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CAPE COD HEALTHCARE 88 LEWIS BAY ROAD HYANNIS, MA 02601 March 25, 2016
VIOLATION: PROGRAM DATA, PROGRAM ACTIVITIES Tag No: A0283
Based on records reviewed, 2 (Patients #1 and #2) of 12 sampled patients, interviews and observations the Hospital failed to assure quality improvement activities thoroughly investigated 2 adverse patient events and immediately implemented corrective action(s) after Patient #1 received a Lugol's solution (iodine medication) overdose on 2/18/16, and after Patient #2's surgery was conducted with non-sterile equipment on 2/18/16.

Findings include:

1.) The Hospital quality improvement activities failed to:

Revise the policy titled DaTscan Protocol SPECT Brain Imaging, to include accurate dose information for Lugol's solution.

Dispense Lugol's solution to the Nuclear Medicine Department according to the Pharmacy and Therapeutics Committee meeting minutes of 3/1/16.

Assure that the Pharmacy and Therapeutics Committee reviewed the Nuclear Medicine DaTscan order form.

Assure that the Medical Executive Committee reviewed the Nuclear Medicine DaTscan order form.

Assure physicians were informed of the Nuclear Medicine DaTscan order form.

Assure that the Pharmacy reported the unclear Lugol's solution labeling and unclear medication information supplied from the pharmaceutical company, to MedWatch (Food and Drug Administration Safety Information and Adverse Event Reporting Program).

The History and Physical, dated 2/18/16, indicated physicians admitted Patient #1 to the Hospital after Patient #1 experienced burning of the throat, swelling of the mouth, teeth tingling, vomiting and headache with the ingestion of Lugol's solution, in preparation for a DaTscan [nuclear medicine scan of the brain specific for patients with Parkinson (a brain) disease].

The Surveyor interviewed the Risk Manager at 8:30 A.M. and 1:45 P.M. on 3/23/15. The Risk Manager said the Hospital quality improvement activities identified system breakdowns in ordering the correct amount of Lugol's solution. The Risk Manager said the Hospital policy regarding DaTscan's was unclear and corrective action included policy revision for Lugol's solution dosage clarity. The Risk Manager said that the Pharmacy would now pre-fill an oral syringe with Lugol's solution. The Risk Manager said corrective action included Registered Nurses (RN) would now administer Lugol's solution.

The Surveyor interviewed Nuclear Medicine Technologist #1 at 2:00 P.M. on 3/23/16. Nuclear Medicine Technologist #1 said she reviewed the medication information that came with the bottle of Lugol's solution prior to administering the Lugol's solution in preparation for Patient #1's DaTscan on 2/18/16. Nuclear Medicine Technologist #1 said the bottle of Lugol's solution did not contain how many milliliters were equal to 6 drops.

The document titled Lugol's solution, package insert (medication information packaged with the medication), dated 3/2015, indicated administration directions for Lugol's solution as 2 to 6 drops was equal to 0.1-0.3 milliliters. The package insert did not indicate that 0.8 milliliters of the Lugol's solution was equal to 100 milligrams of iodine according to acceptable standards of practice.

The Surveyor interviewed the Chief Medical Officer (CMO) at 9:00 A.M. on 3/24/16. The CMO said the Lugol's solution label should have identified the medication as Lugol's solution 5% and that 100 milligrams was equal to 0.8 milliliters.

The Surveyor interviewed RN #1 at 7:50 A.M. on 3/24/16. RN #1 said the Hospital Pharmacy dispensed the Lugol's solution and he would administer 0.8 milliliters of the Lugol's solution. RN #1 said that the policy did not specify 0.8 milliliters.

The Hospital policy titled DaTscan Protocol SPECT Brain Imaging, dated 5/5/15, indicated the Lugol's solution directions were that the solution was 100 milligrams of iodine. The revised DaTscan Protocol SPECT Brain Imaging, dated 3/11/16, indicated the same directions as the 5/5/15 policy and remained unclear according to medication administration acceptable standards of practice (because the policy did not indicate that 0.8 milliliters of the Lugol's solution was equal to 100 milligrams of iodine).

The document titled Pharmacy & Therapeutics Committee Meeting Minutes, dated 3/1/16, indicated that the Hospital Pharmacy would provide Lugol's solution in the form of 0.8 milliliters as a unit (individual) dose to the Nuclear Medicine Department.

The Surveyor interviewed Pharmacist #1 at 11:30 A.M. on 3/23/16. Pharmacist #1 said the Hospital Pharmacy sent 0.8 milliliters of Lugol's solution in a glass bottle to the Nuclear Medicine Department for administration to a patient.

The Surveyor observed at 11:45 A.M. on 3/23/16, bottles of Lugol's solution, dispensed by the Hospital Pharmacy to the Nuclear Medicine Department. The Surveyor observed that Lugol's solution was not pre-filled into an oral syringe and was not a unit dose as indicated in the Pharmacy & Therapeutics Committee Meeting Minutes, dated 3/1/16. The Surveyor observed that the bottle of Lugol's solution did not contain 0.8 milliliter (it contained 14 milliliters). The Surveyor observed that the Lugol's solution bottle was not labeled for a specific patient by the Hospital Pharmacy with the dose and volume (amount of fluid) to be administered according to medication administration acceptable standards of practice.

The Risk Manager said the Hospital quality improvement activities identified a system breakdown in ordering a DaTscan. The Risk Manager said a Nuclear Medicine DaTscan order form was developed as a corrective action. The Risk Manager said Lugol's solution dose information on the Nuclear Medicine DaTscan order form was unclear. The Risk Manager said the Nuclear Medicine DaTscan order form was not reviewed by the Hospital Pharmacy and Therapeutics Committee.

The Nuclear Medicine DaTscan order form, undated, indicated directions for administering Lugol's solution as 100 milligrams. The Nuclear Medicine DaTscan order form did not indicate the Lugol's solution dose according to acceptable standards of care for medication administration (Lugol's solution 5% and that 100 milligrams was equal to 0.8 milliliters).

The Risk Manager said that the Lugol's solution dose information was unclear and the Nuclear Medicine DaTscan order form was not reviewed by the Medical Executive Committee. The Risk Manager said the Hospital quality improvement activities included physician education about the order form.

The Surveyor interviewed the Radiology Manager at 10: 00 A.M. on 3/23/16. The Radiology Manager said that the physicians would be informed today by mail of the Nuclear Medicine DaTscan order form (3/23/16, the day of the Survey, the Lugol's solution dose information was unclear and did not meet acceptable standards of practice because the form did not indicate that 0.8 milliliters of the Lugol's solution was equal to 100 milligrams of iodine).

Nuclear Medicine Technologist #2 said that a patient was scheduled for a DaTscan tomorrow (3/24/16).

The Chief Nursing Officer and Risk Manager said at 7:30 A.M. on 3/14/16 that the patient scheduled for the DaTscan was canceled because the Hospital was not ready to perform the DaTscan.

The document titled GE Healthcare DaTscan, dated 9/2015, indicated Lugol's solution was equivalent to 100 milligrams of iodine. The document did not indicate milligrams per milliliter.

The document titled GE Health Care Imaging with DaTSCAN A workbook, 9/2006, indicated that the Lugol's solution was equal to 0.8 milliliters and the document did not indicate milligrams per milliliter according to acceptable standards of practice.

The document Drugs DaTscan, 4/2011, indicated Lugol's solution was equivalent to 100 milligrams of iodine. The document did not indicate milligrams per milliliter according to acceptable standards of practice.

Pharmacist #1 said that the Hospital did not report the lack of dose specific information on the Lugol's solution bottle and the lack of dose specific information on the Lugol's solution information sheet included with the Lugol's solution bottle to MedWatch.

2.) The History and Physical, dated 2/16/16, indicated physicians admitted Patient #2 to the Hospital for surgery to remove a kidney stone.

The Surveyor interviewed Surgical Technologist #1 at 11:50 A.M. on 3/25/16. Surgical Technologist #1 said she told the surgeon the laser fiber (piece of equipment) did not have a sterility tag and they continued with the procedure without ensuring sterility of the equipment.

The Surveyor interviewed the Risk Manager at 12:30 on 3/24/16. The Risk Manager said that surgical team staff had concerns about the sterility of the laser fiber (piece of equipment) during Patient #2's surgery and the surgery was conducted using a clean but not sterile piece of equipment. The Risk Manager said that correction actions regarding Patient #2's adverse patient event included education about stopping the patient procedure until resolution of the concern.

The CMO and the Risk Manager said that, as of 3/25/16, the Hospital had not informed approximately 37% of the surgeons regarding the corrective action plan to stop a patient procedure until resolution of a concern.

There was no indication that all surgeons were informed of all components of the Hospital's corrective action plans.

The Surveyor interviewed the Chief of the Department of Surgery at 8:00 A.M. on 3/25/16. The Chief of the Department of Surgery said the Hospital had scheduled surgeon education for 4/14/16 (after the Survey).

The Hospital quality improvement activities failed to assure that physicians were educated about the immediate corrective plan to stop the patient procedure until resolution.

The Risk Manager and the CMO said that Patient #1 and #2's adverse events had the same stop-the-line (stop the patient procedure) concerns.