Planned Parenthood Keystone-Allentown

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of the laboratory's American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) proficiency testing (PT) records and interview with the Quality Manager (QM), the laboratory failed to examine 5 of 5 AAB-MLE PT immunohematology testing events in the same manner as patient specimens in 2023 and 2024. Findings include: 1. On the day of survey, 09/16/2024 at 11:12 am, review of the laboratory's AAB-MLE PT records and Rh testing Attestation forms revealed that the laboratory failed to examine the ABO Group and D (Rho) typing PT samples in the same manner as patient specimens in 2023 (events #1-3) and 2024 (events #1 and #2). 2. Interview with the QM on 09/16/2024 at 12:00 pm confirmed the PT samples for Rh testing were analyzed by each testing personnel (CMS 209 personnel #4, #5, #6, #7, #8) and the final result reported was based on the group consensus. 3. The laboratory could not provide documentation stating the Rh testing was included in the laboratory's patient repeat criteria. 4. The QM confirmed the findings above on 09/16/2024 at 12:45 pm D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) 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 -- (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 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 the laboratory's American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) proficiency testing (PT) records and interview with the Quality Manager (QM), the laboratory failed to provide 2 of 3 AAB-MLE PT attestation statements for immunohematology testing events performed in 2023. Findings include: 1. On the day of the survey, 09/16/2024, the laboratory failed to provide attestation statements for the 1st and 2nd event of ABO Group and D (Rho) typing proficiency testing performed in 2023. 2. The QM confirmed the findings above on 9/16/2024 at 12:45 pm. D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on document review and interview with the Quality Manager (QM), the Laboratory Director (LD) failed to be present for a reasonable period of each working day in each laboratory for which he was director from 11/01/2018 to 09/16/2024 as required by Pennsylvania (PA) state regulations. Findings include: 1. The PA State regulation 5.22 (g) states: "A director shall be present for a reasonable period of each working day in each laboratory for which he is director." 2. Review of the Application for Approval to Direct more than Two Clinical Laboratories (Exception to 5.22) form, revealed the LD currently oversees 7 compliance laboratories (39D0190807) throughout multiple sites in the state of PA. 3. The Planned Parenthood Keystone laboratory manual states, "The Lab Director will annually assess competencies of APCs (Advanced Practice Clinicians) for moderate complexity tests. Additional quality assurance standards in place for moderately complex laboratory procedures on- site include annual review of laboratory logs and daily controls by Laboratory Director or designee." 4. During an interview on 09/16/2024 at 12:45 pm, the QM confirmed the Lab Director is on-site as needed but failed to provide the date of his last on-site visit. 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, -- 2 of 3 -- consultant competency. This STANDARD is not met as evidenced by: Based on review of competency assessment records, lack of documentation, and interview with the Quality Manager (QM), the laboratory failed to establish a competency assessment procedure to assess 2 of 2 technical consultants (TC) for their supervisory responsibilities in 2022 and 2023. Findings Include: 1. On the day of survey, 09/16/2024 at 11:05 am, the laboratory failed to provide a competency assessment procedure to assess the competency of 2 of 2 TC (CMS 209 personnel #2 and #3) for their supervisory responsibilities in 2022 and 2023. 2. The laboratory failed to provide competency assessment documentation for 2 of 2 TC (CMS 209 personnel #2 and #3) for 2022 and 2023. 3. The QM confirmed the findings above on 09/16/2024 at 12:45 pm. -- 3 of 3 --

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing (PT) records, and interview with the risk quality management manager, the laboratory failed to ensure that the verification of accuracy of wet mount and potassium hydroxide (KOH) microscopic examinations were performed at least twice annually as required from 11/25/2020 to 01/25/2023. Findings Include: 1. On the day of the survey, 01/25/2023 at 11:06 am, the laboratory could not provide documentation that the verification of accuracy for KOH and wet mount microscopic examinations were performed at least twice annually from 11/25/2020 to the the date of the survey. 2. The risk quality management manager confirmed the finding above on 01/25/2023 around 02:00 pm. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of quality control (QC) records, and interview with the risk quality management manager, the laboratory failed to include a negative and positive control 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 -- material each day of patient testing for Rhesus factor (Rh) Group testing from 12/21 /2021 to the date of the survey . Findings Include: 1. On the day of survey, 01/25/2023 at 01:00 pm, review of the Rh QC records revealed the laboratory performed external quality controls on the Eldon Rh typing cards weekly from 12/21/2021 to 01/25/2023. 2. The risk quality management manager confirmed the findings above on 01/25/2023 around 02:00 pm. D5463 CONTROL PROCEDURES CFR(s): 493.1256(d)(7)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Over time, rotate control material testing among all operators who perform the test. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of quality control records and interview with the risk quality management manager, the laboratory failed to over time rotate control material testing between 5 of 5 testing personnel (TP) who perform Rhesus factor (Rh) Group testing on the Eldon Rh typing card from 12/21/2021 to the date of the survey. Findings include: 1. On the date of the survey, 01/25/2023 at 01:00 pm, review of the laboratory's weekly Rh Control test log revealed that 4 of 5 TP (CMS 209 personnel # 5, 6, 7, and 9) did not perform QC from 12/21/2021 to 01/25/2023 for Rh testing performed on the Eldon Rh typing cards. 2. The risk quality management manager confirmed the finding above on 01/25/2023 around 02:00 pm. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on the review of laboratory health center assessment and infection control audit records and interview with the risk quality management manager, the laboratory director failed to ensure quality assessment (QA) programs were maintained and documented to assure the quality of laboratory services provided from 11/25/2020 to the date of survey. Findings Include: 1. On the day of survey, 01/25/2023 at 12:35 pm, a review of the laboratory's health center assessment records revealed no documented review was performed by the LD for the following from 11/25/2020 to 01/25/2023. - 07/06/2022: health center assessment performed by risk quality management manager - 09/14/2022: health center assessment performed by risk quality management manager - 08/16/2021: health center assessment performed by risk quality management manager 2. The risk quality management manager confirmed the findings above on 01/25/2023 around 02:00 pm. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES -- 2 of 3 -- CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of the laboratory's personnel competency records, lack of documentation, and interview with the risk quality management manager, the technical consultant failed to evaluate the competency assessment of 6 of 6 testing personnel (TP) that performed potassium hydroxide (KOH) and wet mount microscopic examinations in 2021 and 2022. Findings include: 1. On the day of survey, 01/25/2023 at 10:16 am, the laboratory could not provide documentation of the competency assessments for 6 of 6 TP (CMS 209 personnel # 2, 3, 4, 10, 11, 12) that perfomed KOH and wet mount microscopic examinations in 2021 and 2022. 2. The risk quality management manager confirmed the finding above on 01/25/2023 around 02:00 PM. -- 3 of 3 --

Summary Statement of Deficiencies 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: A. Based on review of the Laboratory's competency policy, competency assessment records and interview with the manager, the laboratory failed to establish a complete competency assessment procedure to assess the competency of 1 of 1 Technical Consultant (TC) (on the CMS 209 form, listed as personnel #2) for their supervisory responsibilities in 2018, 2019 and 2020. Findings include: 1. On the day of survey, 11 /25/2020, the manager could not provide a complete competency assessment policy that reviews how to assess the competency for 1 of 1 TC for their supervisory responsibilities in 2018, 2019 and 2020. 2. The manager confirmed the finding above on 11/25/2020 around 10:15 a.m. B. Based on review of competency assessment records and interview with the manager, the laboratory failed to perform competency assessments for 1 of 1 Testing Personnel (TP) (on the CMS 209 form, listed as personnel #2) who performed Potassium hydroxide (KOH) and wet mount microscopic examinations in 2018, 2019 and 2020. Findings include: 1. On the day of survey, 11/25/2020, the manager could not provide competency assessment records for 1 of 1 TP who performed KOH and wet mount microscopic examinations in 2018, 2019 and 2020. 2. The manager confirmed the finding above on 11/25/2020 around 10: 15 a.m. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an 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 -- ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of Quality Assessment (QA) records and interview with the manager, the Laboratory failed to ensure QA programs were maintained and documented to ensure the quality of laboratory services provided in 2019 (01/01/2019 to 12/31/2019). Findings Include: 1. On the day of survey, 11/25/2020, the manager could not provide QA documentation for the periodic evaluation of the laboratory's pre-analytical, analytical, and post-analytical processes in 2019 (01/01/2019 to 12/31 /2019). 2. The manager confirmed the findings above on 11/25/2020 at 12:10 p.m. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on observation of the laboratory and interview with the manager, the laboratory failed to ensure the maintenance/function for 1 of 1 thermometer used to monitor the temperature of the laboratory refrigerator where the Rhesus (Rh) testing controls were store in 2018, 2019 and 2020. Findings Include: 1. On the day of survey, 11/25/2020, the surveyor observed 1 of 1 refrigerator thermometer in use to monitor the temperatures where the Rh testing controls were store in 2018, 2019, and 2020. 2. The laboratory could not provide documentation of maintenance/function checks performed on the thermometer in 2018, 2019 and 2020. 3. The laboratory could not provide a maintenance/function policy for the thermometer. 4. The manager confirmed the findings above on 11/25/2020 at 12:15 p.m. D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on review of Medical Laboratory Evaluation (MLE) proficiency testing (PT) records and interview with the manager, the Technical Consultant (TC) failed to evaluate the test performance of 1 of 4 testing personnel (TP) through internal blind testing samples or external PT samples for Rhesus (Rh) D factor assay examinations performed in 2018, 2019 and 2020. Findings Include: 1. On the day of survey, 11/25 /2020, review of MLE PT records revealed, 1 of 4 TP (TP#3) did not perform in external PT samples for Rh D factor assay examinations for 3 of 3 events in 2018, 3 of 3 events in 2019, and 3 of 3 events in 2020. 2. The manager could not provide -- 2 of 3 -- documentation of internal blind testing evaluations performed for 1 of 4 TP (TP# 3) for Rh D assay examinations performed in 2018, 2019 and 2020. 3. The manager confirmed the findings above on 11/25/2020 at 10:49 a.m. -- 3 of 3 --

Summary Statement of Deficiencies 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 of review of laboratory's procedure manuals and interview with the Center Manager and Director of Health Center Operations , the laboratory failed to establish policies and procedures to assess the competency of Technical consultant (TC) delegated regulatory responsibilities from 2017 to the date of survey. Findings include: 1. On the date of survey, 06/13/2018, the laboratory could not provide a competency assessment procedure that included how to assess a TC delegated regulatory responsibilities. 2. The Center Manager and Director of Health Center Operations confirmed the findings on 06/13/2018 around 11:45 AM. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on laboratory testing personnel competency records review and interview with the Center Manager and Director of Health Center Operations, the technical consultant (Laboratory Director) failed to evaluate the competency assessment of all (6 of 6) Testing personnel (TP) in 2017 for KOH, Wet Prep and RH typing. Findings 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 -- include: 1. On the day of survey (06/13/2018) the laboratory could not provide documentation of all (6 of 6) TP 2017 Competency assessments records for KOH, Wet Prep and RH typing. 2. 1483 patients specimen were performed in 2017. 3. The Center Manager and Director of Health Center Operations confirmed the findings above on 06/13/2018 around 01:00 PM. 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: Based on review of the CLIA ' s Laboratory Personnel Report (Form CMS-209), review of personnel qualification records, and interview with the Center Manager and Director of Health Center Operations, the laboratory failed to ensure that each individual performing Moderate level Complexity testing is qualified. Refer to 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 review of the CLIA' s Laboratory Personnel Report (Form CMS-209), review of personnel qualification records, and interview with the Center Manager and Director of Health Center Operations, the laboratory failed to ensure that each individual performing Moderate level Complexity testing is qualified. Findings Include: 1. On the day of survey, 06/13/2018 the laboratory could not provide acceptable personnel credentials for testing personnel #2 and #4. 2. 1483 patient specimen were tests were performed in 2017. 3. The Center Manager and Director of Health Center Operations confirmed the findings above on 06/13/2018 around 11:30 am. -- 2 of 2 --