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Based on observation, interview, and record review, the facility failed to ensure that equipment and supplies were stored and maintained to maintain a level of safety and quality as evidenced by:

1. Preventative maintenance was not performed annually on patient care equipment;

2. Hazardous cleaning supplies were accessible to children;

3. Unlabeled liquid was present in the surgery department;

4. Clamps and scissors were not sterilized in an open position;

5. A clamp was not cleaned and stored properly in the operating room (OR) suite; and

6. A box of sterile syringes was stored on the floor in the CT (Computer Tomography, xray) scan room.

These failures had the potential for equipment failures, inaccurate patient testing, accidental ingestion, infections, and errors in use which could negatively impact a patient's health status.

Findings:

1. On 6/11/13 during the initial tour, starting at 10:45 am, the following items were observed to have outdated or a lack of preventative maintenance stickers:
- A patient scale in the Dexa (a type of xray) Room of the radiology department had a sticker dated 7/08;
- A patient monitor for blood pressure and vitals signs in the CT room of the radiology department had no preventative maintenance sticker;
- An arthroscopy pump (equipment for knee surgery) in the operating suite (OR) had a sticker dated 3/23/12; and
- A Cabot Medical Niagara 2 liter fluid pumper (irrigation equipment) of in the clean storage room for endoscopy (visual scope) equipment had no preventative maintenance sticker

In a concurrent interviews, the above findings were acknowledged by Radiology Manager F and OR Nurse I for their respective departments. OR Nurse I stated the fluid pumper in the OR was no longer in use.

On 6/12/13, the hospital policy, titled, "Medical Equipment Management," dated 9/11, indicated that all mechanical and/or electronic devices used inpatient care or diagnosis, including new and used incoming equipment would be evaluated a least annually for safety and risk.

On 6/12/13 at 9 am, Biomedical Technician (BT) V acknowledged the above findings. BT V stated the fluid pumper should be removed from the OR suite if it was not longer in use. BT V provided evidence that the arthroscopy pump had been tested on 5/20/13 but did not have an accurate sticker.

2. On 6/11/13 at 11 am, the public bathroom in the CT room contained an unlocked under-sink cabinet that contained six bottles of five different cleaning supplies. Each bottle contained a warning to keep out of the reach of children and gave instruction to call the poison control center if the product was accidently ingested. The cabinet had a key lock that was not used.

On 6/12/13, the hospital policy, titled, "Hazardous Chemical Program," last reviewed 2/13, indicated that the labels of hazardous chemicals will be followed."

In a concurrent interview, Radiology Manager F acknowledged that children do enter the area and the cleaning supplies should be locked.

3. On 6/11/13 at 11:30 am, the surgery department handwashing sink was observed to have an unlabeled bottle with white liquid. In a concurrent interview, Licensed Nurse (LN) I, who supervises the surgeries, stated the bottle contained soap and should be labeled when it was filled.

The hospital policy, titled, "Hazardous Chemical Program," last reviewed 2/13, indicated that all containers should be labeled with the contents.

4. On 6/11/13 at 11:40 am, the supply of sterile clamps and scissors was observed. A small sampling revealed nine packages of sterile scissors and three packages of sterile clamps were processed in the closed position.

In a concurrent interview, LN I stated the hospital followed AORN standards (Association of periOperative Registered Nurses). LN I acknowledged the the packages should have been processed in the open position.

On 6/12/13, the AORN recommended practice for cleaning surgical instruments, recommendation XXII, read, "Cleaned surgical instruments should be organized for packaging in a manner to allow the sterilant to contact all exposed surfaces...Instruments should be open and unlocked position..."

5. On 6/11/13 at 11:30 am, the anesthesia (artifically induced loss of ability to feel discomfort and/or sensation) cart in the OR suite was observed to have a clamp on top of the cart and several clamps in the drawer. LN I stated they had endoscopies the previous day and had cleaned the room following the last procedure. LN I stated the clamps do not have to be sterile because they are used to hold towels in place during the surgery to protect the patient's face during surgery. LN 1 stated the clamps are cleaned after use and stored in the cart. LN I acknowledged that the clamp on top of the anesthesia cart should have been cleaned and placed in the cart at the end of the procedure.

6. On 6/11/13 at 11:20 am, a box of sterile syringes was observed on the floor in the CT scan room of the radiology department.

In a concurrent interview, Radiology Manager F acknowledged that patient care supplies were not to be stored on the floor.

On 6/12/13, the hospital policy, titled, "Storage of Clean Supplies and Equipment," revised on 2/12, read, "Clean supplies are to be placed in proper storage areas...in cabinets and drawers."

Based on observation, interview, and record review, the hospital failed to have a current CLIA (Clinical Laboratory Improvement Amendments - regulates all laboratory testing) certificate. This failure may result in inaccurate test results.

Findings:

On 6/11/13 at 10:45 am, the laboratory posting board was observed to have the hospital's CLIA certificate posted. The expiration date on the license was 4/9/13.

On 6/12/13 at 2 pm, Laboratory Manager (LM) U stated there was confusion regarding the the CLIA certificate and the license which were previously timed to expire at the same time. LM U stated the hospital passed its inspection but the fee for certification had not yet been paid.

On 6/12/13 at 2:20 pm, a representative from the California Laboratory Field Services confirmed that the hospital was in compliance but needed to send a check prior to the certification being issued.

The regulation above references part 493 of this chapter which reads, "Laboratories performing only waived tests, PPM (Provider Performed Microscopy) procedures, or any combination of these tests, are not required to obtain a registration certificate.
(a) A registration certificate is required-- (1) Initially for all laboratories performing test procedures of moderate complexity (other than the subcategory of PPM procedures) or high complexity, or both; and
(2) For all laboratories that have been issued a certificate of waiver or certificate for PPM procedures that intend to perform tests of moderate or high complexity, or both, in addition to those tests listed in ?493.15(c) or specified as PPM procedures.
Interpretive Guidelines ?493.45(a)
All facilities performing laboratory testing must have a registration certificate or certificate of waiver prior to performing patient testing.
See ??6006 and 6030 of the SOM for instructions on handling a laboratory operating without an appropriate CLIA certificate.
(b) HHS (Health and Human Services Department) will issue a registration certificate if the laboratory--
(1) Complies with the requirements of ?493.43;
(2) Agrees to notify HHS or its designee (CDPH Lab Field Services) within 30 days of any changes in ownership, name, location, director or technical supervisor (laboratories performing high complexity testing only);
(3) Agrees to treat proficiency testing samples in the same manner as it treats patient specimens; and
(4) Remits the fee for the registration certificate, as specified in subpart F of this part.
(c) Prior to the expiration of the registration certificate, a laboratory must--
(1) Remit the certificate fee specified in subpart F of this part;
(2) Be inspected by HHS as specified in subpart Q of this part; and
(3) Demonstrate compliance with the applicable requirements of this subpart and subparts H, J, K, M, and Q of this part.
(d) In accordance with subpart R of this part, HHS will initiate suspension or revocation of a laboratory's registration certificate and will deny the laboratory's application for a certificate of compliance for failure to comply with the requirements set forth in this subpart. HHS may also impose certain alternative sanctions. In addition, failure to meet the requirements of this subpart will result in suspension of payments under Medicare and Medicaid as specified in subpart R of this part."