Summary:
Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to retain quality control documentation for four of twelve medical records reviewed for Rh (Rhesus factor) testing. Annual testing volume for Rh factor is 4,079. Findings Include: 1) Review of policy titled, "PLANNED PARENTHOOD OF INDIANA AND KENTUCKY LABORATORY MANUAL REVIEW AND APPROVAL," signed by the laboratory director on 5/24/18, read on page 29, under section, "Quality Assurance:," "...The reactivity of blood grouping reagents must be confirmed on each day of use..." 2) Medical record review indicated no quality control documentation was available for Rh testing for the following patients (PT=patients): PT#3=11/10/17 PT#4=10/5/17 PT#5=8/18/17 PT#6=7/18/17 3) In interview on 1/9/19 at 12:33 pm, SP-1 confirmed quality control records for PTs (#3-#6) was not available for review. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --