N.J. Admin. Code § 8:43A-29.9

Current through Register Vol. 56, No. 11, June 3, 2024

Section 8:43A-29.9 - Policies and procedures

(a) The governing authority shall develop and implement written policies and procedures for lithotripsy services, in accordance with the governing authority and medical staff bylaws. The policies and procedures shall be reviewed annually and revised as needed, and shall include at least the following:

1. Delineation of the lithotripsy services which may be performed;

2. Delineation of the responsibilities of urologists in providing care to patients;

3. Identifying the staff qualified to participate in the provision of lithotripsy services;

4. Developing and implementing operational policies addressing at least the following concerns:

i. The maximum number of shocks and/or voltage allowable or their equivalent;

ii. Bilateral treatment;

iii. Treatment of females of childbearing age;

iv. Patient weight limitations;

v. Treatment of patients with pacemakers;

vi. Post ESWL follow-up care;

vii. Contraindicated medications;

viii. Pre-admission testing requirements;

ix. Patient outcomes;

x. Pre-and post-procedure calls to the patient;

xi. Pediatric cases;

xii. Treatment criteria;

xiii. Cancellation criteria;

xiv. Retreatment criteria;

xv. General safety protocols; and

xvi. Treatment simulation;

5. Lithotripters shall be inspected at least quarterly by a qualified person in accordance with policies and procedures approved by the urologist, all preventive maintenance shall be documented, and a service contract shall be maintained on the lithotripter according to manufacturer specifications;

6. All lithotripters shall be operated by qualified and competent personnel in accordance with facility policies and procedures approved by the urologist;

7. Policies for cleaning equipment before and after use shall be maintained and followed, including procedures for properly covering mobile or transportable equipment upon delivery;

8. Protocols to ensure that procedures are performed only after completion and documentation of appropriate history and physical examination, any indicated diagnostic tests, and the pre-procedure diagnosis;

9. Assurance that every patient is examined by a urologist immediately prior to the procedure; and

10. Requirements for written documentation of all lithotripsy services provided at the facility, including at least a description of the fragmentation, procedures, stones removed, patient's condition, any unusual events occurring during the procedure, post-procedure diagnosis, and names of the urologist and clinical staff. The procedure note shall be written or dictated immediately following the procedure by the urologist performing the procedure and incorporated into the patient's medical record.

N.J. Admin. Code § 8:43A-29.9