for the disposal of “tissue” and the clinical flushing rim sink located in a room used for storage was not used The existing clinical sink is not used for fluid waste disposal Facility has no anesthesia work room for the cleaning, testing and storing of anesthesia equipment Facility has ho staff clothing change area Patient changing area not equipped with lockers, clothing change or gowning areas, space for administering medications and no provisions for the securing patients personal effects No stretcher storage area Housekeeping room located in surgical suite is not used exclusively for the surgical suite; surgical suite housekeeping closet is used for all areas of the facility on the first floor Entry corridor is not six feet wide Ceilings and walls in operating rooms and the bathrooms of the two operating rooms are not readily washable and free of crevices; surfaces and fixtures in bathroom of the two operating rooms cannot maintain the sterile environment required in an operating room No physical evidence or documentation presented to verify that the existing heating and ventilation system meets the ventilation requirements as evidenced by: no evidence of positive pressure within the operating rooms, no documentation presented to verify that each operating room has a minimum of 15 air changes per hour, of which 3 are outside air, bathrooms not equipped with mechanical or natural ventilation Installation of carpeting in the two examination rooms, the corridor adjacent to the examination rooms and the blood draw room and in the sterile corridor does not meet the requirement for floor material that is readily cleanable Third floor office common corridor was blocked with facility's supplies, impeding egress to the rear fire exit—a violation of state law A lack of surgical and anesthesia services that included: lack of credentialing of staff; lack of accountability of medications; lack of history and physicals for surgical patients; lack of a mechanical ventilator; lack of a consultant pharmacist; lack of provision for nursing services throughout facility

Governing authority shall be responsible for but not limited to appointment, reappointment, assignment of privileges and curtailment of privileges of health care professionals and written confirmation of such actions	Facility could not provide any documented evidence these medical and anesthesia personnel were appointed/reappointed and assigned privileges by the governing authority
GA shall be responsible for ensuring development and review of all policies and procedures in accordance with a schedule established by the GA	Facility could not provide any documented evidence that the GA reviewed and approved policies and procedures in accordance with a schedule established by the GA The Alternatives GA policy stipulates “review of all policies procedures will be revised and discussed at least annually and as often as needed Only documented review and approval of these policies and procedures developed in January 1995 was by the medical director and former administrator in Dec. 2005
GA shall be responsible for the establishment and implementation of a system whereby patient and staff grievances and/or recommendations including those relating to patient rights can be identified within the facility. This system shall include a feedback mechanism through management to the GA indicating what action was taken	This requirement was not met; GA did not establish and implement a system whereby patient and staff grievances and/or recommendations, including those relating to patient rights can be identified within the facility
GA shall be responsible for the determination of the frequency of the GA and its committees or equivalent conducing such meetings and documenting them through minutes	Requirement not met; no documentation provided for a GA, current government body by-laws and GA meeting minutes
GA shall be responsible for the delineation of the duties of the officers of any committees or equivalent of the GA. When the GA establishes committees, their purpose, structure, responsibilities and authority and the relationship of the committee to other entities within the facility shall be documented	Requirement not met; GA did not establish any committees on patient care policies, medical staff, credentialing, QA and infection control
GA shall be responsible for the approval of the medical staff bylaws or equivalent	Facility could not provide any documented evidence that the GA approved the medical staff bylaws Bylaws issued in January 1995 but not approved by the current medical director and administrator No evidence that these bylaws were approved by the GA
GA shall appoint an administrator who shall be accountable to the GA. The administrator or an alternate designated in writing shall be available in the facility during its hours of operation	GA failed to appoint/designate in writing an administrator or alternate to act in the absence of an administrator
Administrator shall be responsible for ensuring the development, implementation and enforcement of all policies and procedures, including patient rights	The administrators are not aware of established policies and procedures for the facility and are not involved in the development, review, implementation and enforcement of these policies Facility could not provide any documented evidence of how the administrators ensured that patient rights were reviewed with patients on admission to the faculty Two staff members said “we don't have any” facility policies and procures; however, the survey staff found the policies and procedures
Administrator shall be responsible for planning for and administration of the managerial, operational, fiscal and reporting components of the facility	Facility could not provide any documented evidence that the administrators are responsible for any aspect of planning and administration of the managerial, operational, fiscal and reporting components of the facility
Administrator shall be responsible for participating in the quality assurance program for patient care and staff performance	Facility could not provide any evidence that the administrators participated in the quality assurance program for patient care and staff performance. Employees stated they were not aware of a QA program at the facility.
Administrator shall be responsible for ensuring that all personnel are assigned duties based upon their education training, competencies and job descriptions	Administrator failed to ensure that all employees are assigned duties based on their training, competencies and job descriptions. 7 of 7 employee files reviewed for compliance with state licensure requirements did not contain evidence of training, competencies and job descriptions.
Administrator shall be responsible for establishing and maintaining liaison relationships and communication with facility staff and services, with support services and community resources, and with patients	Facility could not provide any documented evidence that the administrator is responsible for establishing and maintaining liaison relationships and communication with facility staff and services, with support services and community resources, and with patients
Facility shall establish and implement written patient care policies and procedures governing the services provided	Facility could not provide any current written patient care policies and procedures governing the services provided Policy stipulates “review of all policies and procedures will be revised and discussed at least annually and as often as needed” Only documented review and approval of these policies and procedures developed in January 1995, was by the medical director and former administrator in December 2005 5 out of 5 employees interviewed did not know these policies existed and could not implement them
Facility shall establish a patient care policy committee or its equivalent consisting of the administrator, the medical director and a representative of the nursing service. A representative of each service offered by the facility shall attend all patient care policy committee meetings in which policies or procedures for that particular service are developed or reviewed.	That requirement is not met; facility could not provide any evidence of patient care policy committee consisting of the administrator, the medical director and a representative of the nursing service had been developed
All patient care policies and procedures shall be reviewed by the patient care policy committee in accordance with a schedule established by the GA, at least triennially. Each review shall be documented.	Facility could not provide any evidence that the patient care policy committee ever met to review policies and procedures
Facility shall specify in its policies and procedures the circumstances under which a physical examination will be performed, the frequency and the contents. The contents shall include at least an assessment of body systems.	Facility failed to ensure that physical examinations were performed and included at least an assessment of body systems preoperative physical examination form in 5 out of 10 medical records where surgical procedures were performed reviewed were blank and not signed by the physician 3 of 10 medical records reviewed were blank except for temperature, pulse and blood pressure and were not signed by the physican facility's physical examination policy stipulated “each patient admitted for care at Alternatives will have a physical examination that will include but not be limited to: ultrasound, laborator workup, pelvic exam, assessment of body systems ….” The lack of evidence of physical examinations in the patients' medical records was acknowledged by two employees who stated it was “the normal practice at the facility.”
GA shall designate a physician to serve as medical director. The medical director shall designate, in writing, a physician to act in the absence of the medical director. The medical director, or a designee, shall be available to the facility at all times.	The facility failed to provide documentation that the GA designated a physician to serve as medical director and designate a physician to act in the absence of the medical director. 2005 letter to this state agency indicated that staff member #13 replaced the outgoing medical director and director of laboratory services at Alternatives a 2007 letter to employee #1 by the medical director indicated a resignation
The medical director shall be responsible for direction, provision and quality of medical services provided to patients	Facility failed to ensure that the medical director was responsible for the direction, provision and quality of medical services provided to patients there was no evidence in documentation reviewed that the medical director was involved in: a quality assurance program, infection control program, review and revision of the policies and procedures, credentialing committee and the patient care committee
Medical director shall be responsible for assisting in developing and maintaining written job descriptions for the medical staff, participating in the review of credentials and delineation of privileges of medical staff members and assigning duties based upon education, training, competencies and job descriptions	Based on review of the facility's policy and procedure manual, a review of 2 of 2 medical staff records of credentials provided, it was determined that the M.D. failed to participate in the review of credentials and delineation of privileges of medical staff members and to ensure that medical staff members are assigned duties based upon training, competencies and job descriptions. A review of the facility medical staff bylaws revised 11/17/05 states that reappointment to the medical staff will be made annually in January of each year by the M.D. and will become effective when approved by the GA; credentials committee shall investigate the character, qualifications, professional competence and ethical standing of the applicant. Within two weeks, the credentials committee shall recommend that the application be accepted, deferred or rejected. The decision is then sent to the M.D. who will forward it to the governing body for approval or disapproval …” There is no evidence that a credentials committee was formed There is no documentation of any credentialing procedures and results for the medical staff members annually and approved by the governing body There is no evidence that M.D. participated in the review of credentials and delineation of privileges annually for staff member #5 who was performing procedures from June 8, 2007 through the present (June 26, 2007)
M.D. shall be responsible for participating in staff orientation and staff education activities	Facility failed to provide evidence to ensure that the M.D. participated in staff education to ensure staff were competent to provide care to the patients There was no evidence the M.D. participated in staff education
M.D. shall be responsible for developing, implementing and reviewing written medical policies, including medical staff bylaws, in cooperation with the medical staff. These shall be approved by the GA.	Facility failed to ensure that the M.D. implemented the approved policies, procedures and bylaws. A review of the medical staff bylaws revised 11/17/05 incated that M.D. or acting M.D. and the administrator must be notified in connection with every case falling into these categories: over 16 weeks pregnant, negative pregnancy test, any case involving an abnormality, any problems (uterus not empty, products of conception removed are less than expected, perforation, difficulty in dilating the cervix, any problems during or after the case A review of medical record #7 indicated that the urine pregnancy test was negative and there was no evidence of further testing to verify pregnancy. There is no evidence of notification to the M.D. and administrators that patient #7 had a negative pregnancy test 7 of 13 medical records reviewed for ultrasound reports indicated on the fetal ultrasonography reports that the patients were past 16 weeks pregnant. There is no evidence of notification to the M.D. and administrators of the above patients past 16 weeks of pregnancy. A review of the minor complications log for 2006 and 2007 indicated there ere 37 minor complications recorded. There is no evidence that the M.D. and administrator were notified of the complications. A review of the major Complications log for 2006 and 2007 indicated that there were five major complications for 2006 and one of which was recorded as a “perforation.” There is no evidence that the Medical Director and administrator were notified of the complications. Staff #4 was interviewed 6/26/07 and stated that the administrators were not aware of a complications log, of who was recording the information pertaining to the log and that they were not aware that the facility bylaws existed.
Medical policies, including medical staff bylaws, shall include a plan for medical staff meetings and their documentation through minutes.	The MD failed to develop a plan for medical staff meetings. No evidence of meetings was documented.
Nursing services as required by this chapter shall be provided in the facility, directly by the facility or through written agreement.	The facility did not provide nursing services consistently in the facility Employees #2 and #4 said the facility “only has one registered nurse who works on Thursdays and Saturdays. A review of the records confirmed this. In reviewing the June 2007 staffing schedule, it was noted that the facility was in operation June 8, 10, 15, 18, 22 and 25 without nursing services.
Facility shall designate in writing a registered professional nurse as the director of nursing services, who shall be on the premises of the facility during its hours of operation. A registered professional nurse shall be designated in writing to act in the absence of the director of nursing services.	Facility did not designate in writing a registered professional nurse who shall be on the premises of the facility during its hours of operation and/or a registered professional nurse to act the absence of the director of nursing services.
The director of nursing services shall be responsible for the direction, provision and quality of nursing services provided to patients.	Facility did not have a director of nursing services.
The nursing care needs of the patient shall be assessed only by a registered professional nurse.	Based on 10 out of 10 medical records reviewed where surgical procedures were performed and staff interviewed, the facility did not ensure that nursing care needs of the patient were assessed by a registered professional nurse.
In accordance with job descriptions and with these rules, nursing personnel shall enter the nursing portion of the patient plan of care, in accordance with the facility's policies and procedures, in the patient's medical record.	Facility did not ensure that the RN has a written job description and that nursing personnel documented in the nursing portion of the patient plan of care, in accordance with the facility's policies and procedures. There were no nursing clinical notes documented in 5 out of 10 medical records reviewed. This is against the facility's “Responsibilities of Nursing Personnel” policy which stipulates “services provided shall be documented in the patient's medical records.”
In accordance with written job descriptions and with these rules, nursing personnel shall enter clinical notes in the patient's medical record.	Facility did not ensure that the RN has a written job description and that nursing personnel documented clinical notes in the patient's medical record in accordance with the facility's policies and procedure In 5 of 10 medical records where surgical procedures were performed, there were no clinical notes by nursing personnel. This is against the facility's “Responsibilities of Nursing Personnel” policy which stipulates “services provided shall be documented in the patient's medical records.”
The facility shall develop and implement written policies and procedures approved by the patient care policy committee for the administration, control and storage of medications. The patient care policy committee shall review the policies and procedures and document the review at least annually.	Facility failed to have a policy addressing administration of medications that were brought into the facility by individual physicians. Staff #2 and #4 stated that staff #5 brought his/her own drugs into the facility to administer during procedures. There was no evidence of a policy that addressed physicians bringing their own supply of medications to the facility. There was not a system in place to ensure that the medications were not expired or otherwise not usable.
The facility's policies and procedures for the administration, control and storage of medications shall include policies and procedures for documenting and reviewing adverse drug reactions and medication errors.	Facility failed to ensure the documenting and reviewing of adverse drug reactions and medication errors. Facility policy “Adverse Drug Reactions and Medication Errors,” dated 11/17/2005 , states, “An incident report shall be completed and filed in the incident report file. The Patient Care Committee shall review the incident report file yearly and make recommendations based on its findings.” On June 26, 2007 , staff #2 was requested to show evidence of a Patient Care Committee meeting that had been held within the past year in which adverse drug reactions and/or medication errors had been discussed. He/she was unable to provide evidence of this. Additionally, there were no incident reports available for review.
Facility's policies and procedures for the administration, control and storage of medications shall include policies and procedures for the use of parenterals, if used, including the labeling of intravenous infusion solutions, such that a supplementary label is affixed to the container of any intravenous infusion solution to which drugs are added	Facility failed to ensure that policies addressing the preparation of intravenous medications were implemented. Facility policy “Policy and Procedure for Mixing Drugs” section I.A. states “Cleanliness and sterility is to be maintained at all times. Intravenous admixtures will be prepared in a clean work area at the nurse's station.” There was no evidence of a nurse's station or a clean work area within the facility Facility policy “Procedure for Mixing Drugs-Brevital” states “To make a 0.1% solution of Brevital it is necessary to mix one vial of Brevital 2.5G with a 250 ml bag of Sterile Water.” Brevital was available at the facility and there was evidence of the administration of Brevital to patients on the Daily Record of Controlled Drug Us records throughout the months of May and June 2007. Bags of 250 ml of sterile water were not available at the facility. Staff #4 said he/she thought that Brevital was diluted in Lactated Ringer's Solution, which was available in each operating room. The package insert for Brevital states “Incomatible diluents: lactated ringer's injection.”
The facility's policies and procedures for the administration, control and storage of medications shall include policies and procedures for the purchase, storage, safeguarding, accountability, use and disposition of drugs in accordance with the New Jersey State Board of Pharmacy rules (NJAC 13:39) and the Controlled Dan gerous Substances Act and amendments thereto. Pharmaceutical services provided through written agreement shall be provided by a pharmacy licensed by the NJSBP. An individual patient may choose to obtain medications from a pharmacy which is not located in New Jersey.	Facility failed to ensure implementation of policies and procedures addressing the storage of medications. Facility policy “Storage of Drugs, dated 11/17/05, states, “The medication refrigerator is used exclusively for medication storage. Refrigerated medications were found in an unlocked refrigerator in the ultrasound room along with laboratory items.
The facility's policies and procedures for the control of drugs subjected to the Controlled Dan gerous Substances Act and amendments thereto shall include a provision for a verifiable record system for controlled drugs.	Facility failed to ensure implementation of policies and procedures addressing controlled substances and compliance with state and federal regulations. Reference: Facility policy “Controlled Substances,” dated 11/17/05, was not followed in the following instances: The policy states “A count of all controlled drugs is made at the beginning and end of each procedure day. Both counts are to be witnessed by two signatures, the anesthesiologist present and the administrator or change nurse. A declining inventory shall be kept of all controlled substances. The inventory shall be checked by the anesthesiologist or certified registered anesthesiologist and the administrator.” For June 26, 2007, only one person reviewed these records, a person without any medical expertise. There was no evidence that an end of the day count was conducted June 21, 2007. There was no evidence that an end of the day count was conducted June 22, 2007. Two inventory counts done in May did not include the date. On June 27, 2007 , the controlled drugs in the storage cabinet did not reconcile with the last count by a staff member: counting discrepancies existed for Fentanyl, Versed and Brevital. The strength or size of the vials was not included in the controlled drug inventory sheet for any of the controlled drugs. The beginning and end counts for the same drugs listed above did not reconcile on May 3, 2007 . One staff member said that another staff member had taken some of the controlled substances out of the clinic. Records for the administration of Fentanyl “50” to a patient do not reconcile with daily record of controlled drug use sheet.
Policy requires use of all controlled drugs to be logged by patient name and number on a daily controlled drug record sheet, indicating drug, strength, patient's name, chart number, doctor prescribing drug, date and method of administration, dosage administered, signature of person administering drug, amounts of drug destroyed, wasted and remaining and signature of persons witnessing destruction.	Daily controlled drug records from May and June were reviewed and did not meet these requirements.
The New Jersey Controlled Dan gerous Substances Act 24:21 requires that it be distributed only by a registrant pursuant to a written order form and clearly identified.	The New Jersey Controlled Dan gerous Substances Act 24:21 was not followed in the following instances: Staff doctor removed Fentanyl from the facility. The DEA form 222 transferring ownership was not filled out. Nor was the amount recorded.
NJAC Title 8 Chapter 65 on controlled dangerous substances requires registered persons to take inventory of all stocks of controlled substances.	Controlled drugs were purchased under the DEA registration of Staff #13 until 10/06 when drugs were purchased under registration of Staff #14. Facility was unable to provide any evidence of which drugs belonged to each registrant, the initial inventories for each registrant and the disposition of drugs for each registrant.
NJAC Title 8 Chapter 65 requires that every two years following the date on which the initial inventory is taken by a registrant, the registrant shall take an inventory of all stocks of controlled substances on hand.	A biennial inventory had never been conducted.
NJAC Title 8 Chapter 65: Purchaser shall record on copy 3 of the order form the number of commercial or bulk containers furnished on each item and the dates on which such containers are received by the purchaser.	This was not done for any of the six records reviewed.
Facility's policies and procedures for the administration, control and storage of medications shall include policies and procedures for the security of the keys or codes to locked drug storage areas, including specification of the personnel who may retain the keys or security codes. Only licensed personnel shall retain the keys or security codes to storage areas in which drugs subject to the Controlled Dan gerous Substances Act and amendments thereto are kept.	This requirement was not met. Facility failed to ensure that only licensed nursing or medical personnel retained the keys to storage areas in controlled dangerous substances were stored. The facility policy “Storage of Drugs” (2005) states that only licensed nursing personnel shall retain the keys to the medication storage areas, on their person, including keys to the controlled dangerous substances. Two staff members each had a key to the medication storage areas and neither is a licensed nurse.
Medications shall be dispensed only in accordance with prescriber order and all federal and state laws and rules, by licensed personnel.	Facility failed to ensure that medications were dispensed in accordance with all state laws and rules: Patients were given drugs in envelopes, rather than in sealed containers.
All drugs shall be stored under proper conditions, as indicated by the U.S. Pharmacopoeia, product labeling and or package inserts.	Facility failed to ensure that drugs were stored under proper conditions. Methergine was found in storage cabinet, but law requires it be refrigerated.

All drugs in Schedule II of the Controlled Dan gerous Substances Acts and amendments shall be stored in a separate, locked, permanently affixed compartment within the locked medication cabinet.	Fentanyl was found locked with Versed, Propofol and Brevital, all of which are not Schedule II drugs.
Drugs in single dose or single use containers which are open or which have broken seals, drugs in containers missing drug source or exact identification and outdated, recalled or visibly deteriorated medications shall be returned to the institutional pharmacy for disposal. In the absence of an institutional pharmacy, such drugs shall be brought to a location specified in the facility's policies and procedures for disposal in accordance with federal and state laws.	Three open single dose vials of Fetanyl were found in the controlled drug cabinet. One single dose vial of Fentanyl is used for many patients, until the medication is finished. Seven vials of diphenhydramine (with expired dates) were found in the code cart drug box. One lactated ringer's solution (with expired date) was found in the recovery room.
Facility shall provide dietary counseling and social work services. All patients who have been identified as needing, or who have requested, other counseling services such as genetic, psychological and drug abuse counseling shall be referred to appropriate providers.	Facility did not provide dietary counseling and social work services. Facility did not employ a social worker and/or dietician directly, through a referral mechanism, or written agreement. One employee claimed to be the counselor, but she lacked training/competency to perform this role and could not provide any written plan/program for the provision of counseling services.
Facility shall establish and implement written policies and procedures concerning the identification of the need for counseling services and referral to counseling services. The policies and procedures shall be reviewed at least annually.	Facility could not provide any documented evidence of established written policies and procedures concerning the identification of the need for counseling services and referral to counseling services.
Social work services which fall within the scope of practice defined by the Social Workers' Licensing Act of 1991 and the New Jersey State Board of Social Work Examiners shall be provided by a social worker.	Facility does not employ a social worker.
Dietary counseling shall be provided by a dietician.	Facility did not provide dietary counseling.
Facility shall provide laboratory and radiological services directly or through written agreement.	Facility did not provide laboratory and radiology services.
There shall be a physician director who is clinically responsible for the surgical service and is board certified by the American Board of Medical Specialists.	Facility failed to ensure that a physician director was board certified by the American Board of Medical Specialists.
Surgical procedures shall be performed only by practitioners who are licensed to practice in New Jersey and have been granted privileges to perform those procedures by the governing body of the facility, upon the recommendation of the medical staff, after medical review of each practitioner's documented education, training, experience and current competence.	Facility failed to ensure that surgical procedures are performed only by practitioners who have been granted privileges. Staff member #5 had not been granted privileges to perform surgical procedures, but he was providing surgical services to patients.
A physician and a registered nurse, one of whom maintains current training in advanced cardiac life support, shall be present when surgery is in progress.	Facility failed to ensure that a physician or RN, one of whom maintains current training in advanced cardiac life support, is present during the performing of surgery On 6/18/07, 15 surgical procedures were performed without benefit of anyone certified in advanced cardiac life support Staff member #5 had no certification in advanced cardiac life support. On 6/8/07 and 6/15/07 , he performed 14 surgical procedures without the presence of anyone certified in advanced cardiac life support
All anesthesia providers who administer and/or supervise the administration of anesthesia shall maintain current training in advanced cardiac life support	Employees #10 and #11 administer conscious sedation, but have no ALCS training
The monitoring of patients who have been administered an anesthetic agent for the purpose of creating conscious sedation shall be provided by an individual who is continuously present for the primary purpose of anesthesia monitoring, who is separate from the individual performing the operation. This individual shall be currently trained in ACLS and shall be either a registered nurse or a licensed respiratory care therapist	Facility failed to ensure that a patient receiving conscious sedation was monitored by a qualified individual who is continuously present and who is separate from the individual performing the operation.
Facility shall develop and implement written bylaws, rules, regulations, policies and procedures for surgical and anesthesia services, in accordance with the governing authority and medical staff bylaws. The policies and procedures shall be reviewed at least every three years and revised as needed.	Facility failed to implement its own policies for anesthesia services.
The surgical and anesthesia policies and procedures shall include, at least, policies and procedures to ensure that every patient is examined by a practitioner immediately prior to surgery.	In 6 of 10 records examined, facility failed to ensure that all patients were examined by a practitioner immediately prior to surgery.
The surgical anesthesia policies and procedures shall include that a registered nurse shall be assigned to circulating nurse duties in each room where surgery is being performed.	Facility did not ensure that an RN was assigned to circulating nurse duties in each room where surgery is being performed.
A record shall be maintained of all service and maintenance performed on all anesthesia machines, ventilators and vaporizers. The record shall include machine identification, name of the servicing agent, work performed and the date. This maintenance shall conform with maintenance requirements established by the machine manufacturer. Credentials of each servicing agent shall be approved by the machine manufacturer or shall be determined by the physician director of anesthesia services as equivalent to the credentials of manufacturers' servicing agents.	Facility was unable to demonstrate that maintenance on the two anesthesia machines conformed with maintenance requirements established by the manufacturer.
Equipment and services available in the post-anesthesia care unit shall include at least a crash cart with defribillator, drugs, pulse oximetry, electrocardiographic monitoring, body temperature monitoring, equipment necessary for intubation and various means of oxygen delivery. Constant and intermittent suction, blood pressure monitoring, adequate lighting, peripheral nerve stimulator, immediate access to a ventilator and end-tidal carbon dioxide monitoring in accordance with NJAC 8:43A-12.17(g) shall be made available. Provisions to ensure the patient's privacy shall be maintained.	Facility did not provide all equipment and services required for the post-anesthesia care unit. Facility could not provide immediate access to a ventilator for use by patients in the case of a medical emergency. The post-anesthesia care unit lacked privacy curtains at each recovery station, which does not provide each patient with privacy and dignity.
If an ambulatory surgical facility does not have an institutional pharmacy, the facility shall designate a consultant pharmacist who shall review all facility policies and procedures concerning the administration, control and storage of medications at least semi-annually. The consultant pharmacist shall not be affiliated with the pharmacy which provides pharmaceutical services for the facility.	Facility failed to ensure the services of a consultant pharmacist.
Written objectives, policies and procedures, an organizational plan and a quality assurance program for medical record services shall be developed and implemented. All medical records policies and procedures shall be reviewed at least annually.	Facility could not provide any documented evidence of a quality assurance program for medical record services and that all medical records policies and procedures are reviewed at least annually. The only documented review and approval of medical record policies was by the former medical director and former administrator in December 2005.
An employee shall be designated to act as coordinator of medical record services. The facility shall designate an employee to act in the absence of the coordinator to ensure staff access to the medical record at all times during the hours of operation.	Facility did not designate any employee to act as coordinator of medical record services.
The complete medical record shall include the patient's complaint or purpose of the visit.	Based on review of 5 of 10 medical records where surgical procedures were performed, and staff interview, facility did not ensure that the complete medical record included the patient's complaint or purpose of the visit.
The complete medical record shall include the diagnosis or medical impressions.	Facility did not ensure that the complete medical record included the diagnosis or medical impressions.
The complete medical record shall include orders for laboratory, radiological, diagnostic and/or screening tests and their results.	Facility did not ensure the complete medical record included orders for laboratory, radiological, diagnostic and/or screening tests and their results.
The complete medical record shall include all orders for treatment, medication and diets, signed by the prescriber.	Facility did not ensure that the complete medical record included all orders for treatment, medication and diets, signed by the prescriber.
The complete medical record shall include documentation of the medical history and physical examination, if performed, signed and dated by the examiner.	Facility did not ensure that the complete medical record included documentation of the medical history and physical examination, if performed, signed and dated by the examiner.
The complete medical record shall include patient assessments developed by each service providing care to the patient.	Facility did not ensure that the complete medical record included, but not be limited to, patient assessments developed by each service providing care to the patient.
The complete medical record shall include a patient plan of care, in accordance with the facility's policies and procedures.	Facility did not ensure that the complete medical record included a patient plan of care.
The complete medical record shall include clinical notes which shall be entered on the day service is rendered.	Facility did not ensure that the complete medical record included clinical notes entered on the day service is rendered.
The complete medical record shall include a medication sheet indicating at least the name, date, dosage and duration of all medications prescribed.	Facility did not ensure that the complete medical record included a medication sheet.
A complete medical record shall include documentation that informed consent was obtained for any procedure or treatment provided which is specified in the facility's policies and procedures as requiring informed consent.	Facility did not ensure that the complete medical record included documentation that informed consent was obtained for any procedure or treatment provided which is specified in the facility's policies and procedures as requiring informed consent.
A complete medical record shall include the patient's signed acknowledgement that the patient has been informed of patient rights, either verbally or through written copy and has been offered a copy.	Facility did not ensure that the complete medical record included the patient's signed acknowledgement that the patient has been informed of patient rights, either verbally or through written copy, and has been offered a copy.
A complete medical record shall include the discharge plan, where applicable, and a discharge summary sheet containing the patient's name, address, dates of admission and discharge, and a summary of the treatment and medication rendered during the patient's stay.	Facility did not ensure that the complete medical record included a discharge plan and a discharge summary sheet.
The administrator or designee shall ensure the development and implementation of an infection prevention and control program.	The administrator, or designee, did not ensure the development and implementation of an infection prevention and control program.
The administrator shall designate an infection control professional who shall be responsible for the direction, provision and quality of infection prevention and control services. The designated person shall be responsible for developing and maintaining written objectives, policies and procedures, an organization plan and a quality improvement program for the infection prevention and control service. The infection control professional may be a consultant; however, there must be a health care professional on site that is responsible for the day-to-day activities related to infection control.	The administrator did not designate an infection control professional responsible for the direction, provision and quality of infection prevention and control services.
The facility shall establish an infection control committee which shall include the medical director, the infection control professional and representatives from at least administration and the nursing service. If this facility is owned or operated by an acute care hospital, then the facility may participate in the hospital's infection control program.	Facility did not establish an infection control committee, including the medical director, the infection control professional and representatives from at least administration and the nursing service.
The infection control committee with assistance from each service in the facility shall develop, implement, and review every three years or more frequently as necessary written policies and procedures regarding infection prevention and control.	Facility did not develop, implement, and review every three years or more frequently as necessary written policies and procedures regarding infection prevention and control. Written policies and procedures related to infection prevention and control lacked formal signed approvals by the infection control committee, including initial, review and revision dates. Written infection control and prevention policies and procedures were not provided for: a system of identifying, reporting and evaluating the occurrence of all infections or diseases which are reportable or conditions which may be related to activities and procedures of the facility, identifying and reporting of HIV/AIDS, a system for identifying and monitoring healthcare-associated infections, control measure or studies to be initiated following identification of an infection control program, employee health and staff training, care of patients with communicable diseases, exclusion from work and authorization to return to work for personnel with communicable diseases, and surveillance techniques to identify sources and minimize transmission of an infection Policies and procedures related to infection prevention and control did not correspond to the ASC's actual practice; policies and procedures were either not implemented as written or were not revised to accommodate current practice ASC's policies entitled “Decontamination and Sterilization” and “Care of Instruments” specify that soiled instruments shall be placed in an enzymatic/bleach solution, but in actual practice an antiseptic hand soap/detergent solution is used instead of an enzymatic cleaner ASC's policies entitled “Care of instruments” and “Autoclaving of Instruments” specify that suction machine tubing shall be washed and rinsed in “preparation for chemical sterilization” and “chemically sterilized in Cidex solution for 24 hours,” respectively, but in actual practice the tubing is cleaned only with antiseptic hand soap/bleach solution and neither chemically sterilized nor disinfected. ASC's policies on shelf lives for reprocessed sterile instruments include one year for Sterilization of Patient Care Items, one month for Sterilization of Instruments and one week for Care and Use of Sterilizers. ASC policy “Dating of Autoclaved Items” specifies that “Alternatives uses an ‘event related' expiration policy” and that “items are considered sterile for a period of one year from the date of original sterilization as long as package integrity is maintained.” However, no shelf life expiration date was used for sterile supplies in actual practice and 50 instrument packages inspected June 25/26 had sterilization dates well over one year. A policy and procedure for the reprocessing of the vaginal ultrasound wand was not provided when requested.

Methods for processing reusable medical devices shall conform with the following document, incorporated herein by reference, as amended and supplemented: The Association for Advancement of Medical Instrumentation (AAMI) requirements, “Safe Handling and Biological Decontamination of Medical Devices in Health Care Facilities and in Nonclinical Settings,” ST 35.	Facility's methods for processing reusable medical devices did not conform to the Association for Advancement of Medical Instrumentation (AAMI) requirements, “Safe Handling and Biological Decontamination of Medical Devices in Health Care Facilities and in Nonclinical Settings,” ST 35, Subchapter 7, “Decontamination processes,” (7.4.2 Cleaning Agents and 7.5.2 Disinfection processes) as evidenced by: In the Decontamination Room, the ASC uses a solution of Spartan Antiseptic Hand Cleaner and household bleach to clean reusable medical devices, including stainless steel instruments and suction tubing. The label on the Spartan Antiseptic Hand Cleaner describes its use as “Hand wash to help reduce bacteria which can potentially cause disease.” No labeling instruction regarding use for cleaning reusable medical devices were provided. Bleach may be corrosive to metal instruments. The manufacturers' instructions for the devices regarding the appropriate type of cleaning agent was not provided for review upon request. ASC's policies “Decontamination and Sterilization” and “Care of Instruments” specify that soiled instruments should be placed in an enzymatic cleaning solution. Suction tubing was not disinfected prior to reuse. The vaginal ultrasound wand is decontaminated by the following method: the protective condom is removed and discarded followed by the use of a PSS Select Disinfectant Wipes, an intermediate level tuberculocidal disinfectant. The manufacturer's instructions specified on the PSS Select Disinfectant Wipes container's label states: “not for instruments in contact with blood of mucous membranes.” The manufacturer's cleaning and disinfecting instructions for the vaginal wand were not readily available onside on review. Four peel packages containing long instruments with a hooked end were incorrectly labeled “uterine sound,” according to employee #6, who could not identify the instruments. The instruments had obvious corrosion and the interior of the packages had dark dust-like residues. The instruments did not appear to be of surgical grade quality.
All hinged instruments shall be processed in an open position.	Hinged instruments in ASC's sterile storage areas were not consistently processed in an open position. More than 50 of 100 inspected were not in the open position. Employee #6 admitted that peel packs used to reprocess instruments were often too small in size to permit open reprocessing.
Sterilized materials shall be stored, handled and transported to maintain sterility. Package integrity shall be maintained until used.	Sterilized materials were not consistently stored, handled and transported to maintain sterility and package integrity until used. More than 25 of 100 packages were folded over and/or moderately crumpled, torn or water stained, potentially compromising the integrity and sterility of the package. Sterile supplies were stored unprotected on an open shelving rack located in the carpeted hallway directly the Decontamination Room. Five ASC processed instrument peel packages with 2000 expiration dates were found exceeding the ASC's written shelf life policy of one year. 16 ASC processed small speculum peel packages with 2002 and 2003 expiration dates exceeding the ASC's written shelf life policy of one year.
Sterile supplies which bear an expiration date shall not exceed the shelf life date as recommended by the manufacturer of the packaging selected or the device contained therein.	Sterile supplies bearing expiration dates were not consistently maintained within manufacturer's shelf life dates. Sterile peel packages stored in the shelving rack located in the “sterile hallway” and the store room off the hallway; both were commercially produced and ASC-processed sterile packages with expired shelf life dates, including: 5 catheters with June 2003 expiration dates, 3 boxes of catheter safety systems with 2003 expiration dates, 4 boxes of Teruma needles with 2006 expiration dates16 ASC-processed small speculum peel packages with 2002 and 2003 expiration dates, exceeding the ASC's written shelf life policy of one year, 5 ASC-processed instrument peel packages with 2000 expiration dates, exceeding facility written shelf life policy of one year.
If the facility is using an event-related sterility program, the process shall include a continuous quality plan with documentation of facility compliance.	A continuous quality plan with documentation of facility compliance was not included in the ASC's event-related sterility program. The ASC's policies and procedures include a policy titled “Dating of Autoclaved Items,” that states: “Alternatives utilizes an event-related expiration policy. All sterilized items are to be inspected at least quarterly for proper storage conditions and package integrity. Any items improperly stored or any items in damaged packages are to be removed from supply and repacked and sterilized.” A continuous quality plan with documentation of facility compliance was not included in the ASC's records provided when requested. Neither a plan nor documentation was included in the event related sterility program. Thermometers and hygrometers for the measurement of ambient temperature and humidity in sterile storage and reprocessing areas, as part of a continuous quality plan, were not provided for use by the ASC.
Biological monitoring with live spores, or an FDA approved equivalent, shall be performed as follows: A biological monitor with live spores shall be performed following repair or breakdown of the equipment mentioned in NJAC 8:43A-14.5(a)1, 2, 3 and 4.	A biological monitor with live spores was not performed following repair or breakdown of the facility's sterilizers. Autoclave #2 was not operational from March 17, 2007 to June 8, 2007 when a replacement sterilizer was placed into service in the Sterilization Room and two loads of instruments were processed. A biological monitoring test was conducted June 8, 2007 , but the result of the monitoring was not known for 48 hours, until June 10, 2007 . On June 26, 2007 , the autoclave was not properly cleared for use prior to instrument reprocessing.
A chemical indicator/integrator, applicable to the sterilization process used, shall be used in the following: each package processed in steam.	A chemical indicator/integrator, applicable to the sterilization process, was not used in each package processed in steam. Individual sterile peel packages stored on the shelving rack in the sterile hallway and the storeroom off the hallway lacked internal process indicators.
The individual responsible for reprocessing reusable medical instruments shall be certified by a national central service certification program upon hire or within two years of employment.	The individual responsible for reprocessing reusable medical instruments was not certified by a national central service certification program within two years of employment.
The infection control professional shall develop and implement a program of quality improvement that is integrated into the facility quality improvement program and includes regularly collecting and analyzing data to help determine the effectiveness of infection control practices. When corrective actions need to be taken based on data collected the infection control committee shall recommend, implement and monitor those actions. The infection control professional shall supervise these quality improvement activities shall be overseen by the continuous quality improvement program.	The program and quality improvement for infection control that is integrated into the facility quality improvement program was not developed and implemented.
Procedures for emergencies shall include, at least, protocols for notification of emergency service providers and officials.	Facility's procedures for emergencies did not include protocols for notification of emergency service providers and officials.
Procedures for emergencies shall include procedures for evacuating patients.	Facility's procedures for emergencies did not include procedures for evacuating patients.
Procedures for emergencies shall include identification of one or more facilities to which patients would be referred in the event of extended closure of the facility.	Facility's procedures for emergencies did not identify one or more facilities to which patients would be referred in the event of extended closure of the facility.
Procedures for emergencies shall include procedures for reentry after evacuation.	Facility's procedures for emergencies did not include procedures for reentry after evacuation.
Procedures for emergencies shall include the tasks and responsibilities assigned to all personnel and identification of the person in the facility designated to coordinate emergency activities.	Facility's procedures for emergencies did not include the tasks and responsibilities assigned to all personnel and identification of the person in the facility designated to coordinate emergency activities.
Procedures for emergencies shall include protocols for removal and return of records, medications, supplies and equipment after evacuation.	Facility's procedures for emergencies did not include protocols for removal and return of records, medications, supplies and equipment after evacuation.
Procedures for emergencies shall include the alternative procedures if patients cannot be returned to the facility.	Facility's procedures for emergencies did not include alternative procedures if patients cannot be returned to the facility.
The facility shall ensure that patients receive necessary services during the evacuation or other emergency.	Facility's procedures for emergencies did not ensure that patients receive necessary services during the evacuation or other emergency.
All employees shall be trained in procedures to be followed in the event of a fire and instructed in the use of fire-fighting equipment and patient evacuation as part of their initial orientation and at least annually thereafter.	Facility's procedures for emergencies did not delineate the procedures for all of employees to follow in the event of a fire and did not require instruction of staff in the use of fire-fighting equipment and patient evacuation as part of its initial orientation and at least annually thereafter.
Drills of emergency plans shall be conducted on each shift at least quarterly. The facility shall maintain documentation of all drills, including date, hour, description of the drill, participating staff and signature of the person in charge. The drills on each shift shall include at least one drill for emergencies due to disasters other than fire, such as storm, flood, other natural disaster, bomb threat or radiological accident.	The last documented emergency evacuation drill was 21 January 2005 .
The facility shall perform quarterly tests of the building's manual pull alarm system and shall maintain documentation of test dates, locations of manual pull alarms tested, persons testing the alarms and results of the test.	The last documented testing of the manual pull alarm was on 24 June 2005.
Fire extinguishers shall be examined annually and maintained in accordance with manufacturers' requirements, National Fire Protection Association 10 as amended and supplemented and NJAC 5:18, the New Jersey Uniform Fire Code.	Facility's fire extinguishers were not examined monthly as required by the National Fire protection Association 10, as amended and supplemented and NJAC 5:18, the New Jersey Uniform Fire Code. The last documented monthly check of the fire extinguishers was 1 February 2007.
The facility shall request, at least annually, that a fire inspection be performed by the local fire code authority, and the request shall be documented. The date of inspection, the results, and the inspector or agent conducting the inspection shall be documented.	The last documented fire inspection performed by the local fire code authority was 10 March 2006. No documentation requesting a fire inspection for 2007 was presented.
There shall be at least a semiannual inspection of the fire detection system. The date of inspection, the results, and the inspector or agent conducting the inspection shall be documented.	The last documented inspection of the fire detection system was 24 June 2005.
There shall be at least monthly testing of emergency lighting. A logbook shall be maintained which shall include the date of each test, the results, and the person conducting the test.	There was no written verification for the testing of the emergency lights. When tested, the emergency lights located in the corridor, adjacent to the entrance door to the surgical suite, did not work, providing no illumination.
There shall be at least an annual inspection of the heating and ventilation system. The date of inspection, the results, and the inspector or agent conducting the inspection shall be documented.	The last inspection of the heating and ventilation system was 25 July 2004.
The facility shall be able to respond to medical emergencies occurring on the premises during its hours of operation.	Facility failed to ensure the ability to respond to medical emergencies occurring on the premises during its hours of operation. Facility was unable to demonstrate that personnel certified in ACLS were available on the premises during its hours of operation.
The facility shall establish and implement written policies and procedures regarding the rights of patients. These policies and procedures shall be available to patients, staff and the public and shall be conspicuously posted in the facility.	Facility did not conspicuously post written policies and procedures regarding the rights of patients in the facility.
The staff of the facility shall receive in-service education concerning the implementation of policies and procedures regarding patient rights annually and as part of new employee orientation.	Facility did not provide any in-service education for staff concerning the implementation of policies and procedures regarding patient rights annually.
Each patient receiving services in an ambulatory care facility shall have the right to be informed of these rights, as evidenced by the patient's written acknowledgement, or by documentation by staff in the medical record, that the patient was offered a written copy of these rights and given a written or verbal explanation of these rights, in terms the patient could understand. The facility shall have a means to notify patients of any rules and regulations it has adopted governing patient conduct in the facility.	Based on a review of 10 out of 10 medical records where surgical procedures were performed, and staff interview, the facility did not ensure that each patient receiving services in the facility was informed of required patient rights, as evidenced by the patient's written acknowledgement, or by documentation by staff in the medical record, that the patient was offered a written copy of these rights and given a written or verbal explanation of these rights, in terms the patient could understand.
The housekeeping service shall have written policies and procedures that are reviewed every three years or as needed, revised as needed and implemented. They shall include scope of responsibility, assignment by designated unit and responsibility for all cleaning tasks.	Housekeeping procedures did not include the scope of responsibility, assignment by designated unit and responsibility for all cleaning tasks.
There shall be an individual responsible for the housekeeping or environmental services. This individual may be a contracted provider.	There is no designated individual responsible for the housekeeping or environmental services and there is no contracted provider for housekeeping services. An employee said the staff “pitches in” when cleaning is needed, but could not confirm the frequency of the cleaning and could not identify the products used for the cleaning.
Housekeeping personnel shall be trained upon hire and on an annual basis or more frequently as necessary. Training should focus on cleaning procedures, including the selection and use of appropriate chemicals in the cleaning and care of equipment and surfaces.	Facility could not provide evidence for the training of staff and/or contracted personnel upon hire and annually thereafter on cleaning procedures, including the selection and use of appropriate chemicals in the cleaning and care of equipment and surfaces.
All areas, including areas with limited access such as cabinet, drawers, locked medication rooms and storage areas, shall be kept clean to sight and touch and free of condensation, mold growth and noxious odors.	Facility failed to maintain all areas, including areas with limited access such as cabinet, drawers, locked medication rooms and storage areas clean to sight and touch and free of condensation and mold growth. There was mold growing on the ceiling tiles of but not limited to the ceiling tiles of the store room adjacent to the scrub sink and operating room #2. Large amounts of condensation from the air conditioner in the waiting room was wetting the cloth covered chairs and the carpeting directly below the unit.
Housekeeping and cleaning supplies shall be selected and approved by the Infection Control Committee. They shall be measured and used correctly according to the manufacturers' written instructions.	There was no written verification that housekeeping and cleaning supplies were selected and approved by an Infection Control Committee. Staff members stated the facility has no infection control committee or infection control policies.
All toilets and bathrooms shall be kept clean to sight and touch, in good repair, and free of odors that reflect poor housekeeping practices.	Facility failed to maintain all bathrooms in good repair, as evidenced by: The wall toilet paper holder in, but not limited to, the handicapped accessible bathroom, adjacent to the waiting room, was not mounted on the wall and was placed on the top of the water tank of the water closet. The radiator cover in, but not limited to, the bathroom adjacent to operating room #2, was soiled and heavily rusted.
Carpeting shall be kept clean and odor-free and shall not be frayed, worn, torn or buckled.	Facility failed to maintain carpeting clean and odor-free as evidenced by: Carpeting was stained and soiled in, but not limited to, the waiting room, examination rooms, patient changing room, corridor adjacent to the examination rooms and the clean corridor of the surgical suite.
Walls, ceilings and vents shall be kept clean to sight and touch and odor-free.	Facility failed to maintain walls, ceilings and vents clean to sight and touch as evidenced by: Walls of, but not limited to, the two operating rooms, soiled utility room, housekeeping closet, storage room, recovery room and the walls surrounding the scrub sink were soiled, stained, chipped and gouged to the substrate. The ceiling mounted heating and air conditioning diffuses throughout the facility were dust laden. Ceiling tiles were soiled and stained in, but not limited to, the two storage rooms. Ceiling tiles were missing or improperly set in the ceiling grid work in, but not limited to, the storage room adjacent to the patient changing room, the storage room within the surgical suite, the soiled utility room and the janitors closet. There were large holes in the ceiling and the walls were damaged in storage room 212. There were large holes in the ceiling and the walls were damaged in room 214.
The following environmental condition shall be met: articles in storage shall be elevated from the floor and away from walls, ceilings and air vents to facilitate cleaning. Storage units shall be non-porous and cleanable.	Facility failed to elevate materials from the floor as evidenced by: Materials were stored on the floors, of, but not limited to, the two storage rooms within the surgical suite, the janitor's closet within the surgical suite, the storage room adjacent to the patient changing room, the receptionist area and the laboratory. Wires were on the floors of, but not limited to, the first floor laboratory and the counseling and charting desk.
The following environmental condition shall be met: All furnishings shall be clean and in good repair, and mechanical equipment shall be in good working order. Equipment shall be kept covered to protect from contamination and accessible for cleaning and inspection. Broken or worn items shall be repaired, replaced or removed promptly.	Facility failed to maintain all furnishings in a clean condition and in good repair, mechanical equipment in good working order and covered to protect from contamination, accessible for cleaning and inspection as evidenced by: Cloth covered chairs throughout the facility were soiled and stained. The largest number of the soiled and stained cloth covered chairs were in the waiting room, patient changing room and the patient lounge with additional chairs throughout the facility for use by the patients and facility staff members. The facility staff could not provide evidence of the testing of electrical diagnostic and patient care equipment throughout the facility. The scale in examination room A had no seal or documentation to verify testing and calibration. Equipment in the two operating rooms including but not limited to suction machines, storage cabinets, carts and operating lights were soiled, stained and rusted. Unused equipment, including but not limited to, an anesthesia machine, suction machine, operating lights, flexible (chair) gurney stored in rooms 212 and 214 were dust laden, soiled, stained and rusted. A metal stool in the sterile corridor adjacent to the scrub sink was rust laden.

The following environmental condition shall be met: All equipment and environmental surfaces shall be kept clean to sight and touch.	Facility failed to maintain all equipment and environmental surfaces clean to sight and touch as evidenced by: Base and wall hung composite wood cabinets, throughout the facility were chipped, soiled and stained. Door and drawers that were misaligned and had large areas of laminate finish missing, exposing the composite wood substrate. The plastic scrub sink, located in sterile corridor was soiled and stained. The soiled utility sink was soiled and stained. Metal carts and storage shelving within the sterile corridor were soiled and stained. Carpeting in the corridor, waiting room, patient changing room, examination rooms (2) and the sterile corridor were soiled and stained. The flooring in the operating room (2), recovery room, patient lounge and the laboratory, (in the room labeled ultrasound) was soiled and stained. The floors of storage rooms 212 and 214 were soiled, stained and debris laden.
The facility shall establish and implement a written plan for a quality assurance program for patient care. The quality assurance plan shall be reviewed at least annually and revised as necessary. The plan shall specify a timetable and the individual responsible for coordinating the quality assurance program and shall be provide for ongoing monitoring of staff and patient care services.	Facility failed to implement a written plan for a quality assurance program for patient care.
There shall be a multidisciplinary committee responsible for the direction of the quality assurance program. The committee shall include at least representation from the medical staff, nursing staff and administration. The committee shall establish a mechanism to include participation of all disciplines in the identification of areas for review that affect patient care throughout the facility.	Facility did not have a multidisciplinary committee responsible for the direction of the quality assurance program.
New buildings and alterations and additions to existing buildings for freestanding ambulatory care facilities shall conform with the New Jersey Uniform Construction Code, NJAC 5:23-3.2, subchapters of the current model code of the Building Officials and Code Administrators International, Inc., appropriate to Use Group B, as amended and supplemented and the current edition of the Guidelines for Construction and Equipment of Hospital and Medical Facilities, as amended and supplemented, incorporated herein by reference.	Facility was not incompliance with the 1992-93 edition of the Guidelines for Construction and Equipment of Hospital and Medical Facilities, as evidenced by: The recovery room with the lack of privacy curtains at each recovery station, does not provide patient privacy and dignity as required by 9.1H The facility has no nurse's station as required by 9.2.B5. The facility has no drug distribution station equipped with a work counter, sink, refrigerator and locked storage for biologicals as required by 9.2.B6. Currently drugs are stored in a closet within the sterile corridor. The facility does not have a soiled holding room or closet for the collection, storage and disposal of soiled materials as required by 9.2.B5. Soiled materials are stored in room 212 with unused equipment and patient records. The facility has no parking for patients as required by 9.5.C. The facility is not equipped with a covered entrance for the pick up of patients as required by 9.5D.1. The facility's waiting room does not have wheelchair storage, public telephone and a water fountain as required by 9.5D.2. The facility has not interview space for private interviews with patients as required by 9.5D3. The room shown on the posted evacuation plan as a counseling room is now being used as a patient changing room. The facility has no multipurpose or consultation room as required by 9.5D5. The facility has no special storage for staffs' personal effects as required by 9.5D7. The soiled utility room is not equipped with a worktable, a flush type device and washer/sterilizer as required by 9.5E1. The clean utility room is not equipped with a hand washing sink, worktables, counters, ultrasonic storage facilities for backup supplies and instrumentation, and a drying cabinet or drying equipment and is not large enough to accommodate sterilizer carts as required by 9.5E.2. The facility stores sterilized packs with no provision for ventilation, humidity and temperature control as required by 9.5.F3. The two operating rooms are less than 360 square feet, are not equipped with an emergency communication system connected to a surgical suite control station and do not have a minimum of one x-ray illuminator in each as required by 9.5F2. The post-anesthesia recovery room, equipped with five recovery beds on the day of the survey, is approximately 12'-0” x 17'-0” and does not provide a minimum of 3'-0” at each side of each recovery bed to a wall or privacy curtain, recovery beds are not visible from a nurses' station, (facility has no nurses station) and does not have bed pan cleaning facilities nearby as required by 9.5F4. The patient recovery lounge is not supervised, does not contain a control station, and does not have convenient access to toilet facilities as required by 9.5.F.4. Patients must cross the post-anesthesia recovery room or the waiting room to access a toilet, a minimum of 20'-0” and 16'-0” respectfully. There is no control station to provide visible surveillance of all traffic entering the operation suite as required by 9.5.F5a. The soiled utility room is not equipped with a clinical equivalent flushing type fixture, work counter, handwashing sink and waste receptacle as required by 9.5.F5d. The lefthand bay of the existing three bay stainless steel sink, in the soiled utility room is equipped with a garbage disposal. The garbage disposal was used for the disposal of tissue and the clinical flushing rim sink located in a room used for storage was not used. The existing clinical sink, located in a room used for storage, is not used for the fluid waste disposal as required by 9.5.F5e. The facility has no anesthesia work room, for the cleaning, testing and storing of anesthesia equipment as required by 9.5Fg. The facility has no staff clothing change area as required by 9.5.F5j. The staff changing area that was on the third floor was converted to offices years ago. The patient changing area is not equipped with lockers, clothing change or gowning areas, space for administering medications and no provisions for the securing patients' personal effects as required by 9.5F5k. There is no stretcher storage area as required by 9.5.F5l. The housekeeping room, located in the surgical suite, is not used exclusively for the surgical suite as required by 9.5.F5m. The surgical suite housekeeping closet is used for all areas of the facility on the first floor. The third floor office area and the two storage rooms on the second floor do not have access to a housekeeping closet. The entry corridor within the facility is not six feet wide as required by 9.5H1. The existing entry corridor within the facility is approximately 3 ½ feet wide. The ceilings and walls in the two operating rooms and the bathrooms off of the two operating rooms are not readily washable and free of crevices as required by 9.5.H2. The surfaces and fixtures in bathroom, off of the two operating rooms, cannot maintain the sterile environment required in an operating room. There was no physical evidence or documentation presented to verify that the existing heating and ventilation system meets the ventilation requirements of 9.4.l as evidenced by: There was no physical or documented evidence of positive pressure within the operating rooms. There was no documentation presented to verify that each operating room has a minimum of 15 air changes per hour, of which three are with outside air as required by table 2, chapter 7 of the 1993-94 American Institute of Architects guidelines for Design and Construction of Hospital and Health Care Facilities. The bathrooms were not equipped with mechanical or natural ventilation. The installation of carpeting in the two examination rooms, the corridor adjacent to the examination rooms and the blood draw room and in the sterile corridor does not meet the requirement for floor material that is readily cleanable as required by 9.H2. The third floor office common corridor was blocked with the facility's supplies, impeding egress to the rear fire exit, a violation of the New Jersey Uniform Construction Code, NJAC 5:23-.3.2, subchapters of the current model code of the Building Officials and Code Administrators International, appropriate to Use Group B, as amended and supplemented and 7.1.3.2.3 of the National Fire Protection Association 101.

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The Abortion Industry The following list of violations resulted in the closure of the Alternatives Abortion Clinic, in Atlantic City, New Jersey, in 2007:

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The Abortion Industry

The following list of violations resulted in the closure of the Alternatives Abortion Clinic,
in Atlantic City, New Jersey, in 2007: