Houston Ivf Dba Ccrm Houston

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. 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 D2016 Condition: Successful participation [proficiency testing] 493.1403 D6000 Condition: 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: Based on a desk review of proficiency testing records obtained from the CMS (Center 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 -- for Medicare Services) national database and verified with the proficiency testing company, American Association of Bioanalysts (AAB), it was determined the laboratory had not successfully participated in a proficiency testing program approved by CMS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the sub- specialty of Endocrinology. Refer to D2100 and D2108. 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 desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the laboratory's American Association of Bioanalysts (AAB) proficiency test results, it was revealed the laboratory failed to achieve satisfactory performance of at least 80% for 3 of 3 analytes in the sub-specialty of Endocrinology. Findings included: Event Analyte Score Ch21Q3 TSH 0.0** Ch22Q1 TSH 0.0NR Ch22Q1 HCG 0.0NR Ch22Q1 FT4 0.0NR Legend: TSH = Thyroid Stimulating Hormone HCG = Human Chorionic Gonadotropin FT4 = Thyroxine, Free ** = Out of grading range or incorrect response NR = Not received D2099 ENDOCRINOLOGY CFR(s): 493.843(b) 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 desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the laboratory's American Association of Bioanalysts (AAB) proficiency test results, it was revealed the laboratory failed to achieve an overall testing event score of at least 80% in the sub- specialty of Endocrinology. Findings included: Event Sub-specialty Score Ch21Q3 66.7 Ch22Q1 0.0 D2100 ENDOCRINOLOGY CFR(s): 493.843(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. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the laboratory's American Association of Bioanalysts (AAB) proficiency test results, it was revealed the laboratory failed to participate in a testing event resulting in an unsatisfactory performance and results with a score of 0 for the first testing event of 2022 in the sub- specialty of Endocrinology. Findings included: Event Sub-specialty Score Ch22Q1 0.0 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 proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the laboratory's American Association of Bioanalysts (AAB) proficiency test results, it was revealed the laboratory failed to achieve satisfactory performance with scores of at least 80% for the same analyte in 2 out of 3 consecutive testing events in sub-specialty of Endocrinology for the analyte TSH (Thyroid Stimulating Hormone). Findings include: TSH: Event Ch21Q3 - unacceptable score of 0.0 Event Ch22Q1 - unacceptable score of 0.0 D2108 ENDOCRINOLOGY CFR(s): 493.843(g) Failure to achieve an overall testing event score of satisfactory performance for 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 proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the laboratory's American Association of Bioanalysts (AAB) proficiency test results, it was revealed the laboratory failed to achieve an overall testing event score of at least 80% in 2 out of 3 consecutive testing events in the sub-specialty of Endocrinology. Findings included: Event Sub-specialty Score Ch21Q3 66.7 Ch22Q1 0.0 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: -- 3 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 laboratory's American Association of Bioanalysts (AAB) proficiency test results, 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; This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the laboratory's American Association of Bioanalysts (AAB) proficiency test results, it was revealed the laboratory director failed to ensure successful participation in a CMS-approved proficiency testing program. Refer to D2098, D2099, D2100, D2107 and D2108. -- 4 of 4 --

Summary Statement of Deficiencies D0000 An unannounced onsite investigation of complaint TX00316509 was conducted on 06 /11/2019. Based on the investigation completed on 06/11/2019, this facility was found to be out of compliance with CLIA regulations. Immediate jeopardy findings were identified. The conditions not met were: D2000 - 42 C.F.R. 493.801 Enrollment And Testing Of Samples; D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director; D6033 - 42 C.F.R. 493.1409 Condition: Laboratories performing moderate complexity testing; technical consultant; Complaint TX00316509 was substantiated. Actual survey date was 06/11 /19 and 06/21/19, with several email correspondance requesting documentation received 06/14/19 and 06/18/19. The facility representative was given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on a review of the American Association of Bioanalysts (AAB) proficiency testing (PT) records , facility procedure manual and confirmed in interview the facility engaged in inter-laboratory communications pertaining to the results of proficiency testing samples prior to the date by which the laboratory must report proficiency 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 -- testing results to the program for the testing event in which the samples were sent. Refer to D2011 D2011 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(3) Laboratories that perform tests on proficiency testing samples must not engage in any inter-laboratory communications pertaining to the results of proficiency testing sample (s) until after the date by which the laboratory must report proficiency testing results to the program for the testing event in which the samples were sent. Laboratories with multiple testing sites or separate locations must not participate in any communications or discussions across sites/locations concerning proficiency testing sample results until after the date by which the laboratory must report proficiency testing results to the program. This STANDARD is not met as evidenced by: I. Based on review of the laboratory's policy and review of the 2017 to 2019 American Association of Bioanalysts (AAB) proficiency testing records, interview with the AAB technical support representative, and confirmed in interview with the laboratory manager, the laboratory engaged in inter-laboratory communications with Houston IVF-Medical Center 45D2102384 prior to the submission date for 2 of 5 testing events (2019 AAB 1st event and 2017 AAB 2nd event). A) 2019 AAB 1st event B) 2017 AAB 2nd event Findings included: A) 2019 AAB 1st event 1. Review of the laboratory's policy External and Internal Proficiency Testing Policy revealed "the technician performing the proficiency testing will avoid any inter-laboratory communication regarding proficiency testing samples during the PT event. This is to ensure maximum integrity of the proficiency testing process in out laboratory. We do NOT send any of our PT material to another lab for referral testing or reflex testing... no contact is to be made with other testing labs regarding proficiency test results until after our lab results have been submitted." 2. Review of 2019 AAB 1st event PT records for Andrology and Embryology 2019 with a submission cut-off date of 04/18 /19 included the following for Houston IVF 45D0999095: a) An attestation for the test Sperm Count was signed by the laboratory manager, who is the same lab manager for both laboratories, who attested "the undersigned analyst attests that samples were tested in the same manner as patient samples" on 4/17/19. b) Review of the AAB result worksheet for Sperm Count revealed 2 post it notes with the following counts: 1st post it note: "13, 20, 14, 21, 15, 17, 13, 15, 13" for a total of "157" "13, 18, 18, 19, 18, 16, 18, 18, 13, 14" for a total of "166" both counts averaged to "161" 2nd post it note: "23, 18, 21, 20, 14, 27, 22, 18, 21,17" for a total of "201" There are also annotations with crossed out numbers of "27, 19, 20, 18" "23, 26, 23, 17, 21, 20, 17, 17, 21, 25" for a total of "210" both counts averaged to "205" c) An interview with an AAB technical support representative on 06/18/19 at 1100 hours revealed the results submitted online on 4/17/19 at 1311 hours that correlated with the above worksheet for Sperm Count . Specimen 1 - 205 Specimen 2 - 161 3. Review of 2019 AAB 1st event PT records for Andrology and Embryology 2019 with a submission cut-off date of 04/18/19 included the following for Houston IVF-Medical Center 45D2102384: a) Review of the AAB 1st event PT records for Andrology and Embryology 2019 for Houston IVF-Medical Center 45D2102384 revealed 2 sets of AAB worksheets for Sperm Count: one form with the Houston IVF-Medical Center 45D2102384 address and one form with the Houston IVF 45D0999095. Both forms had different results for Specimen 1 and Specimen 2: Houston IVF-Medical Center 45D2102384 result worksheet performed by the primary testing person at the Medical Center location for -- 2 of 5 -- Sperm Count: Specimen 1 - 123 Specimen 2 - 171 Houston IVF 45D0999095 result worksheeet with the laboratory manager's name written on the upper right hand corner had the following results for Sperm Count: Specimen 1 - 205 Specimen 2 - 161 b) An attestation for the test Sperm Count was signed by the laboratory manager, who is the laboratory manager for both locations, who attested "the undersigned analyst attests that samples were tested in the same manner as patient samples" on 4/17/19 for Houston IVF-Medical Center 45D2102384. c) An interview with an AAB technical support representative on 06/18/19 at 1100 hours revealed Houston IVF-Medical Center 45D2102384 submitted the same results on 04/17/19 at 1325 hours as the Houston IVF 45D0999095 worksheet: Specimen 1 - 205 and Specimen 2 - 161. d) Review of the results submitted for AAB for Houston IVF-Medical Center 45D2102384 revealed the results did not match the worksheet for Houston IVF- Medical Center 45D2102384; however, the submitted results correlated with the above results from the Houston IVF 45D0999095 worksheet. 4. Review of the submission dates and times provided via phone interview with the AAB technical support representative revealed both Houston IVF 45D0999095 and Houston IVF- Medical Center 45D2102384 had the same results submitted on the same date 4/17/19 and 14 minutes apart. 5. Review of the attestation statements for both Houston IVF 45D0999095 and Houston IVF-Medical Center 45D2102384 revealed the laboratory manager attested to performing the same tests for the same PT event for 2 separate laboratories. 6. An interview with the laboratory manager on 06/21/19 at 0915 hours in the laboratory confirmed the above findings. She also confirmed that she submitted the PT results for both locations. 7. The laboratory communicated Sperm count with another laboratory (Houston IVF-Medical Center 45D2102384) via duplicate results prior to the April 18 submission cutoff date for 2019 AAB 1st event for Andrology and Embryology. B) 2017 AAB 2nd event 1. Review of the laboratory's policy External and Internal Proficiency Testing Policy revealed "the technician performing the proficiency testing will avoid any inter-laboratory communication regarding proficiency testing samples during the PT event. This is to ensure maximum integrity of the proficiency testing process in out laboratory. We do NOT send any of our PT material to another lab for referral testing or reflex testing...no contact is to be made with other testing labs regarding proficiency test results until after our lab results have been submitted." 2. Review of 2017 AAB 2nd event PT records for Andrology and Embryology 2019 with a submission cut-off date of 11/15/17 included the following for Houston IVF 45D0999095: a) An attestation for the 2017 AAB 2nd event was signed by the laboratory manager, who is the laboratory manager for both laboratories who attested "the undersigned analyst attests that samples were tested in the same manner as patient samples" on 11/14/17. b) Review of the AAB worksheet for Houston IVF 45D0999095 revealed the following results: Sperm Count: Specimen 1 - 10; Specimen 2 - 155 Sperm Morphology: Specimen 1 - 18; Specimen 2 - 10 Sperm Motility: Specimen 1 - 50; Specimen 2 - 79 Sperm Viability: Specimen 1 - 27; Specimen 2 - 57 c) An interview with an AAB technical support representative on 06 /18/19 at 1100 hours revealed the results were submitted on 11/14/17 at 1445 hours. Review of the submitted results correlated with the above results. 3. Review of 2017 AAB 2nd event PT records for Andrology and Embryology 2017 with a submission cut-off date of 11/15/17 included the following for Houston IVF-Medical Center 45D2102384 : a) Review of the AAB 2nd event PT records for Andrology and Embryology 2017 for Houston IVF-Medical Center 45D2102384 revealed the following worksheets with the Houston IVF 45D0999095 address and the following results: Sperm Count: Specimen 1 - originally 39 and marked off and a 12 written; Specimen 2 - 159 Sperm Morphology: Specimen 1 - 13; Specimen 2 - 9 Sperm Motility: Specimen 1 - originally 16 and marked off and a 43 written; Specimen 2 - 75 Sperm Viability: Specimen 1 - 20; Specimen 2 - 48 b) Review of the above -- 3 of 5 -- worksheets revealed 2 fax stamps on the upper left hand corner of each page with the following annotation: "11/14/17 03:38 Houston IVF 7132550509" and "Nov 08 2017 03:01 PM HP Fax" c) An attestation for 2017 AAB 2nd event was signed by the primary testing person who attested "the undersigned analyst attests that samples were tested in the same manner as patient samples" on 11/14/17 for Houston IVF-Medical Center 45D2102384. d) An interview with an AAB technical support representative on 06/18/19 at 1100 hours revealed Houston IVF-Medical Center 45D2102384 submitted the results on 11/14/17 at 1613 hours. e) Review of the results submitted to AAB for Houston IVF-Medical Center 45D2102384 correlated with the worksheets with the name and address for Houston IVF 45D0999095. 4. Review of the submission dates and times provided via phone interview with the AAB technical support representative revealed both Houston IVF 45D0999095 and Houston IVF- Medical Center 45D2102384 had similar results submitted on the same date 11/14/17 and 88 minutes apart. 5. An interview with the laboratory manager on 06/21/19 at 0915 hours in the laboratory confirmed the above findings. She confirmed that she submitted the PT results for both locations. 6. The laboratory communicated with another laboratory (Houston IVF-Medical Center 45D2102384) the results prior to the November 15, 2017 submission cutoff date for 2017 AAB 2nd event for Andrology and Embryology. II. Based on review of the laboratory's policy and review of the 2017 to 2019 American Association of Bioanalysts (AAB) proficiency testing records, interview with the AAB technical support representative, and confirmed with the laboratory manager, the laboratory engaged in inter-laboratory communications with Houston IVF-Medical Center 45D2102384 and Houston IVF- Sugarland 45D2161660 prior to the submission date for 1 of 1 testing event (2019 AAB 1st event). The laboratory manager had access to and knowledge of the PT results for all locations. Findings were: 1. Review of the laboratory's policy External and Internal Proficiency Testing Policy revealed "the technician performing the proficiency testing will avoid any inter-laboratory communication regarding proficiency testing samples during the PT event. This is to ensure maximum integrity of the proficiency testing process in out laboratory. We do NOT send any of our PT material to another lab for referral testing or reflex testing...no contact is to be made with other testing labs regarding proficiency test results until after our lab results have been submitted." 2. An interview with an AAB technical support representative on 06/18/19 at 1100 hours revealed the results were submitted online on 4/17/19 at 1311 hours for Houston IVF 45D0999095 for the 2019 1st event. 3. An interview with an AAB technical support representative on 06/18/19 at 1100 hours revealed the results were submitted online on 4/17/19 at 1325 hours for Houston IVF-Medical Center 45D2102384 for the 2019 1st event. 4. An interview with an AAB technical support representative on 06/18/19 at 1100 hours revealed the results were submitted online on 4/17/19 at 1339 hours for Houston IVF -Sugarland 45D2161660 for the 2019 1st event. 5. An interview with the laboratory manager on 06/21/19 at 0915 hours in the laboratory confirmed that she entered all PT results for all locations. She acknowledged that she had access to and knowledge of the PT results for all locations. 6. The laboratory engaged in inter- laboratory communication with both sister laboratories (Houston IVF-Medical Center 45D2102384 and Houston IVF -Sugarland 45D2161660) prior to the April 18 submission cutoff date for 2019 AAB 1st event for Andrology and Embryology. 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. -- 4 of 5 -- This CONDITION is not met as evidenced by: Based on review of American Association of Bioanalysts (AAB) proficiency testing records, and confirmed in interview, the laboratory director failed to provide overall management and direction of the laboratory. 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; This STANDARD is not met as evidenced by: Based on review of the proficiency testing (PT) records and confirmed in interview, the Laboratory Director had not ensured that proficiency testing samples were tested as required and did not engage in any inter-laboratory communications pertaining to the results of proficiency testing samples. (Refer to D2011-I, II) 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 a review of the laboratory's proficiency testing records, facility procedures, record review and staff interview, it was revealed that the Technical Consultant failed to provide technical and scientific oversight. (Refer to D6036) D6036 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413 The technical consultant is responsible for the technical and scientific oversight of the laboratory. This STANDARD is not met as evidenced by: Based on review of the proficiency testing (PT) records, instrument printouts, and confirmed in interview, the Technical Consultant failed to provide technical oversignt and ensure the laboratory did not engage in any inter-laboratory communications pertaining to the results of proficiency testing samples. (Refer to D2011) -- 5 of 5 --