Planned Parenthood Great Plains

Summary Statement of Deficiencies D0000 The recertification survey was performed on 01/24/2022. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the center manager and director of abortion and surgical services at the conclusion of the survey. 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 a review of records and interview with the center manager, the testing person (s) failed to sign proficiency testing attestation statements for two of seven events. Findings include: (1) The surveyor reviewed 2019 (third event), 2020 (first, second, and third events), and 2021 (first, second, and third events) proficiency testing records and identified the following for two of seven events: (a) Third 2019 Immunohematology Event - The attestation statement had not been signed by the person performing the test; (b) First 2021 Immunohematology Event - The attestation statement had not been signed by the person performing the test. (2) The surveyor 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 -- reviewed the findings with the center manager who stated on 01/24/2022 at 10:10 am, the attestation statements had not been signed by the person(s) performing the test as shown above. 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 review of records, written policy, and interview with the center manager, the laboratory failed to have a written technical consultant competency policy based on the position responsibilities as listed in Subpart M. Findings include: (1) On 01/24 /2022, the surveyor reviewed the competency assessment policy. It did not include guidance for assessing the competency of the technical consultant, including the frequency for the assessments; (2) The surveyor then reviewed personnel records for competency assessments performed during 2019, 2020, 2021, and to date in 2022. There was no evidence of competencies performed for the technical consultant based on job responsibilities; (3) The surveyor asked the center manager if a written policy to evaluate the technical consultant based on job responsibilities was available and if competencies had been performed. The center manager stated on 01/24/2022 at 11:05 am, a policy had not been written and the above competencies had not been performed. NOTE: D5209 was cited on the previous recertification survey performed on 09/26/2019. 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 a review of the procedure manual and interview with the center manager, the laboratory failed to ensure written policies and procedures had been approved, signed, and dated by the laboratory director. Findings include: (1) On 01/24/2022 at 09:35, the center manager stated to the surveyor the following testing was performed in the laboratory: (a) Wet Prep Analysis as a PPM (Provider Performed Microscopy) procedure (b) Rh testing using Eldon Cards (2) The survey reviewed the manual titled, "Lab Manual", which contained written policies and procedures. There was no indication the manual had been approved, signed, and dated by the laboratory director; (3) The surveyor showed the manual to the center manager who stated on 01/24/2022 at 12:15 pm, the manual contained the policies and procedures and had not been signed and dated by the laboratory director. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have -- 2 of 3 -- deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on a review of records and interview with the center manager, the laboratory failed to ensure reagents had not exceeded their expiration date for one of 13 months reviewed. Findings include: (1) On 01/24/2022 at 09:35, the center manager stated the following to the surveyor: (a) The laboratory performed Rh testing using Eldon Cards; (b) QC (Quality Control) testing was performed each day of patient testing using Panoscreen Reagent Red Blood Cells (level I was used as the positive control and level III was used as the negative control). (2) The surveyor reviewed QC and patient testing records from 01/04/2021 through 01/21/2022 and identified expired QC material had been used during one of the 13 months reviewed: (a) Panoscreen Reagent Red Blood Cells level I and level III, lot #31491 had an expiration date of 10/08/2021; (b) The QC had been used to determine acceptability of patient testing on 10/11,12 /2021. (3) The surveyor reviewed the records with the center manager who stated on 01/24/2022 at 12:20 pm the documentation on the logs showed that expired QC had been used as stated above. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database. 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 desk review of proficiency testing scores, the laboratory failed to successfully participate in a proficiency testing program for the subspecialty of ABO Group and D (Rho) Typing. Findings include: (1) The laboratory failed to achieve satisfactory performance for two of three testing events for D (Rho) Typing. Refer to D2160 and D2162. 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 -- D2160 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(e) (1) For any unsatisfactory testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or unsatisfactory testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores, the laboratory failed to achieve successful performance for D (Rho) Typing. Findings include: (1) The laboratory failed to achieve satisfactory performance on the First 2020 Event and the Third 2020 Event. Refer to D2162. NOTE: The only acceptable

Summary Statement of Deficiencies D0000 A recertification survey was performed on 09/26/19. The findings were reviewed with the health center manager at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. 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 a review of records and interview with the health center manager, the laboratory director failed to sign proficiency testing attestation statements. Findings include: (1) During the survey, the surveyor reviewed 2018 and 2019 proficiency testing records and identified the following for 6 of 9 events: (a) First 2018 Hematology Event - The attestation statement had not been signed by the laboratory director; (b) Second 2018 Hematology Event - The attestation statement had not been signed by the laboratory director; (c) Third 2018 Hematology Event - The attestation statement had not been signed by the laboratory director; (d) First 2018 Immunohematology Event - The attestation statement had not been signed by the laboratory director; (e) Second 2018 Immunohematology Event - The attestation statement had not been signed by the laboratory director; (f) Third 2018 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 -- Immunohematology Event - The attestation statement had not been signed by the laboratory director. (2) The surveyor reviewed the findings with the health center manager, who stated the attestation statement had not been signed by the laboratory director or designee. 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 a review of records and interview with the health center manager, the laboratory failed to participate in a proficiency testing event for D (Rho) typing. Findings include: (1) During the survey, surveyor #1 reviewed proficiency testing records. The Performance Summary (generated by the proficiency testing program) verified the laboratory received 0% scores for D (Rho) typing on the first 2019 event due to a failure to participate; (2) Surveyor #1 asked the health center manager to explain the 0% score. The health center manager explained the following: (a) The health center manager stated the laboratory had discontinued D (Rho) typing between 07/24/18 and 08/05/19. However, the laboratory failed to notify the proficienty testing provider and the state agency as required. 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 review of records, written policy and interview with the health center manager, the laboratory failed to have a written technical consultant competency policy based on the job responsibilities as listed in Subpart M. Findings include: (1) At the beginning of the survey, the surveyor reviewed personnel records for competency assessments performed during 2018 and 2019. There was no evidence competencies had been performed for the technical consultant, based on their job responsibilities; (2) The surveyor asked the health center manager if a written policy to evaluate the technical consultant based on job responsibilities was available. The health center manager stated a policy to evaluate the technical consultant based on job responsibilities had not been written; and competencies had not been performed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The findings were reviewed with the medical director, regional director of health services and testing person #1 at the conclusion of the survey. 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 a review of records, observation and interview with the regional director of health services and testing person #1, the laboratory failed to follow the manufacturer's instructions for waived testing. Findings include: REFRIGERATOR TEMPERATURES (1) At the beginning of the survey, the regional director of health services and testing person #1 stated to the surveyors the following tests were performed: (a) Urine pregnancy testing using the Stanbio Labs cassettes (b) Hemoglobin testing using the Stanbio Hemocue Hb 201 analyzer (c) Urinalysis testing using the Urispec Plus analyzer (2) The surveyors observed the contents of the laboratory refrigerator. The following control materials were being stored in the refrigerator, with a manufacturer's storage requirement of 36-46 degrees F (Fahrenheit): (a) One box of Stanbio Hemoglobin Bi-Level Controls (lot# 171151) (b) One box of Standio hCG Bi-Level (positive and negative) Urine Controls (lot# 171571) (3) The surveyors requested temperature records from November 2016 through the day of the survey. The surveyors reviewed the records and identified that either daily monitoring of the refrigerator was not performed, or the documented temperatures were not within the manufacturer's required storage of 36-46 degrees F as follows: (a) December 2016 - temperatures not documented on days 14,15,16,19,20,21,22,23,27,28,30 (b) May 2017 - temperatures not documented on days 26,30; 6 of the 17 temperatures were documented as 34 degrees F (c) June 2017 - 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 -- 1 of 22 temperatures was documented at 50 degrees F (d) August 2017 - 3 of 22 temperatures were documented as 34 degrees F (e) November 2017 - 2 of 19 temperatures were documented as 34 degrees F; 3 of 19 temperatures were documented as 35 degrees F (f) December 2017 - 6 of 21 temperatures were documented as 35 degrees F (g) January 2018 - 3 of 21 temperatures were documented as 34 degrees F; 1 of 21 temperatures was documented as 35 degrees F; 2 of 21 temperatures was documented at 33 degrees F (4) The surveyors reviewed the findings with the regional director of health services and testing person #1. Both stated the refrigerator temperatures were not being monitored as indicated above and materials were not being stored at temperatures required by the manufacturer. ROOM TEMPERATURE (1) At the beginning of the survey, the regional director of health services and testing person #1 stated to the surveyors the following tests were performed and stored at room temperaturewith a manufacturer's storage requirement of 59 - 86 degrees F (Fahrenheit):: (a) Urine pregnancy testing using the Stanbio Labs cassettes (b) Hemoglobin testing using the Stanbio Hemocue Hb 201 analyzer (2) The surveyors requested temperature records from November 2016 through the day of the survey. The surveyors reviewed the records and identified daily monitoring of the room temperature was not documented as performed: (a) Between 11/18/2016 through 11/01/2017 (b) Between 11/05/17 through 12/01/2017 (3) The surveyors reviewed the findings with the regional director of health services and testing person #1. Both stated the room temperatures were not being monitored as indicated above. 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 a review of records and interview with the regional director of health services and testing person #1, the laboratory failed to maintain copies of proficiency testing records. Findings include: (1) At the beginning of the survey, surveyor #2 reviewed 2016 and 2017 proficiency testing records. The following was identified for 4 of 4 testing events: (a) Third 2016 Immunohematology Event (i) A copy of the proficiency testing report forms could not be located. (b) First 2017 Immunohematology Event (i) The attestation statement could not be located; (ii) A copy of the proficiency testing report forms could not be located. (c) Second 2017 Immunohematology Event (i) A copy of the proficiency testing report forms could not be located. (d) Second 2017 Immunohematology Event (i) A copy of the proficiency testing report forms could not be located. (e) Third 2017 Immunohematology Event (i) A copy of the proficiency testing report forms could not be located. (2) The findings were reviewed with the regional director of health services and testing person #1 who stated an attestation and copies of the proficiency testing reports could not be located. -- 2 of 5 -- 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 a review of records, and interview with the regional director of health services and testing person #1, the laboratory failed to verify the accuracy of Wet Prep testing at least twice annually. Findings include: (1) At the beginning of the survey, the regional director of health services and testing person #1 stated Wet Prep testing was performed as a PPM (Provider Performed Microscopy)Procedure; (2) Surveyor#2 reviewed 2016 and 2017 records. There were no records to indicate the accuracy of the testing had been verified before or after 07/17/17 (the accuracy of wet prep testing had been verified once during the review period); (3) The records were reviewed with the director of health services and testing person #1 who stated the accuracy of wet prep testing had not been verified twice annually. 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 a review of written policies and procedures and interview with the regional director of health services and testing person #1, the laboratory failed to ensure policies and procedures had been approved, signed, and dated by the current laboratory director. Findings include: (1) At the beginning of the survey, the regional director of health services and testing person #1 stated to the surveyors the following testing were performed: (a) Rh typing using the Eldon Cards (b) Wet Prep analysis as a PPM (Provider Performed Microscopy) Procedure (2) Surveyor #2 reviewed the procedure manual for the above testing. It had not been approved, signed, and dated by the current laboratory director; (3) The surveyors reviewed the procedure manual with the regional director of health services and testing person #1, who stated it had not been approved, signed, and dated by the current laboratory director. 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 a review of records, observation and interview with the regional director of -- 3 of 5 -- health services and testing person #1, the laboratory failed to ensure laboratory tests and testing materials were being stored as required. Findings include: REFRIGERATOR TEMPERATURES (1) At the beginning of the survey, the regional director of health services and testing person #1 stated to the surveyors Rh typing was performed using the Eldon Cards; (2) The surveyors observed the contents of the laboratory refrigerator. The following control materials were being stored in the refrigerator, with a manufacturer's storage requirement of 36-46 degrees F (Fahrenheit): (a) Two boxes (3 bottles) of Immunocor Panoscreen I, II, III Red Blood Cells (lot# 01084) (3) The surveyors requested temperature records from November 2016 through the day of the survey. The surveyors reviewed the records and identified that either daily monitoring of the refrigerator was not performed, or the documented temperatures were not within the manufacturer's required storage of 36-46 degrees F as follows: (a) December 2016 - temperatures not documented on days 14,15,16,19,20,21,22,23,27,28,30 (b) May 2017 - temperatures not documented on days 26,30; 6 of the 17 temperatures were documented as 34 degrees F (c) June 2017 - 1 of 22 temperatures was documented at 50 degrees F (d) August 2017 - 3 of 22 temperatures were documented as 34 degrees F (e) November 2017 - 2 of 19 temperatures were documented as 34 degrees F; 3 of 19 temperatures were documented as 35 degrees F (f) December 2017 - 6 of 21 temperatures were documented as 35 degrees F (g) January 2018 - 3 of 21 temperatures were documented as 34 degrees F; 1 of 21 temperatures was documented as 35 degrees F; 2 of 21 temperatures was documented at 33 degrees F (4) The surveyors reviewed the findings with the regional director of health services and testing person #1. Both stated the refrigerator temperatures were not being monitored as indicated above and materials were not being stored at temperatures required by the manufacturer. ROOM TEMPERATURE (1) During the survey, the surveyors observed the following stored at room temperature: (a) Eldon Cards - used for Rh typing (storage requirement 41 - 98.6 degrees F) (b) Blood Collection tubes used for collecting reference (send out) specimens: (i) Vacutte 4 ml K2EDTA tubes (50 tubes of lot# B17053MQ with a storage requirement of 39.2 - 77 degrees F) (ii) Vacutte 9 ml Z Serum Clot Activator tubes (79 tubes of lot# B17013CD with a storage requirement of 39.2 - 77 degrees F) (iii) Vacutte 7 ml Z Serum Clot Activator tubes (100 tubes of lot# B1711374 with a storage requirement of 39.2 - 77 degrees F) (2) The surveyors requested temperature records from November 2016 through the day of the survey. The surveyors reviewed the records and identified daily monitoring of the room temperature was not documented as performed: (a) Between 11/18/2016 through 11/01/2017 (b) Between 11/05/17 through 12/01/2017 (3) The surveyors reviewed the findings with the regional director of health services and testing person #1. Both stated the room temperatures were not being monitored as indicated above. D6053 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 semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of records and interview with the regional director of health services and testings person #1, the technical consultant failed to ensure that persons performing moderate complexity testing had been evaluated semiannually during the first year of testing. Findings include: (1) At the beginning of the survey, surveyor #2 -- 4 of 5 -- reviewed personnel records. The following was identified: (a) Testing Person #1 - The initial training was completed on 12/02/16. There was no evidence that a semiannual evaluation had been performed (due 06/17); (b) Testing Person #2 - The initial training was completed on 09/04/16. There was no evidence that a semiannual evaluation had been performed (due 3/17). (2) The surveyors reviewed the records with the regional director of health services and testing person#1, who stated there were no records to prove the above persons had been evaluated semiannually. -- 5 of 5 --