Pediatric Associates Pc

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records from 2023 and 2024 and interview with the facility personnel, the laboratory failed to test PT samples by testing personnel who routinely perform patient testing in the laboratory, using the laboratory's routine methods. Findings include: 1. The laboratory participates in 3 PT events annually for testing performed under the specialty of Microbiology. 2. The CMS-209, Laboratory Personnel Form presented during the survey conducted on 2/19 /25 listed five testing personnel who routinely perform patient testing. 3. Interview with testing personnel during the survey confirmed that the PT samples were not rotated among the 5 testing personnel in the laboratory and that the same testing personnel: initials "DL" performed PT testing for every PT event from 2023-2024. 4. The facility personnel interviewed on 2/19/25 at 11:00 AM confirmed that the same individual participated in each testing event as indicated above. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- Based on review of proficiency testing (PT) records from 2023 and 2024 and interview with facility personnel, the laboratory director and testing personnel failed to sign the PT attestation statements. Findings include: 1. The laboratory performs testing in the speciality of Microbiology with an annual test volume of 900. 2. The PT attestation statements presented for review for the first, second and third events of 2023 and 2024 lacked the signatures of the laboratory director and testing personnel. 3. The facility personnel interviewed on 2/19/25 at 11:00 AM confirmed that the PT attestation statements indicated above were not signed by the laboratory director and testing personnel. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of Proficiency Testing (PT) records from 2023 through 2024 and interview with the facility personnel, the laboratory failed to provide a documented review of PT results from the 1st, 2nd, and 3rd testing events of 2023 and 2024. Findings include: 1. The laboratory performs patient testing under the specialty of Microbiology. The laboratory performs 900 tests annually. 2. No evidence, either by written comment or signature, was presented during the survey conducted on 2/19/25 to indicate the laboratory director or other laboratory personnel reviewed the PT results for the 1st, 2nd, or 3rd testing events of 2023. 3. No evidence, either by written comment or signature, was presented during the survey conducted on 2/19/25 to indicate the laboratory director or other laboratory personnel reviewed the PT results for the 1st, 2nd, or 3rd testing events of 2024. 4. The facility personnel interviewed on 2/19/25 at 11:00 AM confirmed the PT results indicated above were not reviewed by laboratory personnel. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (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 review of the laboratory's policy and procedure manual and interview with the facility personnel, the laboratory failed to have the current laboratory director approve, sign and date test procedures before use. Findings include: 1. The current laboratory director indicated in the CLIA Federal Database and assigned on the CMS- 209, Laboratory Personnel Form presented for review during the survey has been serving as laboratory director since 5/5/2023. 2. The policy and procedure manual presented for review during the survey conducted on 2/19/25 was not approved, signed and dated by the current laboratory director. 3. The facility personnel interviewed on 2/19/25 at 12:20 PM confirmed that the policy and procedure manual indicated above was not approved, signed and dated by the current laboratory director. 4. The laboratory performs patient testing under the specialty of Microbiology with an annual test volume of 900. -- 2 of 4 -- D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) (e)(11) Ensure that prior to testing patients specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results; This STANDARD is not met as evidenced by: Based on lack of initial training documentation for one out of one testing personnel (TP-5) and interview with the facility personnel, the laboratory director failed to ensure that prior to testing patients' specimens, all personnel have the appropriate training for the type and complexity of services offered. Findings include: 1. No initial training documentation was presented for review for one out of one testing personnel (TP-5). 2. The facility personnel interviewed on 2/19/25 at 10:30 AM confirmed the laboratory failed to provide documentation of initial training for TP-5 as indicated above. 3. The laboratory performs 900 patient tests annually under the specialty of Microbiology. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) 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 lack of performance evaluation documentation from 2024 and interview with the facility personnel, the technical consultant failed to evaluate and document the performance of one out of one testing personnel, at least semiannually during the first year the individuals tested patient specimens. Findings include: 1. No semiannual competency evaluation documentation was presented for review for one out of one testing personnel (TP-5) who began patient testing in January 2024. 2. The facility personnel interviewed on 2/19/25 at 10:30 AM confirmed the technical consultant failed to perform and document a semiannual competency evaluation for the testing personnel indicated above. 3. The laboratory performs 900 tests annually under the specialty of Microbiology D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually This STANDARD is not met as evidenced by: Based on lack of competency evaluation documentation for review from 2023 and 2024 and interview with the facility personnel, the technical consultant failed to evaluate and document the performance of individual responsible for moderate complexity testing at least annually. Findings include: 1. No annual competency evaluation documentation from 2023 and 2024 was presented for review for four out of five testing personnel who perform testing under the specialty of Microbiology. 2. -- 3 of 4 -- The facility personnel interviewed on 2/19/25 at 10:30 AM confirmed the technical consultant failed to evaluate and document the performance of the above personnel at least annually during 2023 and 2024.. -- 4 of 4 --

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 Proficiency Testing (PT) reports from 2021 sent to the State Agency by the PT provider and interview with the facility personnel, the laboratory failed to successfully participate in a PT program for the regulated analyte, Urine Identification, for testing performed under the sub-specialty of Bacteriology. Findings include: 1. The laboratory's PT performance was unsatisfactory for the first event of 2021 for the regulated analyte, Urine Identification, with a score of 60%. 2. The laboratory's PT performance was unsatisfactory for the third event of 2021 for the regulated analyte, Urine Identification, with a score of 60%. 3. The facility personnel interviewed on March 7, 2023 at 10:05am confirmed the laboratory failed to Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- successfully participate in PT for Urine Identification testing during 2021, as evidenced by the unsatisfactory PT scores listed above. D2028 BACTERIOLOGY CFR(s): 493.823(e) 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 information the Proficiency Testing (PT) provider furnished to the State Agency, the laboratory failed to achieve satisfactory performance for the regulated analyte, Urine Identification, for two out of three testing events (1st event of 2021 and 3rd event of 2021) resulting in unsuccessful PT performance. See D2016 for findings. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on lack of Quality Control (QC) documentation and interview with the facility personnel, the laboratory failed to perform and document control procedures using the number and frequency as required for testing performed in the specialty of Microbiology. Findings include: 1. The laboratory performs Urine Culture (growth/no growth) testing on patient specimens using the media, Blood Agar/MacConkey Bi- Plate. In addition, the laboratory performs DTM (Dermatophyte Test Media) testing on patient specimens. The laboratory's approximate annual test volume for Urine Culture and DTM testing is 858. 2. On the date of the survey, March 7, 2023, the laboratory's established QC procedure for Urine Culture testing includes testing a known positive (E. Coli) and a known negative (E. faecalis) on each new lot and/or shipment of media prior to using the media for patient testing. 3. Review of urine culture test results for patient ID# 7794 from testing performed on 5-02-2022 indicated the lot number of the media used was j32-5011722 (exp. 5/12/22). 4. No documentation was presented for review during the survey to indicate the laboratory performed QC as required on lot# j32-5011722, prior to testing patient specimens. 5. On the date of the survey, March 7, 2023, the laboratory's established QC procedure for DTM testing includes testing a known positive (C. albicans) and a known negative (P. aeruginosa) on each new lot and/or shipment of media prior to using the media for patient testing. 6. Review of DTM test results for patient ID# C.S. from testing performed on 4-28-2022 indicated the lot number of the DTM media used was x15- 498296 (exp. 6/05/22). 7. No documentation was presented for review during the survey to indicate the laboratory performed QC as required on lot# x15-498296, prior -- 2 of 5 -- to testing patient specimens. 8. No evidence was presented for review during the survey to indicate the laboratory maintains documentation of QC lot information for each lot/shipment of control materials used for Urine culture media and DTM media including, but not limited to, the control name, lot number, expiration date and date in use. 9. The facility personnel interviewed on March 7, 2023 at 11:25am confirmed the laboratory failed to perform and document external controls on each lot of media referenced above prior to testing patient specimens and confirmed the laboratory failed to maintain documentation of each lot of Urine culture and DTM control material used. 10. The number of patient tests performed using the media lot numbers indicated above could not be determined at the time of the survey. 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 review of Quality Control (QC) documentation for Microbiology plated media and interview with the facility personnel, the laboratory failed to check each batch of media for sterility. Findings include: 1. The laboratory performs Urine culture and DTM testing under the specialty of Microbiology, with an approximate annual test volume of 858. 2. It is the practice of the laboratory to perform a sterility check on each lot and/or shipment of media used for Urine culture and DTM testing. 3. No documentation was presented for review during the survey conducted on March 7, 2023 to indicate the laboratory performed and documented sterility checks on each of the following media lots used for patient testing: Urine culture media (lot# j32- 5011722, exp. 5/12/22) and DTM media (lot# x15-498296, exp. 6/25/22). 4. The facility personnel interviewed on March 7, 2023 at 11:30am confirmed the laboratory failed to perform sterility checks on each lot of media referenced above. 5. The number of patient tests performed using the media from the lot numbers indicated above could not be determined at the time of the survey. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on review of Quality Assessment (QA) policies and procedures, analytic test records and interview with the facility personnel, the laboratory failed to follow established QA policies and procedures to monitor, assess and, when indicated, correct problems identified in the analytic systems. Findings include: 1. The -- 3 of 5 -- laboratory's established QA policy titled 'Quality Assurance Plan' states, "The laboratory director will review all quality control charts and logs on a monthly basis. All controls exceeding the acceptable limits and not resolved by repeat testing will be reviewed by the laboratory director as soon as practical after the event.

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on review of patient test results and interview with the facility personnel, the laboratory used DTM culture media for patient testing when it had exceeded the expiration date. Findings include: 1. The laboratory performs DTM testing in the sub- specialty of Mycology, with an approximate annual test volume of 19. 2. Review of patient test results and test records in the electronic medical record (EMR) indicated a DTM culture was ordered/performed for patient ID #7523, with the final results entered on 03/05/2020. Documentation in the patient's EMR revealed the DTM media used by the laboratory on this patient was lot #445785, expiration date of 02/24/2020. 3. The facility personnel confirmed that the DTM media used to perform testing on the patient indicated above had exceeded its expiration date at the time of the final test result entry. 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 --

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of Proficiency Testing (PT) records for 2017 and 2018 and interview with the facility personnel, the laboratory failed to provide a documented review of the PT results for testing events in the specialty of Bacteriology and Mycology. Findings include: 1. No documentation of a review, either by written comment or signature, was presented during the survey to indicate the laboratory director or designee reviewed the PT results for all three events in 2017 and the first event of 2018. 2. There must be evidence of PT results reviewed even if the laboratory received 100% 3. The facility personnel confirmed that the PT results indicated above were not reviewed by laboratory director or designee. 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 review of the laboratory manual presented during the survey and interview with the facility personnel, the laboratory failed to have a procedure manual that was approved, signed, and dated by the current laboratory director. Findings include: 1. The laboratory's procedure manual presented for review during the survey failed to include the approval, signature and date of the laboratory director. 2. 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 -- manual (revised May 3, 2016) had a cover sheet with a section for the laboratory director to sign and date, but there was no signature and date. The revision date of the manual was the same day as the previous survey date of May 3, 2016. 2. The facility personnel acknowledged that the procedure manual was not signed and dated by the laboratory director at the time of the survey. 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 review of (A) plate media sterility checks done by the laboratory for urine cultures, (B) DTM media for positive and negative reactivity, (C) lack of packing slips to review for comment on media inspection and interview with the facility personnel, the laboratory failed to include lot numbers for sterility checks, failed to indicate that quality control (QC) was performed for specific lot numbers and failed to present all of the media packing slips with comments regarding media acceptability. Findings include: A 1. There was no evidence of lot numbers and expiration dates for the plate media sterility checks performed on 05/04/18 for patient ID #42126 with a date of service 05/18/18. B 1. QC lot numbers were missing in the patients' medical records sporadically for both DTM and urine culture media. Media QC records could not be consistently matched to each patient tested including Patient ID #44461 with a date of service of 11/30/2017 for a urine culture and patient #11160 with a date of service on 02/05/18 for a DTM culture. C 1. Some media packing lists were not presented for review to indicate that the media received from the supplier was checked by the laboratory before use and the specific lot was checked for sterility and quality control. The laboratory personnel acknowledged that certain information was missing and/or not documented including the items reference above. D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) 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)(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; This STANDARD is not met as evidenced by: Based on lack of signature and date of the laboratory director on the signature page of the procedure manual, the director failed to ensure an approved procedure manual was available for personnel (See D5407 for findings) -- 2 of 3 -- 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 lack of documentation presented for review and interview with the facility personnel, the technical consultant failed to have annual competency assessment of 7 out of 7 testing personnel that perform DTM testing and Urine culture testing for growth/no growth. Findings include: 1. The procedure manual contains an assessment list for DTM and Urine Cultures that is titled "non-waived competency annual testing". No completed documents of competency was presented for any of the testing personnel. The document was revised on 05/03/2016. 2. Each testing personnel has a sheet indicating if competency assessment was performed. The last assessment date indicated was in 2014. 3. The facility personnel acknowledged that there were no completed documents for review. -- 3 of 3 --