Planned Parenthood Of Pasadena

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 the lack of competency assessment documentation and interview with the office manager (OM) on the day of the survey, January 24, 2024, as specified in the personnel requirements in subpart M, it was determined that the laboratory failed to establish and follow written policies and procedures to assess the technical consultant (TC) and testing personnel (TP) competency for the years 2022 and 2023. Findings include: 1. The laboratory failed to provide documentation of competency assessment for six (6) out of eight (8) randomly selected patients' results reviewed on 01/24/2024. 2. This deficient practice stated in 1 was affirmed by interview with the OM on 1/24 /2024, at approximately 12:15 p.m. 3. The laboratory reported to process and report 8,277 tests annually. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system 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 -- performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory quality control (QC) records, randomly chosen patients' mycology and parasitology tests results, lack of QC documentation, and interview with the office manager (OM) and compliance officer (CO); it was determined that the laboratory failed to establish and perform quality control procedures that monitor the accuracy and precision of the complete analytic process including the number, the type, and the correction and documentation of those QC performed in mycology and parasitology examinations. 1. On the day of the survey January 24, 2024, at approximately 12:00 p.m., the surveyor observed that QC was not performed for all of three (3) out of three (3) patients' records reviewed for mycology and parasitology. In addition, patients' samples were examined, and results were reported despite of lack of QC performed. 2. The OM and CO confirmed on January 24, 2024, that the laboratory lacked an established policy and procedure for QC and documentation for mycology and parasitology. 3. According to the annual test volume declared and signed by the laboratory LD on January 23, 2024, the laboratory performs approximately 8,002 mycology and parasitology tests annually. D6007 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(1) 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)(1) Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing; This STANDARD is not met as evidenced by: Based on observation, review of the laboratory records, and interview with the office manager; it was determined that the laboratory director failed to be responsible for the overall operation, including, but are not limited to ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing. The findings included: See D5209, D5441, and D6053. 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 review of randomly chosen competency assessment records and the lack of -- 2 of 3 -- documentation for competency assessments for the years 2022 and 2023, and interview with the office manager and compliance officer; it was determined that the laboratory's technical consultant failed to perform and document the performance of individuals responsible for moderate complexity testing annually the individual tests for patient specimens. (See D5209). -- 3 of 3 --

Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES 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: Based on review of the American Proficiency Institute (API) proficiency testing (PT) records for the years of 2019, 2020, and 2021 and interview with the laboratory's technical consultant TC on August 3, 2021 the laboratory failed to test PT samples the same number of times that it routinely tests patient samples. The findings include: 1. The laboratory tested API samples for Rh (D) for the years 2019, 2020, and 2021 by multiple testing personnel (TP) multiple times before reporting results. 2. The laboratory TC affirmed on August 23, 2021 at approximately 3:00 p.m. that the PT samples are tested multiple times by multiple TP before reporting to API. 3. The laboratory's testing declaration form stated that the laboratory performs 814 Rh grouping annually. D3027 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(1) Test requisitions and authorizations. Retain records of test requisitions and test authorizations, including the patient's chart or medical record if used as the test requisition or authorization, for at least 2 years. This STANDARD is not met as evidenced by: Based on the lack of documentation, review of randomly chosen patient test results, and interviews with the technical consultant (TC) and testing personnel (TP); it was determined that the laboratory failed to provide test requisition and sample testing log 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 -- records for the years 2019 and 2020. Findings included: 1. The laboratory had no available documentation to show requisition for tests ordered and sample results logs for the years 2019 and 2020. 2. For three (3) out of five (5) randomly chosen patient test results reviewed covering period from 11/26/2019 to 09/15/2020 no documentation was retained or accessible for all tests performed in the laboratory for the years 2019 and 2020. 3. The TC and TP affirmed on August 23, 2021 at approximately 3:30 p.m. that the laboratory had no documentation to show for the tests requisition or patient log results for the years 2019 and 2020. 4. 5. The laboratory reportedly performs approximately 2,968 tests annually. 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 the lack of documentation, random patient records review, and interview with the technical consultant (TC) and testing personnel (TP) on August 23, 2021 as specified in the personnel requirements in subpart M, the laboratory failed to establish and follow written policies and procedures to assess testing personnel competency. Findings include: 1. Based on review of the laboratory's policies and procedures, the laboratory failed to establish and follow written policies and procedures for competency assessment of the TP. 2. The laboratory listed in the CMS 209 Form twenty TP. 3. For five (5) out of five (5) randomly chosen TP from the laboratory personnel report Form CMS-209 and final test reports, the laboratory fail to provide documentation of training or competency assessment for the TP performing testing at the laboratory for the years 2019, and 2020. 4. This deficient practice was affirmed by interview with the TC and TP on 8/23/2021 at approximately 4:00 p.m. 5. The laboratory reportedly performs approximately 2,968 tests annually. D6007 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(1) 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)(1) Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing; This STANDARD is not met as evidenced by: Based on the lack of laboratory personnel competency evaluations, the lack of laboratory written policies and procedures for competency assessment, testing proficiency samples not in the same manner as patients' samples are tested, failure to provide testing requisitions and testing logs, and interviews with the technical consultant and testing personnel; the laboratory director failed to: 1. Ensure that policies and procedures including competency assessment, document retention, and -- 2 of 3 -- proficiency testing policies are established and followed for all the test performed in the laboratory. . 2. Monitor that competency assessments of testing personnel are performed in a timely manner on all individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures, and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. See D2010, D3027, D5209 and D6053. 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 review of randomly chosen competency assessmnet records and the lack of documentation for competency assessments for the years 2019 and 2020, and interview with the technical consultant and testing personnel; it was determined that the laboratory's technical consultant failed to perform and document the performance of individuals responsible for moderate complexity testing annually the individual tests patient specimens. (See D5209). -- 3 of 3 --

Summary Statement of Deficiencies 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 Surveyor review of patient testing records, quality control data, and interview with the laboratory testing personnel, the laboratory failed to perform quality control procedure each day patient specimens were assayed for 15 days out of 44 days, reviewed from January - August 2019. The findings include: a. The laboratory's quality control log for blood Rh type test showed that it did not perform quality control on the following days of the year 2019 even though the patients' results were released on those days: 1/3, 1/4, 1/16, 1/30, 2/6, 3/21, 3/23, 4,23, 5/7, 5/15, 6/18, 6/26, 6/28, 8/6 and 8/16. b. On 8/23/2019 at 12:35 pm, laboratory testing personnel affirmed that it did not perform quality control procedure on the above days. c. The laboratory's testing declaration form, signed by the laboratory Director on 8/12/2019, stated that the laboratory performs 536 tests, annually. D6020 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 the quality control program is established and 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 -- maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on Surveyor review of patient testing records, quality control data, laboratory policy and procedure, and interview with the laboratory testing personnel, it was determined that the laboratory director failed to ensure that the quality control programs are maintained to assure the quality of laboratory services provided. The findings include: See D5449. -- 2 of 2 --