Dc Dfs Public Health Laboratory

Summary Statement of Deficiencies D0000 Federal Jurisdictional Survey The laboratory is not in compliance with 42 CFR part 493 with standard level deficiencies cited: D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies, manufacturer's instructions, review of laboratory's testing records, interview with Laboratory Director and interview with the processing department staff, the laboratory failed to follow their written policies for conditions for specimen transportation and acceptability for 3 of 24 specimens reviewed from January 1, 2024 to the date of the survey as evidenced by: SARS-COV- 2 Specimen 1. In review of the laboratory's policy states, "Specimens should be stored at 2 to 8 degrees C prior to testing and during transport." 2. In review of the Panther Fusion manufacturer's instructions Rev 006 states, "Specimens in the Panther Lysis Tube may be stored under one of the following conditions: 15 to 30 degrees C up to 6 days or 2 to 8 degrees C up to 3 months." 3. In review of the laboratory's testing records, the following specimen temperature condition was recorded as -22 degrees C during transportation: patient #24040090005 was received on 4/8/2024 and reported on 4/9/2024. 4. In review of the laboratory's testing records, the following specimen temperature condition was recorded as -65 degrees C during transportation: patient #24042230001 was received on 4/23/2024 and reported on 4/23/2024. Mumps Specimen 1. In review of the laboratory's policy states,"Specimens should be stored at 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 -- 2 to 8 degrees C prior to testing and transport." 2. In review of the laboratory's testing records, the following specimen temperature condition was recorded as -10 degrees C degrees during transportation: patient #2405150016 was received on 5/15/2024 and reported on 5/16/2024. 4. In interview with the processing department staff on June 5, 2024 at 1024 stated that they are not sure why the temperatures were recorded out of range. 5. In interview with the Laboratory Director on June 5,2024 at 1415 stated that she would look into the issue. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions, laboratory maintenance records (3/1 /24 - 5/31/24), test volume records, and interview with the General Supervisor (GS) - 3 (as per the Form CMS-209), the laboratory failed to follow the operator's manual for the Hologic Panther Fusion System for daily maintenance requirements and cleaning for 3 of 3 months. Findings included: Mag Wash Clean 1. The manufacturer's instructions for the Hologic Panther Fusion System (AW-20220-001 Rev. 001) listed the following maintenance requirements: "As part of system maintenance, it is required that this task be performed after each testing day. For example, if processing test orders on Monday-Friday, schedule the Mag Wash Clean task to be run after working hours on Monday-Friday." 2. A review of the laboratory's maintenance record titled, "DC Dept of Forensic Sciences Panther Fusion Maintenance Log Report" from March 1, 2024 through May 31, 2024 revealed the laboratory failed to follow manufacturer's instructions to perform daily Mag Wash Clean maintenance after testing, for the following months testing was performed on the Hologic Panther Fusion Analyzers: (Serial Number 01720) - March, April, May (Serial Number 02113) - March, April, May 3. A review of the laboratory's test volume records between January 1, 2024 and May 31, 2024 showed daily Mag Wash Clean maintenance was not performed after testing for 17 SARS-COV-2 specimens (Serial Number 01720), 37 CT/GC specimens (Serial Number 01720) and 237 SARS-COV-2 specimens (Serial Number 02113). 4. In an interview within the IVU room on 6/04/24 at 12:35pm, the General Supervisor - 3 (As per the Form CMS-209) confirmed the settings were from when the laboratory was testing SARS-COV-2 24 hours a day, and further confirmed the Mag Wash settings were not set to run after each testing day. Word Key: GC- Neisseria gonorrhea CT-Chlamydia trachomatis SARS-COV-2- Severe Acute Respiratory Syndrome Coronavirus 2 IVU-Immunology Virology Unit -- 2 of 2 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director 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 a proficiency testing desk review of the Certification and Survey Provider 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 -- Enhanced Reporting (CASPER) 0155 report and Wisconsin State Laboratory of Hygiene (WSLH) records, 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 failed to successfully participate in the subspecialty of Toxicology for the Lead analyte. Refer to D2118 and D2119. D2118 TOXICOLOGY CFR(s): 493.845(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 the CASPER 0155 report and Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing records (2022 and 2023), the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two of three consecutive testing events (2022, Event 2 and 2023, Event 1) in the subspecialty of Toxicology for the Lead analyte. Findings included: 1. Review of the CASPER 0155 report revealed the following results: WSLH Chemistry 2022 - 2nd Event. The laboratory received an unsatisfactory score of 20% for Lead. WSLH Chemistry 2023 - 1st Event. The laboratory received an unsatisfactory score of 40 % for the Lead. 2. A review of WSLH 2022 and 2023 proficiency testing records confirmed the laboratory received the above results. D2119 TOXICOLOGY CFR(s): 493.845(g) Failure to achieve an overall testing event score of satisfactory performance for 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 the CASPER 0155 report and Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing records (2022 and 2023), the laboratory failed to achieve satisfactory performance (80% or greater) for the overall subspecialty of Toxicology in two of three consecutive testing events (2022, Event 2 and 2023, Event 1). Findings included: 1. Review of the CASPER 0155 report revealed the following results: WSLH Chemistry 2022 - 2nd Event. The laboratory received an overall Toxicology unsatisfactory score of 20%. WSLH Chemistry 2023 - 1st Event. The laboratory received an overall Toxicology unsatisfactory score of 20%. 2. A review of WSLH 2022 and 2023 proficiency testing records confirmed the laboratory received the above results D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. -- 2 of 3 -- This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155 report and Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing records (2022 and 2023), the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure 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 proficiency testing desk review of the CASPER 0155 report and Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing records (2022 and 2023), 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 D2118 and D2119. -- 3 of 3 --

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to follow written procedures for an ongoing mechanism to monitor, assess, and correct problems identified in regards to an unsuccessful proficiency testing event for blood metals. 1. The laboratory's procedure "DOM08 - Procedures for Quality Preventive Action" states under 5.2 Part A: Situation/Condition: 5.2.1. Part A of a Q-PAR describes the background of the situation/ potential nonconformity. This will include all information regarding the event, parties involved (If a Situation/Condition occur within an ISO Unit, list the names of individuals involved), the frequency of occurrence, possible impacts, and any immediate actions taken to address the potential nonconformity. 5.2.2. Part A must be completed within 15 calendar days of a Q-PAR being issued Note: Examples of possible nonconformities leading to QPAR: PT score greater than or equal to 80% and less than 100% 2. The laboratory's procedure "DOM08 - Procedures for Quality Preventive Action" states 5.3. Part B: Root Cause Analysis/Action Plan: 5.3.1. In certain instances, a root cause analysis may be required in order to determine the appropriate preventive action steps. A root cause analysis is an in-depth investigation of the underlying causation factors rather than cursory symptom analysis. Root cause analysis may require a process review to include technical procedures, instrumentation utilization and maintenance, controls and standards requirements and employee performance. If a root cause analysis is needed, the selection of action steps should be made by the individual or team performing the root cause analysis whenever possible. 5.3.2. Part B must be 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 -- completed within 15 calendar days of a Q-PAR Part A being issued, whenever practicable. 3. The laboratory record "LRN-C PT Results Report" for 2022 Event 2 states the composite PT result for Blood Metals (Pb, Cd, Hg) was 80%. The record also states under review an comments: "Reviewed and discussed need to further investigate Pb results and consider Pb adjustment for network alignment. QPAR initiated." It is signed on 9/2/2022. The record also has a report created line with a date of 6/29/2022. 65 days elapsed between the laboratory receiving graded results from LRN-C and initiating the QPAR. 4. The laboratory's record QPAR 31434 states it was submitted on 9/12/2022, with an occurrence date of 9/2/2022. The laboratory's proficiency testing records show the samples were submitted to the PT program on 5 /19/2022. The laboratory's QPAR 31434 states a due date of 10/7/2022. The documentation does not have a preventative action plan, and was not completed by laboratory personnel by the date of the survey on 11/9/2022. 5. During an interview on 11/9/2022, around 5 PM the laboratory director confirmed the documentation was incomplete and did not follow the timeline in the laboratory's policies and procedures. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to ensure the reference intervals for urine toxicology drug quantification were available on 2 of 2 patient test reports. 1. During a review of patient final report records on 11/9/2022, sample ID 328157 and sample 319699 reported on 2/7/2022 both had no information under "Reference Interval" for Methadone and EDDP. 2. Laboratory personnel and laboratory director confirmed on the findings on 11/9/2022 around 11:30 AM. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Federal Jurisdictional Survey The laboratory is on compliance with 42 CFR part 493 with standard level deficiencies cited: 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, review of documentation for both the microbiology and Laboratory Response Network (LRN) sections, and interview with section supervisors, the laboratory failed to document incubation time frames and read times of microbiology plates to ensure that they were reviewed according to manufacturer's instructions of 18-24 hours as evidenced by: 1. In review of the microbiology media package inserts that the laboratory uses it states the following: BD TSA soy agar with 5% sheep blood, " Examine plates after 18-24 h for growth, colony size and hemolytic reactions." BD MacConkey agar, "Examine plates after 18- 24 h for growth, colony size, pigmentation and selectivity." BD Chocolate agar, "Examine plates after 18-24 and 48 h for growth." 2. In review of documentation for both the microbiology lab and the LRN, the laboratory did not document times when patient samples plated on BD TSA soy agar with 5% sheep blood, BD MacConkey agar, and BD Chocolate agar were started to be incubated and when they were read to determine colony growth. The following patients worksheets were reviewed: patient 20-0099, subbed on BAP, MAC, Choc, on 11/4/2020 no time of incubation, no time when culture was read to ensure 18-24 growth on 11/5/2020. patient 20-0100, subbed on BAP, MAC, Choc, on 11/4/2020 no time of incubation, no time when culture was read to ensure 18-24 growth on 11/5/2020. patient 20-0101 subbed on BAP, MAC, 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 -- Choc, on 11/4/2020 no time of incubation, no time when when culture was read to ensure 18-24 growth on 11/5/2020. patient #2009170390 subbed on BAP, MAC, Choc on 09/17/2020 no time of incubation, no time when when culture was read to ensure 18-24 growth on 9/18/2020. patient 200924098 subbed on BAP, MAC, Choc on 9/24/2020 no time of incubation, no time when when culture was read to ensure 18- 24 growth on 9/25/2020. 3. In interview with the Microbiology section supervisor on 11-9-2020 @1044 she stated that they did not have the time documented when the plates started to be incubated and the when the plates were read. 4. In interview with the LRN section supervisor on 11-10-2020 @0921 she also stated that the LRN lab doesn't document the time when plates were started and read. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on direct observation, manufacturer's instructions, and interviews, the laboratory failed to indicate the new open vial stability date and preparation date on BD Gram's iodine reagent as evidenced by: 1. In review of the manufacturer's BD Gram stains kits and Reagents instructions states, "Use the traditional Gram iodine working solution within 3 months of preparation, not exceeding the expiry of either component." 2. In direct observation on 11-19-2020@0952, the Gram's iodine did not have an new vial stability date (3 months) or a date of preparation. 3. In interview with testing person #3 (on CMS-209) on 11-19-2020@0953, she stated, "We usually open the Gram's stains as a set, I think we opened the set on 11-3-2020." 4. In a follow-up question with testing person #3 on 11-19-2020 @0954 she was asked when the iodine reagent expired when it was opened. She thought it was the open date provided by the manufacturer on the label. She was unaware of the manufacturer's 3 month new vial stability date that was indicated by the manufacturer's instructions. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory's Quality Control (QC) documentation in Laboratory Response Network (LRN) , interview with the section supervisor, the laboratory failed to document actual QC reaction results for gram stain, catalase, oxidase, indole, and other biochemical results on 11-3-2020 as evidenced by: 1. In review of the laboratory's QC BT worksheet on 11-3-2020 the laboratory did not document the actional reactions of the QC organism tested, they wrote the following: Gram stain: QC Okay Catalase : QC Okay oxidase : QC Okay indole : QC Okay urea: QC Okay motility: QC Okay 2. In interview with the LRN section supervisor, on 11-20-2020 -- 2 of 3 -- @0930 she stated that the laboratory could do better on documentation. She confirmed the finding. -- 3 of 3 --

Summary Statement of Deficiencies D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: Based on review of competency testing records and interview with staff, the laboratory director failed to ensure two of two testing personnel within the Bacteriology section had maintained their competency during calendar years 2016 and 2017 to process, perform and accurately identify microbial agents in bioterriorism. Findings include: 1. Testing records for two testing personnel (TP1;TP2) only indicated, an evaluation of Gram Stain competency was performed during calendar years 2016 and 2017 by the technical supervisor. 2. During interview with the current technical supervisor (TS1) at approximately 11:00am on 5-17-18, there was an admission to the surveyor that, besides the records of the evaluation of the Gram Stain, the section did not have records of further competency testing for microbial bioterrorism agents during 2016 and 2017. 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 --