Cuero Regional Hospital

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 Association of Bioanalysts. 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 493.807 (a) Reinstatement after Failure 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, American Association of Bioanalysts (AAB), 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 Hematology for the analyte PT. Refer to D2130. 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 AAB found the laboratory failed to participate successfully for the analyte prothrombin time (PT). Findings: 1. The laboratory received the following failing scores (passing = >80%) for the analyte prothrombin time: AAB 2017 - 3rd event laboratory received an unsatisfactory score of 40% for prothrombin time. AAB 2018 - 1st event laboratory received an unsatisfactory score of 60% for prothrombin time. AAB 2018 - 2nd event laboratory received an unsatisfactory score of 60% for prothrombin time. AAB 2018 - 3rd event laboratory received an unsatisfactory score of 40% for prothrombin time. 2. These four consecutive failures result in a third unsuccessful performance for the analyte prothrombin. 3. The laboratory must demonstrate sustained satisfactory performance (>80%) on two consecutive testing events for reinstatement. 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 American Association of Bioanalysts (AAB) 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. AAB 2018 - 3rd event lab received an unsatisfactory score of 60% for bacteriology testing event. -- 2 of 4 -- 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 Association of Bioanalysts (AAB) 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 for the analyte creatine kinase, isoenzyme (CKMB). Findings: 1. AAB 2018 - 2nd event the laboratory received an unsatisfactory score of 20% for CKMB. 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 AAB proficiency records found the laboratory failed to attain a score of at least 80% acceptable responses for each analyte in the subspecialty of hematology for the analyte prothrombin time. Findings: 1. The laboratory received the following failing scores (passing = >80%) for the analyte prothrombin time: AAB 2017 - 3rd event laboratory received an unsatisfactory score of 40% for prothrombin time. AAB 2018 - 1st event laboratory received an unsatisfactory score of 60% for prothrombin time. AAB 2018 - 2nd event laboratory received an unsatisfactory score of 60% for prothrombin time. AAB 2018 - 3rd event laboratory received an unsatisfactory score of 40% for prothrombin time. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 for the same analyte in two consecutive testing events or two out of three consecutive testing events. The laboratory failed to achieve satisfactory performance (80 % or greater) in the specialty of hematology for the analyte prothrombin time (PT) for 2 of 3 consecutive testing events. Findings: 1. The laboratory received the following failing scores (passing = >80%) for the analyte prothrombin time: AAB 2017 - 3rd event laboratory received an unsatisfactory score of 40% for prothrombin time. AAB 2018 - 1st event laboratory received an unsatisfactory score of 60% for prothrombin time. AAB 2018 - 2nd event laboratory received an unsatisfactory score of 60% for prothrombin time. AAB 2018 - 3rd event laboratory received the unsatisfactory score of 40% for prothrombin time. -- 3 of 4 -- D2173 COMPATIBILITY TESTING 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: Based on a review of CMS and AAB proficiency testing records , it was found the laboratory failed to attain a overall compatibility testing event score of at least 100% which constitutes unsatisfactory performance. Findings: 1. AAB 2018 - 3rd event lab received the unsatisfactory scored of 60% for Compatibility Testing. 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 review of the laboratory's quality control records, facility procedures, record review and staff interview, 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 D2130 -- 4 of 4 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted July 18 -19, 2018. 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. 1250 analytic systems 493.1403 laboratories performing moderate complexity testing; laboratory director D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: A. Based on direct observation, review of manufacturer's instructions, and confirmed in interview of facility personnel, the laboratory failed to provide documentation of following the manufacturer's instructions for monitoring revised expiration dates for quality control reagents and test strips for the NOVA STAT strip whole blood glucose monitoring system. The findings included: 1. Direct observation made by the surveyor on July 18, 2018 at 1330 hours in the Emergency Department revealed the following in use items: a. NOVA STAT glucometer test strips (quantity of 14 remaining in vial) Lot 0318025249 Manufacturer Expiration Date: 01-25-2020 b. NOVA STAT quality control reagent (level 1) Lot 0417060301 Manufacturer Expiration Date: 09-01-2019 c. NOVA STAT quality control reagent (level 3) Lot 0477027303 Manufacturer Expiration Date: 07-27-2019 d. NOVA STAT quality control reagent (level 3) Lot 0417230303 Manufacturer Expiration Date: 02-18-2020 2. Further observation of the items revealed each of the 4 of 4 items were not labeled with a revised expiration date or an open date. 3. Review of the manufacturer's instructions revealed NOVA STAT strips have a revised expiration date once they are opened of 180 days or 6 months. 4. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 15 -- Review of the manufacturer's instructions revealed NOVA STAT quality control reagents have a revised expiration date once they are opened of 90 days or 3 months. 5. An interview with the phlebotomy supervisor on July 18, 2018 at 1330 hours confirmed the findings. She agreed the items were not labeled with open dates or revised expiration dates. B. Based on direct observation, review of manufacturer's instructions, and confirmed in interview of facility personnel, the laboratory failed to provide documentation of following the manufacturer's instructions to monitor the room temperature where glucometer supplies were stored. The findings included: 1. Direct observation made in the Emergency Department Supply Room on July 18, 2018 at 13:30 hours revealed NOVA STAT glucometer test strips were stored in a bin. 2. Further observations made in the supply room revealed no means to monitor the room temperature. 3. Review of the manufacturer's instructions on the outside of the supply packing revealed the strips are to be stored at 15-30 degrees Celsius. 4. The above findings were confirmed in interview of the phlebotomy supervisor on July 18, 2018 at 13:30 hours in the Emergency Department. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of laboratory policy, review of the laboratory's American Association of Bioanalysts (AAB) proficiency testing records from 2016, 2017, and 2018, and confirmed in interview of facility personnel, the laboratory failed to provide documentation of performing proficiency testing using routine patient procedures. The findings were: 1. Review of laboratory policy "Proficiency Testing" approved by the laboratory director stated, under "Procedure: F. Process proficiency specimens following guidelines established for patient specimen testing ..." 2. Review of the laboratory's AAB proficiency testing records for 2016 (event 3), 2017 (events 1, 2, and 3) and 2018 (event 1) revealed 2 of 5 the events were tested by multiple testing persons. Quarter 1 Nonchemistry 2018 Tested by 6 testing persons Quarter 1 Nonchemistry 2017 Tested by 6 testing persons 3. An interview with the laboratory manager on July 18, 2018 in the private dining room at 14:00 hours confirmed the findings. She revealed she thought the additional testing was done after the proficiency testing event had been submitted. 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 -- 2 of 15 -- 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 review of laboratory policy, review of the laboratory's American Association of Bioanalysts (AAB) proficiency testing records from 2016, 2017 and 2018, 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 hematology for the analyte Prothrombin Time (PT). (refer to D2130) 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 review of laboratory policy, review of the laboratory's American Association of Bioanalysts (AAB) proficiency testing records from 2016, 2017, and 2018, and confirmed in interview, it was determined the laboratory failed to attain a score of at least 80% acceptable responses for each analyte in the subspecialty of hematology. The findings included: 1. A review of the laboratory's AAB proficiency testing records for 2016 (event 3), 2017 (events 1, 2, and 3) and 2018 (event 1) revealed the following unsatisfactory scores: AAB 2017 - event 3 Prothrombin Time Score = 40% AAB 2018 - event 1 Prothrombin Time Score = 60% 2. An interview with the laboratory manager on July 19, 2018 at 14:20 hours in the Huddle Room confirmed the findings. She revealed the failures were due to a clerical error. 3. On July 18, 2018, the surveyor conducted a telephone interview with a representative from AAB who revealed the proficiency testing agency was unable to retrieve documentation of the laboratory notifying the agency of a method code change for Prothrombin Time (PT) and would not be issuing a corrected report. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of laboratory policy, review of the laboratory's American Association of Bioanalysts (AAB) proficiency testing records from 2016, 2017, and 2018, and confirmed in interview, it was determined the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in the specialty of hematology in two consecutive testing events or two out of three consecutive testing -- 3 of 15 -- events. Two out of three unsatisfactory scores results in unsuccessful PT (proficiency testing) performance. The findings included: 1. A review of the laboratory's AAB proficiency testing records for 2016 (event 3), 2017 (events 1, 2, and 3) and 2018 (event 1) revealed the following unsatisfactory scores: AAB 2017 - event 3 Prothrombin Time Score = 40% AAB 2018 - event 1 Prothrombin Time Score = 60% 2. An interview with the laboratory manager on July 19, 2018 at 14:20 hours in the Huddle Room confirmed the findings. She revealed the failures were due to a clerical error. 3. On July 18, 2018, the surveyor conducted a telephone interview with a representative from AAB who revealed the proficiency testing agency was unable to retrieve documentation of the laboratory notifying the agency of a method code change for PT and would not be issuing a corrected report. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of the laboratory's American Proficiency Institute (API) proficiency testing results from 2016, 2017, and 2018, and confirmed in interview of facility personnel, the laboratory failed to provide documentation of evaluating proficiency testing results returned as 'not graded' by the proficiency testing agency. The findings included: 1. This is a repeat deficiency 2. A review of the laboratory's API proficiency testing results from 2016 (event 3), 2017 (events 1, 2, and 3), and 2018 (event 1) revealed the proficiency agency returned the following results as "Not Graded": 2018 Hematology / Coagulation - event 1 Analyte / Method: PMN (CSF/body fluid) (%) Sample ID: BFL-02 Grade: "Not Graded" (with a superscript of 2) 3. The proficiency testing agency defined code "2" as: No Consensus. 4. An interview with the laboratory manager on July 18, 2018 at 14:00 hours in the private dining room confirmed the findings. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of