Potomac Family Planning Center – Rockville

Violations discovered during Feb. 2013 facility inspection: HIPAA violations - administrator failed to protect clinical records from loss or misues, leaving them unlocked inside the recovery room; the patient reception area also containes file cabinets of active patients; the storage area also has 15 boxes of medical records from the past two years and it is not locked or secured; all records are also left open and unlocked after hours while non-clinic cleaning agents work inside ---- no policy/procedure for patient safety practices that include the control of fire and mechanical hazards ---- 2 of 3 physicians missing their information on claims against them from the National Practicioner Data Bank ---- in both procedure rooms the blinds and window ledges are covered with a white dusty substance, all five sets of windows in recovery room also coated with this ---- failure to use chemical indicator strips to ensure sterilization of instruments

Abortion website advertises secret, cover-up abortions for VIP clients - promises their "Private VIP abortion service" will preserve the patient's "discretion"

Failure to ensure that quality control materials in laboratory were not used after their expiration date.

Deficiencies cited and plan of correction

Serious violations here, especially relating to expired meds and supplies: facility staff did not monitor or discard expired medications, did not label multi-dose medication vials which increases chance of patient infection, and did not secure drugs and prescription pads --- recovery room contained 75 blunt needles expired 4/15 and accessible prescription pad --- procedure room 1 contained unlocked pitocin for stimulating contractions --- procedure room 2 contained expired currette and expired medicine --- medication storage contained 80 expired needles and medication multidose vials for emergency reversal of respiratory depression not dated

A huge number of serious violations here, especially relating to patient care, quality assurance, expired meds/supplies, infection control, etc: failure to to maintain and clean medical equipment, to maintain disinfection wipes, secure medical waste containers, label solution containers, maintain the surgical beds (in both prodecure rooms, the labratory, and the recovery room), and prevent compromise of surgical wrapped sterile instruments ----- laryngoscope had coarse, white substance on the outside, and when tested, it was not working; surgical bed in procedure room 2 has multiple cracks and tears allowing for cross contamination between patients; tracheal tume yas yellow-browning stains, blood collection kit with yellow discoloration ----- 2 of 2 supervisory staff were unaware that an anesthesia provider needs to perform a pre-anesthesia assessment of patients, nor that nurses or physicians were not documenting or signing off on medications and IVs ----- 10 of 10 patient records show no documentation of physician orders for IV, no drug orders noted by the physician, yet in all 10 they were administered without necesary information such as who administerd, when administered, where on the body injected, or response, INCLUDING A CASE WITH A PATIENT HEMORRHAGE; also mifepristone orders are written incorrectly and not signed either ----- 8 of 10 patients did NOT recevieve history and physical exam by a physician or medical professional before receiving anesthesia, sedation, or surgery; heart and lung records not assessed; 6 of 10 patients did not receive pre-anesthetic evaluation or assessment of risk before administering anesthesia ----- facility staff did not monitor or discard expired medications, did not label multi-dose medication vials which increases chance of patient infection, did not label sterile water, and did not secure drugs and prescription pads; expired in procedure room 1 (1 airway mask and 1 vial lidocane), autoclave area (10 kits), recovery room (tracheal tube, 4 winged infusion sets, blood collection set, two vials sodium bicarbonate exp in 2014; in procedure room 2 TWENTY-TWO drugs or items expired (some in 2014) including needles, muscle relaxer, lidocane, endotracheal tube, etc. ----- no counting of narcotics or medications maintained since 2012 ----- no tracheostomy set in the general anesthesia room, as required; clinic staff do not know if the clinic even has a tracheostomy set; no MH cart at facility (required for malignant hypothermia reaction to anesthesia which causes circulatory collapse and death if not treated immediately), not set up to handle MH crisis

A 36-year-old woman suffers a severe hemorrhage following her abortion procedure, and requires emergency transport to the hospital.

Contains details on patient death from a 1999 botched abortion performed by Earl McLeod at Potomac Family Planning Center in Rockville. See page 2.