Childhood Health Assoc Of Salem

Summary Statement of Deficiencies D5002 BACTERIOLOGY CFR(s): 493.1201 If the laboratory provides services in the subspecialty of Bacteriology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1261, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of the Laboratory's Microbiology records provided during on site survey, interviews with the Laboratory Director (LD) and testing personnel (TP), the laboratory failed to perform and document the Quality Control (QC) requirements for Microbiology testing. See D5471, D5477, D5507. D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's records, lack of documentation, and interview with the Laboratory Director (LD) and testing personnel (TP), the laboratory failed to perform and document quality checks for the reagents and media used in Microbiology patient testing. Findings include: 1.Review of the Microbiology Quality Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- Control (QC) procedure requires that reagents and disc's have daily or weekly QC. 2. The lab performs wound, urine and throat cultures, which require the use of Catalase, Oxidase, Bacitracin, Optichin and Indole tests to identify specific strains of bacteria as defined in the Laboratory's Microbiology procedure manual. These reagents and discs require QC to be performed when patient testing is performed. 3. A review of the Laboratory's QC records revealed the laboratory had not been performing QC on each day of use for the following reagents and discs: a. Catalase last QC performed 3/18 /2023 b. Oxidase last QC performed could not be located. c. Indole last QC performed 3/12/2023 d. Bacitracin last QC performed 3/12/2023 e. Optichin last QC performed 10/22/2022 4. A review of the MicroScan Identification system revealed the lack of weekly QC, as required in the Laboratory's Microbiology QC Control procedures. a. The last QC available for review for the biochemical reactions on both the Gram- negative and Gram-positive organism panels was performed on 11/27/2023. b. The last QC available for review for Gram negative and Gram positive organisms for minimal inhibitory concentration (MICs) or antimicrobial sensitivities was on 3/12 /2023. 5. The Microbiology QC procedure specifies two specific QC strains of bacteria to be run each day of patient testing when using the Christie, Atkins, Munch, Peterson test (CAMP) test. a. The Laboratory had no stock organisms on site the 2 days of survey. b. The last record of QC performed for the CAMP test was on 12/30 /2022. c. The laboratory had no documentation of purchase for the required American Type Culture Collection (ATCC) stock cultures to be used in gram-positive and gram- negative biochemical identification and MIC susceptibility QC testing. 6. Interview with TP # 1 on 3/14/2024, at 1030 am and again at 1230 pm, TP # 1 stated, "I have not performed QC on the MicroScan plates or media". 7. Interview by email, received from the Technical Supervisor (TS) on 3/22/2024 confirmed findings that the lab had not ordered, received, or maintained any QC organisms since March of 2023. 8. The laboratory reports performing 2289 cultures annually. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the laboratory's Microbiology policies and procedures and interview with testing personnel (TP # 1), the laboratory failed to ensure that all Microbiology media received the appropriate Quality Control (QC) by inspection and confirmation of growth when received. Findings include: 1. Microbiology QC procedures state that all Microbiology media and reagents will be assessed for sterility, physical condition, contamination, and any other damage, such as cracked plates upon receipt. 2. Upon request for records of media and reagents received and QC performed, the laboratory lacked documentation demonstrating the evaluation of differential media characteristics and selective media's growth and inhibitory characteristics to demonstrate the appropriate biochemical responses of certain organisms. 3. The laboratory lacked documentation of any physical assessment or lot numbers of media or reagents received, including expiration dates and QC performed. -- 2 of 10 -- 4. TP # 1 confirmed during interview on 03/18/2024, at 11:00 a.m., that he did not perform QC on the microbiological media/reagents when new media and/or reagents were received, either before or concurrent with initial use. 5. TP # 1 also confirmed by interview on 03/18/2024, at 11:00 a.m., that he does not keep a log of the media or reagents received, lot numbers, expiration dates, or QC results. 6. The lab reports doing 2289 cultures annually. D5507 BACTERIOLOGY CFR(s): 493.1261(b)(c) (b) For antimicrobial susceptibility tests, the laboratory must check each batch of media and each lot number and shipment of antimicrobial agent(s) before, or concurrent with, initial use, using approved control organisms. (b)(1) Each day tests are performed, the laboratory must use the appropriate control organism(s) to check the procedure. (b)(2) The laboratory's zone sizes or minimum inhibitory concentration for control organisms must be within established limits before reporting patient results. (c) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a review of microbiology test records, observation, and interview with testing personnel (TP#1), it was revealed that a lack of performance and documentation for Minimum Inhibitory Concentration (MIC's) quality control (QC), using the MicroScan plates for Gram-negative and Gram-positive organisms, the laboratory failed to perform QC prior to or concurrent with each day of patient testing. Findings include: 1. The laboratory's Microbiology QC procedure requires that QC be performed weekly on the MicroScan MIC plates using specific American Type Culture Collection (ATCC) strains of organisms and are to be recorded on "Form B". 2. Review of Microbiology test records involving MICs reported on patient specimens and requested MIC QC records for 2022 and 2023. the Laboratory failed to perform and document QC for MICs using the Dry MicroScan plates for Gram-negative and Gram-positive organisms after 3/12/2023. 3. By observation during a tour of the laboratory on 3/14/2924 and 3/15/2024, the Laboratory had no ATCC stock organisms on site, either on agar media plates or as lyophilized cultures. 4. The laboratory's established limits for MICs, which are required to be determined before reporting patient results, could not be determined during the survey as the last MIC QC of record was performed on 3/12/2023. 5. TP # 1 confirmed during interview on 3/18 /2024, at 11:00 a.m., the lack of performing MIC QC after 3/12/2023. 6. An interview by email received from the Technical Supervisor (TS), dated 3/22/2024, confirmed that the laboratory had not ordered or received QC organisms since March 2023. 7. The laboratory reports performing 2289 cultures annually. 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. This CONDITION is not met as evidenced by: Based on a review of Microbiology patient testing records, Quality Control (QC) -- 3 of 10 -- records, and interviews with the Laboratory Director (LD), and testing personnel (TP), the LD failed to provide adequate oversight of Microbiology patient testing performed, including competency of TP, Quality Control (QC) requirements and reporting for all phases of patient testing prior to reporting patient results. See D6079, D6087, D6092, D6094, D6100, and D6103. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(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, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If 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 review of testing personnel (TP), Technical Supervisor (TS) and General Supervisor (GS) competency records, review of Microbiology Quality Control (QC) records and interview with the Laboratory Director (LD) and TP # 1, the LD failed to ensure that all laboratory personnel were qualified and competent to perform high complexity Microbiology patient testing. Findings include: 1. Record review of the Laboratory's form CMS-209 submitted during survey 3/14/2024 identified one individual as the TS / GS for the laboratory and two testing personnel (TP) performing high complexity Microbiology patient testing. TS / GS- unable to determine start date TP # 1 Start Date - May 2022 TP # 2 Start Date - Unable to determine during survey 2. The request for and lack of documentation of competency assessments for the TS / GS revealed no competency assessments were performed for the years 2022, 2023, 2024. 3. The request for and lack of documentation revealed that TP # 1 had not had a competency assessment performed in 2023 or 2024 to date of survey. 4. A review of training records revealed that TP # 2's initial training was performed by TP # 1. Review of TP # 1's training records revealed that TP # 1 was not qualified or delegated the authority to perform training for TP#2 in the specialty of Microbiology. 5. TP # 2's 6 month competency assessment was not performed, which was due 2 /2024. 6. Further review of form CMS-209 submitted at the time of survey, revealed that a qualified GS was not available on site to provide daily supervision and oversight of TP performing Microbiology testing after March, 2023. 7. The LD confirmed by interview on 3/15/2024, at 1:00 p.m. that she had not performed a competency assessment for the TS / GS in 2022, 2023, or 2024 to date of survey. 8. The TS / GS confirmed by interview on 03/18/2024 at 11:00 a.m. via video call that the TS / GS had not performed a competency assessment on TP # 1 for 2023 to date of the survey. 9. The TS / GS confirmed by interview on 03/18/2024 at 11:00 a.m. via video call that the TS / GS had not performed any training or competency assessment for TP # 2 in 2023 to date of survey. D6087 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(iii) -- 4 of 10 -- The laboratory director must ensure that laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on review of Microbiology testing personnel (TP) competency records, Quality Control (QC) records and interview with testing personnel (TP), the Laboratory Director (LD) failed to ensure that TP were performing patient testing in accordance with CLIA regulations and the laboratory's policies and procedures. See D5471 and D6079 D6092 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iv) The laboratory director must ensure an approved

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 review of Proficiency Testing (PT) records from The College of American Pathologists (CAP) for Microbiology in the years 2020 and 2021 and discussion and interview with the Technical Supervisors (TS) for Microbiology at this facility on 12/6 /2021, the laboratory failed to ensure that the attestation forms for 2020 and 2021 (to date) were signed by the testing personnel (TP) and the Laboratory Director (LD). Findings include: 1. Upon review of the attestation forms (3 of them) for the year 2020, none of them had the requisite signature of the TP or the LD. 2. Upon review of the attestation forms (2 of them) for the year 2021, none of them had the requisiite signature of the TP or the LD. D2026 BACTERIOLOGY CFR(s): 493.823(d) (1) For any unsatisfactory testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) Remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD 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 2 -- Based on review of Microbiology Proficiency Testing (PT) records for event #3 in 2020 and discussion with two (2) Microbiology Technical Supervisors (TS), the laboratory failed to ensure