DialysisEthics2_Forum
Other => Historical Posts => Topic started by: admin on September 28, 2009, 06:32:31 PM
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Letter
Joined: 15 Jul 2003
Posts: 1
PostPosted: Tue Jul 15, 2003 4:46 am Post subject: New Jersey Hospital fined.
<
> New Jersey Hospital Fines & Enforcement Actions<
> Penalty Letter <
><
><
><
> April 5, 2002 <
><
> CERTIFIED MAIL<
> RETURN RECEIPT REQUESTED<
><
> Darlene Cox<
> Chief Executive Officer<
> East Orange General Hospital<
> 300 Central Ave.<
> East Orange, N.J. 07019 <
> <
> Re: Notice of Proposed Assessment <
> of Penalties<
> Facility ID # 10704<
> <
><
><
> Dear Ms. Cox: <
><
> The Health Care Facilities Planning Act, N.J.S.A. 26:2H-1 et seq., is intended to ensure that all licensed New<
> Jersey health care facilities are of the highest quality. In furtherance of this objective, N.J.S.A. 26:2H-5 authorizes<
> the Commissioner of Health and Senior Services to inquire into health care services and the operation of health care<
> facilities, and to conduct periodic inspections of such facilities with respect to the fitness and adequacy of the<
> premises, equipment and personnel. <
><
> Department of Health and Senior Services (Department) staff visited East Orange General Hospital on October 18<
> and 19, 2001, for the purpose of conducting a biennial survey. Based upon a tour of the facility's renal dialysis<
> treatment areas, interviews with staff, and review of the facility's policies and procedures, it was determined that the<
> hospital was in violation of various requirements of N.J.A.C. 8:43G, the Hospital Licensing Standards, particularly<
> 8:43G-30, relating to dialysis. Since the hospital's renal dialysis service is physically located in two separate places,<
> both the hospital itself and a medical office building (MOB) adjacent to the hospital, it is necessary to state that all of<
> the physical plant deficiencies listed below were in the dialysis area within the hospital, and not within the MOB. The<
> deficiencies related to reuse of dialyzers, in contrast, relate to both the MOB and the hospital, since the equipment is<
> sterilized jointly. <
><
> The specific deficiencies are as follows: <
><
> 1. Based upon a tour of the dialysis unit, it was evident that the area in general was not kept clean to sight and touch,<
> in violation of several individual provisions of N.J.A.C. 8:43G-13.4: <
><
> a. Walls were soiled throughout the unit, including the entry corridor to the treatment area, the<
> treatment area itself and the peritoneal dialysis treatment area, patient and staff bathrooms, and soiled<
> utility room.<
> b. Ceiling tiles were soiled, stained, or missing throughout. <
> c. Air ceiling vents were dirty and dust-laden throughout the unit, including in the treatment area.<
> d. Floor tiles and base moldings throughout the unit were soiled and stained, or buckled, peeling, or<
> missing.<
> e. Patient privacy curtains were soiled and stained throughout the unit.<
> f. Windows located in the area behind the treatment area were soiled and stained.<
> g. Patient treatment recliner chairs were dirty, ripped, and torn, with the stuffing protruding, and the<
> wheels rusted. Laminate surface materials on cabinets, countertops, and work surfaces throughout the<
> renal dialysis unit were
oken or missing.<
><
> These items are all violations of N.J.A.C. 8:43G-13.4, (d), (g), (h), (i), and (j), which require that all areas and<
> physical aspects of a hospital be kept clean to sight and touch and in good repair, and of 8:43G-24.4(f), which<
> requires floors, ceilings, and walls to be free of cracks and holes, discoloration, or other signs of disrepair. <
><
> 2. The facility failed to ensure that all equipment and environmental surfaces throughout the renal dialysis unit were<
> kept clean to sight and touch, as evidenced by the following: <
><
> a. The upper surface of the reverse osmosis water storage tank was heavily covered with dust and<
> de
is.<
> b. The service sinks in the soiled utility room and clean utility room were stained and dirty.<
> c. The refrigerator in the peritoneal dialysis room was dirty and contained a mold-like substance on the<
> inside surface.<
> d. The metal water outlets located at each hemodialysis station were dirty and rusted, and contained a<
> residue buildup.<
> e. Suction machines in the treatment area were dusty. <
> f. The inside base of the sink cabinet in the treatment area was dirty and stained with a mold-like<
> substance. <
> g. The ceiling light fixtures throughout the unit were stained and dirty. <
><
> These items are violations of N.J.A.C. 843G-13.4(k), which requires that all equipment and environmental surfaces<
> shall be kept clean to sight and touch. <
><
> 3. The facility failed to ensure that portable equipment was kept clean, as evidenced by the following:<
><
><
> a. Equipment carts throughout the renal dialysis unit, including in the patient treatment areas, were<
> soiled, stained, and had rusted wheels. <
> b. Two portable reverse osmosis machines were soiled and stained. Hoses on the backs of the<
> machines were coiled and stored on a soiled cloth pad. <
><
> These items are violations of N.J.A.C. 8:43G-13.5(c), which requires that all portable equipment be kept clean and<
> in good repair. <
><
> 4. The facility failed to ensure that the floor area allocated for each dialysis machine was 100 square feet, with a net<
> usable area of 80 square feet, and 30 inches of clear space around each machine, as required at N.J.A.C.<
> 8:43G-30.14(b). <
><
> 5. Based upon observation, the renal dialysis unit had one handwashing sink for 6 stations. A service sink located in<
> the main treatment area is inaccessible to staff for routine handwashing, and was not utilized during the survey. This is<
> a violation of N.J.A.C. 8:43G-30.14(f), which requires a ratio of one handsink per every three stations, distributed<
> throughout the dialysis area. <
><
> 6. The facility failed to provide various service areas which are required within a dialysis unit, as follows: <
><
> a. The facility failed to provide a 120 square foot combined clean linen and clean utility room equipped<
> with a handwashing sink and a 120 square foot soiled holding and soiled utility room equipped with a<
> handwashing sink. <
><
> b. The facility failed to provide a janitor's closet exclusively for the renal suite equipped with a floor<
> receptor or service sink and storage space for housekeeping supplies and equipment. <
><
> c. The facility failed to provide a staff locker room. <
><
> d. The facility failed to provide a nourishment station containing a sink equipped for handwashing,<
> equipment for serving nourishment, refrigerator, storage cabinets and ice maker-dispenser unit. <
><
> e. The facility failed to provide an equipment and emergency storage room. <
><
> f. The facility failed to provide a storage room or rooms to house the working equipment to maintain<
> the equipment applicable to the machines for the dialysis suite. There shall be 70 square feet per<
> machine/station of storage. <
><
> g. The facility failed to provide storage space for wheelchairs and stretchers out of direct line of traffic. <
><
> h. The facility failed to provide patient toilet rooms with doors equipped with hardware which will<
> permit access by staff in an emergency. <
><
> These items are a violation of N.J.A.C. 8:43G-30.15(a), which requires all of the items listed to be located in an<
> acute renal dialysis suite, and readily available to the treatment area. <
><
> 7. The renal dialysis unit did not have a written evacuation diagram conspicuously posted, specific to the unit, with<
> evacuation procedures, location of fire exits, alarm boxes, and fire extinguishers, as required at N.J.A.C.<
> 8:43G-24.13(d). <
><
> The following deficiencies, relating to the reuse of hemodialyzers, relate to both the dialysis unit within the hospital<
> and the unit in an adjacent medical office building. <
><
> 8. Based on observation, staff interviews, and a review of policies and procedures, the facility failed to ensure that<
> reuse of dialyzers conformed with guidelines in the publication of the Association for the Advancement of Medical<
> Instrumentation
(AAMI), "Recommended Practices for the Reuse of Hemodialyzers." This was evidenced by the<
> following: <
><
> a. Water samples for bacterial monitoring are not being taken from the reprocessing machines where<
> the reused dialyzers are connected to the reprocessing systems (AAMI 7.1.2). <
><
> b. On October 18, 2001, staff were observed using germicide test strips which had expired to test<
> each reused dialyzer for the presence of germicide before rinsing (AAMI 12.3.2). <
><
> c. Documentation of the germicide presence test for reprocessed dialyzers was inconsistent among<
> staff, and a definitive policy on documentation was not available. Five staff members asked gave three<
> different responses as to where test results should be recorded. Test results were not found on any of<
> the dialyzer labels reviewed (AAMI 12.3.2). <
><
> d. The facility's written policy states that dialyzers will be used within one hour after Renalin is rinsed,<
> or new dialyzers will be issued. On October 18, 2001, staff were observed priming and rinsing reused<
> dialyzers <
> at approximately 11:15 am, before leaving for lunch. Since the next treatment shift was scheduled to<
> begin at 12:30 pm, this would result in reuse of the dialyzers more than one hour after the germicide<
> was rinsed off (AAMI 12.4.1). <
><
> e. The written policies and procedures for dialyzer reuse contained numerous typing mistakes,<
> misspellings, grammatical errors, and conflicting statements, making them difficult to understand and<
> follow (AAMI 4.1). <
><
> Examples included:<
> (Procedure for) Renalin Reprocessing Concentration Mixture:<
> Step #4: "Renalin concentrated will be mixed 1 part reverse osmosis water to concentrate."<
> Step #10: "Dilution of renalin must be 2.5 gallons of solution the dilution must be made in the original<
> container."<
> Step#14: "Dialyzers will be reprocessed within one hours after being used, but can be refrigerated up<
> to 36 hours after being used." <
><
> Title: Dialyzer Labeling:<
> 1.1 Purpose: "All dialyzers will be labeled to ensure that dialyzers are not<
> used for the same patient."<
> 2.111 Procedure: <
> Step #6. "All information contained on the dialyzer label will coefficient and type of dialysis flow<
> record."<
> Step #7. "No label is to obtain the dialyzer manufacturer's model or lot number flow direction<
> indicator." <
><
> Items (a) through (e) above are in violation of N.J.A.C. 8:43G-30.8(b), which requires that any reuse<
> of a dialyzer shall conform with guidelines in the AAMI publication, "Recommended Practice for Reuse<
> of Hemodialyzers." <
><
> 9. Based on observation, staff interviews, and a review of policies, procedures, and documentation, the facility failed<
> to ensure that water treatment equipment, water and dialysate conformed with the requirements in the AAMI<
> publication, "American National Standard for Hemodialysis Systems." This was evidenced by the following: <
><
> a. The supplier of the water treatment equipment used in the facility recommended that staff conduct<
> daily water quality monitoring and complete a two page log sheet. With the exception of one daily<
> chlorine/chloramines test, at the time of this survey, water system monitoring had been documented<
> only once since Fe
uary, 2001. <
><
> b. Both the manufacturer of the dialysis machines, and facility policy require that the conductivity of the<
> dialysate be tested with a device independent of the dialysis machine. Such independent conductivity<
> testing was not observed being done prior to initiation of patient treatment on <
> October 18, 2001. Facility policy for independent conductivity refers to the use of Myron meters. A<
> different
and (Phoenix) of meter was available in a lab area. However, there was no written policy<
> for its use, and staff were not familiar with its operation. <
><
> c. The facility mixes bicarbonate dialysate concentrate on site. Their procedure requires completion of<
> a log sheet detailing batch size, bicarbonate lot number, and concentration, determined by a test for<
> specific gravity. Based on a review of log sheets for the month prior to the survey date, this information<
> was recorded less than 30% of the time. <
><
> d. Bicarbonate dialysate concentrate is not being tested for bacterial quality.<
><
> e. Plastic jugs, used for bicarbonate dialysate in the hospital dialysis unit, are being cleaned and<
> disinfected with untreated city water. <
><
> f. The facility's policy for disinfection of dialysis machines contains conflicting statements. Under the<
> "Policy" heading, it states that machines are disinfected after each use. Under 'Procedure," it indicates<
> daily disinfection. Most machines are used three or four times a day. <
><
> g. Following cleaning and disinfection and rinsing of the dialysis machines and bicarbonate mixing<
> equipment with bleach, this facility tests for residual chlorine with Hemastix, which are sensitive to<
> approximately 3 ppm of chlorine. AAMI requires that chlorine levels be below 0.5 ppm. The test strips<
> being used are not sensitive enough to meet this standard. <
><
> Items (a) through (g) above are in violation of N.J.A.C. 8:43G-30.8(c), which requires that water treatment<
> equipment, water, and dialysate shall conform with the requirements in the AAMI publication, "American National<
> Standard for Hemodialysis Systems." <
><
> N.J.S.A. 26:2H-14 allows for the imposition of a penalty of not more than $2,500 for each day that a facility<
> violates any rule or regulation as such pertains to the care of patients or physical plant standards. In accordance with<
> N.J.S.A. 26:2H-14 and N.J.A.C. 8:43E-3.4(a)8 and10, you are hereby assessed a penalty of $9,500 for the<
> violations cited above, calculated as follows: <
><
> For N.J.A.C. 8:43G-13.4(d)-(k), 13.5(c), and 24.4(f): $2,500 <
><
> For N.J.A.C. 8:43G-30.14(b) and (f): $1,000 <
><
> For N.J.A.C. 8:43G-30.15(a): $1,000 <
><
> For N.J.A.C. 8:43G-30.8(b): $2,500 <
><
> For N.J.A.C. 8:43G-30.8(c): $2,500<
> TOTAL: $9,500 <
><
> The Department has determined that a monetary penalty will not be assessed at this time for violation of N.J.A.C.<
> 8:43(G)-24.13(d), concerning the lack of an evacuation diagram specific to the dialysis unit. Please be advised,<
> however, that failure to correct this deficiency, as evidenced by the citation of a repeat deficiency upon a revisit, may<
> result in the assessment of a monetary penalty. I anticipate your full cooperation in assuring that the health, safety,<
> and well being of patients at your facility is protected and maintained. <
><
> A certified check or money order made payable to "Treasurer, State of New Jersey" must be submitted within 30<
> days of the date of this letter. In accordance with N.J.A.C. 8:43E-3.5(c), failure to pay this penalty may result in a<
> summary civil proceeding in the Superior Court of New Jersey pursuant to the Penalty Enforcement Law, N.J.S.A.<
> 2A:58-1 et seq., or placement of East Orange General Hospital on provisional licensure status. Payments should be<
> forwarded to:<
><
> New Jersey Department of Health and Senior Services<
> Certificate of Need and Acute Care Licensure Program<
> P.O. Box 360, Room 403<
> Trenton, New Jersey 08625-0360<
> Attn: John A. Cala
ia <
><
> Pursuant to N.J.S.A. 26:2H-13, you may contest this proposed penalty assessment by giving written notice to this<
> Department of your desire for a hearing before the Office of Administrative Law. Such notice must be accompanied<
> by a written answer addressing each of the violations. This penalty may be held in abeyance until such time as the<
> hearing has been concluded and a final decision rendered. A request for such a hearing must be submitted to this<
> office within 30 days after the date of this letter and should be forwarded to: <
><
> New Jersey Department of Health and Senior Services<
> Office of Legal and Regulatory Affairs<
> P.O. Box 360, Room 805<
> Trenton, New Jersey 08625-0360<
> Attn: Mrs. Carole Slimm<
><
> If you have any questions concerning this matter, please do not hesitate to contact Mr. John A. Cala
ia, Director,<
> Certificate of Need and Acute Care Licensure Program at (609) 292-8773.<
><
/>> FOR: Clifton R. Lacy. M.D.<
> Acting Commissioner <
><
><
> BY: ___________________________________<
> Marilyn Dahl<
> Senior Assistant Commissioner <
><
> c: Ms. Dahl<
> Ms. Thornton<
> Ms. Otterbourg <
> Mr. Cala
ia<
> Ms. Jacob<
> Ms. Barreto, DAG<
> Mr. Sunkiskis <
> Ms. Brown<
> Mrs. Slimm<
> Mr. Greenberg
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leadsag
Joined: 31 Oct 2002
Posts: 263
PostPosted: Tue Jul 15, 2003 5:35 am Post subject: public records
This should be included in the public records file on this website.<
><
>I look around the unit I do business with and see many of these same violations. Of course, I am in a different state but I would imagine the same standards apply.<
><
>
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BE
Joined: 23 Jun 2003
Posts: 25
PostPosted: Wed Jul 16, 2003 8:39 am Post subject: Two things
I have two things to comment on here. First is the knowledge of the inspectors is increasing and it appears that they really know the technical side of dialysis. Was wondering why the clinical side was not commented on. Usually, short and long term care plans are noted. It appears that the nursing side of this unit is functioning properly, but the technical side needs improvement. Second is the quality of the diaysis technical staff is not there. Making grammatical mistakes in a procedure manual is totally unacceptable. If they do not know enough to write it properly, they probably do not know how to perform the task either. If it was not written it probably was not done. Not documenting test results is also unacceptable.