Planned Parenthood Of Southern New England

Summary Statement of Deficiencies D5821 TEST REPORT CFR(s): 493.1291(k) When errors in the reported patient test results are detected, the laboratory must do the following: (k)(1) Promptly notify the authorized person ordering the test and, if applicable, the individual using the test results of reporting errors. (k)(2) Issue corrected reports promptly to the authorized person ordering the test and, if applicable, the individual using the test results. (k)(3) Maintain duplicates of the original report, as well as the corrected report. This STANDARD is not met as evidenced by: Based on staff interview and record review, the laboratory failed to provide a prompt corrective report when incorrect laboratory results were identified in the specialty of microbiology. Finding include: 1. Staff interview on 02/16/2022 at 12:50 pm with Technical Consultant (TC) revealed a patient complaint regarding a reporting issue of laboratory results as follows: a. A patient inquired on 08/21/2021 about a positive laboratory result in the electronic patient portal for trichomoniasis when she was told she had a yeast infection. b. Investigation of the patient visit notes by the provider on 08/23/2021 revealed that the patient did not have symptoms for and was not treated for trichomoniasis. c. The report stated yeast was not detected and 'Trich' was detected. d. A corrected report was not issued to date. 2. Record review on 02/16/2022 of the patient provider communication confirmed incorrect patient result as stated in 1b above. 3. Record review on 02/16/2022 of the laboratory report in the electronic medical record revealed no corrected report to date. 4. The laboratory processes 16,666 samples a year in the specialty of microbiology. 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 D0000 The Planned Parenthood of Southern New England (PPSNE) Laboratory is a not-for- profit laboratory engaged in limit public health testing and has a single certificate for multiple sites. Two sites were chosen for a sample survey; West Hartford PPSNE at 1030 New Britain Avenue, West Hartford, CT. 06110 and Torrington PPSNE at 249 Winsted Road, Torrington, CT. 06790. 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 record review and staff interview the laboratory failed to indicate the proper address location of the laboratory where the Immunohematology tests were being performed. Findings include: 1. Record review of 5 patient final reports on 10/29/18 revealed the reports did not indicate that the Rh tests were performed at the West Hartford and Torrington laboratory locations. All patient final reports indicated the Rh tests were performed at the New Haven location. 2. Staff interview with the technical consultant on 10/29/18 at 10:30 AM confirmed the patient final reports failed to indicate where the laboratory tests were performed between the 2 locations. 3. Laboratory performs approximately 9,290 Rh tests annually. * This is a repeat deficiency 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 --