Planned Parenthood Of The Rocky Mountains

Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on a review of patient test reports and an interview with the laboratory's technical consultant #2 (TC #2), the laboratory failed to include the testing laboratory's name and address of where patient samples sent to reference laboratories for D Rh(o) types, and Aptima Gonorrhea and Chlamydia tests were performed since the last recertification survey was performed on March 30, 2022. The laboratory sends approximately 150 specimens per year to reference laboratories. Findings include: 1. A review of patient test reports revealed the laboratory failed to ensure the name and address of the reference laboratory was included on patient test reports when the laboratory sent specimens to reference laboratories for D Rh(o) typing, and Aptima Gonorrhea and Chlamydia testing. 2.. An interview on October 9, 2024, at approximately 11:00 AM, with the laboratory's TC 2, confirmed the reference laboratory name and the address was not included on the patient test reports for specimens sent to reference laboratories for D Rh(o) typing, and Aptima Gonorrhea and Chlamydia testing. 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 --

Summary Statement of Deficiencies D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: The laboratory failed to ensure that 1 of 70 new testing personnel met the minimum qualification requirements to perform the moderate complexity testing performed on- site (Ref D6065). D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on a review of personnel records and staff confirmation, the laboratory failed to Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- ensure that 1 of 70 new testing personnel (#10 on Form CMS-209, Boulder facility) was qualified to perform the moderate complexity ABO/Rh testing since being hired in June 2017. The laboratory provided a high school diploma that had been earned outside the U.S. without any documentation that the high school credits earned had been evaluated for U.S. equivalency by a national credentialing service before allowing the staff member to perform non-waived testing on patient specimens. -- 2 of 2 --