Crescent Medical Center Lancaster

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the CMS (Centers for Medicare and Medicaid Services) national database and verified with the proficiency testing company, American Proficiency Institute (API). The facility was found to be out of compliance with CLIA regulations 42 CFR Part 493. CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 493.803 Successful participation [proficiency testing] 493.1441 Laboratories performing high 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, the laboratory failed to 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 -- successfully participate 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 failed to successfully participate in the specialty of Immunohematology for Compatibility Testing. Refer to D2181. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory 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 proficiency testing desk review of the CASPER- 0155 Individual Laboratory Report obtained from the CMS national database and API 2022 (3rd event) and 2023 (2nd event) records, the laboratory failed to achieve satisfactory performance (100%) for the same analyte in two out of three consecutive testing events in the specialty of Immunohematology for Compatibility Testing. Two of three consecutive unsatisfactory scores result in unsuccessful PT performance. The findings include: 1. Review of the CASPER- 0155 report revealed the following: Compatibility Testing 2022 - 3rd Event Laboratory received an unsatisfactory score of 60% Compatibility Testing 2023 - 2nd Event Laboratory received an unsatisfactory score of 80% 2. A proficiency testing desk review from API 2022 and 2023 proficiency testing records confirmed the above findings. Key: CASPER: Certification and Survey Provider Enhanced Reporting CMS: Centers for Medicare and Medicaid API: American Proficiency Institute D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 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 D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure 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 an HHS approved proficiency testing program. Refer to D2181. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the CMS (Centers for Medicare and Medicaid Services) national database and verified with the proficiency testing company, American Proficiency Institute (API). 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 Laboratory Director, Moderate Complexity 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 3 -- Based on a desk review of proficiency testing records, 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 pO2 blood gas analyte. Refer to D2096. 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 0155 and American Proficiency Institute (API) records, the laboratory failed to attain a satisfactory score of at least 80% acceptable responses for each analyte in the specialty of Routine Chemistry for the pO2 blood gas analyte. Findings included: 1. Review of the CMS 0155 report revealed the following results: Routine Chemistry 2020 - 1st Event laboratory received an unsatisfactory score of 60% for pO2 blood gas analyte. Routine Chemistry 2020 - 2nd Event laboratory received an unsatisfactory score of 60% for pO2 blood gas analyte. 2. A proficiency desk review from American Proficiency Institute (API) 2020 proficiency testing records confirmed the laboratory received the following results: API Chemistry Core 2020 - 1st Event laboratory received an unsatisfactory score of 60% for pO2 blood gas analyte. API Chemistry Core 2020 - 2nd Event laboratory received an unsatisfactory score of 60% for pO2 blood gas analyte. 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 review of proficiency testing (PT) records from 2020 (1st Event and 2nd Event), it was revealed that 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 Routine Chemistry for the Chloride analyte. Two consecutive unsatisfactory scores result in unsuccessful PT performance. Findings included: 1. Review of the CMS 0155 report revealed the following results: Routine Chemistry 2020 - 1st Event laboratory received an unsatisfactory score of 60% for pO2 blood gas analyte. Routine Chemistry 2020 - 2nd Event laboratory received an unsatisfactory score of 60% for pO2 blood gas analyte. 2. A proficiency desk review of the American Proficiency Institute (API) 2020 proficiency testing records confirmed the laboratory received the following results: API Chemistry Core 2020 - 1st Event laboratory received an unsatisfactory score of 60% for pO2 blood gas analyte. API Chemistry Core 2020 - 2nd Event laboratory received an unsatisfactory score of 60% for pO2 blood gas analyte. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR -- 2 of 3 -- 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 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 D2096 -- 3 of 3 --

Summary Statement of Deficiencies 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: Revisit 01/30 -01/31/2020 NEW DEFICIENCY Based on review of Centers for Medicare and Medicaid (CMS) and API proficiency testing records for 2019, it was revealed 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 Immunohematology/Compatibility Testing. Refer to D2181 D2173 COMPATIBILITY TESTING 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 -- CFR(s): 493.863(a) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Revisit 01/30 -01/31/2020 NEW DEFICIENCY Based on a review of Centers for Medicare and Medicaid (CMS) and API proficiency testing records for 2019, it was revealed the laboratory failed to attain an overall compatibility testing event score of at least 100% (2019-3rd Event) for Immunohematology/Compatibility Testing which constitutes unsatisfactory performance. Findings included 1. Review of the CMS 0155 report revealed the following results: API 2019 - 3rd Event laboratory received an unsatisfactory score of 60% for Immunohematology/Compatibility Testing. 2. Review of the laboratory's API proficiency testing records revealed the following results: API 2019 - 3rd Event laboratory received an unsatisfactory score of 60% for Immunohematology/Compatibility Testing. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Revisit 01/30 -01/31/2020 NEW DEFICIENCY Based on a review of Centers for Medicare and Medicaid (CMS) and API proficiency testing records from 2019 (1st, 2nd, and 3rd Events), it was revealed that the laboratory failed to achieve satisfactory performance for the same analyte in two consecutive testing events or two out of three consecutive testing events. The laboratory failed to achieve satisfactory performance (100 %) in the specialty of Immunohematology for Compatibility Testing for 2 of 3 consecutive testing events. Two out of three unsatisfactory scores results in unsuccessful PT performance. Findings included: 1. Review of the CMS 0155 report revealed the following results: API 2019 - 1st Event laboratory received an unsatisfactory score of 0% for Immunohematology/Compatibility Testing. API 2019 - 3rd Event laboratory received an unsatisfactory score of 60% for Immunohematology /Compatibility Testing. 2. Review of the laboratory's API proficiency testing records revealed the following results: API 2019 - 1st Event laboratory received an unsatisfactory score of 0% for Immunohematology/Compatibility Testing. API 2019 - 3rd Event laboratory received an unsatisfactory score of 60% for Immunohematology /Compatibility Testing. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Revisit 01/30/2020 - 01/31/2020 New deficiency. Based on review of CMS 155 report -- 2 of 4 -- and proficiency testing records, the laboratory director failed to ensure the PT samples were tested as required under subpart H of this part. The laboratory failed to achieve satisfactory performance for the same analyte in two consecutive testing events or two out of three consecutive testing events. Refer to D2181. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Revisit 01/30/2020-01/31/2020 New Condition-Level Deficiency. Based on review of the CMS 209 form, personnel records, and in interview with staff, the laboratory failed to ensure all individuals met qualification requirements. The laboratory failed to ensure 1 of 5 newly hired individuals met one of the requirements to perform high complexity testing. Refer to D6171. D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such -- 3 of 4 -- training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Revisit 01/30/2020-01/31/2020 New Deficiency. Based on review of the CMS 209 form, personnel records, and in interview with staff, the laboratory failed to ensure 1 of 5 newly hired individuals met one of the requirements to perform high complexity testing. Findings included: 1. Review of the CMS 209 form provided onsite 01/31 /2020 included 5 newly hired individuals who were to perform high complexity. 2. Review of testing person - 3 (TP-3) personnel records included documentation of "...U. S. equivalent of senior high school graduation and ninety-three semester units of undergraduate coursework." The high school diploma was obtained in November /December 1983. TP-3 records did not include, in addition to a high school diploma obtained before September 1, 1997, documentation required in 493.1489 (b)(5)(i) - (b) (5)(i) Until September 1, 1997-- (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; TP-3 did not have all required documentation to perform high complexity testing (immunohematology and hematology). 3. During the exit interview on 01/31/2020 at 12:45 pm, all attendees confirmed not all documentation was available to qualify TP-3 for performing high complexity testing. -- 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, American Proficiency Institute (API). 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 3 -- 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, American Proficiency Institute (API), 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. Refer to D2108. 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 American proficiency Institute API 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: 1. API 2018 - 1st testing event the laboratory received the following unsatisfactory scores: Albumin 60% Total CK 40% 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 American proficiency Institute API 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. Findings: 1. API 2018 - 3rd event the laboratory received an unsatisfactory score of 0% for TSH (Thyroid Stimulating Hormone). 2. API 2019 - 1st event the laboratory received the following unsatisfactory scores: HCG (Human chronic gonadotropin 60% Free Thyroxine 20% 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: Review of the CMS report 155 and API proficiency testing records found that the laboratory failed to achieve a satisfactory score of at least 80% for the overall endocrinology testing event score. Findings: 1. API 2018 - 3rd event lab received an unsatisfactory event score of 50% for Endocrinology. 2. API 2019 - 1st event lab received an unsatisfactory event score of 40% for Endocrinology D2108 ENDOCRINOLOGY -- 2 of 3 -- 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 desk review of API proficiency testing records, it was determined the laboratory failed to achieve satisfactory performance (80% or greater) for the same testing event in two consecutive testing events or two out of three consecutive testing events in the specialty of Endocrinology. Two out of three unsatisfactory scores results in unsuccessful PT performance. Findings: 1. API 2018 - 3rd event the laboratory received an unsatisfactory event score of 50% in endocrinology. 2. API 2019 -1st event the laboratory received an unsatisfactory event score of 40% in endocrinology. 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 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 D2108 -- 3 of 3 --

Summary Statement of Deficiencies D0000 An unannounced investigation of complaint TX00291030 was conducted onsite. An entrance conference was held on 11/14/2018 with the Laboratory Manager and Director of Quality/Compliance. Based upon the onsite investigation conducted 11/14 /2018 - 11/16/2018, this facility was found NOT to be compliance with CLIA regulations found at 42 CFR for the specialties/subspecialties in which it was surveyed. 493.1217 Immunohematology 493.1441 Laboratory Director, (high complexity) 493.1459 General Supervisor An exit conference was held on 11/16/2018 with the Laboratory Manager and Director of Quality/Compliance. The exit conference attendees were advised the laboratory was out of compliance and advised of conditions and deficiencies found during the survey. An opportunity for questions and comments was provided. Complaint TX00291030 was substantiated 2567 report to be sent to Regional CMS office. D3023 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(c)(2) The facility must establish and follow policies to ensure positive identification of a blood or blood product recipient. This STANDARD is not met as evidenced by: Based on review of facility records and interview with staff, the facility failed to ensure positive identification of a patient's specimen prior to patient immunohematology testing and the receipt of blood products. Findings included: 1. Review of facility records revealed on 06/06/2018 a blood type, antibody screen and crossmatch were ordered for Patient # 2036791. Patient #2036791 had no previous transfusion history (blood type, antibodies, crossmatches). Patient #2036791 was initially typed as O Negative and O Negative donor units were crossmatched and transfused from the patient specimen collected 06/06/2018 at 2020 hours. Patient # 2036791 blood type was changed to O Positive on 06/13/2018. 2. During an interview on 11/15/2018 at 1257 in the conference room, the laboratory manager was asked to Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- explain events that occurred relating to the immunohematology testing for Patient #2036791. The laboratory manager stated that the patient was initially typed as O Negative and that the next morning the testing person told her that she may have mistyped the patient. The laboratory manager then recollected a blood specimen and retyped the patient as O Positive. The laboratory manager was asked how did the testing person know that the blood type was incorrect. She stated, "I don't know." The laboratory was asked for documentation of date and time of the recollected specimen. No documentation was provided. The laboratory was asked if the patient's antibody screen was repeated and the transfused units were re-crossmatched (compatibility testing) with the recollected specimen. The laboratory manager stated that only the ABO was verified with the recollected specimen. The laboratory manager was asked who was notified of the mistype. She stated that the patient's doctor was notified of the error. 3. The laboratory manager was asked to provide all documentation (specimen mislabel investigation, interview with collection personnel, root cause analysis, etc.) related to the mistyping of Patient # 2036791. No documentation was provided. 4. The facility policy titled "Blood/Blood Components-Ordering, Obtaining and Administering" stated the following: "ii. Ordering i. A physician must give the order to initiate any blood transfusion ii. Once the blood bank order has been placed in the EHR (Electronic Health Records), the following must obtained: 1. Informed consent on the attached consent form 2. A blood band for the patient 3. Two purple top blood sample tubes ... ... iv. Preparation at the Bedside i. At the bedside, two licensed nurses (one must be a Registered Nurse) or a nurse and physician are to check the blood product against the patient's blood band, original physicians order, and verify that the consent form has been signed. ii. Compare information on the component tag with the unit. Verifiying 1. Patient Name 2. Medical record Number 3. Date of birth 4. Unit number 5. Blood band number 6. Unit expiration iii. Do not transfuse if there are any discrepancies" The facility failed to ensure the positive identification of the patient's specimen prior to transfusion of the blood products. D5026 IMMUNOHEMATOLOGY CFR(s): 493.1217 If the laboratory provides services in the specialty of Immunohematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1271, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of laboratory records, patient records, and staff interview, the laboratory failed to meet the requirements for the specialty of immunohematology as evidenced by: 1. The laboratory failed to ensure blood bank quality control material had not exceeded their expiration date. Refer to D5417. 2. The laboratory failed to ensure that unexpected antibody screening and compatibility testing were performed on a recollected patient specimen as part of a blood typing error. Refer to D5551 3. The laboratory failed to ensure all blood specimen collection and testing records were maintained. Refer to D5787. 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 deteriorated, or are of substandard quality. -- 2 of 11 -- This STANDARD is not met as evidenced by: Based on random review of laboratory blood bank quality control (QC) records (04 /2018) and confirmed in staff interview, the laboratory failed to ensure blood bank quality control material had not exceeded their expiration date for 2 of 16 days. Findings included: 1. Review of the laboratory's blood bank record titled "Daily QC Worksheet" revealed the following: A1 Reagent Red Cells in Use Lot number: V192776 Expiration Date: 04/16/18 B Reagent Red Cells in Use Lot number: V192781 Expiration Date: 04/16/18 Daily Test: 04/17/18 A1 = 4+ B= 4+ Daily Test: 04/18/2018 A1 = 4+ B= 4+ The laboratory utilized quality control material beyond the expiration date. 2. The above findings were confirmed in an interview with the laboratory manager on 11/15/2018 at 0956 hours in the conference room. D5551 IMMUNOHEMATOLOGY CFR(s): 493.1271(a)(f) (a) Patient testing. (a)(1) The laboratory must perform ABO grouping, D (Rho) typing, unexpected antibody detection, antibody identification, and compatibility testing by following the manufacturer's instructions, if provided, and as applicable, 21 CFR 606.151(a) through (e). (a)(2) The laboratory must determine ABO group by concurrently testing unknown red cells with, at a minimum, anti-A and anti-B grouping reagents. For confirmation of ABO group, the unknown serum must be tested with known A1 and B red cells. (a)(3) The laboratory must determine the D (Rho) type by testing unknown red cells with anti-D (anti-Rho) blood typing reagent. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of laboratory records and staff interview, the laboratory failed to ensure that unexpected antibody screening and compatibility testing were performed on a recollected patient specimen as a result of blood typing error. 1. Review of laboratory records revealed on 06/06/2018 a blood type, antibody screen and crossmatch was ordered for Patient # 2036791. Patient #2036791 had no previous transfusion history (blood type, antibodies, compatibility testing). Patient #2036791 was initially typed as O Negative and five O Negative donor units were tested for compatibility and transfused from the patient specimen collected 06/06/2018 at 2020 hours. Review of Patient # 2036791's history index card and the laboratory information system (LIS), the blood type was changed to O Positive on 06/13/2018. 2. During an interview on 11/15/2018 at 1257 in the conference room, the laboratory manager was asked to explain events that occurred relating to the immunohematology testing for Patient #2036791. The laboratory manager stated that the patient was initially typed as O Negative and that the next morning the testing person told her that she may have mistyped the patient. The laboratory manager then recollected a blood specimen and retyped the patient as O Positive (documentation of the recollection was not available). The laboratory was asked if the patient's antibody screen was repeated and the transfused units were re-crossmatched for compatibility with the recollected specimen. The laboratory manager stated that only the ABO/Rh blood typing was verified using the recollected specimen. The laboratory did not ensure that unexpected antibody screening and compatibility testing were performed on the recollected patient #2036791 specimen. This confirmed the above findings. -- 3 of 11 -- D5783