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Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on manufacturer's instructions for use (IFU) and temperature log record review and interview with the laboratory's assistant manager (AM), the laboratory failed to define, monitor, and document laboratory room temperature to ensure proper reagent storage and reliable test system operation. Findings: 1. The laboratory uses the "DOCTOR'S KIT DKS RhD" kit to test for the presence or absence of RhD antigen on patients' red blood cells. The test is performed using the "ELDONCARD RhD" card (EldonCard). 2. Review of the manufacturer's IFU shows that the EldonCards "should be stored between 5 and 37 C." 3. A review of the laboratory's "Daily Lab Tasks" logs from January 2023 through January 2024 showed that the laboratory records refrigerator temperatures but does not document the room temperature where the EldonCards are stored. 4. During an interview on 01/22/2024 at 10:40 AM, the AM confirmed that the laboratory failed to document room temperatures in the laboratory. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) 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 -- Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation, review of the manufacturer's instructions for use (IFU), and interview with the laboratory's assistant manager (AM), the laboratory did not ensure that blood antigen testing cards were labeled with the date that they expire. Findings: 1. The laboratory uses the "DOCTOR'S KIT DKS RhD" kit to test for the presence or absence of RhD antigen on patients' red blood cells. The test is performed using the "ELDONCARD RhD" card (EldonCard). 2. During a tour of the laboratory at 9:30 AM, it was observed that the opened and in use envelope of EldonCards were labeled with the date that they were put in to use but were not labeled with the expiration date. Review of the manufacturer's IFU showed that EldonCards "kept in properly closed EldonBags are stable for up to 6 months after the first opening." 3. During an interview on 01/22/2024 at 10:40 AM, the AM confirmed that the in use blood antigen testing cards were not labeled with the new expiration date once opened. -- 2 of 2 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory (lab) director did not attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. Findings: 1. To assess the accuracy of the Rh (D) testing performed on patient samples, the lab enrolled in a proficiency testing program through a proficiency test provider. The lab receives unknown samples for testing from the proficiency test provider, tests the samples and submits the results to the provider for evaluation. The proficiency test provider evaluates the accuracy of the test results and reports the score to the lab. The proficiency test provider sends the lab three shipments (events) in a one year period; 2. The lab director attests to the routine integration of the unknown samples by signing and dating a statement that accompany the unknown samples. The statement is a declaration that the director will ensure the unknown samples obtained by the proficiency test provider will be tested in the same manner as patient samples; 3. The director signature did not appear on attestation statements for the the third, second and first test events in 2019; and 4. This was confirmed during interview with lab staff in the afternoon on the day of the survey. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. 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 -- This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory (lab) director did not sign and date the proficiency testing performance reviews showing that the director reviewed the results. Findings: 1. To assess the accuracy of the Rh (D) testing performed on patient samples, the lab enrolled in a proficiency testing program through a proficiency test provider. The lab receives unknown samples for testing from the proficiency test provider, tests the samples and submits the results to the provider for evaluation. The proficiency test provider evaluates the accuracy of the test results and reports the score to the lab. The proficiency test provider sends the lab three shipments (events) in a one year period; 2. The lab director signs performance reviews to show that the results were reviewed and if needed

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the federal proficiency testing data report and onsite observations of the laboratory on the day of survey, the laboratory failed to successfully participate in the proficiency testing program for Rh testing (See D2121) 000); the laboratory failed to successfully participate in the American Proficiency Institute proficiency testing program for hematology testing (See D2121); and the laboratory Failed to return proficiency testing results to the proficiency testing program within the time frame specified for unsatisfactory performance resulting in a score of 0% for the testing event (See D2127). Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- D2155 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on review of the federal proficiency testing data report, review of the performance summary during the onsite survey of the laboratory, the laboratory failed to successfully participate in the proficiency testing program for Rh testing, in which the laboratory is certified under CLIA. Findings: 1. The laboratory failed to return Rh proficiency test results to its provider for the First event (no data published by the provider) and Second event (score 0%) of 2017; and 2. The lab did not have a written