Planned Parenthood Of Michigan

Summary Statement of Deficiencies 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 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 record review and interview with the Director of Quality and Director of Risk and Compliance, the laboratory failed to maintain records of proficiency testing attestation statements showing proficiency testing samples were tested in the same manner as patient samples for 5 (2022 events 1 and 2, 2023 events 1, 2, and 3) of 6 testing events reviewed. Findings include: 1. A review of the laboratory's "Proficiency" policy revealed a section stating, "Health Center Manager receives test event samples. To coordinate testing HCM must: a. Monitor to ensure that scheduled shipments have arrived. b. Notify the Director of QRC if the samples have not been received with 5 days of the expected ship date. c. Notify DPCO and Directors of QRC if material is incomplete or damaged. d. Ensure that samples are stored in the refrigerator until testing begins. e. Complete of the API Proficiency Testing (PT) survey. f. Assign competent staff to complete PT event testing. g. Ensure that the samples are tested within the laboratory ' s regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory ' s routine methods. Document the testing of PT samples on the Lab Log. The personnel 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 5 -- the samples and the Laboratory Director must be able attest to the routine integration of the samples into the patient workload using the laboratory ' s routine methods." 2. A review of the laboratory's proficiency testing records revealed a lack of signed attestation statement for 2022 events 1 and 2, 2023 events 1, 2, and 3. 3. An interview on 3/11/24 at 1:42 pm with the Director of Quality and Director of Risk and Compliance confirmed the laboratory did not maintain a signed attestation statement for 2022 events 1 and 2 and 2023 events 1, 2, and 3. 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 record review and interviews, it was determined the laboratory failed to successfully participate in a CMS-approved proficiency testing program for the immunohematology specialty analyte D (Rho) typing. Findings include: The laboratory failed to participate in 3 (2022 events 1 and 3, 2023 event 3) of 6 proficiency testing events. Refer to D2155. 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 record review and interview with the Director of Quality and Director of Risk and Compliance, the laboratory failed to participate in 3 (2022 events 1 and 3, -- 2 of 5 -- 2023 event 3) of 6 proficiency testing events reviewed. Findings include: 1. A review of the laboratory's American Proficiency Institute (API) Proficiency Testing records revealed proficiency testing results were not reported to API for 2022 events 1 and 3, 2023 event 3 for the immunohematology specialty analyte D (Rho) typing. 2. A review of the laboratory's "Proficiency" policies revealed a section stating, "The Director Quality and Director of Risk and Compliance work with API to enroll locations in annual PT test events and ensure samples are sent to PPMI laboratories. The Director of Quality also monitors results received from laboratories, ensures results are entered into API and collaborates with Laboratory Director for any testing or proficiency concerns." and "Health Center Manager receives test event samples. To coordinate testing HCM must: a. Monitor to ensure that scheduled shipments have arrived. b. Notify the Director of QRC if the samples have not been received with 5 days of the expected ship date. c. Notify DPCO and Directors of QRC if material is incomplete or damaged. d. Ensure that samples are stored in the refrigerator until testing begins. e. Complete of the API Proficiency Testing (PT) survey. f. Assign competent staff to complete PT event testing. g. Ensure that the samples are tested within the laboratory ' s regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory ' s routine methods. Document the testing of PT samples on the Lab Log. The personnel testing the samples and the Laboratory Director must be able attest to the routine integration of the samples into the patient workload using the laboratory ' s routine methods. h. Ensure that tests will be performed without consultation from any personnel. i. Review the results with the person who performed the proficiency test. j. Ensure that results are entered into the API website by the deadline. k. The HCM, testing personnel and Lab Director must sign the completed Result form and Comparative Evaluation. l. All paperwork from API must be saved this includes shipping labels, kit folder, result form, attestation statement, comparative evaluation, proficiency testing performance evaluation and performance summary. Annual API Certificate. m. External proficiency test results will be maintained and kept with the records from the same calendar year." 3. An interview on 3/11/24 at 2:37 pm with the Director of Quality and Director of Risk and Compliance confirmed the laboratory had not participated in 2022 events 1 and 3, 2023 event 3 for the immunohematology specialty analyte D (Rho) typing. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview with the Director of Quality, the laboratory failed to follow written policies to ensure positive identification of 2 of 2 urine specimens observed. Findings include: 1. The surveyor observed two urine specimens in the laboratory on 3/11/24 at 1:05 pm labeled with initials and dates of birth. 2. A review of the laboratory's "Urine Test" policy revealed a section stating, "Label empty urine cup with 2 identifiers (ie. name and dob, no initials), date and time." 3. An interview on 3/11/24 at 1:09 pm with the Director of Quality confirmed the urine cups were labeled only with the initials and dates of birth. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR -- 3 of 5 -- 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 record review and interviews, the Laboratory Director failed to ensure proficiency testing samples were tested in the same manner as patients (refer to D6016), failed to ensure the laboratory reported proficiency testing results to the proficiency testing program (refer to D6017), failed to ensure proficiency testing reports received were reviewed by staff to identify problems requiring

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 record review and interview with the Director of Quality, the laboratory failed to follow its competency procedure to assess testing personnel competency for 1 (Testing Personnel #13) of 28 testing personnel listed on Form CMS-209. Findings include: 1. A review of the laboratory's "Competency" procedure revealed a section stating, "Staff who will conduct Rh testing, using the Eldon Card, undergo face to face training, which includes monitoring of patient preparation, specimen handling, and interpretation. In addition, PPMI purchases blood from a vendor in order to do blind blood samples to test staff competency. Staff are observed by the Laboratory Director or a Technical Consultant, and the Rh Training Checklist 143A is signed to show that competency was demonstrated." 2. A review of testing personnel competency assessments revealed the competency assessment dated 4/1/22 for Testing Personnel #13 was not signed by the Laboratory Director or the Technical Consultant to show competency was demonstrated for the performance of Rh testing. 3. An interview on 6 /23/22 at 11:19 am with the Director of Quality confirmed Testing Personnel #13 did not have their competency assessment signed by the Laboratory Director or the Technical Consultant to show competency was demonstrated for the performance of Rh 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 1 --

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 record review and interview with the Director of Quality, Risk and Compliance, the laboratory failed to monitor and document the room temperature and refrigerator each day of clinic operation for 4 (Ann Arbor, Marquette, Petoskey, and Traverse City) of 5 locations reviewed for 2 years (February 2019 to February 2021). Findings include: 1. A review of the laboratory's "Controls" procedure revealed the lack of a policy for the monitoring of laboratory room temperature and a disconnect between the "Vaccine Refrigerator Temperature Log" and the "Non-Vaccine Refrigerator Temperature Log" for documenting room temperature. 2. A record review of the laboratory's temperature monitoring log "Vaccine Refrigerator Temperature Log" and "Non-Vaccine Refrigerator Temperature Log - 2020" revealed for 4 (Ann Arbor, Marquette, Petoskey, and Traverse City) of 5 locations a lack of documentation of the room temperature and/or refrigerator on the days as follow: a. Ann Arbor 1. Room temperature - 11/6/2019, 1/8/2020, 10/20/2020, and 1/15/2021 2. Refrigerator + room temperature - 7/12/2019 and 2/2/2021 b. Marquette 1. Room temperature - 12/5/2019 2. Refrigerator - 4/13/2020 3. Refrigerator + room temperature - 9/19/2019 and 7/19/2019 c. Petoskey 1. Room temperature - 3/2/2020 2. Refrigerator - 7/9/2020 d. Traverse City 1. Room temperature - 2/6/2019, 7/31/2019, and 9/11/2019 3. A interview on 2/18/2021 at approximately 4:00 pm, the Director of 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 -- Quality, Risk and Compliance confirmed the laboratory did not record the laboratory room temperature and refrigerator each day of clinic operation. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on record review and interview with the Director of Quality, Risk and Compliance, the laboratory failed to ensure the immunohematology Rh quality control was performed and documented before patient testing for 4 (chart #1 - #4) of 9 patient charts reviewed for the Traverse City location. Findings include: 1. A record review for 4 (chart #1 - #4) of 9 patient charts reviewed revealed the laboratory did not perform and document the immunohematology Rh quality control before patient testing as follows: a. chart #1 on 2/6/2019 b. chart #2 on 2/19/2020 c. chart #3 on 7/31 /2019 d. chart #4 on 9/11/2019 2. When queried on 2/10/2021 via email, the Director of Quality, Risk and Compliance returned an email on 2/13/2021 at 1:38 pm revealed "it looks like they weren't doing it right at that time." 3. During the exit interview on 2 /18/2021 at approximately 4:00 pm, the Director of Quality, Risk and Compliance confirmed the location was testing the controls but did not document on the "Rh Lab Log." 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 record review and interview with the Director of Quality, Risk and Compliance, the Technical Consultant failed to evaluate the competency of testing personnel performing the immunohematology Rh testing for 2 (Testing Personnel [TP] #14 and #16) of 21 TP listed on a spreadsheet provided by Planned Parenthood of Michigan. Findings include: 1. A review of records received on 2/10/2021 at 1:48 pm labeled "Rh Competencies 2019-2021" revealed lack of documentation of competency assessments for 2 (TP #14 and #16) of 21 TP listed on a spreadsheet as follows: a. TP #14 - no 2020 annual assessment b. TP #16 - no semi-annual assessment from 2020 2. An interview on 2/18/2021 at approximately 4:00 pm, the Director of Quality, Risk and Compliance stated "she felt all competencies had been completed." D6063 LABORATORY TESTING PERSONNEL -- 2 of 3 -- 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 record review and interview with the Director of Quality, Risk, and Compliance, the laboratory failed to ensure the testing personnel met the qualification requirements at 493.1423. Findings include: 1. The laboratory failed to ensure testing personnel were qualified to perform moderately complex immunohematology Rh testing. 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 a review of records and lack of documentation provided by the Director of Quality, Risk and Compliance, the laboratory failed to ensure testing personnel were qualified to perform moderately complex immunohematology Rh testing for 1 (Testing Personnel (TP) #4) of 9 testing personnel listed on the laboratory's CMS-209 form for the Ann Arbor location. Findings include: 1. The surveyor requested qualification credentials and documentation for all staff listed on the CMS-209 for each location (Ann Arbor, Marquette, Traverse City, Petoskey, and Warren) showing they were qualified for moderately complex immunnohematology Rh testing on 2/03 /2021 at approximately 10:30 am. 2. A record review of personnel records submitted to the surveyor from the Director of Quality, Risk and Compliance on 2/09/2021 at approximately 3:35 pm revealed lack of documentation of the US Equivalency for 1 (TP #4) of 9 TP at the Ann Arbor location. 3. The laboratory was provided 7 days to supply documentation and it was not made available to the surveyor. 4. An email conversation with the Director of Quality, Risk and Compliance on 2/16/2021 at 1:00 pm, the surveyor informed the Director that the documentation presented was a translation and not a US Equivalency. -- 3 of 3 --

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: . Grand Rapids and Lansing locations Based on record review and interview, the laboratory failed to test the immunohematology proficiency testing (PT) samples for five (3rd event 2016, 1st-3rd events 2017, and 1st event 2018) of five events reviewed in the same manner as patient samples. Findings include: 1. On June 5, 2018 at 12:15 PM and 1:45 PM, record review of the final graded American Proficiency Institute (API) proficiency testing reports for five (3rd event 2016, 1st-3rd events 2017, and 1st event 2018) of five events reviewed the laboratory did not document the proficiency testing samples on the "AB Services Rh Laboratory Log" for the Grand Rapids and Lansing sites. 2. On June 5, 2018 at 12:15 PM and at 6:40 PM when queried, the Regional Patient Services Manager and the Regional Director of Patient Services were not able to provide documentation to show the PT samples were tested in the same manner as patient samples. 3. During the interview on June 5, 2018 at 12:15 PM and 6: 40 PM, the Regional Patient Services Manager and the Regional Director of Patient Services confirmed the PT samples were not recorded on the "AB Services Rh Laboratory Log" for the Grand Rapids and Lansing sites. D2010 TESTING OF PROFICIENCY TESTING SAMPLES 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 -- CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: . Traverse City Location Based on record review and interview, the laboratory failed to test the immunohematology proficiency testing samples the same number of times that it routinely tests patient samples for one (1st event 2018) of five events reviewed. Findings include: 1. On June 5, 2018 at 1:23 PM, record review of the American Proficiency Institute (API) proficiency testing reports revealed for one (1st event 2018) of five events reviewed, the testing personnel (TP) that signed the attestation statement sheet shows the specimens were run by multiple people for the same specimen on the same day of testing as follows: a. TP #1 - ran specimens #1, #3, and #5 b. TP #2 - ran specimens #2, #4, and #5 c. TP #3 - ran specimens #2, #3, and #4 2. During the interview on June 5, 2018 at 1:23 PM, the Regional Patient Services Manager confirmed the test samples were not run the same number of times that it routinely tests patient samples. ***Repeat Deficiency from August 2, 2012 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 record review and interview, the laboratory failed to ensure written competency policies were implemented for 19 (#34 - #48 and #50 - #53) of 76 testing personnel performing the moderately complex mycology, parasitology, and the microscopic urinary sediment testing for two years. Findings include: 1. On June 5, 2018 at 4:00 PM, record review of the competency evaluations revealed for 19 (#34 - #48 and #50 - #53) of 76 testing personnel the competency requirements from subpart M containing the six required categories were not included in the assessment for the mycology, parasitology, and microscopic urinary sediment testing as following: a. Direct observations of routine patient test performance, including patient preparation, specimen handling, processing, and testing. b. Monitoring the recording and reporting of patient test results. c. Review of test results, worksheets, quality control records, proficiency testing results, and preventive maintenance records. d. Direct observation of performance of instrument maintenance and function checks. e. Assessment of test performances through testing previously analyzed specimens, internal blind testing samples or external proficiency testing specimens. f. Assessment of problem solving skills. 2. On June 5, 2018 at 4:00 PM when queried, the Regional Director of Patient Services was not able to provide the surveyor with the annual competency evaluations with the six requirements for 19 (#34 - #48 and #50 - #53) of 76 testing personnel in 2016 and 2017. 3. During the interview on June 5, 2018 at 4:00 PM, the Regional Director of Patient Services confirmed the annual competencies did not contain the required categories. ***Repeat Deficiency from May 4, 2016 survey*** -- 2 of 2 --