Planned Parenthood Of Metropolitan

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 review of proficiency testing (PT) records and interview with the practice manager, laboratory personnel failed to maintain attestations needed to ensure PT was performed in the same manner as patient testing. Findings: Repeat Deficiency 1. The laboratory performs Red Cell RH, HIV and KOH testing. 2. The LD and the testing personnel failed to review and sign the PT attestation for the API 2022 3rd event Hematology/Coagulation. 3. The laboratory director (LD) failed to review and sign the PT attestation for the API 2023 2nd event Hematology/Coagulation. 4. The LD failed to review and sign the PT attestation for the API 2022 1st event Hematology /Coagulation. 5. The practice manager confirmed on the day of the survey at 1:00 PM that lab personnel failed to maintain attestations needed to ensure PT was performed in the same manner as patient testing. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and interview with the practice manager, the laboratory failed to maintain all documents and records acquired during the 2023 and 2022 PT testing events for Hematology/Coagulation. Findings:Repeat Deficiency 1. The laboratory performs Red Cell RH, HIV and KOH testing. 2. The lab failed to maintain PT raw data for the API 1st and 2nd event 2023 Hematology /Coagulation. 3. The lab failed to maintain PT raw data for the API 2nd and 3rd event 2022 Hematology/Coagulation. 4. The practice manager confirmed on the day of the survey at 1:00 PM that the lab did not maintain all documents and records acquired during the 2023 and 2022 PT testing events for Red Cell RH, HIV, and KOH testing. 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 proficiency testing records and interview with the practice manager, The laboratory director failed to ensure that PT was returned to the PT agency in time for grading and resulted in a score of "0" for the testing event (refer to D2043). D2043 MYCOLOGY CFR(s): 493.827(c) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and interview with the practice -- 2 of 6 -- manager, The laboratory director (LD) failed to ensure that PT was returned to the PT agency in time for grading and resulted in a score of "0" for the testing event. Findings: 1.The laboratory performs KOH testing. 2. The lab failed to return the API 2nd event PT 2022 KOH testing in the time required by the PT agency. 3. The practice manager stated that the API 2nd event PT 2022 KOH testing was not performed. 4. The practice manager confirmed on the day of the survey at 1:00 PM that the LD failed to ensure that PT was returned to the PT agency in time for grading and resulted in a score of "0" for the testing event. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of proficiency testing (PT) records and interview with the practice manager, The laboratory director failed to ensure that PT was returned to the PT agency in time for grading and resulted in a score of "0" for the API 2nd event PT 2022 KOH (refer to D6017); failed to review and evaluate PT performance (refer to D6018); and failed to ensure that approved

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 review of the written procedure manual and interview with the practice manager, the laboratory director (LD) failed to review, sign and maintain all proficiency testing attestations. Findings: 1. The LD did not review and sign the 2021 Immunology/Immunohematology 2nd event nor the 2021 Hematology/Coagulation 2nd and 1st event PT attestations. 2. The 2021 Immunology/Immunohematology 2nd event attestation was review and signed by the practice manager who was not a delegated technical consultant meeting CLIA qualifications. 3. The 2021 Hematology /Coagulation 2nd and 1st event PT attestations was not included with the PT results. 4. The 2020 Hematology/Coagulation 2nd event PT attestations was not included with the PT results. 5. The practice manager confirmed that the LD failed to review, sign and maintain all proficiency testing attestations. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two 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 -- years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and interview with the practice manager, the laboratory failed to maintain all documents and records acquired during the 2020 and 2021 PT testing events for Immunohematology/ Immunology and Hematology/Coagulation. Findings: 1. The laboratory performs red cell Rh, KOH, HIV, and wet prep testing. 2. The laboratory failed to maintain all completed attestations, worksheets, logs, and raw data that the lab acquired during testing when performing PT. 3. The practice manager stated that she was unaware that all documents for PT needed to be maintained for review. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the written procedure manual and interview with the testing person, the laboratory did not ensure that all persons performing patient testing were informed of the written procedure. Findings: 1. The laboratory performs red cell Rh testing. 2. The laboratory determines when patients should receive the Rho D Immunoglobulin (RhoGAM) to prevent RhD immunization in patients who are RhD Negative. 3. The testing person stated that prior to giving Rho D Immunoglobulin to the patient. The patient should have a previous Rh historical result on file with lab or a Rh result card from another lab. 4. The written procedure states the lab will accept a self report from the patient for the Rh status prior to receiving the Rho D Immunoglobulin. 5. The self reporting of the Rh status from the patient does not ensure accurate and reliable patient laboratory testing. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

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) did not maintain attestation statements for Rh(D) proficiency testing. Findings: 1. The proficiency test provider mails the laboratory 5 unknown samples 3 times each year. The lab tests the samples and reports the test results to the proficiency test provider to score for accuracy and reports the score to the lab;: 2. The lab director attests in writing to performance of proficiency testing in the same manner as patient samples, the lab did not have written documentation of the lab directors attestation statement for the second event of 2019 and the second event of 2018; 3. This was confirmed with lab staff during interview on the day of survey. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of competency records the technical consultant was not reviewed by the laboratory director to evaluate competency in performance of technical consultant duties. Findings: 1. Technical consultant #3 did not have written competency checks Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- performed by the lab director for evaluation of technical consultant duties. The competency check record shows that testing duties were reviewed, but not technical consultant duties. 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. This STANDARD is not met as evidenced by: Based on record review and interview with staff, the laboratory did not document review of Rh (D) proficiency testing results. Findings: 1. The proficiency test provider mails the laboratory 5 unknown samples 3 times each year. The lab tests the samples and reports the test results to the proficiency test provider to score for accuracy and reports the score to the lab; 2. The lab director did not document and perform review for results of the second proficiency test event for Rh(D) testing in 2019; 3. The lab director did not document and perform review for results of the third proficiency test event for Rh(D) testing in 2018; 4. This was confirmed during interview with staff on the day of survey. D5779