Planned Parenthood South Texas

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company, College of American Pathologists (CAP). The facility was found to be out of compliance with the conditions of participation of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 493.803 successful participation in a proficiency testing program; 493.807 (a) reinstatement after failure; 493.1403 laboratories performing moderate complexity testing; laboratory director 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: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- Based on a desk review of proficiency testing records obtained from the Casper 155 Report and verified with the proficiency testing company, College of American Pathologists (CAP) it was determined the laboratory had not successfully participated in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of routine chemistry for the analyte BUN (Blood Urea Nitrogen). Refer to D2096. Key: CLIA - Clinical Laboratory Improvement Amendments HHS - Health and Human Services D2017 REINSTATEMENT OF NONWAIVED LABORATORIES CFR(s): 493.807(a)(b) (a) If a laboratory's certificate is suspended or limited or its Medicare or Medicaid approval is cancelled or its Medicare or Medicaid payments are suspended because it fails to participate successfully in proficiency testing for one or more specialties, subspecialties, analyte or test, or voluntarily withdraws its certification under CLIA for the failed specialty, subspecialty, or analyte, the laboratory must then demonstrate sustained satisfactory performance on two consecutive proficiency testing events, one of which may be on site, before CMS will consider it for reinstatement for certification and Medicare or Medicaid approval in that specialty, subspecialty, analyte or test. (b) The cancellation period for Medicare and Medicaid approval or period for suspension of Medicare or Medicaid payments or suspension or limitation of certification under CLIA for the failed specialty, subspecialty, or analyte or test is for a period of not less than six months from the date of cancellation, limitation or suspension of the CLIA certificate. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing scores from College of American Pathologists (CAP) and review of the Casper 155 Report found the laboratory failed to participate successfully for the analyte BUN (Blood Urea Nitrogen). Findings included: 1. The laboratory received the following failing scores (passing is greater than or equal to 80%) for the analyte BUN: CAP 2019 - 1st event laboratory received an unsatisfactory score of 40% for BUN CAP 2019 - 3rd event laboratory received an unsatisfactory score of 40% for BUN CAP 2020 - 1st event laboratory received an unsatisfactory score of 60% for BUN 2. These failures result in a third unsuccessful performance for the analyte BUN. 3. The laboratory must demonstrate sustained satisfactory performance (>80%) on two consecutive testing events for reinstatement. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of CMS 155 Report and College of American Pathologists (CAP) records found that the laboratory failed to attain a satisfactory score of at least 80% of acceptable responses for each analyte in the subspecialty of chemistry. Findings included: 1. CAP 2019 - 1st event laboratory received an unsatisfactory score of 40% for BUN 2. CAP 2019 - 3rd event laboratory received an unsatisfactory score of 40% for BUN 3. CAP 2020 - 1st event laboratory -- 2 of 4 -- received an unsatisfactory score of 60% for BUN 4. CAP 2019 - 3rd event laboratory received an unsatisfactory score of 0% for Glucose 5. CAP 2020 - 1st event laboratory received an unsatisfactory score of 0% for Sodium 6. CAP 2020 - 1st event laboratory received an unsatisfactory score of 60% for Chloride 7. CAP 2020 - 1st event laboratory received an unsatisfactory score of 20% for Total Protein 8. CAP 2020 - 2nd event laboratory received an unsatisfactory score of 20% for Total Bilirubin 9. CAP 2020 - 2nd event laboratory received an unsatisfactory score of 20% for HDL Cholesterol Key: CMS - Centers for Medicare and Medicaid BUN - Blood Urea Nitrogen HDL - High Density Lipoprotein D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test 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 desk review of College of American Pathologists (CAP) proficiency testing (PT) records and the Casper 155 Report, it was determined that laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two out of three consecutive testing events. The laboratory failed to achieve satisfactory performance in the specialty of chemistry for the analyte BUN (Blood Urea Nitrogen). Two out of three unsatisfactory scores results in unsuccessful PT performance. Findings included: 1. CAP 2019 - 1st event laboratory received an unsatisfactory score of 40% for BUN 2. CAP 2019 - 3rd event laboratory received an unsatisfactory score of 40% for BUN 3. CAP 2020 - 1st event laboratory received an unsatisfactory score of 60% for BUN D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR 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 desk review of laboratory proficiency testing it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016 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; -- 3 of 4 -- This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing results it was revealed that the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in a HHS approved proficiency testing program. Refer to D2096 -- 4 of 4 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company, College of American Pathologists (CAP). The facility was found to be out of compliance with the conditions of participation of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 493.803 successful participation in a proficiency testing program; 493.807 (a) reinstatement after failure; 493.1403 laboratories performing moderate complexity testing; laboratory director 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: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- Based on a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company, College of American Pathologists (CAP) it was determined the laboratory had not successfully participated in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of endocrinology for the analyte human chorionic gonadotropin (HCG). D2017 REINSTATEMENT OF NONWAIVED LABORATORIES CFR(s): 493.807(a)(b) (a) If a laboratory's certificate is suspended or limited or its Medicare or Medicaid approval is cancelled or its Medicare or Medicaid payments are suspended because it fails to participate successfully in proficiency testing for one or more specialties, subspecialties, analyte or test, or voluntarily withdraws its certification under CLIA for the failed specialty, subspecialty, or analyte, the laboratory must then demonstrate sustained satisfactory performance on two consecutive proficiency testing events, one of which may be on site, before CMS will consider it for reinstatement for certification and Medicare or Medicaid approval in that specialty, subspecialty, analyte or test. (b) The cancellation period for Medicare and Medicaid approval or period for suspension of Medicare or Medicaid payments or suspension or limitation of certification under CLIA for the failed specialty, subspecialty, or analyte or test is for a period of not less than six months from the date of cancellation, limitation or suspension of the CLIA certificate. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the CMS (Center for Medicare Services) national database, and verified with the College of American Pathologists, the laboratory failed to participate successfully for the analyte human chorionic gonadotropin (HCG). The findings were: 1. The laboratory received the following unsatisfactory scores (passing = >80%) for the analyte HCG: CAP 2018 (event 2) 20% CAP 2018 (event 3) 60% CAP 2019 (event 2) 60% 2. These failures result in a second unsuccessful performance for the analyte HCG. 3. The laboratory must demonstrate sustained satisfactory performance (>80%) on two consecutive testing events for reinstatement. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of CMS Form-155 and College of American Pathologists (CAP) proficiency testing records found that the laboratory failed to attain a score of at least 80% of acceptable responses for each analyte in the subspecialty of chemistry for the analyte Bilirubin, Total, Cholesterol, Total, and BUN. The findings were: 1. CAP 2019 (event 3): the laboratory received an unsatisfactory score of 40% for Bilirubin, Total. 2. CAP 2019 (event 3): the laboratory -- 2 of 4 -- received an unsatisfactory score of 0% for Cholesterol, Total. 3. CAP 2019 (event 2): the laboratory received an unsatisfactory score of 40% for BUN. Key: CMS - Centers for Medicare and Medicaid Services D2098 ENDOCRINOLOGY CFR(s): 493.843(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of CMS Form-155 and College of American Pathologists (CAP) proficiency testing records found that the laboratory failed to attain a satisfactory score of at least 80% of acceptable responses for each analyte in the subspecialty of endocrinology. The findings were: 1. CAP 2018 (event 2) 20% (unsatisfactory) 2. CAP 2018 (event 3) 60% (unsatisfactory) 3. CAP 2019 (event 2) 60% (unsatisfactory) D2107 ENDOCRINOLOGY CFR(s): 493.843(f) Failure to achieve satisfactory performance for the same analyte or test 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 desk review of proficiency testing records, it was determined the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two consecutive testing events or two out of three consecutive testing events in the specialty of Endocrinology for human chorionic gonadotropin (HCG). Two out of three unsatisfactory scores are unsuccessful PT performance. The findings include: 1. CAP 2018 (event 2) 20% (unsatisfactory) 2. CAP 2018 (event 3) 60% (unsatisfactory) 3. CAP 2019 (event 2) 60% (unsatisfactory) D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR 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 a desk review of laboratory proficiency testing performance it was revealed that the laboratory director failed to provide overall management and direction of the laboratory service (refer to D6016). D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of -- 3 of 4 -- 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 a desk review of proficiency testing results it was revealed that the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in a HHS approved proficiency testing program (refer to D2107). -- 4 of 4 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company, College of American Pathologists (CAP) . The facility was found to be out of compliance with the conditions of participation of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 493.803 successful participation in a proficiency testing program 493.1403 laboratories performing moderate complexity testing; laboratory director 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: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- Based on a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company, College of American Pathologists (CAP) it was determined the laboratory had not successfully participated in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of endocrinology for the analyte human chronic gonadatropin (HCG). D2020 BACTERIOLOGY CFR(s): 493.823(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of CMS form 155 and CAP records found that the laboratory failed to attain an overall score of at least 80% for each testing event in the specialty of bacteriology. Findings: 1. CAP 2017 - 1st event lab received an unsatisfactory score of 70% for bacteriology testing event. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of CMS form 155 and CAP records found the laboratory failed to attain a satisfactory score of at least 80% of acceptable responses for each analyte in the subspecialty of chemistry for the analyte Sodium (NA). Findings: 1. CAP 2016 - 3rd event the laboratory received an unsatisfactory score of 40% for NA. D2098 ENDOCRINOLOGY CFR(s): 493.843(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of CMS form 155 and CAP records found that the laboratory failed to attain a score of at least 80% acceptable responses for each analyte in the specialty of endocrinology for the analyte HCG. Findings: 1.CAP 2018 - 2nd event the laboratory received an unsatisfactory score of 20% for HCG. 2. CAP 2018 - 3rd event the laboratory received an unsatisfactory score of 60% for HCG. D2099 ENDOCRINOLOGY CFR(s): 493.843(b) -- 2 of 4 -- Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of CMS form 155 and CAP records found that the laboratory failed to attain an overall score of at least 80% for each testing event in the specialty of endocrinology. Findings: 1. CAP 2018 - 2nd event the laboratory received an unsatisfactory score of 60% for the testing event. D2107 ENDOCRINOLOGY CFR(s): 493.843(f) Failure to achieve satisfactory performance for the same analyte or test 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 desk review of CAP proficiency testing records, it was determined that the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two out of three consecutive testing events. The laboratory failed to achieve satisfactory performance in the specialty of Endocrinology for the analyte HCG. Two out of three unsatisfactory scores results in unsuccessful PT performance. Findings: 1. CAP 2018 - 2nd event the laboratory received an unsatisfactory score of 20% for HCG. 2. CAP 2018 - 3rd event the laboratory received an unsatisfactory score of 60% for HCG. D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of CMS form 155 and CAP records found that the laboratory failed to attain a score of at least 80% acceptable responses for each analyte in the subspecialty of hematology for the analyte platelets. Findings: 1. CAP 2018 - 2nd event laboratory received an unsatisfactory score of 0% for platelets. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR 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 a desk review of laboratory proficiency testing performance it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016 -- 3 of 4 -- 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 a desk review of proficiency testing results it was revealed that the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in a HHS approved proficiency testing program. Refer to D2107 -- 4 of 4 --

Summary Statement of Deficiencies D0000 The laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES resulting in a finding of IMMEDIATE JEOPARDY: D5300 - 42 C.F.R. 493.1240 Condition: Pre-Analytic Systems D5400 - 42 C.F.R. 493.1250 Condition: Analytic Systems D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director; moderate complexity D6076 - 42 C.F.R. 493.1441 Condition: Laboratory Director; high complexity Noted deficiencies and plans of correction were discussed with the laboratory representative at the exit conference. The facility representative was given an opportunity to provide evidence of compliance with noted deficiencies and no such evidence was provided prior to survey exit. NOTE: THE FACILITY WAS ASKED TO CEASED TESTING FOR: - CHLAMYDIA AND GONORRHEA TESTING UTILZING ORAL PHARYNGEAL AND RECTAL SWABS, - CHLAMYDIA AND GONORRHEA TESTING OF URINE SAMPLES FOR PATIENTS UNDER THE AGE OF 14 YEARS - SYPHILLIS TESTING - HEMATOLOGY TESTING - SPERM COUNTS - CHEMISTRY AND ENDOCRINOLOGY TESTING. THE LABORATORY COMPLIED. PLEASE SEE THE ATTACHED LETTER. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the