Planned Parenthood Of Montana

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on record review, product inserts, and interview with testing personnel TP #4, the laboratory failed to follow the manufacturer's instructions to perform external quality controls at the frequency required by Syphilis Health Check from May 21, 2022, to May 23, 2024, for four out of four testing locations. Findings: 1. A review of quality control records for syphilis testing revealed laboratory staff failed to perform and document the external positive and negative QC monthly per the Syphilis Health Check product insert for four out of four testing locations from May 21, 2022, to May 23, 2024. 2. Based on the test volume sheet, 1713 syphilis patient tests were performed from May 2023 to May 2024 (12 months). 3. An interview with TP #4 on May 23, 2024 at 11:30 AM, confirmed laboratory staff were not performing external QC monthly per the Syphilis Health Check product insert from May 21, 2022, to May 23, 2024. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or 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 -- baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on observation, review of maintenance documentation, product inserts, procedure manual, and interview with the Clinical Operations Coordinator (not listed on the CMS 209 form), the laboratory failed to establish and follow a procedure for performing function checks on each piece of equipment, including timers involved in patient testing, from May 21, 2022, to May 23, 2024. Findings: 1. Observed timers in the laboratory on May 21, 2024, at 11:00 AM at the Billings, MT location and on May 23, 2024, at 10:45 AM at the Helena, MT location. 2. A review of product inserts for EldonCard RhD, Syphilis Health Check, Alere hCG Cassette, and OraQuick Advance Rapid HIV-1/2 Antibody Test revealed testing steps with time constraints. 3. A review of maintenance documentation revealed the laboratory failed to perform and document function checks for their timers. 4. A review of laboratory procedures revealed the laboratory failed to establish a procedure that defines the function checks on each piece of equipment, including timers that are peripherally involved in patient testing. 5. An interview with the Clinical Operations Coordinator (not listed on the CMS 209 form) on May 21, 2024, at 11:40 AM confirmed the laboratory failed to perform function checks on their timers from May 21, 2022, to May 23, 2024. D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) 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)(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; This STANDARD is not met as evidenced by: Based on a review of laboratory policies and an interview with the testing personnel (TP) #4, the laboratory director failed to ensure that an approved policy manual was available to all personnel responsible for any aspect of the testing process from May 21, 2022, to May 23, 2024. Findings: 1. No policy manual signed by the laboratory director listed on the CMS-209 form was available for review at the Helena location on May 23, 2024. 2. An interview with TP #4 on May 23, 2024, at 11:35 AM confirmed the lack of an onsite policy manual approved by the laboratory director from May 21, 2022, to May 13, 2024. -- 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 a record review and an interview with the testing personnel (TP) #1, the laboratory failed to establish procedures and perform annual competency assessment for the position of technical consultant listed on the CLIA CMS-209 Personnel Report form. Findings: 1. A record review of the CMS-209 Personnel Report Form revealed one out of one technical consultant listed failed to have competency assessment performed for 2021 and 2022 2. A record review of the laboratory's procedure manual revealed the laboratory failed to have a policy or procedure to assess the technical consultant position. 3. An interview on September 20, 2022, at 11:30 AM, confirmed the laboratory failed to establish a policy or procedure and perform competency for the positions of technical consultant listed on the CMS-209 Personnel Report form. 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. 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 with testing personnel (TP) #1, the laboratory failed to perform external quality controls (QC) for Syphilis Health Check at the frequency required by the manufacture's instruction from February 1, 2022, through April 6, 2022. Findings: 1. Review of Diagnostics Direct, LLC product insert for Syphilis Health Check revealed external controls (positive and negative) should be tested with each new lot, new shipment, each new operator, monthly as a continued check on storage conditions and whenever problems are identified. 2. Review of procedure, "Section III: Laboratory Logbooks and Records" revealed, "F. Quality Control test and results will be performed and documented per the manufacturer's instructions. The results will be entered into the Laboratory Control logs." 3. A review of Syphilis Laboratory Control logs revealed: Great Falls location lacked external QC for April, June, and August of 2022 Missoula location lacked external QC for May and August of 2022. Helena location lacked external QC for March, May, June, and August of 2022. 4. Interview with TP#1 on September 20, 2022, at 2:30 PM, confirmed the laboratory failed to routinely perform external QC for the Syphilis test per manufacturer's instructions. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Based on an on-site recertification survey conducted on 6/5/18-6/12/18, condition level deficiencies were cited for Planned Parenthood of Montana in Missoula, MT. 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 record review and interview, the laboratory failed to perform positive and negative controls every day of patient testing for 14 days between 3/1/17 and 12/31 /17. The findings include: 1. A review on 6/5/18 at 3:30 p.m. of the Planned Parenthood Laboratory Manual included to review the analyte quality control (QC) form for "evidence of documentation of QC testing for each analyte performed on Form with regular review and evaluation of all QC results." 2. A review on 6/5/18 at 3: 50 p.m. of the RH EldonCard Laboratory Log and list of days with charges for Rh testing included 12 days of patient results without quality control documented. a. 7/12 /17, 7/16/17, 7/26/17, 8/1/17, 8/2/17, 8/8/17, 8/9/17, 8/15/17, 8/22/17, 8/23/17, 8/29 /17, and 8/30/17. 3. On 6/5/18 at 4:30 p.m., staff member A stated the control results were not located in the archived files. 4. A review on 6/12/18 at 2:15 p.m. of the RH EldonCard Laboratory Log included results for patients on 10/11/17 and 12/27/17 without documented quality control results. 5. On 6/12/18 at 2:15 p.m., staff member B stated controls may be performed on a previous day when the clinic is not busy. D5805 TEST REPORT CFR(s): 493.1291(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 3 -- 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 record review and interview, the laboratory failed to indicate the address of the laboratory where the test was performed on four of four test reports reviewed. The findings include: 1. A review on 6/5/18 at 3:20 p.m. of two test reports lacked the address of the laboratory where the test was performed. 2. On 6/5/18 at 3:20 p.m., staff member A stated the reports did not have the address. 3. A review on 6/5/18 at 3: 30 p.m. of the Planned Parenthood Laboratory Manual included the test report "will include name and address of the lab actually performing the tests." 4. A review on 6/12 /18 at 2:30 p.m. of two additional test reports lacked the address of the laboratory where the test was performed. 5. On 6/12/18 at 2:30 p.m., staff member A stated the request is submitted to the company to add the address. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory failed to have a qualified technical consultant resulting in the laboratory's lack of technical oversight from 6/21 /17 to 6/5/18. See D6035. D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (b)(2)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the -- 2 of 3 -- technical consultant in hematology); or (b)(3)(i) Hold an earned doctoral or master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (b)(3)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. Note: The technical consultant requirements for "laboratory training or experience, or both" in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service, excluding waived tests. For example, an individual who has a bachelor's degree in biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to have a qualified technical consultant from 6/21/17 to 6/5/18. The findings include: 1. A review on 6/5 /18 at 2:35 p.m. of the CMS-209 form filled out by the facility failed to list a technical consultant. 2. On 6/5/18 at 2:45 p.m., staff member A stated the laboratory director does not qualify as the technical consultant but another provider may qualify as technical consultant. 3. A review on 6/5/18 at 3:30 p.m. of the Planned Parenthood Laboratory Manual included under the laboratory director responsibilities that the "lab director must employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities described by CLIA." 4. On 6/5/18 at 5:00 p.m., staff member A stated the other provider was working on updating the resume for qualifying as technical consultant. 5. On 6/12/18 at 2:35 p.m., staff member A stated the provider had not completed the resume and had not provided information on qualifying for technical supervisor. 6. A review on 6/12/18 at 2:35 p.m. of the CMS- 209 form did not list any other staff as technical supervisor. Qualifications of the providers trying to qualify as technical consultant were not provided. -- 3 of 3 --