Encompass Health Rehabilitation Hospital

Summary Statement of Deficiencies D0000 The laboratory was found out of compliance with the CLIA regulations. The condition not met was: D6063 - 42 C.F.R. 493.1421 Condition: Laboratories performing moderate complexity testing; testing personnel; Noted deficiencies and plans of correction were discussed with the laboratory representative at the exit conference. The facility representatives were given an opportunity to provide evidence of compliance with noted deficiencies and no such evidence was provided prior to survey exit. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of the manufacturer's instructions for the Abbott i-STAT analyzer, and staff interview, it was revealed the laboratory failed to have documentation of ensuring test cartridges were received at an acceptable temperature. The findings include: 1. Base on review of the manufacturer's instructions for the Abbott i-STAT analyzer (REV. DATE: 15-Apr-2020) under the section titled "Check Temperature Monitor" revealed: "i-STAT cartridges are shipped refrigerated with a four-window indicator to monitor temperature during transit. Note: All control and calibration verification materials, except for those shipped on dry ice, will also include a four- window indicator to monitor temperature during transit. Action: If all windows are white or if only the A or B windows are blue or the 1 and 2 windows are red, then transit temperatures were satisfactory and the cartridges can be used. Remedial Action: If the C or D windows are blue, or the 3 and 4 windows are red: - quarantine the suspect cartons. - notify the i-STAT 1 System coordinator immediately - DO NOT 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 -- USE cartridges from the suspect cartons." 2. The laboratory was asked to provide documentation of evaluating the four-window indicators which were received with each shipment for acceptable temperatures being maintained during shipment. No documentation was provided. 3. An interview with the technical consultant on 10/12 /2022 at 1200 hours in the office revealed the laboratory did not evaluate the temperature of the cartridges upon arrival. This confirmed the findings. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of the laboratory's personnel records, and staff interview, it was revealed the facility failed to have documentation of the technical consultant performing competency assessments on 3 of 10 competency assessments performed in 2021 and 2022. The findings include: 1. A review of the laboratory's personnel files revealed 3 of 10 competency assessments performed in 2021 and 2022 were performed by someone other than the technical consultant. They were (as listed on Form CMS 209): Testing personnel number 1 annual competency performed April 2022 Testing personnel number 3 annual competency performed October 2022 Testing personnel number 4 semiannual competency performed April 2022 2. The laboratory was asked to provide documentation of the technical consultant performing the identified competency assessments. No documentation was provided. 3. An interview with the technical consultant on 10/12/2022 at 0940 hours in the office - after her review of the records- confirmed the findings. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's personnel records, and staff interview, it was revealed the laboratory failed to have documentation of the technical consultant perform two competency assessments within the first year for 1 of 3 testing personnel. The findings include: 1. A review of the laboratory's personnel records revealed the laboratory failed to have documentation of the technical consultant performing two competency assessments within the first year for testing personnel number 3 (as listed on Form CMS 209). Hire date: July 2021 1st competency: December 2021 2nd competency: October 2022 2. The laboratory was asked to provide documentation of the technical consultant performing a second competency assessment by July 2022. No documentation was provided. 3. An interview with the technical consultant on 10 /12/2022 at 0940 hours in the office - after her review of the records- confirmed the findings. D6063 LABORATORY TESTING PERSONNEL -- 2 of 3 -- CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on review of the laboratory's submitted Form CMS 209, review of the laboratory's personnel records, and staff interview, it was revealed the laboratory failed to have documentation of education to qualify 1 of 4 testing personnel (refer to D6065). D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy 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; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on review of the laboratory's submitted Form CMS 209, review of the laboratory's personnel records, and staff interview, it was revealed the laboratory failed to have documentation of education to qualify 1 of 4 testing personnel. The findings include: 1. A review of the laboratory's submitted Form CMS 209 revealed the facility identified 4 testing personnel. 2. A review of the laboratory's personnel records revealed the facility failed to have documentation of education to qualify 1 of 4 testing personnel. The person was (as listed on Form CMS 209): Testing personnel number 2 3. The laboratory was asked to provide documentation of education to qualify testing personnel number 2. No documentation was provided. 4. An interview with the technical consultant on 10/12/2022 at 0940 hours in the office - after her review of the records- confirmed the findings. -- 3 of 3 --

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 pH blood gas analyte. Refer to D2096. 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 proficiency testing desk review of CMS form 0155 and American Proficiency Institute (API) 2021 (2nd Event and 3rd Event) and 2022 (1st event) records, it was revealed that the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in three consecutive testing events in the specialty of Routine Chemistry for the pH blood gas analyte. Three consecutive unsatisfactory scores result in a non-initial unsuccessful PT performance. Findings included: 1. Review of the CMS 0155 report revealed the following results: Routine Chemistry 2021 - 2nd Event laboratory received an unsatisfactory score of 40% for the pH blood gas analyte. Routine Chemistry 2021 - 3rd Event laboratory received an unsatisfactory score of 60% for pH blood gas analyte. Routine Chemistry 2022 - 1st Event laboratory received an unsatisfactory score of 60% for pH blood gas analyte. 2. A proficiency desk review from American Proficiency Institute (API) 2021 and 2022 proficiency testing records confirmed the above scores. 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; -- 2 of 3 -- 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 D2096. -- 3 of 3 --

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 pH 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 Centers for Medicare and Medicaid (CMS) form 0155 and American Proficiency Institute (API) 2021 (2nd Event and 3rd Event) records, it was revealed the laboratory failed to attain a satisfactory score of at least 80% acceptable responses for Ph blood gas analyte in the specialty of Routine Chemistry for 2 of 2 proficiency testing events in 2021. Findings included: 1. Review of the CMS 0155 report revealed the following results: Routine Chemistry 2021 - 2nd Event laboratory received an unsatisfactory score of 40% for the Ph blood gas analyte. Routine Chemistry 2021 - 3rd Event laboratory received an unsatisfactory score of 60% for pH blood gas analyte. 2. A proficiency desk review from American Proficiency Institute (API) 2021 (2nd Event and 3rd Event) proficiency testing records confirmed the laboratory received the following results: Routine Chemistry 2021 - 2nd Event laboratory received an unsatisfactory score of 40% for the pH blood gas analyte. Routine Chemistry 2021 - 3rd Event laboratory received an unsatisfactory score of 60% for pH 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 proficiency testing desk review of CMS form 0155 and American Proficiency Institute (API) 2021 (2nd Event and 3rd Event) records, 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 pH blood gas 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 2021 - 2nd Event laboratory received an unsatisfactory score of 40% for the pH blood gas analyte. Routine Chemistry 2021 - 3rd Event laboratory received an unsatisfactory score of 60% for pH blood gas analyte. 2. A proficiency desk review from American Proficiency Institute (API) 2021 proficiency testing records confirmed the laboratory received the following results: Routine Chemistry 2021 - 2nd Event laboratory received an unsatisfactory score of 40% for the pH blood gas analyte. Routine Chemistry 2021 - 3rd Event laboratory received an unsatisfactory score of 60% for pH blood gas analyte. -- 2 of 3 -- 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 D2096. -- 3 of 3 --