Planned Parenthood Sepa

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 on a lack of the laboratory's competency assessment records and interview with the Center Manager (CM) and Office Director (OD), the laboratory failed to establish a competency assessment procedure to assess and follow the competency of 3 of 3 Technical Consultant (TC) for their supervisory responsibilities performed in 2022 and 2023. Findings include: 1. On the day of survey, 01/03/2024, at 11:45 am, the laboratory failed to provide a competency assessment procedure to assess 3 of 3 TC for their supervisory responsibilities. 2. The laboratory could not provide competency assessment records for the 3 of 3 TC (CMS 209 personnel #2, #3, #4) for their supervisory responsibilities performed in 2022 and 2023. 3. The CM and OD confirmed the findings above on 01/03/2024 at 01:00 pm. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of laboratory's competency assessment records and interview with the Center Manager (CM) and Office Director (OD), the Technical Consultant (TC) 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 -- #3 (CMS 209) failed to evaluate the competency assessment for 1 of 2 Testing Personnel (TP) who performed moderate complexity testing in mycology and parasitology in 2022. Findings include: 1. On the day of the survey, 01/03/2024 at 11: 30 am, a review of laboratory's competency records revealed that the laboratory failed to perform a competency assessment for 1 of 2 TP (CMS 209 TP #1) who performed Potassium hydroxide and wet mount testing in 2022. 2. The laboratory performed 186 Mycology and Parasitology tests in 2022 (per CMS 116 total estimated annual test volume). 3. The CM and OD confirmed the findings above on 01/03/2024 at 01:00 pm. -- 2 of 2 --

Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on the review of Medical Laboratory Evaluation (MLE) proficiency testing (PT) records and interview with the Laboratory Manager (LM), the Laboratory failed to provide 6 of 6 MLE PT attestation statement documents for Potassium Hydroxide (KOH) and wet mounts microscopic examinations for 2020, 2021 and 2022. Findings include: 1. On the day of survey, 05/19/2022 at 10:45am, the LM could not provide the following 6 of 6 attestation statements for KOH and wet mounts: 2020 = Event 2 and Event 3 2021 = Event 1, Event 2 and Event 3 2022 = Event 1 2. The LM comfirmed the findings above on 5/19/2022 at 12:30 pm. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of American Association of Bioanalysts (AAB) proficiency test (PT) records and interview with the Laboratory Manager (LM) on the date of the survey 05 /20/2022, the Laboratory Director (LD) failed to ensure that all proficiency 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 2 -- attestations were signed by appropriate staff for Rhesus factor (Rh) in 2021. Findings include: 1. On the day of survey 5/19/2022 at 10:46am, the Laboratory Director failed to sign the AAB Event 1 and Event 2 2021 proficiency attestations. 2. Interview with Laboratory Manager on 5/19/2022 at 12:35pm, confirmed this finding above. 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 review of competency assessment records and interview with Laboratory Manager (LM), the Technical Consultant (TC) failed to provide seperate competency records for 3 of 3 testing personnel (TP) who performed potassium hydroxide (KOH) and wet mounts microscopic examinations for 2020 and 2021. Findings include: 1. On the day of survey 5/19/2022 at 10:25am, the Technical Consultant (TC) failed to provide seperate competency records for KOH and Wet mount procedures for 2 of 3 TP (CMS 209 personnel # 6 and # 8) for 2020 and 2021. 2. The laboratory could not provide competency records for 1 orf 3 TP (CMS 209 personnel # 7 ) who performed KOH and wet mounts in 2021. 3. Interview with Laboratory Manager on 5/19/2022 at 12:20pm, confirmed the findings above. -- 2 of 2 --

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 on review of laboratory procedure manuals and interview with the center manager, the laboratory failed to establish a procedure to assess the competency of 1 of 1 technical consultant (TC) from 2017 and 2019. Findings Include: 1. On the day of survey, 12/09/2019, the laboratory failed to provide a written policy to assess the competency of 1 of 1 TC from 11/08/2017 to 12/09/2019. 2. The center manager confirmed the finding above on 12/09/2019 around 09:55 am. 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 in-house evaluation process for KOH and wet mount examination records and interview with center manager, the laboratory failed perform at least twice annually the accuracy of KOH and wet mount examinations from 2018 to the date of survey. Findings Include: 1. On the day of survey, 12/09 /2019, review of the laboratory's in-house evaluation process for KOH and wet mount examination records revealed, the laboratory did not perform KOH and wet mount evaluations at least twice annually for accuracy in 2018 and 2019. 2. The laboratory 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 -- only provided evaluation records performed for KOH and wet mount examinations, once in 2018 and once in 2019. 3. The center manager confirmed the findings above on 12/09/2019 around 10:25 am. ****KOH= Potassium Hydroxide D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an 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 the laboratory's procedure manuals and interview with the center manager, the laboratory failed to establish written policy to assess the quality of its laboratory systems from 11/08/2019 to the day of survey. Findings Include: 1. On the day of survey, 12/09/2019, review of laboratory manuals revealed, the laboratory did not have a written policy to assess the quality of its laboratory pre-analytical, analytical and post-analytical systems for Rh D typing, KOH and wet preps examination from 11/08/2019 to 12/09/2019. 2. The center manager confirmed the finding above on 12/09/2019 around 11:15 am. ****KOH= Potassium Hydroxide 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 the review of patient test reports and interview with the center manager, the laboratory failed to include on test reports (3 of 3 reviewed) the interpretation of Rh D typing, KOH and Wet prep examination results from 11/08/2017 to the day of survey. Finding Include: 1. On the day of survey, 12/09/2019, a review of some test reports (3 of 3) revealed the test reports did not include the interpretation for Rh D typing, KOH and Wet prep examinations results from 11/08/2017 to 12/09/2019. 2. The center manger confirmed the finding above on 12/09/2019 around 11:00 am. ****KOH= Potassium Hydroxide 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. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on review of laboratory testing personnel competency records and interview with the center manager, the technical consultant (Laboratory Director) failed to evaluate the competency of 1 of 1 Testing personnel (TP) performing KOH and Wet Prep examinations in 2018 and 2019. Findings Include: 1. On the day of survey, 12/09 /2019, the laboratory could not provide competency assessment documentation for 1 of 1 TP who performed KOH and Wet Prep testing in 2018 and 2019. 2. The center manager confirmed the finding above on 12/09/2019 around 10:45 am. ****KOH= Potassium Hydroxide 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 testing personnel (TP) records, the American Association Proficiency Institute (API) 2018 and 2019 proficiency testing (PT) attestation sheets and interview with the center manager, the technical consultant (TC) failed to assess the competency of 1 of 3 TP through internal blind testing samples or external PT for immunohematology Rh D typing in 2018. Findings Include: 1. On the day of survey, 12/09/2019, review of TP records and API PT attestation sheets revealed, the laboratory did not assess the test performance of 1 of 3 TP (#3) for immunohematology Rh D typing samples or internal blind testing samples in 2018. 2. The center manager confirmed the finding above on 12/09/2019 around 10:42 am. -- 3 of 3 --

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 a review of the CASPER Report 155 and performance evaluations from the proficiency testing organization American Association of Bioanalysts (AAB), the laboratory failed to successfully participate in a proficiency testing program approved by CMS for the analyte: D (RHO) which is of the specialty Immunohematology. The laboratory had unsatisfactory scores for the 3rd event of 2017and the 2nd event of 2018. See D2162. D2162 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(f) 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 -- Failure to achieve satisfactory performance for the same analyte in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the CASPER Report 0155D and performance evaluations from the proficiency testing organization American Association of Bioanalysts (AAB), the laboratory failed to successfully participate in a proficiency testing program approved by CMS for the anayte: D(RHO) which is in the specialty of Immunohematology in which the laboratory is certified under CLIA. The laboratory had unsatisfactory scores for the 2nd event of 2017 and 2nd event of 2018 for the analyte listed above. Findings include: 1. AAB 2017 Event 2 for D (RHO), the score was 0%. 2. AAB 2018 Event 2 for D (RHO), the score was 0%. -- 2 of 2 --