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Summary Statement of Deficiencies 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: Based on review of the laboratory's delegation of duties and written competency procedure, the laboratory failed to establish and follow written procedures to assess the competency of the laboratory manager. Findings: 1. The document titled "Delegation of Duties" was submitted with the second allegation of compliance (AoC) on 03/31/2023. It delegated the following duties to the "General Supervisor": Review of proficiency testing, quality control review, review of maintenance logs, review of temperature logs, competency assessments, training,

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: Based on record review and interview, the laboratory failed to successfully participate in a proficiency testing program (refer to D2107). D2107 ENDOCRINOLOGY CFR(s): 493.843(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 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 -- unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and interview with the regional manager (RM), the laboratory failed to achieve satisfactory performance for triiodothyronine (T3) in three consecutive testing events. Findings: 1. The laboratory was enrolled with College of American Pathologists (CAP) in two different PT programs that tested for T3 in three annual events (A, B, and C): 1) General Chemistry /Therapeutic Drugs (C) and 2) Ligand-General (K). 2. The laboratory received the following grades for the following CAP PT events: a. 2021 C-C, T3, 0% b. 2022 K-A, T3, 40% c. 2022 K-B, T3, 0% 3. The "Action Taken to Prevent Recurrence" section of the investigation form for the 2021 C-C event stated "TT3 = Result Not Multiplied by 100." The investigation also indicated that results from PT samples CHM-13 and CHM-15 were switched. Had the results been converted correctly, sample CHM-13 would have been within the acceptable range for sample CHM-15, but sample CHM- 15 would have been out of the acceptable range for sample CHM-13. There was no further investigation into why specimen CHM-15 was out of the acceptable range. There was no indication on the form who performed the investigation and when. There was no signature and date of approval from the laboratory director (LD) or designee to indicate that the investigation had been reviewed. 4. The original results evaluation form for the 2022 K-A PT event was released by CAP on 05/06/2022 and signed by the LD on 06/01/2022. There was no investigation on file during day 1 of the on-site recertification survey on 09/28/2022. A copy of an investigation was received via email on 11/03/2022 at 5:50 PM. The investigation was signed by the supervisor and LD on 11/03/2022. The investigation stated that three of five samples were not converted correctly, but would have been within acceptable range if they were converted correctly. Laboratory results for specimen K-03, if converted correctly, were 270 nanograms per deciliter (ng/dL). The acceptable range from CAP was 277.2-407.6 ng/dL. There was no further investigation into why specimen K-03 was out of the acceptable range. Attached to the investigation was a memo to the testing personnel (TP) dated 09/30/2022 instructing the TP to multiply the T3 instrument results by 100. 5. The original results evaluation form for the 2022 K-B PT event was released by CAP on 08/19/2022. There was no investigation on file during the on-site recertification survey on 09/28/2022. A copy of an investigation was received via email on 11/03/2022 at 5:50 PM. The investigation stated that results were not calculated correctly, but were within the acceptable range. The investigation was signed by the LD, but not dated. Attached to the investigation was a memo to the TP dated 09/30/2022 instructing the TP to multiply the T3 instrument results by 100. 6. During day 2 of the survey on 10/03/2022 at 7:45 PM, the RM confirmed that the laboratory had three consecutive failures for T3 in the CAP PT program. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Note: This is a repeat deficiency. The laboratory was cited during the complaint survey completed on 11/12/2022 for not maintaining all testing records from the -- 2 of 19 -- chemistry analyzer. The laboratory's allegation of compliance received on 12/08/2020 stated that the laboratory director or designee would conduct bi-annual audits of all laboratory records to assure that the laboratory remained compliant. Based on laboratory record review and interview with the regional manager (RM), the laboratory failed to retain all analytic systems records for at least 2 years. Findings: 1. A review of monthly temperature logs from January through August 2022 showed that temperature logs for "Refrigerator #6," "Storage Room #1," "Dry Bath Incubator," "Incubator," and "C-Diff Incubator" were missing for 2 of 8 months reviewed; and 2. The second page of the August 2022 "AU 5800 Maintenance Logsheet" which documents monthly and quarterly chemistry instrument maintenance was not present at the time of the survey. 3. During an interview on 10/03/2022 at 7:45 PM, the RM confirmed that the laboratory did not retain all analytic system records for at least 2 years. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on proficiency testing (PT) record review and interview with the regional manager (RM), the laboratory did not ensure that a copy of all PT documents was maintained by the laboratory for a minimum of two years from the date of the PT testing event. Findings: 1. A review of chemistry PT records from 2021 to 2022 showed that not all of the chemistry instrument printouts from 1 of 3 "Ligand- General" PT events (K-B 2022) were available for review at the time of the survey; and 2. The "Original Evaluation Report" which contains PT scores from the same event was not present. 3. During an interview on 10/03/2022 at 7:45 PM, the RM confirmed that the laboratory did not maintain all PT documents for a minimum of two years from the date of the PT testing event. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Note: This is a repeat deficiency. The laboratory was cited during the complaint survey completed on 11/12/2020 for not consistently documenting notification of the laboratory manager when transport coolers were out of range (OOR) and supervisory review of the check-in logs. The laboratory's allegation of compliance (AOC) received on 12/08/2020 stated that the laboratory director or designee would conduct monthly audits of the check-in logs to ensure that the supervisory staff were performing daily reviews and any errors requiring quality assurance or staff retraining were being performed. Based on review of the previous AOC, client services (CS) procedure manual, and facility check-in logs and interview with the CS staff and regional manager (RM), the laboratory failed to follow procedures for monitoring specimen transport temperatures. Findings: 1. The laboratory documented the time -- 3 of 19 -- specimens were dropped off at the laboratory and the temperature of the transport coolers each day on facility check-in logs. There were five different facility check-in log templates based on facility location. 2. The "CS Specimen In-Take" procedure stated that on "the Facility Check-In Log, the phlebotomist must record their initial's and record the drop off time for each facility that is being dropped off", that if the transport cooler temperature "is NOT within acceptable range, the staff working at the specimen in-take area must notify the laboratory manager and fill in the Specimen In- Take Problem Log", that "the Facility Check-In Logs and Specimen In-Take problem logs must be review by supervisor staff", and that the "Medical Director will review the Facility Check-In Logs and Specimen In-Take Problems logs during their monthly visit." 3. The acceptable temperature range for specimen coolers was 40-77 F and there was a section at the bottom of each check-in log for the "Supervisory Review Signature." 4. The "VA Facility Check-In" log dated 08/03/2021 showed a transport cooler carrying specimens from four facilities as received at 34.4 F. The column labeled "Acceptable Y or N" was blank. There was no documentation of the OOR cooler temperatures on the problems log. Review of one of the four facilities showed that patient results were reported. The log was signed as reviewed on 08/03/2021. 5. The "MG County Facility Check-In" log dated 08/07/2021 showed a transport cooler carrying specimens from five facilities as received at 39 F. The column labeled "Acceptable Y or N" stated "Y" (yes) when it was not acceptable. The "Supervisor Review Signature" was missing. 6. All five daily facility check-in logs from May 2022 were reviewed for a total of 24 days. Of 24 days of logs, 17 days had no signatures on any of the five logs. 7. The "Baltimore Facility Check-In" logs dated 05 /10/2022 and 05/17/2022 were missing transport cooler temperatures for six facilities and five facilities, respectively. The "Supervisor Review Signature" was missing for both logs. 8. The "PA County Facility Check-In" log dated 07/26/2022 was blank. Patient samples from one of the PA County facilities listed on the log were received, tested, and reported. The "Supervisor Review Signature" was missing on the log. 9. The "MG Facility Check-In" log dated 08/31/2022 showed that samples from three facilities were received in a transport cooler with a recorded temperature of 96.3 F. There was no documentation of the OOR specimens in the problems log. At 12:30 PM on 10/03/2022, the CS staff member stated that the temperature was erroneously entered as 96.3 F instead of 46.3 F and the laboratory manager was notified, but no response was received back. The Check-In log was signed as reviewed on 08/31/2022 with no additional notes. 10. There was no documentation that the facility check-in logs were reviewed by the medical director on a monthly basis as stated in the "CS Specimen In-Take" procedure. 11. During day 2 of the survey on 10/03/2022 at 7:45 PM, the RM confirmed that the laboratory was not consistently documenting daily supervisor review of the facility check-in logs, was not documenting

Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on record review and interview, the lab director failed to be in compliance with The Code of Maryland Regulations (COMAR) 10.10.07B(5) Medical Laboratories - Personnel. 04 Permitted Laboratory Other than a POL or POCL - Director. The lab director failed to make monthly onsite visits to the laboratory as required. Findings: 1. According to the lab manager, the lab director visits are documented on the "Director Log"; 2. The director log has monthly entries recorded until September 15, 2017, and after this date the documentation in the log has only two later entries for December 19, 2017 and May 23, 2018; 3. The entry dated for September 15, 2017 has no records for time in and time out, comments and initials. The records made for December 19, 2017 and May 23, 2018 do not include initials of the lab director, showing onsite presence; 4. When interviewed on May 22, 2018 the regional laboratory manager stated that the new policy is to have the lab director make onsite visits every six months; 5. The CLIA 116 audit record shows that on November 8, 2017 the current director was approved as lab director; 6. The lab director has not documented her initials on the "Medical Director Log' since taking over as lab director; and 7. The lab director has failed to be onsite monthly as required by COMAR. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems 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 -- activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: A. Based on review of the written procedure manual, interview with the lead technologist, and the testing person, the laboratory did not maintain all quality control (QC) printouts when performing bacteriology testing. Findings: 1. The laboratory did not maintain failed Clostridium Difficile QC results. 2. The C. Diff QC failed on March 15th, 14th, and 9th during the year 2018. 3. The review of the C. Diff QC log sheet showed that only the repeated passing QC result was documented. 4. The lead technologist stated that they were not documenting the failed QC results on the QC log sheet and he was unaware that they needed to maintain the failed QC result along the repeated and passing result. B. Based on quality control (QC) record review and interview with the hematology supervisor, the laboratory did not retain QC records for at least 2 years. Findings: 1. The hematology laboratory utilizes a monthly "QC Review Logsheet" or "Daily QC Sheet" for each of its 3 Beckman Coulter DxH hematology analyzers. The acceptability of daily QC is recorded by marking, "Y" or "N" and noting details of

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: Based on review of the federal proficiency testing data report, email from laboratory manager, and telephone conversation with the laboratory manager on February 12, 2018, the laboratory failed to successfully participate in the College of American Pathologist proficiency testing program for immunology testing, in which the laboratory is certified under CLIA. (Refer to D2084) D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(f) 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 -- 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 federal proficiency testing data report, email from laboratory manager, and telephone conversation with the laboratory manager on February 12, 2018 , the laboratory failed to successfully participate in the College of American Pathologist proficiency testing program for immunology testing, in which the laboratory is certified under CLIA. The following analyte was noted as failed in the immunology 3rd and 1st event 2017. Findings: 1. College of American Pathologist 2017 3rd event immunology RA/RF 60% 2. College of American Pathologist 2017 1st event immunology RA/RF 20% 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 review of the federal proficiency testing data report, email from laboratory manager, and telephone conversation with the laboratory manager on February 12, 2018, the laboratory director failed to ensure that the laboratory successfully participated in the College of American Pathologist proficiency testing program for immunology testing, in which the laboratory is certified under CLIA. (Refer to D2084) D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved