Pam Health Rehabilitation Hospital Of Sugar Land

Summary Statement of Deficiencies D0000 The laboratory was found out of compliance with the CLIA regulations. The conditions not met were: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D5200 - 42 C.F.R. 493.1230 Condition: General laboratory systems; D5400 - 42 C.F.R. 493.1250 Condition: Analytic systems; 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; D6076 - 42 C.F.R. 493.1441 Condition: Laboratories performing high complexity testing; laboratory director; D8100 - 42 C.F.R. 493.1771 Condition: Inspection requirements applicable to all CLIAcertified and CLIA-exempt laboratories. 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. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 19 -- compliance history. This CONDITION is not met as evidenced by: Based on review of proficiency testing records and interview of facility personnel, the laboratory failed to successfully participate in a proficiency testing program for the specialty of routine chemistry for the analyte AST. 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 review of the laboratory's American Proficiency Institute (API) Chemistry proficiency testing records from 2019 and confirmed in interview, the laboratory failed to attain a satisfactory score of at least 80% for the analyte AST (aspartate aminotransferase) for 1 of 2 testing events. The findings were: 1. A review of the laboratory's API from 2019 revealed the laboratory failed to attain a satisfactory score of at least 80% for the analyte AST. API 3rd event AST (0%)) CH-11 98 (expected result 100 - 150) CH-12 111 (expected result 114 - 172) CH-13 155 (expected result 158 - 238) CH-14 167 (expected result 173 - 260) CH-15 195 (expected result 202- 305) 2. An interview with the laboratory consultant on 1/14/2020 at 1110 hours in the conference room confirmed the above findings. D2089 ROUTINE CHEMISTRY CFR(s): 493.841(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. This STANDARD is not met as evidenced by: Based on review of the laboratory's American Proficiency Institute (API) proficiency testing records for 2019, quality assurance records, testing records and confirmed in interview, the laboratory failed to participate for all analytes in the specialty of Chemistry for the second event of 2019. The findings were: 1. A review of the laboratory's API proficiency testing records for the second event of 2019 revealed the laboratory failed to participate in the proficiency testing and received a score of 0 NR (not reported) for Chemistry Core API 2nd event for the following 18 analytes: Albumin, Alkaline Phosphatase, ALT, AST, Total Bilirubin, Calcium, Chloride, Cholesterol HDL, Total Cholesterol, CO2, Creatinine, Glucose, Cholesterol LDL, Potassium, Sodium, Total Protein, Triglycerides, and Urea Nitrogen. 2. A review of quality assurance records for 2019 revealed the facility had not notified API nor the -- 2 of 19 -- state agency that they had not started patient testing during the time period of non participation. No records were available for review that the laboratory participated in the past 2 events. Surveyor review of testing records confirmed no patient testing was performed in 2019 until 09/30/19. 3. An interview with the laboratory consultant on 1 /14/20 at 1045 hours in the conference room confirmed the above findings. She stated that the laboratory did not have reagents to run the PT specimens and could not participate. 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 review of the laboratory American Proficiency Institute (API) proficiency testing records, and confirmed in interview, the laboratory failed to attain 80% (passing) for the analyte AST for 2 of 2 testing events in Chemistry for 2019. Findings were: 1. Review of the 2019 API proficiency testing records revealed the laboratory failed to attain an 80% for the analyte AST for 2 of 2 testing event for Chemistry. Cross refer to D2087 and D2089 2019 Event 2 AST (0%) NR 2019 Event 3 AST (0%) 2. An interview with the laboratory consultant on 1/14/20 at 1640 hours in the conference room confirmed the above findings. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: The laboratory failed to monitor and evaluate the overall quality of the general laboratory systems as evidenced by: 1. Failure of the laboratory to review and evaluate proficiency testing (refer to D5211). 2. Failure to ensure an effective QA (Quality Assessment) system was in place to monitor, assess and correct problems in the laboratory general systems(refer to D5291). D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: -- 3 of 19 -- Based on review of the laboratory's submitted Form CMS-209, review of laboratory policy, review of the laboratory's personnel records, and confirmed in interview, the laboratory failed to have documentation of a competency assessment for 1 of 1 technical consultant. The findings were: 1. A review of the laboratory's submitted Form CMS-209 (signed by the laboratory director on 1/31/20) revealed the laboratory identified 1 technical consultant. 2. A review of personnel records from 2019-2020 revealed no competency assessments for 1 of 1 technical consultant. 4. An interview with the laboratory consultant on 1/14/20 at 1030 hours in the conference room confirmed the findings. Key: CMS - Centers for Medicare and Medicaid Services D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory policy, review of the American Proficiency Institute (API) proficiency testing (PT) records, and confirmed in interview, the laboratory failed to document the review of the proficiency testing performed for 1 of 2 PT events in 2019. Findings were: 1. Review of the laboratory policy Proficiency Testing Protocol (Policy #510) effective 5/4/19 under Ungraded PT Analytes revealed "there are cases where although the laboratory performed and reported PT results, these results have not been scored or evaluated for accuracy or the laboratory may have received scores that do not truly reflect laboratory performance...PT program assigns an artificial score of 0% due to nonparticipation, such as when the laboratory did not test the samples (due to oversight, instrument problems, reagent on backorder, etc), the laboratory fails to submit test results or submission of the results occurred after the cutoff date. When such a situation occurs, the laboratory must perform and document its own verification of accuracy for the analyte, specialty or subspecialty affected...The laboratory may compare its performance against the stated target and allowable range of the PT specimen as defined in the participant summary available from the PT provider...missed cut off dates or failures to submit results - the laboratory will receive a 0% on the survey in these instances; however, upon receipt of the summary report, the laboratory director or designee must determine a self-grade based on the analyte and method results reported. Document on Proficiency Testing