Pain Management Partners Llc

Summary Statement of Deficiencies 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. In addition, retain the following: This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to retain analytical system records for at least 2 years in the subspecialty of toxicology. Findings Include: 1. Based on record review on 01/13/2025 of the laboratory's analytical system electronic records revealed lack of retention of the following documentation for 2023 and 2024: a. Daily, weekly and monthly function checks for the Agilent Ultivo Liquid Chromatography Tandem Mass Spectrometer. b. Room temperature readings. c. Refrigerator temperature readings. d. Freezer temperature readings. e. Humidity readings. f. Quality control data. g. Calibration verification data. 2. Staff interview on 01/13/2025 at 11:45 AM with the technical supervisor (TS) confirmed the above findings. The TS further commented that he/she had lost all the electronic data after a system wide update that corrupted the above records 3. The laboratory performs 259,597 tests annually in the subspecialty of toxicology. 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. 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 -- This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to establish competency assessment policy and procedures to assess competency for the regulatory requirements for the technical supervisor (TS) and the general supervisor (GS) in the subspecialty of toxicology. Findings include: 1. Record review on 01/13/2025 of the staff training and competency files revealed lack of competency assessment documentation for the regulatory positions of TS and GS for the year 2024. 2. Staff interview on 01/13/2025 at 10:30 AM with the TS confirmed the above findings. 3. This is a repeat deficiency. 4. The laboratory performs 259,597 tests annually in the subspecialty of toxicology. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to ensure the accuracy of the liquid chromatography tandem mass spectroscopy test system for all reportable analytes twice annually in the subspecialty of toxicology. Findings Include: 1. Record review on 01/13/2025 of the laboratory's proficiency testing binder for 2023 and 2024 revealed lack of documentation of biannual accuracy assessment for the following analytes: a. Flunitrazepam b. Triazolam c. Aripiprazole d. Bupropion e. Citalopram f. Duloxetine g. Fluoxetine h. Paroxetine i. Venlafaxine 2. Staff interview on 01/15/2024 at 1:29 PM with the technical supervisor confirmed the above finding. 3. This is a repeat deficiency. 3. The laboratory performs 37,683 tests annually for the analytes listed in 1 above in the subspecialty of toxicology. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) (b)(1)(i) Establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(1)(ii) Perform and document the maintenance activities specified in paragraph b(1)(i) of this section. This STANDARD is not met as evidenced by: Based on surveyor observation and staff interview, the laboratory failed to Establish a policy and procedures for proper function of ancillary equipment for accurate and reliable test results in the subspecialty of toxicology. Findings include: 1. Surveyor observation on 01/13/2025 at 9:30 AM of the toxicology laboratory area revealed the following ancillary equipment lacking calibration for the year 2024: a. Eppendorf Research Plus 1 Channel (100-1000 ?L), serial number: I49461K, expiration date: 05 /31/2024. b. Eppendorf Research Plus 1 Channel (10-100 ?L), serial number: K47206K, expiration date: 05/31/2024. c. Eppendorf Research Plus 1 Channel (20- 200 ?L), serial number: H53618K, expiration date: 05/31/2024. d. Multi-Channel Pipette (1-10 ?L), serial number: B53810143, expiration date: 05/31/2024. e. Multi- Channel Pipette (20-200?L), serial number: B5380303, expiration date: 05/31/2024. f. VWR excursion-trac thermometer, serial number: 911833, expiration date of 11/28 /2024. 2. Staff interview on 01/13/2025 at 9:45 AM with the technical supervisor (TS) -- 2 of 4 -- confirmed the above findings. The TS further commented that he/she was planning on sending them out to be calibrated but they are the only set available to utilize. 3. This is a repeat deficiency. 4. The laboratory performs 259,597 tests annually in the subspecialty of toxicology. D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (1) 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. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to verify the performance of each lot number and shipment of calibrators, controls, and internal standards prior to patient testing in the subspecialty of toxicology. Findings include: 1. Record review on 01/13/2025 of the laboratory's liquid chromatography tandem mass spectrometry multi-analyte confirmatory panel laboratory binders revealed lack of documentation of lot-to-lot verification for calibrators, controls, and internal standards. 2. Staff interview on 01/13/2025 at 12:10 PM with the technical supervisor (TS) confirmed the above findings. 3. This is a repeat deficiency. 4. The laboratory performs 259,597 tests annually in the subspecialty of toxicology. D5781

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 record review and staff interview, the laboratory failed to establish competency assessment policy and procedures to assess competency for the regulatory requirements for the technical supervisor (TS), the general supervisor (GS) and the clinical consultant (CC) in the subspecialty of toxicology. Findings include: 1. Record review on 04/25/2023 of the staff training and competency files revealed lack of competency assessment documentation for the regulatory positions of TS, GS, and CC for the years of 2021 and 2022. 2. Staff interview on 04/25/2023 at 9:30 AM with the TS confirmed the above findings. The TS further commented that he/she was unaware that a competency assessment is a regulatory requirement for TS, GS, and CC. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to ensure the accuracy of the LC/MS/MS test system for all reportable analytes twice annually in the subspecialty of toxicology. Findings Include: 1. Record review on 04/25/2023 of the 2022 proficiency testing binder revealed the following: a. Enrollment in College 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 -- of American Pathologists (CAP) drug monitoring for pain management. b. The above survey results versus the laboratory test menu revealed lack of documentation for the following analytes: amitriptyline, aripiprazole, bupropion, carisoprodol, citalopram, dextromethorphan, diazepam, dihydrocodeine, duloxetine, EDDP, flunitrazepam, fluoxetine, ketamine, MDPV, methylphenidate, mitragynine, N,N- dimethyltryptamine, naloxone, normeperidine, nortriptyline, paroxetine, PCP, phentermine, tapentadol, temazepam, triazolam, venlafaxine, and zolpidem. c. Lack of documentation of biannual accuracy assessment for the analytes in 1B above. 2. Staff interview on 04/25/2023 at 12:45 PM with the technical supervisor (TS) confirmed the above findings. 3. The laboratory performs 22,452 tests annually for the analytes listed in 1B above in the subspecialty of toxicology. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on surveyor observation, record review and staff interview, the laboratory failed to establish policy and procedures for proper function of ancillary equipment for accurate and reliable test results in the subspecialty of toxicology. Findings include: 1. Surveyor observation on 04/25/2023 at 11:30 AM of the toxicology laboratory area revealed a centrifuge and multiple pipettes, both lacking calibration dates for 2022. 2. Record review on 04/25/2023 of the pipette calibration revealed last calibration was performed in 2021 for the following pipettes: a. Eppendorf Research Plus 1 Channel (100-1000 L), serial number: I49461K b. Eppendorf Research Plus 1 Channel (10-100 L), serial number: K47206K c. Eppendorf Research Plus 1 Channel (20-200 L), serial number: H53618K d. Multi-Channel Pipette (1-10 L), serial number: B53810143 e. Multi-Channel Pipette (1-10 L), serial number: B5380303 3. Record review on 04/25/2023 of the MPC-P25 mini-plate centrifuge performance test statement revealed last calibration was performed on 08/17/2020. 4. Staff interview on 04/25/2023 at 11:46 AM with the technical supervisor (TS) confirmed the above findings. The TS further commented that he/she began the process of sending the pipettes out for calibration. 5. The laboratory performs 139,638 tests annually in the subspecialty of toxicology. 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. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to verify the performance of each lot number and shipment of calibrators, controls, and internal standards prior to patient testing in the subspecialty of toxicology. Findings include: 1. Record review on 04/25/2023 of the LC/MS/MS multi-analyte confirmatory panel laboratory binders revealed lack of documentation of lot-to-lot verification for calibrators, controls, and internal standards. 2. Staff interview on 04/25/2023 at 12:20 PM with the technical supervisor (TS) confirmed the above findings. The TS further commented that he/she was unaware of this requirement. 3. The laboratory performs 139,638 tests annually in the subspecialty of toxicology. -- 3 of 3 --