Saint Augustine Manor

Summary Statement of Deficiencies 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 record review and an interview with Testing Personnel (TP) #1, the Laboratory Director failed to provide overall management and direction in accordance with 493.1407 of this subpart in the specialty of Chemistry. 131 out of 131 patient arterial blood gas (ABG) testing procedures performed in this laboratory from 07/13 /2021 to 12/05/2022 had the potential to be affected by this deficient practice. Findings Include: 1. The Laboratory Director failed to delegate the Technical Consultant (TC) responsibilities to a qualified individual for the arterial blood gas (ABG) testing conducted in the subspecialty of Routine Chemistry. (Refer to D6004) 2. The Laboratory Director failed to employ an individual functioning in the role of a Technical Consultant (TC), who possessed the appropriate education to perform the TC responsibilities described in subpart M. (Refer to D6028) D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If 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 -- the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on record review and an interview with the Office Manager (OM), the Laboratory Director failed to delegate the Technical Consultant (TC) responsibilities to a qualified individual for the arterial blood gas (ABG) testing conducted in the subspecialty of Routine Chemistry. This deficient practice had the potential to affect 131 out of 131 patient ABG tests that were conducted between 07/13/2021 to 12/05 /2022. Findings Include: 1. Review of the Laboratory Director's TC delegation letter to TP#1, provided for the inspection, found that the Laboratory Director did not delegate to a qualified individual. TP#1 had achieved an Associate of Applied Science in Respiratory Care and did not meet the TC qualification requirements. 2. Review of the laboratory's 2021 and 2022 competency assessment documentation, provided for the inspection, revealed TP#1, TP#2, TP#3, and an individual not listed on the CMS- 209 conducted TP competency assessments for nine out of nine TP. 3. Review of the laboratory's 2021 and 2022 quality control and quality assessment documentation provided for the inspection, did not find any indication of the listed TC initials or signatures for any review activities. 4. The OM confirmed on 12/05/2022 at 11:45 AM and again on 12/14/2022 at 2:05 PM via a telephone conversation that the Laboratory Director delegated TC responsibilities to TP#1 and listed another individual as the TC on the CMS-209. D6028 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(10) 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)(10) Employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities described in this subpart; This STANDARD is not met as evidenced by: Based on review of the laboratory's Form CMS-209, competency assessment documentation and education records, the Laboratory Director failed to employ an individual functioning in the role of a Technical Consultant (TC), who possessed the appropriate education to perform the TC responsibilities described in subpart M. This deficient practice had the potential to affect 131 out of 131 patient arterial blood gas (ABG) tests that were conducted between 07/13/2021 to 12/05/2022. Findings Include: 1. Review of the laboratory's Form CMS-209, signed by the Laboratory Director on 11/18/2022, listed and credentialed one individual as the sole TC. 2. Review of the laboratory's 2021 and 2022 competency assessment documentation, found annual assessment records for all testing personnel (TP). The records indicated that the TP were assessed by TP#1, TP#2, TP#3, or an individual not listed on the CMS-209 and not by the listed and credentialed TC. 3. Review of the Laboratory Director's delegation of responsibility letter to TP#1 and the highest level of education by degree/diploma for TP#1 revealed that TP#1 was delegated TC responsibilities by the Laboratory Director, had achieved an Associate of Applied Science in Respiratory -- 2 of 3 -- Care and did not meet the moderate complexity TC qualification requirements. Additionally, the Laboratory Director did not delegate TC responsibilities to the listed and credentialed TC on the CMS-209. 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 record review and an interview with the Office Manager (OM), the Technical Consultant (TC) failed to evaluate and document the competency of nine out of nine Testing Personnel (TP) in 2021 and 2022 assuring their competency was maintained in order to perform moderately complex arterial blood gas (ABG) testing in the subspecialty of Routine Chemistry and report the test results promptly, accurately, and proficiently. 131 out of 131 patient ABG tests conducted by TP#1, TP#2, TP#3, TP#4, TP#5, TP#6, TP#7, TP#8, and TP#9 from 07/13/2021 to 12/05 /2022 had the potential to be affected by this deficient practice. Findings Include: 1. Review of the laboratory's "Technical Consultant Responsibilities", provided for the inspection, found the following: "Ensures personnel have been appropriately trained and demonstrates competency prior to testing patient specimens." "Policy & Procedure established for monitoring personnel competencies." "Continuing education needs are identified, and training provided." 2. Review of the laboratory's Form CMS- 209, approved via signature and date by the Laboratory Director on 11/18/2022, found one individual listed and credentialed by the Laboratory Director as a TC. 3. Review of the laboratory's competency assessment documentation provided for the inspection identified the following dates and individuals who performed TP competency assessments: TP initial 6 month 12 month annual 1 8/21-LD 2/22-TP3 8/22-* n/a 2 7 /22-TP1 3 10/22-TP1 4 8/22-TP1 5 9/22-TP1 6 10/22-TP1 7 9/22-TP1 8 8/22-TP1 9 10/22-TP1 * 7/21-TP2 1/22-TP1 8/22-TP1 n/a LD; Laboratory Director n/a; not applicable *; by an individual not listed on the CMS-209 4. Review of the "Laboratory Director Responsibilities Delegation", approved by the Laboratory Director on 08/03/2022, provided for the inspection, found that the Laboratory Director delegated TC responsibilities to TP#1 who had achieved an Associates of Applied Science in Respiratory Care and does not meet the TC regulatory qualification requirements. 5. Review of the laboratory's 2021 and 2022 competency assessment records did not find that any of the nine TP had their competency assessed by the only listed and credentialed TC. The Inspector requested the 2021 and 2022 competency assessment documentation as assessed by the sole TC for TP#1, TP#2, TP#3, TP#4, TP#5, TP#6, TP#7, TP#8, and TP#9 from TP#1. TP#1 confirmed, via a telephone conversation on 12/14/2022 at 2:05 PM, that the TC did not conduct any of the 2021 and 2022 TP competency assessments and was unable to provide the requested documentation on the date of or within seven days after the onsite inspection. -- 3 of 3 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on record reviews and an interview with Testing Personnel (TP) #3, the Laboratory Director (LD) failed to attest to the routine integration of chemistry proficiency testing (PT) samples into the patient workload using the laboratory's methods for one out of one PT event in 2021. This deficient practice had the potential to affect 60 patients tested under the specialty of chemistry. Findings Include: 1. Review of the laboratory's policy and procedure signed and dated on 11/20/2017 by the previous LD, titled "Proficiency Testing", provided on the date of the inspection, found the following statement: " Procedure...9. Testing personnel and the medical director will sign the attestation sheet documenting that the samples were tested in the same manner as patient samples." 2. Review of the 2021 API chemistry core 1st event attestation statement page revealed TP#1 had signed the LD attestation. 3. The inspector requested the 2021 API chemistry core 1st event attestation statement page which contained the LD signature from TP#3. TP#3 was unable to provide the requested document and confirmed TP#1 had attested for the LD. The interview occurred 06/23/2021 at 12:15 PM. 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 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 -- 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 record reviews and interviews with Testing Personnel (TP) #1 and TP#3, the laboratory failed to successfully participate in a PT program for the non-waived pCO2, pH and pO2 testing performed under the specialty of routine chemistry. This deficient practice had the potential to affect 24 patients tested under the specialty of chemistry from 01/26/2021 to 06/23/2021. Findings Include: 1. Review of 2021 API PT documents revealed no 2nd event testing records. 2. The inspector requested the 2021 API 2nd event testing records from TP#1 and TP#3. TP#1 via a conference call confirmed the laboratory failed to submit PT for pCO2, pH and pO2 for 2021 2nd event testing which resulted in a subsequent unsuccessful analyte performance. TP#3 was unable to provide the requested documents as requested. The interviews occurred 06/23/2021 at 12:15 PM. pCO2: partial pressure carbon dioxide pH: potential of hydrogen pO2: partial pressure oxygen D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on record reviews and an interview with Testing Personnel (TP) #3, the current Laboratory Director (LD) failed to ensure policies and procedures were approved, signed and dated before use. All patients tested under the subspecialty of chemistry from 01/07/2019 to 06/23/2021 had the potential to be affected by this deficient practice. Findings Include: 1. Review of the laboratory's policy and procedures provided on the date of the inspection revealed no current LD approval signature and date. 2. The inspector requested policies and procedures approved, signed and dated by the current LD from TP#3. 3. TP#3 confirmed all policies and procedures were not approved, signed and dated by the current LD before use. The interview occurred 06 /23/2021 at 2:30 PM. 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 -- 2 of 3 -- 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 record reviews and interviews with Testing Personnel (TP) #1 and TP#3, the Laboratory Director failed to ensure 2021 API 2nd event proficiency testing (PT) activities were conducted as required under subpart H of this part. This deficient practice had the potential to affect 24 patients tested under the specialty of chemistry from 01/26/2021 to 06/23/2021. Findings Include: 1. Review of the policy and procedure titled "Proficiency Testing" found the following statement: "Procedure...2. Proficiency testing samples will be performed tri-annually as designated by the provider." 2. Review of 2021 API core chemistry PT documents revealed no 2021 API 2nd event testing records. 3. The inspector requested the 2021 API 2nd event testing records for pCO2, pH and pO2 from TP#1 via conference call, and TP#3. 4. TP#1 via a conference call confirmed the laboratory failed to submit 2021 API 2nd event testing for pCO2, pH and pO2 which resulted in a subsequent unsuccessful analyte performance. The interviews occurred 06/23/2021 at 11:30 AM. pCO2: partial pressure carbon dioxide pH: potential of hydrogen pO2: partial pressure oxygen D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) 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)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based upon record reviews and an interview with Testing Personnel (TP) #3, the Laboratory Director (LD) failed to specify the duties and responsibilities of each person listed on the Form CMS 209. This deficient practice had the potential to affect 60 patients tested under the specialty of chemistry. Findings include: 1. Review of the Form CMS 209 found two individuals listed as the Technical Consultant and 14 individuals listed as Testing Personnel. 2. Review of policies and procedures provided on the date of inspection failed to find evidence of the duties and responsibilities for the Technical Consultant and each Testing Personnel in writing by the laboratory director. 3. The inspector requested the approved, signed and dated duties and responsibilities for Technical Consultants and Testing Personnel from TP#3. TP#3 confirmed the LD failed to specify in writing the duties of all personnel listed on the Form CMS 209 and was unable to provide the requested document. The interview occurred 06/23/2021 at 10:55 AM. -- 3 of 3 --

Summary Statement of Deficiencies 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 record review and an interview with Testing Personnel (TP) #11, the Technical Consultant (TC) failed to evaluate and document the competency of 10 out of 11 TP in 2017 to current date assuring their competency was maintained in order to perform moderately complex arterial blood gas testing procedures and report the test results promptly, accurately, and proficiently. Findings Include: 1. Review of the laboratory's policies and procedures, provided on the date of the inspection, found instructions for TP competency assessments conducted by the TC. 2. Review of the laboratory's Form CMS-209, approved, signed, and dated by the Laboratory Director on 09/17/2018, revealed 11 out of 11 TP were listed and credentialed by the Laboratory Director to perform moderately complex arterial blood gas testing procedures. 3. Review of the laboratory's 2017 and 2018 competency assessment records revealed TP#11 conducted arterial blood gas competency assessments on TP#1 through TP#10, while TP#11 was assessed by the TC. 4. TP#11 confirmed the solely listed TC, also the Laboratory Director, assessed the competency of TP#11 and then designated TP#11 to conduct the competency assessments on the remaining 10 TP, however TP#11's highest level of education achieved is an Associates of Applied Science in Respiratory Care degree and therefore does not meet the minimum TC qualification requirements. The interview occurred on 09/11/2018 at 11:46 AM. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --